TY - JOUR
T1 - Transcatheter closure of patent foramen ovale with radiofrequency
T2 - Acute and intermediate term results in 144 patients
AU - Sievert, Horst
AU - Ruygrok, Peter
AU - Salkeld, Matt
AU - Baumgartner, Helmut
AU - Meier, Bernhard
AU - Windecker, Stephan
AU - Juliard, Jean Michel
AU - Aubry, Pierre
AU - Tiefenbacher, Christiane
AU - Krumsdorf, Ulrike
AU - Vermeersch, Paul
AU - Ewert, Peter
AU - Piéchaud, Jean François
PY - 2009/2/15
Y1 - 2009/2/15
N2 - Aims: 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. Methods and 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). Conclusion: 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.
AB - Aims: 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. Methods and 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). Conclusion: 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.
UR - http://www.scopus.com/inward/record.url?scp=65549091129&partnerID=8YFLogxK
U2 - 10.1002/ccd.21809
DO - 10.1002/ccd.21809
M3 - Article
C2 - 19133667
AN - SCOPUS:65549091129
SN - 1522-1946
VL - 73
SP - 368
EP - 373
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
IS - 3
ER -