title: Left Atrial Appendage Closure With the New Occlutech® Device: First in Man Experience and Neurological Outcome.
abstract: OBJECTIVE
  Percutaneous left atrial appendage closure (LAAC) is a valuable treatment option for stroke prevention in patients with atrial fibrillation and a HAS-BLED-Score ≥3. Determinants of procedural safety events and neurological outcome of the patients with the Occlutech device (OD) are not established yet.
  
  
  RESULTS
  Between 2012 and 2016, 30 patients underwent LAAC using the OD. This is a prospective study. Neurological examination and transesophageal echocardiography was performed directly before and after the procedure and after 1, 3, and 12 months. The OC was successfully implanted in 28 of the 30 enrolled patients (93%). Two patients presented a hemodynamic relevant pericardial effusion. A leak <3 mm could be documented direct after implantation in 4 patients. After 3 months, there were only 2/4 patients with persistent LAA leakage with a maximum leakage of <3 mm. The correct position of the device was confirmed in 27/28 patients during 3-month follow-up. In 2 patients, there was a thrombus at the OC. In 12 patients, a transoesophageal echocardiography was performed after 12 months. All patients (12/12) showed a correct placement of the device. None of the patients developed a clinically apparent stroke or died during follow-up.
  
  
  CONCLUSIONS
  In this uncontrolled, nonrandomized study, acute and 3-month follow-up success of LAAC using OD was high. No patient showed significant neurological deficits.
authors.affiliation: Department of Cardiology, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Barbara
authors.initials: B
authors.lastname: Bellmann
authors.affiliation: Department of Cardiology, Hospital Klinikum Coburg, Coburg, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Schnupp
authors.affiliation: Department of Neurology, Hospital Klinikum Coburg, Coburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Kühnlein
authors.affiliation: Department of Neurology, Hospital Klinikum Coburg, Coburg, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Javernik
authors.affiliation: Department of Cardiology, Hospital Klinikum Coburg, Coburg, Germany.
authors.forename: Caroline
authors.initials: C
authors.lastname: Kleinecke
authors.affiliation: Department of Cardiology, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Rillig
authors.affiliation: Department of Cardiology, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Ulf
authors.initials: U
authors.lastname: Landmesser
authors.affiliation: Department of Cardiology, Hospital Klinikum Coburg, Coburg, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Brachmann
authors.affiliation: Department of Cardiology, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Berlin, Germany.|Department of Cardiology, Hospital Klinikum Coburg, Coburg, Germany.
authors.forename: Jai-Wun
authors.initials: JW
authors.lastname: Park
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020517:Atrial Appendage / Q000503:physiopathology*; D001281:Atrial Fibrillation / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000295:instrumentation*; D018618:Echocardiography, Doppler, Color; D019560:Echocardiography, Three-Dimensional; D017548:Echocardiography, Transesophageal; D005260:Female; D006339:Heart Rate; D006801:Humans; D008297:Male; D009460:Neurologic Examination; D011446:Prospective Studies; D012307:Risk Factors; D020521:Stroke / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome
keywords: Occlutech®; atrial fibrillation; bleeding; left atrial appendage closure; stroke; stroke prevention