A fully biodegradable polydioxanone occluder for ventricle septal defect closure.
A fully biodegradable polydioxanone occluder for ventricle septal defect closure.
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一种完全可生物降解的聚二恶酮闭塞剂用于室间隔缺损封闭。
DOI：
10.1016/j.bioactmat.2022.12.018
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发表时间：
2023-06
影响因子：
18.9
通讯作者：
Pan, Xiangbin
中科院分区：
文献类型：
--
作者：
Li, Zefu;Kong, Pengxu;Liu, Xiang;Feng, Shuyi;Ouyang, Wenbin;Wang, Shouzheng;Hu, Xiaopeng;Xie, Yongquan;Zhang, Fengwen;Zhang, Yuxin;Gao, Rui;Wang, Weiwei;Pan, Xiangbin
关键词：
室间隔缺损（VSD）是最常见的先天性心脏病（CHDs）之一。目前治疗室间隔缺损的封堵器主要由镍钛诺制成，存在镍过敏、持续心肌磨损和致死性心律失常的风险。本文研制了一种完全可生物降解的聚二氧杂环酮（PDO）封闭剂，该封闭剂配备了形状线和聚l-乳酸PLLA膜，用于VSD封闭，无需添加金属标记物。PDO闭塞剂具有良好的机械强度、抗疲劳性、几何适应性、生物相容性和可降解性。在大鼠皮下植入模型中，与镍钛诺相比，PDO纤维可显著减轻炎症反应，减轻纤维化，促进内皮化。通过对犬VSD模型的3年随访，证实了PDO闭塞剂的安全性和有效性，表明可生物降解的PDO闭塞剂不仅可以有效修复VSD，诱导心脏重构，而且可以解决金属闭塞剂相关的并发症。此外，5例VSD患者的临床试验表明，在超声心动图指导下，所有封堵器植入成功，随访3个月无不良事件发生。总的来说，完全生物可吸收的PDO封堵器对于临床室间隔关闭是安全有效的，并且在治疗结构性冠心病方面具有很大的前景。由于金属封堵器在心脏中的永久残留，可能导致并发症。PDO闭塞剂减轻炎症反应，促进内皮化。犬模型3年随访证实PDO闭塞器的安全性和有效性。5例VSD患者成功植入PDO闭塞器。
Ventricular septal defect (VSD) is one of the commonest congenital heart diseases (CHDs). Current occluders for VSD treatment are mainly made of nitinol, which has the risk of nickel allergy, persistent myocardial abrasion and fatal arrythmia. Herein, a fully biodegradable polydioxanone (PDO) occluder equipped with a shape line and poly-l-lactic acid PLLA membranes is developed for VSD closure without the addition of metal marker. PDO occluder showed great mechanical strength, fatigue resistance, geometry fitness, biocompatibility and degradability. In a rat subcutaneous implantation model, PDO filaments significantly alleviated inflammation response, mitigated fibrosis and promoted endothelialization compared with nitinol. The safety and efficacy of PDO occluder were confirmed in a canine VSD model with 3-year follow-up, demonstrating the biodegradable PDO occluder could not only effectively repair VSD, induce cardiac remodeling but also address the complications associated with metal occluders. Furthermore, a pilot clinical trial with five VSD patients indicated that all the occluders were successfully implanted under the guidance of echocardiography and no adverse events occurred during the 3-month follow-up. Collectively, the fully bioresorbable PDO occluder is safe and effective for clinical VSD closure and holds great promise for the treatment of structural CHDs. Metal occluders may lead to complications due to permanent residues in the heart. PDO occluders mitigate inflammation response and promote endothelialization. 3-year follow-up of canine model testifies safety and efficacy of PDO occluders. PDO occluders were successfully implanted in 5 VSD patients.
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影响因子：
3.4
作者：
Ou-Yang, Wen-Bin;Wang, Shou-Zheng;Pan, Xiang-Bin
通讯作者：
Pan, Xiang-Bin
DOI：
10.1080/00222349808220453
发表时间：
1998-01-01
期刊：
JOURNAL OF MACROMOLECULAR SCIENCE-PHYSICS
影响因子：
--
作者：
Ishikiriyama, K;Pyda, M;Wunderlich, B
通讯作者：
Wunderlich, B
影响因子：
5.5
作者：
Shah, Anand D.;Hirsh, David S.;Langberg, Jonathan J.
通讯作者：
Langberg, Jonathan J.
影响因子：
8.4
作者：
Pan, Maoen;Xu, Zeya;Huang, Heguang
通讯作者：
Huang, Heguang
影响因子：
24
作者：
Toumanides, Savvas;Sideris, Eleftherios B.;Moulopoulos, Spyridon
通讯作者：
Moulopoulos, Spyridon