Transcatheter closure of patent foramen ovale with radiofrequency: acute and intermediate term results in 144 patients.
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.
Sievert
Horst
H
Cardiology Department, CardioVascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany.
Ruygrok
Peter
P
Salkeld
Matt
M
Baumgartner
Helmut
H
Meier
Bernhard
B
Windecker
Stephan
S
Juliard
Jean-Michel
JM
Aubry
Pierre
P
Tiefenbacher
Christiane
C
Krumsdorf
Ulrike
U
Vermeersch
Paul
P
Ewert
Peter
P
Piéchaud
Jean François
JF
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