title: Percutaneous closure of the patent foramen ovale using the HELEX® Septal Occluder: acute and long-term results in 405 patients.
abstract: OBJECTIVE
  Although routinely used, limited data are available regarding the long-term outcome after patent foramen ovale (PFO) closure using the HELEX® Occluder system. The aim of this study was therefore the examination of the acute and long-term outcome after transcatheter PFO closure using this system.
  
  
  RESULTS
  All (n=407) patients included had undergone PFO closure with the HELEX® Occluder system for secondary prevention of stroke, transient ischaemic attack (TIA) or peripheral embolism at a single centre. Primary endpoints were residual shunts at six or 12 months (assessed by transoesophageal echocardiography) and the number of neurological and other adverse events during follow-up. Device implantation was successful in 99% of patients. Complete closure at six months was achieved in 81%. During follow-up of 1,695 patient-years, 10 neurologic events occurred (four TIA, six strokes). The annual incidence of stroke was 1.2%. Other adverse events were wire frame fractures requiring no further intervention in five (1%), device-associated thrombus formation in one (0.25%), and paroxysmal atrial fibrillation in nine patients (2%).
  
  
  CONCLUSIONS
  PFO closure using the HELEX® Occluder system is feasible and safe. Complications and adverse events during long-term follow-up are rare. The safety profile and efficacy in prevention of recurrent events compare well to that reported with other closure devices.
authors.affiliation: CardioVascular Center, Frankfurt, Germany.
authors.forename: Corinna
authors.initials: C
authors.lastname: Heinisch
authors.forename: Stefan
authors.initials: S
authors.lastname: Bertog
authors.forename: Nina
authors.initials: N
authors.lastname: Wunderlich
authors.forename: Nico
authors.initials: N
authors.lastname: Majunke
authors.forename: Andreas
authors.initials: A
authors.lastname: Baranowski
authors.forename: Michaela
authors.initials: M
authors.lastname: Leetz
authors.forename: Evelyne
authors.initials: E
authors.lastname: Fischer
authors.forename: Stefan
authors.initials: S
authors.lastname: Staubach
authors.forename: Wibke
authors.initials: W
authors.lastname: Zimmermann
authors.forename: Ilona
authors.initials: I
authors.lastname: Hofmann
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D016009:Chi-Square Distribution; D018572:Disease-Free Survival; D017548:Echocardiography, Transesophageal; D004617:Embolism / Q000401:mortality / Q000517:prevention & control; D005260:Female; D054092:Foramen Ovale, Patent / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D005858:Germany / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D002546:Ischemic Attack, Transient / Q000401:mortality / Q000517:prevention & control; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D055502:Secondary Prevention / Q000295:instrumentation*; D055989:Septal Occluder Device; D020521:Stroke / Q000401:mortality / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult