title: Patent foramen ovale closure with the Intrasept occluder: Complete 6-56 months follow-up of 247 patients after presumed paradoxical embolism.
abstract: OBJECTIVE
  We report our experience of transcatheter patent foramen ovale (PFO) closure with the new Intrasept occluder.
  
  
  BACKGROUND
  The Intrasept device is the fourth generation of the Cardia occluder family. Developed for transcatheter closure of PFO, the main difference between the Intrasept and prior generations of the Cardia occluder is its articulating center post. This modification allows better alignment of the umbrellas on both sides of the atrial septum. We report our experience with this new PFO occluder.
  
  
  METHODS
  From July 2002 until October 2006, PFO closure with the Intrasept occluder was attempted in 247 patients with presumed paradoxical embolism. Prior to PFO closure, a total of 269 cerebrovascular thromboembolic events (TEs) had occurred. Implantation of the device was guided by fluoroscopy and transesophageal echocardiography with conscious sedation.
  
  
  RESULTS
  Median age was 53 years (range, 21-77). One hundred twenty-seven (51%) patients had an atrial septal aneurysm. The device was implanted successfully in all cases. Acute complications occurred in 4 (1.6%) patients (air embolism = 2, pericardial effusion = 1, supraventricular tachycardia = 1). Follow-up information is available for all 247 (100%) patients. Median follow-up time was 14 months (range 6-56). Residual shunt at 6 months follow-up was 13%. After 1 year, the presence of residual shunt rate decreased to 10%. Following PFO closure, seven recurrent TEs (TIA = 4, CVA = 3) were observed in 6 patients. No wire fractures or device-associated thrombi were seen.
  
  
  CONCLUSIONS
  PFO closure with the Intrasept occluder is safe and efficient. Rates of residual shunt and recurrent TE compare favorably with other contemporary devices.
authors.affiliation: Rush University Medical Center, Section of Cardiology, Chicago, Illinois, USA.
authors.forename: Christian
authors.initials: C
authors.lastname: Spies
authors.forename: Ines
authors.initials: I
authors.lastname: Timmermanns
authors.forename: Ulrich
authors.initials: U
authors.lastname: Reissmann
authors.forename: Jörg
authors.initials: J
authors.lastname: van Essen
authors.forename: Rainer
authors.initials: R
authors.lastname: Schräder
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D021721:Balloon Occlusion / Q000295:instrumentation* / Q000379:methods; D006328:Cardiac Catheterization / Q000379:methods*; D015331:Cohort Studies; D019320:Embolism, Paradoxical / Q000209:etiology* / Q000628:therapy; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D019919:Prosthesis Implantation; D012189:Retrospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D012737:Sex Factors; D013997:Time Factors; D016896:Treatment Outcome