title: Long-term results of a randomized trial comparing three different devices for percutaneous closure of a patent foramen ovale.
abstract: OBJECTIVE
  Percutaneous patent foramen ovale (PFO) closure for secondary stroke prevention is discussed controversially. Long-term data comparing different closure devices are limited. The objective is the prospective comparison of procedural complications and long-term results after PFO closure in patients with cryptogenic stroke randomized to three different closure devices.
  
  
  RESULTS
  Between January 2001 and December 2004, 660 patients with cryptogenic stroke were randomized to three different closure devices (Amplatzer, CardioSEAL-STARflex, and Helex occluder, 220 patients per group). The primary endpoint was defined as recurrent cerebral ischaemia [stroke, transient ischaemic attacks (TIA), or Amaurosis fugax], death from neurological cause, or any other paradoxical embolism within 5 years after the index procedure. Device implantation was technically successful in all interventions (n = 660; 100%). The procedure was complicated by pericardial tamponade requiring surgery in one patient (Amplatzer group) and device embolization in three patients (all Helex group). Thrombus formation on the device was detected in 12 cases (11 CardioSEALSTARflex, 1 Helex, 0 Amplatzer; P < 0.0001), of which 2 required surgery. Complete closure after single device implantation was more common with the Amplatzer and with the CardioSEAL-STARflex than with the Helex occluder: Amplatzer vs. Helex vs. CardioSEAL-STARflex: n = 217 (98.6%) vs. n = 202 (91.8%) vs. n = 213 (96.8%; P = 0.0012). Within 5 years of follow-up, the primary endpoint occurred in 25 patients (3.8%; 10 TIAs, 12 strokes and 3 cases of cerebral death). Compared with the CardioSEAL-STARflex (6%; 6 TIAs, 6 strokes, 1 cerebral death) and Helex groups (4%; 4 TIAs, 4 stroke, 1 cerebral death), significantly fewer events (P = 0.04) occurred in the Amplatzer group (1.4%; 2 strokes, 1 cerebral death).
  
  
  CONCLUSIONS
  Although procedural complications and long-term neurological event rates are low regardless of the device used, the recurrent neurological event rate was significantly lower after Amplatzer than after CardioSEAL-STARflex or Helex implantation. This has important implications regarding the interpretation of trials comparing PFO closure with medical management.
authors.affiliation: CardioVascular Center Frankfurt, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany.
authors.forename: Marius
authors.initials: M
authors.lastname: Hornung
authors.forename: Stefan C
authors.initials: SC
authors.lastname: Bertog
authors.forename: Jennifer
authors.initials: J
authors.lastname: Franke
authors.forename: Dani
authors.initials: D
authors.lastname: Id
authors.forename: Margaret
authors.initials: M
authors.lastname: Taaffe
authors.forename: Nina
authors.initials: N
authors.lastname: Wunderlich
authors.forename: Laura
authors.initials: L
authors.lastname: Vaskelyte
authors.forename: Ilona
authors.initials: I
authors.lastname: Hofmann
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D055502:Secondary Prevention; D055989:Septal Occluder Device; D020521:Stroke / Q000517:prevention & control*; D016896:Treatment Outcome; D055815:Young Adult
keywords: Patent foramen ovale; Percutaneous closure