title: Late results after percutaneous closure of patent foramen ovale for secondary prevention of paradoxical embolism using the amplatzer PFO occluder without intraprocedural echocardiography: effect of device size.
abstract: OBJECTIVE
  We sought to assess the safety and clinical efficacy of patent foramen ovale (PFO) closure under fluoroscopic guidance only, without intraprocedural echocardiography.
  
  
  BACKGROUND
  Percutaneous PFO closure has been shown to be safe and feasible using several devices. It is generally performed using simultaneously fluoroscopic and transesophageal or intracardiac echocardiographic guidance. Transesophageal echocardiography requires sedation or general anesthesia and intubation to avoid aspiration. Intracardiac echocardiography is costly and has inherent risks. Both lengthen the procedure. The Amplatzer PFO Occluder (AGA Medical Corporation, Golden Valley, Minnesota) can be safely implanted without echocardiographic guidance.
  
  
  METHODS
  A total of 620 patients (51 +/- 12 years; 66% male) underwent PFO closure using the Amplatzer PFO Occluder for secondary prevention of presumed paradoxical embolism. Based on size and mobility of the PFO and the interatrial septum, an 18-mm device was used in 50 patients, a 25-mm device in 492, and a 35-mm device in 78.
  
  
  RESULTS
  All procedures were successful, with 5 procedural complications (0.8%): 4 arteriovenous fistulae requiring elective surgical correction, and 1 transient ischemic attack. Contrast transesophageal echocardiography at 6 months showed complete closure in 91% of patients, whereas a minimal, moderate, or large residual shunt persisted in 6%, 2%, and 1%, respectively. During a mean follow-up period of 3.0 +/- 1.9 years (median: 2.6 years; total patient-years: 1,871), 5 ischemic strokes, 8 transient ischemic attacks, and no peripheral emboli were reported. Freedom from recurrent ischemic stroke, transient ischemic attack, or peripheral embolism was 99% at 1 year, 99% at 2 years, and 97% at 5 years.
  
  
  CONCLUSIONS
  The Amplatzer PFO Occluder affords excellent safety and long-term clinical efficacy of percutaneous PFO closure without intraprocedural echocardiography.
authors.affiliation: Department of Cardiology, University Hospital, Bern, Switzerland.
authors.forename: Andreas
authors.initials: A
authors.lastname: Wahl
authors.forename: Tony
authors.initials: T
authors.lastname: Tai
authors.forename: Fabien
authors.initials: F
authors.lastname: Praz
authors.forename: Markus
authors.initials: M
authors.lastname: Schwerzmann
authors.forename: Christian
authors.initials: C
authors.lastname: Seiler
authors.forename: Krassen
authors.initials: K
authors.lastname: Nedeltchev
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Heinrich P
authors.initials: HP
authors.lastname: Mattle
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D017548:Echocardiography, Transesophageal; D019320:Embolism, Paradoxical / Q000000981:diagnostic imaging / Q000517:prevention & control* / Q000628:therapy; D005260:Female; D005471:Fluoroscopy; D054092:Foramen Ovale, Patent / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D055502:Secondary Prevention; D013997:Time Factors