Twenty-Year Follow-Up After Patent Foramen Ovale Closure in Patients With Paradoxical Embolism

Importance: Transcatheter closure of patent foramen ovale (PFO) is a definitive therapy to prevent recurrent ischemic events in patients with PFO-associated embolism. However, very long-term outcome data remain scarce; these data are essential to fully understand the enduring safety and efficacy of this therapy. Objective: To assess the 20-year clinical outcomes following PFO closure in patients with PFO-associated embolism. Design, Setting, and Participants: This single-center cohort study with prospective procedure, early follow-up data collection, and retrospective long-term follow-up took place at a tertiary university hospital. The study included 130 consecutive patients who had PFO closure for cryptogenic stroke, transient ischemic attack (TIA), or peripheral embolism between 2001 and 2006. These data were analyzed from February 2025 to June 2025. Exposure: All PFO closure procedures were technically successful and echocardiographic follow-up was performed within 1 to 6 months. Main Outcomes and Measures: Long-term clinical outcomes were assessed via medical record review and telephone interviews. Results: Mean (SD) age of the study population was 46 (14) years, with 67 women (51.5%) and 63 men (48.5%). Follow-up was complete for all but 5 patients (3.8%). At 20-year follow-up, a total of 20 patients (15.3%) had died (noncardiovascular causes in 12.2%) and recurrent ischemic events were infrequent (1 stroke [0.04 per 100 patients, per year] and 6 TIAs [0.25 per 100 patients, per year]). There was a higher prevalence of thrombophilia among patients who had recurrent ischemic events (33% vs 4.8%; P = .04). Up to 20.5% of patients discontinued antithrombotic treatment and none of them had any ischemic event at follow-up. Bleeding events occurred in 17 patients (13%) with 9 cases (6.9%) classified as major. These events were more frequent in women (19.4% vs 6.3%; P = .03) and occurred exclusively in patients receiving long-term antithrombotic therapy (17% vs 0% in patients who discontinued antithrombotic treatment; P = .04). Conclusions and Relevance: The results of this cohort study with 20-year follow-up showed the sustained very long-term safety and efficacy of transcatheter PFO closure, with less than 1% rate of recurrent stroke events. However, bleeding events occurred in about 1 in 10 patients and were more frequent in women and in patients under long-term antithrombotic therapy. These findings underscore the need for tailored long-term antithrombotic strategies after PFO closure. Further studies are warranted.