Prevention and Treatment of Venous Thromboembolism Guidelines for Care and Development of National Performance Measures

1
Prevention and Treatment of Venous
ThromboembolismGuidelines for Care and
Development of National Performance Measures
Dale W. Bratzler, DO, MPH QIOSC Medical
Director Oklahoma Foundation for Medical Quality
Dale W. Bratzler, DO, MPH QIOSC Medical Director
2
Outline

• The problem VTE in US hospitals
• Need for national performance standards
• Overview of the Consensus Development Process
• Pilot testing of draft VTE measures
• Near final recommendations

3
Prevention of Venous Thromboembolism

• Recent estimates show that
• more than 900,000 Americans suffer VTE each year
• about 400,000 of these being DVT
• About 500,000 being manifest as PE
• In about 300,000 cases, PE proves fatal it is
  the third most common cause of hospital-related
  deaths in the United States.

Is pulmonary embolism the most common cause of
death in the US?
Heit JA, Cohen AT, Anderson FA on behalf of the
VTE Impact Assessment Group. Abstract American
Society of Hematology Annual Meeting, 2005.
4
Annual Incidence of VTE in Olmsted County, MN
1966-1995By Age and Gender
Men
Annual incidence/100,000
Women
?
Age group (yr)
5
Prevention of Venous ThromboembolismIntroduction

• VTE Remains a major health problem
• In addition to the risk of sudden death
• 30 of survivors develop recurrent VTE within 10
  years
• 28 of survivors develop venous stasis syndrome
  within 20 years
• Incidence increases with age

Goldhaber SZ. N Engl J Med. 199833993-104. Silve
rstein MD, et al. Arch Intern Med.
1998158585-593. Heit JA, et al. Thromb Haemost.
200186452-463. Heit JA. Clin Geriatr Med.
20011771-92. Heit JA, et al. Mayo Clin Proc.
2001761102-1110.
6
Prevention of Venous Thromboembolism

• The majority (93) of estimated VTE-related
  deaths in the US were due to sudden, fatal PE
  (34) or followed undiagnosed VTE (59)

For many patients, the first symptom of VTE is
sudden death! How many of those patients with
sudden death in the hospital or after discharge
attributed to an acute coronary event actually
died of acute pulmonary embolism?
Heit JA, Cohen AT, Anderson FA on behalf of the
VTE Impact Assessment Group. Abstract American
Society of Hematology Annual Meeting, 2005.
7
National Body Position Statements

• Leapfrog1
• PE is the most common preventable cause of
  hospital death in the United States
• Agency for Healthcare Research and Quality
  (AHRQ)2
• Thromboprophylaxis is the number 1 patient safety
  practice
• American Public Health Association (APHA)3
• The disconnect between evidence and execution as
  it relates to DVT prevention amounts to a public
  health crisis.

• The Leapfrog Group Hospital Quality and Safety
  Survey. Available at www.leapfrog.medstat.com/pdf
  /Final/doc
• Shojania KG, et al. Making Healthcare Safer A
  Critical Analysis of Patient Safety Practices.
  AHRQ, 2001. Available at www.ahrq.gov/clinic/ptsa
  fety/
• White Paper. Deep-vein thrombosis Advancing
  awareness to protect patient lives. 2003.
  Available at www.alpha.org/ppp/DVT_White_Paper.pd
  f

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Medical Injuries During Hospitalization

• Postoperative DVT or PE
• 2nd commonest medical injury overall
• 2nd commonest cause of excess length of stay
• 3rd commonest cause of excess mortality
• 3rd commonest cause of excess charges

Zhan et a. JAMA 20032901868
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Annual cost to treat VTE

• 11,000 per DVT episode per patient
• 17,000 per PE episode per patient
• Recurrence increases hospitalization costs by 20
• Complications of anticoagulation
• Time lost from work
• Quality of life venous stasis and pulmonary HTN

10
Consequences of Surgical Complications

• Dimick and colleagues demonstrated increased
  costs of care
• infectious complications was 1,398
• cardiovascular complications 7,789
• respiratory complications 52,466
• thromboembolic complications 18,310

Dimick JB, et al. J Am Coll Surg 2004199531-7.
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Inherited risk factors for DVT

