49
Slide 1 Thursday, December 3, 2015 11:00 a.m. Eastern Dial In: 888.863.0985 Conference ID: 62201128 Thursday, December 3, 2015 11:00 a.m. Eastern Dial In: 888.863.0985 Conference ID: 62201128

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Slide 1

Thursday December 3 2015

1100 am EasternDial In 8888630985

Conference ID 62201128

Thursday December 3 2015

1100 am EasternDial In 8888630985

Conference ID 62201128

Slide 2Slide 2

Speakers

Alexander Friedman MD MPH FACOG Columbia University Medical Center New York NY

Douglas Montgomery MD FACOGSouthern California Permanente Medical GroupRiverside Medical Center Riverside CaliforniaDirector Maternal Fetal Medicine Chair Southern California Kaiser Obstetric VTE committeeCo- Chair California Maternal Quality Care Collaborative VTE Task Force

Slide 3

Disclosures

Alexander Friedman MD MPH FACOG has no real or perceived conflicts of interest to disclose

Douglas Montgomery MD FACOG has no real or perceived conflicts of interest to disclose

Slide 4

Objectives

Provide an in-depth overview of the Maternal Venous Thromboembolism Prevention Patient Safety Bundle

Take a look at the processes methods and tools that were used to develop the bundle

Give suggestions for how to effectively implement and utilize the bundle within your organization

Identify resources to customize the bundle for use within your organization

Slide 5

National Partnership for Maternal SafetyFocus on decreasing Maternal Mortality amp Morbidity

Three core bundles focus on leading causes of maternal mortality and morbidity that are amenable to prevention Bundles are sets of critical clinical practices when performed systematically have been validated to improve outcomes Safety Bundles are not meant to introduce new guidelines but rather organize existing materials in ways that facilitate systematic implementation in every maternity unit in the United States

Venous Thromboembolism Severe Hypertension in pregnancy

Obstetric Hemorrhage

DAlton ME et al The national partnership for maternal safety Obstet Gynecol 2014123973

Institute for Healthcare Improvement Evidence-Based Care Bundles Ihiorg

Slide 6

VTE WORKING GROUPComprised of the following individuals with representation from obstetrics nursing midwifery and anesthesia

bull STEVEN CLARK MD

bull MARY DrsquoALTON MD

bull ROBYN DrsquoORIA MA RNC APC

bull ALEXANDER FRIEDMAN MD

bull JENNIFER FROST MD MPH

bull AFSHAN HAMEED MD

bull DEBORAH KARSNITZ DNP CNM

bull DOUGLAS MONTGOMERY MD

bull MICHAEL PAIDAS MD

bull RICHARD SMILEY MD

Slide 7

Pregnancy Related MortalityUnited States (1987-2010)

Creanga AA et al Pregnancy-related mortality in the United States 2006-2010 Obstet Gynecol (2015 Jan)125(1)5-12 doi 101097AOG0000000000000564

Slide 8

New York City 2006-2010Pregnancy-Associated Mortality

NYC Department of Health and Hygiene Bureau of Maternal Infant and Reproductive Health (2015) Report of the Pregnancy-Associated Mortality Review Project

Slide 9

Morbidity

Long-term sequelae include

bull Recurrent VTEbull Post-thrombotic syndrome May develop in up to 50 of patients

who experience DVT Chronic leg pain edema erythema

and ulcerationsbull Lung damagebull Cardiovascular

Vasquez SR et al Cardiology Patient Page Postthrombotic Syndrome Circulation (2010) 121217-219

Slide 10

Venous Thromboembolism (VTE) Prophylaxisldquosingle cause of death most amenable to reduction by systematic change in practicerdquo ndash Steven Clark MD SeminPerinatol 201236(1)42-7

Saving Mothersrsquo Lives 2006-2008 National Launch March 2011 Professor Gwyneth Lewis OBE FRCOG FACOG

Direct Deaths per Million

Maternities by Cause UK 1994-2008

Slide 11

VTE ProphylaxisThe Agency for Healthcare Research and Quality defined VTE as the ldquonumber one patient safety practicerdquo for hospitalized

patients

Safe practices published by the National Quality Forum (NQF) recommend

bull Routine evaluation of hospitalized patients for risk of VTEbull Use of appropriate prophylaxis

ENDORSE Survey

bull Evaluated prophylaxis rates in 17084 major surgery patients

bull More than one third of patients at risk for VTE (38) did not receive prophylaxis

bull Rates varied by surgery type

Shojania KG Duncan BW McDonald DM et al (Eds) (2001) Making healthcare safer A critical analysis of patient safety practices (Evidence ReportTechnology Assessment No 43) Prepared by the University of California at San Francisco-Stanford Evidenced-based Practice Center under Contract no 290-97-0013 (AHRQ Publication NO01-E058) Rockville MD Agency for Healthcare Research and Quality

National Quality Forum National Voluntary Consensus Standards for Prevention and Care of Venous Thromboembolism (2006)

Cohen AT Tapson VF Bergmann JF et al Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study) a multinational cross-sectional study The Lancet 2008 371 387-394

Slide 12

Prophylaxis in Vaginal Delivery Hospitalizations

No Prophylaxis Any Prophylaxis

Characteristic n n

All Patients 2605151 974 68835 26

Year of Delivery

2006 366317 984 5950 16

2007 374851 983 6662 18

2008 352438 978 7825 22

2009 354460 973 9884 27

2010 367470 969 11675 31

2011 402359 971 11911 29

2012 390881 972 11303 28

Friedman A et al Thromboembolism incidence and prophylaxis during vaginal delivery hospitalizations Am J Obstet Gynecol 2015 Feb 212(2) 221e1-12

Slide 13

Underuse of Post-cesarean Thromboembolic Prophylaxis

Characteristic None Mechanical Pharmacologic Combination

955787 (757) 278669 (221) 16639 (13) 12110 (10)

Year of Surgery

2003 115663 (916) 8717 (69) 1274 (10) 664 (05)

2004 124230 (874) 15674 (110) 1319 (09) 923 (07)

2005 131220 (846) 21013 (135) 1889 (12) 1051 (07)

2006 154876 (810) 32302 (169) 2413 (13) 1608 (08)

2007 145589 (747) 44842 (230) 2451 (13) 2053 (11)

2008 131250 (660) 62545 (314) 2852 (14) 2294 (12)

2009 125096 (605) 75315 (364) 3609 (18) 2753 (13)

2010 27863 (584) 18261 (383) 832 (17) 764 (16)

Friedman AM Ananth CV et al (2013) Underuse of post cesarean thromboembolic prphylaxis Am J Obstet and Gynecol 122(6)1197-204

Slide 14

Underuse of Post-cesarean Thromboembolic Prophylaxis

Lack of Protocol Adherence

bull Systematic review of over 2500 surgical patients demonstrated up to one fourth are noncompliant with post operative mechanical thromboprophylaxis

bull Observational study demonstrated noncompliance with post-cesarean mechanical thromboprophylaxis in 21 of 293 patients

bull Lack of adherence persist despite education amp audits

Craigie Samantha et al Adherence to mechanical thromboprophylaxis after surgery A systematic review and meta-analysis Thrombosis Research (2015) 136 (4) 723 ndash 72

Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Brady et al Sequential Compression Device Compliance in Postoperative Obstetrics and Gynecology Patients Obstet amp Gynecol (2015 Jan) 125 (1) 19

Slide 15

Maternal Venous Thromboembolism Prevention Safety Bundle

bull Use a standardized thromboembolism risk assessment tool for VTE during

bull Outpatient prenatal care

bull Antepartum hospitalization

bull Hospitalization after cesarean or vaginal deliveries

bull Postpartum period (up to 6 weeks after delivery)

RECOGNITION (Every Patient)bull Apply standardized tool to all patient to asses VTE risk at time point designated under

ldquoReadinessrdquo

bull Apply standardized tool to identify patients for thromboprophylaxis

bull Provide patient education

bull Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis

RESPONSE (Every Unit)bull Use standardized recommendations for mechanical thromboprophylaxis

bull Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation

bull Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia

REPORTINGSYSTEMS LEARNING (Every Unit)bull Review all thromboembolism events for systems issues and compliance with protocols

bull Monitor process metrics and outcomes in a standardized fashion

bull Assess for complications of pharmacologic thromboprophylaxis

READINESS (Every Unit)

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 2Slide 2

Speakers

Alexander Friedman MD MPH FACOG Columbia University Medical Center New York NY

Douglas Montgomery MD FACOGSouthern California Permanente Medical GroupRiverside Medical Center Riverside CaliforniaDirector Maternal Fetal Medicine Chair Southern California Kaiser Obstetric VTE committeeCo- Chair California Maternal Quality Care Collaborative VTE Task Force

Slide 3

Disclosures

Alexander Friedman MD MPH FACOG has no real or perceived conflicts of interest to disclose

Douglas Montgomery MD FACOG has no real or perceived conflicts of interest to disclose

Slide 4

Objectives

Provide an in-depth overview of the Maternal Venous Thromboembolism Prevention Patient Safety Bundle

Take a look at the processes methods and tools that were used to develop the bundle

Give suggestions for how to effectively implement and utilize the bundle within your organization

Identify resources to customize the bundle for use within your organization

Slide 5

National Partnership for Maternal SafetyFocus on decreasing Maternal Mortality amp Morbidity

Three core bundles focus on leading causes of maternal mortality and morbidity that are amenable to prevention Bundles are sets of critical clinical practices when performed systematically have been validated to improve outcomes Safety Bundles are not meant to introduce new guidelines but rather organize existing materials in ways that facilitate systematic implementation in every maternity unit in the United States

Venous Thromboembolism Severe Hypertension in pregnancy

Obstetric Hemorrhage

DAlton ME et al The national partnership for maternal safety Obstet Gynecol 2014123973

Institute for Healthcare Improvement Evidence-Based Care Bundles Ihiorg

Slide 6

VTE WORKING GROUPComprised of the following individuals with representation from obstetrics nursing midwifery and anesthesia

bull STEVEN CLARK MD

bull MARY DrsquoALTON MD

bull ROBYN DrsquoORIA MA RNC APC

bull ALEXANDER FRIEDMAN MD

bull JENNIFER FROST MD MPH

bull AFSHAN HAMEED MD

bull DEBORAH KARSNITZ DNP CNM

bull DOUGLAS MONTGOMERY MD

bull MICHAEL PAIDAS MD

bull RICHARD SMILEY MD

Slide 7

Pregnancy Related MortalityUnited States (1987-2010)

Creanga AA et al Pregnancy-related mortality in the United States 2006-2010 Obstet Gynecol (2015 Jan)125(1)5-12 doi 101097AOG0000000000000564

Slide 8

New York City 2006-2010Pregnancy-Associated Mortality

NYC Department of Health and Hygiene Bureau of Maternal Infant and Reproductive Health (2015) Report of the Pregnancy-Associated Mortality Review Project

Slide 9

Morbidity

Long-term sequelae include

bull Recurrent VTEbull Post-thrombotic syndrome May develop in up to 50 of patients

who experience DVT Chronic leg pain edema erythema

and ulcerationsbull Lung damagebull Cardiovascular

Vasquez SR et al Cardiology Patient Page Postthrombotic Syndrome Circulation (2010) 121217-219

Slide 10

Venous Thromboembolism (VTE) Prophylaxisldquosingle cause of death most amenable to reduction by systematic change in practicerdquo ndash Steven Clark MD SeminPerinatol 201236(1)42-7

Saving Mothersrsquo Lives 2006-2008 National Launch March 2011 Professor Gwyneth Lewis OBE FRCOG FACOG

Direct Deaths per Million

Maternities by Cause UK 1994-2008

Slide 11

VTE ProphylaxisThe Agency for Healthcare Research and Quality defined VTE as the ldquonumber one patient safety practicerdquo for hospitalized

patients

Safe practices published by the National Quality Forum (NQF) recommend

bull Routine evaluation of hospitalized patients for risk of VTEbull Use of appropriate prophylaxis

ENDORSE Survey

bull Evaluated prophylaxis rates in 17084 major surgery patients

bull More than one third of patients at risk for VTE (38) did not receive prophylaxis

bull Rates varied by surgery type

Shojania KG Duncan BW McDonald DM et al (Eds) (2001) Making healthcare safer A critical analysis of patient safety practices (Evidence ReportTechnology Assessment No 43) Prepared by the University of California at San Francisco-Stanford Evidenced-based Practice Center under Contract no 290-97-0013 (AHRQ Publication NO01-E058) Rockville MD Agency for Healthcare Research and Quality

National Quality Forum National Voluntary Consensus Standards for Prevention and Care of Venous Thromboembolism (2006)

Cohen AT Tapson VF Bergmann JF et al Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study) a multinational cross-sectional study The Lancet 2008 371 387-394

Slide 12

Prophylaxis in Vaginal Delivery Hospitalizations

No Prophylaxis Any Prophylaxis

Characteristic n n

All Patients 2605151 974 68835 26

Year of Delivery

2006 366317 984 5950 16

2007 374851 983 6662 18

2008 352438 978 7825 22

2009 354460 973 9884 27

2010 367470 969 11675 31

2011 402359 971 11911 29

2012 390881 972 11303 28

Friedman A et al Thromboembolism incidence and prophylaxis during vaginal delivery hospitalizations Am J Obstet Gynecol 2015 Feb 212(2) 221e1-12

Slide 13

Underuse of Post-cesarean Thromboembolic Prophylaxis

Characteristic None Mechanical Pharmacologic Combination

955787 (757) 278669 (221) 16639 (13) 12110 (10)

Year of Surgery

2003 115663 (916) 8717 (69) 1274 (10) 664 (05)

2004 124230 (874) 15674 (110) 1319 (09) 923 (07)

2005 131220 (846) 21013 (135) 1889 (12) 1051 (07)

2006 154876 (810) 32302 (169) 2413 (13) 1608 (08)

2007 145589 (747) 44842 (230) 2451 (13) 2053 (11)

2008 131250 (660) 62545 (314) 2852 (14) 2294 (12)

2009 125096 (605) 75315 (364) 3609 (18) 2753 (13)

2010 27863 (584) 18261 (383) 832 (17) 764 (16)

Friedman AM Ananth CV et al (2013) Underuse of post cesarean thromboembolic prphylaxis Am J Obstet and Gynecol 122(6)1197-204

Slide 14

Underuse of Post-cesarean Thromboembolic Prophylaxis

Lack of Protocol Adherence

bull Systematic review of over 2500 surgical patients demonstrated up to one fourth are noncompliant with post operative mechanical thromboprophylaxis

bull Observational study demonstrated noncompliance with post-cesarean mechanical thromboprophylaxis in 21 of 293 patients

bull Lack of adherence persist despite education amp audits

Craigie Samantha et al Adherence to mechanical thromboprophylaxis after surgery A systematic review and meta-analysis Thrombosis Research (2015) 136 (4) 723 ndash 72

Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Brady et al Sequential Compression Device Compliance in Postoperative Obstetrics and Gynecology Patients Obstet amp Gynecol (2015 Jan) 125 (1) 19

Slide 15

Maternal Venous Thromboembolism Prevention Safety Bundle

bull Use a standardized thromboembolism risk assessment tool for VTE during

bull Outpatient prenatal care

bull Antepartum hospitalization

bull Hospitalization after cesarean or vaginal deliveries

bull Postpartum period (up to 6 weeks after delivery)

RECOGNITION (Every Patient)bull Apply standardized tool to all patient to asses VTE risk at time point designated under

ldquoReadinessrdquo

bull Apply standardized tool to identify patients for thromboprophylaxis

bull Provide patient education

bull Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis

RESPONSE (Every Unit)bull Use standardized recommendations for mechanical thromboprophylaxis

bull Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation

bull Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia

REPORTINGSYSTEMS LEARNING (Every Unit)bull Review all thromboembolism events for systems issues and compliance with protocols

bull Monitor process metrics and outcomes in a standardized fashion

bull Assess for complications of pharmacologic thromboprophylaxis

READINESS (Every Unit)

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 3

Disclosures

Alexander Friedman MD MPH FACOG has no real or perceived conflicts of interest to disclose

Douglas Montgomery MD FACOG has no real or perceived conflicts of interest to disclose

Slide 4

Objectives

Provide an in-depth overview of the Maternal Venous Thromboembolism Prevention Patient Safety Bundle

Take a look at the processes methods and tools that were used to develop the bundle

Give suggestions for how to effectively implement and utilize the bundle within your organization

Identify resources to customize the bundle for use within your organization

Slide 5

National Partnership for Maternal SafetyFocus on decreasing Maternal Mortality amp Morbidity

Three core bundles focus on leading causes of maternal mortality and morbidity that are amenable to prevention Bundles are sets of critical clinical practices when performed systematically have been validated to improve outcomes Safety Bundles are not meant to introduce new guidelines but rather organize existing materials in ways that facilitate systematic implementation in every maternity unit in the United States

Venous Thromboembolism Severe Hypertension in pregnancy

Obstetric Hemorrhage

DAlton ME et al The national partnership for maternal safety Obstet Gynecol 2014123973

Institute for Healthcare Improvement Evidence-Based Care Bundles Ihiorg

Slide 6

VTE WORKING GROUPComprised of the following individuals with representation from obstetrics nursing midwifery and anesthesia

bull STEVEN CLARK MD

bull MARY DrsquoALTON MD

bull ROBYN DrsquoORIA MA RNC APC

bull ALEXANDER FRIEDMAN MD

bull JENNIFER FROST MD MPH

bull AFSHAN HAMEED MD

bull DEBORAH KARSNITZ DNP CNM

bull DOUGLAS MONTGOMERY MD

bull MICHAEL PAIDAS MD

bull RICHARD SMILEY MD

Slide 7

Pregnancy Related MortalityUnited States (1987-2010)

Creanga AA et al Pregnancy-related mortality in the United States 2006-2010 Obstet Gynecol (2015 Jan)125(1)5-12 doi 101097AOG0000000000000564

Slide 8

New York City 2006-2010Pregnancy-Associated Mortality

NYC Department of Health and Hygiene Bureau of Maternal Infant and Reproductive Health (2015) Report of the Pregnancy-Associated Mortality Review Project

Slide 9

Morbidity

Long-term sequelae include

bull Recurrent VTEbull Post-thrombotic syndrome May develop in up to 50 of patients

who experience DVT Chronic leg pain edema erythema

and ulcerationsbull Lung damagebull Cardiovascular

Vasquez SR et al Cardiology Patient Page Postthrombotic Syndrome Circulation (2010) 121217-219

Slide 10

Venous Thromboembolism (VTE) Prophylaxisldquosingle cause of death most amenable to reduction by systematic change in practicerdquo ndash Steven Clark MD SeminPerinatol 201236(1)42-7

Saving Mothersrsquo Lives 2006-2008 National Launch March 2011 Professor Gwyneth Lewis OBE FRCOG FACOG

Direct Deaths per Million

Maternities by Cause UK 1994-2008

Slide 11

VTE ProphylaxisThe Agency for Healthcare Research and Quality defined VTE as the ldquonumber one patient safety practicerdquo for hospitalized

patients

Safe practices published by the National Quality Forum (NQF) recommend

bull Routine evaluation of hospitalized patients for risk of VTEbull Use of appropriate prophylaxis

ENDORSE Survey

bull Evaluated prophylaxis rates in 17084 major surgery patients

bull More than one third of patients at risk for VTE (38) did not receive prophylaxis

bull Rates varied by surgery type

Shojania KG Duncan BW McDonald DM et al (Eds) (2001) Making healthcare safer A critical analysis of patient safety practices (Evidence ReportTechnology Assessment No 43) Prepared by the University of California at San Francisco-Stanford Evidenced-based Practice Center under Contract no 290-97-0013 (AHRQ Publication NO01-E058) Rockville MD Agency for Healthcare Research and Quality

National Quality Forum National Voluntary Consensus Standards for Prevention and Care of Venous Thromboembolism (2006)

Cohen AT Tapson VF Bergmann JF et al Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study) a multinational cross-sectional study The Lancet 2008 371 387-394

Slide 12

Prophylaxis in Vaginal Delivery Hospitalizations

No Prophylaxis Any Prophylaxis

Characteristic n n

All Patients 2605151 974 68835 26

Year of Delivery

2006 366317 984 5950 16

2007 374851 983 6662 18

2008 352438 978 7825 22

2009 354460 973 9884 27

2010 367470 969 11675 31

2011 402359 971 11911 29

2012 390881 972 11303 28

Friedman A et al Thromboembolism incidence and prophylaxis during vaginal delivery hospitalizations Am J Obstet Gynecol 2015 Feb 212(2) 221e1-12

Slide 13

Underuse of Post-cesarean Thromboembolic Prophylaxis

Characteristic None Mechanical Pharmacologic Combination

955787 (757) 278669 (221) 16639 (13) 12110 (10)

Year of Surgery

2003 115663 (916) 8717 (69) 1274 (10) 664 (05)

2004 124230 (874) 15674 (110) 1319 (09) 923 (07)

2005 131220 (846) 21013 (135) 1889 (12) 1051 (07)

2006 154876 (810) 32302 (169) 2413 (13) 1608 (08)

2007 145589 (747) 44842 (230) 2451 (13) 2053 (11)

2008 131250 (660) 62545 (314) 2852 (14) 2294 (12)

2009 125096 (605) 75315 (364) 3609 (18) 2753 (13)

2010 27863 (584) 18261 (383) 832 (17) 764 (16)

Friedman AM Ananth CV et al (2013) Underuse of post cesarean thromboembolic prphylaxis Am J Obstet and Gynecol 122(6)1197-204

Slide 14

Underuse of Post-cesarean Thromboembolic Prophylaxis

Lack of Protocol Adherence

bull Systematic review of over 2500 surgical patients demonstrated up to one fourth are noncompliant with post operative mechanical thromboprophylaxis

bull Observational study demonstrated noncompliance with post-cesarean mechanical thromboprophylaxis in 21 of 293 patients

bull Lack of adherence persist despite education amp audits

Craigie Samantha et al Adherence to mechanical thromboprophylaxis after surgery A systematic review and meta-analysis Thrombosis Research (2015) 136 (4) 723 ndash 72

Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Brady et al Sequential Compression Device Compliance in Postoperative Obstetrics and Gynecology Patients Obstet amp Gynecol (2015 Jan) 125 (1) 19

Slide 15

Maternal Venous Thromboembolism Prevention Safety Bundle

bull Use a standardized thromboembolism risk assessment tool for VTE during

bull Outpatient prenatal care

bull Antepartum hospitalization

bull Hospitalization after cesarean or vaginal deliveries

bull Postpartum period (up to 6 weeks after delivery)

RECOGNITION (Every Patient)bull Apply standardized tool to all patient to asses VTE risk at time point designated under

ldquoReadinessrdquo

bull Apply standardized tool to identify patients for thromboprophylaxis

bull Provide patient education

bull Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis

RESPONSE (Every Unit)bull Use standardized recommendations for mechanical thromboprophylaxis

bull Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation

bull Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia

REPORTINGSYSTEMS LEARNING (Every Unit)bull Review all thromboembolism events for systems issues and compliance with protocols

bull Monitor process metrics and outcomes in a standardized fashion

bull Assess for complications of pharmacologic thromboprophylaxis

READINESS (Every Unit)

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 4

Objectives

Provide an in-depth overview of the Maternal Venous Thromboembolism Prevention Patient Safety Bundle

Take a look at the processes methods and tools that were used to develop the bundle

