The main randomized trials evaluating patent foramen ovale (PFO) closure after a presumed PFO-associated stroke excluded patients older than 60 years. We aimed to evaluate the early- and long-term clinical outcomes of transcatheter PFO closure in older (>60 years) patients with a cryptogenic ischemic event.

This is a multicenter study including consecutive patients older than 60 years (mean age, 67±5 years) who had a PFO closure following a presumed PFO-related ischemic event. Patients ≤60 years old (mean age, 44±10 years) served as the control group. The primary end point was the occurrence of stroke, transient ischemic attack, or peripheral embolism over the follow-up period. New-onset atrial fibrillation was a secondary end point.

A total of 388 and 883 patients >60 and ≤60 years old were included, respectively. Procedural success rate was high (99.9%), and procedural-related complications low (<2%) in both groups. After a median follow-up of 3 (1-8) years, older patients exhibited an incidence of stroke/transient ischemic attack/peripheral embolism of 1.6 events per 100 patient-years (stroke: 0.6 events per 100 patient-years), lower than that expected according to the risk of paradoxical embolism score (observed-to-expected ratio, 0.31 [95% CI, 0.11-0.91]). However, the event rate in older patients was higher than that observed in their younger counterparts (incidence rate ratio, 4.7 [95% CI, 2.36-9.8]). De novo atrial fibrillation after the procedure was more frequent in older patients (2.66 per 100 patient-years versus 0.49 per 100 patient-years, <0.001).

In patients older than 60 years with a presumed PFO-related ischemic event, PFO closure was safe and associated with a relatively low incidence of recurrent ischemic events after a median follow-up of 3 years compared with historical cohorts of patients who did not undergo PFO closure. However, a higher risk of recurrent cerebrovascular events was observed in older patients compared to their younger counterparts. Randomized trials are warranted in this population.