Bioresorbable vs Metallic Occluders for Transcatheter Atrial Septal Defect Closure: A Randomized Clinical Trial.

Summary

In a multicenter noninferiority RCT of 229 patients with secundum ASD, a bioresorbable occluder achieved similar closure success and device-related safety to a metallic occluder at 6 months and 2 years, with ~99.8% device degradation by 2 years. The trial supports bioresorbable occluders as a viable alternative that may preserve future transseptal access.

Key Findings

• ASD closure success at 6 months: 96.5% (bioresorbable) vs 97.4% (metallic), meeting noninferiority (P < .001).
• Two-year closure success and device-related adverse events were similar between groups (P = .75 and P = .72, respectively).
• Bioresorbable occluder degraded by ~99.8% at 2 years, indicating near-complete resorption.

Clinical Implications

Bioresorbable occluders can be considered for secundum ASD closure with noninferior efficacy and safety to metallic devices, potentially facilitating future left atrial access and reducing long-term device-related risks.

Limitations

• Open-label design and enrollment limited to 10 sites in China may affect generalizability
• Two-year follow-up may not capture very late outcomes beyond device resorption

Future Directions

Longer-term surveillance for late arrhythmia, erosion, or thromboembolism after full resorption; evaluation in broader anatomies and age ranges; and health-economic analyses.