Background: Patent foramen ovale (PFO) and atrial septal aneurysm (ASA) have been associated with stroke in young adults. Patients with PFO suffering from paradoxical embolism are at increased risk for recurrent events. Percutaneous PFO closure is a new treatment modality aimed at secondary prevention.
Methods and results: Since April 1994, 132 consecutive patients, aged 51 +/- 12 years with PFO and with at least one paradoxical embolic event, underwent percutaneous PFO closure using six different device types. The embolic index event was an ischemic stroke in 62% of patients, a transient ischemic attack (TIA) in 33% of patients, and a peripheral embolism in 5% of patients. Thirty-six (27%) patients had PFO associated with ASA, whereas 96 (73%) patients had PFO only. The implantation procedure was successful in 130 (98%) patients. During and up to 6 years of follow-up (mean 1.8 +/- 1.6 years, 231 patient years), a total of eight recurrent embolic events were observed, with six TIAs, two peripheral emboli, and no ischemic stroke. The actuarial freedom from recurrence of the combined end point of TIA, ischemic stroke, and peripheral embolism was 95.3% (95% confidence interval [CI], 91.0%-96.4%) at 1 year and 90.5% (95% CI, 83.6%-97.2%) at 6 years.
Conclusions: Percutaneous PFO closure can be performed with a high success rate. The procedure appears a promising therapeutic modality for secondary prevention of recurrent embolism in patients with PFO. Randomized trials must define its therapeutic value.