• Group 1 disorders
• Protein C deficiency (2.5-6)
• Protein S deficiency (1.3-5)
• Antithrombin deficiency (0.5-7.5)

• Group 2 disorders
• Factor V leiden (6)
• Prothrombin (G20210A) (5-10)
• Elevated VIII, IX, XI
• Hyperhomocysteinemia
• Arteriosclerosis

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Acquired Risk Factors
Being in the hospital is the greatest risk factor
for VTE!
13
Risk Factors for VTE

• Previous venous thromboembolism
• Increased age
• Surgery
• Trauma - major, local leg
• Immobilization - ? bedrest, stroke, paralysis
• Malignancy its Rx (CTX, RTX, hormonal)
• Heart or respiratory failure
• Estrogen use, pregnancy, postpartum
• Central venous lines
• Thrombophilic abnormalities

Most hospitalized patients have at least one
additional risk factor for VTE
Therefore, most patients in the hospital need VTE
prophylaxis!
14
Risk Factors for DVT or PENested Case-Control
Study (n625 case-control pairs)
Surgery Trauma Inpatient Malignancy with
chemotherapy Malignancy without
chemotherapy Central venous catheter or
pacemaker Neurologic disease Superficial vein
thrombosis Varicose veins/age 45 yr Varicose
veins/age 60 yr Varicose veins/age 70 yr CHF, VTE
incidental on autopsy CHF, antemortem VTE/causal
for death Liver disease
0
5
10
15
20
25
50
Odds ratio
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Independent Risk Factors for VTE afterMajor
SurgeryOlmsted County 1988-97 (n163)
Controlled for Surgery Type, Active Cancer, and
Event Year Heit, et al. J Thromb Haemost 2005
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VTE is a Disease of Hospitalized and Recently
Hospitalized Patients
1000
VTE 100X more common in hospitalized patients!
100
Recently hospitalized
Cases per 10,000 person-years
10
1
Hospitalized patients Community residents
Heit JA. Mayo Clin Proc. 2001761102
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Risk of DVT in Hospitalized Patients
No prophylaxis routine objective screening for
DVT
Patient group DVT incidence
Medical patients 10 -
20 Major gyne/urol/gen surgery 15 - 40
Neurosurgery 15
- 40 Stroke
20 - 50 Hip/knee surgery
40 - 60 Major trauma
40 - 80 Spinal cord injury
60 - 80 Critical care
patients 15 - 80
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Prevention of Venous Thromboembolism

• Despite the well known risk of VTE and the
  publication of evidence-based guidelines for
  prevention, multiple medical record audits have
  demonstrated underuse of prophylaxis

Anderson FA Jr, et al. Ann Intern Med.
1991115591-595. Anderson FA Jr, et al. J
Thromb Thrombolysis. 1998 5 (1
Suppl)7S-11S. Bratzler DW, et al. Arch Intern
Med. 19981581909-1912. Stratton MA, et al.
Arch Intern Med. 2000160334-340.
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Thromboprophylaxis Use in Practice 1992-2002
Prophylaxis Patient Group Studies
Patients Use (any) Orthopedic surgery
4 20,216 90 (57-98)
General surgery 7 2,473
73 (38-98) Critical care
14 3,654 69 (33-100)
Gynecology 1 456
66 Medical patients 5
1,010 23 (14-62)
How many patients with COPD, CVA, heart failure,
pneumonia, etc do you have in your hospital that
are not on DVT prophylaxis?
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Cumulative Incidence of VTE After Primary Hip or
Knee Replacement
Primary hipPrimary knee
VTEevents()
Days
White RH, et al. Arch Intern Med. 1998 158
1525-1531
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Prevention of Venous Thromboembolism W. Geerts,
chair G. Pineo J. Heit D. Bergqvist M. Lassen C.
Colwell J. Ray
Seventh ACCP Consensus Conference on
Antithrombotic Therapy
Chest 2004126338S-400S
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Prevention of Venous ThromboembolismLow-,
moderate-, or high-risk

• Benefit risk favors
• routine prophylaxis
• Major orthopedic surgery
• (THR, TKR, HFS)
• Major trauma
• Spinal cord injury
• Major general, gyne,
• urologic surgery
• Major neurosurgery
• Medical patients with
• additional risk factors
• Most ICU patients

