Sex-Based Clinical Outcomes Following Percutaneous Closure of Patent Foramen Ovale

Objectives: Although sex differences have been emphasized in stroke and congenital heart disease, there has been limited investigation into their role in patent foramen ovale (PFO) closure for secondary prevention of stroke. We aimed to explore differences by sex in baseline profiles, procedural characteristics, and short-term outcomes of patients undergoing transcatheter PFO closure. Methods: A retrospective analysis was conducted on 458 consecutive patients (265 women and 193 men) treated with PFO closure at Centro Cardiologico Monzino in Milan between 2006 and 2011. Baseline information included demographic characteristics, medical history, diagnostic and procedural information, and periprocedural complications. Post-closure outcomes were assessed at index hospitalization and during the first follow-up. Results: The indications for PFO closure were as follows: cryptogenic stroke/TIA in 78% of women vs. 88% of men (p = 0.04). Positive thrombophilic screening was observed in 16% of women vs. 19% of men (non-significant). We observed age-matched (mean age 44 ± 12 years) patients without sex-related differences in baseline and procedural characteristics, with the exception of greater arterial hypertension in women. The mean follow-up time was 13 years for both groups. Recurrent stroke was observed in 0.1% and TIA observed in 0.4% of the 'cryptogenic stroke/TIA' group; in the 'other indications' group, 1.4% experienced stroke and no TIA was reported. No significant differences were present between sexes. Conclusions: There were no differences in procedural and short-term outcomes between males and females undergoing transcatheter PFO closure, but significant baseline differences in risk factors were identified. There is a critical need for long-term, systematic studies to understand sex and gender differences in the PFO population.