Research of the CH-VAD Left Ventricular Assist Device in vivo
Zhang Dong1 Yang Baiqing1 Chen Haibo1 Wang Hongyue1 Yuan Weimin1 Yang Jianzhong1 Jia Liujun1 Luo Fuliang1 Yang Peng2 Tang Yue1*
1Chinese Academy of Medical Sciences, Peking Union Medical College, National Center for Cardiovascular Disease, Fuwai Hospital, State Key Laboratory of Cardiovascular Disease, Beijing Key Laboratory of Pre-Clinical Research and Evaluation for Cardiovascular Implant Materials, Animal Experimental Center, Beijing 100037, China 2CH-VAD Biomedical Inc, Suzhou 215125, Jiangsu, China
Abstract 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 ventricular 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 and histopathologically.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 research direction on the subsequent implantation and clinical operation.
Zhang Dong Yang Baiqing Chen Haibo Wang Hongyue Yuan Weimin Yang Jianzhong Jia Liujun Luo Fuliang Yang Peng Tang Yue. Research of the CH-VAD Left Ventricular Assist Device in vivo[J]. Chinese Journal of Biomedical Engineering, 2016, 35(6): 705-711.
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