Transcript VTE Prophylaxis - Stratis Health

Prevention of Venous
Thromboembolism
Surgical Care Improvement Project
Dale W. Bratzler, DO, MPH
President and CEO
Dale W. Bratzler, DO, MPH
Oklahoma Foundation for Medical Quality
QIOSC Medical Director
Why is there a need to measure the
quality of hospital care?
• The passive strategy of guideline publication
and dissemination does not effectively
change clinical practice
– The time lag between publication of evidence
and incorporation into care at the bedside is very
long
– Variations in care and delivery of care that is not
consistent with evidence-based
recommendations is well documented
Bratzler DW. Development of national performance measures on the prevention and treatment of venous
thromboembolism. J Thromb Thrombolysis. 2009 (in press)
Prevention of Venous Thromboembolism
(VTE) – an example
• The American College of Chest Physicians
published their first consensus conference
on antithrombotic therapy in 1986
– In 2008 published their 8th edition of the
evidence-based guideline
– Despite all of these published editions…..
VTE
- the most common preventable cause of hospital death
- 2/3 of all cases occur in recently hospitalized patients
- up to 3/4 of all cases of PE death are a result of hospitalization
Prevention of Venous
Thromboembolism – an example
• Multiple studies that have included
hospital medical record audits show
consistent underuse of VTE prophylaxis
– Up to 2/3 of patients with hospital-acquired
VTE did not receive prophylaxis
• Audits of patients receiving treatment for
confirmed VTE show non-compliance with
guideline-recommended treatment
Bratzler DW. Development of national performance measures on the prevention and treatment of venous
thromboembolism. J Thromb Thrombolysis. 2009 (in press)
“The best estimates indicate
that 350,000 to 600,000
Americans each year suffer
from DVT and PE, and that at
least 100,000 deaths may be
directly or indirectly related to
these diseases. This is far too
many, since many of these
deaths can be avoided.
Because the disease
disproportionately affects older
Americans, we can expect
more suffering and more
deaths in the future as our
population ages–unless we do
something about it.”
Risk Factors for DVT or PE
Nested Case-Control Study (n=625 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
15
10
20
Odds ratio
25
50
Risk Factors for VTE
Most hospitalized patients have at least one additional risk factor for VTE
• Surgery
• Acute medical illness
• Trauma
• Heart failure
• Immobility, paresis
• Respiratory failure
• Malignancy
• Inflammatory bowel disease
• Cancer therapy
• Nephrotic syndrome
– hormonal therapy,
chemotherapy or
radiotherapy
• Previous VTE
• Increasing age
• Pregnancy and
post-partum period
• Estrogen-containing oral
contraception or HRT or SERM
• Myeloproliferative disorders
• Obesity
• Smoking
• Varicose veins
• Central venous catheterization
• Inherited or acquired
thrombophilia
• Travel
Geerts W et al. Chest. 2004;126:338S-400S.
VTE Facts
• Less than half of the
recently hospitalized
patients had received
VTE prophylaxis during
their hospitalizations
• About half had a length
of stay (LOS) of < 4
days
Days After Discharge
0-29
Outpatients With VTE, %
• Almost half of the
outpatients with VTE
had been recently
hospitalized
30-59
60-90
70
60
50
40
30
20
10
0
Medical
Hospitalization
Only
Hospitalization
with Surgery
Goldhaber S. Arch Intern Med. 2007;167:1451-2.
Spencer FA et al. Arch Intern Med. 2007;167(14):1471-5.
Categories of Risk for Venous
Thromboembolism in Patients
Low risk:
• Minor surgery in mobile patients
Moderate risk:
• Most medically ill, general, open gyn
or urologic surgery patients
High risk:
• Cancer surgery, hip or knee arthroplasty,
hip fracture surgery, major trauma or
spinal cord injury
Geerts W et al. Chest. 2008;133:381S-453S.
Mechanical Methods of VTE Prevention
• Graduated Compression Stockings
(GCS)
• Intermittent Pneumatic Compression
Devices (IPCs)
• Venous Foot Pump (VFP)
Pharmacologic Options
for VTE Prevention
• Unfractionated Heparin (UFH)
• Low-Molecular Weight Heparins
(LMWHs)
• Pentasaccharide (Fondaparinux)
• Warfarin
Prophylaxis Against Fatal Post-Operative PE With
LDUH: A Multicenter, Prospective, Randomized Trial
Study population: 4,121 patients age > 40 y undergoing a variety
of elective major surgical procedures
P < 0.005
Patients with PE (%)
0.9
0.8
0.77
0.7
0.6
0.5
0.4
0.3
0.2
0.097
0.1
0
Control (N = 2,076)
UFH* (N = 2,045)
• 5,000 IU SC 2 hours preoperatively and 8 hours thereafter for 7 days.
Kakkar VV et al. Lancet. 1975;2:45-51.
