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Optimal Strategies for DVT Optimal Strategies for DVT Prophylaxis: Translating Evidence Prophylaxis: Translating Evidence into Practice into Practice Samuel Z. Goldhaber, MD Samuel Z. Goldhaber, MD Cardiovascular Division Cardiovascular Division Brigham and Women’s Hospital Brigham and Women’s Hospital Professor of Medicine Professor of Medicine Harvard Medical School Harvard Medical School DVT-WRAP SlideCAST DVT-WRAP SlideCAST

Optimal Strategies for DVT Prophylaxis: Translating Evidence into Practice Samuel Z. Goldhaber, MD Cardiovascular Division Brigham and Women’s Hospital

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  • Optimal Strategies for DVT Prophylaxis: Translating Evidence into Practice Samuel Z. Goldhaber, MD Cardiovascular Division Brigham and Womens Hospital Professor of Medicine Harvard Medical School Samuel Z. Goldhaber, MD Cardiovascular Division Brigham and Womens Hospital Professor of Medicine Harvard Medical School DVT-WRAP SlideCAST
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  • The Challenge DVT/ PE are rampant but often preventable. Hospitalized patients are at risk, but prophylactic measures are often omitted. Behavior Modification and Quality Improvement strategies: - Electronic, Human alerts - 3-screen alert with default prophylaxis - Continuum of Care (ensure prophylaxis from admission to discharge, to SNF, and at home) DVT/ PE are rampant but often preventable. Hospitalized patients are at risk, but prophylactic measures are often omitted. Behavior Modification and Quality Improvement strategies: - Electronic, Human alerts - 3-screen alert with default prophylaxis - Continuum of Care (ensure prophylaxis from admission to discharge, to SNF, and at home)
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  • Lung with PE
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  • PE SXS/ Signs (PIOPED II) Dyspnea (79%) Tachypnea (57%) Pleuritic pain (47%) Leg edema, erythema, tenderness, palpable cord (47%) Cough/ hemoptysis (43%) Dyspnea (79%) Tachypnea (57%) Pleuritic pain (47%) Leg edema, erythema, tenderness, palpable cord (47%) Cough/ hemoptysis (43%) Stein PD. Am J Med 2007; 120: 871-879
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  • Incidence 900,000 PEs/ DVTs in USA in 2002. Estimated 296,000 PE deaths: 7% treated, 34% sudden and fatal, and 59% undetected. Heit J. ASH Abstract 2005 ----------------------------------------- 762,000 PEs/ DVTs in EU in 2004. Thromb Haemostas 2007; 98: 756
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  • The high death rate from PE (exceeding acute MI!) and the high frequency of undiagnosed PE causing sudden cardiac death emphasize the need for improved preventive efforts. Failure to institute prophylaxis is a much bigger problem with Medical Service patients than Surgical Service patients. The high death rate from PE (exceeding acute MI!) and the high frequency of undiagnosed PE causing sudden cardiac death emphasize the need for improved preventive efforts. Failure to institute prophylaxis is a much bigger problem with Medical Service patients than Surgical Service patients.
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  • Annual # At-Risk for VTE: US Hospitals 7.7 million Medical Service inpatients 3.4 million Surgical Service inpatients Based upon ACCP guidelines for VTE prophylaxis Anderson FA Jr, et al. Am J Hematol 2007; 82: 777-782 7.7 million Medical Service inpatients 3.4 million Surgical Service inpatients Based upon ACCP guidelines for VTE prophylaxis Anderson FA Jr, et al. Am J Hematol 2007; 82: 777-782
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  • Malignant Gliomas (N=9,489) and VTE California Cancer Registry 2-year VTE Incidence: 7.5% 16 VTE events per 100 person-years during 1 st 6 months Risk factors: older age, neurosurgery VTE: 30% increased risk of death California Cancer Registry 2-year VTE Incidence: 7.5% 16 VTE events per 100 person-years during 1 st 6 months Risk factors: older age, neurosurgery VTE: 30% increased risk of death J Neurosurg 2007; 106: 601-608
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  • Outpatient and Inpatient VTE are Linked 74% of VTEs present in outpatients. 42% of outpatient VTE patients have had recent surgery or hospitalization. Only 40% had received VTE prophylaxis. 74% of VTEs present in outpatients. 42% of outpatient VTE patients have had recent surgery or hospitalization. Only 40% had received VTE prophylaxis. Spencer FA, et al. Arch Intern Med 2007; 167: 1471-1475
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  • ICOPER Cumulative Mortality Mortality (%) Days From Diagnosis 17.5% 0 5 10 15 20 25 714306090 Lancet 1999; 353: 1386-1389
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  • Progression of Chronic Venous Insufficiency From UpToDate 2006
