Feasibility Testing of Miniaturized Ventricular Assist Device (MVAD)

小型化心室辅助装置（MVAD）的可行性测试

• 批准号: 8057276
• 负责人: Daniel Tamez
• 金额: $ 38.58万
• 依托单位: HEARTWARE, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-14 至 2012-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8057276
• 关键词: Acute; Adult; Animal Experiments; Animal Model; Animals; Area; Cadaver; Cannulas; Cardiac Surgery procedures; Cardiopulmonary Bypass; Cardiovascular system; Caring; Chronic; Clinical; Clinical Trials; Communities; Computer-Aided Design; Core Assembly; Development; Device Safety; Devices; Effectiveness; Engineering; Ensure; Heart failure; Hemolysis; Hospital Costs; Hospitals; Housing; Human; Implant; Institutes; Left; Left ventricular structure; Length; Liquid substance; Medical; Minimally Invasive Surgical Procedures; Modeling; Myocardial; Myocardium; Operative Surgical Procedures; Organ; Outcome; Patients; Performance; Perfusion; Phase; Physicians; Positioning Attribute; Postoperative Period; Preparation; Pump; Quality of life; Recovery; Research; Risk; Staging; Sternotomy; Surface; Surgical incisions; Target Populations; Technology; Testing; Thoracotomy; Thrombus; Time; Universities; Ventricular; Woman; Work; Workload; aortic valve; base; blood pump; design; follower of religion Jewish; implantation; improved; in vivo; innovation; miniaturize; next generation; pre-clinical; programs; prototype; research study; success; ventricular assist device; verification and validation

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.

描述（由申请人提供）：REMATCH 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比最佳医疗管理治疗提供了更好的患者结果。尽管泵的设计、性能和可靠性有了显着改进，可以挽救生命并恢复生活质量，但医生仍不愿意将心力衰竭较晚期的患者转诊至 LVAD 技术。 HeartWare（佛罗里达州迈阿密湖）正在开发一种微型心室辅助装置（MVAD），该装置可以以微创方式“非体外循环”植入，以治疗更多的心力衰竭患者目标群体。 HeartWare MVAD 是一款轴流式血泵，采用“宽叶片”叶轮，每个叶片上均配有双流体动力轴承，可提供高达 6 L/m 的流量。该装置由一个固定在心尖附近心肌外表面的锚定部分、一个将驱动电缆传送到左心室外部并将泵壳固定在心肌内部表面的立管、一个包含 MVAD 核心组件和叶片扩散器的泵壳以及一个穿过主动脉瓣的流出插管组成。这种方法的临床好处包括有机会治疗病情较轻的患者。 心力衰竭、改善患者治疗效果、缩短恢复时间并降低住院费用。该提案的目的是开发微创外科手术并完成 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，并评估解剖结构适合度并开发人类尸体的外科手术。拟议的可行性测试研究将在路易斯维尔大学 (UofL) 的心血管创新研究所 (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 FDA 提交临床试验做准备。 ） 公共健康相关性：HeartWare（佛罗里达州迈阿密湖）正在开发一种微型心室辅助装置 (MVAD)，该装置可以“脱离泵”并使用侵入性较小的外科手术进行植入。 HeartWare MVAD 的临床优势包括有机会治疗病情较轻的心力衰竭患者、改善患者治疗效果、缩短恢复时间并降低住院费用。

项目成果

Transapical miniaturized ventricular assist device: design and initial testing.

经心尖微型心室辅助装置：设计和初始测试。

• DOI: 10.1016/j.jtcvs.2011.01.011
• 发表时间: 2011
• 期刊: The Journal of thoracic and cardiovascular surgery
• 作者: Slaughter,MarkS;Giridharan,GuruprasadA;Tamez,Dan;LaRose,Jeff;Sobieski,MikeA;Sherwood,Leslie;Koenig,StevenC
• 通讯作者: Koenig,StevenC