VTE Prophylaxis in the Hospitalized Patient

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VTE Prophylaxis in the
Hospitalized Patient:
Importance and
Strategies for Improved
Compliance
Andrew H. Dombro, M.D.
Instructor of Medicine
Division of General Internal Medicine, Hospital Medicine Section
University of Colorado Health Sciences Center
Overview
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Background / Prevalence of VTE
Benefits / Rationale for VTE prophylaxis
Identification of hospitalized patients most at risk
Methods of VTE prophylaxis
National Consensus Standards for Prevention and Care
of VTE (CMS as well?)
Factors related to under-use of established guidelines
Strategies to improve compliance
Background / Prevalence of VTE
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PE is responsible for up to 200K
deaths per year in the United States¹
PE remains the most common
preventable cause of hospital death,
accounting for up to 10%²
DVT/PE is much more common in
the hospitalized patient -- medical
and surgical³
1. Horlander, KT, Mannino, DM, Leeper, KV. Arch Intern Med 2003; 163:1711
2. Pendleton R et al. Am J Hemat. 2005;79:229-237.
3. Edelsberg J et al. Am J Health Syst Pharm 2006; 63: 16S-22S
Background / Prevalence
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VTE is more than 130 times greater among
hospitalized patients than community residents¹
half of community-based cases nursing home
patients or within 90 days of hospital discharge
 60% of all cases occurred in either hospitalized,
recently d/c’d, or NH patients!
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Hospitalization for acute medical illness is
associated with up to an 8-fold increase in
relative risk for VTE
1. Heit, JA, Melton, LJ, Lohse, CM, et al. Mayo Clin Proc 2001; 76: 1102
Background / Prevalence
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Death occurs in about 6% of DVT cases within one month of
diagnosis1
Death occurs in about 12% of PE cases within one month of
diagnosis1
Up to 25% of distal DVT can propagate into proximal DVT²
Pulmonary emboli are detected in approximately 50% of
patients with proximal DVT²
Recurrent DVT:
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Can occur in 30% of DVT patients within 10 years after
initial treatment³
1. American Heart Association. Heart Disease and Stroke Statistics – 2005 Update.
2. Anand, SA et al. JAMA. 1998;279:1094-1099.
3. Prandoni P et al. Haemotologia 2007; 92: 199-205
Background / Prevalence¹
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Without prophylaxis, overall DVT incidence in
hospitalized medical and general surgical
patients is 10-40%
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40-60% following major orthopedic surgery
Without prophylaxis, fatal PE occurs with the
following frequency in hospitalized patients:
0.1-0.8% undergoing elective general surgery
 2-3% undergoing elective hip replacement
 4-7% undergoing surgery for fractured hip!
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1. Geerts WH et al. Chest. 2004;126(3 suppl):338S-400S
Background / Prevalence
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Without prophylaxis, reported VTE occurrence in the
ICU ranges between <10% to nearly 100%!!
Virtually all critical care patients are at moderate to high risk
Up to 10% to 15% of patients with cancer may develop a VTE1
Malignancy independent factor for decreased early and late
survival after VTE event²
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1. Viale PH, Schwartz RN. Clin J Onco Nurs. 2004;8:455-461.
2. Heit JA et al. Arch Intern Med. 1999;159:445-453
Consequences of Unprevented VTE
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Fatal PE -- usually occurs without warning and often with no
potential to resuscitate¹
Patient discomfort associated with VTE
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Initial pain and discomfort
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Post-thrombotic syndrome (PTS)²
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Chronic Thromboembolic Pulmonary Hypertension (CTPH)³
$$ spent in the investigation of suspected and treatment of
documented VTE
Risk of treatment once VTE occurs
Increased length of initial hospital stay
More frequent hospital readmission
Increased future risk of VTE (4)
1. Anderson FA et al. Arch Intern Med 1991; 151: 933-8
2. Büller, HR et al. Chest. 2004;126:4018-4288.
3. Pengo V et al. N EnglJ Med. 2004;350:2257-2264.
4. Heit JA et al. Arch Intern Med 2000; 160:761-8
Benefits / Rationale of VTE
Prophylaxis
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DVT and PE are prevalent and serious complications1
Difficult to predict with any certainty which patients will
develop VTE²
Patients can experience VTE weeks after surgery2
Clinical consequences of VTE, including mortality, are
common3
Health burden associated with VTE is expected to grow
dramatically during coming years, in part due to aging
population (4)
