Patent Foramen Ovale Closure Versus Medical Therapy for Cryptogenic Stroke: An Updated Systematic Review and Meta-Analysis

Abstract Objectives To compare safety and efficacy of Patent Foramen Ovale (PFO) closure compared with medical therapy in patients with cryptogenic stroke (CS) Background The role of PFO closure in preventing recurrent stroke in patients with prior CS has been controversial. Methods We searched PubMed, EMBASE, the Cochrane Central Register of Controlled trials, and the clinical trial registry maintained at clinicaltrials.gov for randomized control trials that compared device closure with medical management and reported on subsequent stroke and adverse events. Event rates were compared using a Forest plot of relative risk using a random-effects model assuming inter-study heterogeneity. Results A total of 6 studies (n= 3747) were included in the final analysis. Mean follow-up ranged from 2 to 5.9 years. Pooled analysis revealed that device closure compared to medical management was associated with a significant reduction in stroke (RR = 0.41, 95% CI = 0.20-0.83, I2 = 51%, P = 0.01).There was, however, a significant increase in atrial fibrillation with device therapy (RR = 5.29, 95% CI = 2.32-12.06, I2 = 38%, P  Conclusion PFO closure is associated with a significant reduction in the risk of stroke compared to medical management. However, it causes an increased risk of atrial fibrillation.