Department of Cardiothoracic Surgery, Newcastle upon Tyne Freeman Hospital, Newcastle upon Tyne, United Kingdom.
Department of Cardiothoracic Surgery, Transplantation, and MCS Programme, Harefield Hospital, Harefield, United Kingdom.
J Thorac Cardiovasc Surg. 2023 Oct;166(4):1119-1129.e1. doi: 10.1016/j.jtcvs.2021.11.093. Epub 2022 Mar 1.
Due to severely limited donor heart availability, durable mechanical circulatory support remains the only treatment option for many patients with end-stage heart failure. However, treatment complexity persists due to its univentricular support modality and continuous contact with blood. We investigated the function and safety of reBEAT (AdjuCor GmbH), a novel, minimal invasive mechanical circulatory support device that completely avoids blood contact and provides pulsatile, biventricular support.
For each animal tested, an accurately sized cardiac implant was manufactured from computed tomography scan analyses. The implant consists of a cardiac sleeve with three inflatable cushions, 6 epicardial electrodes and driveline connecting to an electro-pneumatic, extracorporeal portable driver. Continuous epicardial electrocardiogram signal analysis allows for systolic and diastolic synchronization of biventricular mechanical support. In 7 pigs (weight, 50-80 kg), data were analyzed acutely (under beta-blockade, n = 5) and in a 30-day long-term survival model (n = 2). Acquisition of intracardiac pressures and aortic and pulmonary flow data were used to determine left ventricle and right ventricle stroke work and stroke volume, respectively.
Each implant was successfully positioned around the ventricles. Automatic algorithm electrocardiogram signal annotations resulted in precise, real-time mechanical support synchronization with each cardiac cycle. Consequently, progressive improvements in cardiac hemodynamic parameters in acute animals were achieved. Long-term survival demonstrated safe device integration, and clear and stable electrocardiogram signal detection over time.
The present study demonstrates biventricular cardiac support with reBEAT. Various demonstrated features are essential for realistic translation into the clinical setting, including safe implantation, anatomical fit, safe device-tissue integration, and real-time electrocardiogram synchronized mechanical support, result in effective device function and long-term safety.
由于供体心脏严重短缺，耐用的机械循环支持仍然是许多终末期心力衰竭患者的唯一治疗选择。然而，由于其单心室支持方式和与血液的持续接触，治疗的复杂性仍然存在。我们研究了 reBEAT（AdjuCor GmbH）的功能和安全性，这是一种新型的微创机械循环支持装置，完全避免血液接触，并提供搏动性、双心室支持。
对于每个接受测试的动物，都根据计算机断层扫描分析制造出尺寸精确的心脏植入物。该植入物由一个带有三个可充气垫的心脏套管、6 个心外膜电极和与电动、体外便携式驱动器相连的传动线组成。连续的心外膜心电图信号分析允许双心室机械支持的收缩和舒张同步。在 7 头猪（体重 50-80 公斤）中，急性（β受体阻滞剂下，n=5）和 30 天长期生存模型（n=2）中分析数据。获取心内压和主动脉及肺动脉流量数据，用于确定左心室和右心室每搏功和每搏量。
每个植入物都成功地定位在心室周围。自动算法心电图信号注释实现了与每个心动周期的精确实时机械支持同步。因此，急性动物的心脏血液动力学参数得到了逐步改善。长期生存证明了设备的安全整合，以及随着时间的推移清晰稳定的心电图信号检测。
本研究证明了 reBEAT 的双心室心脏支持。各种已证明的特征对于现实转化到临床环境中至关重要，包括安全植入、解剖适配、安全的设备-组织整合以及实时心电图同步机械支持，从而实现有效的设备功能和长期安全性。
