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Brief Summary

GUIDELINE TITLE

American Academy of Orthopaedic Surgeons clinical guideline on prevention of symptomatic pulmonary embolism in patients undergoing total hip or knee arthroplasty.

BIBLIOGRAPHIC SOURCE(S)

  • American Academy of Orthopaedic Surgeons clinical guideline on prevention of symptomatic pulmonary embolism in patients undergoing total hip or knee arthroplasty. Rosemont (IL): American Academy of Orthopaedic Surgeons (AAOS); 2007. 63 p. [49 references]

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • February 28, 2008, Heparin Sodium Injection: The U.S. Food and Drug Administration (FDA) informed the public that Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection and their heparin lock flush solutions. Alternate heparin manufacturers are expected to be able to increase heparin production sufficiently to supply the U.S. market. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension.
  • August 16, 2007, Coumadin (Warfarin): Updates to the labeling for Coumadin to include pharmacogenomics information to explain that people's genetic makeup may influence how they respond to the drug.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Definitions of the levels of evidence (I-V) and grades of recommendation (A-C) and are provided at the end of the "Major Recommendations" field.

The following recommendations are based on a systematic review of the literature and are evidence-based.

Recommendation 3.3: Chemoprophylaxis of patients undergoing hip or knee replacement

Recommendation 3.3.1:

Patients at standard risk of both pulmonary embolism (PE) and major bleeding should be considered for one of the chemoprophylactic agents evaluated in this guideline, including in alphabetical order: aspirin, low-molecular weight heparin (LMWH), synthetic pentasaccharides, and warfarin. (Level III, Grade B (choice of prophylactic agent), Grade C (dosage and timing)).

Note: The grade of recommendation was reduced from B to C for dosage and timing because of the lack of consistent evidence in the literature defining a clearly superior regime.

Recommendation 3.3.2

Patients at elevated (above standard) risk of PE and at standard risk of major bleeding should be considered for one of the chemoprophylactic agents evaluated in this guideline, including in alphabetical order: LMWH, synthetic pentasaccharides, and warfarin. (Level III, Grade B (choice of prophylactic agent), Grade C (dosage and timing)).

Note: The grade of recommendation was reduced from B to C for dosage and timing because of the lack of consistent evidence in the literature on risk stratification of patient populations.

Recommendation 3.3.3

Patients at standard risk of PE and at elevated (above standard) risk of major bleeding should be considered for one of the chemoprophylactic agents evaluated in this guideline, including in alphabetical order: aspirin, warfarin, or none. (Level III, Grade C)

Note: The grade of recommendation was reduced from B to C for dosage and timing because of the lack of consistent evidence in the literature on risk stratification of patient populations.

Recommendation 3.3.4

Patients at elevated (above standard) risk of both PE and major bleeding should be considered for one of the chemoprophylactic agents evaluated in this guideline, including in alphabetical order: aspirin, warfarin, or none. (Level III, Grade C)

Note: The grade of recommendation was reduced from B to C for dosage and timing because of the lack of consistent evidence in the literature on risk stratification of patient populations. No studies currently include patients at elevated risk of major bleeding and/or PE in study groups.

The following additional recommendations are based on the results of the objective American Academy of Orthopaedic Surgeons Consensus Process in which the work group members participated.

Recommendation 1.1

All patients should be assessed pre-operatively for elevated risk (greater than standard risk) of pulmonary embolism. (Level III, Grade B)

Recommendation 1.2

All patients should be assessed pre-operatively for elevated risk (greater than standard risk) of major bleeding. (Level III, Grade C)

Note: Grade of Recommendation reduced because of lack of consistent evidence on risk stratification of patient populations.

Recommendation 1.3

Patients with known contraindications to anticoagulation should be considered for vena cava filter replacement. (Level V, Grade C)

Recommendation 2.1

Patients should be considered for intra-operative and/or immediate postoperative mechanical prophylaxis. (Level III, Grade B)

Recommendation 2.2

In consultation with the anesthesiologist, patients should be considered for regional anesthesia. (Level IV, Grade C)

Recommendation 3.1

Postoperatively, patients should be considered for continued mechanical prophylaxis until discharge to home. (Level IV, Grade C)

Recommendation 3.2

Postoperatively, patients should be mobilized as soon as feasible to the full extent of medical safety and comfort. (Level V, Grade C)

Recommendation 3.4

Routine screening for deep venous thrombosis (DVT) or PE postoperatively in asymptomatic patients is not recommended. (Level III, Grade B)

Recommendation 4.1

Patients should be encouraged to progressively increase mobility after discharge to home. (Level V, Grade C)

Recommendation 4.2

Patients should be educated about the common symptoms of DVT and PE. (Level V, Grade B)

Note: The level of evidence is level V, expert opinion, but the strength of recommendation is B rather than C because patient education is consistent with the minimal expected standard of care for today's medical practices.

