新型国产二尖瓣夹合器系统的动物实验研究

通过动物实验,对一种新型国产二尖瓣夹合器系统的可行性和安全性进行评价。14只正常三元杂交系猪分为实验组10只和对照组4只,实验组植入新型二尖瓣夹合器系统,对照组行传统二尖瓣修复术。分别于术前、术后不同时间点行超声心动图检查、血液检查,术后140 d对动物安乐死取材,进行心脏及主要脏器大体、病理检查,观察植入后的情况。实验组共8只动物、对照组共4只动物达到实验终点,所有动物术中未出现夹合器脱落、心脏破裂、瓣膜损伤、顽固性心律失常、脏器栓塞、心力衰竭、死亡等严重并发症。超声显示,所有夹合器均固定在二尖瓣处,不同时间点二尖瓣平均跨瓣压差、左心室射血分数等两组间均未见具有统计学意义的差异。血液学检查,未见植入器械对肝肾功能产生明显影响。病理检查提示,夹合器周围瓣叶呈现慢性炎症、黏液样变性、少量出血,未引起二尖瓣及心脏组织损伤,未出现心脏血栓、感染,各脏器也未见血栓栓塞。动物实验结果表明,新型国产二尖瓣夹合器系统生物相容性好,能够有效固定在二尖瓣处而不引起严重的相关并发症。

Experimental Study on a New Type of Chinese-Made Mitral Valve Clip System

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.