Abstract Body: Background: Patent foramen ovale (PFO) is commonly diagnosed in patients over 60-65 years with cryptogenic stroke. Despite robust evidence and guidelines supporting PFO closure in individuals aged 18-60, the efficacy of this intervention in preventing recurrent ischemic strokes in elderly patients (>60 years) with PFO and cryptogenic stroke remains uncertain, as existing evidence is inconclusive.

Objective: We aimed to synthesize findings from observational studies until July 2024 to evaluate the long-term efficacy and safety of PFO closure in elderly patients over 60 years of age, with the primary outcome focused on its impact on reducing the composite risk of recurrent ischemic stroke/transient ischemic attack (TIA).

Methods: We analyzed data using RevMan 5.4 with a random effects model, employing the inverse variance method pooling outcomes as odds ratios (OR) with 95% confidence intervals (CI). Our study protocol is registered in PROSPERO (CRD42024564171).

Results: Our study included 9 observational studies comprising 3,525 subjects, of whom 1,572 were elderly patients aged over 60 years. The average follow-up period ranged from 2.5 to 14 years. Upon pooled analysis comparing the primary composite outcome of recurrent ischemic stroke/TIA after PFO closure, the elderly cohort (aged >60 years) demonstrated a significant reduction in risk compared to the non-elderly (18-60 years), with an OR of 3.47 (95% CI: 2.01 to 5.99, p < 0.00001), and no significant heterogeneity was observed. Secondary outcomes revealed a statistically significant reduction in all-cause mortality among the elderly following PFO closure (OR: 7.83, 95% CI: 2.59 to 23.65, p = 0.0003), as well as a decreased incidence of recurrent strokes (OR: 3.97, 95% CI: 1.58 to 9.97, p = 0.003). Furthermore, there was no statistically significant difference in the occurrence of post-procedure new-onset atrial fibrillation between elderly and younger patients (OR: 1.31, 95% CI: 0.67 to 2.57, p = 0.43).

Conclusion: PFO closure in elderly patients may be as effective and safe as in younger patients. However, there is a pressing need for further multicenter large randomized controlled trials to specifically include patients over 60 years of age. These trials should evaluate the safety and long-term efficacy of PFO closure, with the goal of reassessing and refining current treatment guidelines to optimize outcomes for elderly patients with PFO and cryptogenic stroke.