新型完全生物可吸收封堵器经导管封堵膜周部室间隔缺损:一项多中心前瞻性随机对照研究  

Transcatheter closure of perimembranous ventricular septal defect using a novel fully bioabsorbable occluder:multicenter randomized controlled trial

作　　者：王首正 李泽夫 王云兵 赵天力 莫绪明 范太兵 李建华 尤涛 邓润迪 欧阳文斌 王伟伟 张闯年 Gianfranco Butera Ziyad MHijazi 逄坤静 朱达 蒋世良 张戈军 胡晓鹏 谢涌泉 张凤文 房芳 孙静平 李萍 陈娟 骆志玲 潘湘斌 Shouzheng Wang;Zefu Li;Yunbing Wang;Tianli Zhao;Xuming Mo;Taibing Fan;Jianhua Li;Tao You;Rundi Deng;Wenbin Ouyang;Weiwei Wang;Chuangnian Zhang;Gianfranco Butera;Ziyad MHijazi;Kunjing Pang;Da Zhu;Shiliang Jiang;Gejun Zhang;Xiaopeng Hu;Yongquan Xie;Fengwen Zhang;Fang Fang;Jingping Sun;Ping Li;Juan Chen;Zhiling Luo;Xiangbin Pan(Department of Structural Heart Disease,Fuwai Hospital&National Center for Cardiovascular Disease,Key Laboratory of Innovative Cardiovascular Devices,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 100037,China;National Engineering Research Center for Biomaterials,Sichuan University,Chengdu 610064,China;Department of Cardiovascular Surgery,The Second Xiangya Hospital,Central South University,Changsha 410011,China;Department of Cardiovascular Surgery,Children’s Hospital of Nanjing Medical University,Nanjing 210008,China;Department of Cardiovascular Surgery,Fuwai Central China Cardiovascular Hospital,Zhengzhou 451464,China;Department of Cardiovascular Surgery,The Children’s Hospital,Zhejiang University School of Medicine,Hangzhou 310052,China;Department of Cardiovascular Surgery,Gansu Province Hospital,Lanzhou 730000,China;Tianjin Key Laboratory of Biomaterial Research,Institute of Biomedical Engineering,Chinese Academy of Medical Science&Peking Union Medical College,Tianjin 300192,China;Department of Pediatric and Adult Congenital Heart Disease,Evelina London Children’s Hospital,Guy’s and St Thomas’NHS Foundation Trust,London SE19RT,UK;Department of Pediatrics,Sidra Heart Center,Sidra Medical&Research Center,Doha 999043,Qatar;Department of Echocardiography,Fuwai Hospital&National Center for Cardiovascular Disease,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,

机构地区：[1]Department of Structural Heart Disease,Fuwai Hospital&National Center for Cardiovascular Disease,Key Laboratory of Innovative Cardiovascular Devices,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 100037,China [2]National Engineering Research Center for Biomaterials,Sichuan University,Chengdu 610064,China [3]Department of Cardiovascular Surgery,The Second Xiangya Hospital,Central South University,Changsha 410011,China [4]Department of Cardiovascular Surgery,Children’s Hospital of Nanjing Medical University,Nanjing 210008,China [5]Department of Cardiovascular Surgery,Fuwai Central China Cardiovascular Hospital,Zhengzhou 451464,China [6]Department of Cardiovascular Surgery,The Children’s Hospital,Zhejiang University School of Medicine,Hangzhou 310052,China [7]Department of Cardiovascular Surgery,Gansu Province Hospital,Lanzhou 730000,China [8]Tianjin Key Laboratory of Biomaterial Research,Institute of Biomedical Engineering,Chinese Academy of Medical Science&Peking Union Medical College,Tianjin 300192,China [9]Department of Pediatric and Adult Congenital Heart Disease,Evelina London Children’s Hospital,Guy’s and St Thomas’NHS Foundation Trust,London SE19RT,UK [10]Department of Pediatrics,Sidra Heart Center,Sidra Medical&Research Center,Doha 999043,Qatar [11]Department of Echocardiography,Fuwai Hospital&National Center for Cardiovascular Disease,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 100037,China [12]Department of Structural Heart Disease,Fuwai Yunnan Cardiovascular Hospital,Kunming 650102,China [13]Cardiology Department,The Clinic Cleveland Foundation,Cleveland 44195,USA [14]Cardiology Department,Fuwai Hospital&National Center for Cardiovascular Disease,Chinese

