Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Medical Faculty, RWTH Aachen University, Aachen, Germany.
ReinHeart TAH GmbH, Aachen, Germany.
ASAIO J. 2022 Jan 1;68(1):34-40. doi: 10.1097/MAT.0000000000001415.
A downsized version of the ReinHeart total artificial heart (TAH) was developed. Hemocompatibility needs to be revised since the operating point of the downsized TAH has changed to a higher pump frequency to accomplish the same cardiac output. A mock circulation loop was designed, containing a left side for hemocompatibility testing and a right side to mimic realistic work conditions. A protocol for hemolysis testing was established using pooled porcine blood with an operation point of 5 L/min, a mean outlet pressure of 100 mm Hg and a mean inlet pressure of 12 mm Hg. Six trials were performed testing two downsized TAH (one with a compliance chamber [CC] connected, necessary for a pneumatic decoupling of both membranes and one open to atmosphere) and a BPX-80 as reference pump. The average modified index of hemolysis and normalized index of hemolysis (NIH in mg/100L) from six individual trials of the reference pump were 0.34 (0.07) and 3.21 (0.61) and of the TAH open to atmosphere 4.18 (1.19) and 38.85 (10.59), respectively. In between TAH with and without CC, there was no significant difference. A NIH ratio of TAH and reference pump was calculated to minimize variation of the different blood batches used in individual trials. Due to the downsizing, the ReinHeart's hemolysis level increased by around 22% compared with the original size version. Comparing the results to clinically approved left ventricular assist devices, the level of hemolysis can still be considered acceptable.
一种缩小版的 ReinHeart 全人工心脏（TAH）已经开发出来。由于缩小版 TAH 的工作点已改变为更高的泵频率以实现相同的心输出量，因此需要对血液相容性进行修正。设计了一个模拟循环回路，其中左侧用于血液相容性测试，右侧用于模拟实际工作条件。使用汇集的猪血建立了溶血测试协议，操作点为 5 L/min，平均出口压力为 100 mmHg，平均入口压力为 12 mmHg。进行了六次试验，测试了两个缩小版 TAH（一个连接有顺应性室[CC]，这对于两个膜的气动解耦是必要的，另一个与大气相通）和一个 BPX-80 作为参考泵。参考泵的六个单独试验的平均改良溶血指数和归一化溶血指数（NIH，以 mg/100L 表示）分别为 0.34（0.07）和 3.21（0.61），而 TAH 与大气相通的分别为 4.18（1.19）和 38.85（10.59）。在 TAH 有和没有 CC 的情况下，没有显著差异。计算了 TAH 和参考泵的 NIH 比值，以最小化单个试验中使用的不同血液批次的变化。由于缩小版，与原始尺寸版本相比，ReinHeart 的溶血水平增加了约 22%。与已批准的临床左心室辅助设备相比，溶血水平仍可被认为是可以接受的。
