Results of percutaneous closure of patent foramen ovale with the GORE^® septal occluder

Abstract

PFO closure with the GSO is accompanied by a high technical success rate and closure rates similar to other currently used devices. The incidence of AF was higher than reported with most other devices. This may be a chance finding but warrants further investigation in larger trials.

Using the GORE® Septal Occluder (GSO) in Challenging Patent Foramen Ovale (PFO) Anatomies

“…Thus, a dedicated device allowing safe, complete and rapid defect closure especially in those challenging PFO anatomies is desirable. The Gore ® Septal Occluder has already proven low periprocedural risk, high successful implantation rates and good closure rates at short‐term follow‐up examination in a number of previous studies . However, patients enrolled in these trials were mainly presenting with “ordinary” PFO anatomies (ASA 194/589; 32.9%; long tunnel 91/339; 26.8%, tunnel length data of 250 patients enrolled in 4 trials are missing .…”

“…Pooling data from trials employing the Gore ® Septal Occluder published so far, successful device implantation could be achieved in 588/589 patients (99.8%). Notably, in our challenging patient cohort, 100% successful device implantation was achieved, emphasizing advanced device properties for adaptation to anatomic PFO variability.…”

“…Trials employing the GSO device for PFO closure published so far, achieved 91.1% closure rate (452/496 patients; range 75% to 100%) at short‐term follow‐up examination (time to follow‐up range 0–18 months). In our study, including only patients with challenging anatomies, 95.1% PFO closure rate was achieved on 6‐months follow‐up evaluation.…”

“…Concerning relevant mid‐term safety events, we detected 1 device thrombus on the left atrial disc at 6‐weeks follow‐up, dissolving without further sequelae on oral anticoagulation. To date, thrombus formation on the GSO device has only been described by Thomson, et al and Knerr, et al Thus, in a total of only 3/537 patients (0.6%) with at least 1‐month follow‐up after GSO device implantation a thrombus occurred. However, contrary to our series, most of the other trials using the GSO device published so far did not routinely employ TEE examination on follow‐up visit.…”

“…Due to the flexible and soft consistency of the Gore ® Septal Occluder, allowing asymmetrical opening, device misalignment—typical for the Amplatzer device family in challenging anatomies—is intended to decrease. The studies published so far have consistently shown low periprocedural risk and good closure rates when implanting the Gore ® Septal Occluder . However, data regarding procedural and outcome results with the GSO, especially when applied in patients with difficult septal anatomies, are limited.…”