title: Transcatheter PFO closure with GORE(®) septal occluder: early and mid-term clinical results.
abstract: BACKGROUND
  Transcatheter closure of patent foramen ovale (PFO) is a widespread procedure. However the "quest" for the ideal device is still ongoing. Here we present the procedural and early results of transcatheter closure of PFO with the GORE® Septal Occluder.
  
  
  METHODS
  Three Italian centers participated in a registry and collected data from 122 consecutive patients undergoing PFO closure by using GSO device. Indication for closure was previous stroke or transient cerebral ischemia in 110 and migraine in 12 subjects.
  
  
  RESULTS
  The procedure was successful in all patients. The procedure was performed under general anesthesia, fluoroscopic, and trans-esophageal echocardiographic imaging in 80 subjects while it was performed with local anesthesia, fluoroscopic, and intracardiac echocardiographic monitoring in 42 subjects. Twenty patients received a 20 mm device, 70 patients received a 25 mm device, and 32 received a 30 mm device. Procedure and fluoroscopy times were 30 ± 20 and 5 ± 4 min, respectively. In three cases, the implanted device was retrieved because of unsatisfactory position. Four subjects (2.5%) experienced vascular complications. During a median follow-up of 9 months (range 1-18 months) seven patients experienced atrial arrhythmias and four of them required medical treatment. At six months follow-up, at chest X-ray in two cases there was evidence of fracture of two wires of the device. Devices were stable and no treatment was required. Moderate residual shunting was found in two patients at 6- and 12-months follow-up. No other complication occurred.
  
  
  CONCLUSIONS
  GORE® Septal Occluder is an easy, safe, and effective device in closing PFO.
authors.affiliation: Department of Pediatric Cardiology and GUCH Unit, Policlinico San Donato IRCCS, Milan, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Butera
authors.forename: Antonio
authors.initials: A
authors.lastname: Saracino
authors.forename: Paolo
authors.initials: P
authors.lastname: Danna
authors.forename: Paolo
authors.initials: P
authors.lastname: Sganzerla
authors.forename: Massimo
authors.initials: M
authors.lastname: Chessa
authors.forename: Mario
authors.initials: M
authors.lastname: Carminati
mesh_terms: D000328:Adult; D000368:Aged; D000768:Anesthesia, General; D000772:Anesthesia, Local; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D017548:Echocardiography, Transesophageal; D005260:Female; D005471:Fluoroscopy; D054092:Foramen Ovale, Patent / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000209:etiology / Q000517:prevention & control; D007558:Italy; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000209:etiology / Q000517:prevention & control; D011474:Prosthesis Design; D015641:Radiography, Interventional / Q000379:methods; D012042:Registries; D055989:Septal Occluder Device; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: closure; patent foramen ovale; transcatheter