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

编号：

2077F22E652CF650F8DD5692D9F02C47
作者：

Wang, Shouzheng(王首正)#^[1,2]Li, Zefu#^[1,2]Wang, Yunbing(王云兵)#^[3]Zhao, Tianli(赵天力)^[4]Mo, Xuming(莫绪明)^[5]Fan, Taibing(范太兵)^[6]Li, Jianhua(李建华)^[7]You, Tao(尤涛)^[8]Deng, Rundi^[1,2];Ouyang, Wenbin(欧阳文斌)Wang, Weiwei(王伟伟)^[9]Zhang, Chuangnian(张闯年)^[9]Butera, Gianfranco^[10]Hijazi, Ziyad M.^[11]Pang, Kunjing(逄坤静)^[12,13]Zhu, Da^[1];Jiang, Shiliang^[1,2];Zhang, Gejun(张戈军)^[1,2]Hu, Xiaopeng(胡晓鹏)^[1,2]Xie, Yongquan(谢涌泉)^[1,2]Zhang, Fengwen(张凤文)^[1,2]Fang, Fang^[1,2];Sun, Jingping^[14];Li, Ping^[2,15];Chen, Juan^[16];Luo, Zhiling(骆志玲)*^[17]Pan, Xiangbin(潘湘斌)*^[1,2]
语种：

英文
期刊：

SCIENCE BULLETIN ISSN：2095-9273 2023 年 68 卷 10 期 (1051 - 1059) ; MAY 30
收录：
关键词：

Ventricular septal defect Transcatheter closure Bioabsorbable Degradation Echocardiography
摘要：

Although the use of bioabsorbable occluder is expected to reduce the risk of metal occluder-related com-plications, 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 inves-tigate 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 bioab-sorbable 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 occluder-related 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 bioab-sorbable occluder can be successfully and safely implanted under echocardiography guidance and reduce (2023) the incidence of sustained postprocedural arrythmia. The efficacy and safety of this fully biodegradable occluder are non-inferior to that of a traditional nitinol one.& COPY; 2023 Science China Press. Published by Elsevier B.V. and Science China Press. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
推荐引用方式
GB/T 7714：

Wang Shouzheng,Li Zefu,Wang Yunbing, et al. Transcatheter closure of perimembranous ventricular septal defect using a novel fully bioabsorbable occluder: multicenter randomized controlled trial [J].SCIENCE BULLETIN,2023,68(10):1051-1059.
APA：

Wang Shouzheng,Li Zefu,Wang Yunbing,Zhao Tianli,&Pan Xiangbin.(2023).Transcatheter closure of perimembranous ventricular septal defect using a novel fully bioabsorbable occluder: multicenter randomized controlled trial .SCIENCE BULLETIN,68(10):1051-1059.
MLA：

Wang Shouzheng, et al. "Transcatheter closure of perimembranous ventricular septal defect using a novel fully bioabsorbable occluder: multicenter randomized controlled trial" .SCIENCE BULLETIN 68,10(2023):1051-1059.
入库时间：

2023/7/22 21:48:36
更新时间：

2023/7/22 21:48:36
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