Sex differences in clinical characteristics and outcomes after transcatheter patent foramen ovale closure

Abstract Aims Although transcatheter patent foramen ovale (PFO) closure is a well-established intervention for secondary prevention of cryptogenic embolism, whether outcomes differ by sex remains underexplored. We aimed to evaluate sex-based disparities in baseline characteristics, procedural outcomes, and long-term events in patients undergoing transcatheter PFO closure. Methods and results From 1999 to 2013, a total of 1,245 patients (694 female [55.7%] and 551 male [44.3%]) at 13 Centers underwent PFO closure for secondary prevention of cryptogenic stroke or systemic embolism. Male patients were older (49±12 vs. 46±13 years, p=0.002), whereas female patients had higher RoPE scores (6.4±1.7 vs. 6.0±1.7, p<0.001) and a greater prevalence of migraine at baseline (38% vs. 23%, p<0.001). Procedural success was high and comparable in both groups (99.0% vs. 99.3%, p=0.82). In-hospital complications were similarly low (2.4% vs. 3.4%, p=0.63). At a median follow-up of 14.5±2.4 years, the incidence of the composite endpoint (ischemic stroke, transient ischemic attack, or systemic embolism) was not significantly different between female and male patients (0.21 vs. 0.17 per 100 patient-years, IRR 1.29, 95% CI 0.64–2.57, p=0.48). Conclusions In this large multicenter registry, sex did not significantly influence long-term safety and efficacy outcomes following transcatheter PFO closure for secondary prevention of cryptogenic embolism. Further prospective studies are warranted to confirm these observations and optimize patient management based on sex-specific risk profiles.