title: Left atrial appendage closure with the Amplatzer™ Cardiac Plug: impact of shape and device sizing on follow-up leaks.
abstract: BACKGROUND
  The Amplatzer Cardiac Plug (ACP) is a relatively new system for left atrial appendage (LAA) closure. In general, the particular design of the device and the variability of the LAA anatomy make the sizing process challenging. The objective of our study was to analyze the impact of the shape and sizing of the device on the presence of follow-up leaks.
  
  
  METHODS
  The shape was evaluated by angiography and classified as "strawberry-like", "square-like" and "tire-like". The presence of peri-device leaks was assessed by transesophageal echocardiography (TEE) and graded as: 1) severe, 2) major, 3) moderate, 4) minor and 5) absent.
  
  
  RESULTS
  Twenty five patients were included. Overall, the device was oversized by 3.38 ± 2.26 mm and 1.58 ± 2.75 mm in relation to the largest angiographic and TEE diameter respectively. None of the patients presented any intra-procedural complication. After discharge, one patient was admitted for cardiac tamponade and another for stroke. In both, the device was optimally deployed. Follow-up TEE was done after a mean time of 7.9 ± 5.9 months. The presence of a leak was associated with a lower degree of device over-sizing by TEE (0.06 ± 3.31 mm if leak vs. 2.73 ± 1.85 mm if no leak; p=0.04) and a trend towards by angiography (2.39 ± 3.06 mm if leak vs. 3.98 ± 1.57 mm if no leak; p=0.16). The shape of the device was not associated with the presence of TEE leaks. Neither the shape nor the presence of leaks was associated with worse clinical outcomes.
  
  
  CONCLUSIONS
  Although the shape and sizing of the device were not linked to any particular clinical outcome, we found an association between a lower degree of over-sizing and the presence of follow-up leaks.
authors.affiliation: Department of Medicine, Montreal Heart Institute, and Université de Montréal, Quebec, Canada.
authors.forename: Xavier
authors.initials: X
authors.lastname: Freixa
authors.forename: Apostolos
authors.initials: A
authors.lastname: Tzikas
authors.forename: Ayax
authors.initials: A
authors.lastname: Sobrino
authors.forename: Jason
authors.initials: J
authors.lastname: Chan
authors.forename: Arsène J
authors.initials: AJ
authors.lastname: Basmadjian
authors.forename: Réda
authors.initials: R
authors.lastname: Ibrahim
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020517:Atrial Appendage / Q000000981:diagnostic imaging* / Q000601:surgery*; D017548:Echocardiography, Transesophageal / Q000379:methods; D004867:Equipment Design / Q000592:standards*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011446:Prospective Studies; D055989:Septal Occluder Device / Q000592:standards*; D016896:Treatment Outcome