Mechanical Thromboprophylaxis
• For particularly high-risk surgery patients with
multiple risk factors, pharmacologic method
should be combined with mechanical method
(GCS, IPC) (1C)
• Use mechanical methods for patients with
high bleeding risk (1A), when bleeding risk
decreases substitute or add pharmacological
thromboprophylaxis (1C)
Geerts WH et al. Chest. 2008;133(6 Suppl):381S-453S.
Problems with Mechanical
Prophylaxis
• Non-compliance
– ~ 50% of med-surg floors
– ~80% in intensive care units
• Most common reasons for non-compliance
– ~80% of the time, not on the patient
– ~20% of the time, on the patient but not turned on
VTE Prophylaxis
Grade 1 Recommendations
Surgery*
Recommended Prophylaxis
General surgery
Low-dose unfractionated heparin (LDUH)
Low molecular weight heparin (LMWH)
Fondaparinux (effective 10/01/07)
LDUH or LMWH combined with IPC or GCS
General surgery with a reason
for not administering
pharmacologic prophylaxis
documented
Graduated Compression stockings (GCS)
Intermittent pneumatic compression (IPC)
Gynecologic surgery
Low-dose unfractionated heparin (LDUH)
Low molecular weight heparin (LMWH)
Factor Xa inhibitor
Intermittent pneumatic compression devices (IPC)
LDUH, LMWH, or factor Xa inhibitor combined with IPC
or GCS
*Limited to those patients who have an anesthesia duration of at least 60 minutes, and a
hospital stay of at least three calendar days (two nights in the hospital).
*Open surgical procedure > 30 minutes requiring in-hospital stay > 24 hours postoperative.
VTE Prophylaxis
Grade 1 Recommendations
Surgery
Recommended Prophylaxis
Urologic surgery
Low-dose unfractionated heparin (LDUH) 5000 units bid or tid
Low molecular weight heparin (LMWH)
Factor Xa inhibitor (fondaparinux)
Intermittent pneumatic compression devices (IPC)
Graduated compression stockings (GCS)
LDUH, LMWH, or factor Xa inhibitor combined with IPC or GCS
Elective total hip
replacement
Low molecular weight heparin (LMWH)
Factor Xa inhibitor (fondaparinux)
Adjusted-dose warfarin (INR target 2.5, range 2.0-3.0)
Elective total knee
replacement
Low molecular weight heparin (LMWH)
Factor Xa inhibitor (fondaparinux)
Adjusted-dose warfarin (INR target 2.5, range 2.0-3.0)
Intermittent pneumatic compression devices (IPC)
Venous foot pumps (VFP)
VTE Prophylaxis
Grade 1 Recommendations
Surgery
Recommended Prophylaxis
Hip fracture surgery
Low molecular weight heparin (LMWH)
Factor Xa inhibitor
Adjusted-dose warfarin (INR target 2.5, range 2.0-3.0)
Low-dose unfractionated heparin (LDUH)
Hip fracture surgery (HFS) or
elective total hip replacement
with a reason for not
administering pharmacologic
prophylaxis documented
Graduated Compression stockings (GCS) (HFS only)
Intermittent pneumatic compression (IPC)
Venous foot pumps (VFP)
Intracranial neurosurgery
IPC with or without GCS
Low-dose unfractionated heparin (LDUH)
Postoperative Low molecular weight heparin (LMWH)
LDUH or LMWH combined with IPC or GCS
*Open surgical procedure > 30 minutes requiring in-hospital stay > 24 hours postoperative.
Performance Measurement Does Not
Happen without Controversy
Summary American Academy of Orthopedic Surgeons (AAOS) Clinical Guideline on Prevention
of Symptomatic Pulmonary Embolism in Patients Undergoing Total Hip or Knee Arthroplasty
Standard risk PE, Standard risk Bleeding*
aspirin
LMWH
synthetic pentasaccharides
warfarin
Level III, Grade B recommendation
Standard risk PE, Elevated risk Bleeding
aspirin
warfarin
none
Level III, Grade C recommendation
Elevated risk PE, Standard risk Bleeding
LMWH
synthetic pentasaccharides
warfarin
Level III, Grade B recommendation
Elevated risk PE, Elevated risk Bleeding
aspirin
warfarin
none
Level III, Grade C recommendation
SCIP VTE 1 Performance Measure
Hip or Knee Arthroplasty
No Bleeding Risk Documented
Documented Bleeding Risk
Hip or knee arthroplasty:
LMWH
synthetic pentasaccharides
warfarin
Mechanical Prophylaxis
[any other modality (including aspirin or warfarin)
can be added]
Knee arthroplasty only:
intermittent pneumatic compression devices
venous foot pump
What else does the AAOS guideline
say?
• They do NOT recommend the use of aspirin
alone
– They recommend the use of mechanical prophylaxis
started in the operating room or immediately
postoperatively in all patients – continued to
discharge
– They recommend pharmacologic prophylaxis with
LMWH, factor Xa inhibitor, or warfarin in high risk
patients
• previous history of cancer, thromboembolism,
hypercoagulable states such as polycythemia, spinal cord
injury patients, multi-trauma patients, and genetic
predisposition
VTE Prophylaxis
• Other issues
– Timing of prophylaxis
– Neuraxial anesthesia
– Renal insufficiency
– Duration of prophylaxis
Venous Thromboembolism
Statement 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.”