1. Geerts WH et al. Chest. 2004;126(3 suppl):338S-400S.
2. White RH et al. Arch Intern Med. 1998;158:1525-1531.
3. Pengo V et al. N Engl J Med. 2004;350:2257-2264.
4. Stein PQ et al. Arch Intern Med 2004. 164:2260-65
Benefits / Rationale of VTE
Prophylaxis¹
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Hospital-acquired DVT/PE is usually clinically silent -only 1/3 present with classic symptoms²
Overall incidence likely underestimated³
Screening, either by physical exam or noninvasive
testing, is not clinically effective or cost effective
Prophylaxis is far more effective for preventing
death/morbidity from VTE than is treatment of
established disease
1. Geerts WH et al. Chest. 2004;126(3 suppl):338S-400S
2. Turkstra F et al. Ann Intern Med 1997; 126: 775-81
3. Kyrle PA et al. Lancet 2005; 365: 1163-74
Benefits / Rationale of VTE
prophylaxis
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Effective and safe prophylactic measures are available for most
high-risk patients (1,2)
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pharmacologic prophylaxis lowers the risk of symptomatic
and asymptomatic VTE in medical patients by 50%-75%!
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little or no increase in rates of clinically important bleeding
complications
Based on solid principles and scientific evidence from large
numbers of randomized clinical trials³
Most hospitalized patients have one or more risk factor for
VTE – and importantly, these are cumulative(4)
1. Gerotziafas, GT, Samama, MM. Curr Opin Pulm Med 2004; 10:356
2. Clagett, GP, Reisch, JS. Ann Surg 1988; 208:227
3. Patel R et al. J Crit Care 2005; 20:34-7
4. Dorfman, et al. J Clin Pharm Therap 2006; 31: 455-9
Benefits of VTE Prophylaxis
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Appropriate VTE
prophylaxis achieves two
very desirable results:
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Improved patient
outcomes
Reduced costs
Risk Factors: Predicting VTE
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No definitive way to predict which patients will
acquire VTE1
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Risk factors for VTE have been reported1,2
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Preexisting and surgical risk factors for VTE can
be cumulative for patients undergoing surgery3
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Patients undergoing hip or knee replacement or
hip fracture surgery are among those at highest
risk1
1. Geerts WH et al. Chest. 2004;126(3 suppl):338S-400S.
2. Heit JA et al Arch Intern Med. 2000;160:809-815.
3. Geerts WH, et al. Chest. 2001;119:132S-175S.
VTE Risk: Medical and Surgical
Patient Characteristics
(1,2)
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History of VTE
Family history VTE
Malignancy
Increased age (possibly ≥ 41)
CHF
AMI
Ischemic CVA
Pregnancy/Postpartum
Infection/Sepsis
Prolonged immobilization
Acute/chronic lung disease
Hypotension/shock
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Inflammatory disease (including
IBD)
Estrogen therapy
Obesity (BMI>25)
Tobacco use
Varicose veins
Inhibitor deficiency states
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Antiphospholipid Ab’s
Protein C/S
Factor V Leiden (3-7%)
Prothrombin Gene Mutation (2%)
AT III
1. Geerts WH et al. Chest. 2004;126(3 suppl):338S-400S; Heit JA et al. Arch Intern Med. 2000;160:809-815.
2. Kikura, M, Takada, T, Sato, S. Preexisting morbidity as an independent risk factor for perioperative acute
thromboembolism syndrome. Arch Surg 2005; 140:1210
Surgical Risk Factors
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Procedure
Surgical site
Surgical technique
Anesthetic
Duration of procedure
Presence of infection
Postoperative immobilization
Virchow’s Triad¹
Venous Stasis²
Obesity
Immobility
Chronic heart disease
Age above 40
Hypercoaguable State2
Vascular Injury²
Recurrent DVT/PE
Surgery
Cancer treatment
Trauma
Venipuncture
Atherosclerosis
IV drug
administration
Hereditary risk factors
Bleeding disorders
Malignancy
Risk Factors are Cumulative3
1. Anderson, FA et al. Circulation.2003;107:I-9--I-10.
2. Viale PH, Schwartz RN. Clin J Onco Nurs. 2004;8:455-461.
3. Rosendaal FR. Lancet. 1999;353:1167-1173.
Extended VTE Risk Following
Hospital Discharge
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VTE can occur for up to 3 months after total knee and
hip arthroplasty1
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Hypercoagulability can persist for 6 weeks after hip
fracture2
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Venous function was significantly impaired for up to 42
days following hip fracture surgery3
Recurrent DVT:
 30% of DVT patients 8 to 10 years after initial
treatment4
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1. White RH et al. Arch Intern Med. 1998;158:1525-1531.
