title: Transcatheter closure of patent foramen ovale with radiofrequency: acute and intermediate term results in 144 patients.
abstract: OBJECTIVE
  Currently available devices for transcatheter closure of patent foramen ovale (PFO) which rely on a permanent implant have limitations, including late complications. The study objective was to evaluate the safety, feasibility, and effectiveness of the PFx Closure System, the first transcatheter technique for PFO closure without an implantable device.
  
  
  RESULTS
  A prospective study of 144 patients was conducted at nine clinical sites from October 2005 through August 2007. All patients had a history of cryptogenic stroke, transient ischemic attack, migraines, or decompression illness. The mean balloon stretched diameter of the PFO was 7.9 +/- 2.5 mm. Technical success (successful application of radiofrequency energy) was achieved in 130 patients. One patient required a transfusion as a result of blood loss during the procedure. There were no other major procedural complications. There were no recurrent strokes, deaths, conduction abnormalities, or perforations following the procedure. At a mean follow-up of 6 months, successful closure was achieved in 79 patients (55%). In PFOs with balloon sized or stretched diameters less than 8 mm, the closure rate was 72% (53/74).
  
  
  CONCLUSIONS
  This study demonstrates that transcatheter closure of a PFO without a permanent implant is technically feasible and safe. Further technique and device modifications are required to achieve higher closure rates.
authors.affiliation: Cardiology Department, CardioVascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.forename: Peter
authors.initials: P
authors.lastname: Ruygrok
authors.forename: Matt
authors.initials: M
authors.lastname: Salkeld
authors.forename: Helmut
authors.initials: H
authors.lastname: Baumgartner
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Juliard
authors.forename: Pierre
authors.initials: P
authors.lastname: Aubry
authors.forename: Christiane
authors.initials: C
authors.lastname: Tiefenbacher
authors.forename: Ulrike
authors.initials: U
authors.lastname: Krumsdorf
authors.forename: Paul
authors.initials: P
authors.lastname: Vermeersch
authors.forename: Peter
authors.initials: P
authors.lastname: Ewert
authors.forename: Jean François
authors.initials: JF
authors.lastname: Piéchaud
mesh_terms: D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization / Q000295:instrumentation / Q000379:methods*; D017115:Catheter Ablation / Q000295:instrumentation / Q000379:methods*; D004867:Equipment Design; D004869:Equipment Safety; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome