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In vitro and vivo evaluation of Tongxin LVAD

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机构: [a]Biomedical Engineering Department, Capital University of Medical Sciences, Beijing Anzhen Hospital, Beijing 100029, China [b]China Heart Biomedical Incorporation, Suzhou, Jiangsu Province 215125, China
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关键词: hemocompatibility implantation possibility in vivo experiment magnetic suspending blood pump ventricular assist device

摘要:
Background Tongxin left ventricular assist device (LVAD), an implantable magnetic suspending VAD developed in Chinaheart Biomedical Incorporation aiming for clinical use, weighs about 350g and can deliver 6 L/min for pressures of 145 mm Hg at 2,500 rpm. Objective This study aimed to investigate the implantation possibility, hemolysis and hemocompatibility of the LVAD before clinic use. Methods The tests of implantation possibility, hemolysis and hemocompatibility to the LVAD were completed by fitting study, hemolysis test and in vivo experiments respectively. Meanwhile the hemolysis was evaluated by the amount of free hemoglobin in plasma and studied using the normalized index of hemolysis (NIH). Results The fitting study showed that the blood pump could be implanted in the sheep heart chambers without squeezing the surrounding organs by comparing the preoperative and the postoperative chest X-ray. the NIH value of Tongxin LVAD was 0.0075±0.0017g/100L in vitro hemolysis test. Two sheep in vivo experiments showed the hemolysis in vivo was below 7.5 mg/dL. Hematologic and biochemical test results were within normal limits during the study period. There were no significant complications. Postmortem examination of the explanted organs revealed no evidence of microemboli, ischemia or infarction. The pump's inflow and outflow conduits were free of thrombus. Conclusions These results indicated that the implantable magnetic suspending LVAD showed exceptional implantation possibility, hemolysis and hemocompatibility, which are crucial to the clinical success of this implantable LVAD. © 2013 Springer-Verlag.

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