PRIMARY TOTAL KNEE & HIP

Transcription

1 Clinical Guideline Version 2.0 Title: PRIMARY TOTAL KNEE & HIP Venous ThromboEmbolic (VTE) Guideline Target Audience: thopedic Surgeons and their Advanced Practice Practitioner partners; Hospitalists, Internal Medicine Physicians or Primary Care Physicians who help manage total joint patients; surgical teams on staff at any MHS facility who perform primary total knee and hip joint replacement procedures; Anesthesiologists on staff at any MHS facility; MHS Pre-admission Clinic Nurses; MHS Perioperative Nurses and MHS Pharmacists. Scope/Patient Population: All patients scheduled for and who undergo elective primary total hip or knee replacement surgery Objective: Establish a MHS standard approach to reduce post-operative VTE and minor/major bleeding complications in patients undergoing total joint replacement. Rational: Prevention of Venous ThromboEmbolic (VTE) events including Deep Venous Thrombosis (DVT) and Pulmonary Embolus (PE) reduces morbidity and mortality in patients following surgery for knee and hip joint replacement procedures. Some reports demonstrate that in-hospital VTE can be reduced by 50-60% and PE by 66% in those receiving prophylaxis; representing 13 VTE events for every 1,000 patients undergoing major orthopedic surgery. Additional History: Historically, the guideline recommendations to prevent VTEs have varied widely depending on underlying assumptions, goals, and methodology. This effort has previously been exemplified by the American College of Chest Physicians (ACCP) and the American Academy of thopaedic Surgeons (AAOS). The former group of medical specialists targeted minimizing venographically proven DVT (the vast majority of which are asymptomatic) as their primary goal prior to The latter group of surgeons targeted minimizing symptomatic VTE. Prior to 2012, the recommendations of the two groups were widely divergent; recently, both groups have become closely aligned with their individual Clinical Practice Guidelines and are both focused upon minimizing symptomatic VTE and bleeding complications. MHS carefully reviewed both the VTE prophylaxis guidelines provided by AAOS and ACCP. Based upon consensus of an internal review panel, the AAOS guideline will serve as the basis for the MHS total joint VTE prophylaxis guideline and order set development. Here is a brief overview of the AAOS recommendations. The full guideline is available here. Page 1 of 8 Clinical Guideline

2 Consensus Inconclusive Limited Moderate Strong Summary of AAOS Ratings, Recommendations, Implications Definitions and Descriptions* Recommendation Implications Definition Description Do not routinely obtain post-operative duplex ultrasonography screening - Patients should discontinue antiplatelet agents (e.g., aspirin, clopidogrel) prior to undergoing elective hip or knee arthroplasty. - Pharmacologic agents and/or mechanical compressive devices should be used for the prevention of VTE in patients who are not at elevated risk beyond that of the surgery itself for VTE or bleeding. - Neuraxial (such as intrathecal, epidural, and spinal) anesthesia is suggested for use in patients undergoing elective hip or knee arthroplasty to help limit blood loss. There is no evidence to suggest that neuraxial anesthesia affects the occurrence of VTE. Practitioners should follow unless a clear and compelling rationale for an alternative approach is present. Practitioners should generally follow but remain alert to new information and be sensitive to patient preferences. Benefits of the recommended approach clearly exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a strong negative recommendation), and that the strength of the supporting evidence is high. Benefits exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but the strength of the supporting evidence is not as strong. Evidence is based on two or more High strength studies with consistent findings for recommending for or against the intervention. Evidence from two or more Moderate strength studies with consistent findings, or evidence from a single High quality study for recommending for or against the intervention. Patients undergoing elective hip or knee arthroplasty are already at high risk for VTE providers are encourage to further assess the risk of VTE by determining whether these patients have had a previous VTE. Current evidence is not clear about: - A history of previous VTE increase the risk of VTE in patients undergoing elective hip or knee arthroplasty and, therefore, the AAOS workgroup cannot recommend for or against routinely assessing these patients for these factors. - The presence of a known bleeding disorder or active liver disease increasing the chance of bleeding - unable to recommend for or against using them to assess a patient s risk of bleeding. - Which prophylactic strategy (or strategies) is/are optimal or suboptimal - unable to recommend for or against specific prophylactics. Practitioners should exercise clinical judgment when following, and should be alert to emerging evidence that might negate the current findings. Patient preference should have a substantial influencing role. Practitioners should feel little constraint in following, exercise clinical judgment, and be alert for emerging evidence that clarifies or helps to determine the balance between benefits and potential harm. Patient preference should have a substantial influencing role. The quality of the supporting evidence that exists is unconvincing, or that wellconducted studies show little clear advantage to one approach versus another There is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm (unable to recommend for or gains use). Evidence from two or more Low strength studies with consistent findings, or evidence from a single Moderate quality study recommending for or against the intervention or diagnostic. Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. - Whether IVC filters prevent PE in patients who also have a contraindication to chemoprophylaxis and/or known residual venous thromboembolic disease unable to recommend for or against vena cava (IVC) filter implantation - Patients undergoing elective hip or knee arthroplasty are at risk for bleeding and bleedingassociated complications and should assessed for known bleeding disorders (e.g. hemophilia, active liver disease) which further increase the risk for bleeding and bleeding-associated complications. - Patients and physicians discuss the duration of prophylaxis. - Patients with history of a previous VTE event should receive both pharmacologic prophylaxis and mechanical compressive devices. - Patients who a known bleeding disorder (e.g., hemophilia) and/or active liver disease should receive mechanical compressive devices for preventing VTE. Practitioners should be flexible in deciding whether to follow a recommendation, although they may give it preference over alternatives. Patient preference should have a substantial influencing role. Expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria of the guideline s systematic review. The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. - Early mobilization - is of low cost, minimal risk to the patient, and consistent with current practice. *Adapted from the 2012 executive summary of American Academy of thopaedic Surgeons clinical practice guideline on: preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. Page 2 of 8 Clinical Guideline

