ChinaHeart左心辅助装置的动物在体存活实验  

In vivo Survival Evaluation of the ChinaHeart Left Ventricular Assist Device

作　　者：刘修健[1,2] 吴广辉[1,2] 徐创业[1,2] 王璟[1,2] 侯晓彤[1] 李海洋[1] 杨朋 渠文波 蔺嫦燕[1,2] 

机构地区：[1]首都医科大学附属北京安贞医院,北京100029 [2]北京市心肺血管疾病研究所,北京100029 [3]苏州同心医疗器械有限公司,苏州215125

出　　处：《中国生物医学工程学报》2012年第5期736-741,共6页Chinese Journal of Biomedical Engineering

基　　金：国家高技术研究发展计划(863计划)(2012AA041605);北京市自然科学基金(2010311)

摘　　要：验证磁悬浮离心式左心辅助装置—ChinaHeart VAD的在体血液相容性和可靠性,评估其对实验动物主要终末器官的影响。通过6例健康绵羊的在体存活实验进行评估。在心脏不停跳的情况下,装置入口插入左心尖,出口与降主动脉吻合。术前和术后做血常规、生化及血凝检查,术后连续监测动物存活及辅助装置运行状况。择期动物安乐死后,进行终末主要脏器的宏观和病理学检查。4只羊术后3～28 h内因麻醉或手术意外死亡;2只羊成功复苏并分别辅助20 d和38 d后施行安乐死。对于成功存活的2例实验动物,术后护理期间血常规、生化和血凝检查结果均在正常范围内,辅助装置无机械故障发生。尸检时1只羊(存活20 d)血泵泵体内发现一肉眼可见小块血栓沉积,其余无血栓形成;组织病理检查发现2只羊左肺贴近辅助装置部位均可见有小叶性肺炎,其余终末脏器无明显病变发生。ChinaHeart VAD在体辅助期间血液相容性能良好,对各主要终末脏器无显著影响,具有较好的可靠性;动物存活实验中麻醉呼吸管理和手术操作也至关重要。An in vivo experimental investigation was performed in ovine model to evaluate hemocompatibility, reliability and end-organ effects of the ChinaHeart VAD, a magnetic left ventricular assist device. The device was implanted in 6 healthy male sheep. Under anesthesia, via left lateral thoracotomy, the inflow cannula was inserted into the left ventricular apex on beating hearts, and the outflow graft was anastomosed to the descending aorta. Routine hematologic and biochemical tests were performed preoperatively and postoperatively to evaluate peripheral organ functions. Pump operating parameters were recorded continuously until termination of the experiment. At the end of the experimental period the sheep was humanely killed, and the end-organs were examined macroscopically and histopathologieally. Two of the 6 animals survived for 20 and 38 days, the other four died of anesthesia or blood leakage at the inflow cannula or outflow graft within the first 3 to 28 hours. For the two survival animals, hematological and biochemical data showed no evidence of organ dysfunction during the experimental period. At autopsy, one small thrombosis formatted at the bottom housing in one pump （20- day survival sheep） , but no other thrombosis was found in the ventricular cavity of both two sheep. In addition, except lobular pneumonia was observed the left lung lobe adjacent to the pump, there were no histological changes in the other major end-organs. The ChinaHeart VAD system demonstrated excellent hemocompatibility and reliability for more than 20 days, and had no significant side effect on the major end-organs. In addition, aneshesia management and surgical procedures are crucial in animal survived experiment.

关 键 词：左心室辅助装置 ChinaHeart 磁悬浮血泵 在体实验 

分 类 号：R318[医药卫生—生物医学工程]