PULMONARY EMBOLISM/VTE CARE PROCESS MODELIMCP FALL CONFERENCE 2017

Scott Stevens, MD

Co-Director, Thrombosis Clinic & Thrombosis Research Group

Intermountain Medical CenterProfessor of Clinical Medicine

The University of Utah School of Medicine

• VTE is COMMON

Why a VTE Care Process Model?

The Scope of the Problem

2006 2050

Fatal PE

N= 30,000

PE

N= 300,000

VTE

N= 950,000

Fatal PE

N= 60,000

PE

N= 600,000

VTE

N= 1,820,000

Arterioscler Thromb Vasc Biol. 2008 March ; 28(3): 370–372. Am J Hematol 2011;86:217-20

• VTE is CHALLENGING TO DIAGNOSE

Why a VTE Care Process Model?

Recommendations

Recommendations Algorithm Figures

3.2. In patients with a low pretest probability of first lower extremity DVT (see Fig 1 ), we recommend one of the following initial tests: (i) a moderately sensitive d-dimer, (ii) a highly sensitive d-dimer, or (iii) CUS of the proximal veins rather than (i) no diagnostic testing (Grade 1B for all comparisons) , (ii) venography (Grade 1B for all comparisons) , or (iii) whole-leg US (Grade 2B for all comparisons) .

We suggest initial use of a moderately sensitive (Grade 2C) or highly sensitive (Grade 2B) D-dimer rather than proximal CUS.

Chest 2012;141;e351S-e418S

• IMAGING for VTE is OVERUTILIZED

Why a VTE Care Process Model?

VTE Imaging

• >90% of VTE imaging is negative

• 1592 of 3500 (45.5%) CTPA studies were avoidable in an Intermountain series

• Isolated subsegmental PE and isolated distal DVT may not require treatment, but comprise 15-40% of cases

Am J Med 2013;126:36-42. J Thromb Haemost 2017;15:1040-3. Chest 2016;149:315-52. Arch Intern Med. 2011; 171:831-9

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Events per 100,000 persons

AnticoagulantComplications

Fatal PE

CTPA Enters Widespread

Use

• VTE has MANY THERAPEUTIC CHOICES

Why a VTE Care Process Model?

VTE Therapy

• At least eight different anticoagulant regimens are available for VTE

• Additionally• Systemic thrombolysis

• Catheter-directed thrombolysis

• Pharmaco-mechanical thrombus removal

• Surgical (open) embolectomy

JAMA. 2014;312(11):1122-35

VTE Care Process Model

Flow of Care

Secondary Prevention/Indefinite

Anticoagulation

Acute Phase Anticoagulation

Anticoagultion Initiation

Severity Assessment & Special Procedures

Diagnosis Confirm Diagnosis

Determine Venue of Treatment

Determine Need for Special Procedures

Choose Anticoagulant Agent

Determine Initiation Strategy

Monitor Safety and Efficacy of Therapy

Determine Need for Ongoing Anticoagulation

vs. Cessation

VTE Care Process Model

Detailed Roadmap

VTE Suspected

PE Diagnosis

Algorithm

AC ContraindicationAssessment

PE Risk Assessment & Interventional

Treatment Algorithm

Low Risk

Anticoagulation Initiation Algorithm

Acute Phase Anticoagulation*

Indefinite Anticoagulation vs. Cessation Algorithm

Subsegmental PE Assessment

Low-Intermediate Risk

Anticoagulation Initiation Algorithm

Acute Phase Anticoagulation*

Indefinite Anticoagulation vs. Cessation Algorithm

High-Intermediate Risk

Anticoagulation Initiation Algorithm

Acute Phase Anticoagulation*

Indefinite Anticoagulation vs. Cessation Algorithm

Interventional Therapy for PE

High Risk

Interventional Therapy for PE

Anticoagulation Initiation Algorithm

Acute Phase Anticoagulation*

Indefinite Anticoagulation vs. Cessation Algorithm

IVC Filter Algorithm

Pregnant Patient:

See PE Diagnosis in Pregnancy Algorithm

DVT Diagnosis Algorithm

AC Contraindication Assessment

DVT Risk Assessment & Interventional

Treatment Algorithm

Anticoagulation Initiation Algorithm

Acute Phase Anticoagulation*

Indefinite Anticoagulation vs. Cessation Algorithm

Interventional Therapy for DVT

IVC Filter Algorithm

SVT Diagnosed:

SVT Management Algorithm

*If unfractionated heparin or unfractionated heparin used and a fall in platelets occurs, refer to:

HIT Algorithm

Overview Page

• Provides a view of the entire process from diagnosis through decision-making regarding duration of anticoagulant treatment.

• The gray trapezoids are hyperlinks to more detailed information and decision support.