Give suggestions for how to effectively implement and utilize the bundle within your organization

Identify resources to customize the bundle for use within your organization

Slide 5

National Partnership for Maternal SafetyFocus on decreasing Maternal Mortality amp Morbidity

Three core bundles focus on leading causes of maternal mortality and morbidity that are amenable to prevention Bundles are sets of critical clinical practices when performed systematically have been validated to improve outcomes Safety Bundles are not meant to introduce new guidelines but rather organize existing materials in ways that facilitate systematic implementation in every maternity unit in the United States

Venous Thromboembolism Severe Hypertension in pregnancy

Obstetric Hemorrhage

DAlton ME et al The national partnership for maternal safety Obstet Gynecol 2014123973

Institute for Healthcare Improvement Evidence-Based Care Bundles Ihiorg

Slide 6

VTE WORKING GROUPComprised of the following individuals with representation from obstetrics nursing midwifery and anesthesia

bull STEVEN CLARK MD

bull MARY DrsquoALTON MD

bull ROBYN DrsquoORIA MA RNC APC

bull ALEXANDER FRIEDMAN MD

bull JENNIFER FROST MD MPH

bull AFSHAN HAMEED MD

bull DEBORAH KARSNITZ DNP CNM

bull DOUGLAS MONTGOMERY MD

bull MICHAEL PAIDAS MD

bull RICHARD SMILEY MD

Slide 7

Pregnancy Related MortalityUnited States (1987-2010)

Creanga AA et al Pregnancy-related mortality in the United States 2006-2010 Obstet Gynecol (2015 Jan)125(1)5-12 doi 101097AOG0000000000000564

Slide 8

New York City 2006-2010Pregnancy-Associated Mortality

NYC Department of Health and Hygiene Bureau of Maternal Infant and Reproductive Health (2015) Report of the Pregnancy-Associated Mortality Review Project

Slide 9

Morbidity

Long-term sequelae include

bull Recurrent VTEbull Post-thrombotic syndrome May develop in up to 50 of patients

who experience DVT Chronic leg pain edema erythema

and ulcerationsbull Lung damagebull Cardiovascular

Vasquez SR et al Cardiology Patient Page Postthrombotic Syndrome Circulation (2010) 121217-219

Slide 10

Venous Thromboembolism (VTE) Prophylaxisldquosingle cause of death most amenable to reduction by systematic change in practicerdquo ndash Steven Clark MD SeminPerinatol 201236(1)42-7

Saving Mothersrsquo Lives 2006-2008 National Launch March 2011 Professor Gwyneth Lewis OBE FRCOG FACOG

Direct Deaths per Million

Maternities by Cause UK 1994-2008

Slide 11

VTE ProphylaxisThe Agency for Healthcare Research and Quality defined VTE as the ldquonumber one patient safety practicerdquo for hospitalized

patients

Safe practices published by the National Quality Forum (NQF) recommend

bull Routine evaluation of hospitalized patients for risk of VTEbull Use of appropriate prophylaxis

ENDORSE Survey

bull Evaluated prophylaxis rates in 17084 major surgery patients

bull More than one third of patients at risk for VTE (38) did not receive prophylaxis

bull Rates varied by surgery type

Shojania KG Duncan BW McDonald DM et al (Eds) (2001) Making healthcare safer A critical analysis of patient safety practices (Evidence ReportTechnology Assessment No 43) Prepared by the University of California at San Francisco-Stanford Evidenced-based Practice Center under Contract no 290-97-0013 (AHRQ Publication NO01-E058) Rockville MD Agency for Healthcare Research and Quality

National Quality Forum National Voluntary Consensus Standards for Prevention and Care of Venous Thromboembolism (2006)

Cohen AT Tapson VF Bergmann JF et al Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study) a multinational cross-sectional study The Lancet 2008 371 387-394

Slide 12

Prophylaxis in Vaginal Delivery Hospitalizations

No Prophylaxis Any Prophylaxis

Characteristic n n

All Patients 2605151 974 68835 26

Year of Delivery

2006 366317 984 5950 16

2007 374851 983 6662 18

2008 352438 978 7825 22

2009 354460 973 9884 27

2010 367470 969 11675 31

2011 402359 971 11911 29

2012 390881 972 11303 28

Friedman A et al Thromboembolism incidence and prophylaxis during vaginal delivery hospitalizations Am J Obstet Gynecol 2015 Feb 212(2) 221e1-12

Slide 13

Underuse of Post-cesarean Thromboembolic Prophylaxis

Characteristic None Mechanical Pharmacologic Combination

955787 (757) 278669 (221) 16639 (13) 12110 (10)

Year of Surgery

2003 115663 (916) 8717 (69) 1274 (10) 664 (05)

2004 124230 (874) 15674 (110) 1319 (09) 923 (07)

2005 131220 (846) 21013 (135) 1889 (12) 1051 (07)

2006 154876 (810) 32302 (169) 2413 (13) 1608 (08)

2007 145589 (747) 44842 (230) 2451 (13) 2053 (11)

2008 131250 (660) 62545 (314) 2852 (14) 2294 (12)

2009 125096 (605) 75315 (364) 3609 (18) 2753 (13)

2010 27863 (584) 18261 (383) 832 (17) 764 (16)

Friedman AM Ananth CV et al (2013) Underuse of post cesarean thromboembolic prphylaxis Am J Obstet and Gynecol 122(6)1197-204

Slide 14

Underuse of Post-cesarean Thromboembolic Prophylaxis

Lack of Protocol Adherence

bull Systematic review of over 2500 surgical patients demonstrated up to one fourth are noncompliant with post operative mechanical thromboprophylaxis

bull Observational study demonstrated noncompliance with post-cesarean mechanical thromboprophylaxis in 21 of 293 patients

bull Lack of adherence persist despite education amp audits

Craigie Samantha et al Adherence to mechanical thromboprophylaxis after surgery A systematic review and meta-analysis Thrombosis Research (2015) 136 (4) 723 ndash 72

Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Brady et al Sequential Compression Device Compliance in Postoperative Obstetrics and Gynecology Patients Obstet amp Gynecol (2015 Jan) 125 (1) 19

Slide 15

Maternal Venous Thromboembolism Prevention Safety Bundle

bull Use a standardized thromboembolism risk assessment tool for VTE during

bull Outpatient prenatal care

bull Antepartum hospitalization

bull Hospitalization after cesarean or vaginal deliveries

bull Postpartum period (up to 6 weeks after delivery)

RECOGNITION (Every Patient)bull Apply standardized tool to all patient to asses VTE risk at time point designated under

ldquoReadinessrdquo

bull Apply standardized tool to identify patients for thromboprophylaxis

bull Provide patient education

bull Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis

RESPONSE (Every Unit)bull Use standardized recommendations for mechanical thromboprophylaxis

bull Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation

bull Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia

REPORTINGSYSTEMS LEARNING (Every Unit)bull Review all thromboembolism events for systems issues and compliance with protocols

bull Monitor process metrics and outcomes in a standardized fashion

bull Assess for complications of pharmacologic thromboprophylaxis

READINESS (Every Unit)

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 5

National Partnership for Maternal SafetyFocus on decreasing Maternal Mortality amp Morbidity

Three core bundles focus on leading causes of maternal mortality and morbidity that are amenable to prevention Bundles are sets of critical clinical practices when performed systematically have been validated to improve outcomes Safety Bundles are not meant to introduce new guidelines but rather organize existing materials in ways that facilitate systematic implementation in every maternity unit in the United States

Venous Thromboembolism Severe Hypertension in pregnancy

Obstetric Hemorrhage

DAlton ME et al The national partnership for maternal safety Obstet Gynecol 2014123973

Institute for Healthcare Improvement Evidence-Based Care Bundles Ihiorg

Slide 6

VTE WORKING GROUPComprised of the following individuals with representation from obstetrics nursing midwifery and anesthesia

bull STEVEN CLARK MD

bull MARY DrsquoALTON MD

bull ROBYN DrsquoORIA MA RNC APC

bull ALEXANDER FRIEDMAN MD

bull JENNIFER FROST MD MPH

bull AFSHAN HAMEED MD

bull DEBORAH KARSNITZ DNP CNM

bull DOUGLAS MONTGOMERY MD

bull MICHAEL PAIDAS MD

bull RICHARD SMILEY MD

Slide 7

Pregnancy Related MortalityUnited States (1987-2010)

Creanga AA et al Pregnancy-related mortality in the United States 2006-2010 Obstet Gynecol (2015 Jan)125(1)5-12 doi 101097AOG0000000000000564

Slide 8

New York City 2006-2010Pregnancy-Associated Mortality

NYC Department of Health and Hygiene Bureau of Maternal Infant and Reproductive Health (2015) Report of the Pregnancy-Associated Mortality Review Project

Slide 9

Morbidity

Long-term sequelae include

bull Recurrent VTEbull Post-thrombotic syndrome May develop in up to 50 of patients

who experience DVT Chronic leg pain edema erythema

and ulcerationsbull Lung damagebull Cardiovascular

Vasquez SR et al Cardiology Patient Page Postthrombotic Syndrome Circulation (2010) 121217-219

Slide 10

Venous Thromboembolism (VTE) Prophylaxisldquosingle cause of death most amenable to reduction by systematic change in practicerdquo ndash Steven Clark MD SeminPerinatol 201236(1)42-7

Saving Mothersrsquo Lives 2006-2008 National Launch March 2011 Professor Gwyneth Lewis OBE FRCOG FACOG

Direct Deaths per Million

Maternities by Cause UK 1994-2008

Slide 11

VTE ProphylaxisThe Agency for Healthcare Research and Quality defined VTE as the ldquonumber one patient safety practicerdquo for hospitalized

patients

Safe practices published by the National Quality Forum (NQF) recommend

bull Routine evaluation of hospitalized patients for risk of VTEbull Use of appropriate prophylaxis

ENDORSE Survey

bull Evaluated prophylaxis rates in 17084 major surgery patients

bull More than one third of patients at risk for VTE (38) did not receive prophylaxis

bull Rates varied by surgery type

Shojania KG Duncan BW McDonald DM et al (Eds) (2001) Making healthcare safer A critical analysis of patient safety practices (Evidence ReportTechnology Assessment No 43) Prepared by the University of California at San Francisco-Stanford Evidenced-based Practice Center under Contract no 290-97-0013 (AHRQ Publication NO01-E058) Rockville MD Agency for Healthcare Research and Quality

National Quality Forum National Voluntary Consensus Standards for Prevention and Care of Venous Thromboembolism (2006)

Cohen AT Tapson VF Bergmann JF et al Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study) a multinational cross-sectional study The Lancet 2008 371 387-394

Slide 12

Prophylaxis in Vaginal Delivery Hospitalizations

No Prophylaxis Any Prophylaxis

Characteristic n n

All Patients 2605151 974 68835 26

Year of Delivery

2006 366317 984 5950 16

2007 374851 983 6662 18

2008 352438 978 7825 22

2009 354460 973 9884 27

2010 367470 969 11675 31

2011 402359 971 11911 29

2012 390881 972 11303 28

Friedman A et al Thromboembolism incidence and prophylaxis during vaginal delivery hospitalizations Am J Obstet Gynecol 2015 Feb 212(2) 221e1-12

Slide 13

Underuse of Post-cesarean Thromboembolic Prophylaxis

Characteristic None Mechanical Pharmacologic Combination

955787 (757) 278669 (221) 16639 (13) 12110 (10)

Year of Surgery

2003 115663 (916) 8717 (69) 1274 (10) 664 (05)

2004 124230 (874) 15674 (110) 1319 (09) 923 (07)

2005 131220 (846) 21013 (135) 1889 (12) 1051 (07)

2006 154876 (810) 32302 (169) 2413 (13) 1608 (08)

2007 145589 (747) 44842 (230) 2451 (13) 2053 (11)

