First experiences with the GORE^® Septal Occluder in children and adults with atrial septal defects

Abstract

The GORE(®) Septal Occluder is an efficient device for closing ASDs up to 15 mm. It is feasible for defects with different anatomy including a deficient aortic rim, septal aneurysm and multiple fenestrations and due to its compliance and conformability it has a presumed low risk of erosion.

Transcatheter closure of atrial septal defects in children and adolescents: Single‐center experience with the GORE® septal occluder

“…Our study confirms the results of Nyboe et al, who reporting no residual shunt during follow‐up of the GSO either in their first 10 reported children or in 12 adults . We observed primary closure immediately after implantation in most cases, and no incidence of any residual leak during a median follow‐up time of 4 months, with the exception of the two aforementioned children with multiple defects.…”

“…Our mean fluoroscopy time was 9 min in the patients whose implantation was successful, much better than in former HSO studies , and comparable with the two published GSO studies in children . In any case, we experienced a learning curve like the others, meaning that we needed <5 min to conduct fluoroscopy in the last patients we treated, as long as they were straightforward.…”

“…The GORE® Septal Occluder (WL Gore & Associates, Flagstaff, AZ) is a new double‐disc device with a very flat profile and high compliance. It received CE Mark approval in June 2011, and has been implanted in many adults with patent foramen ovale (PFO), but rarely in children . We report about our initial experience with the GORE® Septal Occluder (GSO) for ASD closure in 45 children and adolescents with hemodynamically relevant ASDs due to left‐right shunt.…”

Closure of patent foramen ovale defects using GORE® CARDIOFORM septal occluder: Results from a prospective European multicenter study

“…Compared with implantation data from the RESPECT trial using the Amplatzer PFO Occluder (St. Jude Medical, Plymouth, MN) (procedure time 51.9 ± 28.6 min, fluoroscopy time 11.8 ± 8.9 min), implantation and radiation times in the present study are considerably shorter (procedure time 41 ± 25 min and fluoroscopy time: 5.6 ± 4.7 min) . The data of this multicenter trial are comparable to other studies applying the GSO device for PFO closure (range of mean procedure times 30 ± 20 min to 47 ± 12 min; range of mean fluoroscopy time 3.0 ± 1.7min to 6.9 ± 2.7 min) .…”

Historical developments of atrial septal defect closure devices: what we learn from the past

“…This device served to improve delivery and fixation by replacing Nitinol by platinum and adding a porous coating and delivery handle. The first experiences in children and adults supported compatibility with defects smaller than 18 mm, including different types of septal anatomy like a deficient aortic rim, septal aneurysm, and multiple defects [50,51]. Due to absence of a self-centering mechanism, the GSO is less suitable for ASD sizes beyond 18 mm, similar to the recommendations of the HSO [49,52].…”