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Editorial Commentary| Volume 14, ISSUE 9, P1309-1310, September 2017

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EWOLUTION—The next evolution in appendage closure?

Published:June 22, 2017DOI:https://doi.org/10.1016/j.hrthm.2017.06.029
EWOLUTION—The next evolution in appendage closure?
Previous ArticleEfficacy 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
Next ArticleSecond-generation cryoballoon ablation in the setting of left common pulmonary veins: Procedural findings and clinical outcome
      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.
      Circulation. 2014; 130: 2071-2104
      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.
      JAMA Cardiol. 2016; 1: 55-62
      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.
      J Am Coll Cardiol. 2015; 65: 2614-2623
      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.
      Trends Cardiovasc Med. March 24, 2017; (Epub ahead of print)
      http://dx.doi.org/10.1016/j.tcm.2017.03.006
      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.
      Circ J. 2014; 78: 619-624
      		 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.
      EuroIntervention. 2013; 9: 463-468
      		 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.
      Heart Rhythm. 2013; 10: 1792-1799
      		 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.
      J Am Heart Assoc. 2012; 1: e002212
      		 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.
      J Am Coll Cardiol. 2015; 65: 2614-2623
      , 
      • 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.
      J Am Coll Cardiol. 2017; 69: 253-261
      		 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.
      J Am Coll Cardiol. 2017; 69: 253-261
      ,
      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.
      J Am Coll Cardiol. 2015; 65: 2614-2623
      , 
      • 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.
      J Am Coll Cardiol. 2017; 69: 253-261
      		 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.
      J Am Coll Cardiol. 2017; 69: 253-261
      ,
      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).
      J Am Coll Cardiol. 2013; 61: 2551-2556
      		 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.
      Heart Rhythm. 2017; 14: 1302-1308
      		 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.
      J Am Coll Cardiol. 2017; 69: 253-261
      ,
      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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        • Wann L.S.
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        Post-approval U.S. experience with left atrial appendage closure for stroke prevention in atrial fibrillation.
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        Interventional closure of the left atrial appendage for stroke prevention.
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        New technical and anticoagulation aspects for left atrial appendage closure using the WATCHMAN device in patients not taking warfarin.
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        Left atrial appendage closure followed by 6 weeks of antithrombotic therapy: a prospective single-center experience.
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        • Boersma L.V.
        Ablation for atrial fibrillation in combination with left atrial appendage closure: first results of a feasibility study.
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      Article info

      Publication history

      Published online: June 22, 2017

      Footnotes

      Conflict of interest: None.

      Identification

      DOI: https://doi.org/10.1016/j.hrthm.2017.06.029

      Copyright

      © 2017 Published by Elsevier Inc. on behalf of Heart Rhythm Society.

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