[Percutaneous closure of patent foramen ovale: preliminary experience with the PFO Star]

This article reports the experience of percutaneous closure of patent foramen ovale with the PFO Star device. Between January 2000 and December 2002, 44 consecutive patients with a mean age of 53 years were included in this registry. The implantation of the prosthesis was successful in 43 patients (98%): in 1 patient the atrial septum could not be crossed at operation. An early complication was observed in 3 patients (7%): one had transient amnesia and two patients had temporary ST elevation in the inferior ECG leads. Four patients (7%) had late complications: there was one case of spontaneously regressive atrial fibrillation, two recurrences of stroke (one in the patient without an implanted prosthesis and the other in a patient in whom the patent foramen ovale had been closed). Finally, one patient developed a fistula between the aorta and right atrium which occluded spontaneously when the anticoagulants were stopped. Complete closure of the patent foramen ovale was confirmed at 1 year in 92% of patients. The authors conclude that this preliminary experience shows that closure of patent foramen ovale with this device is effective and safe.