Risk of Ischemic Stroke After Patent Foramen Ovale Closure.

ABSTRACT

BACKGROUND: Transcatheter patent foramen ovale (PFO) closure is the recommended treatment for patients age 18 to 60 years with cryptogenic stroke having a high probability of being PFO-related. Limited data exist on stroke recurrence after PFO closure outside clinical trials. OBJECTIVES: The purpose of this study was to examine stroke recurrence after PFO closure in routine clinical practice. METHODS: We used nationwide population-based Danish registries to conduct a cohort study of all patients with PFO closure during 2008 to 2021 (n = 1,162) and a birth year and sex-matched comparison cohort from the general population (n = 11,620). We calculated absolute and relative risks of ischemic stroke within 4 years after PFO closure. We used weighted Cox regression to estimate adjusted HRs of the association between PFO closure vs the general population and ischemic stroke. RESULTS: The absolute risks of ischemic stroke in patients with PFO closure and in the general population, respectively, were 1.4% (95% CI 0.8%-2.3%) and 0.1% (95% CI 0.0%-0.1%) at 1 year, 1.4% (95% CI 0.8%-2.3%) and 0.2% (95% CI 0.2%-0.4%) at 2 years, 2.2% (95% CI 1.3%-3.5%) and 0.4% (95% CI 0.2%-0.5%) at 3 years, and 2.5% (95% CI 1.5%-4.0%) and 0.4% (95% CI 0.3%-0.6%) at 4 years. Thus, the absolute 4-year risk of ischemic stroke was 2.1% (95% CI 0.9%-3.3%) higher in patients with PFO closure than in the general population, corresponding to an adjusted HR of 6.3 (95% CI 3.1-12.6). CONCLUSIONS: The 4-year risk of ischemic stroke after routine PFO closure for cryptogenic stroke was comparable to that observed in clinical trials, but remained higher than in the general population.