Patent Foramen Ovale (PFO) Closure in Thrombophilia as Primary Prevention in Patients Without Prior PFO-Associated Thromboembolic Events.

Patent foramen ovale (PFO) is a common anatomical variant with potential clinical implications in embolic phenomena. In some situations, transcatheter closure is considered a treatment option. For patients with thrombophilia who have not had embolic events, it is not always clear whether this approach is appropriate. Individuals with clotting disorders may face different considerations, and approaches can vary between cases. This study was conducted based on the PICO-formatted research question: Population - thrombophilic patients with no history of embolic events; Intervention - PFO closure; Comparison - medical therapy; Outcome - stroke prevention. We focused on asymptomatic individuals due to their theoretical but unproven elevated risk of stroke and the current absence of specific guidelines for primary prevention. Studies addressing PFO screening and management in thrombophilic patients without a prior history of stroke or embolic events were included. English-language articles published up to December 2024 were reviewed using data extracted from MEDLINE, Cochrane Library, and Scopus. The included studies primarily consisted of observational designs, such as prospective and retrospective cohort studies, case-control studies, and case series, which collectively provided the evidence base for evaluating PFO management strategies in patients with thrombophilia. After full-text screening, only one retrospective cohort study met our inclusion criteria. This study of 136 thrombophilic patients with PFO, all maintained on antithrombotic therapy, found that primary percutaneous PFO closure was independently associated with a nearly five-fold reduction in the risk of cerebrovascular accident or transient ischemic attack (adjusted hazard ratio 0.18; 95% CI: 0.03-0.3; p = 0.001), demonstrating a statistically significant benefit of closure in this high-risk population. Although this result suggests a potential benefit of early intervention, the evidence remains limited and non-randomized. These findings should be viewed as hypothesis-generating, highlighting the need for prospective studies to better define the role of PFO closure in this specific population and to inform future guideline development.