Abstract

Background: Recent successful randomized clinical trials showed that patent foramen ovale (PFO) closure lower risk of recurrent stroke or transient ischemic attack (TIA), compared to medical therapy. However, older patients (age≥60 years old) were excluded in these trials. In this study, we investigate the effect of PFO treatment in older adults with PFO related cryptogenic embolism. Methods: We prospectively enrolled 209 patients older than 60 years of age, with cryptogenic stroke or TIA attributed to PFO from MGH Cardio-Neurology Clinic. Extensive cryptogenic stroke workup included MRI/A, echo, and MCOT. Primary end point was a composite of recurrent ischemic stroke, TIA. Results: Of the 209 PFO stroke patients, 66 patients underwent PFO closure and 143 patients received medical therapy ( Table 1 ). The mean duration of follow-up was 49 months in the closure group and 45 months in the medical-therapy group. The primary end point occurred in 4 patients (6.1%) in the closure group and in 27(18.9%) in the medical therapy group (HR for medical therapy vs. closure, 3.763; 95% CI, 1.306 to 10.840; P = 0.014) ( Figure 1 ). The respective rates were 1.5% vs 4.9% for TIA (P = 0.426) and 4.5% vs 14.0% for stroke (P = 0.043). Conclusions: Older patients with PFO related cryptogenic embolism may also derive more benefits from PFO closure compared to medical treatment.

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