Patent foramen ovale closure versus medical therapy for cryptogenic stroke: An updated systematic review and meta-analysis.

Objectives: The objective of this study was 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 interstudy 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 (risk ratio [RR] = 0.41, 95% CI = 0.20-0.83, I = 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, I = 38%, P < 0.0001). No effect was observed on major bleeding (P = 0.50) or mortality (P = 0.42) with device therapy. Subgroup analyses showed that device closure significantly reduced the incidence of the composite primary end point among patients who had large shunt sizes (RR = 0.35, 95% CI = 0.18-0.68, I = 27%, P = 0.002). The presence/absence of atrial septal aneurysm (P = 0.52) had no effect on the outcome.

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.