2. Wilson D et al. Injury. 2001;32:765-770.
3. Wilson D et al. Injury. 2002;33:33-39.
4. American Heart Association. Heart Disease and Stroke Statistics – 2005 Update.
Features of an Ideal VTE
Prophylaxis Regimen
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Effective
Safe
Good compliance
Easily administered
No laboratory monitoring needed
Cost effective
Methods of VTE Prophylaxis
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Mechanical:
Graduated Compression Stockings (GCS)
 Intermittent Pneumatic Compression Devices
(IPC)
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Pharmacologic
Mechanical Prophylaxis
Advantages
 Lack of bleeding potential1
 No clinically important side effects
 No laboratory monitoring
needed2
 IPC stimulates endogenous
fibrinolytic activity (reduces
plasminogen activator inhibitor-1
levels by unknown mechanism) 2
Disadvantages
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1. Geerts WH et al. Chest. 2004;126(3 suppl):338S-400S.
2. Davis P. J Ortho Nurs. 2004;8:50-56.
3. Agu O et al. Br J Surg. 1999;86:992-1004.
No mechanical prophylaxis options
have been shown to reduce the risk
of death or PE1
Must be worn continuously: pre-,
intra- and postoperatively for 72
hours1
GCS can cause impairment in tissue
oxygenation (PVD)3
GCS need to be sized and fitted
properly3
Pharmacologic Prophylaxis
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Aspirin – NOT recommended as sole prophylaxis agent1
Low-dose unfractionated heparin (LDUH)2
Low molecular weight heparin (LMWH)2
 Enoxaparin
 Dalteparin
 Tinzaparin
Vitamin K antagonist (VKA)1
 Warfarin
Factor Xa inhibitor2
 Fondaparinux
Choice of pharmacologic agent depends on VTE risk reduction,
complication rate and proper dosing of agent2
1. Geerts WH et al. Chest. 2004;126(3 suppl):338S-400S.
2. Pendleton R et al. Am J Hemat. 2005;79:229-237.
Risky Business
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The majority of hospitalized medical and
surgical patients are at increased risk of VTE²
Risks appear to be cumulative¹
Risk stratification is cumbersome, not adequately
validated, and therefore not as widely agreedupon in medical patients as in surgical patients
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Guidelines, however, do exist (2,3)
1. Dorfman, et al. J Clin Pharm Therap 2006; 31: 455-9
2. Edelsberg, J et al. Am J Health-Syst Pharm 2006. 63: S16-S22
3. Geerts WH et al. Chest. 2004;126(3 suppl):338S-400S.
ACCP Recommendations (since
1986)
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Geerts, WH, et
al. CHEST 2004;
126: 338s-400s
VTE Prophylaxis Usage
Varies markedly, overall remaining abysmally low
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Audit of 384 patients with VTE¹:
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201 (52%) received prophylaxis
(112 anticoagulation, 31 mechanical prophylaxis, 58 combination)
183 (48%) No prophylaxis
13 deaths due to PE
One study showed that only 46% of hospitalized medical patients, with
risk factors for VTE, received appropriate prophylaxis²
Various studies show a VTE prophylaxis rate in surgical patients
varying from 38% to 94% (3,4)