• Benefit risk uncertain- local practice or
  individual prophyl.
• Laparoscopic surgery
• Vascular surgery
• Cardiac surgery
• Elective spine surgery
• Arthroscopic surgery
• Burns
• Isolated lower
• extremity fracture

• Benefit risk favors no prophylaxis
• Surgical patients
• - brief duration
• - fully mobile
• - no additional RFs
• Medical patients
• - fully mobile
• - no additional RFs
• Long distance travel

Focus of New Measures
How many of these patients do we actually admit
to the hospital anymore?
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Prophylaxis Modalities

• Mechanical
• Graduated compression stockings (GCS) (e.g.,
  white hose)
• Sequential compression devices
• Venous foot pumps (currently recommended only for
  orthopedic surgery in patients with bleeding
  risk)
• In most studies, less effective than
  pharmacologic prophylaxis and patient compliance
  rates are generally low.

Rates of compliance with mechanical forms of
prophylaxis in many studies is less than 50 -
has become a new target of malpractice litigation.
24
Pharmacologic Prophylaxis

• Low-dose unfractionated heparin (LDUH)
• Low-molecular weight heparin (LMWH)
• Fondaparinux
• Warfarin

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Development of National Performance Measures to
Prevent and Treat VTE
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Why the need for performance measures?

• Despite widespread publication and dissemination
  of guidelines, practices have not changed at an
  acceptable pace
• There are still far too many needless deaths from
  VTE in the US
• Reasonably good evidence that using performance
  measures for accountability can accelerate the
  rate of change

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The Consensus Development Process The National
Quality Forum
www.qualityforum.org
28
What is the NQF?

• The National Quality Forum is a private,
  non-profit
• voluntary consensus standards- setting
  organization.

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VoluntaryConsensus Standards

• Widely used in non-healthcare enterprises
• Developed voluntarily and collaboratively by
  stakeholders
• Have legal status
• Must abide by the requirements specified in
  federal law and adhere to a specified process

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National Technology and Transfer Advancement of
Act of 1995 (NTTAA)

• Defines the five key attributes of a voluntary
  consensus standards-setting body (i.e.,
  openness, balance of interest, due process,
  consensus, and an appeals process)
• Obligates federal government to adopt voluntary
  consensus standards (when the government is
  adopting standards)
• Encourages federal government to participate in
  setting voluntary consensus standards

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Steering CommitteeVTE Consensus Standards

• T. Bruce Ferguson, Jr, MD Co-chair
• John R. Bartholemew, MD
• Michael Becker, RN, MSN
• Melanie Bloom
• Ralph G. DePalma, MD
• Nancy L. Fisher MD, MPH, RN
• Mary E. Foscue, MD
• Samuel Z. Goldhaber, MD
• Virginia A. Hemelt, MD

• John A. Heit, MD Co-chair
• David W. Hunter, MD
• Belinda, Ireland, MD, MS
• Jay R. Lieberman, MD
• Edith Nutescu, PharmD
• Arthur L. Pelberg MD, MPA
• Mary Lou Sole, PhD, RN
• Richard M. Weinberg, MD
• Richard H. White, MD
• David C. Zanick, MD, MPH

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Venous ThromboembolismStatement of Organization
Policy

• Every healthcare facility shall have a written
  policy appropriate for its scope, that is
  evidence-based and that drives continuous quality
  improvement related to VTE risk assessment,
  prophylaxis, diagnosis, and treatment.

34
Venous ThromboembolismCharacteristics of
Preferred Practices

• General
• Protocol selection by multidisciplinary teams
• System for ongoing QI
• Provision for RA/stratification, prophylaxis,
  diagnosis, treatment
• QI activity for all phases of care
• Provider education

35
Venous ThromboembolismCharacteristics of
Preferred Practices(cont.)

• Risk Assessment/Stratification
• RA on all patients using evidence-based policy
• Documentation in patient record that done
• Prophylaxis
• Based on assessment risk/benefit,
  efficacy/safety
• Based on formal RA, consistent with accepted,
  evidence-based guidelines

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Venous ThromboembolismCharacteristics of
Preferred Practices(cont.)

