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EWOLUTION—The next evolution in appendage closure?

      Oral anticoagulation (OAC) is a class I indication for patients with nonvalvular atrial fibrillation (AF) and ≥2 risk factors for stroke.
      • January C.T.
      • Wann L.S.
      • Alpert J.S.
      • et al.
      American College of Cardiology/American Heart Association Task Force Members
      2014 AHA/ACC/HRS Guideline for the management of patients with atrial fibrillation. A report of the American College of Cardiology/American Heart Association task force on practice guidelines and the Heart Rhythm Society.
      However, many patients with AF are ineligible for OAC because of prohibitive bleeding. Subsequently, as a result of the pivotal role of the left atrial appendage (LAA) in the formation of thrombi, an alternative strategy to OAC is occlusion of the LAA.
      • Hsu J.C.
      • Maddox T.M.
      • Kennedy K.F.
      • et al.
      Oral anticoagulant therapy prescription in patients with atrial fibrillation across the spectrum of stroke risk: Insights from the NCDR PINNACLE registry.
      The WATCHMAN device (Boston Scientific Corporation, Marlborough, MA) is the only US Food and Drug Administration (FDA)–approved LAA occlusion product that has been studied in randomized control trials (RCTs) (Table).
      • Holmes Jr., D.R.
      • Doshi S.K.
      • Kar S.
      • Price M.J.
      • Sanchez J.M.
      • Sievert H.
      • Valderrabano M.
      • Reddy V.Y.
      Left atrial appendage closure as an alternative to warfarin for stroke prevention in atrial fibrillation: a patient-level meta-analysis.
      Outside the United States, the Amplatzer occluder (St. Jude Medical, Minneapolis, MN) is also available; however, there is no completed RCT evaluating this device.
      • Bergmann M.W.
      LAA occluder device for stroke prevention: data on WATCHMAN and other LAA occluders.
      TableSummary of WATCHMAN studies
      Study ID Matsuo et al
      • Matsuo Y.
      • Sandri M.
      • Mangner N.
      • Majunke N.
      • Dahnert I.
      • Schuler G.
      • Kurabayashi M.
      • Mobius-Winkler S.
      Interventional closure of the left atrial appendage for stroke prevention.
      Meincke et al
      • Meincke F.
      • Schmidt-Salzmann M.
      • Kreidel F.
      • Kuck K.-H.
      • Bergmann M.W.
      New technical and anticoagulation aspects for left atrial appendage closure using the WATCHMAN device in patients not taking warfarin.
      Chun et al
      • Chun K.R.
      • Bordignon S.
      • Urban V.
      • Perrotta L.
      • Dugo D.
      • Furnkranz A.
      • Nowak B.
      • Schmidt B.
      Left atrial appendage closure followed by 6 weeks of antithrombotic therapy: a prospective single-center experience.
      Swaans et al
      • Swaans M.J.
      • Post M.C.
      • Rensing B.J.
      • Boersma L.V.
      Ablation for atrial fibrillation in combination with left atrial appendage closure: first results of a feasibility study.
      PROTECT AF
      • Holmes Jr., D.R.
      • Doshi S.K.
      • Kar S.
      • Price M.J.
      • Sanchez J.M.
      • Sievert H.
      • Valderrabano M.
      • Reddy V.Y.
      Left atrial appendage closure as an alternative to warfarin for stroke prevention in atrial fibrillation: a patient-level meta-analysis.
      • Reddy V.Y.
      • Gibson D.N.
      • Kar S.
      • O'Neill W.
      • Doshi S.K.
      • Horton R.P.
      • Buchbinder M.
      • Gordon N.T.
      • Holmes D.R.
      Post-approval U.S. experience with left atrial appendage closure for stroke prevention in atrial fibrillation.
      CAP-1
      • Reddy V.Y.
      • Gibson D.N.
      • Kar S.
      • O'Neill W.
      • Doshi S.K.
      • Horton R.P.
      • Buchbinder M.
      • Gordon N.T.
      • Holmes D.R.
      Post-approval U.S. experience with left atrial appendage closure for stroke prevention in atrial fibrillation.
      ,
      Continued access protocol after PROTECT-AF.
      PREVAIL
      • Holmes Jr., D.R.
      • Doshi S.K.
      • Kar S.
      • Price M.J.
      • Sanchez J.M.
      • Sievert H.
      • Valderrabano M.
      • Reddy V.Y.
      Left atrial appendage closure as an alternative to warfarin for stroke prevention in atrial fibrillation: a patient-level meta-analysis.
      • Reddy V.Y.
      • Gibson D.N.
      • Kar S.
      • O'Neill W.
      • Doshi S.K.
      • Horton R.P.
      • Buchbinder M.
      • Gordon N.T.
      • Holmes D.R.
      Post-approval U.S. experience with left atrial appendage closure for stroke prevention in atrial fibrillation.
      CAP-2
      • Reddy V.Y.
      • Gibson D.N.
      • Kar S.
      • O'Neill W.
      • Doshi S.K.
      • Horton R.P.
      • Buchbinder M.
      • Gordon N.T.
      • Holmes D.R.
      Post-approval U.S. experience with left atrial appendage closure for stroke prevention in atrial fibrillation.
      ,
      Continued access protocol after PREVAIL.
      ASAP
      • Reddy V.Y.
      • Mobius-Winkler S.
      • Miller M.A.
      • Neuzil P.
      • Schuler G.
      • Wiebe J.
      • Sick P.
      • Sievert H.
      Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology).
      EWOLUTION
      • Boersma L.V.
      • Ince H.
      • Kische S.
      • et al.
      EWOLUTION Investigators
      Efficacy and safety of left atrial appendage closure with WATCHMAN in patients with or without contraindication to oral anticoagulation: 1-year follow-up outcome data of the EWOLUTION trial.
      Reddy et al
      • Reddy V.Y.
      • Gibson D.N.
      • Kar S.
      • O'Neill W.
      • Doshi S.K.
      • Horton R.P.
      • Buchbinder M.
      • Gordon N.T.
      • Holmes D.R.
      Post-approval U.S. experience with left atrial appendage closure for stroke prevention in atrial fibrillation.
      ,
      Post approval US experience.
      WATCHMAN patients, n 167 59 40 30 463 566 269 579 150 1025 3822
      CHA2DS2 VASc, mean 4.3 4.4 4.1 3 3.2 3.9 4 4.5 4.4 4.5 NA
      Procedure success, % 98.9 98 95 100 90.9 94 95.1 94.8 94.7 98.5 95.6
      Mean F/U, mo 6 6.3 12.2 (median) 12 48 43 26 NA 55.4 (median) 12 NA
      Eligibility for OAC, % 0 11 0 73 100 100 100 100 0 27 100
      Postprocedure medication, % Warfarin

