Published 2011 by the American Academy of Orthopaedic Surgeons 6300 North River Road Rosemont, IL AAOS Clinical Practice Guidelines Unit

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1 Volume 4. AAOS Clinical Guideline on Preventing Venous Thromboembolic Disease in Patients Undergoing Elective Hip and Knee Arthroplasty Comparison with Other Guidelines Disclaimer This clinical guideline was developed by an AAOS physician volunteer Work Group and experts in systematic reviews. It is provided as an educational tool based on an assessment of the current scientific and clinical information and accepted approaches to treatment. The recommendations in this guideline are not intended to be a fixed protocol as some patients may require more or less treatment or different means of diagnosis. Patients seen in clinical practice may not be the same as those found in a clinical trial. Patient care and treatment should always be based on a clinician s independent medical judgment given the individual clinical circumstances. Disclosure Requirement In accordance with AAOS policy, all individuals whose names appear as authors or contributors to this clinical practice guideline filed a disclosure statement as part of the submission process. All panel members provided full disclosure of potential conflicts of interest prior to beginning work on the recommendations contained within this clinical practice guideline. Funding Source The American Academy of Orthopaedic Surgeons exclusively funded this clinical practice guideline. The Academy received no funding from outside commercial sources to support the development of this document. FDA Clearance Some drugs or medical devices referenced or described in this clinical practice guideline may not have been cleared by the Food and Drug Administration (FDA) or may have been cleared for a specific use only. The FDA has stated that it is the responsibility of the physician to determine the FDA clearance status of each drug or device he or she wishes to use in clinical practice. Copyright All rights reserved. No part of this clinical practice guideline may be reproduced, stored in a retrieval system, or transmitted, in any form, or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the AAOS. Published 2011 by the American Academy of Orthopaedic Surgeons 6300 North River Road Rosemont, IL

2 Second Edition Copyright 2011 by the American Academy of Orthopaedic Surgeons COMPARISON WITH PRIOR GUIDELINES/AHRQ REVIEW Several guidelines on this topic have previously been published, including the prior AAOS guideline from 2007, 1 the American College of Chest Physicians (ACCP) guideline from 2008, 2 and the National Institute for Health and Clinical Excellence (NICE) guideline from In addition, the Agency for Healthcare Research and Quality (AHRQ) has published a draft systematic review on this topic in The following pages compare and contrast the current AAOS guideline with these prior publications. COMPARING REVIEW METHODS INCLUSION CRITERIA The major differences in inclusion criteria include the differences in the time period for eligible studies, the minimum number of patients allowed in a study, the outcomes considered for inclusion, and the patient populations considered. Another major difference is that the prior AAOS guideline was mainly consensus-based; only the recommendations for chemoprophylaxis were based on a systematic review of the literature. The time period of eligible studies for the current AAOS guidelines was 1966 February This compares to 1980 September 2010 for the AHRQ review, 1950 December 2008 for the NICE guideline, 1966 May 2006 (the 2008 guideline updated the search from the prior edition of the guidelines) for the ACCP guideline, and 1996 August 2006 for the prior AAOS guideline. The minimum number of patients needed for a study to be included for the current AAOS guideline was 100 patients enrolled per arm for the outcomes PE, DVT, and mortality, and 10 patients per arm for other outcomes. The AHRQ review included controlled trials of any size and controlled observational studies of at least 750 patients. The NICE guideline appeared to include studies of any size, the ACCP guideline included studies of at least 10 patients per arm, and the prior AAOS guideline included randomized trials of at least 10 patients per arm and prospective studies of at least 100 patients. For outcomes considered, a major difference is that the prior AAOS guideline did not consider DVT, while the other guidelines and reviews did. Also, the current AAOS guideline, while using DVT as an outcome, did not consider DVT to be a critical outcome. In terms of patient populations, all guidelines and reviews included elective hip and knee arthroplasty patients. Only the AHRQ also considered hip fracture patients in the same analyses with elective arthroplasty patients. ACCP and NICE analyzed hip and knee patients separately. The current AAOS guideline analyzed hip and knee patients both separately and together, as did AHRQ. For major bleeding only, the NICE analysis pooled studies across all included populations of surgical and hospitalized medical patients. 2