Highlights

Diagnosis

VTE: The Early Diagnostic Toolkit

Pre 1960’s

1980’s

+ +

The Contemporary Diagnostic Toolkit

Pretest Probability

Clinical Prediction Guides (CPG’s)Rates of DVT by Category

5%

17%

53%

0

0.1

0.2

0.3

0.4

0.5

0.6

Low Moderate High

%DVT

JAMA 2006;295 (2):199-207

Wells Score - DVTItem Points

Active Cancer 1

Paralysis, Paresis, Recent Cast 1

Bedridden or Surgery in last 12 weeks

1

Localized Tenderness 1

Entire leg swollen 1

> 3cm calf asymmetry 1

Pitting edema (affected leg) 1

Collateral (non-varicose) veins 1

Previous DVT 1

Alternate Diagnosis as likely -2

< 0 = Low 1-2 = Moderate > 3 = High

Thromb Haemost 2000; 83: 416–20. Ann Intern Med 2006; 349: 144-165

Revised Geneva ScoreItem Points

Age > 65 1

Previous VTE 3

Surgery/Fracture (within 4 weeks) 2

Active Cancer 2

Pulse 74-94 3

Pulse > 94 5

Leg pain on palpation or edema 4

Unilateral leg pain 3

Hemoptysis 2

0-3 = Low 4-10 = Intermediate

11 = High

<10 = PE Unlikely >10 = PE Likely

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Low Int High

% PE

Pretest Probability Clinical Prediction Guides (CPG’s)Rates of PE by Category

PE DiagnosisPublished Models

Model McGinn Scale VTE Rate(With –DD)

% With no Imaging

Revised Geneva 1 0.5% 22%

Wells 1 0.5% 23%

Simplified Wells 2 0.6% 23%

Simplified Revised Geneva 3 0.5% 24%

Arch Intern Med 2001;161:92-7. Ann Intern Med 2006;144:165-71. Thromb Haemost 2000;83:416-20. Eur J Nucl Med Mol Imaging 2003;30:1450-6. Am J Med 2003;114:173-9. Ann Emerg Med 2002;39:144-52. Arch Intern Med 2008;168:2131-6. Thromb Haemost 2008;99:229-34. J Thromb Haemost Feb 9 2010. Ann Intern

Med. 2011 Jun 7;154(11):709-718.

Laboratory

Highly Sensitive• Sensitivity 93-95%

• ELISAs, quantitative latex or immunoturbidimetric

Moderately Sensitive• Sensitivity 85%

• Whole blood assay

Di Nisio et al. J Thromb Haemost 2007;5 (2):296-304

Advances in D-dimerAge-adjusted thresholds

Rationale• D-dimer elevates with age

• Active PE likely further adds to this baseline value

D-dimer “negative”o < Age x 10 (age 50+)

0 20 40

VTE Rate

% Negative

<Age x 10

<500

JAMA. 2014;311(11):1117-1124

Is D-dimer always needed?

• D-dimer is nonspecific

• A positive d-dimer obliges an imaging order, even if pre-test probability of PE is very low

• The PERC score safely rules out PE in 20% of patients without d-dimer

Thromb Haemost 2008;6:772-80

PERC Score

Item Points

PE likelihood 15% or more(Gestalt)

1

Age > 50 years 1

Sa02 < 93% 1

Surgery or Hospitalization within 4 weeks

1

Unilateral Leg Swelling 1

Previous VTE 1

Estrogen Use 1

Pulse > 100 bpm 1

Hemoptysis 1

Score = 0 PE Ruled Out

Score > 0 Obtain d-dimer

• Algorithmic approach reduces imaging by 25-30% while safely excluding VTE

• Checklists assist with pre-test probability scoring

VTE Diagnosis

Highlights

Selection of Anticoagulant

Phases of Treatment for Acute VTE

Init

iati

on

Ph

ase Suppress

Thrombin Burst

Prevent Embolization

Lon

g-Te

rm P

has

e Prevent propagation while thrombus heals/organizes

Exte

nd

ed P

has

e Prevent new episodes of thrombosis

5 Days – 3 Weeks

3 MonthsNo planned

stop date

Treatment OptionsInitiation Long Term Extended

UFH/LMWH + Warfarin(5+ Days)

Warfarin @ INR 2-3 Warfarin @ INR 2-3

Enoxaparin 1mg/kg BID (5-10 days)

Dabigatran 150 BID Dabigatran 150 BID

Enoxaparin 1mg/kg BID(7 days)

Edoxaban 60mg Daily Edoxaban 60mg Daily

Apixaban 10mg BID(7 days)

Apixaban 5mg BID(6 months)

Apixaban 2.5mg BID

Rivaroxaban 15mg BID(21 days)

Rivaroxaban 20mg Daily Rivaroxaban 20mg Daily

Dalteparin 200 IU/Kg Daily(1 month)

Dalteparin 150 IU/Kg Daily Dalteparin 150 IU/Kg Daily(? Reduce dose)

Enoxaparin 1mg/kg BID Enoxaparin 1mg/kg BID Enoxaparin 1mg/kg BID (?Reduce Dose)

Swit

cher

sLo

ader

sC

ance

r

Treatment Selection

JAMA. 2014;312(11):1122-35

AT10 Guideline Statement:

AT10 Choice of anticoagulant for long-term treatment of DVT and PE: DOAC vs. warfarin

In patients with DVT of the leg or PE and no cancer, as long-term (first 3 months) anticoagulant therapy, we suggest apixaban or edoxaban or rivaroxaban or dabigatran over VKA therapy (Grade 2B).Remarks: Acute therapy with parenteral anticoagulation is given before dabigatran and edoxaban.

