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

被引：9

作者：

Wang, Shouzheng ^{[1
,2
]}

Li, Zefu ^{[1
,2
]}

Wang, Yunbing ^{[3
]}

Zhao, Tianli ^{[4
]}

Mo, Xuming ^{[5
]}

Fan, Taibing ^{[6
]}

Li, Jianhua ^{[7
]}

You, Tao ^{[8
]}

Deng, Rundi ^{[1
,2
]}

Ouyang, Wenbin

Wang, Weiwei ^{[9
]}

Zhang, Chuangnian ^{[9
]}

Butera, Gianfranco ^{[10
]}

Hijazi, Ziyad M. ^{[11
]}

Pang, Kunjing ^{[12
,13
]}

Zhu, Da ^{[1
]}

Jiang, Shiliang ^{[1
,2
]}

Zhang, Gejun ^{[1
,2
]}

Hu, Xiaopeng ^{[1
,2
]}

Xie, Yongquan ^{[1
,2
]}

Zhang, Fengwen ^{[1
,2
]}

Fang, Fang ^{[1
,2
]}

Sun, Jingping ^{[14
]}

Li, Ping ^{[2
,15
]}

Chen, Juan ^{[16
]}

Luo, Zhiling ^{[17
]}

Pan, Xiangbin ^{[1
,2
]}

机构：

[1] Chinese Acad Med Sci & Peking Union Med Coll, Fuwai Hosp, Dept Struct Heart Dis, Beijing 100037, Peoples R China

[2] Chinese Acad Med Sci & Peking Union Med Coll, Natl Ctr Cardiovasc Dis, Natl Clin Res Ctr Cardiovasc Dis,Natl Hlth Commis, Key Lab Innovat Cardiovasc Devices,Key Lab Cardiov, Beijing 100037, Peoples R China

[3] Sichuan Univ, Natl Engn Res Ctr Biomat, Chengdu 610064, Peoples R China

[4] Cent South Univ, Xiangya Hosp 2, Dept Cardiovasc Surg, Changsha 410011, Peoples R China

[5] Nanjing Med Univ, Dept Cardiovasc Surg, Childrens Hosp, Nanjing 210008, Peoples R China

[6] Fuwai Cent China Cardiovasc Hosp, Dept Cardiovasc Surg, Zhengzhou 451464, Peoples R China

[7] Zhejiang Univ, Childrens Hosp, Dept Cardiovasc Surg, Sch Med, Hangzhou 310052, Peoples R China

[8] Gansu Prov Hosp, Dept Cardiovasc Surg, Lanzhou 730000, Peoples R China

[9] Chinese Acad Med Sci & Peking Union Med Coll, Inst Biomed Engn, Tianjin Key Lab Biomat Res, Tianjin 300192, Peoples R China

[10] Guys & St ThomasNHS Fdn Trust, Evelina London Childrens Hosp, Dept Pediat & Adult Congenital Heart Dis, London SE1 9RT, England

[11] Sidra Med & Res Ctr, Sidra Heart Ctr, Dept Pediat, Doha 999043, Qatar

[12] Chinese Acad Med Sci & Peking Union Med Coll, Fuwai Hosp, Dept Echocardiog, Beijing 100037, Peoples R China

[13] Chinese Acad Med Sci & Peking Union Med Coll, Natl Ctr Cardiovasc Dis, Natl Clin Res Ctr Cardiovasc Dis, Natl Hlth Commiss Key Lab Cardiovasc Regenerat Med, Beijing 100037, Peoples R China

[14] Clin Cleveland Fdn, Cardiol Dept, Cleveland, OH 44195 USA

[15] Chinese Acad Med Sci & Peking Union Med Coll, Fuwai Hosp, Cardiol Dept, Beijing 100037, Peoples R China

[16] Hefei High Tech Cardiovasc Hosp, Dept Cardiovasc Surg, Hefei 230088, Peoples R China

[17] Fuwai Yunnan Cardiovasc Hosp, Dept Echocardiog, Kunming 650102, Peoples R China

来源：

SCIENCE BULLETIN | 2023年 / 68卷 / 10期

基金：

中国国家自然科学基金;

关键词：

Ventricular septal defect; Transcatheter closure; Bioabsorbable; Degradation; Echocardiography; DEVICE CLOSURE; EXPERIENCE; PERFORATION;

D O I：

10.1016/j.scib.2023.04.027

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

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/).

引用

页码：1051 / 1059

页数：9

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