新型经导管二尖瓣单片置换系统的临床前研究  

Preclinical study of a novel transcatheter mono-leaflet mitral valve replacement system

作　　者：曹静怡 蔡亮 周广为 宋智钢 乔帆 徐志云 陆方林 CAO Jing-yi;CAI Liang;ZHOU Guang-wei;SONG Zhi-gang;QIAO Fan;XU Zhi-yun;LU Fang-lin(Department of Cardiovascular Surgery,Changhai Hospital,Naval Medical University,Shanghai 200433,China;Jenscare Scientific Company Limited,Ningbo 315000,China;Department of Cardiovascular Surgery,Shanghai General Hospital,Shanghai Jiao Tong University,Shanghai 200080,China)

机构地区：[1]海军军医大学附属长海医院心血管外科,上海市200433 [2]宁波健世科技股份有限公司 [3]上海市第一人民医院心血管外科

出　　处：《中国心血管病研究》2024年第2期172-177,共6页Chinese Journal of Cardiovascular Research

基　　金：宁波市科技创新2025重大项目(2018B10092);甬江人才工程青年创新人才项目(2022A-206-G)。

摘　　要：目的设计一款原创性的经导管二尖瓣单片置换系统,验证该装置的安全性及有效性,并在临床应用前优化植入程序。方法通过体外流体学模拟验证植入的初步有效性,并建立无反流猪模型(n=3)以及自体反流的猪模型(n=4)验证装置植入的可操作性及有效性。结果体外流体学模拟显示,装置植入后反流减少。所有猪动物模型中,置换装置均成功植入,无术中不良事件发生,术后解剖显示瓣膜装置在位,周围组织无明显损伤。反流动物模型中,术后即刻超声提示反流明显减少或消失,二尖瓣对合高度明显增加(P=0.007),术后1月提示无明显反流与瓣周漏,瓣周未见明显血栓形成。结论该原创性经导管二尖瓣单片置换系统能够有效改善二尖瓣反流,有望成为二尖瓣反流外科手术高危患者的一种新的治疗选择。Objective To design an original transcatheter mitral valve mono-leaflet mitral valve replacement system,validate the safety and efficacy of the device and optimize the implantation procedure before clinical application.Methods The initial validity of implantation was verified by in vitro fluidics simulations,and a porcine model without regurgitation(n=3)as well as a porcine model with mitral regurgitation(n=4)were established to verify the maneuverability and effectiveness of the device implantation.Results In vitro fluidics simulations showed a reduction in regurgitation after the device implantation.In all porcine animal models,the replacement devices were successfully implanted without intraoperative adverse events,and postoperative autopsy showed the valve device in place without significant damage to the surrounding tissues.In the regurgitation animal model,immediate postoperative ultrasound suggested a significant reduction or disappearance of regurgitation and a significant increase in the height of mitral valve alignment(P=0.007),and suggested no significant regurgitation with perivalvular leakage and no significant perivalvular Thrombosis at 1 month postoperatively.Conclusion This original transcatheter mitral valve mono-leaflet replacement system can effectively alleviate mitral regurgitation and would be expected to be a new treatment option for the patients at high risk for surgery.

关 键 词：二尖瓣关闭不全 后瓣脱垂 单片置换 经导管介入治疗 

分 类 号：Q95-33[生物学—动物学] R542.5[医药卫生—心血管疾病]