Fukamachi Kiyotaka, Horvath David J, Massiello Alex L, Ootaki Yoshio, Kamohara Keiji, Akiyama Masatoshi, Zahr Firas, Kopcak Michael W, Dessoffy Raymond, Chen Ji-Feng, Benefit Stephen, Golding Leonard A R
Department of Biomedical Engineering, Lerner Research Institute, The Cleveland Clinic Foundation, Cleveland, OH 44195, USA.
ASAIO J. 2005 Nov-Dec;51(6):730-5. doi: 10.1097/01.mat.0000181031.66900.b6.
The purpose of this program is to design, develop, and clinically evaluate a new, implantable right ventricular assist device (RVAD) that can be used as a component of an implantable biventricular assist device for patients with severe biventricular heart failure. The initial phase of this program resulted in a prototype RVAD, named DexAide, a modified version of the CorAide left ventricular assist device. In vitro testing was performed in a stand-alone circuit and in a true RVAD mode to evaluate pump performance. Pump flow and power were measured under various afterload and pump speed conditions. The pump performance requirements of 2 to 6 l/min and a pressure rise of 20 to 60 mm Hg were successfully met with pump speeds between 1,800 and 3,200 rpm. The nominal design point of 4 l/min and 40 mm Hg pressure rise was achieved at 2,450 +/- 70 rpm with a power consumption of 3.0 +/- 0.2 W. The initial in vitro testing met the design criteria for the new DexAide RVAD. Initial in vivo testing is under way, which will be followed by preclinical readiness testing and a pilot clinical trial in this 5-year program.
本项目的目的是设计、开发并对一种新型可植入式右心室辅助装置（RVAD）进行临床评估，该装置可作为严重双心室心力衰竭患者植入式双心室辅助装置的一个组件。本项目的初始阶段产生了一个名为DexAide的RVAD原型，它是CorAide左心室辅助装置的改进版本。在独立回路和真正的RVAD模式下进行了体外测试，以评估泵的性能。在各种后负荷和泵速条件下测量了泵流量和功率。泵速在1800至3200转/分钟之间时，成功满足了2至6升/分钟的泵性能要求以及20至60毫米汞柱的压力上升要求。在2450±70转/分钟时达到了4升/分钟和40毫米汞柱压力上升的标称设计点，功耗为3.0±0.2瓦。初步体外测试符合新型DexAide RVAD的设计标准。初始体内测试正在进行中，在这个为期5年的项目中，随后将进行临床前准备测试和一项试点临床试验。
