Tuzun Egemen, Harms Kelly, Liu Dong, Dasse Kurt A, Conger Jeff L, Richardson J Scott, Fleischli Andreas, Frazier O H, Radovancevic Branislav
Cardiovascular Surgical Research Laboratories, Texas Heart Institute, Houston, TX, USA.
ASAIO J. 2007 May-Jun;53(3):392-6. doi: 10.1097/MAT.0b013e3180340974.
We evaluated the effects of the Levitronix UltraMag pediatric ventricular assist system on healthy animals during 29- to 90-day periods by assessing hemocompatibility and hepatic and renal functions while operating the device in a flow range suitable for pediatric patients. Nine lambs (weight, 15 to 24 kg) received the Levitronix UltraMag with an outflow cannula anastomosed to the descending aorta and an inflow cannula inserted into the left ventricular apex. Pump function data were collected at 1-hour intervals, and postoperative hematology and clinical chemistry tests were performed weekly throughout the study. Complete necropsy and histopathologic examinations were performed at study termination. Pump and circuit were thoroughly inspected for evidence of thrombi. All animals reached the scheduled endpoint of 29 to 90 days without device-related problems. Mean flow was maintained at 1.14 +/- 0.19 L/min. Hematologic values were within normal range in all animals except in one lamb that had a severe hemolytic reaction after cefazolin sodium administration. In all animals, serum glutamic-oxaloacetic transaminase and creatinine kinase levels increased after surgery but gradually returned to normal limits within 1 week. Postmortem examination of the explanted organs revealed small infarcted areas in five lamb kidneys, but renal function was unaffected. All other major organs were unremarkable. In one explanted pump (a 30-day study), a small thrombus was seen within the impeller blade. The other eight pumps were free of thrombus. The Levitronix UltraMag successfully operated in pediatric flow ranges without device-related adverse events.
我们通过评估血液相容性以及肝脏和肾脏功能，在适合儿科患者的流量范围内操作Levitronix UltraMag儿科心室辅助系统，对健康动物进行了为期29至90天的研究。九只羔羊（体重15至24千克）接受了Levitronix UltraMag，其流出插管吻合至降主动脉，流入插管插入左心室心尖。每隔1小时收集一次泵功能数据，在整个研究过程中每周进行术后血液学和临床化学检测。在研究结束时进行完整的尸检和组织病理学检查。对泵和回路进行全面检查以寻找血栓证据。所有动物均无器械相关问题地达到了预定的29至90天终点。平均流量维持在1.14±0.19升/分钟。除一只在给予头孢唑林钠后发生严重溶血反应的羔羊外，所有动物的血液学值均在正常范围内。在所有动物中，血清谷草转氨酶和肌酸激酶水平在术后升高，但在1周内逐渐恢复至正常范围。对取出器官的尸检显示五只羔羊肾脏中有小梗死区域，但肾功能未受影响。所有其他主要器官均无异常。在一个取出的泵（一项为期30天的研究）中，在叶轮叶片内发现一个小血栓。其他八个泵无血栓。Levitronix UltraMag在儿科流量范围内成功运行，未发生器械相关不良事件。
