Lin Changyan, Wu Guanghui, Liu Xiujian, Xu Chuangye, Hou Xiaotong, Li Haiyang, Chen Chen, Yang Peng, Wang Jing, Liu Yuyang
2 Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing - China.
Int J Artif Organs. 2015 Mar;38(3):138-45. doi: 10.5301/IJAO.2015.14486. Epub 2015 Mar 30.
The CH-VAD is an implantable, fully magnetically suspended ventricular assist device developed by the China Heart Biomedical Corporation (Suzhou, China) for full cardiac support. This study was performed to evaluate the reliability, hemocompatibility and end-organ effects of CH-VAD in a 35-day animal model trial.
The pump was implanted in 6 sheep. The pump inflow was inserted into the left ventricle and the outflow graft was anastomosed to the descending aorta. Data on pump function and the health condition of the animals, including hematologic and biochemical tests, were collected during the study period. When each study was determined to termination, the sheep were humanely euthanized and the end organs were examined macroscopically and histopathologically. Hemolysis was evaluated based on the amount of free hemoglobin in the plasma.
Except for one device that stopped operation on postoperative day 25 because of thrombus formation, the devices functioned normally until the scheduled termination. Gross examination of the pump interiors, inflow and outflow, and of the arterial anastomosis sites showed no significant abnormalities. Hematologic and biochemical test results were within normal limits during the study period. Macroscopic and histopathologic examinations of the explanted organs revealed no evidence of ischemia or infarction associated with the device implantation, except for small foci of infarction in the kidneys of two sheep. The free hemoglobin level in plasma peaked at 9.5 mg/dl on postoperative day 5.
The CH-VAD system demonstrated promising reliability and blood-handling characteristics without obvious damage to end organs during a 35-day implantation in sheep.
CH-VAD是由中国心脏生物医学公司（中国苏州）研发的一种可植入式、完全磁悬浮心室辅助装置，用于全心支持。本研究旨在评估CH-VAD在为期35天的动物模型试验中的可靠性、血液相容性和对终末器官的影响。
将该泵植入6只绵羊体内。泵的流入端插入左心室，流出移植物与降主动脉吻合。在研究期间收集有关泵功能和动物健康状况的数据，包括血液学和生化检测。当每项研究确定终止时，对绵羊实施安乐死，并对终末器官进行大体和组织病理学检查。根据血浆中游离血红蛋白的量评估溶血情况。
除1个装置因术后第25天形成血栓而停止运行外，其余装置在预定终止前均正常运行。对泵内部、流入和流出端以及动脉吻合部位的大体检查未发现明显异常。研究期间血液学和生化检测结果均在正常范围内。对取出器官的大体和组织病理学检查显示，除两只绵羊的肾脏有小梗死灶外，未发现与装置植入相关的缺血或梗死证据。血浆中游离血红蛋白水平在术后第5天达到峰值，为9.5 mg/dl。
在绵羊体内进行的35天植入试验中，CH-VAD系统显示出良好的可靠性和血液处理特性，且未对终末器官造成明显损害。
