Fumoto Hideyuki, Shiose Akira, Flick Christine R, Noble Lawrence D, Dudzinski David T, Casas Fernando, Takaseya Tohru, Arakawa Yoko, Fukamachi Kiyotaka, Smith William A, Duncan Brian W
Department of Biomedical Engineering, Lerner Research Institute.
Artif Organs. 2014 May;38(5):374-82. doi: 10.1111/aor.12179. Epub 2013 Oct 1.
The PediPump was implanted in six healthy lambs (mean 25.6 ± 1.4 kg) between the left ventricular apex and the descending aorta to evaluate in vivo performance for up to 30 days. Anticoagulation was achieved by continuous heparin infusion. Three animals were euthanized prematurely, two because of respiratory dysfunction and one because of deteriorating pump performance resulting from thrombus formation inside the pump. Three lambs were electively sacrificed 30 days after implantation; all had stable hemodynamics and minimal hemolysis, as indicated by low plasma free hemoglobin (2.5 ± 3.1 mg/dL). Mean 30-day pump flow was 1.8 ± 0.1 L/min at a pump speed of 12 200 ± 400 rpm. Neither activated clotting time nor activated partial thromboplastin time followed the changes in heparin dose. At necropsy, depositions were observed at the front (n = 1) and rear rotor axial positioning stops (n = 4); improved polishing techniques on the stationary stop surfaces and the addition of a hard-carbon, thin-film coating on the rotating stop of the pumps used for the last two experiments addressed the deposition seen earlier. In conclusion, the PediPump showed excellent hydraulic performance and minimal hemolysis during support for up to 30 days. Depositions observed at the axial positioning stops in earlier experiments were addressed by design and material refinements. We continue to focus on developing effective anticoagulation management in the lamb model as well as on further evaluating and demonstrating pump biocompatibility.
将PediPump植入6只健康羔羊（平均体重25.6±1.4千克）的左心室心尖与降主动脉之间，以评估其长达30天的体内性能。通过持续输注肝素实现抗凝。3只动物过早实施安乐死，2只因呼吸功能障碍，1只因泵内血栓形成导致泵性能恶化。3只羔羊在植入后30天被选择性处死；所有羔羊血流动力学稳定，血浆游离血红蛋白水平较低（2.5±3.1毫克/分升），表明溶血轻微。在泵速为12 200±400转/分钟时，30天的平均泵流量为1.8±0.1升/分钟。活化凝血时间和活化部分凝血活酶时间均未随肝素剂量的变化而改变。尸检时，在泵的前部（n = 1）和后部转子轴向定位止动处（n = 4）观察到沉积物；在最后两次实验所用泵的固定止动表面改进抛光技术，并在旋转止动处添加硬碳薄膜涂层，解决了早期观察到的沉积物问题。总之，PediPump在长达30天的支持期间表现出优异的水力性能和轻微的溶血。早期实验中在轴向定位止动处观察到的沉积物问题通过设计和材料改进得到了解决。我们继续致力于在羔羊模型中开发有效的抗凝管理方法，并进一步评估和证明泵的生物相容性。
