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

Abstract

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 2 = 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 2 = 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 2 = 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.

Secondary Prevention of Cryptogenic Stroke and Outcomes Following Surgical Patent Foramen Ovale Closure Plus Medical Therapy vs. Medical Therapy Alone: An Umbrella Meta-Analysis of Eight Meta-Analyses Covering Seventeen Countries

“…This could explain why the PFO closure group has a higher rate of AF. This argument is supported by the RESPECT trial findings, which excluded paroxysmal AF and found no difference in AF rates between the two groups (0.6% in both surgical closure and medical therapy group) [ 28 ]. The majority of the AF episodes were peri-procedural, with very little persistent or long-term AF.…”

“…A secondary aim of this study was to evaluate new-onset non-valvular AF, mortality, and major bleeding (gastrointestinal (GI) bleeding, serious bleeding, fatal bleeding, thrombolysis in myocardial infarction (TIMI)-defined major bleeding, and hemorrhagic stroke) following both interventions. Study-specific definitions are mentioned in Table 1 [24][25][26][27][28][29][30][31].…”

Patent foramen ovale closure review: decades of research and the evolution of the evidence

“…A meta-analysis of the six studies indicated that PFO closure reduced the risk of stroke by 60% [25]. This was particularly true in people under the age of 60 who had a large right-to-left shunt.…”