Clinical Performance of the Gore Septal Occluder in Patent Foramen Ovale Closure in Different Septal Anatomies: 1 Year- Results From a Single-Center Experience

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. The PFO closure procedure is widely available to date with the most used Amplatzer PFO Occluder, also in complex anatomy, but 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 for PFO closure were treated using the GSO system and included in a prospective analysis and followed. After 12 months, every patient underwent transcranial Doppler 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 2 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 respectively, p <0,001), allowing identification of complex anatomy and simple anatomy, respectively. Regardless of the aforementioned cluster, the GSO performance to reach an effective closure was independent of anatomy type and the chosen device size. Conclusion: GSO device showed efficacy and safety at 1-year follow-up in patients with at least 1 anatomical factor of complexity of PFO, irrespectively from the level of complexity itself.