Key result
The GORE CARDIOFORM ASD Occluder achieved a 6-month composite clinical success rate of 87.6% and 100% closure success among patients with 6-month imaging.
Why the study?
The study sought to report the long-term results through 36 months for the combined pivotal and continued access cohorts of the ASSURED trial evaluating the GORE CARDIOFORM ASD Occluder.
Does transcatheter closure using the GORE CARDIOFORM ASD Occluder achieve closure and composite clinical success in patients with ostium secundum atrial septal defects?
Does transcatheter closure using the GORE CARDIOFORM ASD Occluder achieve closure and composite clinical success in patients with ostium secundum atrial septal defects?
The GORE CARDIOFORM ASD Occluder demonstrated high rates of successful ASD closure and composite clinical success up to 36 months, despite a high incidence of benign wire frame fractures.
BACKGROUND: The GORE CARDIOFORM ASD Occluder (GCA, W. L. Gore & Associates) was approved in 2019 for ostium secundum atrial septal defect (ASD) closure. OBJECTIVES: This study sought to report the combined pivotal and continued access cohorts of the ASSURED (Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs) trial results through 36 months. METHODS: This prospective, multicenter, single-arm trial evaluated procedural and clinical outcomes of ASD closure with the GCA. The primary endpoints were 6-month closure success following device implantation and composite clinical success (deployment/retention of device, safety, and closure). Technical and procedure success, safety, clinically significant new arrhythmia (CSNA) secondary endpoints, and wire frame fracture (WFF, with fluoroscopy) at 6 and 36 months were evaluated. RESULTS: Of 569 patients (median age of 10.4 years and median weight of 35.0 kg) who underwent attempted secundum ASD closure, 526 were technical successes. The mean stop-flow ASD diameter was 17.6 ± 5.3 mm. All 478 patients with 6-month imaging achieved closure success. Composite clinical success at 6 and 36 months was achieved in 87.6% (468/534) and 84.0% (351/418) of patients, respectively. Technical failure occurred in 8.1% (43/548), 30-day device- or procedure-related serious adverse event in 3.9% (21/534), and 6-month device events in 2.8% (15/534) of patients. At 30 days, 21 of 569 patients (3.7%) had CSNA. At 6 months, 138 of 436 (31.7%) patients had WFFs and 105 of 185 (56.8%) at 36 months (without sequelae). CONCLUSIONS: In this large congenital ASD device trial, the GCA had acceptable results. WFFs, although common, did not result in any clinical sequelae. The unique features, size range, and safety profile expand the options for secundum ASD closure. (Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs [ASSURED]; NCT02985684).
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Qureshi et al. (2024) studied ostium secundum atrial septal defect (ASD) (n=569). GORE CARDIOFORM ASD Occluder was evaluated on 6-month closure success and composite clinical success. The GORE CARDIOFORM ASD Occluder achieved a 6-month composite clinical success rate of 87.6% and 100% closure success among patients with 6-month imaging.
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