2008 131250 (660) 62545 (314) 2852 (14) 2294 (12)

2009 125096 (605) 75315 (364) 3609 (18) 2753 (13)

2010 27863 (584) 18261 (383) 832 (17) 764 (16)

Friedman AM Ananth CV et al (2013) Underuse of post cesarean thromboembolic prphylaxis Am J Obstet and Gynecol 122(6)1197-204

Slide 14

Underuse of Post-cesarean Thromboembolic Prophylaxis

Lack of Protocol Adherence

bull Systematic review of over 2500 surgical patients demonstrated up to one fourth are noncompliant with post operative mechanical thromboprophylaxis

bull Observational study demonstrated noncompliance with post-cesarean mechanical thromboprophylaxis in 21 of 293 patients

bull Lack of adherence persist despite education amp audits

Craigie Samantha et al Adherence to mechanical thromboprophylaxis after surgery A systematic review and meta-analysis Thrombosis Research (2015) 136 (4) 723 ndash 72

Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Brady et al Sequential Compression Device Compliance in Postoperative Obstetrics and Gynecology Patients Obstet amp Gynecol (2015 Jan) 125 (1) 19

Slide 15

Maternal Venous Thromboembolism Prevention Safety Bundle

bull Use a standardized thromboembolism risk assessment tool for VTE during

bull Outpatient prenatal care

bull Antepartum hospitalization

bull Hospitalization after cesarean or vaginal deliveries

bull Postpartum period (up to 6 weeks after delivery)

RECOGNITION (Every Patient)bull Apply standardized tool to all patient to asses VTE risk at time point designated under

ldquoReadinessrdquo

bull Apply standardized tool to identify patients for thromboprophylaxis

bull Provide patient education

bull Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis

RESPONSE (Every Unit)bull Use standardized recommendations for mechanical thromboprophylaxis

bull Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation

bull Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia

REPORTINGSYSTEMS LEARNING (Every Unit)bull Review all thromboembolism events for systems issues and compliance with protocols

bull Monitor process metrics and outcomes in a standardized fashion

bull Assess for complications of pharmacologic thromboprophylaxis

READINESS (Every Unit)

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 6

VTE WORKING GROUPComprised of the following individuals with representation from obstetrics nursing midwifery and anesthesia

bull STEVEN CLARK MD

bull MARY DrsquoALTON MD

bull ROBYN DrsquoORIA MA RNC APC

bull ALEXANDER FRIEDMAN MD

bull JENNIFER FROST MD MPH

bull AFSHAN HAMEED MD

bull DEBORAH KARSNITZ DNP CNM

bull DOUGLAS MONTGOMERY MD

bull MICHAEL PAIDAS MD

bull RICHARD SMILEY MD

Slide 7

Pregnancy Related MortalityUnited States (1987-2010)

Creanga AA et al Pregnancy-related mortality in the United States 2006-2010 Obstet Gynecol (2015 Jan)125(1)5-12 doi 101097AOG0000000000000564

Slide 8

New York City 2006-2010Pregnancy-Associated Mortality

NYC Department of Health and Hygiene Bureau of Maternal Infant and Reproductive Health (2015) Report of the Pregnancy-Associated Mortality Review Project

Slide 9

Morbidity

Long-term sequelae include

bull Recurrent VTEbull Post-thrombotic syndrome May develop in up to 50 of patients

who experience DVT Chronic leg pain edema erythema

and ulcerationsbull Lung damagebull Cardiovascular

Vasquez SR et al Cardiology Patient Page Postthrombotic Syndrome Circulation (2010) 121217-219

Slide 10

Venous Thromboembolism (VTE) Prophylaxisldquosingle cause of death most amenable to reduction by systematic change in practicerdquo ndash Steven Clark MD SeminPerinatol 201236(1)42-7

Saving Mothersrsquo Lives 2006-2008 National Launch March 2011 Professor Gwyneth Lewis OBE FRCOG FACOG

Direct Deaths per Million

Maternities by Cause UK 1994-2008

Slide 11

VTE ProphylaxisThe Agency for Healthcare Research and Quality defined VTE as the ldquonumber one patient safety practicerdquo for hospitalized

patients

Safe practices published by the National Quality Forum (NQF) recommend

bull Routine evaluation of hospitalized patients for risk of VTEbull Use of appropriate prophylaxis

ENDORSE Survey

bull Evaluated prophylaxis rates in 17084 major surgery patients

bull More than one third of patients at risk for VTE (38) did not receive prophylaxis

bull Rates varied by surgery type

Shojania KG Duncan BW McDonald DM et al (Eds) (2001) Making healthcare safer A critical analysis of patient safety practices (Evidence ReportTechnology Assessment No 43) Prepared by the University of California at San Francisco-Stanford Evidenced-based Practice Center under Contract no 290-97-0013 (AHRQ Publication NO01-E058) Rockville MD Agency for Healthcare Research and Quality

National Quality Forum National Voluntary Consensus Standards for Prevention and Care of Venous Thromboembolism (2006)

Cohen AT Tapson VF Bergmann JF et al Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study) a multinational cross-sectional study The Lancet 2008 371 387-394

Slide 12

Prophylaxis in Vaginal Delivery Hospitalizations

No Prophylaxis Any Prophylaxis

Characteristic n n

All Patients 2605151 974 68835 26

Year of Delivery

2006 366317 984 5950 16

2007 374851 983 6662 18

2008 352438 978 7825 22

2009 354460 973 9884 27

2010 367470 969 11675 31

2011 402359 971 11911 29

2012 390881 972 11303 28

Friedman A et al Thromboembolism incidence and prophylaxis during vaginal delivery hospitalizations Am J Obstet Gynecol 2015 Feb 212(2) 221e1-12

Slide 13

Underuse of Post-cesarean Thromboembolic Prophylaxis

Characteristic None Mechanical Pharmacologic Combination

955787 (757) 278669 (221) 16639 (13) 12110 (10)

Year of Surgery

2003 115663 (916) 8717 (69) 1274 (10) 664 (05)

2004 124230 (874) 15674 (110) 1319 (09) 923 (07)

2005 131220 (846) 21013 (135) 1889 (12) 1051 (07)

2006 154876 (810) 32302 (169) 2413 (13) 1608 (08)

2007 145589 (747) 44842 (230) 2451 (13) 2053 (11)

2008 131250 (660) 62545 (314) 2852 (14) 2294 (12)

2009 125096 (605) 75315 (364) 3609 (18) 2753 (13)

2010 27863 (584) 18261 (383) 832 (17) 764 (16)

Friedman AM Ananth CV et al (2013) Underuse of post cesarean thromboembolic prphylaxis Am J Obstet and Gynecol 122(6)1197-204

Slide 14

Underuse of Post-cesarean Thromboembolic Prophylaxis

Lack of Protocol Adherence

bull Systematic review of over 2500 surgical patients demonstrated up to one fourth are noncompliant with post operative mechanical thromboprophylaxis

bull Observational study demonstrated noncompliance with post-cesarean mechanical thromboprophylaxis in 21 of 293 patients

bull Lack of adherence persist despite education amp audits

Craigie Samantha et al Adherence to mechanical thromboprophylaxis after surgery A systematic review and meta-analysis Thrombosis Research (2015) 136 (4) 723 ndash 72

Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Brady et al Sequential Compression Device Compliance in Postoperative Obstetrics and Gynecology Patients Obstet amp Gynecol (2015 Jan) 125 (1) 19

Slide 15

Maternal Venous Thromboembolism Prevention Safety Bundle

bull Use a standardized thromboembolism risk assessment tool for VTE during

bull Outpatient prenatal care

bull Antepartum hospitalization

bull Hospitalization after cesarean or vaginal deliveries

bull Postpartum period (up to 6 weeks after delivery)

RECOGNITION (Every Patient)bull Apply standardized tool to all patient to asses VTE risk at time point designated under

ldquoReadinessrdquo

bull Apply standardized tool to identify patients for thromboprophylaxis

bull Provide patient education

bull Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis

RESPONSE (Every Unit)bull Use standardized recommendations for mechanical thromboprophylaxis

bull Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation

bull Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia

REPORTINGSYSTEMS LEARNING (Every Unit)bull Review all thromboembolism events for systems issues and compliance with protocols

bull Monitor process metrics and outcomes in a standardized fashion

bull Assess for complications of pharmacologic thromboprophylaxis

READINESS (Every Unit)

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 7

Pregnancy Related MortalityUnited States (1987-2010)

Creanga AA et al Pregnancy-related mortality in the United States 2006-2010 Obstet Gynecol (2015 Jan)125(1)5-12 doi 101097AOG0000000000000564

Slide 8

New York City 2006-2010Pregnancy-Associated Mortality

NYC Department of Health and Hygiene Bureau of Maternal Infant and Reproductive Health (2015) Report of the Pregnancy-Associated Mortality Review Project

Slide 9

Morbidity

Long-term sequelae include

bull Recurrent VTEbull Post-thrombotic syndrome May develop in up to 50 of patients

who experience DVT Chronic leg pain edema erythema

and ulcerationsbull Lung damagebull Cardiovascular

Vasquez SR et al Cardiology Patient Page Postthrombotic Syndrome Circulation (2010) 121217-219

Slide 10

Venous Thromboembolism (VTE) Prophylaxisldquosingle cause of death most amenable to reduction by systematic change in practicerdquo ndash Steven Clark MD SeminPerinatol 201236(1)42-7

Saving Mothersrsquo Lives 2006-2008 National Launch March 2011 Professor Gwyneth Lewis OBE FRCOG FACOG

Direct Deaths per Million

Maternities by Cause UK 1994-2008

Slide 11

VTE ProphylaxisThe Agency for Healthcare Research and Quality defined VTE as the ldquonumber one patient safety practicerdquo for hospitalized

patients

Safe practices published by the National Quality Forum (NQF) recommend

bull Routine evaluation of hospitalized patients for risk of VTEbull Use of appropriate prophylaxis

ENDORSE Survey

bull Evaluated prophylaxis rates in 17084 major surgery patients

bull More than one third of patients at risk for VTE (38) did not receive prophylaxis

bull Rates varied by surgery type

Shojania KG Duncan BW McDonald DM et al (Eds) (2001) Making healthcare safer A critical analysis of patient safety practices (Evidence ReportTechnology Assessment No 43) Prepared by the University of California at San Francisco-Stanford Evidenced-based Practice Center under Contract no 290-97-0013 (AHRQ Publication NO01-E058) Rockville MD Agency for Healthcare Research and Quality

National Quality Forum National Voluntary Consensus Standards for Prevention and Care of Venous Thromboembolism (2006)

Cohen AT Tapson VF Bergmann JF et al Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study) a multinational cross-sectional study The Lancet 2008 371 387-394

Slide 12

Prophylaxis in Vaginal Delivery Hospitalizations

No Prophylaxis Any Prophylaxis

Characteristic n n

All Patients 2605151 974 68835 26

Year of Delivery

2006 366317 984 5950 16

2007 374851 983 6662 18

2008 352438 978 7825 22

2009 354460 973 9884 27

2010 367470 969 11675 31

2011 402359 971 11911 29

2012 390881 972 11303 28

Friedman A et al Thromboembolism incidence and prophylaxis during vaginal delivery hospitalizations Am J Obstet Gynecol 2015 Feb 212(2) 221e1-12

Slide 13

Underuse of Post-cesarean Thromboembolic Prophylaxis

Characteristic None Mechanical Pharmacologic Combination

955787 (757) 278669 (221) 16639 (13) 12110 (10)

Year of Surgery

2003 115663 (916) 8717 (69) 1274 (10) 664 (05)

2004 124230 (874) 15674 (110) 1319 (09) 923 (07)

2005 131220 (846) 21013 (135) 1889 (12) 1051 (07)

