Long-Term Results of the Atrial Septal Defect Occluder ASSURED Trial for Combined Pivotal/Continued Access Cohorts

JACC Cardiovasc Interv. 2024 Oct 14;17(19):2274-2283. doi: 10.1016/j.jcin.2024.07.013. Epub 2024 Sep 18.

Abstract

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).

Keywords: atrial septal defect; closure device; congenital heart disease; structural heart; transcatheter intervention.

Publication types

  • Multicenter Study
  • Clinical Trial

MeSH terms

  • Adolescent
  • Adult
  • Arrhythmias, Cardiac / physiopathology
  • Arrhythmias, Cardiac / therapy
  • Cardiac Catheterization* / adverse effects
  • Cardiac Catheterization* / instrumentation
  • Child
  • Child, Preschool
  • Europe
  • Female
  • Heart Septal Defects, Atrial* / diagnostic imaging
  • Heart Septal Defects, Atrial* / therapy
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Prosthesis Design*
  • Risk Factors
  • Septal Occluder Device*
  • Time Factors
  • Treatment Outcome
  • United States
  • Young Adult

Supplementary concepts

  • Atrial Septal Defect, Secundum Type

Associated data

  • ClinicalTrials.gov/NCT02985684