3 The article inclusion criteria in these various sources are summarized in Table 1. Table 1 Article Inclusion Criteria Guideline/Review Dates Minimum N* Outcomes Patients All reported AAOS (Current) Feb, 2011 outcomes (but DVT not a critical outcome) AHRQ (2011) NICE (2010) Sept, /arm for PE, DVT, and mortality; 10 for all other outcomes Any size for controlled trials, 750 patients for controlled observational studies Dec, 2008 Any size May, patients per arm All reported outcomes All reported outcomes All reported ACCP (2008) outcomes All patientoriented 10 patients/arm for RCTS, 100 patients outcomes (does Aug, for all other not include AAOS (2007) 2006 prospective trials DVT) *Minimum N refers to the smallest number of patients in any included trial. Elective hip and knee arthroplasty Elective hip and knee and hip fracture patients Elective hip and knee and, for major bleeding, also surgical and hospitalized patients Elective hip and knee Elective hip and knee arthroplasty QUALITY ASSESSMENT The AHRQ review evaluated individual study quality as good, fair, or poor, according to a quality checklist specific to study design. The overall strength of evidence was graded as high, moderate, low, or insufficient based on four domains: risk of bias, consistency, directness, and precision. The applicability of each study and of the body of evidence was also determined, with more applicable studies labeled as effectiveness studies and less applicable studies labeled efficacy studies. The NICE guideline used the Scottish Intercollegiate Guidelines Network (SIGN) system for ranking the evidence and included studies of the highest available evidence. For example, if a high-quality systematic review, meta-analysis, or randomized controlled trial was found, lower quality studies were not included. The reviewers first determined the design of a study and then rated the quality of each study using a quality checklist specific to the study design. The ACCP guideline rated study quality by assessing randomization, allocation concealment, blinding, completeness of follow-up, and intention-to-treat analysis. The quality of the body of evidence was rated A, B, or C, based on the quality of the studies as well as the consistency and precision of results, the directness of the evidence, and the probability of reporting bias. The prior AAOS guideline rated individual studies in a manner similar to that of the AHRQ review, while the body of evidence was rated based on a level of evidence system largely based on study design. 3

4 In each of these quality assessment systems, as well as that used for the current AAOS guideline, arriving at a final score is subjective and arbitrary. However, only the current AAOS system explicitly used a scoring system in which highly specific criteria determined what answer would be given to any given quality-related question. STATISTICAL METHODS For questions addressed by sufficient data, AHRQ conducted traditional meta-analyses. They did not performed network meta-analyses. The AHRQ review involved a series of analyses, first grouping all pharmacologic agents together to compare to no prophylaxis and grouping all mechanical devices together to compare to no prophylaxis. Then interclass comparisons of agents were performed, followed by intraclass comparisons. Like the current AAOS guideline, the NICE guideline performed network meta-analyses of the thromboprophylaxis literature. NICE grouped all low-molecular-weight heparins (LMWH) together in their analysis, while AAOS did not. Both guidelines grouped foot pumps with intermittent pneumatic compression devices in these analyses. For major bleeding, NICE grouped mechanical devices with no prophylaxis. ACCP relied on previously published pooled estimated from high-quality systematic reviews or conducted traditional meta-analysis to obtain pooled estimates for specific questions. The prior AAOS guideline, due to the rarity of events, conducted meta-analyses to estimate the incidence of each outcome according to treatment. These analyses were used to indirectly compare event rates by treatment. GRADING RECOMMENDATIONS Being a systematic review, The AHRQ review did not make recommendations; it only summarized the available evidence. The NICE guideline did not assign a grade to their recommendation but tried to convey its strength through the wording and discussion of the recommendation. ACCP used a grading system based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. The guideline used two levels of recommendation: grade 1 for strong recommendations ( we recommend ) and grade 2 for weak recommendations ( we suggest ). This differs from the current AAOS system which uses a third level for moderate recommendations, with the corresponding language of we suggest, while the practitioner might is the phrase used for weak recommendations. Each recommend is therefore labeled for strength of recommendation (1 or 2) and quality of evidence (A, B, or C). The prior AAOS guideline graded recommendations A, B, or C, based on good, fair, or poor evidence, respectively. 4

