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.