3 MHS Recommendations: Patients should receive VTE prophylaxis with any of the pharmacological and/or mechanical options listed below in the table unless contraindicated. The recommendations are consistent with the AAOS guidelines and local best practice. In addition, they also attempt to standardize care and establish a basis from which order sets are established. Consult MHS drug formulary for availability of specific medications within therapeutic class or recommended alternatives. Contraindications may include any of the following: Pharmacological prophylaxis contraindications Surgery and or invasive procedure in past or next 24 hours Patient receiving therapeutic anticoagulation and is within therapeutic window Active bleeding unspecified location Active bleeding CNS Active bleeding GI Active bleeding retroperitoneal hemorrhage Patient at perceived elevated risk of bleeding Coagulopathy Thrombocytopenia Patient or family refusing pharmacological prophylaxis Patient on hospice care Mechanical prophylaxis contraindications Patient receiving therapeutic anticoagulation Severe lower extremity edema Lower extremity injury or wound Lower extremity deformity Lower extremity amputation Lower extremity DVT either suspected or confirmed Lower extremity arterial occlusive disease Lower extremity peripheral vascular disease Patient or family refusing mechanical prophylaxis Patient on hospice care Page 3 of 8 Clinical Guideline

4 Medication Cohort Dose Duration Renal Adjustment Hepatic Adjustment Weight Adjustment Geriatric Adjustment Initiate rivaroxaban 10 mg once daily 21 days No adjustment required avoid use in patients with CrCl < 30 ml/min Avoid use with moderate-tosevere disease (Child-Pugh class B or C) No adjustment required No adjustment required Following hemostasis establishment 6 to 10 hours postoperatively 2.5 mg 21 days No adjustment necessary Avoid use with severe No information reported No adjustment required Following hemostasis apixaban twice daily avoid use in patients with CrCl < 15 ml/min disease (Child-Pugh class C) establishment 12 to 24 hours postoperatively fondaparinux (Use in patients with 2.5 mg once daily 21 days CrCl 30 to 50 ml/min reduce dose by 50%; CrCl < 30 ml/min - contraindicated Optimal dose not established in severe disease (Child-Pugh class C) monitor closely for signs of bleeding Use with caution in patients < 50 kg No adjustment required Following hemostasis 6 to 8 hours postoperatively HIT) Knee 30 mg 21 days or until CrCl < 30 ml/min reduce No adjustment required use BMI > 40 - Increase once Close observation in patients 12 to 24 hours after every 12 risk for DVT dose to 30 mg dally with caution daily dose by 30% - < 45 kg; increased incidence surgery hours diminished or recommend 30 mg every 12 of bleeding with doses of 1.5 enoxaparin Hip 30 mg every 12 hours or 40 mg daily patient adequately anticoagulated with warfarin, rivaroxaban, or apixaban hours. Not approved by FDA for use in dialysis patients mg/kg/day or 1 mg/kg every 12 hours & risk of serious adverse events with geriatric patients 12 to 24 hours after surgery First dose 9 to 15 hours prior to surgery Dose 21 days No adjustment required No information reported No information reported Typical starting dose < 5mg; No information based lower dosages are typically reported warfarin upon INR target of required (2-5 mg/day) to produce a therapeutic level of 1.5 to 2.5 anticoagulation 325 mg BID 6 weeks Avoid use in patients with CrCl < 10 ml/min Avoid use with severe disease (Child-Pugh class C). No adjustment required No adjustment required No information reported Aspirin Decrease dose to 81 mg BID if history of GI bleed, GI upset/gastritis, or other intolerance to 325mg dose SCD Sequential Compression Device Recommend use on all patients while hospitalized Use as adjunct to anticoagulant-based thromboprophylaxis. Use mechanical devices alone in patients at high risk of bleeding when pharmacologic methods are contraindicated Recommended mechanical methods include sequential compression device (intermittent pneumatic compression) or plexi-pulse foot device (venous foot pump). *Drug information including dosage, initiation and various titration adjustments adapted from Lexicomp (2015). Page 4 of 8 Clinical Guideline

5 The following tables are intended to be used as a guide for those surgeons who wish to determine prophylaxis based on patient risk factors for VTE and bleed risk although not required per AAOS guidelines. Prophylaxis based on Patient Risk Factors for VTE High Risk for VTE Options Moderate Risk for VTE Options Low Risk for VTE Options Aspirin Aspirin Contraindication Pharmacologic Approach SCD or VFP Prophylaxis based on Patient Risk Factors for VTE & High Risk for Bleed High Risk for VTE & High Risk for Bleed Options SCD alone Aspirin + SCD Moderate Risk for VTE & High Risk for Bleed Options SCD alone Aspirin + SCD Low Risk for VTE & High Risk for Bleed Options SCD alone Aspirin + SCD Contraindication Pharmacologic Approach SCD or VFP Page 5 of 8 Guideline Clinical

6 Primary Evidence: AAOS VTE Prophylaxis Guideline Full Version 1. Jacobs, J.J., Mont, M.A., Bozic, K.J., Della Valle, C.J., Goodman, S.B., Lewis, C.G., Hitchcock, K., (2012). American Academy of thopaedic Surgeons clinical practice guideline on: preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. J Bone Joint Surg Am, 18;94(8): Link Secondary Sources Reviewed: 2. Barrack R.L. (2012). Current guidelines for total joint VTE prophylaxis: dawn of a new day. J Bone Joint Surg Br, 94(11 Suppl A): Bozic, K.J., Vail, T.P., Pekow, P.S., Maselli, J.H., Lindenauer, P.K., Auerbach, A.D., (2010). Does aspirin have a role in venous thromboembolism prophylaxis in total knee arthroplasty patients? J Arthroplasty, 25(7): Burnett, R.S., Clohisy, J.C., Wright, R.W., McDonald, D.J., Shively, R.A., Givens, S.A., Barrack, R.L., (2007). Failure of the American College of Chest Physicians-1A protocol for lovenox in clinical outcomes for thromboembolic prophylaxis. J Arthroplasty, 22(3): Callaghan, J.J., Warth, L.C., Hoballah, J.J., Liu, S.S., Wells, C.W., (2008). Evaluation of deep venous thrombosis prophylaxis in low-risk patients undergoing total knee arthroplasty. J Arthroplasty, 23(6 Suppl 1): Centers for Medicare & Medicaid Services. (2015). Specifications Manual for National Hospital Inpatient Quality Measures. Retrieved from etpublic%2fpage%2fqnettier2&cid= %20 7. Colwell, C.W. Jr, Froimson, M.I., Mont, M.A., Ritter, M.A., Trousdale, R.T., Buehler, K.C., Padgett, D.E., (2010). Thrombosis prevention after total hip arthroplasty: a prospective, randomized trial comparing a mobile compression device with low-molecularweight heparin. J Bone Joint Surg Am, 92(3): Falck-Ytter, Y., Francis, C.W., Johanson, N.A., Curley, C., Dahl, O.E., Schulman, S., Colwell, C.W. Jr., 2012). American College of Chest Physicians. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: Page 6 of 8 Guideline Clinical

