title: Early safety of the Amplatzer Cardiac Plug™ for left atrial appendage occlusion.
abstract: OBJECTIVE
  To assess the cumulative experience of a single operator using a strict set of deployment and release criteria for the Amplatzer Cardiac Plug™ (ACP) and the impact of these criteria on procedural success and complications.
  
  
  BACKGROUND
  Following strong evidence that the left atrial appendage (LAA) is the site of the majority of thrombus formation within the left atrium in patients with non-valvular atrial fibrillation, non-pharmacological approaches to LAA exclusion have been developed and shown to be effective.
  
  
  METHODS
  Procedural and in-hospital outcomes of LAA occlusion performed by or under the supervision of a single operator using the ACP™ in 100 anticoagulant ineligible patients with a high stroke risk were assessed.
  
  
  RESULTS
  One hundred patients with a mean CHADS2 score of 3.21 ± 1.23 underwent catheterization for closure of LAA with the ACP™. The mean landing zone as assessed by TEE was 20.01 ± 3.21 mm, and 20.8 ± 3.19 mm by fluoroscopy. The mean difference between the TEE and the fluoroscopic measurements was 0.8 ± 1.13 mm. Device deployment was successful in 100/100 attempted cases with a mean deployed device size of 24.36 ± 3.27 mm. Procedural complications were limited to a single case of pericardial tamponade and one post-procedural pulmonary edema both of which were adequately treated with no long-term sequelae.
  
  
  CONCLUSIONS
  In this single operator report, LAA occlusion using the double element ACP™ can be safely performed with excellent success rates. Using very specific deployment success, stability and release criteria, this device can achieve LAA occlusion with extremely low complication rates in an extremely frail oral anticoagulant ineligible population with multiple co-morbidities.
authors.affiliation: Structural and Congenital Heart Disease Unit, Shaare Zedek Medical Center, Jerusalem, Israel. Electronic address: meerkin@SZMC.org.il.
authors.forename: David
authors.initials: D
authors.lastname: Meerkin
authors.forename: Adi
authors.initials: A
authors.lastname: Butnaru
authors.forename: Dmitry
authors.initials: D
authors.lastname: Dratva
authors.forename: Olivier F
authors.initials: OF
authors.lastname: Bertrand
authors.forename: Dan
authors.initials: D
authors.lastname: Tzivoni
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020517:Atrial Appendage / Q000000981:diagnostic imaging* / Q000601:surgery*; D001281:Atrial Fibrillation / Q000000981:diagnostic imaging* / Q000601:surgery*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055989:Septal Occluder Device / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography
keywords: Atrial fibrillation; Device occlusion; Left atrial appendage; Stroke; Thromboembolism