Chest 2016;149(2):315-52

• DOAC preferred in most cases

• Assistance with selection and dosing strategy

Selection of Anticoagulant

Highlights

Treatment Venue

PE Risk Stratification

ESC System

Acu

te P

E

Low Risk

Low-Intermediate Risk

High-Intermediate Risk

High-Risk

PESI Score

Item Points

Age Age x 1

Male 10

History of Cancer 30

History of Heart Failure 10

History of Chronic Lung Disease 10

Pule > 110 bpm 20

SBP < 100 mmHg 30

Respirations > 30/min 20

Temperature < 36 20

Altered Mental Status 60

Sa02 < 90% 20

Class I < 65

Class II 66 - 85

Eur Heart J 2008;29:2276-315. Lancet 2011;378:41-8

VTE Hospitalization Rates

Venue of Care US Versus Canada

• PE• An RCT and multiple prospective trials

support outpatient treatment for low-risk PE(PESI < 85)o Watch for a study from Intermountain

• Higher risk PE requires ICU care

• DVT• Outpatient management of DVT has been

supported by RCT data since the early 1990’so Mortality does not differ

o Morbidity is better in outpatients

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Chart Title

US Canada

Thromb Res 2017;156:149-54

AT10 Guideline Statement:

AT10 Treatment of Acute PE Out of the Hospital

In patients with low-risk PE and whose home circumstances are adequate, we suggest treatment at home or early discharge over standard discharge (eg, after first 5 days of treatment)(Grade 2B).

Chest 2016;149(2):315-52

• Assistance with prognostic scoring

• Protocol support for outpatient care of selected low-risk PE

• Emergency/ICU treatment for high-risk PE

Venue of Care

Highlights

Avoiding Overtreatment

Isolated Distal DVT Outcomes and Prognosis

Proximal DVT• Rate of PE >40%

• Rate of PTS 20-40%

IDDVT

Rate of PE <5% (Axial)

Rate of PTS ~10% (Axial)

Rate of Propagation

21.4% (10-29%) (Axial)

~3% (Muscular)

J Vasc Surg 2003;37:523-527. Chest 2012;141;e351S-e418S. Health Technol Assess . 2006; 10 ( 15 ): 1 - 168.0.

AT10: Whether to Anticoagulate Isolated Distal Deep Vein Thrombosis

Extension Risk Factors

• Positive D –dimer

• Extensive or close to the proximal veins

• No reversible provocation

• Cancer

• Prior DVT

• Inpatient

13. In patients with acute isolated distal DVT of the leg and (i) without severe symptoms or risk factors forextension (see text), we suggest serial imaging of the deep veins for 2 weeks over anticoagulation (Grade 2C).

Chest 2016;149(2):315-52

Wiener RS et al. Arch Intern Med. 2011; 171:831-9

Is PE Overtreated?Secular Trend in Anticoagulation Complications following CTPA

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Events per 100,000 persons

AnticoagulantComplications

Fatal PE

CTPA Enters Widespread

Use

Evaluation of Individuals with Pulmonary Nodules: General Approach

42. In patients with subsegmental PE (no involvement of more proximal pulmonary arteries), no proximal DVT in the legs, and a low risk for recurrent VTE (see text), we suggest clinical surveillance over anticoagulation(Grade 2C).

AT10: Whether to Anticoagulate SubsegmentalPulmonary Embolism

43. In patients with subsegmental PE (no involvement of more proximal pulmonary arteries), no proximal DVT in the legs, and a high risk for recurrent VTE (see text), we suggest anticoagulation over clinical surveillance (Grade 2C).

Chest 2016;149(2):315-52

Progression Risk Factors

• Hospitalized or immobile patient

• Active cancer

• No reversible risk factors

• D-dimer elevated (marked, unexplained)

• Assistance for deciding whether to offer anticoagulation therapy for:

• Isolated subsegmental PE

• Isolated Distal DVT

Avoiding Overtreatment

This is Intermountain, right?

Where are my eProtocols?

The VTE Care Pathway in iCentra

The VTE CPM Team

Stacy HillingCarl BlackColleen RobertsDavid JacksonDon LappeC. Gregory ElliottJames HellewellJoseph BledsoeKaren ConnerKathryn KutlerMark KringlenMark MankivskyNancy NelsonPeter HaugRich PattenScott StevensScott WollerSteven HessTerry Clemmer

Thank you!

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