European Heart Journal Advance Access originally published online on October 27, 2005
European Heart Journal 2006 27(3):365-371; doi:10.1093/eurheartj/ehi617
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Patent foramen ovale closure in patients with cryptogenic thrombo-embolic events using the Cardia PFO occluder
1Section of Cardiology, Rush University Medical Center, Chicago, IL, USA
2Cardioangiologisches Centrum Bethanien (CCB), Markuskrankenhaus, Wilhelm-Epstein-Strasse 2, 60431 Frankfurt, Germany
Received 23 February 2005; revised 16 September 2005; accepted 6 October 2005; online publish-ahead-of-print 27 October 2005.
* Corresponding author. Tel: +49 69 9533 2202; fax: +49 69 9533 2528. E-mail address: r.schraeder{at}ccb.de
See page 258 for the editorial comment on this article (doi:10.1093/eurheartj/ehi671)
Aims We report our experience with three generations of the Cardia patent foramen ovale (PFO) occluder in patients with cryptogenic thrombo-embolic events (TE).
Methods and results Between 1998 and 2004, interventional PFO closure was attempted in 403 patients. Prior to PFO closure, 605 TE occurred, translating into an annual incidence of 3.1%. PFO closure was successful in all patients. Peri-procedural complications occurred in eight patients (2.0%). At 6 months follow-up, residual shunt was present in 10.8% of patients. Transient thrombi developed on 10 devices (predominantly generation II) and asymptomatic wire fractures were detected in 14 cases (generation I and II). The annual incidence of recurrent TE was 2.0% (n=13). Atrial septal aneurysm and prior device-related thrombus formation were identified as predictors of recurrent TE.
Conclusion Owing to technical improvements and modified adjunctive pharmacotherapy, the rate of thrombus formation has declined and wire fractures are virtually absent in generation III devices. The overall rate of recurrent TE is reduced by transcatheter PFO closure with the Cardia PFO occluder, and seems comparable to recurrence rates reported for other devices used for this purpose.
Key Words: Patent foramen ovale • Structural heart disease • Paradoxical embolism • Stroke • Transcatheter closure
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 J. D.R. Thomson Percutaneous PFO closure, further data but many unanswered questions Eur. Heart J., February 1, 2006; 27(3): 258 - 259. [Full Text] [PDF]
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