Measure specifications available at:
www.qualitynet.org
Electronic Submission of
Performance Measures
In the recently published final IPPS rule for fiscal
year 2010, CMS has announced that through an
interagency agreement with the Office of the National
Coordinator for Healthcare Information Technology, they
are developing interoperable standards for electronic
medical record submission of the newly-endorsed VTE
measures. Vendors of electronic medical record systems
would be able to code their systems with the new
specifications by the end of 2009.
Centers for Medicare & Medicaid Services. Medicare Program; Changes to the Hospital Inpatient Prospective Payment
Systems for Acute Care Hospitals and Fiscal Year 2010 Rates; and Changes to the Long-Term Care Hospital
Prospective Payment System and Rate Years 2010 and 2009 Rates. Available at:
http://www.federalregister.gov/OFRUpload/OFRData/2009-18663_PI.pdf. Accessed 10 August 2009.
Improving Use of VTE Prophylaxis
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
Electronic Alerts to Prevent VTE among
Hospitalized Patients
• Hospital computer system identified patient VTE risk factors
• RCT: no physician alert vs physician alert
No.
Any prophylaxis
VTE at 90 days
Major bleeding
* NNT = 30
Control Alert
group group
P
1,251 1,255
15 %
34 % <0.001
8.2 % * 4.9 %
0.001
1.5 % 1.5 %
NS
Kucher – NEJM 2005;352:969
Improving Compliance with
Treatment Protocols
• Use of standardized protocols,
nomograms, algorithms, or preprinted
orders
– Address overlap (either 5 days in hospital or
discharge on overlap)
– When used, UFH should be managed by
nomogram/protocol, and the protocol should
ensure routine platelet count monitoring
Essential Elements for Improvement
• Institutional support
• A multidisciplinary team or steering
committee
• Reliable data collection and performance
tracking
• Specific goals or aims
• A proven QI framework
• Protocols
SHM Resource Room. http://www.hospitalmedicine.org. Accessed September 2009.
Risk
Assessment
Prophylaxis
Low
Ambulatory patient without VTE risk
factors; observation patient with
expected LOS 2 days; same day
surgery or minor surgery
Early ambulation
Moderate
All other patients (not in low-risk or
high-risk category); most
medical/surgical patients; respiratory
insufficiency, heart failure, acute
infectious, or inflammatory disease
UFH 5000 units SC q 8
hours; OR LMWH q day;
OR UFH 5000 units SC
q 12 hours (if weight <
50 kg or age > 75 years);
AND suggest adding IPC
High
Lower extremity arthroplasty; hip,
pelvic, or severe lower extremity
fractures; acute SCI with paresis;
multiple major trauma; abdominal or
pelvic surgery for cancer
LMWH (UFH if ESRD);
OR fondaparinux 2.5 mg
SC daily; OR warfarin,
INR 2-3; AND IPC
(unless not feasible)
Maynard GA, et al. J Hosp Med 2009 Sep 14. [Epub ahead of print]
Maynard GA, et al. J Hosp Med 2009 Sep 14. [Epub ahead of print]
Maynard GA, et al. J Hosp Med 2009 Sep 14. [Epub ahead of print]
Maynard GA, et al. J Hosp Med 2009 Sep 14. [Epub ahead of print]
Attention to Transitions of Care
• Ensure adequate training of the patient
– Education on medications, diet, follow up
appointments, lab monitoring, dietary
precautions, and adverse reactions or drugdrug interactions
– Education for family
– Referral to anticoagulation clinic
• Hospital abstractors must find explicit
documentation of this training/education in the
chart
Does public reporting accelerate
quality improvement?
Changes in National Performance
Baseline to Q1, 2009
Recommended VTE prophylaxis
100
80
VTE prophylaxis received
91.8
92.6
91.6
92.8
89.3
90.3
89.1
90.3
71.9
Percent
69.7
60
40
20
//
0
Q1,
2005*
Q2 2006 Q3 2006 Q4 2006 Q1 2007 Q2 2007 Q3 2007 Q4 2007 Q1 2008 Q2 2008 Q3 2008 Q4 2008 Q1 2009
*National sample of 19,497 Medicare patients undergoing surgery in US hospitals during the
first quarter of 2005. (Bratzler, unpublished data
Hospital-acquired Conditions
Background of the “Never Events”
• Deficit Reduction Act (DRA) of 2005
requires the Secretary of HHS to identify
conditions that are:
– High cost or high volume (or both); and
– Result in the assignment of a case to a DRG
that has a higher payment when present as a
secondary diagnosis; and
– Could reasonably have been prevented
through the application of evidence-based
guidelines.
Hospital-acquired Conditions
10. Deep vein thrombosis/pulmonary
embolism following
– Total knee replacement
– Hip replacement
Conclusions
• VTE remains a substantial health problem
in the US
• VTE prophylaxis remains underutilized
• National performance measures will
address both prophylaxis and treatment of
VTE across broad hospital populations
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