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  • Risk Factors Linking Venous and Arterial TE: Biologically Plausible 1.Activation of platelets and coagulation proteins 2.Increased fibrin turnover 3.Inflammation 4.Lipid profiles 1.Activation of platelets and coagulation proteins 2.Increased fibrin turnover 3.Inflammation 4.Lipid profiles
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  • Dabish 20-Year Cohort: VTE, Subsequent CV Events Assessed risk of MI, Stroke 25,199 with DVT 16,925 with PE 163,566 population controls Assessed risk of MI, Stroke 25,199 with DVT 16,925 with PE 163,566 population controls Sorensen HT. Lancet 2007; 370: 1773-1779
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  • RR CV Event in PE Patients CV Event 1 Year RR 2-20 Year RR Acute MI 2.61.3 Stroke2.91.3 Sorensen HT. Lancet 2007; 370: 1773-1779
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  • Cardiovascular Risk Factors and VTE (N=63,552 meta-analysis) RFRR Obesity2.3 Hypertension1.5 Diabetes1.4 Cigarettes1.2 High Cholesterol1.2 RFRR Obesity2.3 Hypertension1.5 Diabetes1.4 Cigarettes1.2 High Cholesterol1.2 Ageno W. Circulation 2008; 117: 93-102
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  • Risk Factors Meta-Analysis Implications 1.RFs for atherothrombosis are also associated with VTE 2.Cardiovascular RFs may be involved in pathogenesis of VTE 3.Atherosclerosis and VTE are not completely distinct entities. 1.RFs for atherothrombosis are also associated with VTE 2.Cardiovascular RFs may be involved in pathogenesis of VTE 3.Atherosclerosis and VTE are not completely distinct entities. Ageno W. Circulation 2008; 117: 93-102
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  • Obesity and VTE: NHDS AGE RR (PE) RR (DVT) < 40 y 5.25.2 All Ages 2.22.5 Stein PD. Am J Med 2005; 118: 978-980
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  • Steffen LM. Circulation 2007;115:188-195 Eat Veggies and Lower VTE Risk; Careful with Red Meat Adjusted Hazard Ratios (Quintiles) 2345p Fruits, veggie 0.730.570.47 0.59 0.03 Fish 0.580.600.55 0.70 0.30 Red Meat 1.241.211.09 2.01 0.02
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  • Reversible Risk Factors 1.Nutrition: eat fruits, veggies, fish; less red meat 2.Quit cigarettes 3.Lose weight/ exercise 4.Prevent DM/ metabolic syndrome 5.Control hypertension 6.Lower cholesterol 1.Nutrition: eat fruits, veggies, fish; less red meat 2.Quit cigarettes 3.Lose weight/ exercise 4.Prevent DM/ metabolic syndrome 5.Control hypertension 6.Lower cholesterol
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  • VTE Prophylaxis in 19,958 Medical Patients/ 9 Studies (Meta-Analysis) 62% reduction in fatal PE 57% reduction in fatal or nonfatal PE 53% reduction in DVT 62% reduction in fatal PE 57% reduction in fatal or nonfatal PE 53% reduction in DVT Dentali F, et al. Ann Intern Med 2007; 146: 278-288
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  • Intermittent Pneumatic Compression Meta-Analysis in Postop Patients 2,270 patients in 15 randomized trials IPC devices reduced DVT risk by 60% (Relative Risk 0.40, 95% CI 0.29-0.56, p< 0.001) 2,270 patients in 15 randomized trials IPC devices reduced DVT risk by 60% (Relative Risk 0.40, 95% CI 0.29-0.56, p< 0.001) Urbankova J. Thromb Haemost 2005; 94: 1181-5
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  • The Amin Report: Prophylaxis Rates in the US Studied 196,104 Medical Service discharges from 227 hospitals (Premier database). VTE prophylaxis rate was 62%. ACCP-deemed appropriate prophylaxis rate was 34%. Studied 196,104 Medical Service discharges from 227 hospitals (Premier database). VTE prophylaxis rate was 62%. ACCP-deemed appropriate prophylaxis rate was 34%. J Thromb Haemostas 2007; 5: 1610-6
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  • Medical Patient Prophylaxis in Canada Studied 1,894 Medical Service discharges from 29 hospitals. VTE prophylaxis was indicated in 90% of patients. ACCP-deemed appropriate prophylaxis rate was 16%. Studied 1,894 Medical Service discharges from 29 hospitals. VTE prophylaxis was indicated in 90% of patients. ACCP-deemed appropriate prophylaxis rate was 16%. Thrombosis Research 2007; 119: 145-155
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  • ENDORSE : WORLDWIDE (Lancet 2008; 371: 387-394) 68,183 patients; 32 countries; 358 sites First patient enrolled August 2, 2006;Last patient enrolled January 4, 2007
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  • 42% at Risk for VTE Medical 40% receive ACCP Rec. Px 64% at Risk for VTE 59% receive ACCP Rec. Px Surgical Worldwide Prophylaxis Status for 68,183 Patients 52% at Risk for VTE (50% receive ACCP recommended prophy)
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  • We have initiated trials to change MD behavior and improve implementation of VTE prophylaxisnot trials of specific types of prophylaxiseAlert RCT, eAlert cohort, human Alert, 3-screen eAlert.
