Abstract
AIM: To investigate if patent foramen ovale (PFO) closure device reduces the risk of recurrent stroke in patients with cryptogenic stroke. METHODS: We searched five databases - PubMed, EMBASE, Cochrane, CINAHL and Web-of-Science and clinicaltrials.gov from January 2000 to September 2017 for randomized trials comparing PFO closure to medical therapy in cryptogenic stroke. Heterogeneity was determined using Cochrane's Q statistics. Random effects model was used. RESULTS: Five randomized controlled trials with 3440 patients were included in the analysis. Mean follow-up was 50 ± 20 mo. PFO closure was associated with a 41% reduction in incidence of recurrent strokes when compared to medical therapy alone in patients with cryptogenic stroke [risk ratio (RR): 0.59, 95%CI: 0.40-0.87, P = 0.008]. Atrial fibrillation was higher with device closure when compared to medical therapy alone (RR: 4.97, 95%CI: 2.22-11.11, P < 0.001). There was no difference between the two groups with respect to all-cause mortality, major bleeding or adverse events. CONCLUSION: PFO device closure in appropriately selected patients with moderate to severe right-to-left shunt and/or atrial septal aneurysm shows benefit with respect to recurrent strokes, particularly in younger patients. Further studies are essential to evaluate the impact of higher incidence of atrial fibrillation seen with the PFO closure device on long-term mortality and stroke rates.