title: PFO closure with the Premere PFO closure device: acute results and follow-up of 263 patients.
abstract: OBJECTIVE
  The aim was to assess the safety and efficacy of percutaneous patent foramen ovale (PFO) closure with the Premere (St. Jude Medical, Inc., St. Paul, MN, USA) device.
  
  
  RESULTS
  This is a prospective clinical and echocardiographic follow-up of 264 patients who underwent transcatheter PFO closure with planned implantation of the Premere device. Implantation was successful in 263 patients (99.6%). Complete closure demonstrated echocardiographically occurred in 92.7%. The 30-day adverse event rate was 5.4% (atrial fibrillation in six, pericardial effusion in three, acute coronary syndrome in two, pseudoaneurysm/fistula formation at the access site in two patients and device dislocation in one patient). At a mean follow-up of 19.3 months (±14.2 months) stroke or transient ischaemic attack (TIA) occurred in nine (3.5%) and thrombus formation on the left atrial anchor in one (0.4%) patient.
  
  
  CONCLUSIONS
  These data demonstrate that PFO closure with the Premere closure device is safe and effective. Complication rates and efficacy are similar to previously studied devices.
authors: CardioVascular Center Frankfurt, SeckbacherLandstrasse 65, Frankfurt, Germany.
authors: Lukasz J
authors: LJ
authors: Stanczak
authors: Stefan C
authors: SC
authors: Bertog
authors: Nina
authors: N
authors: Wunderlich
authors: Jennifer
authors: J
authors: Franke
authors: Horst
authors: H
authors: Sievert
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006348:Cardiac Surgical Procedures / Q000295:instrumentation*; D017548:Echocardiography, Transesophageal; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000150:complications / Q000000981:diagnostic imaging / Q000601:surgery*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D055989:Septal Occluder Device; D020521:Stroke / Q000209:etiology