Transcatheter closure of patent foramen ovale with radiofrequency: acute and intermediate term results in 144 patients

Sievert, Horst; Ruygrok, Peter; Salkeld, Matt; Baumgartner, Helmut; Meier, Bernhard; Windecker, Stephan; Juliard, Jean-Michel; Aubry, Pierre; Tiefenbacher, Christiane; Krumsdorf, Ulrike; Vermeersch, Paul; Ewert, Peter; Piéchaud, Jean François (2009). Transcatheter closure of patent foramen ovale with radiofrequency: acute and intermediate term results in 144 patients. Catheterization and cardiovascular interventions, 73(3), pp. 368-73. Hoboken, N.J.: Wiley-Blackwell 10.1002/ccd.21809

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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.

Item Type:	Journal Article (Original Article)
Division/Institute:	04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
UniBE Contributor:	Meier, Bernhard, Windecker, Stephan
ISSN:	1522-1946
ISBN:	19133667
Publisher:	Wiley-Blackwell
Language:	English
Submitter:	Factscience Import
Date Deposited:	04 Oct 2013 15:09
Last Modified:	05 Dec 2022 14:21
Publisher DOI:	10.1002/ccd.21809
PubMed ID:	19133667
Web of Science ID:	000263585200018
URI:	https://boris.unibe.ch/id/eprint/30255 (FactScience: 191603)