Wire-frame integrity of patch-like Gore devices following atrial septal defect closure.
Gore Septal Occluder (GSO)
atrial septal defect
catheterization
congenital heart disease
long-term follow-up
wire-frame fracture
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
01 03 2019
01 03 2019
Historique:
received:
13
10
2018
revised:
31
12
2018
accepted:
02
01
2019
pubmed:
27
1
2019
medline:
15
4
2020
entrez:
26
1
2019
Statut:
ppublish
Résumé
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. GSO has shown to be effective and safe for ASD device closure in children and adolescents. 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. 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. 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.
Sections du résumé
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.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
E238-E243Informations de copyright
© 2019 Wiley Periodicals, Inc.