Experience using the new GORE^® septal occluder at the margins

Abstract

Complex atrial anatomy continues to challenge transcatheter device closure of septal defects. Devices and technology continue to evolve. We report three cases from our institution where the new Gore Septal Occluder was utilized for the closure of a lateral tunnel fenestration, a moderate-sized secundum atrial septal defect and a long tunnel patent foramen ovale. Each case highlights the successful use of this new generation device in challenging circumstances.

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

“…In the face of 3 patients (7.3%) experiencing either device thrombus formation or new onset paroxysmal atrial fibrillation in our study, the combination of oral anticoagulation (coumadine, target INR 2.0–3.0) in addition to anti‐platelet therapy with aspirin 100 mg daily for 3 months after device implantation could be a reasonable concept for future routine prophylaxis after interventional PFO closure. Notably, this approach should be discussed irrespective of the applied closure device as comparable occurrence rates of new onset atrial arrhythmia and thrombus formation were observed both with the Gore® Septal Occluder as well as with other closure devices used in RCTs (GSO 4.1% vs. other devices in RCTs 4.7%) …”

“…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.…”

“…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.…”