Impact of sex on clinical characteristics and outcomes after percutaneous PFO closure

Background

Patent foramen ovale (PFO) is present in up to 25% of adults and accounts for approximately 5% of all strokes. Sex-specific differences in patient characteristics and outcomes after percutaneous PFO closure remain poorly understood. We evaluated demographic, anatomical and clinical outcome differences between men and women undergoing PFO closure.

Methods

This single-center retrospective study included consecutive patients who underwent PFO closure between January 1, 2020, and October 31, 2025. Patients were grouped by sex. Demographic, anatomical and clinical data were collected from electronic medical records and compared using appropriate statistical tests.

Results

A total of 227 patients were included (115 women, 112 men) with similar mean ages (51 vs. 50 years, p=0.595). The indication for closure did not differ between groups, with cryptogenic ischemic stroke being the most frequent indication in both sexes. Most baseline comorbidities—including diabetes, hypertension, dyslipidemia, smoking and thrombophilia—were similar. Women more frequently had autoimmune disease (14% vs. 5%, p=0.034) and showed a higher prevalence of atrial septal aneurysm (60% vs. 40%, p=0.009).

Mean follow-up was similar in both groups (407 vs. 394 days, p=0.489). Although adverse outcomes were rare, two clinically relevant sex-related differences were observed: women experienced more all-cause hospitalizations after PFO closure (5 vs. 0, p=0.024) and had higher post-procedural mortality (5 vs. 0, p=0.024), all from non-cardiovascular causes. Hospitalizations occurred due to neurological symptoms (n=1), gynecological causes (n=1), COVID-19 (n=1), urinary tract infection (n=1) and inguinal hernia repair (n=1). Importantly, women who died were substantially older than those who survived (73 vs. 50 years, p=0.004). Causes of death included urinary tract infection (n=2), intestinal obstruction (n=1), and were unknown in two cases.

No differences were observed in procedural complications, significant residual shunt, atrial fibrillation or stroke.

Conclusions

Despite similar baseline characteristics and closure indications, women demonstrated a higher-risk anatomical profile and significantly higher rates of hospitalizations and mortality after PFO closure. All adverse events were non-cardiovascular and appeared to reflect overall clinical vulnerability rather than PFO-related procedural factors. Although limited, these findings suggest meaningful sex-related differences that warrant further investigation.