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Left atrial appendage closure device implantation in patients with atrial fibrillation and prior intracranial hemorrhage: “No man left behind”

Published:January 14, 2019DOI:https://doi.org/10.1016/j.hrthm.2019.01.014
      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.
      • Holmes Jr., D.R.
      • Reddy V.Y.
      • Turi Z.G.
      • et al.
      Protect AF Investigators
      Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial.
      • Holmes Jr., D.R.
      • Kar S.
      • Price M.J.
      • et al.
      Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy: the PREVAIL trial.
      • Reddy V.Y.
      • Sievert H.
      • Halperin J.
      • et al.
      Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial.
      However, with the available data this device requires a short period of OAC and dual antiplatelet therapy (DAPT). The optimal treatment option for patients with AF who survive an intracranial hemorrhage (ICH) remains unknown. OAC reintroduction after these events has been associated with a significant reduction in ischemic stroke and all-cause mortality rates based on observational retrospective data.
      • Nielsen P.B.
      • Larsen T.B.
      • Skjoth 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.
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