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Published on: February 18, 2020
Oversized composite braided biodegradable stents with post-dilatation for pediatric applications: mid-term results of
1Department of Pediatric Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. sunkun@xinhuamed.com.cn.
Insights
Composite braided biodegradable stents (CBBS) show promise as a metallic stent alternative for pediatric endovascular disease. These PPDO and PCL stents degraded within 12 months, demonstrating comparable properties to metallic stents with improved mid-term outcomes.
Area of Science:
- Biomaterials Science
- Vascular Surgery
- Pediatric Cardiology
Background:
- Metallic stents are standard for pediatric endovascular disease.
- Biodegradable alternatives are needed to avoid long-term complications.
Purpose of the Study:
- To evaluate a composite braided biodegradable stent (CBBS) made from poly p-dioxanone (PPDO) and polycaprolactone (PCL) as an alternative to metallic stents.
- To assess CBBS properties, degradation, and efficacy in a swine model.
Main Methods:
- CBBS and metallic WALLSTENTs were implanted in swine abdominal aortas and iliac arteries.
- Radial force testing and in vitro degradation studies were performed.
- Angiography and histological examinations were conducted at 1, 4, 6, and 12 months.
Main Results:
- CBBS demonstrated properties similar to metallic stents after post-dilatation.
- CBBS degraded within 12 months, showing mild to moderate neointimal hyperplasia and restenosis.
- Mid-term outcomes of CBBS with post-dilatation were superior to WALLSTENTs.
Conclusions:
- CBBS are a viable alternative to metallic stents in pediatric endovascular disease.
- Post-dilatation and appropriate oversizing are crucial for optimal CBBS performance.
- Further research is needed to optimize stent design and minimize adverse tissue reactions.
Abstract:
Our aim was to apply a composite braided biodegradable stent (CBBS) made from poly p-dioxanone (PPDO) and polycaprolactone (PCL) as an alternative to metallic stents for the treatment of pediatric endovascular disease. CBBS properties after adjunctive post-dilatation were assessed using radial force testing. CBBS degradation was assessed using in vitro measurements. Self-expandable CBBSs (8 × 20 mm) were implanted in abdominal aortas with an oversizing ratio of 1.1-1.4 (group A, n = 12) and in common iliac arteries with an oversizing ratio >1.4 (group B, n = 12). Self-expandable metal WALLSTENTs (8 × 21 mm) were implanted in common iliac arteries with an oversizing ratio >1.4 and served as controls (group C, n = 12). Artery evaluations including angiography and histological examinations were performed at 1, 4, 6 and 12 months after stent implantation. Eight millimeter CBBSs delivered in 8Fr sheaths with adjunctive post-dilatation had properties similar to those of metallic benchmark stents and were degraded in 12 months, with mild to moderate inflammation-induced neointimal hyperplasia and vessel restenosis. Post-dilatation and oversizing are suggested when using CBBSs for polymeric strut tissue embedding and optimal wall apposition, but an overextended ratio should be avoided because of the induction of less-desirable neointimal hyperplasia. Mid-term outcomes of CBBSs with adjunctive post-dilatation were better than those of WALLSTENTs in a swine endovascular disease model.
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