A scaffold-degradable single-rivet ASD occluder with amplatzer-like design: a multicenter randomized controlled trial

Area of Science:

• Cardiology
• Biomaterials Science
• Medical Devices

Background:

• Metallic atrial septal defect (ASD) occluders pose mid- to long-term complication risks.
• A novel biodegradable Pansy occluder using a polydioxanone (PDO) framework was developed to mitigate these risks.

Purpose of the Study:

• To evaluate the effectiveness and safety of the biodegradable Pansy ASD occluder compared to traditional metallic occluders.
• To assess the closure success rate at six months and twelve months post-implantation.

Main Methods:

• A prospective, multicenter, randomized controlled trial involving 112 adult and pediatric patients.
• Patients were randomized into two groups: Pansy occluder (experimental) and metallic occluder (control).
• Primary efficacy endpoint was the closure success rate at six months post-operation.

Main Results:

• 100% closure success rate at six months and twelve months in both the Pansy occluder and control groups.
• No residual shunt greater than 5 mm was detected in any patient during follow-up.
• One patient in the experimental group required explantation due to abnormal tissue hyperplasia; pathological analysis showed PDO framework degradation and endothelial coverage.

Conclusions:

• The biodegradable Pansy ASD occluder demonstrates excellent safety and efficacy at twelve months post-implantation.
• The PDO framework shows promising degradation characteristics with smooth endothelialization.
• Longer-term follow-up is necessary to fully establish the durability of the Pansy occluder.