2006 154876 (810) 32302 (169) 2413 (13) 1608 (08)

2007 145589 (747) 44842 (230) 2451 (13) 2053 (11)

2008 131250 (660) 62545 (314) 2852 (14) 2294 (12)

2009 125096 (605) 75315 (364) 3609 (18) 2753 (13)

2010 27863 (584) 18261 (383) 832 (17) 764 (16)

Friedman AM Ananth CV et al (2013) Underuse of post cesarean thromboembolic prphylaxis Am J Obstet and Gynecol 122(6)1197-204

Slide 14

Underuse of Post-cesarean Thromboembolic Prophylaxis

Lack of Protocol Adherence

bull Systematic review of over 2500 surgical patients demonstrated up to one fourth are noncompliant with post operative mechanical thromboprophylaxis

bull Observational study demonstrated noncompliance with post-cesarean mechanical thromboprophylaxis in 21 of 293 patients

bull Lack of adherence persist despite education amp audits

Craigie Samantha et al Adherence to mechanical thromboprophylaxis after surgery A systematic review and meta-analysis Thrombosis Research (2015) 136 (4) 723 ndash 72

Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Brady et al Sequential Compression Device Compliance in Postoperative Obstetrics and Gynecology Patients Obstet amp Gynecol (2015 Jan) 125 (1) 19

Slide 15

Maternal Venous Thromboembolism Prevention Safety Bundle

bull Use a standardized thromboembolism risk assessment tool for VTE during

bull Outpatient prenatal care

bull Antepartum hospitalization

bull Hospitalization after cesarean or vaginal deliveries

bull Postpartum period (up to 6 weeks after delivery)

RECOGNITION (Every Patient)bull Apply standardized tool to all patient to asses VTE risk at time point designated under

ldquoReadinessrdquo

bull Apply standardized tool to identify patients for thromboprophylaxis

bull Provide patient education

bull Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis

RESPONSE (Every Unit)bull Use standardized recommendations for mechanical thromboprophylaxis

bull Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation

bull Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia

REPORTINGSYSTEMS LEARNING (Every Unit)bull Review all thromboembolism events for systems issues and compliance with protocols

bull Monitor process metrics and outcomes in a standardized fashion

bull Assess for complications of pharmacologic thromboprophylaxis

READINESS (Every Unit)

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 8

New York City 2006-2010Pregnancy-Associated Mortality

NYC Department of Health and Hygiene Bureau of Maternal Infant and Reproductive Health (2015) Report of the Pregnancy-Associated Mortality Review Project

Slide 9

Morbidity

Long-term sequelae include

bull Recurrent VTEbull Post-thrombotic syndrome May develop in up to 50 of patients

who experience DVT Chronic leg pain edema erythema

and ulcerationsbull Lung damagebull Cardiovascular

Vasquez SR et al Cardiology Patient Page Postthrombotic Syndrome Circulation (2010) 121217-219

Slide 10

Venous Thromboembolism (VTE) Prophylaxisldquosingle cause of death most amenable to reduction by systematic change in practicerdquo ndash Steven Clark MD SeminPerinatol 201236(1)42-7

Saving Mothersrsquo Lives 2006-2008 National Launch March 2011 Professor Gwyneth Lewis OBE FRCOG FACOG

Direct Deaths per Million

Maternities by Cause UK 1994-2008

Slide 11

VTE ProphylaxisThe Agency for Healthcare Research and Quality defined VTE as the ldquonumber one patient safety practicerdquo for hospitalized

patients

Safe practices published by the National Quality Forum (NQF) recommend

bull Routine evaluation of hospitalized patients for risk of VTEbull Use of appropriate prophylaxis

ENDORSE Survey

bull Evaluated prophylaxis rates in 17084 major surgery patients

bull More than one third of patients at risk for VTE (38) did not receive prophylaxis

bull Rates varied by surgery type

Shojania KG Duncan BW McDonald DM et al (Eds) (2001) Making healthcare safer A critical analysis of patient safety practices (Evidence ReportTechnology Assessment No 43) Prepared by the University of California at San Francisco-Stanford Evidenced-based Practice Center under Contract no 290-97-0013 (AHRQ Publication NO01-E058) Rockville MD Agency for Healthcare Research and Quality

National Quality Forum National Voluntary Consensus Standards for Prevention and Care of Venous Thromboembolism (2006)

Cohen AT Tapson VF Bergmann JF et al Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study) a multinational cross-sectional study The Lancet 2008 371 387-394

Slide 12

Prophylaxis in Vaginal Delivery Hospitalizations

No Prophylaxis Any Prophylaxis

Characteristic n n

All Patients 2605151 974 68835 26

Year of Delivery

2006 366317 984 5950 16

2007 374851 983 6662 18

2008 352438 978 7825 22

2009 354460 973 9884 27

2010 367470 969 11675 31

2011 402359 971 11911 29

2012 390881 972 11303 28

Friedman A et al Thromboembolism incidence and prophylaxis during vaginal delivery hospitalizations Am J Obstet Gynecol 2015 Feb 212(2) 221e1-12

Slide 13

Underuse of Post-cesarean Thromboembolic Prophylaxis

Characteristic None Mechanical Pharmacologic Combination

955787 (757) 278669 (221) 16639 (13) 12110 (10)

Year of Surgery

2003 115663 (916) 8717 (69) 1274 (10) 664 (05)

2004 124230 (874) 15674 (110) 1319 (09) 923 (07)

2005 131220 (846) 21013 (135) 1889 (12) 1051 (07)

2006 154876 (810) 32302 (169) 2413 (13) 1608 (08)

2007 145589 (747) 44842 (230) 2451 (13) 2053 (11)

2008 131250 (660) 62545 (314) 2852 (14) 2294 (12)

2009 125096 (605) 75315 (364) 3609 (18) 2753 (13)

2010 27863 (584) 18261 (383) 832 (17) 764 (16)

Friedman AM Ananth CV et al (2013) Underuse of post cesarean thromboembolic prphylaxis Am J Obstet and Gynecol 122(6)1197-204

Slide 14

Underuse of Post-cesarean Thromboembolic Prophylaxis

Lack of Protocol Adherence

bull Systematic review of over 2500 surgical patients demonstrated up to one fourth are noncompliant with post operative mechanical thromboprophylaxis

bull Observational study demonstrated noncompliance with post-cesarean mechanical thromboprophylaxis in 21 of 293 patients

bull Lack of adherence persist despite education amp audits

Craigie Samantha et al Adherence to mechanical thromboprophylaxis after surgery A systematic review and meta-analysis Thrombosis Research (2015) 136 (4) 723 ndash 72

Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Brady et al Sequential Compression Device Compliance in Postoperative Obstetrics and Gynecology Patients Obstet amp Gynecol (2015 Jan) 125 (1) 19

Slide 15

Maternal Venous Thromboembolism Prevention Safety Bundle

bull Use a standardized thromboembolism risk assessment tool for VTE during

bull Outpatient prenatal care

bull Antepartum hospitalization

bull Hospitalization after cesarean or vaginal deliveries

bull Postpartum period (up to 6 weeks after delivery)

RECOGNITION (Every Patient)bull Apply standardized tool to all patient to asses VTE risk at time point designated under

ldquoReadinessrdquo

bull Apply standardized tool to identify patients for thromboprophylaxis

bull Provide patient education

bull Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis

RESPONSE (Every Unit)bull Use standardized recommendations for mechanical thromboprophylaxis

bull Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation

bull Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia

REPORTINGSYSTEMS LEARNING (Every Unit)bull Review all thromboembolism events for systems issues and compliance with protocols

bull Monitor process metrics and outcomes in a standardized fashion

bull Assess for complications of pharmacologic thromboprophylaxis

READINESS (Every Unit)

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 9

Morbidity

Long-term sequelae include

bull Recurrent VTEbull Post-thrombotic syndrome May develop in up to 50 of patients

who experience DVT Chronic leg pain edema erythema

and ulcerationsbull Lung damagebull Cardiovascular

Vasquez SR et al Cardiology Patient Page Postthrombotic Syndrome Circulation (2010) 121217-219

Slide 10

Venous Thromboembolism (VTE) Prophylaxisldquosingle cause of death most amenable to reduction by systematic change in practicerdquo ndash Steven Clark MD SeminPerinatol 201236(1)42-7

Saving Mothersrsquo Lives 2006-2008 National Launch March 2011 Professor Gwyneth Lewis OBE FRCOG FACOG

Direct Deaths per Million

Maternities by Cause UK 1994-2008

Slide 11

VTE ProphylaxisThe Agency for Healthcare Research and Quality defined VTE as the ldquonumber one patient safety practicerdquo for hospitalized

patients

Safe practices published by the National Quality Forum (NQF) recommend

bull Routine evaluation of hospitalized patients for risk of VTEbull Use of appropriate prophylaxis

ENDORSE Survey

bull Evaluated prophylaxis rates in 17084 major surgery patients

bull More than one third of patients at risk for VTE (38) did not receive prophylaxis

bull Rates varied by surgery type

Shojania KG Duncan BW McDonald DM et al (Eds) (2001) Making healthcare safer A critical analysis of patient safety practices (Evidence ReportTechnology Assessment No 43) Prepared by the University of California at San Francisco-Stanford Evidenced-based Practice Center under Contract no 290-97-0013 (AHRQ Publication NO01-E058) Rockville MD Agency for Healthcare Research and Quality

National Quality Forum National Voluntary Consensus Standards for Prevention and Care of Venous Thromboembolism (2006)

Cohen AT Tapson VF Bergmann JF et al Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study) a multinational cross-sectional study The Lancet 2008 371 387-394

Slide 12

Prophylaxis in Vaginal Delivery Hospitalizations

No Prophylaxis Any Prophylaxis

Characteristic n n

All Patients 2605151 974 68835 26

Year of Delivery

2006 366317 984 5950 16

2007 374851 983 6662 18

2008 352438 978 7825 22

2009 354460 973 9884 27

2010 367470 969 11675 31

2011 402359 971 11911 29

2012 390881 972 11303 28

Friedman A et al Thromboembolism incidence and prophylaxis during vaginal delivery hospitalizations Am J Obstet Gynecol 2015 Feb 212(2) 221e1-12

Slide 13

Underuse of Post-cesarean Thromboembolic Prophylaxis

Characteristic None Mechanical Pharmacologic Combination

955787 (757) 278669 (221) 16639 (13) 12110 (10)

Year of Surgery

2003 115663 (916) 8717 (69) 1274 (10) 664 (05)

2004 124230 (874) 15674 (110) 1319 (09) 923 (07)

2005 131220 (846) 21013 (135) 1889 (12) 1051 (07)

2006 154876 (810) 32302 (169) 2413 (13) 1608 (08)

2007 145589 (747) 44842 (230) 2451 (13) 2053 (11)

2008 131250 (660) 62545 (314) 2852 (14) 2294 (12)

2009 125096 (605) 75315 (364) 3609 (18) 2753 (13)

2010 27863 (584) 18261 (383) 832 (17) 764 (16)

Friedman AM Ananth CV et al (2013) Underuse of post cesarean thromboembolic prphylaxis Am J Obstet and Gynecol 122(6)1197-204

Slide 14

Underuse of Post-cesarean Thromboembolic Prophylaxis

Lack of Protocol Adherence

bull Systematic review of over 2500 surgical patients demonstrated up to one fourth are noncompliant with post operative mechanical thromboprophylaxis

bull Observational study demonstrated noncompliance with post-cesarean mechanical thromboprophylaxis in 21 of 293 patients

bull Lack of adherence persist despite education amp audits

Craigie Samantha et al Adherence to mechanical thromboprophylaxis after surgery A systematic review and meta-analysis Thrombosis Research (2015) 136 (4) 723 ndash 72

Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Brady et al Sequential Compression Device Compliance in Postoperative Obstetrics and Gynecology Patients Obstet amp Gynecol (2015 Jan) 125 (1) 19

