Silara经导管主动脉瓣膜系统治疗中国重度主动脉瓣狭窄患者安全性和可行性的首次人体研究  

The First-in-human Study of Silara Transcatheter Aortic Valve System in Chinese Patients With Severe Aortic Stenosis

作　　者：张洪亮[1] 郭应强[2] 罗建方 宋光远 王宇彬 刘路路[2] 李捷 陈阳[1] 牛冠男[1] 王墨扬[1] 吕守良 陶春丽 高润霖[1] 吴永健[1] ZHANG Hongliang;GUO Yingqiang;LUO Jianfang;SONG Guangyuan;WANG Yubin;LIU Lulu;LI Jie;CHEN Yang;NIU Guannan;WANG Moyang;LYU Shouliang;TAO Chunli;GAO Runlin;WU Yongjian(Coronary Heart Disease Center,National Center for Cardiovascular Diseases and Fuwai Hospital,CAMS and PUMC,Beijing(100037),China)

机构地区：[1]中国医学科学院北京协和医学院国家心血管病中心阜外医院冠心病中心,北京市100037 [2]四川大学华西医院大血管外科 [3]广东省人民医院(广东省医学科学院)心内科 [4]首都医科大学附属北京安贞医院心脏瓣膜病介入中心 [5]首都医科大学宣武医院心内科 [6]成都赛拉诺医疗科技有限公司

出　　处：《中国循环杂志》2022年第4期335-340,共6页Chinese Circulation Journal

基　　金：国家重点研发计划(2020YFC2008103);中国医学科学院医学与健康科技创新工程(2017-I2M-3-002)。

摘　　要：目的:明确中国重度主动脉瓣狭窄患者应用Silara经导管主动脉瓣膜系统(成都赛拉诺)的安全性和可行性。方法:全国三家中心的11例患者入选本研究。研究终点包括经导管主动脉瓣置换术(TAVR)后即刻器械成功率、手术成功率、TAVR后30 d全因死亡率、主要不良心脑血管事件发生率(包括死亡率及脑卒中、心肌梗死、再次手术、心律失常、传导阻滞发生率)。结果:瓣膜学术研究联盟(VARC)-2定义的器械成功率和手术成功率均为81.8%(9/11)。TAVR后30 d无患者死亡,无事件生存率为90.9%(10/11),1例患者在术后30 d再次进行TAVR,所有患者中无中量及以上程度的主动脉瓣反流和瓣周漏以及新发起搏器植入。结论:中国主动脉瓣狭窄患者应用Silara经导管主动脉瓣膜系统安全、可行。Objectives:Transcatheter aortic valve replacement(TAVR)is one of the major treatment options for patients with severe aortic stenosis(AS).Unlike previous self-expand and balloon dilated TAVR valves,the Silara transcatheter aortic valve system has a unique reactive stationary and fully retrievable design that has not yet been used in Chinese patients with severe AS.The purpose of this prospective multicenter first-in-human study was to determine the safety and feasibility of this valve system in Chinese patients with severe AS.Methods:Eleven patients from 3 Chinese medical centers were enrolled in this study.The study endpoints included device success rate,procedure success rate,all-cause mortality rate and incidence of major adverse cardiocerebrovascular events at 30 days after the procedure.Results:The device success rate and procedure success rate were both 81.8%(9/11).The survival rate was 100%and the event-free rate was 90.9%(10/11)at 30 days after the procedure.One patient received repeat TAVR with VitaFlow valve at 30 days post Silara TAVR due to insufficient valve opening.The rate of moderate and more than moderate aortic regurgitation and perivalvular leakage and the rate of new-onset pacemaker were 0%.Conclusions:The Silara transcatheter aortic valve system is safe and feasible for the treatment of Chinese patients with severe AS.

关 键 词：主动脉瓣狭窄 经导管主动脉瓣置换术 Silara经导管主动脉瓣膜系统 首次人体研究 

分 类 号：R54[医药卫生—心血管疾病]