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

Grohmann, Jochen; Hohn, R B; Fleck, Thilo; Schmoor, Claudia; Stiller, Brigitte

doi:10.1002/ccd.25494

Cited by 19 publications

(18 citation statements)

References 19 publications

(32 reference statements)

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“…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) .…”

Section: Discussionsupporting

confidence: 78%

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

Hardt

Eicken

Berger

et al. 2017

Cathet Cardio Intervent

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Section: Discussionsupporting

confidence: 78%

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

Hardt

Eicken

Berger

et al. 2017

Cathet Cardio Intervent

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“…All patients received peri‐interventional heparin and antimicrobial prophylaxis. Detailed descriptions of ASD sizing, consecutive device selection and implantation were made according to previous publications . Platelet inhibition with acetylsalicylic acid was prescribed for 6 months after implantation.…”

Section: Methodsmentioning

confidence: 99%

“…Based on these experiences, the second‐generation Gore occluder, the Gore Septal Occluder (GSO), features a sturdier frame design made of five wires (rather than just one wire, as in the HSO) and increasing strength as the device's diameter increases. Periprocedural and midterm follow‐up data have shown the GSO to be effective and safe . However, there are limited data on the patch‐like GSO's structural integrity .…”

Section: Introductionmentioning

confidence: 99%

Wire‐frame integrity of patch‐like Gore devices following atrial septal defect closure

Kubicki

Fingerhut

Uhl

et al. 2019

Cathet Cardio Intervent

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Objectives To assess the structural integrity of the patch‐like Gore Septal Occluder (GSO) used for device closure of secundum‐type atrial septal defects (ASD II) in pediatric patients. Background GSO has shown to be effective and safe for ASD device closure in children and adolescents. Methods Single‐center, retrospective mid‐ to long‐term follow‐up of all children and adolescents with a GSO in situ (≥12 months). Periprocedural data and follow‐up data were evaluated, including chest X‐rays to assess the GSO's wire‐frame morphology. Results Ninety‐one consecutive patients were enrolled with a median age and weight of 5 years (range 2–18) and 20 kg (range 11–95) at implantation. ASD anatomy included 64 single and 27 multi‐fenestrated defects, with 39 patients having small retro‐aortic rims (≤4 mm). Median follow‐up period was 42.5 months (range 12–74). Chest X‐rays were available in 80 children: in 74 of them, the GSO's visualization on X‐ray enabled us to reliably assess the wire‐frame structure. Wire‐frame fracture (WFF) was ultimately detected in five of the 74 patients (6.8%); however, those occluders appeared stably anchored and well aligned to both sides of the septum, and no free wire fragments had escaped the GSO matrix. Thus, no further treatment was required. Conclusions Our data confirm that the GSO is safe and effective for ASD closure. Despite its lightweight construction, the GSO seems to offer reliable mechanical durability. Wire‐frame fractures occur, but the free wire‐ends appear to have remained stable within the GSO matrix without any clinical sequelae so far.

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“…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]. …”

Section: Gore Helex/cardioform Septal Occludermentioning

confidence: 97%

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

Nassif

Abdelghani

Bouma

et al. 2016

Expert Review of Medical Devices

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Introduction: Since King and Mills' pioneering work in percutaneous closure devices of secundum atrial septal defects (ASD) four decades ago, developments in device shape, material and implantation technique led to adoption of percutaneous ASD closure as current treatment of choice. Not only was the feasibility of such a percutaneous procedure tested altogether, but pursuing the ideal device in terms of safety and efficacy became priority. Areas covered: In this review we present the historical development of ASD devices in design, material and technique with clinical data, and provide the future perspectives in percutaneous ASD closures. Expert opinion: An 'ideal device' requires complete defect closure with negligible risk of complications using a safe, straightforward delivery technique with repositioning and retrieving properties. Some of the devices currently at hand come close to fulfilling these criteria, however none seem to provide those prerequisites completely. By understanding how challenges in device development were overcome in the past, new insights into future improvements are given. ARTICLE HISTORY

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

Abstract: We found the GSO device closure of ASDs in children to be effective. However, our initial experience is limited to short- and mid-term-follow-up of a low number of patients.

Cited by 19 publications

References 19 publications

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

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

Wire‐frame integrity of patch‐like Gore devices following atrial septal defect closure

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

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