Left atrial appendage closure device implantation in patients with prior intracranial hemorrhage

Published:December 02, 2018DOI:


      The Watchman device (Boston Scientific), used for left atrial appendage closure (LAAC), was approved for stroke prevention in patients with atrial fibrillation (AF) and an appropriate rationale to avoid long-term oral anticoagulation. Patients with AF and prior intracranial hemorrhage (ICH) were excluded from clinical trials because of perceived risks of perioperative anticoagulation.


      The purpose of this study was to study the efficacy and safety of LAAC using Watchman in patients with AF and prior ICH.


      In a multidisciplinary AF/stroke prevention clinic, 38 consecutive patients with AF and prior ICH underwent Watchman implantation. Patients were enrolled in a prospectively maintained data registry.


      Patients’ mean CHA2DS2-VASc score was 5.0 ± 1.3 and HAS-BLED score 4.2 ± 1.0. Prior ICH events were intraparenchymal (60%), subdural (24%), or subarachnoid bleeds (16%). The median event-to-implantation time was 637 days (minimum 60). Watchman was implanted in all patients with no procedural complications. All patients completed 45 days of anticoagulation with warfarin (55%), apixaban (37%), or dabigatran (8%). Transesophageal echocardiograms at 45 days showed no peridevice leak, and 1 patient had a small filamentous echodensity on device that resolved with anticoagulation. While undergoing anticoagulation, none of the patients developed recurrent ICH. Minor bleeding occurred in 1 patient (trauma-related lower extremity hematoma at 19 days postimplantation). At 13.4 months (quartiles 8–19) of follow-up, there were no strokes, ICH, or deaths.