Slide 15

Maternal Venous Thromboembolism Prevention Safety Bundle

bull Use a standardized thromboembolism risk assessment tool for VTE during

bull Outpatient prenatal care

bull Antepartum hospitalization

bull Hospitalization after cesarean or vaginal deliveries

bull Postpartum period (up to 6 weeks after delivery)

RECOGNITION (Every Patient)bull Apply standardized tool to all patient to asses VTE risk at time point designated under

ldquoReadinessrdquo

bull Apply standardized tool to identify patients for thromboprophylaxis

bull Provide patient education

bull Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis

RESPONSE (Every Unit)bull Use standardized recommendations for mechanical thromboprophylaxis

bull Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation

bull Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia

REPORTINGSYSTEMS LEARNING (Every Unit)bull Review all thromboembolism events for systems issues and compliance with protocols

bull Monitor process metrics and outcomes in a standardized fashion

bull Assess for complications of pharmacologic thromboprophylaxis

READINESS (Every Unit)

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 10

Venous Thromboembolism (VTE) Prophylaxisldquosingle cause of death most amenable to reduction by systematic change in practicerdquo ndash Steven Clark MD SeminPerinatol 201236(1)42-7

Saving Mothersrsquo Lives 2006-2008 National Launch March 2011 Professor Gwyneth Lewis OBE FRCOG FACOG

Direct Deaths per Million

Maternities by Cause UK 1994-2008

Slide 11

VTE ProphylaxisThe Agency for Healthcare Research and Quality defined VTE as the ldquonumber one patient safety practicerdquo for hospitalized

patients

Safe practices published by the National Quality Forum (NQF) recommend

bull Routine evaluation of hospitalized patients for risk of VTEbull Use of appropriate prophylaxis

ENDORSE Survey

bull Evaluated prophylaxis rates in 17084 major surgery patients

bull More than one third of patients at risk for VTE (38) did not receive prophylaxis

bull Rates varied by surgery type

Shojania KG Duncan BW McDonald DM et al (Eds) (2001) Making healthcare safer A critical analysis of patient safety practices (Evidence ReportTechnology Assessment No 43) Prepared by the University of California at San Francisco-Stanford Evidenced-based Practice Center under Contract no 290-97-0013 (AHRQ Publication NO01-E058) Rockville MD Agency for Healthcare Research and Quality

National Quality Forum National Voluntary Consensus Standards for Prevention and Care of Venous Thromboembolism (2006)

Cohen AT Tapson VF Bergmann JF et al Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study) a multinational cross-sectional study The Lancet 2008 371 387-394

Slide 12

Prophylaxis in Vaginal Delivery Hospitalizations

No Prophylaxis Any Prophylaxis

Characteristic n n

All Patients 2605151 974 68835 26

Year of Delivery

2006 366317 984 5950 16

2007 374851 983 6662 18

2008 352438 978 7825 22

2009 354460 973 9884 27

2010 367470 969 11675 31

2011 402359 971 11911 29

2012 390881 972 11303 28

Friedman A et al Thromboembolism incidence and prophylaxis during vaginal delivery hospitalizations Am J Obstet Gynecol 2015 Feb 212(2) 221e1-12

Slide 13

Underuse of Post-cesarean Thromboembolic Prophylaxis

Characteristic None Mechanical Pharmacologic Combination

955787 (757) 278669 (221) 16639 (13) 12110 (10)

Year of Surgery

2003 115663 (916) 8717 (69) 1274 (10) 664 (05)

2004 124230 (874) 15674 (110) 1319 (09) 923 (07)

2005 131220 (846) 21013 (135) 1889 (12) 1051 (07)

2006 154876 (810) 32302 (169) 2413 (13) 1608 (08)

2007 145589 (747) 44842 (230) 2451 (13) 2053 (11)

2008 131250 (660) 62545 (314) 2852 (14) 2294 (12)

2009 125096 (605) 75315 (364) 3609 (18) 2753 (13)

2010 27863 (584) 18261 (383) 832 (17) 764 (16)

Friedman AM Ananth CV et al (2013) Underuse of post cesarean thromboembolic prphylaxis Am J Obstet and Gynecol 122(6)1197-204

Slide 14

Underuse of Post-cesarean Thromboembolic Prophylaxis

Lack of Protocol Adherence

bull Systematic review of over 2500 surgical patients demonstrated up to one fourth are noncompliant with post operative mechanical thromboprophylaxis

bull Observational study demonstrated noncompliance with post-cesarean mechanical thromboprophylaxis in 21 of 293 patients

bull Lack of adherence persist despite education amp audits

Craigie Samantha et al Adherence to mechanical thromboprophylaxis after surgery A systematic review and meta-analysis Thrombosis Research (2015) 136 (4) 723 ndash 72

Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Brady et al Sequential Compression Device Compliance in Postoperative Obstetrics and Gynecology Patients Obstet amp Gynecol (2015 Jan) 125 (1) 19

Slide 15

Maternal Venous Thromboembolism Prevention Safety Bundle

bull Use a standardized thromboembolism risk assessment tool for VTE during

bull Outpatient prenatal care

bull Antepartum hospitalization

bull Hospitalization after cesarean or vaginal deliveries

bull Postpartum period (up to 6 weeks after delivery)

RECOGNITION (Every Patient)bull Apply standardized tool to all patient to asses VTE risk at time point designated under

ldquoReadinessrdquo

bull Apply standardized tool to identify patients for thromboprophylaxis

bull Provide patient education

bull Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis

RESPONSE (Every Unit)bull Use standardized recommendations for mechanical thromboprophylaxis

bull Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation

bull Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia

REPORTINGSYSTEMS LEARNING (Every Unit)bull Review all thromboembolism events for systems issues and compliance with protocols

bull Monitor process metrics and outcomes in a standardized fashion

bull Assess for complications of pharmacologic thromboprophylaxis

READINESS (Every Unit)

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 11

VTE ProphylaxisThe Agency for Healthcare Research and Quality defined VTE as the ldquonumber one patient safety practicerdquo for hospitalized

patients

Safe practices published by the National Quality Forum (NQF) recommend

bull Routine evaluation of hospitalized patients for risk of VTEbull Use of appropriate prophylaxis

ENDORSE Survey

bull Evaluated prophylaxis rates in 17084 major surgery patients

bull More than one third of patients at risk for VTE (38) did not receive prophylaxis

bull Rates varied by surgery type

Shojania KG Duncan BW McDonald DM et al (Eds) (2001) Making healthcare safer A critical analysis of patient safety practices (Evidence ReportTechnology Assessment No 43) Prepared by the University of California at San Francisco-Stanford Evidenced-based Practice Center under Contract no 290-97-0013 (AHRQ Publication NO01-E058) Rockville MD Agency for Healthcare Research and Quality

National Quality Forum National Voluntary Consensus Standards for Prevention and Care of Venous Thromboembolism (2006)

Cohen AT Tapson VF Bergmann JF et al Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study) a multinational cross-sectional study The Lancet 2008 371 387-394

Slide 12

Prophylaxis in Vaginal Delivery Hospitalizations

No Prophylaxis Any Prophylaxis

Characteristic n n

All Patients 2605151 974 68835 26

Year of Delivery

2006 366317 984 5950 16

2007 374851 983 6662 18

2008 352438 978 7825 22

2009 354460 973 9884 27

2010 367470 969 11675 31

2011 402359 971 11911 29

2012 390881 972 11303 28

Friedman A et al Thromboembolism incidence and prophylaxis during vaginal delivery hospitalizations Am J Obstet Gynecol 2015 Feb 212(2) 221e1-12

Slide 13

Underuse of Post-cesarean Thromboembolic Prophylaxis

Characteristic None Mechanical Pharmacologic Combination

955787 (757) 278669 (221) 16639 (13) 12110 (10)

Year of Surgery

2003 115663 (916) 8717 (69) 1274 (10) 664 (05)

2004 124230 (874) 15674 (110) 1319 (09) 923 (07)

2005 131220 (846) 21013 (135) 1889 (12) 1051 (07)

2006 154876 (810) 32302 (169) 2413 (13) 1608 (08)

2007 145589 (747) 44842 (230) 2451 (13) 2053 (11)

2008 131250 (660) 62545 (314) 2852 (14) 2294 (12)

2009 125096 (605) 75315 (364) 3609 (18) 2753 (13)

2010 27863 (584) 18261 (383) 832 (17) 764 (16)

Friedman AM Ananth CV et al (2013) Underuse of post cesarean thromboembolic prphylaxis Am J Obstet and Gynecol 122(6)1197-204

Slide 14

Underuse of Post-cesarean Thromboembolic Prophylaxis

Lack of Protocol Adherence

bull Systematic review of over 2500 surgical patients demonstrated up to one fourth are noncompliant with post operative mechanical thromboprophylaxis

bull Observational study demonstrated noncompliance with post-cesarean mechanical thromboprophylaxis in 21 of 293 patients

bull Lack of adherence persist despite education amp audits

Craigie Samantha et al Adherence to mechanical thromboprophylaxis after surgery A systematic review and meta-analysis Thrombosis Research (2015) 136 (4) 723 ndash 72

Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Brady et al Sequential Compression Device Compliance in Postoperative Obstetrics and Gynecology Patients Obstet amp Gynecol (2015 Jan) 125 (1) 19

Slide 15

Maternal Venous Thromboembolism Prevention Safety Bundle

bull Use a standardized thromboembolism risk assessment tool for VTE during

bull Outpatient prenatal care

bull Antepartum hospitalization

bull Hospitalization after cesarean or vaginal deliveries

bull Postpartum period (up to 6 weeks after delivery)

RECOGNITION (Every Patient)bull Apply standardized tool to all patient to asses VTE risk at time point designated under

ldquoReadinessrdquo

bull Apply standardized tool to identify patients for thromboprophylaxis

bull Provide patient education

bull Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis

RESPONSE (Every Unit)bull Use standardized recommendations for mechanical thromboprophylaxis

bull Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation

bull Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia

REPORTINGSYSTEMS LEARNING (Every Unit)bull Review all thromboembolism events for systems issues and compliance with protocols

bull Monitor process metrics and outcomes in a standardized fashion

bull Assess for complications of pharmacologic thromboprophylaxis

READINESS (Every Unit)

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 12

Prophylaxis in Vaginal Delivery Hospitalizations

No Prophylaxis Any Prophylaxis

Characteristic n n

All Patients 2605151 974 68835 26

Year of Delivery

2006 366317 984 5950 16

2007 374851 983 6662 18

2008 352438 978 7825 22

2009 354460 973 9884 27

2010 367470 969 11675 31

2011 402359 971 11911 29

2012 390881 972 11303 28

Friedman A et al Thromboembolism incidence and prophylaxis during vaginal delivery hospitalizations Am J Obstet Gynecol 2015 Feb 212(2) 221e1-12

Slide 13

Underuse of Post-cesarean Thromboembolic Prophylaxis

Characteristic None Mechanical Pharmacologic Combination

955787 (757) 278669 (221) 16639 (13) 12110 (10)

Year of Surgery

2003 115663 (916) 8717 (69) 1274 (10) 664 (05)

2004 124230 (874) 15674 (110) 1319 (09) 923 (07)

2005 131220 (846) 21013 (135) 1889 (12) 1051 (07)

2006 154876 (810) 32302 (169) 2413 (13) 1608 (08)

2007 145589 (747) 44842 (230) 2451 (13) 2053 (11)

2008 131250 (660) 62545 (314) 2852 (14) 2294 (12)

2009 125096 (605) 75315 (364) 3609 (18) 2753 (13)

2010 27863 (584) 18261 (383) 832 (17) 764 (16)

Friedman AM Ananth CV et al (2013) Underuse of post cesarean thromboembolic prphylaxis Am J Obstet and Gynecol 122(6)1197-204

