Benefits of Patent Foramen Ovale Closure Confirmed for Selected Patients with Cryptogenic Stroke

But questions about appropriate patient selection and the potential impacts of atrial fibrillation risks associated with the procedure remain.

Initial trials of patent foramen ovale (PFO) closure devices for cryptogenic stroke failed to consistently demonstrate clear superiority to medical management, but two recent clinical trials have challenged this notion (NEJM JW Neurol Nov 2017 and N Engl J Med 2017; 377:1011 and 1033). Two systematic reviews and meta-analyses have now synthesized this new evidence together with data from previously reported trials. The search strategy for both reviews ultimately identified the same four clinical trials totaling 2892 patients for the final analysis: PC-Trial, RESPECT, REDUCE, and CLOSE. Both reviews excluded the CLOSURE-I study because the device used in that study is no longer available due to high complication rates.

Shah and colleagues reported that PFO closure resulted in a 3.2% lower risk for recurrent stroke but no difference in transient ischemic attack (TIA) or major bleeding rates compared with medical therapy alone. New-onset atrial fibrillation was more common with PFO closure, but the authors concluded that significant heterogeneity among trials precluded reporting a summary statistic for this outcome.

De Rosa and colleagues reported a 2.9% lower risk for the combined outcome of recurrent stroke or TIA and a 3.3% higher risk for new-onset atrial fibrillation or flutter with PFO closure compared with medical therapy alone. Progressively greater benefits of PFO closure were seen as the size of interatrial shunts increased.