Background: Paradoxical embolism due to the presence of patent foramen ovale (PFO) is a well-established possible mechanism of ischaemic stroke of unknown origin. Mechanical sealing of the interatrial septum seems to be the most effective method for the prevention of stroke recurrences.

Aim: To assess prospectively the short- and mid-term results of transcatheter closure of PFO in consecutive patients with a history of cryptogenic ischaemic stroke.

Methods: Between March 1999 and December 2002, thirty two patients with PFO (15 males, age from 19 to 55 years, mean 41 years) with a history of documented ischaemic stroke of unknown origin underwent transcatheter closure of PFO using an Amplatzer occluder. All procedures were performed under general anaesthesia and with transesophageal echocardiographic guidance.

Results: In all patients the procedure was effective and no complications were observed. During the follow-up period of a mean of 25.9 months (>12 months in 22 patients), no new neurological events were recorded. Control transesophageal echocardiography was performed in 28 patients mean 22.3 months after the procedure and confirmed the correct positioning of the occluder. A significant (>30 bubbles of contrast) residual shunt was detected in two patients. One patient developed episodes of paroxysmal supraventricular tachycardia which were effectively cured by radiofrequency ablation.

Conclusions: Transcatheter closure of PFO is safe, effective and devoid of side effects connected with extracorporeal circulation. This procedure may become the treatment of choice in patients with the highest risk of recurrent ischaemic stroke.

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