5 COMPARING RECOMMENDATIONS Here we compare the recommendations of other guidelines to those in the current guideline. First, the current AAOS recommendation is stated, followed by a table summarizing the corresponding recommendation from the prior AAOS guideline, the ACCP guideline, and the NICE guideline. While the AHRQ review did not make recommendations, we summarize its findings for each of the recommendations it addressed. Following the table, we discuss any differences between the guidelines. 1. We recommend against routine post-operative duplex ultrasonography screening of patients who undergo elective hip or knee arthroplasty. (Grade of Recommendation: Strong) Other Guidelines Results Grade of Recommendation Prior AAOS Guideline (2007) Agrees with recommendation Grade B; Consensus recommendation ACCP (2008) Agrees with recommendation Grade 1A NICE (2010) Does not address n/a AHRQ (2011) Does not address n/a Comment: Among guidelines addressing routine screening, there are no differences. NICE and AHRQ do not address this topic. 5

6 2. Patients undergoing elective hip or knee arthroplasty are already at high risk for venous thromboembolism. The practitioner might further assess the risk of venous thromboembolism by determining whether these patients had a previous venous thromboembolism. (Grade of Recommendation: Weak) Current evidence is not clear about whether factors other than a history of previous venous thromboembolism increase the risk of venous thromboembolism in patients undergoing elective hip or knee arthroplasty and, therefore, we cannot recommend for or against routinely assessing these patients for these factors. (Grade of Recommendation: Inconclusive) Other Guidelines Prior AAOS Guideline (2007) ACCP (2008) NICE (2010) AHRQ (2011) Results Recommends risk-stratification for PE gives examples but does not specify complete list of risk factors; guideline does not address DVT Does not explicitly make a recommendation; notes all TKA and THA patients considered high risk for VTED Considers all TKA and THA patients as at elevated risk for VTED; Does not make a recommendation regarding further risk stratification Notes limited data and lists characteristics that have been associated with VTED in a study using multivariate regression analysis Grade of Recommendation Grade B; Consensus recommendation n/a NICE does not formally assign grades n/a Comment: While the present AAOS guideline concurs with NICE and ACCP in that all THA and TKA patients are at elevated risk for VTED, the current AAOS guideline further suggests that patients with a previous history of VTE are of even more concern. NICE and ACCP did not specifically address whether prior VTED or other factors further increase the risk beyond the already high risk due to THA/TKA. 6

7 3. Patients undergoing elective hip or knee arthroplasty are at risk for bleeding and bleeding-associated complications. In the absence of reliable evidence, it is the opinion of this work group that patients be assessed for known bleeding disorders like hemophilia and for the presence of active liver disease which further increase the risk for bleeding and bleeding-associated complications. (Grade of Recommendation: Consensus) Current evidence is not clear about whether factors other than the presence of a known bleeding disorder or active liver disease increase the chance of bleeding in these patients and, therefore, we are unable to recommend for or against using them to assess a patient s risk of bleeding. (Grade of Recommendation: Inconclusive) Other Guidelines Results Grade of Recommendation Prior AAOS Guideline (2007) Recommends risk-stratification gives examples but does not specify complete list of risk factors Grade C; Consensus recommendation ACCP (2008) Does not make a specific recommendation regarding risk-stratification for bleeding but alters recommended thromboprophylaxis for patients at high risk of bleeding n/a NICE (2010) Recommends assessing bleeding risk; among patients with a bleeding risk factor, recommends withholding pharmacological prophylaxis if bleeding risk outweighs VTED risk (consensus) NICE does not formally assign grades AHRQ (2011) Found no data n/a Comment: The prior AAOS guideline and the NICE guideline made their recommendations based on consensus. ACCP does not directly make a recommendation, although its thromboprophylaxis recommendation does separate out patients at high risk of bleeding. Like AHRQ, we found a lack of evidence addressing the topic, so we refrained from making a recommendation except for the two factors for which there was direct, albeit very low quality, evidence among elective hip or knee arthroplasty patients. 7

