Transcript Document

DVT-WRAP SlideCAST
Optimal Strategies for DVT Prophylaxis:
Translating Evidence into Practice
Samuel Z. Goldhaber, MD
Cardiovascular Division
Brigham and Women’s Hospital
Professor of Medicine
Harvard Medical School
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)
Lung with PE
PE SXS/ Signs (PIOPED II)
►
Dyspnea (79%)
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Tachypnea (57%)
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Pleuritic pain (47%)
►
Leg edema, erythema, tenderness, palpable
cord (47%)
►
Cough/ hemoptysis (43%)
Stein PD. Am J Med 2007; 120: 871-879
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
► 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.
Annual # At-Risk for VTE:
US Hospitals
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7.7 million Medical Service inpatients
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3.4 million Surgical Service inpatients
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Based upon ACCP guidelines for VTE
prophylaxis
Anderson FA Jr, et al. Am J Hematol 2007; 82: 777-782
Malignant Gliomas (N=9,489) and VTE
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California Cancer Registry
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2-year VTE Incidence: 7.5%
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16 VTE events per 100 person-years during 1st 6
months
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Risk factors: older age, neurosurgery
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VTE: 30% increased risk of death
J Neurosurg 2007; 106: 601-608
Outpatient and Inpatient VTE are Linked
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74% of VTEs present in outpatients.
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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
ICOPER Cumulative Mortality
Mortality (%)
25
17.5%
20
15
10
5
0
7
14
30
Days From Diagnosis
Lancet 1999; 353: 1386-1389
60
90
Progression of
Chronic Venous Insufficiency
From UpToDate 2006
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
Dabish 20-Year Cohort:
VTE, Subsequent CV Events
►
Assessed risk of MI, Stroke
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25,199 with DVT
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16,925 with PE
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163,566 population controls
Sorensen HT. Lancet 2007; 370: 1773-1779
RR CV Event in PE Patients
CV Event
1 Year RR
2-20 Year RR
Acute MI
2.6
1.3
Stroke
2.9
1.3
Sorensen HT. Lancet 2007; 370: 1773-1779
Cardiovascular Risk Factors and VTE
(N=63,552 meta-analysis)
RF
Obesity
RR
2.3
Hypertension
1.5
Diabetes
1.4
Cigarettes
1.2
High Cholesterol
1.2
Ageno W. Circulation 2008; 117: 93-102
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.
Ageno W. Circulation 2008; 117: 93-102
RISK OF PE: BMI
Nurses' Health Study
JAMA 1997; 277: 642
*
3.0
3.5
3
*
1.7
2.5
RR
(95% CI)
2
1.5
1
1
1.2
0.7
0.5
0
< 21
21-23
23-25
25-29
> 29
BODY MASS INDEX (kg/m2 )
Obesity and VTE: NHDS
AGE
RR (PE)
RR (DVT)
< 40 y
5.2
5.2
All Ages
2.2
2.5
Stein PD. Am J Med 2005; 118: 978-980
PE AND CIGARETTE SMOKING
Nurses' Health Study
(JAMA 1997; 277: 642)
*
2.5
*
1.8
2
RR
(95% CI)
2.1
1.5
1.1
1
0.8
1
0.5
0 Never
Cigs (ref)
1-14
Cigs
15 - 24
Cigs
25 - 34
Cigs
CIGARETTE SMOKING
> 35
Cigs
Eat Veggies and Lower VTE Risk;
Careful with Red Meat
Adjusted Hazard Ratios (Quintiles)
Fruits,
veggie
Fish
Red
Meat
2
0.73
3
0.57
4
0.47
0.59
p
0.03
0.58
0.60
0.55
0.70
0.30
1.24
1.21
1.09
2.01
0.02
Steffen LM. Circulation 2007;115:188-195
5
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
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
Dentali F, et al. Ann Intern Med 2007; 146: 278-288
Intermittent Pneumatic Compression
Meta-Analysis in Postop Patients
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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
The Amin Report:
Prophylaxis Rates in the US
►
Studied 196,104 Medical Service discharges from
227 hospitals (Premier® database).
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VTE prophylaxis rate was 62%.
►
ACCP-deemed appropriate prophylaxis rate was
34%.
J Thromb Haemostas 2007; 5: 1610-6
Medical Patient Prophylaxis in Canada
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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
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
Worldwide Prophylaxis Status
for 68,183 Patients
52% at Risk for VTE
(50% receive ACCP
recommended prophy)
Surgical
Medical
64% at Risk for VTE
42% at Risk for VTE
59% receive ACCP
Rec. Px
40% receive ACCP
Rec. Px
We have initiated trials to change MD
behavior and improve implementation of
VTE prophylaxis—not trials of specific types
of prophylaxis—eAlert RCT, eAlert cohort,
human Alert, 3-screen eAlert.
