Related Experiment Video
Updated: May 14, 2026
Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
Long-Term Comparative Efficacy and Safety of Different Patent Foramen Ovale Closure Devices: Real-World Evidence from
Zeynep Yapan Emren1, Sadık Volkan Emren2, Uğur Karagöz2
1Department of Cardiology, Bakırçay University Çiğli Training and Research Hospital, Izmir 35620, Türkiye.
Insights
The Amplatzer PFO Occluder and other devices show similar long-term safety and efficacy for preventing stroke recurrence after percutaneous Patent Foramen Ovale (PFO) closure.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Percutaneous Patent Foramen Ovale (PFO) closure is a standard secondary prevention for cryptogenic stroke.
- Various devices are available for PFO closure, necessitating comparative outcome analysis.
Purpose of the Study:
- To compare long-term clinical outcomes and stroke recurrence rates between the Amplatzer PFO Occluder and other commercial devices.
- To evaluate the safety and efficacy of different PFO closure devices in cryptogenic stroke patients.
Main Methods:
- Retrospective study of 130 patients undergoing percutaneous PFO closure for PFO-related stroke.
- Comparison of Amplatzer PFO Occluder group (n=90) versus other devices group.
- Primary endpoints: Major Adverse Cardiovascular Events (MACE), including stroke recurrence, atrial fibrillation, and mortality.
Main Results:
- Average follow-up: 2200 days (median 1739 days).
- No significant differences in baseline characteristics between groups.
- Similar rates of MACE, atrial fibrillation, and stroke recurrence observed between Amplatzer and other device groups.
- Kaplan-Meier analysis showed no significant difference in event-free survival.
Conclusions:
- Amplatzer PFO Occluder and other commercial devices offer comparable long-term safety and efficacy.
- Device type does not significantly impact long-term stroke recurrence rates after PFO closure.
- Percutaneous PFO closure is effective in reducing long-term stroke recurrence.
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.