8 4. We suggest that patients discontinue antiplatelet agents (e.g., aspirin, clopidogrel) before undergoing elective hip or knee arthroplasty. (Grade of Recommendation: Moderate) Other Guidelines Results Grade of Recommendation Prior AAOS Guideline (2007) Does not address n/a ACCP (2008) Addresses in a separate publication: 5 Does not make a specific recommendation on whether to discontinue: discusses risk- stratifying patients (if low risk for cardiovascular event, can discontinue) For patients who do requiring stopping antiplatelet therapy, recommends stopping 7-10 days before surgery. n/a Recommends assessing the risks and benefits of stopping pre-existing established antiplatelet therapy 1 week before surgery. Also recommends considering NICE (2010) involving the multidisciplinary team in the assessment. AHRQ (2011) Does not address n/a NICE does not formally assign grades Comment: ACCP discusses the factors to consider when making the decision regarding discontinuation of antiplatelet therapy but does not make a recommendation. Similarly, NICE only recommends assessing the risks and benefits of discontinuing antiplatelet therapy, rather than recommending discontinuation outright. Neither guideline s discussion of the issue is specific to elective hip or knee arthroplasty patients. AHRQ and the prior AAOS guideline do not address this topic. 8

9 Prior AAOS Guideline (2007) 5. We suggest the use of pharmacologic agents and/or mechanical compressive devices for the prevention of venous thromboembolism in patients undergoing elective hip or knee arthroplasty, and who are not at elevated risk beyond that of the surgery itself for venous thromboembolism or bleeding. (Grade of Recommendation: Moderate) Current evidence is unclear about which prophylactic strategy (or strategies) is/are optimal or suboptimal. Therefore, we are unable to recommend for or against specific prophylactics in these patients. (Grade of Recommendation: Inconclusive) In the absence of reliable evidence about how long to employ these prophylactic strategies, it is the opinion of this work group that patients and physicians discuss the duration of prophylaxis. (Grade of Recommendation: Consensus) Other Guidelines Results Grade of Recommendation Grade B for choice of agent, Grade C for dosage and timing ACCP (2008) NICE (2010) Pharmacological prophylaxis: For patients at standard risk of bleeding and PE, recommends aspirin, LMWH, warfarin, or synthetic pentasaccharides (recommended duration varies by agent) Mechanical prophylaxis: recommends (consensus) Elective hip replacement recommendations: Use LMWH, fondaparinux, or adjusted-dose vitamin K antagonist (VKA) (dosage and timing specified for each drug) Do not use aspirin, heparin, graduated compression stockings (GCS), or foot pump as sole prophylaxis method Elective knee replacement recommendations: Same as hip except IPC is an alternative to anticoagulant prophylaxis (also doesn t recommend against GCS alone) Other major orthopedic surgery recommendations: Timing (discussion is of tradeoff between efficacy and bleeding) Duration: at least 10 days; extend beyond 10 days and up to 35 days (recommended for hip, suggested for knee) Recommends combined mechanical and pharmacological methods: Mechanical: start at admission and continue until patient no longer has reduced mobility; use GCS, foot impulse devices, or IPC Pharmacological: start after surgery (specific timing given separately for each drug) and continue for days for hip patients and days for knee patients: Dabigatran, Fondaparinux, LMWH, Rivaroxaban, unfractionated heparin (UFH) (for patients with renal failure) Mechanical prophylaxis (Consensus recommendation): Grade B for use, Grade C for duration Choice of agents: Grade 1A, except IPC as alternative in knee patients is Grade 1B, not using foot pump as sole method in knee patients is Grade 1B Duration: Grade 1A for at least 10 days; extended duration is 1A for hip and 2B for knee; each recommended agent also has a separate grade for extended duration: LMWH: Grade 1A hip, 1C knee VKA: Grade 1B hip, 1C knee Fondaparinux: Grade 1C hip and knee NICE does not formally assign grades 9

