New Data Support Patent Foramen Ovale Closure After Stroke
This article requires a subscription to view the full text. If you have a subscription you may use the login form below to view the article. Access to this article can also be purchased.
Patent foramen ovale (PFO) can be found in ≈1 of 4 adults,1 and it has been implicated as a potential source of ischemic stroke, likely via paradoxical embolization.2 The association between stroke and PFO is particularly robust among younger patients with otherwise cryptogenic stroke.3 However, the merit of percutaneous PFO closure for secondary stroke prevention has been the focus of much debate. Although the first 3 randomized trials of PFO closure did not demonstrate benefit in their primary intention-to-treat analyses, newly available data will likely change practice for many clinicians.
Percutaneous catheter-based PFO closure was introduced to clinical practice in 1992.4 Subsequently, randomized clinical trials were undertaken to demonstrate efficacy of closure for secondary stroke prevention, yet enrollment was slow because many clinicians and patients were pursuing PFO closure outside the trials. Eventually, in 2012, the CLOSURE I trial5 was published, comparing medical therapy with PFO closure with the NMT Medical STARFlex device in 909 patients with PFO and cryptogenic stroke or transient ischemic attack. Patients randomized to medical therapy were given aspirin, warfarin, or both at the discretion of the enrolling investigator. The 2-year recurrent stroke rate was 2.9% after closure and 3.1% with medical therapy (hazard ratio [HR], 0.90; 95% confidence interval [CI], 0.41–1.98; P=0.79). There was no heterogeneity in the results based on the presence of atrial septal aneurysm or large shunt. Major procedural complications, atrial fibrillation, and serious adverse event rates from this and other described trials are reported in the Table.
The PC trial6 (Randomized Clinical Trial Comparing the Efficacy …