Transcatheter Closure of Patent Foramen Ovale in Older Patients With Cryptogenic Thromboembolic Events
Alberto Alperi, Paul Guedeney, Eric Horlick, Luis Nombela‐Franco, Xavier Freixa, Isaac Pascual, Jules Mesnier, Christine Houde, Lusine Abrahamyan, Gilles Montalescot, Josep Rodés‐Cabau
Abstract
Background: 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. Methods: 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. Results: 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, P <0.001). Conclusions: 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.