      AF patients with prior ICH tolerated short-term anticoagulation for the purpose of Watchman implantation. LAAC with attendant short-term anticoagulation seems to be both safe and effective in this patient population.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Heart Rhythm
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Holmes D.R.
        • Reddy V.Y.
        • Turi Z.G.
        • Doshi S.K.
        • Sivert H.
        • Buchbinder M.
        • Mullin C.M.
        • Sick P.
        • PROTECT AF Investigators
        Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomized non-inferiority trial.
        Lancet. 2009; 374: 534-542
        • Holmes Jr., D.R.
        • Kar S.
        • Price M.J.
        • Whisenant B.
        • Sievert H.
        • Doshi S.K.
        • Huber K.
        • Reddy V.Y.
        Prospective randomized evaluation of the Watchman™ left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial.
        J Am Coll Cardiol. 2014; 64: 1-12
        • Reddy V.Y.
        • Doshi S.K.
        • Sievert H.
        • Buchbinder M.
        • Neuzil P.
        • Huber K.
        • Halperin J.L.
        • Holmes D.
        • PROTECT AF Investigators
        Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-year follow-up of the PROTECT AF (Watchman™ Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial.
        Circulation. 2013; 127: 720-729
        • Reddy V.Y.
        • Doshi S.K.
        • Kar S.
        • Gibson D.N.
        • Price M.J.
        • Huber K.
        • Horton R.P.
        • Buchbinder M.
        • Neuzil P.
        • Gordon N.T.
        • Holmes Jr., D.R.
        • PREVAIL and PROTECT AF Investigators
        5-Year outcomes after left atrial appendage closure: from the PREVAIL and PROTECT AF Trials.
        J Am Coll Cardiol. 2017; 70: 2964-2975
        • Alipour A.
        • Wintgens L.I.
        • Swaans M.J.
        • Balt J.C.
        • Rensing B.J.
        • Boersma L.V.
        Novel stroke risk reduction in atrial fibrillation: left atrial appendage occlusion with a focus on the Watchman™ closure device.
        Vasc Health Risk Manag. 2017; 13: 81-90
        • Goldstein J.N.
        • Greenberg S.M.
        Should anticoagulation be resumed after intracerebral hemorrhage.
        Cleve Clin J Med. 2010; 77: 791-799
        • Murthy S.B.
        • Gupta A.
        • Merkler A.E.
        • Navi B.B.
        • Mandava P.
        • Iadecola C.
        • Sheth K.N.
        • Hanley D.F.
        • Ziai W.C.
        • Kamel H.
        Restarting anticoagulant therapy after intracranial hemorrhage: a systematic review and meta-analysis.
        Stroke. 2017; 48: 1594-1600
        • Bergmann M.W.
        • Betts T.R.
        • Sievert H.
        • Schmidt B.
        • Pokushalov E.
        • Kische S.
        • Schmitz T.
        • Meincke F.
        • Stein K.M.
        • Boersma L.V.A.
        • Ince H.
        Early anticoagulation drug regimens after WATCHMAN™ left atrial appendage closure: safety and efficacy.
        Eurointervention. 2017; 13: 877-884
        • Nielsen P.B.
        • Larsen T.B.
        • Skjøth F.
        • Gorst-Rasmussen A.
        • Rasmussen L.H.
        • Lip G.Y.
        Restarting anticoagulant treatment after intracranial hemorrhage in patients with atrial fibrillation and the impact on recurrent stroke, mortality, and bleeding: a nationwide cohort study.
        Circulation. 2015; 132: 517-525
        • Barakat A.F.
        • Hussein A.A.
        • Saliba W.I.
        • et al.
        Initial experience with high-risk patients excluded from clinical trials: safety of short-term anticoagulation after left atrial appendage closure device.
        Circ Arrhythm Electrophysiol. 2016; 9: e004004
        • Qureshi A.I.
        • Palesch Y.Y.
        • Barsan W.G.
        • et al.
        Intensive blood-pressure lowering in patients with acute cerebral hemorrhage.
        N Engl J Med. 2018; 375: 1033-1043
        • Hemphill III, J.C.
        • Greenberg S.M.
        • Anderson C.S.
        • et al.
        Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association.
        Stroke. 2015; 46: 2032-2060
        • Loewen P.
        SPARC—Stroke Prevention in Atrial Fibrillation Risk Tool.
        (September 2017)
        Date accessed: April 8, 2018
        • Nielsen P.B.
        • Larsen T.B.
        • Skjøth F.
        • Lip G.Y.
        Outcomes associated with resuming warfarin treatment after hemorrhagic stroke or traumatic intracranial hemorrhage in patients with atrial fibrillation.
        JAMA Intern Med. 2017; 177: 563-570
        • Price M.J.
        • Reddy V.Y.
        • Valderrábano M.
        • Halperin J.L.
        • Gibson D.N.
        • Gordon N.
        • Huber K.C.
        • Holmes Jr., D.R.
        Bleeding outcomes after left atrial appendage closure compared with long-term warfarin: a pooled, patient-level analysis of the WATCHMAN™ randomized trial experience.
        JACC Cardiovasc Interv. 2015; 8: 1925-1932
        • Renou P.
        • Thambo J.B.
        • Iriart X.
        • Nicot S.
        • Kabore N.
        • Jalal Z.
        • Olindo S.
        • Debruxelles S.
        • Poli M.
        • Rouanet F.
        • Sibon I.
        Left atrial appendage closure in patients with atrial fibrillation and previous intracerebral hemorrhage.
        J Stroke Cerebrovasc Dis. 2017; 26: 545-551
        • Fayos-Vidal F.
        • Arzamendi-Aizpurua D.
        • Millán-Álvarez X.
        • Guisado-Alonso D.
        • Camps-Renom P.
        • Prats-Sánchez L.
        • Martínez-Domeño A.
        • Delgado-Mederos R.
        • Martí-Fábregas J.
        Left atrial appendage closure in patients with intracranial haemorrhage and atrial fibrillation.
        Neurologia. 2017; 17: 30242-30246
        • Holmes D.R.
        • Reddy V.Y.
        • Buchbinder M.
        • Stein K.
        • Elletson M.
        • Bergmann M.W.
        • Schmidt B.
        • Saw J.
        The Assessment of the Watchman™ Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO) trial.
        Am Heart J. 2017; 189: 68-74
        • Chatterjee S.
        • Sardar P.
        • Biondi-Zoccai G.
        • Kumbhani D.J.
        New oral anticoagulants and the risk of intracranial hemorrhage: traditional and Bayesian meta-analysis and mixed treatment comparison of randomized trials of new oral anticoagulants in atrial fibrillation.
        JAMA Neurol. 2013; 70: 1486-1490
        • Reddy V.Y.
        • Möbius-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

      Linked Article

      • Left atrial appendage closure device implantation in patients with atrial fibrillation and prior intracranial hemorrhage: “No man left behind”
        Heart RhythmVol. 16Issue 5
        • Preview
          Several left atrial appendage (LAA) closure devices have been developed for patients with atrial fibrillation (AF) seeking an alternative to long-term oral anticoagulation (OAC). PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) was the first multicenter randomized controlled trial (RCT) comparing LAA closure device vs OAC with warfarin. Primary safety events were statistically more frequent in the device group (7.4% vs 4.4%). At mean follow-up of 3.8 years, LAA closure device showed superiority for the primary efficacy endpoint (ie, composite of stroke, cardiovascular death, and systemic embolism), with a 34% relative risk reduction in total mortality.
        • Full-Text
        • PDF