Efficacy and safety of patent foramen ovale closure for mitigating migraine: a systematic review and meta-analysis of randomized trials and observational studies

Background: Although often asymptomatic, patent foramen ovale (PFO) may cause disabling migraine symptoms. Evidence regarding PFO closure for prevention of migraine is still ambiguous and conflicting. Objectives: This study aims to analyze the efficacy and safety of PFO closure for mitigating migraine symptoms. Design: This is a systematic review and meta-analysis of randomized clinical trials (RCTs) and observational studies. Data sources and methods: A comprehensive search was conducted on the Scopus, Medline, ClinicalTrials.gov, and Cochrane Library databases up until March 12, 2024. This review incorporates literature that examines the comparison between PFO closure and control with outcome data related to migraine. We employed random-effect models to analyze the standardized mean difference (SMD) and odds ratio (OR) for presentation of the outcomes. Results: A total of five RCTs and six observational studies were incorporated. The results of our meta-analysis showed higher reduction of monthly migraine attacks from baseline (SMD −0.34; 95% CI: −0.51, −0.18, p < 0.0001, I 2 = 19%) and monthly migraine days from baseline (SMD −0.30; 95% CI: −0.53, −0.08, p = 0.009, I 2 = 0%) among PFO closure than control. However, the complete resolution of migraine (especially based on the evidence from RCTs; p = 0.24), HIT-6 score ( p = 0.08), and MIDAS score ( p = 0.15) did not differ significantly between two groups of intervention. The majority of adverse events reported were atrial fibrillation and access site infection/bleeding that only occurred in small proportions of patients (⩽5%). Conclusion: This study suggests better efficacy of PFO closure in reducing monthly migraine attacks and days with similar safety profile when compared to control. Registration: PROSPERO (CRD42023453635).