      100
      DAPT

      88
      DAPT 100 Warfarin

      100
      Warfarin

      100
      Warfarin

      100
      Warfarin

      100
      Warfarin

      100
      DAPT

      100
      DAPT: 60 Warfarin: 15.5 DOAC: 11 NA
      DRT, % 4.2 5 7.9 0 3.9 2.2 6 NA 4 3.7 NA
      Major bleeding, % NA 3.3 2.5 10 10.8 N/R 10.8 NA 1.8 2.6 NA
      Ischemic stroke, % 0 0 0 0 1.3
      Per 100 patient-years.
      4.6 2.5 NA 1.8
      Per 100 patient-years.
      1.1 NA
      TIA, % 0.7 1.7 0 0 1.1 1.9 1.5 NA 0.9
      Per 100 patient-years.
      NA NA
      All-cause death, % 0.70 0 2.6 0 3.2
      Per 100 patient-years.
      14.1 8.2 0 4.6
      Per 100 patient-years.
      9.8 3
      ASAP = ASA plavix feasibility study with WATCHMAN left atrial appendage closure technology trial; CAP = continued access to PROTECT AF Registry; DAPT = dual antiplatelet; DOACs = direct oral anticoagulants; DRT = device-related thrombus; EWOLUTION = registry on WATCHMAN outcomes in real-life utilization; F/U = follow-up; NA = not available; OAC = oral anticoagulant; PREVAIL: WATCHMAN LAA closure device in patients with atrial fibrillation versus long term warfarin therapy; PROTECT AF = WATCHMAN left atrial appendage closure technology for embolic protection in patients with atrial fibrillation trial. TIA = transient ischemic attack.
      Continued access protocol after PROTECT-AF.
      Continued access protocol after PREVAIL.
      Post approval US experience.
      § Per 100 patient-years.
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