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Long-Term Comparative Efficacy and Safety of Different Patent Foramen Ovale Closure Devices: Real-World Evidence from a 15-Year Cohort

Year: 2026

Type: article

Abstract: Objectives: Percutaneous Patent Foramen Ovale (PFO) closure has become a standard treatment for secondary prevention following cryptogenic stroke. This study aims to compare the long-term clinical outcomes and stroke recurrence rates between the Amplatzer PFO Occluder and other commercially available devices, including Occlutech, Cardiofix, and Biostar. Methods: This retrospective study included 130 consecutive patients who underwent percutaneous PFO closure due to PFO-related stroke. The participants were divided into two groups: the Amplatzer group (n = 90, 69%) and the Other Devices group. Primary endpoints were Major Adverse Cardiovascular Events (MACE) defined as stroke recurrence, new-onset atrial fibrillation (AF), and mortality during the follow-up period. Results: The average follow-up period was 2200 days (median 1739 days, interquartile range: 1062–2616 days). No statistically significant differences were observed between the groups regarding baseline characteristics such as age, hypertension, or diabetes. The Amplatzer and other device groups showed similar rates for MACE, atrial fibrillation, and stroke recurrence. Kaplan–Meier analysis demonstrated no significant difference in event-free survival between the groups. This study demonstrates that the Amplatzer PFO Occluder and other commercial devices provide comparable long-term safety and efficacy profiles in patients undergoing PFO closure for cryptogenic stroke. Regardless of the device type used, long-term stroke recurrence rates remain low in both groups.

Source: Journal of Clinical Medicine

DOI: 10.3390/jcm15093429