Slide 14

Underuse of Post-cesarean Thromboembolic Prophylaxis

Lack of Protocol Adherence

bull Systematic review of over 2500 surgical patients demonstrated up to one fourth are noncompliant with post operative mechanical thromboprophylaxis

bull Observational study demonstrated noncompliance with post-cesarean mechanical thromboprophylaxis in 21 of 293 patients

bull Lack of adherence persist despite education amp audits

Craigie Samantha et al Adherence to mechanical thromboprophylaxis after surgery A systematic review and meta-analysis Thrombosis Research (2015) 136 (4) 723 ndash 72

Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Brady et al Sequential Compression Device Compliance in Postoperative Obstetrics and Gynecology Patients Obstet amp Gynecol (2015 Jan) 125 (1) 19

Slide 15

Maternal Venous Thromboembolism Prevention Safety Bundle

bull Use a standardized thromboembolism risk assessment tool for VTE during

bull Outpatient prenatal care

bull Antepartum hospitalization

bull Hospitalization after cesarean or vaginal deliveries

bull Postpartum period (up to 6 weeks after delivery)

RECOGNITION (Every Patient)bull Apply standardized tool to all patient to asses VTE risk at time point designated under

ldquoReadinessrdquo

bull Apply standardized tool to identify patients for thromboprophylaxis

bull Provide patient education

bull Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis

RESPONSE (Every Unit)bull Use standardized recommendations for mechanical thromboprophylaxis

bull Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation

bull Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia

REPORTINGSYSTEMS LEARNING (Every Unit)bull Review all thromboembolism events for systems issues and compliance with protocols

bull Monitor process metrics and outcomes in a standardized fashion

bull Assess for complications of pharmacologic thromboprophylaxis

READINESS (Every Unit)

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 13

Underuse of Post-cesarean Thromboembolic Prophylaxis

Characteristic None Mechanical Pharmacologic Combination

955787 (757) 278669 (221) 16639 (13) 12110 (10)

Year of Surgery

2003 115663 (916) 8717 (69) 1274 (10) 664 (05)

2004 124230 (874) 15674 (110) 1319 (09) 923 (07)

2005 131220 (846) 21013 (135) 1889 (12) 1051 (07)

2006 154876 (810) 32302 (169) 2413 (13) 1608 (08)

2007 145589 (747) 44842 (230) 2451 (13) 2053 (11)

2008 131250 (660) 62545 (314) 2852 (14) 2294 (12)

2009 125096 (605) 75315 (364) 3609 (18) 2753 (13)

2010 27863 (584) 18261 (383) 832 (17) 764 (16)

Friedman AM Ananth CV et al (2013) Underuse of post cesarean thromboembolic prphylaxis Am J Obstet and Gynecol 122(6)1197-204

Slide 14

Underuse of Post-cesarean Thromboembolic Prophylaxis

Lack of Protocol Adherence

bull Systematic review of over 2500 surgical patients demonstrated up to one fourth are noncompliant with post operative mechanical thromboprophylaxis

bull Observational study demonstrated noncompliance with post-cesarean mechanical thromboprophylaxis in 21 of 293 patients

bull Lack of adherence persist despite education amp audits

Craigie Samantha et al Adherence to mechanical thromboprophylaxis after surgery A systematic review and meta-analysis Thrombosis Research (2015) 136 (4) 723 ndash 72

Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Brady et al Sequential Compression Device Compliance in Postoperative Obstetrics and Gynecology Patients Obstet amp Gynecol (2015 Jan) 125 (1) 19

Slide 15

Maternal Venous Thromboembolism Prevention Safety Bundle

bull Use a standardized thromboembolism risk assessment tool for VTE during

bull Outpatient prenatal care

bull Antepartum hospitalization

bull Hospitalization after cesarean or vaginal deliveries

bull Postpartum period (up to 6 weeks after delivery)

RECOGNITION (Every Patient)bull Apply standardized tool to all patient to asses VTE risk at time point designated under

ldquoReadinessrdquo

bull Apply standardized tool to identify patients for thromboprophylaxis

bull Provide patient education

bull Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis

RESPONSE (Every Unit)bull Use standardized recommendations for mechanical thromboprophylaxis

bull Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation

bull Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia

REPORTINGSYSTEMS LEARNING (Every Unit)bull Review all thromboembolism events for systems issues and compliance with protocols

bull Monitor process metrics and outcomes in a standardized fashion

bull Assess for complications of pharmacologic thromboprophylaxis

READINESS (Every Unit)

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 14

Underuse of Post-cesarean Thromboembolic Prophylaxis

Lack of Protocol Adherence

bull Systematic review of over 2500 surgical patients demonstrated up to one fourth are noncompliant with post operative mechanical thromboprophylaxis

bull Observational study demonstrated noncompliance with post-cesarean mechanical thromboprophylaxis in 21 of 293 patients

bull Lack of adherence persist despite education amp audits

Craigie Samantha et al Adherence to mechanical thromboprophylaxis after surgery A systematic review and meta-analysis Thrombosis Research (2015) 136 (4) 723 ndash 72

Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Brady et al Sequential Compression Device Compliance in Postoperative Obstetrics and Gynecology Patients Obstet amp Gynecol (2015 Jan) 125 (1) 19

Slide 15

Maternal Venous Thromboembolism Prevention Safety Bundle

bull Use a standardized thromboembolism risk assessment tool for VTE during

bull Outpatient prenatal care

bull Antepartum hospitalization

bull Hospitalization after cesarean or vaginal deliveries

bull Postpartum period (up to 6 weeks after delivery)

RECOGNITION (Every Patient)bull Apply standardized tool to all patient to asses VTE risk at time point designated under

ldquoReadinessrdquo

bull Apply standardized tool to identify patients for thromboprophylaxis

bull Provide patient education

bull Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis

RESPONSE (Every Unit)bull Use standardized recommendations for mechanical thromboprophylaxis

bull Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation

bull Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia

REPORTINGSYSTEMS LEARNING (Every Unit)bull Review all thromboembolism events for systems issues and compliance with protocols

bull Monitor process metrics and outcomes in a standardized fashion

bull Assess for complications of pharmacologic thromboprophylaxis

READINESS (Every Unit)

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 15

Maternal Venous Thromboembolism Prevention Safety Bundle

bull Use a standardized thromboembolism risk assessment tool for VTE during

bull Outpatient prenatal care

bull Antepartum hospitalization

bull Hospitalization after cesarean or vaginal deliveries

bull Postpartum period (up to 6 weeks after delivery)

RECOGNITION (Every Patient)bull Apply standardized tool to all patient to asses VTE risk at time point designated under

ldquoReadinessrdquo

bull Apply standardized tool to identify patients for thromboprophylaxis

bull Provide patient education

bull Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis

RESPONSE (Every Unit)bull Use standardized recommendations for mechanical thromboprophylaxis

bull Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation

bull Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia

REPORTINGSYSTEMS LEARNING (Every Unit)bull Review all thromboembolism events for systems issues and compliance with protocols

bull Monitor process metrics and outcomes in a standardized fashion

bull Assess for complications of pharmacologic thromboprophylaxis

READINESS (Every Unit)

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 16

bull Thromboembolism prophylaxis is a Joint Commission quality measure

bull The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given

the day of or the day after hospital admission

the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admissionrdquo

VTE Prevention Readiness

Specifications Manual for National Hospital Inpatient Safety The Joint Commission (2015) 5

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 17

VTE Prevention ReadinessExcluded populations Joint Commission measure

Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics

Sample Codes

Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A Table 702)

826

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 18

Recommendation The National Partnership recommends that this Joint Commission measure be extended to the obstetric population

All patients should be assessed for VTE risk multiple times in pregnancy including during

bull Presentation for prenatal care bull Hospitalization for an antepartum indicationbull Delivery hospitalization (in-house postpartum)bull Discharge from a delivery hospitalization

VTE Prevention Readiness

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 19

VTE Prevention ReadinessVTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY

Initial Risk Assessment

Delivery amp Postpartum Discharge

5

30

60

Antepartum

frac12 of all VTE

Marik PE Venous thromboembolism in pregnancy Clin Chest Med (2010 Dec) 31(4)731-40 DOI 101016jccm201006004

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 20

VTE Prevention Recognitionbull VTE risk assessment tools should be applied to every

patient to determine risk for VTE

bull Risk assessment tools based on recommendations from major society guidelines

American College of Obstetricians and Gynecology (ACOG)

American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists

(RCOG)

bull Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricians and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 21

VTE Prevention Recognition

ANTEPARTUM MANAGEMENT

ndash ACOGbull Anticoagulation during pregnancy and postpartum for women with

a history of thrombosis or those those with high-risk acquired or inherited thrombophilias Immobility considered as a modifying risk factor

ndash ACCPbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

ndash RCOGbull Thromboprophylaxis recommended for reduced mobility history of VTE or

high risk thrombophilia

Guidelines agree on recommendations for high-risk patients

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 22

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia

1st VTE provokedFamily history of VTE with LR thrombophiliaLR thrombophilia (no prior event)

Treatment doseLMWH or UFH

ProphylacticLMWH or

UFH

No treatment

Anticoagulation

Recognition and Response at First Prenatal Visit

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 23

All patientsIn-Patient Antepartum Hospitalization for at least 72 hours

bull All patients should be considered for pharmacologic prophylaxis

bull For women at high risk of delivery or bleeding mechanical thromboprophylaxis should be utilized

bull Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia

In-Patient Antepartum HospitalizationRecognition amp Response

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 24

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION Length of Stay

TWO LARGE COHORTS SIMILAR RESULTS

HOSPITALIZED gt= 3 days ~ 12 times increased risk of VTE

ldquoThe association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity cardiac disease and varicose veinsrdquo

HOSPITALIZED lt 3 days ~ 4 times increased VTE risk

Sultan et al Risk of first venous thromboembolism in pregnant women in hospital population based cohort study from England BMJ (2013 Nov) 7 347

Virkus et al Risk Factors for Venous Thromboembolism in 13 Million Pregnancies A Nationwide Prospective Cohort PLoS One (2014 May) e96495

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 25

In-Patient Antepartum HospitalizationRecognition

ANTEPARTUM ADMISSION BMI amp Immobility

Bates SM et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice GuidelinesCHEST (2012 Feb) 141(2)(Suppl)e691Sndashe736S

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 26

LEFT

VIRCHOWrsquoS TRIAD

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 27

OB MODIFIED PADUA RISK

ASSESSMENT MODEL

Risk factors Points

Previous VTE 3

Reduced mobility (bed rest with

bathroom privileges for at least 3 days)

3

Thrombophilia 3

Acute infection andor rheumatologic

disorder

1

Obesity (BMI gt25kgm2) 1

Pregnancy 1 Antithrombin deficiency Protein C or S deficiency factor V Leiden G20210A prothrombin gene mutation

antiphospholipid antibody syndrome

Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost (2010 Nov) 8 (11)2450-7 doi 101111j1538-7836201004044x Kahn SR et al Prevention of VTE in nonsurgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (2012 Feb) 141(2 Suppl)e195S-226S doi 101378chest11-2296

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 28

RCOG Clinical Recommendations

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 29

Antepartum Hospitalization RR Warrants VTE Prophylaxis

ADMIT

1 Biologic Plausibility2 Epidemiologic Data3 RCOG amp PADUA RAM

Major Risk Factor

RR 12 - 60

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 30

bull How should patients be prophylaxed

bull After a vaginal delivery

bull After a cesarean delivery

bull Scoring systems

bull RCOG

bull ACCP

bull Caprini

Recognition and ResponsePostpartum patients in the hospital

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 31

bull All patients

Early mobilization

Avoid dehydration

bull Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH

History of VTE or thrombophilia

Already receiving LMWH or UFH as outpatients

bull For women with multiple lesser risk factors for VTE by RCOG criteria

Pharmacologic prophylaxis with LMWH or UFH may be considered

Vaginal Delivery

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 32

Women undergoing cesarean delivery should

bull Receive mechanical prophylaxis devices perioperatively and postpartum

bull Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors

An ldquoopt-outrdquo strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach

Cesarean Delivery

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 33

Chest Post Cesarean Section Recommendations

Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors

Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis

Major risk factors - VTE risk ~ 3 Minor risk factors - VTE risk ~ 3

Immobility (strict bed rest ge1 week in the antepartum period)Postpartum haemorrhage ge1000 mL with surgeryPrevious VTEPre-eclampsia with fetal growth restrictionThrombophilia

