The Safety and Efficacy of Absnow Fully Biodegradable Atrial Septal Defect Occluder: A Prospective, Single-Center Phase III Clinical Trial.

OBJECTIVE

To evaluate the safety, short-term and mid-term occlusion performance of the Absnow fully biodegradable atrial septal occluder in pediatric patients.

BACKGROUND

The Absnow Occluder, an innovative fully biodegradable closure for ASD, has shown its safety and effectiveness in initial animal studies and preclinical trials.

METHODS

As one of the participating multicenter research institutions, our organization conducted interventional closure procedures on 10 pediatric patients with atrial septal defects employing the Absnow fully biodegradable occluder between November 2018 and May 2019. Subsequently, we conducted a clinical follow-up spanning 4 years.

RESULTS

The immediate success rate of the operation was 100% (10/10). The effective closure rates at immediate, 1 day, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, and 4 years post-operation were, respectively, 100%, 90%, 100%, 100%, 100%, 100%, 80%, 80%, and 70%. The cumulative incidence of complications at 1 year, 2 years, 3 years, and 4 years post-operation were 0%, 20%, 20%, and 30%, respectively. No severe complications, such as device dislodgment, high-degree atrioventricular block, or vascular complications, occurred during the 4-year follow-up. Nevertheless, two patients experienced substantial residual shunting due to occluder degradation or umbrella displacement, and underwent further intervention.

CONCLUSION

This study further confirmed the short-to-mid-term safety and acceptable efficacy of the Absnow fully biodegradable atrial septal occluder based on a 4-year follow-up. The late-occurring residual shunts with device degradation have an important impact on its long-term efficacy.