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  • Quality Improvement Initiative to Improve Clinical Practice Randomized controlled trial to issue or withhold electronic alerts to MDs whose high-risk patients were not receiving DVT prophylaxis. Kucher N, et al. NEJM 2005;352:969-977
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  • Definition of High Risk VTE risk score 4 points: Cancer3(ICD codes) Prior VTE3(ICD codes) Hypercoagulability3(Leiden, ACLA) Major surgery2(> 60 minutes) Bed rest1(bed rest order) Advanced age1(> 70 years) Obesity1(BMI > 29 kg/m 2 ) HRT/OC1(order entry) VTE risk score 4 points: Cancer3(ICD codes) Prior VTE3(ICD codes) Hypercoagulability3(Leiden, ACLA) Major surgery2(> 60 minutes) Bed rest1(bed rest order) Advanced age1(> 70 years) Obesity1(BMI > 29 kg/m 2 ) HRT/OC1(order entry)
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  • Randomization VTE risk score > 4 No prophylaxis N = 2,506 INTERVENTION: Single alert N = 1,255 CONTROL No computer alert N = 1,251 Kucher N, et al. NEJM 2005;352:969-977
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  • DVT Alert Screen
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  • Rule Logic Alert Details
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  • Option A
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  • Option B
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  • Option C or Done
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  • 90-Day Primary Endpoint Intervent. Control Hazard Ratio p Intervent. Control Hazard Ratio p N=1255 N=1251 (95% CI) N=1255 N=1251 (95% CI) Total VTE 61 (4.9) 103 (8.2) 0.59 (0.43-0.81) 0.001 Total VTE 61 (4.9) 103 (8.2) 0.59 (0.43-0.81) 0.001 Acute PE 14 (1.1) 35 (2.8) 0.40 (0.21-0.74) 0.004 Acute PE 14 (1.1) 35 (2.8) 0.40 (0.21-0.74) 0.004 Proximal DVT 10 (0.8) 23 (1.8) 0.47 (0.20-1.09) 0.08 Proximal DVT 10 (0.8) 23 (1.8) 0.47 (0.20-1.09) 0.08 Distal DVT 5 (0.4) 12 (1.0) 0.42 (0.15-1.18) 0.10 Distal DVT 5 (0.4) 12 (1.0) 0.42 (0.15-1.18) 0.10 UE DVT 32 (2.5) 33 (2.6) 0.97 (0.60-1.58) 0.90 UE DVT 32 (2.5) 33 (2.6) 0.97 (0.60-1.58) 0.90 Intervent. Control Hazard Ratio p Intervent. Control Hazard Ratio p N=1255 N=1251 (95% CI) N=1255 N=1251 (95% CI) Total VTE 61 (4.9) 103 (8.2) 0.59 (0.43-0.81) 0.001 Total VTE 61 (4.9) 103 (8.2) 0.59 (0.43-0.81) 0.001 Acute PE 14 (1.1) 35 (2.8) 0.40 (0.21-0.74) 0.004 Acute PE 14 (1.1) 35 (2.8) 0.40 (0.21-0.74) 0.004 Proximal DVT 10 (0.8) 23 (1.8) 0.47 (0.20-1.09) 0.08 Proximal DVT 10 (0.8) 23 (1.8) 0.47 (0.20-1.09) 0.08 Distal DVT 5 (0.4) 12 (1.0) 0.42 (0.15-1.18) 0.10 Distal DVT 5 (0.4) 12 (1.0) 0.42 (0.15-1.18) 0.10 UE DVT 32 (2.5) 33 (2.6) 0.97 (0.60-1.58) 0.90 UE DVT 32 (2.5) 33 (2.6) 0.97 (0.60-1.58) 0.90 Kucher N, et al. NEJM 2005;352:969-977
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  • Primary End Point Intervention Control Number at risk 1255977900853 1251976893839 Intervention Control Time (days) 0306090 %Freedom from DVT/ PE 90 92 94 96 98 100 Kucher N, et al. NEJM 2005;352:969-977
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  • Purpose: To evaluate use of the VTE risk score and eAlert system in real world setting To validate the efficacy of continued use of the eAlert after discontinuing randomization To determine whether VTE prophylaxis prescribing changed following NEJM publication Purpose: To evaluate use of the VTE risk score and eAlert system in real world setting To validate the efficacy of continued use of the eAlert after discontinuing randomization To determine whether VTE prophylaxis prescribing changed following NEJM publication J Thromb Thrombolysis 2008;25: 146-50 Electronic Alert Cohort
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  • We identified 866 consecutive patients between January 2004 and July 2006 following completion of original study All patients met same inclusion/ exclusion NEJM eAlert criteria Rules for generating alerts remained identical to original VTE eAlert study We identified 866 consecutive patients between January 2004 and July 2006 following completion of original study All patients met same inclusion/ exclusion NEJM eAlert criteria Rules for generating alerts remained identical to original VTE eAlert study Baroletti S et al. J Thrombosis Thrombolysis 2008; 25: 146-50)
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  • Cohort Study: Results P