7 American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest, 141(2 Suppl):e278S-325S. 9. Galat, D.D., McGovern, S.C., Larson, D.R., Harrington, J.R., Hanssen, A.D., Clarke, H.D., (2009). Surgical treatment of early wound complications following primary total knee arthroplasty. J Bone Joint Surg Am, 91(1): Haas, S. (2001). Prevention of venous thromboembolism: recommendations based on the International Consensus and the American College of Chest Physicians Sixth Consensus Conference on Antithrombotic Therapy. Clin Appl Thromb Hemost, 7(3): Hull, R., Raskob, G., Pineo, G., Rosenbloom, D., Evans, W., Mallory, T., Brant, R. (1993). A comparison of subcutaneous lowmolecular-weight heparin with warfarin sodium for prophylaxis against deep-vein thrombosis after hip or knee implantation. N Engl J Med, 4;329(19): Keeney, J.A., Clohisy, J.C., Curry, M.C., Maloney, W.J., (2006). Efficacy of combined modality prophylaxis including shortduration warfarin to prevent venous thromboembolism after total hip arthroplasty. J Arthroplasty, 21(4): Lotke, P.A., Lonner, J.H., (2006). The benefit of aspirin chemoprophylaxis for thromboembolism after total knee arthroplasty. Clin thop Relat ReS, 452: National Guideline Clearinghouse, (2014). Guideline synthesis: Venous thromboembolism (VTE) following total hip and knee arthroplasty: risk assessment and prevention. Retrieved from Norris, S.L., Holmer, H.K., Burda, B.U., Ogden, L.A., Fu, R., (2012). Conflict of interest policies for organizations producing a large number of clinical practice guidelines. PLoS One, 7(5):e Novicoff, W.M., Brown, T.E., Cui, Q., Mihalko, W.M., Slone, H.S., Saleh, K.J. (2008). Mandated venous thromboembolism prophylaxis: possible adverse outcomes. J Arthroplasty, 23(6 Suppl 1): Parvizi, J., Jacovides, C.L., Bican, O., Purtill, J.J., Sharkey, P.F., Hozack, W.J., Rothman, R.H., (2010). Is deep vein thrombosis a good proxy for pulmonary embolus? J Arthroplasty, 25(6 Suppl): Budhiparama NC, Abdel MP, Ifran NN, Parratte S. Venous Thromboembolism (VTE)Prophylaxis for Hip and Knee Arthroplasty: Changing Trends. Curr Rev Musculoskelet Med 2014;7(2): Page 7 of 8 Guideline Clinical

8 List of Implementation Items and Patient Education: thopedic Pre-Admission der Set Total Knee Post-Op der Set 418 Total Hip Post-Op der Set 591 Primary Total Joint QlikView Quality Improvement Dashboard Patient Education Materials Regarding VTE: MHS Total Joint Guidebooks Metrics Plan: Measure VTE outcomes as part of QlikView Quality improvement Dashboard. Goal set for VTE rate <2% and bleeding complications <1% Review all VTE cases PDCA Plan: The MMA Total Joint Program Medical Director will monitor VTE data and results on a quarterly basis and determine appropriate Quality Improvement countermeasures as indicated. Literature reviews will be conducted in partnership with the Vascular surgery department. Point of Contact: MMA Total Joint Program Medical Director Approval By: Date of Approval: Medical Staff Committee Quality Steering Council iginal Date: 07/15/2015 Revision Dates: 09/10/2015 Reviewed by Surgery Collaborative: 09/17/2015 Distribution: Surgery Collaborative, Clinical Collaborative Program Page 8 of 8 Guideline Clinical