Short- and long-term outcomes in patients with thrombophilia undergoing transcatheter closure of patent foramen ovale

Background — Patients with thrombophilia are underrepresented in studies evaluating outcomes after closure of patent foramen ovale (PFO). Real-world data on long term outcomes in this population are very limited.

Objectives — This study compared outcomes in patients with and without thrombophilia undergoing PFO closure, using data from a large, clinical database linked to population-based databases.

Methods — This retrospective cohort study included consecutive patients who had a transcatheter PFO closure and had preprocedural thrombophilia screening. Data from a retrospective, clinical registry were linked to population-based administrative databases in Ontario Canada to evaluate outcomes. Outcomes were reported as rates per 100 person-years and compared using Poisson regression.

Results — We included 669 patients, with a mean age of 56.4 years, 97.9% of whom underwent PFO closure for a cryptogenic stroke. Thrombophilia was diagnosed among 174 (26.0%), of which 86% had inherited mutations. In-hospital, procedural complications were observed in 3.1% of patients with no difference by thrombophilia status. Similarly, no differences were observed in 30-day emergency department visits and readmissions. Over the median follow-up of 11.6 years, the most common adverse outcome was new-onset atrial fibrillation (1.0 per 100 person-years; 95% CI: 0.8-1.2), followed by recurrent cerebrovascular events (0.8 per 100 person-years; 95% CI: 0.6-1.1) with no differences between the groups (P > 0.05).

Conclusions — After PFO closure, no differences were observed in long-term adverse outcomes between patients with and without thrombophilia. Though these patients have been excluded from randomized clinical trials of PFO closure in the past, real-world evidence supports their eligibility for the procedure.