Copyright © 2004 by the European Society of Cardiology.
Clinical research
Transcatheter closure of patent foramen ovale (PFO) in patients with paradoxical embolism
Periprocedural safety and mid-term follow-up results of three different device occluder systems
a Internal Medicine II, Department of Cardiology, Technical University of Dresden, Fetscherstr. 76, 01307 Dresden, Germany
b Internal Medicine, Department of Cardiology, Charité University of Berlin, Germany
c Department of Neurology, University of Technology Dresden, Germany
d Internal Medicine, Theresienkrankenhaus Mannheim, Germany
e Bethanien Hospital – CCB, Frankfurt/Main, Germany
* Corresponding author. Tel.: +49-351-450-1700/1701; fax: +49-351-450-1702
E-mail address: Martin.Braun{at}mailbox.tu-dresden.de
Received 30 January 2003; revised 15 September 2003; accepted 16 October 2003 See page 361 for the editorial comment on this paper1
Abstract
Aims Interventional PFO closure has previously been reported to reduce the risk for recurrent thromboembolic events. The aim of the present study was to evaluate three different occluder systems in respect to (a) the safety and practicability and (b) the mid-term risk of recurrent thromboembolic events.
Methods and results Since 08/98 until 12/02, 307 consecutive patients (138 women, 169 men, mean age 43 years) with a symptomatic PFO underwent PFO closure using the PFO-Star (
), AmplatzerTM PFO occluder (
) and CardioSeal/Starflex (
). Implantation was successful in all patients. Periinterventional complications occurred in 9 patients (5x ST-segment elevations, 1x arteriovenous fistula, 2x TIA, 1x device dislodgement). All of them were reversible and not associated with a specific type of device. During the median follow-up of 24 months (25/75th percentiles: 14/37 months), the annual risk of recurrence was 0.6% for TIA, 0% for stroke and 0.2% for peripheral embolism (PFO-Star: 0.8%, AmplatzerTM PFO occluder: 0.7% and CardioSeal/Starflex: 1.0%).
Conclusion Interventional PFO closure appears to be safe and a promising technique in symptomatic PFO patients with a low incidence of periinterventional complications and recurrent thromboembolic events using three different devices (PFO-Star, AmplatzerTM PFO occluder or the CardioSeal/Starflex).
Key Words: Embolism • Heart septal defects • Cerebral ischemia • Transcatheter closure
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