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.
张冬 杨伯清 陈海波 王红月 袁卫民 杨建中贾六军 罗富良 杨朋 唐 跃. CH-VAD左心辅助装置动物体内实验研究[J]. 中国生物医学工程学报, 2016, 35(6): 705-711.
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. Chinese Journal of Biomedical Engineering, 2016, 35(6): 705-711.
[1] 吴龙,翁渝国,孙宗全,等. 心室辅助装置临床应用现状及进展 [J].中华胸心血管外科杂志,2012,28(10):627-631. [2] Da SM, MacIver J, Rodger M, et al. Readmissions following implantation of a continuous-flow left ventricular assist device [J]. Card Surg. 2016, 31(5):361-364. [3] Di MA, Ferrari G, Filippelli S, et al.Use of ventricular assist device in univentricular physiology: The Role of Lumped Parameter Models [J]. Artif Organs. 2015, 10(2):368-371. [4] Krabatsch T, Schweiger M, Stepaaenko A, et al. Mechanical circulatory support-results developments and trends [J]. Cardiovasc Transl Res. 2011, 4: 332-339. [5] Cushing K, Kushnir V. Gastrointestinal bleeding following LVAD placement from top to bottom [J]. Dig Dis Sci, 2016, 61(6):1440-1447. [6] Pauls JP, Stevens MC, Bartnikowski N, et al. Evaluation of physiological control systems for rotary left ventricular assist devices: An In-Vitro Study [J]. Ann Biomed Eng. 2016, 44(8):2377-2387. [7] Larose JA, Tamez D, Ashenuga M, et al. Design concepts and principle of operation of the HeartWare ventricular assist system [J]. ASAIO J, 2010, 56: 285-289. [8] Leuck AM. Left ventricular assist device driveline infections: recent advances and future goals [J]. Thorac Dis, 2015, 7(12):2151-2157. [9] Smith LA, Yarboro LT, Kennedy JL. Left ventricular assist device implantation strategies and outcomes [J]. Thorac Dis, 2015, 7(12):2088-2096. [10] Krabatsch T, Potapov E, Soltani S, et al. Ventricular long-term support with implantable continuous flow pumps: on the way to a gold standard in the therapy of terminal heart failure [J]. Herz, 2015, 40(2):231-239. [11] Krabatseh T, Potapov E, Stepanenko A, et al. Biventrieular circulatory support with two miniaturized implantable assist devices [J]. Circulation, 2011, 124(11 Suppl): S179-S186. [12] Kostick KM, Minard CG, Wilhelms LA, et al. Development and validation of a patient-centered knowledge scale for left ventricular assist device placement [J]. Heart Lung Transplant, 2016, 21: S1053-S2498. [13] 蔺嫦燕,吴广辉,刘修健,等,ChinaHeart左心辅助装置的体内动物实验评估[J]. 北京生物医学工程,2013,32(5):472-478. [14] 吴广辉.轴流式心脏辅助装置及其发展现状[J]. 北京生物医学工程,2004,23(4): 306 -308. [15] Daniel T, Jeffrey A, LaRose, MS, et al. Early feasibility testing and engineering development of the transapical approach for the HeartWare MVAD ventricular assist system [J]. ASAIO J, 2014, 60(2): 170-177. [16] 刘修建,吴广辉,徐创业,等,ChinaHeart左心辅助装置的动物在体存活实验[J]. 中国生物医学工程学报,2012(10),31:736-741. [17] Abshire M, Dennison CR, Russell SD. Functional status in left ventricular assist device-supported patients: A literature review [J]. Card Fail, 2014, 20(12):973-983. [18] Holley CT, Harvey L, John R. Left ventricular assist devices as a bridge to cardiac transplantation [J]. Thorac Dis. 2014, 6(8):1110-1119. [19] Nowotny BH, Boner DH, Maltais S. Ventricular assist device Implantation: perioperative nursing considerations [J]. AORN J, 2016, 103(4):388-406. [20] Tchantchaleishvili V, Cheyne C, Sherazi S, et al.Single-center experience with HeartMate II left ventricular assist device explantation [J]. Artif Organs, 2016, 32(6):812-819. [21] Lueck S, Sindermann J, Martens S, et al.Mechanical circulatory support for patients with peripartum cardiomyopathy [J]. Artif Organs, 2016, 22(2): 205-210. [22] Stmeber M,ODriscoll G,Jansz P,et al. Muhiceuter evaluation of all intrapericardial left ventricular assist system [J]. Am Coil Cardiol,2011,57:1375-1382.