10 Other Guidelines Results Grade of Recommendation Any prophylaxis vs. no prophylaxis Pharmacologic prophylaxis: o reduces DVT and increases minor bleeding (moderate evidence) o no reduction in symptomatic DVT, major bleeding, nonfatal PE, mortality, fatal PE, fatal bleeding, major bleeding leading to reoperation (low level evidence) o no reduction in PE unless limit to trials not allowing any background prophylaxis (stockings) in either group o no data for other outcomes, including PTS Mechanical prophylaxis: o reduces overall DVT, no reduction in proximal or distal DVT (low level evidence) o no data for other outcomes Comparing classes of agents AHRQ (2011) LMWHs better than heparin for PE, major bleeding, proximal DVT, and DVT (for THA; opposite result among hip fracture surgery (HFS) for PE and DVT); heparin also worse than direct thrombin inhibitors and mechanical prophylaxis for DVT In base case (THA, TKA, HFS), not many interclass differences for symptomatic outcomes In THA alone, LMWHs better than factor Xa inhibitors for nonfatal PE and symptomatic DVT; but factor Xa inhibitors better than LMWHs for DVT (and proximal DVT for TKA and HFS) in each surgery LMWHs better than vitamin K antagonists for DVT Mechanical better than oral antiplatelets for DVT Major bleeding: LMWHs better than factor Xa inhibitors, worse than vitamin K antagonists Observational studies: one found oral vitamin K antagonist better than oral antiplatelets for fatal PE (only RCT had same direction, but not significant) Intraclass comparisons Not much data, especially for symptomatic outcomes Only significant difference: IPC better than GCS for DVT Combined pharmacologic and mechanical vs. single modality Lack of data, except for DVT For DVT: moderate evidence that pharmacologic and mechanical better than pharmacologic alone Duration of prophylaxis Prolonged prophylaxis reduced PE, symptomatic DVT and DVT, andincreased minor bleeding 10 v1.0_09 n/a 2311

11 Comment: All three prior guidelines recommend thromboprophylaxis of some variety, but the recommended strategies differ. Our current guideline suggests prophylaxis (moderate recommendation because the evidence supporting thromboprophylaxis is based on DVT, a surrogate outcome) but is unable to recommend a specific strategy. The AHRQ review also finds evidence in favor of prophylaxis but with insufficient data to recommend a specific strategy, with the exception of preferring LMWHs over unfractionated heparin. NICE and ACCP recommend extended prophylaxis, at least for hip patients, and the AHRQ review also finds benefits to extended prophylaxis. Evidence on which recommendations based: Prior AAOS - consensus-based for mechanical prophylaxis, systematic review using indirect comparisons across different arms of studies for pharmacological prophylaxis o Did not consider DVT as an outcome o Found no differences, possibly due to lack of statistical power, for any outcome except that major bleeding was very rare among patients receiving aspirin or mechanical devices alone compared to those who received systemic interventions ACCP based on systematic review o Cites two meta-analyses as the main basis that prophylaxis works as compared to no prophlyaxis, one of antiplatelet therapy and one of unfractionated heparin Antiplatelet meta-analysis ACCP notes that the analysis relies on methodologically limited studies: generally small studies that were conducted >30 years ago and that were of variable quality. Only one third of the studies included a group that received aspirin alone; and, of these, generally accepted methods of screening for DVT were performed in only 38%. The meta-analysis found that, among elective orthopaedic surgery patients, antiplatelet therapy significantly reduced DVT; the reduction in PE was not significant but was of similar proportion to the results among general and traumatic orthopaedic surgery patients, which were significant The ACCP meta-analysis found that heparin reduced DVT and fatal PE among orthopaedic surgery patients Empirical evidence in the current AAOS analysis that data from those trials should not be compared to more recent trials. For 11

