Disclosures. Venous Thromboembolism Prophylaxis: What every orthopaedic surgeon needs to know. Published Guidelines

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1 Venous Thromboembolism Prophylaxis: What every orthopaedic surgeon needs to know Paul F. Lachiewicz, MD Chapel Hill Orthopedic Surgery & Sports Medicine Consulting Professor Duke Orthopaedic Surgery Disclosures Board Member: Hip Society Editorial Board: JSOA, J Arthroplasty Royalties: Innomed Speaker s Bureau: Mallinckrodt, Pacira Consultant: Gerson Lehrman, Mallinckrodt Global Guidepoint, Pacira Research-institutional support: Zimmer The Guideline Wars The Empire vs. the Rebels (ACCP) (AAOS) Published Guidelines VTE Prophylaxis Orthopaedic Surgery AAOS 2 nd edition Dec 2011 JAAOS ACCP 9 th edition Feb 2012 Chest 141 S SCIP re-revised edition Jan 2014 Outcomes Fatal + symptomatic PE Symptomatic DVT Symptomatic bleeding event Disutility major bleed = symptomatic VTE Is DVT a good Proxy for PE? 1495 orthopaedic patients evaluated for DVT/PE within 90 days Only 27 cases + for both DVT and PE (1.7% cohort; 10.8% scanned for both) High association between DVT and PE assumed to exist does not hold true! Parvizi et al J Arthroplasty

2 Newer Pharmacologic Agents and devices Oral factor Xa inhibitors Rivaroxiban (Xarelto ) Apixaban (Equilis ) 3 others on the way Oral thrombin inhibitor Dabigatran Rivaroxiban Warfarin Dabigatran Step 3 formation of fibrin clot Newer mechanical compression MCS SFT mobile mechanical device DJO H to H mobile pump; other untested devices! Target for pharmacologic anticoagulants THA or TKA Recommend one of the following for a minimum of days: LMWH, fondaparinux, apixaban, dabigitran rivaroxiban, LDUH, Vit K antagonists, aspirin (All Grade 1B) intermittent pneumatic compression device alone (Grade 1C) Elective Total Knee or Total Hip Replacement Appendix A, Table 5.22 and Table 5.23 SCIP 2014 VTE prophylaxis Any of the following: Low molecular weight heparin (LMWH) Factor Xa Inhibitor Oral Factor Xa Inhibitor1 Warfarin Intermittent pneumatic compression devices (IPC) Venous foot pump (VFP) Low-dose unfractionated heparin (LDUH) Aspirin Hip Fracture Surgery Recommend one of following, rather than no prophylaxis, for minimum days: LMWH, fondaparinux, LDU heparin, vitamin K antagonist, aspirin (all Grade 1B) or intermittent pneumatic compression (Grade 1C) Why is aspirin now accepted and a reasonable VTE prophylaxis for THA, TKA and hip fracture surgery? PEP trial revisited by 9 th ACCP Aspirin 160mg per day vs placebo 17,000 patients (THA, TKA, hip fractures) 22% reduction PE 28% reduction symptomatic VTE The Lancet

3 Aspirin to prevent recurrence of venous thromboembolism ASPIRE trial NEJM Nov 2012 WARFASA trial NEJM May 2012 Both studies: aspirin 100 mg vs placebo randomized 400 (2 yrs) and 800 (4 yrs) pts respectively Aspirin reduced risk of recurrent thromboembolism! Aspirin reduced risks of major vascular events! (MI, stroke, death from any cause) Aspirin Prophylaxis: More Cost Effective Than LMWH! Markov modeling THA + TKA Low probability that LMWH is cost-effective For patients with no history of VTE, aspirin is cost-effective after THA and for TKA patients > 80 years For TKA patients < 80 years, the preferred choice is uncertain economically Schousboe + Brown JBJS July 2013 Extend prophylaxis to 35 days (Grade 2B) Suggest dual prophylaxis with antithrombotic agent and IPCD (Grade 2B) Increased risk of bleeding: IPCD or no prophylaxis (Grade 2C) Risk Factors for Bleeding Previous major bleeding Severe renal failure Concomitant antiplatelet agent Surgical factors: revision surgery extensive surgical dissection difficult-to-control surgical bleeding during current procedure Patient declines injection/ IPCD, recommend apixaban or dabigatran (Grade 1B) Against IVC filter over no prophylaxis (Grade 2C) Against ultrasound/duplex screening before discharge (Grade 1B) Return to Theatre after THA and TKA before and after Rivaroxiban Tinzaparin 489 patients Return to OR 9 (1.8%) Rivaroxiban 599 patients Return to OR 22 (3.94%) (p=0.046) Jensen et al JBJS(B)

4 Return to Theatre after THA and TKA before and after rivaroxiban Infection increased from 1% to 2.5% after introduction of rivaroxiban Wound hematoma 0 vs 9 (p=0.032) Center discontinued use of rivaroxiban Jensen et al JBJS (B) 2011 Problems with Rivaroxiban Lack of specific antidote Major bleeding rates in RECORD 4 study were 3-6 x lower than expected Explained by exclusions of most wound bleeding from major bleeding Analyses by FDA have shown increased bleeding risk with rivaroxiban compared to enoxapirin Gomez-Outes et al Lancet :682 May 21, 2009 Are the newer agents better than LMWH? Systematic review of meta-analyses New Data THA Mobile Mechanical Compression For all-cause death, non-fatal PE and major bleeding, there are NO important differences between LMWH and oral factor Xa inhibitors No data comparing newer oral agents with each other Rivaroxiban associated with more clinically relevant bleeding than apixaban, LMWH Prospective, randomized trial CECT+SFT (+/- 81mg aspirin) vs LMWH 10 days treatment; Duplex ultrasound No difference DVT (5%) or PE (1%) Major bleeding 0% vs 6% (p=0.0004) Study underpowered for efficacy Adam, McDuffie, Lachiewicz, Ortel, Williams Ann Int Med Aug 2013 Colwell et al JBJS 2010 Mobile Mechanical Device Concerns with Mobile Mechanical Study not powered for DVT, PE How much venous velocity? Patient compliance? Problems: tripping over tubes? pump, charger dysfunction pump, charger not returned reimbursement issues Company now affiliated with DME 4