Of the fourteen recommendations listed above, only recommendations 3.3.1, 3.3.2, 3.3.3, and 3.3.4 are based on the systematic review of the literature conducted between August 2006 and March 2007 by The Center for Clinical Evidence Synthesis at Tufts New England Medical Center. The other recommendations contained in this guideline are based on consensus development methods only.

Definitions:

Levels of Evidence

Level I evidence is from high quality randomized clinical trials (e.g., a randomized trial comparing revision rates in patients treated with cemented and uncemented total hip arthroplasty).

Level II evidence is from cohort studies (e.g., revision rates in patients treated with uncemented total hip arthroplasty compared with a control group of patients treated with cemented total hip arthroplasty at the same time and institution).

Level III evidence is from case-control studies (e.g., the rates of cemented and uncemented total hip arthroplasty in patients with a particular outcome called "cases"; i.e. revised total hip arthroplasty, are compared to those who did not have outcome, called "controls"; i.e. non-revised total hip arthroplasty).

Level IV evidence is from an uncontrolled case series (e.g., a case series of patients treated with uncemented total hip arthroplasty).

Level V evidence is from expert opinion.

Recommendation Grades

A: Good evidence (Level I Studies with consistent finding) for recommending intervention.

B: Fair evidence (Level II or III Studies with consistent findings) for recommending intervention.

C: Poor quality evidence (Level IV or V) for recommending intervention.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is specifically stated for each recommendation (see "Major Recommendations").

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • American Academy of Orthopaedic Surgeons clinical guideline on prevention of symptomatic pulmonary embolism in patients undergoing total hip or knee arthroplasty. Rosemont (IL): American Academy of Orthopaedic Surgeons (AAOS); 2007. 63 p. [49 references]

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2007 May 19

GUIDELINE DEVELOPER(S)

American Academy of Orthopaedic Surgeons - Medical Specialty Society

SOURCE(S) OF FUNDING

American Academy of Orthopaedic Surgeons

GUIDELINE COMMITTEE

American Academy of Orthopaedic Surgeons (AAOS) Pulmonary Embolism Work Group

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Work Group Members: Norman A. Johanson, MD (Chair) Drexel University College of Medicine, Department of Orthopaedic Surgery, Philadelphia, PA; Paul F Lachiewicz, MD (Hip Society Rep) University of North Carolina School of Medicine, Chapel Hill, NC; Jay R. Lieberman, MD, Director, The Musculoskeletal Institute, Chairman, Department of Orthopaedic Surgery, University of Connecticut Health Center, Farmington, CT; Paul A. Lotke, MD (Knee Society Representative) Havertown, PA; Javed Parvizi, MD (AAHKS Representative) Rothman Institute, Philadelphia, PA; Vincent Pellegrini, MD, University of Maryland School of Medicine, Department of Orthopaedics, Baltimore, MD; Theodore A. Stringer, MD (BOC Representative) Colorado Springs, CO; Paul Tornetta III, MD (OTA Representative) Boston Medical Center, Department of Orthopedic Surgery, Boston, MA

American Academy of Orthopaedic Surgeons (AAOS) Staff: Robert H. Haralson III, MD, MBA, Medical Director, Rosemont, IL; Charles M. Turkelson, PhD, Director of Research and Scientific Affairs, Rosemont, IL; Janet L. Wies, MPH, Clinical Guideline Manager, Rosemont, IL

Panel Guest and Alternate Guidelines Oversight Chair: William C. Watters, III MD, Houston, TX

The Center for Clinical Evidence Synthesis (CCES), Tufts-New England Medical Center Staff: Ethan Balk, MD, MPH, Project Leader. Associate Director, CCES; Stanley Ip, MD; Gowri Raman, MD; May Adra, PharmD; Joseph Lau, MD, Director, CCES

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Dr. P. Lotke disclosed that he received an institutional research grant from DePuy/Johnson and Johnson from 1998-2003. No other members of the panel declared any conflict of interest.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available from the American Academy of Orthopaedic Surgeons Web site.

Print copies: Available from the American Academy of Orthopaedic Surgeons, 6300 North River Road, Rosemont, IL 60018-4262. Telephone: (800) 626-6726 (800 346-AAOS); Fax: (847) 823-8125; Web site: www.aaos.org.

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI Institute on July 10, 2007. The information was verified by the guideline developer on July 26, 2007. This summary was updated by ECRI Institute on September 7, 2007 following the revised U.S. Food and Drug Administration (FDA) advisory on Coumadin (warfarin). This summary was updated by ECRI Institute on March 14, 2008 following the updated FDA advisory on heparin sodium injection.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. For more information, please contact AAOS Department of Research and Scientific Affairs, 6300 North River Road, Rosemont, IL 60018; Phone: (847) 823-7186; Fax: (847) 823-8125.

DISCLAIMER

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