Abstract Background and aims Percutaneous closure of patent foramen ovale (PFO) is recommended for selected ischemic stroke patients to reduce stroke recurrence risk. While randomized trials have demonstrated efficacy, real-world data on short and long-term clinical and safety are limited. We aimed to evaluate procedural safety and long term clinical outcomes following PFO closure in clinical routine practice. Methods We retrospectively analyzed all patients undergoing percutaneous PFO closure after multidisciplinary evaluation in a dedicated Heart Stroke Team at the Radboudumc, Nijmegen, the Netherlands between September 2018 and June 2025. We recorded procedural complications and short-term outcome. The residual shunt at first out-patient follow-up was also recorded. Results A total of 365 patients underwent PFO closure. Mean age was 43.7 ± 11.2 years; 44 % were females. Median follow-up duration was 90 days (IQR 60–180 days). Major procedural complications were rare and found in 6 patients including one device dislocation that was retrieved percutaneously. New-onset AF occurred in 5 of the patients. No recurrent ischemic stroke or TIA occurred. Residual moderate to severe shunt was present in 22% of patients at follow-up. PFO anatomical features were not significantly associated with new-onset AF. Conclusions In this large real-world cohort, percutaneous PFO closure was safe and associated with very low rates adverse events. Longer follow-up to capture late cerebrovascular events and assess residual shunt after complete endothelialization of the device are needed. Conflict of interest Tim Ten Cate and Frank-Erik De Leeuw: declare an unrestricted research grant from Abbott; Erin Paige Mudaly, Anil Tuladhar, Nina Hilkens: nothing to disclose
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Erin Mudaly
Radboud University Nijmegen
Tim ten Cate
Radboud University Nijmegen
Frank-Erik De Leeuw
Radboud University Nijmegen
European Stroke Journal
Radboud University Nijmegen
Erasmus University Rotterdam
Erasmus MC
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Mudaly et al. (Fri,) studied this question.
synapsesocial.com/papers/69fd7f25bfa21ec5bbf077fb — DOI: https://doi.org/10.1093/esj/aakag023.835