Gräf Felix, Finocchiaro Thomas, Laumen Marco, Mager Ilona, Steinseifer Ulrich
Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, RWTH Aachen University, Aachen, Germany.
Artif Organs. 2015 May;39(5):416-22. doi: 10.1111/aor.12399. Epub 2015 Jan 13.
Hemocompatibility of blood pumps is a crucial parameter that has to be ensured prior to in vivo testing. In contrast to rotary blood pumps, a standard for testing a pulsatile total artificial heart (TAH) has not yet been established. Therefore, a new mock circulation loop was designed to investigate hemolysis in the left ventricle of the ReinHeart TAH. Its main features are a high hemocompatibility, physiological conditions, a low priming volume, and the conduction of blood through a closed tubing system. The mock circulation loop consists of a noninvasive pressure chamber, an aortic compliance chamber, and an atrium directly connected to the ventricle. As a control pump, the clinically approved Medos-HIA ventricular assist device (VAD) was used. The pumps were operated at 120 beats per minute with an aortic pressure of 120 to 80 mm Hg and a mean atrial pressure of 10 mm Hg, generating an output flow of about 5 L/min. Heparinized porcine blood was used. A series of six identical tests were performed. A test method was established that is comparable to ASTM F 1841, which is standard practice for the assessment of hemolysis in continuous-flow blood pumps. The average normalized index of hemolysis (NIH) values of the VAD and the ReinHeart TAH were 0.018 g/100 L and 0.03 g/100 L, respectively. The standard deviation of the NIH was 0.0033 for the VAD and 0.0034 for the TAH. Furthermore, a single test with a BPX-80 Bio-Pump was performed to verify that the hemolysis induced by the mock circulation loop was negligible. The performed tests showed a good reproducibility and statistical significance. The mock circulation loop and test protocol developed in this study are valid methods to investigate the hemolysis induced by a pulsatile blood pump.
血泵的血液相容性是体内测试前必须确保的关键参数。与旋转血泵不同，用于测试搏动性全人工心脏（TAH）的标准尚未确立。因此，设计了一种新的模拟循环回路来研究ReinHeart TAH左心室中的溶血情况。其主要特点是血液相容性高、生理条件、预充量低以及血液通过封闭管道系统传导。该模拟循环回路由一个无创压力腔、一个主动脉顺应性腔和一个直接连接到心室的心房组成。作为对照泵，使用了临床批准的Medos-HIA心室辅助装置（VAD）。泵以每分钟120次搏动运行，主动脉压力为120至80 mmHg，平均心房压力为10 mmHg，产生约5 L/min的输出流量。使用肝素化猪血。进行了一系列六项相同的测试。建立了一种与ASTM F 1841相当的测试方法，ASTM F 1841是评估连续流血液泵中溶血的标准方法。VAD和ReinHeart TAH的平均归一化溶血指数（NIH）值分别为0.018 g/100 L和0.03 g/100 L。VAD的NIH标准偏差为0.0033，TAH为0.0034。此外，还使用BPX-80生物泵进行了一次测试，以验证模拟循环回路引起的溶血可忽略不计。所进行的测试显示出良好的可重复性和统计学意义。本研究中开发的模拟循环回路和测试方案是研究搏动性血泵引起的溶血的有效方法。
