Clinical Performance of the Gore Septal Occluder in Patent Foramen Ovale Closure in Different Septal Anatomies: 1-Year Results from a Single-Center Experience
Related Experiment Video
Updated: Jul 15, 2025
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Giuseppe Verolino1, Dario Calderone1, Mara Gavazzoni2
1Invasive Cardiology, Department of Cardiology, San Luca Hospital, IRCCS Istituto Auxologico Italiano, 20149 Milan, Italy.
Insights
The GORE Septal Occluder (GSO) effectively closes Patent Foramen Ovale (PFO) in most patients, including those with complex anatomy. This study confirms GSO
Area of Science:
- Cardiology
- Medical Devices
- Interventional Cardiology
Background:
- Patent Foramen Ovale (PFO) affects approximately 25% of the population.
- While often asymptomatic, PFO can lead to cryptogenic stroke.
- The GORE Septal Occluder (GSO) is a device for PFO closure, but its performance in diverse septal anatomies requires further exploration.
Purpose of the Study:
- To evaluate the effectiveness of the GORE Septal Occluder (GSO) for Patent Foramen Ovale (PFO) closure.
- To assess GSO device performance across different PFO anatomical complexities.
Main Methods:
- A prospective analysis of 118 consecutive patients undergoing PFO closure with the GSO system.
- Patients were followed for 12 months, with effectiveness evaluated by transcranial Doppler ultrasound.
Main Results:
- Effective PFO closure was achieved in 96.4% (107/111) of evaluated patients; 3.6% had a residual shunt.
- Patients were categorized into complex and simple anatomies based on PFO width and tunnel length.
- GSO performance was independent of PFO anatomy type and device size, achieving high closure rates in both groups.
Conclusions:
- The GORE Septal Occluder demonstrates a high PFO closure rate at 1-year follow-up.
- The device is effective regardless of the anatomical complexity of the Patent Foramen Ovale.
- GSO is a reliable option for PFO closure across various patient anatomies.
Background:
PFO (Patent foramen ovale) is a common defect that affects about 25% of the population. Although its presence is asymptomatic in the majority of the cases, the remaining part becomes overt with different symptoms, including cryptogenic stroke. PFO closure is currently a widely available procedure in complex anatomy, with Amplatzer PFO Occluder (APO) being the most commonly used tool. However, the performance of another device, the GORE Septal Occluder (GSO), has not been completely explored with regard to different septal anatomies.
Methods:
From March 2012 to June 2020, 118 consecutive patients with an indication of PFO closure were treated using the GSO system, included in a prospective analysis, and followed. After 12 months, every patient underwent transcranial Doppler ultrasound to evaluate the effectiveness of treatment.
Results:
Of 111 patients evaluated, 107 showed effective PFO closure (96.4%), and 4 showed a residual shunt (3.6%). To better evaluate the device performance, the overall population was sorted into two clusters based on the echocardiographic characteristics. The main difference between groups was for PFO width (4.85 ± 1.8 vs. 2.9 ± 1 mm, p < 0.001) and PFO tunnel length (12.6 ± 3.8 vs. 7.2 ± 2, p < 0.001), allowing complex and simple anatomies to be identified, respectively. Regardless of the aforementioned cluster, the GSO performance required to reach an effective closure was independent of anatomy type and the chosen device size.
Conclusion:
The GSO device showed a high closure rate at 1-year follow-up in patients, with at least one anatomical factor of complexity of PFO irrespective of the level of complexity itself.
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