TruDelta^(TM)经导管二尖瓣介入置换系统动物试验评价结果  

Animal study results of a novel designed transcatheter mitral valve replacement system

作　　者：朱达 王首正[2] 高建斌 骆志玲 杨克 谢春梅 孔朋旭 冯舒毅 江红 潘湘斌[2] Zhu Da;Wang Shouzheng;Gao Jianbin;Luo Zhiling;Yang Ke;Xie Chunmeit;Kong Pengxu;Feng Shuyit;Jiang Hong;Pan Xiangbin(Department of Structure Heart Center,Fuwai Yunnan Cardiovascular Hospital,Affiliated Cardiovascular Hospital of Kunming Medical University,Kunming 650102,China;Department of Structure Heart Center,Fuwai Hospital,National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037,China;Department of Ultrasound,Fuwai Yunnan Cardiovascular Hospital,Affiliated Cardiovascular Hospital of Kunming Medical University,Kunming 650102,China;Department of Anesthesiology,Fuwai Yunnan Cardiovascular Hospital,Affiliated Cardiovascular Hospital of Kunming Medical University,Kunming 650102,China)

机构地区：[1]云南省阜外心血管病医院昆明医科大学附属心血管医院结构性心脏病中心,昆明650102 [2]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结构性心脏病中心,北京100037 [3]云南省阜外心血管病医院昆明医科大学附属心血管医院超声科,昆明650102 [4]云南省阜外心血管病医院昆明医科大学附属心血管医院麻醉科,昆明650102

出　　处：《中华心血管病杂志》2025年第3期287-292,共6页Chinese Journal of Cardiology

基　　金：十四五重点研发计划(2022YFC2503400);云南省重大科技专项计划项目(202302AA310045);中国医学科学院医学与健康科技创新工程(2021-I2M-1-065)。

摘　　要：目的 初步探讨TruDeltaTM经导管二尖瓣介入置换系统的生物相容性及耐久性。方法 实验用成年绵羊6只, 分为30 d组(1只)、90 d组(3只)及180 d组(2只), 最终观察时间分别为术后30、90、180 d。采用左侧胸小切口心尖入路, 在经食管超声心动图引导下植入TruDelta^(TM)经导管二尖瓣介入置换系统。采用器械性能评价量表(包含39个条目)评价介入置换系统的可操作性, 术者使用1~10分对每个条目进行评分(1分为最差, 10分为最佳)。采用超声心动图于术前、术后即刻和术后30、90、180 d对绵羊进行检查。于最终观察时间点处死绵羊, 解剖取出介入二尖瓣膜及主要器官, 进行大体解剖观察, 取人工瓣膜进行苏木精-伊红(HE)染色, 并采用扫描电镜观察。结果 6只绵羊均顺利完成手术, 所植入的TruDelta^(TM)经导管二尖瓣介入置换系统的型号均为29S。在最终观察时间点瓣膜位置均稳定, 瓣叶运动良好, 未见明显瓣周漏, 二尖瓣平均跨瓣压差(7.8±3.2)mmHg(1 mmHg=0.133 kPa), 二尖瓣瓣口面积(1.8±0.2)cm^(2), 瓣膜未见明显赘生物、狭窄、反流等。大体解剖观察结果提示, 瓣膜无明显结构性衰败及血栓, 90及180 d瓣膜内皮化面积范围>75%。HE染色及电镜观察结果提示, 人工瓣膜及支架内皮化覆盖程度良好。结论动物实验结果证实国产TruDeltaTM经导管二尖瓣介入置换系统具备良好的生物相容性及耐久性。Objective To preliminarily assess the biocompatibility and durability of the TruDelta^(TM) transcatheter mitral valve replacement(TMVR)system.Method Six adult sheep were divided into 3 groups based on the duration of follow-up:30 days(n=1),90 days(n=3)and 180 days(n=2).The TruDeltaTMTMVR system was implanted through a transapical approach under transesophageal echocardiographic guidance.The operability of the TMvR system was evaluated using an instrument performance evaluation scale(consisting of 39 items),with scores ranging from 1(worst)to 1o(best)assigned by the operator Echocardiography was conducted preoperatively,immediately after surgery,and at 30,90,and 180 days post-implantation.At the last follow-up time point,the intervention mitral valve membrane and major organs were dissected for observation.The artificial valves were taken for hematoxylin eosin(HE)staining and observed under a scanning electron microscope.Result All six procedures were successfully completed using 29s size TruDelta^(TM) TMVR device.At the final follow-up,echocardiogram demonstrated good valve function without obvious paravalvular leakage,with a transvalvular gradient of(7.8±3.2)mmHg(1 mmHg=0.133 kPa)and a mitral valve orifice area of(1.8+0.2)cm^(2).Autopsy findings revealed no structural valve failure and almost complete endothelialization(>75%)with 90 to 180 days.Both HE staining and scanning electron microscopy confirmed optimal endothelialization of the valve stent.Conclusion The preclinical animal study indicates that the TruDeltaTM device exhibits favorable biocompatibility and durability.

关 键 词：二尖瓣 二尖瓣闭锁不全 动物实验 

分 类 号：R54[医药卫生—心血管疾病]