Miyagi Chihiro, Kuroda Taiyo, Polakowski Anthony R, Flick Christine R, Gao Shengqiang, Kuban Barry D, Karimov Jamshid H, Fukamachi Kiyotaka
Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.
Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio.
JHLT Open. 2024 Jul 17;5:100118. doi: 10.1016/j.jhlto.2024.100118. eCollection 2024 Aug.
The pediatric continuous-flow total artificial heart (P-CFTAH) is a novel double-ended centrifugal pump designed with the intent to provide circulatory support for pediatric heart failure. To enable continuous monitoring of pump hemodynamics, Hall effect sensors (HES) were embedded inside the P-CFTAH design to track both axial movement and position of the pump rotor postimplantation. Herein, we report an early in vivo evaluation of the P-CFTAH with HES, implanted in small-sized ovine models.
Five healthy lambs were used for the P-CFTAH implantation via a full median sternotomy and cardiopulmonary bypass support. Successful evaluation of the P-CFTAH was achieved in 4 out of 5 ( = 4, 20.9 ± 1.3 kg). The hemodynamics and operating conditions were continuously recorded with varying pump speeds (2,800-5,000 rpm), systemic/pulmonary vascular resistance ratio, and high- and low-volume conditions. Among the 4 cases, P-CFTAH with HES embedded in the rotor was used in 2 cases.
All surgical procedures were uneventful, and the optimal anatomical fit of the pump was shown in the chest. Differences between the left and right atrial pressures were mostly maintained within the intended limit of ±10 mm Hg throughout the design range of systemic and pulmonary vascular resistance. The HES accurately traced the rotor position, showing a positive correlation with atrial pressure differences.
The findings suggest that the P-CFTAH has the potential to provide self-balancing circulatory support for pediatric heart failure patients. The study contributes to the development of a pediatric-sized total artificial heart with improved monitoring.
小儿连续流全人工心脏（P-CFTAH）是一种新型双端离心泵，旨在为小儿心力衰竭提供循环支持。为了能够持续监测泵的血流动力学，霍尔效应传感器（HES）被嵌入到P-CFTAH的设计中，以跟踪植入后泵转子的轴向运动和位置。在此，我们报告了在小型绵羊模型中植入带有HES的P-CFTAH的早期体内评估。
五只健康羔羊通过全胸骨正中切开术和体外循环支持进行P-CFTAH植入。5只羔羊中有4只（n = 4，体重20.9±1.3千克）成功完成了P-CFTAH评估。在不同的泵速（2800 - 5000转/分钟）、体循环/肺循环阻力比以及高容量和低容量条件下，持续记录血流动力学和运行情况。在这4例中，2例使用了转子中嵌入HES的P-CFTAH。
所有手术过程均顺利，泵在胸部显示出最佳的解剖适应性。在体循环和肺循环阻力的整个设计范围内，左心房和右心房压力差大多保持在预期的±10毫米汞柱范围内。HES准确地追踪了转子位置，与心房压力差呈正相关。
研究结果表明，P-CFTAH有可能为小儿心力衰竭患者提供自我平衡的循环支持。该研究有助于开发具有改进监测功能的小儿尺寸全人工心脏。