出　　处：《Science Bulletin》2023年第10期1051-1059,M0004,共10页科学通报（英文版）

基　　金：supported by the National Key Research and Development Program(2022YFC2503400);the Fundamental Research Funds for the Central Universities(2019PT350005);the National Natural Science Foundation of China(81970444);the Beijing Municipal Science and Technology Project(Z201100005420030);the National High Level Talents Special Support Plan(2020-RSW02);the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences(2021-I2M-1-065);the Sanming Project of Medicine in Shenzhen(SZSM202011013)。

摘　　要：生物可吸收封堵器的应用有望降低传统金属封堵器并发症的风险.之前研制的生物可吸收封堵器存在不完全降解的局限性并导致新的并发症,因此目前尚未有相关产品获批上市.本研究使用了一种新型完全可吸收封堵器,旨在探索完全可吸收封堵器治疗室间隔缺损的疗效和安全性.从2019年4月到2020年1月,本研究在七个医学中心入组125名膜周部室间隔缺损患者,经筛查后108名患者被纳入研究并随机分为植入生物可吸收封堵器实验组和金属封堵器组.所有受试者均成功植入封堵器并完成24个月的随访.生物可吸收封堵器组患者经胸超声心动图显示高亮回声在24个月内逐渐消失,说明可吸收封堵器在体内实现完全降解.对比金属封堵器,实验组器械相关心律失常发生率(5.56%vs.14.81%,P=0.112)和持续传导阻滞发生率(0/54 vs.6/54,P=0.036)显著降低.本研究提示新型完全可吸收封堵器可以在单纯超声引导下实现成功植入,同时降低术后永久性心律失常的发生率.Although the use of bioabsorbable occluder is expected to reduce the risk of metal occluder-related complications,it has not been approved due to incomplete degradation and new complications.Novel fully bioabsorbable occluders were designed to overcome such limitations.The aim of this study was to investigate the efficacy and safety of a fully biodegradable occluder in patients with ventricular septal defects.125 patients with perimembranous ventricular septal defect(VSD)larger than 3 mm were screened from April 2019 to January 2020 in seven centers.108 patients were enrolled and randomized into the bioabsorbable occluder group(n=54 patients)and nitinol occluder group(n=54).A non-inferiority design was utilized and all patients underwent transcatheter device occlusion.Outcomes were analyzed with a 24-month follow-up.All patients were successfully implanted and completed the trial.No residual shunt>2 mm was observed during follow-up.Transthoracic echocardiography showed a hyperechoic area corresponding to the bioabsorbable occluder which decreased primarily during the first year after implantation and disappeared within 24 months.Postprocedural arrhythmia was the only occluderrelated complication with an incidence of 5.56%and 14.81%for the bioabsorbable and nitinol groups,respectively(P=0.112).The incidence of sustained conduction block was lower in the bioabsorbable occluder group(0/54 vs.6/54,P=0.036)at 24-month follow-up.In conclusion,the novel fully bioabsorbable occluder can be successfully and safely implanted under echocardiography guidance and reduce he incidence of sustained postprocedural arrythmia.The efficacy and safety of this fully biodegradable occluder are non-inferior to that of a traditional nitinol one.

关 键 词：Ventricular septal defect Transcatheter closure BIOABSORBABLE Degradation ECHOCARDIOGRAPHY 

分 类 号：R318[医药卫生—生物医学工程]