Antithrombin deficiencyFactor V Leiden (homozygous or heterozygous)Prothrombin G20210A (homozygous or heterozygous)

Medical conditionsSystemic Lupus erythematosusHeart diseaseSickle cell disease

Blood transfusionPostpartum infection

BMI gt30 kgm2Multiple pregnancyEmergency caesareanSmoking gt10 cigarettesdayFetal growth restrictionThrombophilia

Protein C deficiencyProtein S deficiency

Pre-eclampsia

ACCP Recommendations

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 34

RCOG Recommendations

bull If total score gt 4 antenatally consider thromboprophylaxis from the first trimester

bull If total score 3 antenatally consider thromboprophylaxis from 28 weeks

bull If total score gt 2 postnatally consider thrombroprophylaxis for at least 10 days

bull If admitted to hospital antenatally consider thromboprophylaxis

bull If prolonged admission (gt 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 35

1 Point

bull Family history of unprovoked or estrogen-related VTE in first-degree relative

bull Known low-risk thrombophilia (no VTEbull Age (gt35 years)bull Obesity (BMI gt30kgm2)bull Parity gt 3bull Smokerbull Gross varicose veinsbull Preeclampsia in current pregnancy

bull Assisted reproductive technologyin vitro fertilization (antenatal only)

bull Multiple pregnancybull Elective cesareanbull Mid-cavity rotational operative deliverybull Prolonged labor (gt24 hours)bull Postpartum hemorrhage (gt1 liter or blood

transfusion)bull Preterm birth lt37 weeks in current pregnancybull Stillbirth in current pregnancy

4 Points

bull Previous VTE (except for a single event related to major surgery

bull Ovarian hyperstimulation syndrome (1st trimester only)

3 Points

bull Previous VTE provoked by major surgerybull Known high-risk thrombophiliabull Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum eg

appendectomy postpartum sterilizationbull Hyperemesisbull Medical comorbidities eg cancer heart failure active systemic lupus erythematosus inflammatory

polyarthropathy or inflammatory bowel disease nephrotic syndrome type I diabetes mellitus with nephropathy sickle cell disease current intravenous drug user

2 Points

bull Cesarean in laborbull Obesity (BMI gt40kgm2)

RCOG Recommendations

Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 36

CHEST APPLICATION CAPRINI MODEL

General Abdominal or Pelvic Surgery

SCORE RISK estimated VTE risk no prophylaxis

PROPHYLAXIS

1-2 Pregnancy = 1 point

Surgery lt 45 minutes = 1

point

LOW ~ 15 risk VTE MECHANICAL- intermittent pneumatic compression

3-4 MEDIUM ~ 3 risk VTE MECHANICAL OR CHEMICAL- LMWH OR LD UFH

gt= 5 Previous VTE= 3 points

Thrombophilia = 3 pointsConsider additional

RisksMany pregnant patients will have multiple additional risks (slide )

HIGH ~ 6 risk VTE MECHANICAL PLUS CHEMICAL

Gould et al Prevention of VTE in nonorthopedic surgical patients Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines CHEST(2012 Feb) 141(2)(Suppl)e227Sndashe277S

Caprini JA Caprini DVT Risk Assessment Venous Resource Center Web httpvenousdiseasecomcaprini-dvt-risk-assessment

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 37

Table 1 Modified Caprini risk assessment model

Risk factors Points

Age 41-60 1

Minor surgery (less than 45 minutes) 1

Visible varicose veins 1

Swollen legs (current) 1

Overweight or obese (body mass index above 25kgm2) 1

Currently on bed rest 1

Serious lung disease including pneumonia (lt1 month) 1

Pregnancy or postpartum (lt1 month) 1

History of unexplained stillborn infant recurrent spontaneous abortion

(gt 3) premature birth with toxemia or growth-restricted infant

1

Other risk factors (smoking diabetes BMI gt40kgm2 blood transfusions) 1

Central venous access 2

Major surgery (gt45 minutes) 2

Patient confined to bed (gt72 hours) 2

Family history of thrombosis 3

History of DVTPE 3

Prothrombin 20210A or factor V Leiden 3

Lupus anticoagulant or elevated anticardiolipin antibodies 3

Elevated serum homocysteine 3

Other congenital or acquired thrombophilia 3

Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 38

Caesarean ThromboprophylaxisComparison of 3 Leading Guidelines

bull 293 patients included in analysis

All based on having a prior event

Emergency caesarean Pre-eclampsiaObesity Multiple gestationPostpartum haemorrhage

1

35

85

ACOG

Chest

RCOG Caesarean during labor Maternal Age ge35Obesity Pre-eclampsia Infection High Parity

In Press Palmerola KL et al A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines BJOG (2015 Oct) DOI 1011111471-052813706

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 39

Multiple VTE episodesVTE with high-risk (HR) thrombophiliaVTE with acquired thrombophilia

Clinical history

Idiopathic VTEVTE with pregnancy or oral contraceptiveVTE with low risk (LR) thrombophiliaFamily history of VTE with HR thrombophiliaHR thrombophilia (including acquired)

VTE provoked LR thrombophilia and family history of VTE

LR thrombophilia

6 Weeks Treatment LMWHUFH

No treatment

Anticoagulation

6 WeeksProphylacticLMWHUFH

(two changes from initial assessment)

Recognition and ResponsePostpartum after delivery hospitalization

Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 40

Agent LMWH

Enoxaparin Dalteparin Tinzaparin

UFH

Unfractionated heparin

Weight based Gestational age-based

lt50kg 20mg daily 2500 units daily 3500 units daily First

trimester

5000-7500 units

Twice daily

50-90kg 40mg daily 5000 units daily 4500 units daily Second

trimester

7500-10000 units

Twice daily

91-130kg 60mg daily 7500 units daily 7000 units

daily

Third

trimester

10000 units

Twice daily

131-170kg 80mg daily 10000 units

daily

9000 units daily

gt170kg 06mgkgday 75 unitskgday 75 unitskgday

Protocols for Prophylaxis

=may be given in two divided doses

Hospitalized antepartum patients may receive 5000 units UFH twice daily for

prophylaxis to facilitate regional anesthesia

Protocols for Prophylaxis

Adapted from American College of Obstetricans and Gynecologists Thromboembolism in Pregnancy Practice Bulletin No 123 Obstet Gynecol (2011) 118 718ndash29 Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015 Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 41

AntepartumIntrapartum

UFH le10000IUdayNo contraindications to timing of heparin dose and performance of neuraxial blockadeyen

UFH gt10000IUdayWait 12 hours after last dose prior to neuraxial blockade or check

aPPT

IV HeparinWait 4-6 hours after discontinuation of IV heparin consider checking aPPT

LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade

LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade

Postpartum

UFH le10000IUdayHeparin may be administered at any time interval after epidural catheter removal or spinal needle placement

UFH gt10000IUday or IV Heparin

Wait ge1 hour after epidural catheter removal or spinal needle placement

LMWH prophylaxisWait ge4 hours after epidural catheter removal or spinal needle placement

LMWH therapeuticAvoid therapeutic dosing with epidural catheter in situ Wait at least 24 hours after catheter removal or spinal needle

Timing of Neuroaxial Anesthesia

yen No specific society guidelines for management of

patients also receiving aspirin No specific society guidelines for management

FDA FDA Drug Safety Communication Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (2013 Nov)

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Horlocker TT et al Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition) Regional Anesthesia and Pain Medicine (2010) 35 (1) 64-101

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 42

bull Unfractionated heparin (UFH)

The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal

A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria

NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 43

bull Low-molecular-weight heparin (LMWH)

The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique

If an epidural catheter remains in situ for pain control it should not be removed until 12 hours after last dose of LMWH

If the epidural catheter is to be removed prior to a dose of LMWH the LMWH may not be given until 4 hours after removal

Sources FDA Drug Safety Communication Nov 2013 NYP protocol

Post-Cesarean VTE Prophylaxis

New York Presbyterian Hospital Surgical Prophylaxis Antibiotic Recommendations for Adult Patients

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 44

Heparin Induced Thrombocytopenia (HIT)

bull Extremely rare complication in the obstetric population receiving UFHLMWH for VTE prevention

bull For patients expected to be on either UFH or LMWH for greater than gt7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy

bull Some guidelines such as those from ASRA recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 45

ReportingSystems LearningRecommendation

Review all thromboembolism events for systems issues and compliance with protocols

Monitor process metrics and outcomes in a standardized fashion

Assess for complications of pharmacologic thromboprophylaxis

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 46

bull All patients require VTE risk assessment at multiple time points in pregnancy and postpartum

bull All patients undergoing cesarean delivery require mechanical prophylaxis early ambulation and adequate hydration

bull Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis

bull Empiric pharmacologic prophylaxis is a reasonable option for

all women undergoing cesarean delivery

all antepartum hospital admissions gt72 hours

Conclusion

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 47

Bundle ResourcesREADINESS

ndash Bahl V et al A validation study of a retrospective venous thromboembolism risk scoring method Ann Surg 2010 Feb251(2)344-50 Note Abstract only must be subscriber to access full-text

ndash Barbar S et al A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism the Padua Prediction Score J Thromb Haemost 2010 Nov8(11)2450-7

ndash Bates S et al VTE thrombophilia antithrombotic therapy and pregnancy Antithrombotic Therapy and Prevention of Thrombosis 9th ed American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 Feb141(2 Suppl)e691S-736S

ndash Royal College of Obstetricians and Gynaecologists Thrombosis and Embolism during Pregnancy and the Puerperium Reducing the Risk Green-top Guideline No 37a April 2015

ndash Thromboembolism in Pregnancy ACOG practice bulletin No 123 American College of Obstetricians and Gynecologists Obstet Gynecol 2011 Sep118(3)718-29 Available until 102816

RECOGNITIONndash National Blood Clot Alliance Available at httpwwwstoptheclotorg Retrieved October 29 2015 ndash Partnership for Patients Venous Thromboembolism (VTE) Resource List ndash Available at httppartnershipforpatientscmsgovp4p_resourcestsp-

venusthromboembolismtoolvenousthromboembolismvtehtml Retrieved October 29 2015

RESPONSE ndash American College of Obstetricians and Gynecologists Safe motherhood initiative Availablendash at httpwwwacogorgAbout-ACOGACOG-DistrictsDistrict-IISMI-Registration Retrieved September

22 2014ndash Dresang L et al Venous Thromboembolism During Pregnancy Am Fam Physician 2008 Jun

1577(12)1709-1716ndash Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ) May 2010 Available at

httparchiveahrqgovnewseventsconference2009maynard2indexhtml Retrieved October 29 2015

REPORTINGSYSTEMS LEARNINGNo resources selected

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 48

QampA Session Press 1 to ask a question

You will enter the question queue

Your line will be unmuted by the operator for your turn

A recording of this presentation will be made available on our website

wwwsafehealthcareforeverywomanorg

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress

Slide 49

Next Safety Action Series

Click Here to Register

Empowering Patients Improving Outcomes

Maternal Mental Health Presentation

Monday December 14th 2015 | 1200 pm Eastern

Lisa Kay

2020 Mom

Lynne McIntyre

Postpartum Support International

Katherine Stone

Postpartum Progress