Kawahito K, Damm G, Benkowski R, Aber G, Bacak J, Tasai K, Shimono T, Takatani S, Nosé Y, Noon G P, DeBakey M E
Department of Surgery, Baylor College of Medicine, Houston, TX 77030-3498, USA.
Artif Organs. 1996 Jan;20(1):47-52. doi: 10.1111/j.1525-1594.1996.tb04417.x.
A small ventricular assist device intended for long-term implantation has been developed by a cooperative effort between the Baylor College of Medicine and the NASA/Johnson Space Center. To date, in vitro tests have been performed to address hemolysis and pump performance issues. In this Phase 1 study, we assessed the durability and atraumatic features aiming for 2 day implantation. Eight pumps were implanted in 2 calves as paracorporeal left ventricular assist devices. The pump running times ranged from 18 to 203 h (78.1 +/- 23.7; mean +/- SEM). All the pump implantations were terminated because of thrombus formation. Plasma-free hemoglobin levels were below 13.7 mg/dl, except for 1 case complicated by inflow cannula obstruction. The pump speed was maintained between 10,100 and 11,400 rpm. Pump outputs were from 3.6 to 5.2 L/min. The electrical power required by the system ranged between 9 and 12 W. Clinically there was no detectable organ dysfunction noted, and postmortem evaluation demonstrated no pump related adverse effects in either calf except for small kidney infarctions. Thrombus deposition was observed mainly at the hub portions and the flow straightener.
贝勒医学院与美国国家航空航天局/约翰逊航天中心合作开发了一种旨在长期植入的小型心室辅助装置。迄今为止，已进行了体外测试以解决溶血和泵性能问题。在这项1期研究中，我们评估了该装置的耐用性和无创伤特性，目标是进行为期2天的植入。将8个泵作为体外左心室辅助装置植入2头小牛体内。泵的运行时间为18至203小时（78.1 +/- 23.7；平均值 +/- 标准误）。由于血栓形成，所有泵的植入均终止。除1例并发流入插管阻塞外，无血浆血红蛋白水平均低于13.7mg/dl。泵速维持在10100至11400转/分钟之间。泵输出量为3.6至5.2升/分钟。系统所需的电功率在9至12瓦之间。临床上未发现可检测到的器官功能障碍，尸检评估表明，除小面积肾梗死外，两只小牛均未出现与泵相关的不良反应。血栓沉积主要见于轮毂部分和整流器。
