Background: The efficacy and safety of patent foramen ovale closure (PFOC) in cryptogenic stroke (CS) patients aged ⩾ 60 remain controversial. This study evaluates the efficacy and safety of PFOC in elderly (aged ⩾ 60) versus non-elderly (aged < 60) patients and examines potential age-related benefit.

Methods: A hospital-based cohort study (January 2013-June 2023) compared the efficacy and safety between PFOC and non-PFOC groups in patient with CS or cryptogenic TIA. The primary efficacy outcome was recurrent ischemic stroke, and safety outcomes included procedure-related adverse events and periprocedural atrial fibrillation (AF). Subgroup analyses, including various age ranges, were performed for the elderly group.

Results: Among 239 patients (mean age 57.2 years), 120 were elderly. During a mean follow-up of 3.1 years, the PFOC group had significantly fewer recurrent ischemic stroke than the non-PFOC group (adjusted hazard ratio (AHR): 0.10, 95% CI: 0.03-0.29, p = 0.001). The risk reduction was similar in elderly (AHR: 0.11, p = 0.004) and non-elderly (AHR: 0.10, p = 0.005) patients (p for interaction = 0.337). Safety outcomes were comparable across age groups, including younger elderly (60-70) and older elderly (⩾70). No life-threatening complications occurred; one patient required additional intervention. Subgroup analysis indicated significant risk reduction for patients aged ⩾ 65 (AHR: 0.01, p = 0.012) but not for those aged 60-65 (AHR: 0.24, p = 0.071).

Conclusions: PFO closure is safe and effective in elderly patients with CS. Advanced age should not be a contraindication for PFOC, as older patients may potentially derive more significant benefits from the procedure.