• Diagnosis
• Objective testing to justify continued initial
  therapy
• Treatment and Monitoring
• Ensure safe anticoagulation, consider setting
• Incorporate Safe Practice 29
• Patient education consider setting and reading
  levels
• Guideline-directed therapy
• Address care setting transitions in therapy

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Surgical Care Improvement ProjectFirst Two VTE
Measures Endorsed by NQF

• Prevention of venous thromboembolism
• Proportion who have recommended VTE prophylaxis
  ordered
• Proportion who receive appropriate form of VTE
  prophylaxis (based on ACCP Consensus
  Recommendations) within 24 hours before or after
  surgery

Limited to surgical patients NQF endorsed,
required reporting to Medicare for Annual Payment
Update, and will be posted to Hospital Compare
soon.
These measures are NQF-endorsed
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Surgical Care Improvement ProjectHospital
Voluntary Self-Reporting, Qtr. 3, 2007
Benchmark rates were calculated for all HQA
reporting hospitals in the US based on discharges
using the Achievable Benchmarks of CareTM
methodology (http//main.uab.edu/show.asp?durki14
527).
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Changes in National Performance
//
National sample of 19,497 Medicare patients
undergoing surgery in US hospitals during the
first quarter of 2005.
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Venous ThromboembolismTAP charge

• Vet the 19 potential measures, agreed upon by the
  Steering Committee, through TAP and The Joint
  Commission survey processes
• Identify a subset of measures that help address
  the identified gaps within the endorsed VTE
  domains
• Oversee final development and testing of measures
  for Steering Committee and NQF endorsement
  consideration

41
Technical Advisory CommitteeVTE Consensus
Standards

• Dale W. Bratzler, DO, MPH Co-chair
• Anne Bass, MD
• Stephen V. Cantrill, MD
• Vanessa K. Dalton, MD, MPH
• William H. Geerts, MD
• James Boyd Groce, III, PharmD
• Kathryn Hassell, MD
• John Heit, MD
• Scott Kaatz, DO
• Nicos Labropoulos, PhD, RVT

• Joseph A. Caprini, MD, MS, RVT Co-chair
• Franklin A. Michota, Jr, MD
• Ruth Morrison, BSN, CVN
• Robert Jeffery Panzer, MD
• Vincent Pellegrini, Jr, MD
• Jodi Beth Segal, MD, MPH
• Victor F. Tapson, MD
• Alexander G. G. Turpie, MB
• Suresh Vedanthan, MD

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7 Refined Measures Recommended for Endorsement by
Steering Committee

• Risk Assessment/Prophylaxis domain
• Prophylaxis w/in 24 hours of admission or
  surgery, OR a documented risk assessment showing
  that the patient does not need prophylaxis
• Prophylaxis/documentation w/in 24 hours after ICU
  admission or surgery

Discards any requirement for a documented risk
assessment allows programs of default
prophylaxis.
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7 Refined Measures Recommended for Endorsement by
Steering Committee

• Treatment and Monitoring domain
• IVC filter appropriate indication
• Documented acute VTE with a contraindication to
  anticoagulation or chronic thromboembolic
  pulmonary hypertension
• Measure recommended for quality improvement only
• Patients w/overlap of anticoagulation therapy
• At least five calendar days of overlap and
  discharge with INR gt 2.0, or discharge on overlap
  therapy
• Patient receiving UFH with dosage/platelet count
  monitoring by protocol/nomogram
• Nomogram/protocol incorporates routine platelet
  count monitoring

Was not endorsed because the measure was for QI
only.
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7 Refined Measures Recommended (cont.)

• Treatment/Monitoring Domain (cont.)
• Discharge instructions consistent with Joint
  Commission safety goals (Follow-up Monitoring,
  Compliance Issues, Dietary Restrictions,
  Potential for Adverse Drug Reactions/Interactions)
  
• Outcome
• Incidence of potentially-preventable VTE
  proportion of patients with hospital-acquired VTE
  who had NOT received VTE prophylaxis prior to the
  event
• Incorporate the new present on admission codes

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Strategies for Improvement
46
Strategies to Improve VTE Prophylaxis

• Hospital policy of risk assessment or routine
  prophylaxis for all admitted patients
• Most will have risk factors for VTE and should
  receive prophylaxis
• Preprinted protocols for surgical patients

