title: Efficacy and safety of percutaneous left atrial appendage closure to prevent thromboembolic events in atrial fibrillation patients with high stroke and bleeding risk.
abstract: OBJECTIVE
  The randomized PROTECT AF trial demonstrated non-inferiority of left atrial appendage (LAA) closure to oral anticoagulation with warfarin. Current guidelines give a class IIb recommendation for LAA closure. We evaluated the efficacy and safety of LAA closure in a consecutive series of non-valvular atrial fibrillation patients with contraindications to long-term oral anticoagulation or at high bleeding risk.
  
  
  RESULTS
  101 consecutive non-valvular atrial fibrillation patients (age 74.7 ± 7.5 years) at high risk for stroke (CHA2DS2-VASc Score 4.4 ± 1.6) and high bleeding risk (HAS-BLED Score 4.2 ± 1.3) received LAA closure with either the Watchman closure device (n = 38) or the Amplatzer cardiac plug (n = 63). Dual antiplatelet therapy with aspirin and clopidogrel was recommended for 3-6 months after device implantation, followed by long-term antiplatelet therapy with aspirin. No anticoagulation was given after device implantation. Mean follow-up was 400 days. One patient (1 %) experienced a transient ischemic attack, and two patients (2 %) suffered from ischemic stroke. While on recommended antiplatelet therapy, bleeding occurred in 12/101 patients (12 %). Bleeding was significantly reduced with 3 compared with 6 months dual antiplatelet therapy (3.0 vs. 16.2 %, p < 0.05) while ischemic or thrombotic events were similar.
  
  
  CONCLUSIONS
  Left atrial appendage closure in patients with non-valvular atrial fibrillation and high risk for stroke and bleeding events effectively prevented stroke and reduced cerebral ischemic events compared to expected stroke rate according to CHA2DS2-VASc Score. Dual antiplatelet therapy for 3 months reduced the rate of bleeding events compared to 6 months therapy with no increase of thrombotic events.
authors: Department of Internal Medicine II, Cardiology, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
authors: Julia
authors: J
authors: Seeger
authors: Department of Internal Medicine II, Cardiology, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
authors: Carlo
authors: C
authors: Bothner
authors: Department of Internal Medicine II, Cardiology, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
authors: Tillman
authors: T
authors: Dahme
authors: Department of Internal Medicine II, Cardiology, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
authors: Birgid
authors: B
authors: Gonska
authors: Department of Internal Medicine II, Cardiology, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
authors: Dominik
authors: D
authors: Scharnbeck
authors: Department of Internal Medicine II, Cardiology, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
authors: Sinisa
authors: S
authors: Markovic
authors: Department of Internal Medicine II, Cardiology, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
authors: Wolfgang
authors: W
authors: Rottbauer
authors: Department of Internal Medicine II, Cardiology, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany. jochen.woehrle@uniklinik-ulm.de.
authors: Jochen
authors: J
authors: Wöhrle
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage; D020517:Atrial Appendage; D001281:Atrial Fibrillation / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D000075202:Contraindications; D004359:Drug Therapy, Combination; D004867:Equipment Design; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D012042:Registries; D012307:Risk Factors; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D013923:Thromboembolism / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors
keywords: Bleeding event; Left atrial appendage; Risk factors; Transcatheter closure