title: Twelve-month follow-up of left atrial appendage occlusion with Amplatzer Amulet.
abstract: BACKGROUND
  The Amplatzer Amulet (St. Jude Medical, Minneapolis, MN, USA) is a second gen-eration Amplatzer device for left atrial appendage (LAA) occlusion (LAAO) for stroke prophylaxis in patients with atrial fibrillation. This research sought to assess the clinical performance of the Amplatzer Amulet device and in follow up for 12 months.
  
  
  METHODS
  In this single-center registry patients with atrial fibrillation and contraindication to oral anticoagulation underwent LAAO with the Amplatzer Amulet device. Follow-up was performed before discharge, by transesophageal echocardiography (TEE) after 6 weeks and telephone interview after 3, 6 and 12 months.
  
  
  RESULTS
  Between October 2014 and August 2015 50 patients (76.1 ± 8.3 years; 30 male) were en-rolled. Procedural success was achieved in 49 (98%) patients. Major periprocedural adverse events were observed in 4 (8%) of patients: 1 device embolization, 2 pericardial effusions requiring pericardiocente-sis and 1 prolonged hospital stay due to retropharyngeal hematoma from the TEE probe. Follow-up TEE was available in 38 of 50 patients showing complete LAA sealing in all. 2 device-related thrombi were also documented. At 12-month follow-up 7 patients had died unrelated to the device. Ischemic stroke occurred in 3 patients. According to neurological examination two were classified as microangiopathic and not cardio-embolic. The other one could not be classified. Bleeding complications (5 minor, 3 major) were documented in 8 patients.
  
  
  CONCLUSIONS
  Although minimizing procedure-related complications remains challenging, LAAO with the Amplatzer Amulet device showed high procedural success and excellent LAA sealing. (Cardiol J 2017; 24, 2: 131-138).
authors.affiliation: Medical Clinic II (Cardiology/Intensive Care Medicine), Ketschendorfer Straße 33, 96450 Coburg, Germany, Tel. +49 9561 22 33215, Fax +49 9561 226419. carolinekleinecke@web.de.
authors.forename: Caroline
authors.initials: C
authors.lastname: Kleinecke
authors.forename: Jai-Wun
authors.initials: JW
authors.lastname: Park
authors.forename: Martin
authors.initials: M
authors.lastname: Gödde
authors.forename: Konstantin
authors.initials: K
authors.lastname: Zintl
authors.forename: Steffen
authors.initials: S
authors.lastname: Schnupp
authors.forename: Johannes
authors.initials: J
authors.lastname: Brachmann
mesh_terms: D000368:Aged; D020517:Atrial Appendage / Q000000981:diagnostic imaging / Q000601:surgery*; D001281:Atrial Fibrillation / Q000150:complications / Q000175:diagnosis / Q000601:surgery*; D006328:Cardiac Catheterization; D006348:Cardiac Surgical Procedures / Q000379:methods*; D017548:Echocardiography, Transesophageal; D005260:Female; D005500:Follow-Up Studies; D005858:Germany / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D011474:Prosthesis Design; D012189:Retrospective Studies; D055989:Septal Occluder Device; D020521:Stroke / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome
keywords: Amplatzer Amulet; atrial fibrillation; left atrial appendage occlusion; stroke prophylaxis