title: Percutaneous left atrial appendage occlusion: Effect of device positioning on outcome.
abstract: OBJECTIVE
  The study in patients with percutaneous left atrial appendage (LAA) occlusion investigates clinical outcomes according to the position of the Amplatzer Cardiac Plug (ACP) disc.
  
  
  BACKGROUND
  The ACP consists of a disc and an anchoring lobe. The disc is meant to cover the ostium of the LAA, but frequently retracts partially or completely into the neck of the LAA. It is not known whether a retracted disc affects outcome.
  
  
  METHODS
  Outcomes of 169 consecutive patients (age 73.1 ± 10.4 years; 76% male) with successful LAA closure were analyzed according to the position of the ACP disc: group A had complete coverage of the LAA ostium; in group B the disc prolapsed partially or completely into the LAA-neck. Transesophageal echocardiography was performed 1-6 months after ACP implantation. The safety endpoint was the composite of clinically significant pericardial effusion, device embolization, procedure-related stroke/transient ischemic attack (TIA), major bleeding, or device thrombus. The efficacy endpoint was the composite of death, neurological events (ischemic and hemorrhagic stroke, TIA), or systemic embolism during follow-up.
  
  
  RESULTS
  Group A comprised 76 patients (age 73.0 ± 9.9 years; 74% male) and group B 93 patients (age 73.3 ± 10.9 years; 79% male). Mean CHA2DS2-Vasc score and HASBLED score were 4.2 ± 1.7 (group A 4.3 ± 1.6; group B 4.2 ± 1.8) and 2.9 ± 1.1 (group A 2.9 ± 1.0; group B 3.0 ± 1.2), respectively. Mean follow-up of the study population was 13.0 ± 10.4 months. Overall, the composite safety and efficacy endpoints occurred in 20 (12%) and 6 patients (4%), respectively. There was no significant difference between groups A and B in the occurrence of the safety endpoint (13% vs. 11%, P = 0.64), or the efficacy endpoint (4% vs. 3%, P = 1.0).
  
  
  CONCLUSIONS
  No evidence for a difference in the occurrence of the safety and efficacy endpoint was found between patients with complete vs. incomplete ACP disc coverage of the LAA ostium. The risk of repositioning attempts in case of incomplete coverage does not seem to be warranted. Current findings need further confirmation in a larger scale clinical trial. © 2016 Wiley Periodicals, Inc.
authors.affiliation: University Heart Center, University Hospital Zurich, Zurich, Switzerland.
authors.forename: Mathias
authors.initials: M
authors.lastname: Wolfrum
authors.affiliation: University Heart Center, University Hospital Zurich, Zurich, Switzerland.
authors.forename: Adrian
authors.initials: A
authors.lastname: Attinger-Toller
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Samera
authors.initials: S
authors.lastname: Shakir
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Steffen
authors.initials: S
authors.lastname: Gloekler
authors.affiliation: Department of Biostatistics, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
authors.forename: Burkhardt
authors.initials: B
authors.lastname: Seifert
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Aris
authors.initials: A
authors.lastname: Moschovitis
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Khattab
authors.affiliation: University Heart Center, University Hospital Zurich, Zurich, Switzerland.
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.affiliation: University Heart Center, University Hospital Zurich, Zurich, Switzerland. fabian.nietlispach@usz.ch.
authors.forename: Fabian
authors.initials: F
authors.lastname: Nietlispach
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020517:Atrial Appendage / Q000000981:diagnostic imaging; D001281:Atrial Fibrillation / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D018572:Disease-Free Survival; D018618:Echocardiography, Doppler, Color; D017548:Echocardiography, Transesophageal; D004867:Equipment Design; D005260:Female; D006801:Humans; D020766:Intracranial Embolism / Q000209:etiology / Q000517:prevention & control; D002546:Ischemic Attack, Transient / Q000209:etiology / Q000517:prevention & control; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome
keywords: bleeding; left atrial appendage closure; outcome; stroke