Long-Term Results of the Atrial Septal Defect Occluder ASSURED Trial for Combined Pivotal/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
Methodological detailsprospective, multicenter, combined pivotal and continued access cohorts
- Prospective
- Multicenter
- Combined pivotal and continued access cohorts
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.
Summarised from the published abstract; every number is checked against it