Feasibility Testing of Miniaturized Ventricular Assist Device (MVAD)

描述（由申请人提供）：REMATCH试验表明，采用左心室辅助装置（LVAD）支持的终末期心力衰竭患者比最佳医疗管理治疗提供了更好的患者预后。尽管在泵的设计、性能和可靠性方面有了显著的改进，挽救了生命，恢复了生活质量，但医生不愿意推荐不太晚期的心力衰竭患者使用LVAD技术。HeartWare公司（Miami Lakes， FL）正在开发一种微型心室辅助装置（MVAD），该装置可以植入侵入性更小且“无泵”，以治疗更多的心衰患者。HeartWare MVAD是一种轴向血流泵，使用“宽叶片”叶轮，每个叶片上有双流体动力轴承，可提供高达6升/米的流量。设备由锚部分相连的外部表面顶点附近的心肌,携带的竖管驱动电缆外部的左心室,泵壳体的内部心肌表面,一个泵壳体,其中包含MVAD核心组装和叶片扩压器,和流出套管穿过主动脉瓣的临床效益这种方法包括治疗的机会少先进的高频,改善患者治疗效果，缩短康复时间，降低住院费用。本提案的目的是开发微创手术程序并完成HeartWare MVAD的可行性测试。在具体目标1中，我们将在急性和30天慢性大型动物模型中完成HeartWare MVAD的可行性测试，以评估设备性能和血液相容性，并评估人体尸体的解剖适应性和开发外科手术程序。拟议的可行性测试研究将在路易斯维尔大学（UofL）心血管创新研究所（CII）进行。如果成功，我们将在第二阶段完成HeartWare MVAD的开发，并进行长期GLP动物植入，为向FDA提交临床试验做准备。)

DESCRIPTION (provided by applicant): The REMATCH trial demonstrated that end-stage heart failure patients supported by a left ventricular assist device (LVAD) provided better patient outcomes than optimal medical management therapy. Despite significant improvements in pump design, performance, and reliability that save lives and restores quality of life, physicians are reluctant to refer patients in less advanced stages of heart failure for LVAD technology. HeartWare (Miami Lakes, FL) is developing a miniature ventricular assist device (MVAD) that may be implanted less invasively and 'off-pump' to treat larger target population of HF patients. The HeartWare MVAD is an axial flow blood pump that uses a 'wide blade' impeller with dual hydrodynamic bearings on each blade to deliver up to 6 L/m flow. The device consists of an anchor section that is attached to the external surface of the myocardium near the apex, a standpipe that carries the drive cables external to the left ventricle and holds the pump housing off of the internal myocardial surface, a pump housing that contains the MVAD core assembly and a vane diffuser, and a outflow cannula that crosses the aortic valve The clinical benefits of this approach include the opportunity to treat patients with less advanced HF, improved patient outcomes, shorter recovery times, and lower hospital costs. The objective of this proposal is to develop minimally invasive surgical procedure and complete feasibility testing of the HeartWare MVAD. In Specific Aim 1, we will complete feasibility testing of the HeartWare MVAD in acute and 30-day chronic large animal models to assess device performance and hemocompatability, and evaluate anatomical fit and develop surgical procedures in human cadavers. The proposed feasibility testing studies will be conducted at the Cardiovascular Innovation Institute (CII) at the University of Louisville (UofL). If successful, in Phase 2 we will complete development of the HeartWare MVAD and perform long-term GLP animal implants in preparation of an FDA submission for clinical trials. ) PUBLIC HEALTH RELEVANCE: HeartWare (Miami Lakes, FL) is developing a miniature ventricular assist device (MVAD) that can be implanted 'off pump' and using a less invasive surgical procedure. The clinical benefits of the HeartWare MVAD include the opportunity to treat patients with less advanced HF, improved patient outcomes, shorter recovery times, and lower hospital costs.