12 example, in the current AAOS guideline, the symptomatic PE rate among untreated/placebo group patients is <1.1% in all 4 trials, whereas the fatal PE rate among control group patients in the heparin meta-analysis was at least 2.6%. The critiques ACCP makes about the antiplatelet meta-analysis also apply to this meta-analysis: small studies conducted >30 years ago of variable quality o Efficacy of LMWH established in relation to unfractionated heparin, and other agents in relation to LMWH, mainly using DVT and proximal DVT as the relevant outcomes NICE based on systematic review performing network meta-analysis o Results indicate almost all agents included in the model are effective at preventing DVT o For PE, insufficient data for knee patients; for hip patients, only LMWH and VKA were statistically significant Includes asymptomatic PE o For major bleeding, the analysis pooled studies across populations (surgical and medical patients); VKA, LMWH, UFH, and fondaparinux increase major bleeding 12

13 6. In the absence of reliable evidence, it is the opinion of this work group that patients undergoing elective hip or knee arthroplasty, and who have also had a previous venous thromboembolism, receive pharmacologic prophylaxis and mechanical compressive devices. (Grade of Recommendation: Consensus) Other Guidelines Grade of Recommendation Results Excludes aspirin from list of recommended agents for patients at standard risk for bleeding and elevated risk Prior AAOS for PE; recommended pharmacologic agents include Guideline low molecular weight heparin (LMWH), synthetic (2007) pentasaccharides, and warfarin Grade B Does not make separate prophylaxis recommendation ACCP (2008) for patients at elevated risk for VTED n/a Does not make separate prophylaxis recommendation NICE (2010) for patients at elevated risk for VTED n/a AHRQ (2011) Does not address n/a Comment: As the ACCP and NICE guidelines consider all patients to be at high risk, they do not make a separate recommendation for this patient population. NICE recommends pharmacologic and mechanical prophylaxis for all patients (except for those with elevated bleeding risk). The prior AAOS guideline also recommended pharmacologic and mechanical prophylaxis for patients with an elevated risk of VTE, but excluded aspirin from the list of recommended agents for these patients. AHRQ does not address this topic. 13

14 7. In the absence of reliable evidence, it is the opinion of this work group that patients undergoing elective hip or knee arthroplasty, and who also have a known bleeding disorder (e.g., hemophilia) and/or active liver disease, use mechanical compressive devices for preventing venous thromboembolism. (Grade of Recommendation: Consensus) Other Guidelines Prior AAOS Guideline (2007) ACCP (2008) Results For patients at elevated risk of bleeding, recommends aspirin, warfarin, or no pharmacological prophylaxis regardless of risk of PE For patients with a high risk of bleeding, recommends using foot pump or intermittent pneumatic compression (IPC) until bleeding risk decreases, then substituting or adding pharmacologic prophylaxis For patients with a bleeding risk factor, recommends withholding pharmacological prophylaxis if bleeding risk outweighs VTED risk (consensus) Grade of Recommendation Grade C IPC: Grade 1A Foot pump: Grade 1A - hip, 1B - knee Substituting pharmacologic: Grade 1C NICE does not formally assign grades NICE (2010) AHRQ (2011) Does not address n/a Comment: The other guidelines agree to provide mechanical prophylaxis and withhold pharmacologic prophylaxis for patients with a higher risk of bleeding, although the specification of which patients have a higher than normal risk of bleeding is not consistent across guidelines. Those with acquired bleeding disorders (such as acute liver failure) and untreated inherited bleeding disorders (such as hemophilia) are included in the NICE guideline s list of bleeding risk factors. The ACCP guideline and the prior AAOS guideline do not have a list of specific risk factors. AHRQ does not address this topic. 14

