Stroke recurrence and its prevention in patients with patent foramen ovale.

BACKGROUND: It is unclear whether medical or invasive (surgical or catheter interventional) treatment is preferable to prevent recurrence of cerebral ischemia in patients with patent foramen ovale (PFO) as the suspected cause of stroke and what the role of concomitant risk factors is in stroke recurrence. METHODS: Over a period of ten years, 124 patients (mean age 51 +/- 15 years) with cryptogenic cerebral ischemia and PFO were included into the study and prospectively followed over a mean of 52 +/- 32 months. Of these, 83 were treated medically, 34 underwent transcatheter closure, and seven had surgical closure of the foramen. Of the medically treated patients, 11 stopped medication during follow-up. Recurrent ischemic events and risk factors for recurrence were analyzed. RESULTS: Annual stroke recurrence rates were generally low and comparable in catheter and medically treated patients, and in patients who had stopped medication (2.9%/2.1%2.2%/year). Patients suffering from recurrence after transcatheter closure (n = 2) both had residual shunts. No stroke recurrence was observed in the few surgically treated patients. An atrial septal aneurysm was not a predictor of recurrent or multiple strokes (p > 0.05, OR = 0.31, and OR = 0.74). Large shunts and a history of previous ischemic events were considerably more frequent in patients with recurrent strokes (p < 0.05, OR = 5.0, and OR = 4.4). Pulmonary embolism and case fatality rates were significantly higher in patients with stroke recurrence (p < 0.001, and p < 0.01). CONCLUSIONS: The absolute risk of recurrent cerebrovascular events in patients with PFO receiving medical or catheter interventional therapy is low. The small group of untreated patients had a comparably low rate of stroke recurrences. Previous ischemic events and shunt size were risk factors in this observational study. Given conflicting findings across multiple studies, enrollment into a randomized controlled trial would be the optimal choice.