title: Safety and Efficacy of Left Atrial Appendage Closure with the Amplatzer Cardiac Plug in Very High Stroke and Bleeding Risk Patients with Non-Valvular Atrial Fibrillation.
abstract: BACKGROUND
  Limited data exist on the outcomes after left atrial appendage closure (LAAC) with the Amplatzer™ Cardiac Plug (ACP; St. Jude Medical, Minneapolis, MN, USA) in patients with atrial fibrillation (AF) with very high stroke and bleeding risks, the subset expected to benefit most from this procedure. The objective of this study was to report clinical outcomes after LAAC with the ACP device in a very high stroke and bleeding risk cohort of patients with non-valvular AF and contraindications to oral anticoagulation (OAC).
  
  
  METHODS
  LAAC using the ACP device was performed in 96 patients with AF who had median CHA2DS2-VASc and HAS-BLED scores of 5 and 3, respectively. Post-procedure, patients received dual antiplatelet therapy for 6 months. A transesophageal echocardiography (TEE) was scheduled at 6 months.
  
  
  RESULTS
  Procedural success was 100%. Procedural-related complications occurred in 7.3% (pericardial effusion, 4.2%; thromboembolic events, 2.1%; device embolization, 1.0%). Additional thromboembolic events occurred in three patients during follow-up (92.7% follow-up). After 93.4 patient-years of follow-up, the annual rates of thromboembolic and major bleeding events were 3.2% and 1.1%, respectively. In those with TEE follow-up (70%), complete LAAC with no leaks was observed. Thrombus formation on the device was noted on TEE in two patients.
  
  
  CONCLUSIONS
  LAAC using the ACP device was associated with an acceptable low rate of embolic and bleeding events after a median follow-up of 9 months in a cohort of patients with AF who were amongst the highest stroke and bleeding risks reported so far in LAAC trials.
authors.affiliation: Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany. jkebernik@gmx.de.
authors.forename: Julia
authors.initials: J
authors.lastname: Kebernik
authors.affiliation: Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany.
authors.forename: John
authors.initials: J
authors.lastname: Jose
authors.affiliation: Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-Wahab
authors.affiliation: Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany.
authors.forename: Björn
authors.initials: B
authors.lastname: Stöcker
authors.affiliation: Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany.
authors.forename: Volker
authors.initials: V
authors.lastname: Geist
authors.affiliation: Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany.
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
keywords: Amplatzer™ Cardiac Plug; Atrial fibrillation; Left atrial appendage closure; Oral anticoagulation; Stroke; Thromboembolism