true even amongst orthopedic surgeons³
1. Goldhaber et al. Chest 2000:118:1680-1684.
2. Ageno et al. Haematologia 2002; 87: 746-50
3. Stratton et al. Arch Intern Med 2000; 160: 334-40
4.Anderson et al. J Thromb Thrombol 1998; 5: S7-S11
VTE Prophylaxis Usage
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Even when used, guideline recommendations often
not followed
Grade IA ACCP recommendations were followed
from 45% (hip fracture surgery) to 84% (elective
THR) of the time¹
Retrospective study – overall compliance rate 13.3%
in greater than 120,000 hospital admissions²
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2.8% Neurosurgery
52.4 % Orthopedic Surgery
13.3 % Medicine
1. Statton et al. Arch Intern Med 2000; 160: 334-40
2. Yu HT et al. Am J Health Syst Pharm 2007. 64: 69-76
VTE Prophylaxis Usage
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Hospitalists found superior!¹
Pneumonia Care + VTE prophylaxis
 96.0% vs. 61.9%
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1. William D et al. Am J Manag Care 2007. 13:129-32
Contributing Factors to Under Use –
Physician Related
(1,2)
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Lack of awareness / unfamiliarity with guidelines
Perception that VTE is not a significant or frequent
problem
Patients will be ambulatory “soon enough”
Concern over bleeding risks (surgical sites and
elsewhere)
Guidelines seem complicated or difficult to apply
Patients so ill on admission that VTE concerns don’t
“hit the radar screen”
More difficult to change habits than to incorporate a new
habit
1. Geerts et al. Chest 2004; 126: 338S-400S
2. Cabana et al. JAMA 1999; 282: 1458-65
Contributing Factors to Under use -Environmental¹
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Not under physicians’ direct control, such as
acquisition of new resources or facilities
Lack of time
Financial constraints (increased practice costs,
lack of reimbursement)
Increased legal liability
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1. Cabana et al. JAMA 1999; 282: 1458-65
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Contributing Factors to Under Use –
Institution Related¹
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Lack of standardized order sets for VTE
prophylaxis
Lack of user-friendly patient risk assessment
tools/mechanisms
Logistical limitations of health care management
systems, for instance lack of medical informatics
systems with computerized “prompts”
1. Cabana et al. JAMA 1999; 282: 1458-65
National Consensus Standards for
Prevention and Care of VTE
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JCAHO and National Quality Forum (NQF) -- project
began 9/04
Eight different measures have been recommended by
the Technical Advisory Panel (TAP) for pilot testing
this year. Regarding VTE prophylaxis, these include:
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VTE Risk Assessment (RA)/Prophylaxis within 24 hours of
hospital admission
VTE Risk Assessment (RA)/Prophylaxis within 24 hours of
transfer to ICU
Incidence of Potentially Preventable Hospital-acquired VTE
Center for Medicare and Medicaid
Services
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CMS is strongly considering using VTE
prophylaxis as a core safety compliance and
performance measure
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This will directly affect hospital / physician
reimbursements (i.e., pay for performance)
The Literature – What Has Worked?
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Respected leaders within institutions¹
Clinical audits with feedback (2,3)
Clinical decision support tools (83% → 95%) (4)
Clinical guidelines combined with chart monitoring (5)
Nursing/patient education for increased compliance with
SCD’s (6)
Establishment of protocols, combined with staff education
and a daily computer driven reminder (reporting tool) for
morning rounds in ICU (7)
Computer based reminders (8)
1. Winkler, et al. Arch Intern Med 1985; 145:314-7
2. Williams, et al. Ann R Coll Surg Engl 1997; 79:55-7
3. Greco, et al. NEJM 1993; 329: 1271-4
4. Durieux, et al. JAMA 2000; 283: 2816-21
5. Phillips, et al. Thromb Haemost 1997; 77: 283-8
6. Stewart, D et al. Ann Surg 2006. 72: 921-3
7. Wahl, WL et al. Surgery 2006. 140: 648-9
8. Patterson R. Proc AMIA Symp 1998. 573-6
Future Directions -- UCHSC
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Increase overall VTE prophylaxis compliance
Improved methods of risk stratification
Increased adherence to established guidelines
Proposed results:
Improved patient safety and outcomes
 Improved adherence to JHACO / CMS standards
and institutionally established compliance
targets/goals
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Proposed Study - UCHSC
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Prospective historical controlled trial
Develop simple, useable method of VTE risk
stratification
 Utilize prompts – written and eventually electronic
 Measure compliance rates compared to historic rates
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Methods
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Using established risk factors, develop simple, useable method
of risk stratifications for clinicians, using methods that have
proved effective¹
 Initially paper admission/transfer orders
 With CPOE, add as “pop-up”²
 Include current ACCP guidelines
Use medication reconciliation sheets/orders as reminder
 Forms would be mandatory for all admissions/transfers
 Again, with CPOE, would be contained therein
Measure rates of physician compliance and choice of method
on high-risk patients (2 or more risk factors) pre and post
implementation
1. McCaffrey R et al. Worldviews Evid Based Nurs 2007; 4:14-20
2. Paterno MD et al. AMIA Annu Symp Proc 2006; 1058
General Conclusions
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VTE prophylaxis is justified, low-risk, and indicated in most
hospitalized patients
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Good for patients
Good for hospitals
Overall, VTE prophylaxis is under-utilized
Hospitals and physicians will soon be judged on compliance
Each hospital needs a standardized approach for VTE prophylaxis
to improve compliance
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protocols, pre-printed orders, risk stratification, etc.
Multi-disciplinary approach
auditing
Thanks …
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