Sex-Based Differences in Long-Term Outcomes Following Transcatheter Closure of Patent Foramen Ovale for Cryptogenic Stroke

Abstract

BACKGROUND: Evidence from trials suggests that patent foramen ovale closure is superior to medical therapy alone in reducing stroke recurrence in men but not in women. Evidence from real-world data on the impact of sex on outcomes after patent foramen ovale closure, however, remains scarce. Therefore, the present study aimed to assess sex-based differences in long-term outcomes after transcatheter closure of patent foramen ovale. METHODS: This was a single-center, retrospective cohort study enrolling patients who underwent transcatheter patent foramen ovale closure to prevent recurrent cerebrovascular events. Detailed information from medical charts was entered into a clinical registry, which has been linked to population-based administrative health databases in Ontario. Procedural, short, and long-term outcomes have been compared by sex. RESULTS: Of the 783 patients included in the sample, 349 (44.5%) were women and 434 (55.5%) were men. Women were younger and had a higher rate of migraine, while men had a higher prevalence of cardiovascular risk factors. No differences were observed in procedural and 30-day outcomes by sex. At a median follow-up of 14 years, the event rates of recurrent cerebrovascular events, survival, and new-onset atrial fibrillation were not different by sex. In adjusted analysis, men experienced higher rates of pacemaker implantation (hazard ratio, 5.62 [95% CI, 1.57–20.1]). CONCLUSIONS: No sex-based differences in recurrent cerebrovascular events, survival, or new-onset atrial fibrillation were observed in this study, suggesting equal benefits for both sexes. Future studies should report outcomes by sex to enhance the reproducibility of our findings and help support guideline development.