CH-VAD左心辅助装置动物体内实验研究  

Research of the CH-VAD Left Ventricular Assist Device in vivo

作　　者：张冬[1] 杨伯清[1] 陈海波[1] 王红月[1] 袁卫民[1] 杨建中[1] 贾六军[1] 罗富良[1] 杨朋 唐跃[1] 

机构地区：[1]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心血管疾病国家重点实验室心血管植入材料临床前评价北京市重点实验室动物实验中心,北京100037 [2]苏州同心医疗器械有限公司,江苏苏州215125

出　　处：《中国生物医学工程学报》2016年第6期705-711,共7页Chinese Journal of Biomedical Engineering

基　　金：北京市科技计划(Z101107052210004)

摘　　要：验证磁悬浮左心辅助装置(CH-VAD)动物体内植入后的安全性及可靠性。选择健康雄性绵羊6只,经麻醉诱导、呼吸插管后开胸,在心脏不停跳的情况下开通由左心尖到辅助装置,再到降主动脉的辅助循环通路。术后常规予以密切监护及抗凝治疗,持续监测装置运行状况,实验动物在术前及术后分别进行细胞学及血液生化指标检测。实验观察结束后,动物予以安乐死,进行尸检及组织病理检查。6例实验动物中:2例因室颤或窒息死亡,1例因肺部感染于20 d终止观察,2例观察至实验结束(60 d)后取材进行病理检查,1例60 d后继续观察并因肺部感染于135 d终止实验。对成功植入的实验动物进行有效观察,装置悬浮状态良好,运转正常;CH-VAD植入后,细胞学及血液生化检查均在正常范围内。尸解及组织病理检查发现:2例存活20和135 d的动物,出现肺炎和肾脏多发性梗死;2例存活60 d的动物,出现肾脏单发小梗死,其余脏器未见明显异常。该实验为CH-VAD临床前评价及临床操作提供理论及技术支持,并证明其具有相对稳定的工作性能;提出建立左心辅助装置临床前评价标准的思路和想法,为后期装置的植入及临床操作提供研究的方向。To evaluate the security and reliability of a magnetic left ventricular assist device（CH-VAD） ,an in vivo experimental investigation was performed in the ovine model. A total of six healthy male sheep were involved in the experiment. Under anesthesia via lateral thoracotomy and ventilator assisted breathing, each of the 6 healthy male sheep was performed the CH-VAD implantation between the left ventrieular apex and descending aorta under beating-heart condition. Postoperative nursing and anticoagulating therapy were completed routinely, and the operating parameters of CH-VAD were recorded continuously. The hematologic and biochemical tests were performed preoperatively and postoperatively to evaluate primary organ functions. Operating parameters of CH-VAD 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 andhistopathologically. Two of the 6 animals died of ventricular fibrillation or asphyxia. One animal died at the 20th day because of respiratory failure, and 2 sheep survived to the end of the experiment （60 days）. The other one animal died at the 135th day because of respiratory failure. For the surviving animals, hematological and biochemical data showed no evidence of organ dysfunctions during the experimental period, and the CH-VADs were in a good condition. At autopsy,histopathologic examination revealed that two sheep surviving for 20 and 135 days showed lobular pneumonia and multiple infarction of kidney, and another two sheep survivingfor 60 days showed local infarction of kidney. However the other end-organs did not have obvious pathological changes. Our study provided a theoretical and technical support for the preclinical evaluation and clinical operation of CH-VAD, and proved that CH-VAD had a relatively stable performance; proposed the thought and idea for building the standard of preclinical evaluation of left ventricular assist device, and provided the resear

关 键 词：左心辅助装置 磁悬浮 CH-VAD 动物实验 

分 类 号：R318[医药卫生—生物医学工程]