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

ABSTRACT

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.