Feasibility Testing of Miniaturized Ventricular Assist Device (MVAD)

描述(由申请人提供)：再匹配试验表明，由左心室辅助装置(LVAD)支持的终末期心力衰竭患者提供比最佳医疗管理疗法更好的患者结果。尽管泵的设计、性能和可靠性有了显著改进，挽救了生命并恢复了生活质量，但医生不愿让心力衰竭程度较低的患者接受LVAD技术。哈特威尔公司(佛罗里达州迈阿密湖市)正在开发一种微型心脏辅助装置(MVAD)，这种装置植入时侵入性较小，不需要体外循环，可用于治疗更多的心衰目标人群。HeartWare MVAD是一种轴流血泵，它使用一个“宽叶片”叶轮，每个叶片上都有双流体动力轴承，可输送高达6 L/米的流量。该装置包括一个固定在心尖附近心肌外表面的固定部分，一个在左心室外部承载驱动电缆并将泵外壳保持在内部心肌表面上的立管，一个包含MVAD核心组件和叶片扩散器的泵罩，以及一个横跨主动脉瓣的流出套管。这种方法的临床好处包括有机会治疗不太严重的心衰患者，改善患者的预后，缩短康复时间，降低医院成本。这项提案的目标是开发微创外科手术程序，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上完成HeartWare MVAD的可行性测试，以评估设备性能和血液相容性，并评估人体身体的解剖适合性和开发手术程序。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，在第二阶段，我们将完成HeartWare MVAD的开发，并进行长期的GLP动物植入，为FDA提交的临床试验做准备。) 与公共卫生相关：哈特威尔(佛罗里达州迈阿密湖)正在开发一种微型心脏辅助装置(MVAD)，该装置可以在非体外循环下植入，并使用一种侵入性较小的手术程序。HeartWare MVAD的临床好处包括有机会治疗心力衰竭程度较低的患者、改善患者的预后、缩短康复时间和降低医院成本。

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.