5 Mobile Mechanical Device 1509 multicenter patients (+/- aspirin) No prior history of VTE 8 of 1509 had VTE (0.53%) 4 distal DVT 1 proximal DVT 3 pulmonary emboli (0.2%) Newer Portable mechanical compression devices Compatible with ACCP No tubes Disposable Biomechanics? Efficacy? No data! Colwell et al JBJS 2015 Cause of death after TJR using different thromboprophylaxis Routine use of potent anticoagulants PAC (LMWH, fondaparinux, rivaroxiban, ximelagatran) does NOT reduce overall mortality or proportion of deaths due to PE! Poultsides et al JBJS Br 2012 Post-thrombotic Syndrome Is not a Late Problem after THA and TKA! Prognosis for this sequella is no different for patients with or without DVT Deehan et al Acta Orthop Scand 2001 Lonner et al Am J Orthop 2006 McAndrew et al Clin Orthop 2010 Fitzgerald et al Clin Orthop 2011 AAOS Guidelines 2011 Network Meta-analysis AAOS Guidelines 2011 Recommend against Duplex screening Use some type of mechanical and/or pharmacologic measure Pharm + IPCD for hx VTE Risk factor query: prior VTE (weak) strategy for other factors (inconclusive) Bleeding risk: IPCD only Suggest D/C antiplatelet drugs preop Ok to continue/start aspirin peri-op Early mobilization Neuraxial anesthesia to decrease EBL Neither for or against IVC filter Mont et al JAAOS Dec 2011 Mont et al JAAOS Dec

6 Thromboembolism Risk? No difference between TXA and placebo VTE after Knee Arthroscopy DVT PE Kaiser Level II study >20, day clinical evaluation DVT 0.25% PE 0.17% higher risk age >50; oral contraceptive meds No routine anticoagulation! ACCP guidelines: no AC, unless prior history VTE Maletis et al JBJS 2012 VTE after Hip Arthroscopy VTE after Shoulder Surgery Retrospective, level IV study 81 consecutive patients 3 (3.7%) had symptomatic DVT on day 8 2 calf, 1 popliteal Only 1 had risk factor (oral contraceptive) Need more data before any recommendation! Salvo et al Orthopedics 2010 Systematic review level III, IV studies shoulder scopes 0.038% TSA 0.52% fracture surgery 0.64% recommend mechanical prophylaxis Kaiser level II study >2500 arthroplasties 1.01% VTE ( 0.51% DVT, 0.54% PE) Navarro et al Clin Orthop 2013 VTE after Ankle-Foot Surgery VTE after Lower-Limb Fracture Achilles tendon rupture USC study 1172; DVT 0.43% PE 0.34% Swedish study 95 pts Duplex scan 32 DVT, 3 PE! Ankle fractures Canada 2478 ORIF 3% VTE (0.32% PE) prophylaxis did not make a difference! NHS data 46,000 DVT 0.12%, PE 0.17% Prophylaxis is NOT required! Multicenter, prospective cohort (KAF) Tibia, fibular, ankle (non-op) Patella, foot (op or non-op) No VTE prophylaxis; 82% immobilized (42 days) Symptomatic VTE 7/1200 (0.6%) Routine anticoagulation NOT recommended Selby et al JBJS

7 VTE after lower extremity trauma, procedures that require immobilization? Quad + patella tendon rupture repair might have a higher risk, but no data (ACCP: no prophylaxis, Grade 2B) PA state trauma registry 279,511 patients PE 0.36% early 2 days; delayed 6 days (4-11) early fixation femur, pelvic fxs: predict early PE Consider removable IVC filter? Data very poor Clinical decision in every case What should every surgeon and physician ask preop patients? Have you ever had a blood clot in your leg or lung? Has anyone in your family had multiple blood clots? Are there any genetic blood disorders in your family? Are you taking warfarin, clopidrogel? Do you have any bleeding disorder or told that you bleed a lot after any surgery? Special Situations Prior history DVT preop Duplex scan Known coagulopathy Protein S or C deficiency; Factor V Leiden hematology consult Stents or clopidrogel cardiology consult Document preop! Complications: Bleeding/ Symptomatic events Bleeding: discontinue prophylaxis! Aspiration, wound management; OR? Deep vein thrombosis: confirm diagnosis! can Rx as outpt therapeutic sq LMWH Pulmonary embolism confirm diagnosis! anticoagulation; CP support; wound observation Conclusions 2016 Thromboembolism Prophylaxis Evaluate bleeding risk + prior history VTE Aspirin now acceptable! Use dual prophyaxis with drug + IPCD Need more studies on new oral agents! Mobile mechanical prophylaxis the future? Careful postop f/u and readmission when necessary for VTE or bleeding 7