Transcatheter closure of patent foramen ovale in patients with cryptogenic stroke.

BACKGROUND About 50% of patients with cryptogenic stroke have a patent foramen ovale (PFO). The recurrence rate of paradoxical embolism is higher if a PFO is detected. METHODS Thirty-five patients with PFO and > or = 1 thromboembolic event due to paradoxical embolism were included in the study (23 males, 12 females, mean age 47.8 +/- 14 years, mean weight 75 +/- 15 kg). Twenty-three patients had a transient ischemic attack whereas 12 experienced an ischemic stroke. Twenty-nine patients had one thromboembolic event, 4 patients had two thromboembolic events, and 2 patients had three thromboembolic events. The implantation procedure was performed, as previously reported, under general anesthesia, fluoroscopic guidance and during transesophageal echocardiography. RESULTS The implantation procedure was successful in all patients. There were no complications related to the procedure. Four different devices were implanted (Amplatzer 3 patients; Cardioseal 12 patients; Starflex 12 patients, PFO Star 8 patients). The procedure time and fluoroscopic time were 50 +/- 21.8 and 12.2 +/- 8.3 min respectively. At transesophageal echocardiography performed after the procedure, 11 patients had a trivial shunt. None of the patients had a residual shunt at 1 month of follow-up. The mean follow-up was 12.3 +/- 8 months (median 11.0 months, range 3-37 months). In no patient did recurrence of a thromboembolic event occur during follow-up. CONCLUSIONS Percutaneous PFO closure is a feasible and safe technique for the prevention of recurrent paradoxical embolism.