Transcatheter closure of patent foramen ovale with radiofrequency: acute and intermediate term results in 144 patients.
Catheter Cardiovasc Interv
; 73(3): 368-73, 2009 Feb 15.
Article
en En
| MEDLINE
| ID: mdl-19133667
ABSTRACT
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 ANDRESULTS:
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.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Cateterismo Cardíaco
/
Ablación por Catéter
/
Foramen Oval Permeable
Tipo de estudio:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Límite:
Adult
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Aged
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Female
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Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Catheter Cardiovasc Interv
Asunto de la revista:
CARDIOLOGIA
Año:
2009
Tipo del documento:
Article
País de afiliación:
Alemania