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
Definition of “High Risk”
VTE risk score ≥ 4 points:
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►
►
►
►
►
►
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Cancer
Prior VTE
Hypercoagulability
Major surgery
Bed rest
Advanced age
Obesity
HRT/OC
3
3 (ICD codes)
3 (ICD codes)
(Leiden, ACLA)
2 (> 60 minutes)
1 (“bed rest” order)
1 (> 70 years)
1 (BMI > 29 kg/m2)
1 (order entry)
Randomization
VTE risk score > 4
No prophylaxis
N = 2,506
INTERVENTION:
CONTROL
Single alert
No computer alert
N = 1,255
N = 1,251
Kucher N, et al. NEJM 2005;352:969-977
DVT Alert Screen
Rule Logic – Alert Details
Option A
Option B
Option C or “Done”
90-Day Primary Endpoint
Intervent. Control
Hazard Ratio p
N=1255
N=1251
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
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
UE DVT
32 (2.5)
Kucher N, et al. NEJM 2005;352:969-977
33 (2.6)
(95% CI)
0.97 (0.60-1.58) 0.90
%Freedom from DVT/ PE
Primary End Point
100
98
Intervention
96
94
92
Control
90
0
Number at risk
Intervention 1255
Control
1251
Kucher N, et al. NEJM 2005;352:969-977
30
60
Time (days)
977
976
900
893
90
853
839
Electronic Alert Cohort
Purpose:
►
To evaluate use of the VTE risk score and eAlert
system in “real world” setting
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To validate the efficacy of continued use of the
eAlert after discontinuing randomization
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To determine whether VTE prophylaxis
prescribing changed following NEJM publication
J Thromb Thrombolysis 2008;25: 146-50
Electronic Alert Cohort
►
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
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“Rules” for generating alerts remained identical to
original VTE eAlert study
Baroletti S et al. J Thrombosis Thrombolysis 2008; 25: 146-50)
Cohort Study: Results
20.0%
18.0%
18.0%
16.0%
14.0%
12.0%
P <0.001
10.0%
Not Receiving
Prophylaxis
at Baseline
9.1%
8.0%
6.0%
4.0%
2.0%
0.0%
Historical Alert
Cohort Alert
Cohort Study: Results
Prophylactic Measure in
response to alert
Cohort
Alert
Historical
Alert
p value
Total
326 (37.7%)
421 (33.6%)
0.052
Pharmacological
234 (27.1%)
296 (23.6%)
0.73
77 (8.9%)
213 (17%)
<0.001
108 (12.5%)
55 (4.4%)
<0.001
Warfarin
49 (5.7%)
28 (2.2%)
<0.001
Mechanical
92 (10.6%)
125 (10%)
0.62
Stockings
33 (3.8%)
52 (4.1%)
0.52
Pneumatic boots
59 (6.8%)
73 (5.8%)
0.61
UFH
LMWH
Baroletti S et al. J Thrombosis Thrombolysis 2008; 25: 146-50
Cohort Summary (N=866)
►
18% high risk patients were not prophylaxed
in the NEJM eAlert RCT
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After “turning off” randomization, 9% high risk
patients were not prophylaxed in the cohort
study
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82% were Medical Service patients
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Symptomatic VTE at 90 days occurred in
5.1%
(Baroletti S et al. J Thrombosis Thrombolysis 2008; 25: 146-50)
VTE Prophylaxis: hALERT
1. We initiated a multicentered RCT of human
alerts (hALERT) (N=2,500)
2. Objective: to recruit hospitals that differ from
BWH re: IT, community vs. academic, urban
vs. suburban/rural, location within USA.
3. Can a human alert be more effective than an
electronic alert?
3-Screen eALERT
► Delves into MD reasoning for withholding
VTE prophylaxis.
► Defaults to graduated compression
stockings as an “opt out” measure
Default Options to Improve Healthcare
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Flu, pneumonia vaccines.
►
Remove urinary catheters within 72h.
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Head of bed at 30-45 angle in ICU.
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Interrupt sedatives daily: vented pts.
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Prophylax against VTE.
Halpern SD et al. NEJM 2007; 357: 1340
Key Points
1. “Lump,” don’t “split”, venous and arterial TE risk
factors. They are not separate silos. The risk
factors and etiologic pathways are shared, similar.
2. VTE and Atherosclerosis [MI/ Stroke/ PVD] are
linked:
a) Worldwide problems
b) VTE may herald arterial event
3. Lifestyle/ reversible risk factors provide foundation
for prevention.
Summary
1. VTE causes CVI, pulmonary hypertension,
disability, and death.
2. Prophylaxis is safe and effective.
3. Prophylaxis is underutilized.
4. Behavior modification strategies:
a) electronic/ human alerts
b) focus on discharge/ continuum of care, as well
as admission