A fully biodegradable polydioxanone occluder for ventricle septal defect closure  

作　　者：Zefu Li Pengxu Kong Xiang Liu Shuyi Feng Wenbin Ouyang Shouzheng Wang Xiaopeng Hu Yongquan Xie Fengwen Zhang Yuxin Zhang Rui Gao Weiwei Wang Xiangbin Pan 

机构地区：[1]Department of Structural Heart Disease,National Center for Cardiovascular Disease,China&State Key Laboratory of Cardiovascular Disease,Fuwai Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,National Health Commission Key Laboratory of Cardiovascular Regeneration Medicine,National Clinical Research Center for Cardiovascular Diseases,Beijing,China [2]Tianjin Key Laboratory of Biomaterial Research,Institute of Biomedical Engineering,Chinese Academy of Medical Science&Peking Union Medical College,Tianjin,China [3]Department of Polymer Science and Engineering,Key Laboratory of Systems Bioengineering(Ministry of Education),School of Chemical Engineering and Technology,Tianjin University,Tianjin,300072,China [4]Research and Development Department,Lepu Medical Technology(Beijing)Co,Ltd,Beijing,102200,China [5]Key Laboratory of Innovative Cardiovascular Devices,Chinese Academy of Medical Sciences,China

出　　处：《Bioactive Materials》2023年第6期252-262,共11页生物活性材料（英文）

基　　金：supported by National Natural Science Foundation of China[81970444];The Fundamental Research Funds for the Central Universities[2019PT350005];Beijing Municipal Science and Technology Project[Z201100005420030];National high level talents special support plan[2020-RSW02];CAMS Innovation Fund for Medical Sciences[2021-I2M-1-065,2021-I2M-1-058];Sanming Project of Medicine in Shenzhen[SZSM202011013];Natural Science Fund for Distinguished Young Scholars of Tianjin[21JCJQJC00020].

摘　　要：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.

关 键 词：Polymer Congenital heart disease Ventricle septal defect Biodegradable occluder Tissue regeneration 

分 类 号：R541.1[医药卫生—心血管疾病]