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Oversized composite braided biodegradable stents with post-dilatation for pediatric applications: mid-term results of a porcine study.
Biomaterials Science ( IF 6.6 ) Pub Date : 2020-08-05 , DOI: 10.1039/d0bm00567c
Jing Sun 1 , Kun Sun , Kai Bai , Sun Chen , Fan Zhao , Fujun Wang , Nanchao Hong , Hanbo Hu
Affiliation  

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.

中文翻译:

用于儿童的超大型复合材料编织式可降解支架,带有扩张后功能:一项猪研究的中期结果。

我们的目标是应用由聚二氧杂环己酮(PPDO)和聚己内酯(PCL)制成的复合编织生物可降解支架(CBBS )作为金属支架的替代产品,用于治疗小儿血管内疾病。使用径向力测试评估辅助后扩张后的CBBS特性。使用体外测量评估CBBS降解。自膨胀CBBS(8×20 mm)被植入到主动脉中,其过大比例为1.1–1.4(A组,n = 12),而在common总动脉中,其过大比例> 1.4(B组,n = 12)。 。将自膨式金属WALLSTENTs(8×21 mm)植入到总动脉中,其过大比例> 1.4,并作为对照(C组,n= 12)。在支架植入后的第1、4、6和12个月进行包括血管造影和组织学检查在内的动脉评估。8毫米CBBS在8Fr鞘管中进行辅助扩张后递送,其性质类似于金属基准支架,并在12个月内降解,伴有轻度至中度的炎症引起的新内膜增生和血管再狭窄。当使用CBBSs进行聚合物支气管组织包埋和最佳壁并置时,建议进行后扩张和过大尺寸,但应避免过度扩张,因为这会引起不太理想的新内膜增生。在猪血管内疾病模型中,伴随扩张后的CBBS的中期结局优于WALLSTENT。
更新日期:2020-09-15
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