15 8. In the absence of reliable evidence, it is the opinion of this work group that patients undergo early mobilization following elective hip and knee arthroplasty. Early mobilization is of low cost, minimal risk to the patient, and consistent with current practice. (Grade of Recommendation: Consensus) Other Guidelines Results Grade of Recommendation Prior AAOS Guideline (2007) Agrees with recommendation Grade C; Consensus recommendation ACCP (2008) Does not address n/a NICE (2010) Agrees with recommendation (consensus recommendation not specific to TKA/THA patients) NICE does not formally assign grades AHRQ (2011) Does not address n/a Comment: Among guidelines addressing this topic, there are no differences. AHRQ and ACCP do not address this topic. 15

16 9. We suggest the use of neuraxial (such as intrathecal, epidural, and spinal) anesthesia for patients undergoing elective hip or knee arthroplasty to help limit blood loss, even though evidence suggests that neuraxial anesthesia does not affect the occurrence of venous thromboembolic disease. (Grade of Recommendation: Moderate) Other Guidelines Prior AAOS Guideline (2007) ACCP (2008) NICE (2010) AHRQ (2011) Results Recommends consideration of regional anesthesia Doesn t directly address: recommends caution when using anticoagulant prophylaxis in patients undergoing neuraxial anesthesia/analgesia Recommends regional anesthesia (recommendation not specific to TKA/THA patients); also has consensus recommendation to plan the timing of pharmacological prophylaxis to minimize the risk of epidural hematoma when using regional anesthesia Data summarized as neutral for symptomatic outcomes and favorable to neutral for DVT when comparing regional vs. general anesthesia Grade of Recommendation Grade C; Consensus recommendation n/a NICE does not formally assign grades n/a Comment: The NICE guideline recommends regional anesthesia based on lower VTE risk, whereas our review suggests regional anesthesia based on lower blood loss and no difference in VTE risk. The evidence on which the NICE recommendation is based is not specific to TKA or THA patients, although 12 of the 15 studies were in elective orthopaedic surgery patients. NICE does point out that the most recent study in their review was from 1996 and that general anesthesia methods have changed since then. The AHRQ review found mainly neutral results for the outcomes of symptomatic DVT, PE, and major bleeding, with favorable to neutral results for DVT. 16

17 10. Current evidence does not provide clear guidance about whether inferior vena cava (IVC) filters prevent pulmonary embolism in patients undergoing elective hip and knee arthroplasty who also have a contraindication to chemoprophylaxis and/or known residual venous thromboembolic disease. Therefore, we are unable to recommend for or against the use of such filters. (Grade of Recommendation: Inconclusive) Other Guidelines Results Grade of Recommendation Prior AAOS Guideline (2007) Recommends consideration of IVC filters for patients with contraindication for anticoagulation Grade C; Consensus recommendation ACCP (2008) Does not address the use of filters in elective arthroplasty patients n/a NICE (2010) Recommends consideration of IVC filters in patients at very high risk for VTED and contraindication to mechanical and pharmacological prophylaxis (consensus recommendation not specific to TKA/THA patients) NICE does not formally assign grades AHRQ (2011) Found no data n/a Comment: NICE and the prior AAOS guideline made consensus recommendations to consider IVC filter use in patients contraindicated for anticoagulation. ACCP does not address the use of filters in elective hip or knee arthroplasty patients, while AHRQ found no data. We similarly refrained from making a recommendation due to the lack of evidence addressing this topic. 17

18 REFERENCES (1) Guideline on the Prevention of Symptomatic Pulmonary Embolism in Patients Undergoing Total Hip or Knee Arthroplasty American Academy of Orthopaedic Surgeons (2) Geerts WH, Bergqvist D, Pineo GF et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008;133:381S-453S. (3) National Institute for Health and Clinical Excellence. Venous thromboembolism - reducing the risk. CG London, National Institute for Health and Clinical Excellence. (4) DRAFT Comparative effectiveness of venous thromboembolism prophylaxis in orthopedic surgery Rockville, MD, Agency for Healthcare Research and Quality (5) Douketis JD, Bakhsh E. Perioperative management of antithrombotic therapy. Pol Arch Med Wewn 2008;118:

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