Effects of a Pulse Induced by a Constant-Flow Total Cardiac Replacement Device

恒流全心脏置换装置引起的脉冲效应

• 批准号: 8098975
• 负责人: O. H. FRAZIER
• 金额: $ 80.68万
• 依托单位: TEXAS HEART INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8098975
• 关键词: Abbreviations; Adherens Junction; Affect; Animals; Attenuated; Belief; Biomedical Engineering; Blood Circulation; Bypass; Cardiac; Cardiopulmonary; Cardiopulmonary Bypass; Cardiovascular system; Cessation of life; Characteristics; Clinical; Clinical Trials; Collaborations; Development; Device or Instrument Development; Devices; Engineering; Equilibrium; Evolution; Exercise; Goals; Healthcare; Heart; Heart failure; Human; Implant; Induced Heart Arrest; Institution; