Congenital heart diseaseCohort study
Long-Term Results of the Atrial Septal Defect Occluder ASSURED Trial for Combined Pivotal/Continued Access Cohorts
- Single-arm trial
- prospective
- multicenter
- combined pivotal and continued access cohorts
Authors' conclusion
In this large congenital ASD device trial, the GCA had acceptable results. WFFs, although common, did not result in any clinical sequelae.
Study context
- Population
- Patients undergoing attempted ostium secundum atrial septal defect (ASD) closure (median age 10.4 years, median weight 35.0 kg)526 technical successes
- Participants
- 569 patients
- Outcome
- Closure success and composite clinical success (deployment/retention of device, safety, and closure)
- Follow-up
- 6 months
Main finding
As reported in the abstract
6-month closure success; composite clinical success:
- Device deployment/retention
- Safety
- Closure
Closure success in all patients with 6-month imaging
478
Composite clinical success at 6 months
87.6% (468/534)
Observational data: associations, not effects.
Secondary outcomes
Composite clinical success · 36 months
- Composite clinical success at 36 months
- 84.0% (351/418)
Technical success / failure
- Technical successes of 569 attempted closures
- 526
- Technical failure
- 8.1% (43/548)
Safety
Device- or procedure-related serious adverse event · 30 days
- Device- or procedure-related SAE
- 3.9% (21/534)
Device events · 6 months
- Device events
- 2.8% (15/534)
Clinically significant new arrhythmia (CSNA) · 30 days
- CSNA
- 21 of 569 (3.7%)
Wire frame fracture (WFF) · 6 and 36 months
- WFF at 6 months
- 138 of 436 (31.7%)
- WFF at 36 months
- 105 of 185 (56.8%)
- without sequelae
Original publication
Long-Term Results of the Atrial Septal Defect Occluder ASSURED Trial for Combined Pivotal/Continued Access Cohorts. JACC Cardiovasc Interv. Published 18 September 2024. doi:10.1016/j.jcin.2024.07.013
Summarised from the published abstract; every number is checked against it