47
Electronic Alerts to Prevent VTE among
Hospitalized Patients

• Hospital computer system identified patient VTE
  risk factors
• RCT no physician alert vs physician alert

Control Alert group group
P No. 1,251 1,255 Any
prophylaxis 15 34 lt0.001 VTE
at 90 days 8.2 4.9 0.001
Major bleeding 1.5 1.5 NS
NNT 30
Kucher NEJM 2005352969
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Electronic Alerts to Prevent VTE among
Hospitalized Patients

• Among hospitalized patients with risk factors for
  VTE and not receiving prophylaxis, use of a
  physician VTE risk alert
• Improved use of prophylaxis by 130
• Reduced symptomatic VTE by 41
• Did not increase bleeding

Kucher NEJM 2005352969
49

• 1 point each
• age 41-60
• minor surgery planned
• major surgery past month
• varicose veins
• inflamm bowel disease
• current leg swelling
• obesity (BMI gt 25)
• acute MI
• CHF past month
• sepsis past month
• serious lung disease past month
• COPD
• medical patient at bedrest
• other_____________________

• 3 points each
• age gt 70
• previous DVT, PE
• family H/O VTE
• factor V Leiden
• prothrombin 20210A
• elevated homocysteine
• lupus anticoagulant
• elevated ACA
• HIT
• other thrombophilia

• 5 points each
• hip / knee arthroplasty
• hip/pelvis/leg fracture (lt 1 month)
• stroke (lt 1 month)
• multiple trauma (lt 1 month)
• acute spinal cord injury (lt 1 mo)

• 2 points each
• age 60-74
• arthroscopic surgery
• malignancy (current or previous)
• major surgery (gt 45 min)
• laparoscopic surgery (gt 45 min)
• confined to bed (gt 72 hrs)
• plaster cast (lt 1 month)
• central venous access

• Women only (1 point each)
• BCP or HRT
• pregnancy / postpartum (lt 1 mo)
• H/O unexplained stillbirth, gt 3
• spontaneous abortions, premature
• birth with toxemia, IUGR

Caprini Dis Mon 20055170
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No individual risk assessment protocol has ever
been validated in a clinical trial. While it
seems intuitive that more points equates to
greater risk of VTE, that has never been proven
in a study, and we certainly have no idea if you
need more prophylaxis for more points!
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Should VTE prophylaxis be the default for all
hospitalized patients?
52
New Quality Measures April 14, 2008 Proposed
Rule

• SCIP Card 2 continuation of beta-blockers
• Pneumonia, AMI, HF 30-day risk-standardized
  readmission (claims-based)
• 4 nursing sensitive measures
• 10 AHRQ PSI or IQI measures (claims-based)
• 6 new VTE prevention/treatment measures
• 5 stroke measures
• 15 cardiac surgery measures (STS registry
  measures)

Hospitals would publicly report 72 measures by
the year 2010.
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Proposed Inpatient Payment Rule April 14, 2008

• Proposed no-pay conditions
• Surgical Site Infections Following Elective
  Procedures
• Total Knee Replacement
• Laparoscopic Gastric Bypass and Gastroenterostomy
• Ligation and Stripping of Varicose Veins
• Legionnaires disease
• Glycemic control (diabetic coma, ketoacidosis,
  hypoglycemic coma, non-ketotic hyperosmolar coma)
• Iatrogenic pneumothorax
• Ventilator-associated pneumonia
• Delirium
• DVT/PE
• S. aureus septicemia
• C. difficile-associated disease
• Entire list of NQF never events

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Performance Measurement Does Not Happen without
Controversy
55
SCIP performance measures are based on Level I
evidence.
56
Summary

• VTE is very common, often unrecognized, and a
  common cause of hospital morbidity and death
• The vast majority of hospitalized patients are at
  risk for VTE
• New national performance measures will focus on
  evidence-based prevention and treatment of VTE

If your organization is serious about Patient
Safety, you have to address VTE prevention and
treatment!
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CEUs/ CMEsIf you would like to receive
CEUs/CMEs for this Webex please contact Theresa
Cameron at tcameron_at_maqio.sdps.org within 24hrs
of this Webex.You will receive an evaluation to
fill out, and will receive you CEUs/CMEs once you
return the evaluation to her.Thank you