Long term outcomes of patent foramen ovale closure in elderly patients

Abstract Aims Transcatheter patent foramen ovale (PFO) closure is an established treatment for patients with PFO and cryptogenic embolism. However, main randomized trials investigating PFO closure for secondary stroke prevention excluded patients older than 60 years. As a result, limited evidence is available for population. This study aimed to investigate the clinical characteristics and long-term outcomes of elderly patients undergoing transcatheter PFO closure. Methods and results This retrospective multicenter registry included patients who underwent transcatheter PFO closure between between 1999 and 2013 at 13 high-volume Centers, ensuring a minimum of 10 years of follow-up. Patients receiving closure for secondary prevention of cryptogenic embolism were identified and stratified by age (60 vs. ≥60 years). Among 1,245 included patients, 216 (17.3%) were aged ≥60 years. Elderly patients exhibited higher rates of cardiovascular risk factors and a lower Risk of Paradoxical Embolism (RoPE) score (3.9±1.0 vs. 6.7±1.4, p0.001). In contrast, a history of migraine was more common in younger patients (33.7% vs. 21.8%, p0.001). Procedural success rates were high and comparable across age groups (98.6% vs. 99.2%, p=0.39). Rates of in-hospital atrial fibrillation (2.8% vs. 2.0%, p=0.50) and significant residual shunt at discharge (1.3% vs. 1.7%, p=0.75) were similarly low in both groups. At a median follow-up of 14.5 ± 2.4 years, the incidence of the composite endpoint (stroke, transient ischemic attack, and systemic embolism) was low among elderly patients (0.28 per 100 patient-years, 95% CI 0.12–0.55) and did not differ significantly from younger patients (IRR 1.58, 95% CI 0.75–3.50, p=0.25). However, older patients exhibited a higher incidence of new-onset atrial fibrillation (0.83 vs. 0.20 per 100 patient-years, IRR 4.10, 95% CI 2.37–7.01, p0.001) and bleeding events (0.30 vs. 0.06 per 100 patient-years, IRR 5.28, 95% CI 1.53–18.25, p=0.01). Conclusions In this large multicenter registry with extended follow-up, transcatheter PFO closure in older patients was safe and comparably effective to younger counterparts. Prospective data are warranted to confirm these observations and guide optimal management in this cohort.