Experimental Study on a New Type of Chinese-Made Mitral Valve Clip System
Li Bin1, Luo Xiaokang1, Zhang Dong2, Luo Fuliang1, Li Bo1, Pan Wenzhi3, Tang Yue1*
1(Animal Experimental Center of State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100037, China) 2(Department of Thoracic Surgery, Beijing Jishuitan Hospital, Beijing 100035) 3(Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032)
Abstract：We conducted an animal experiment to evaluate the feasibility and safety of a new type of Chinese-made mitral valve clip system. Fourteen pigs were divided into experimental group (n=10) and the control group (n=4). The experimental group was implanted with a new type of mitral valve clip, and the control group underwent traditional mitral valve repair. Echocardiography and blood testing were performed before and after operation. Tissue samples were taken from animals after euthanasia 140 days postoperatively. Pathological examination of heart and major organs were conducted. Results: In total, 8 animals in the experimental group and 4 animals in the control group reached the end of the experiment. No serious complications such as clip falling off, heart rupture, valve injury, intractable arrhythmia, viscera embolization, heart failure and death occurred in all animals. Echocardiography showed that all the clips were fixed at the mitral valve, and no statistically significant difference in mitral pressure gradient was found between the two groups. The implantation device had no significant influence on the hepatic and renal function. Pathological examination revealed chronic inflammation, mucinous degeneration and a small amount of bleeding in the leaflets around the clip. No damages to the mitral valve and heart tissue were observed. No thromboembolism was detected in the major organs. Conclusions: Animal experiments suggested that the new type of Chinese-made mitral valve clip system had good biocompatibility and could be effectively fixed at the mitral valve without causing serious complications.
李彬, 罗晓康, 张冬, 罗富良, 李波, 潘文志, 唐跃. 新型国产二尖瓣夹合器系统的动物实验研究[J]. 中国生物医学工程学报, 2020, 39(1): 67-73.
Li Bin, Luo Xiaokang, Zhang Dong, Luo Fuliang, Li Bo, Pan Wenzhi, Tang Yue. Experimental Study on a New Type of Chinese-Made Mitral Valve Clip System. Chinese Journal of Biomedical Engineering, 2020, 39(1): 67-73.
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