Patent Foramen Ovale Closure Following Cryptogenic Embolism: Very Long-Term Follow-Up of a Historical Cohort.

BACKGROUND: Patent foramen ovale (PFO) has been identified as a conduit for paradoxical embolism causing stroke or transient ischemic attack (TIA). Long-term data of PFO closure beyond 10 years are rare. AIMS: We aimed to report the very long-term outcomes of PFO closure and compare the efficacy of different post?procedural antithrombotic treatment (AT). METHODS: Very long-term outcomes of a previously reported cohort of patients undergoing PFO closure between May 2004 and January 2013 were reviewed. Outcomes, including recurrent stroke or TIA, bleeding, venous thromboembolism (VTE), newly diagnosed atrial fibrillation (AF), and all-cause death, were adjudicated. The cohort was further stratified into short- and long-term post-procedural AT groups. Propensity-score matching was performed to adjust for differences in baseline characteristics across subgroups. RESULTS: Three hundred and one patients were included in the analysis. Median follow-up duration was 15.0 [95% confidence interval 14.7-15.3] years. Stroke and TIA occurred in 3.4% (0.27 per 100 patient-year) and 6.2% (0.46 per 100 patient-year), respectively. Bleeding and VTE were noted in 3.8% and 6.5%. 9.6% of patients (0.71 per 100 patient-year) developed AF. Thirty patients (0.70 per 100 patient-year) died. Patients receiving long-term AT (a single antiplatelet in > 85% of the population) experienced more bleeding and major bleeding events (log-rank p = 0.03 and 0.02, respectively), and had a tendency toward more frequent bleeding after propensity score matching (p = 0.09). Other outcome events were similar between subgroups. CONCLUSION: Benefits from PFO closure persist over the long term. A limited post-closure AT regimen is equally effective in preventing recurrent embolic events and is associated with potentially less bleeding.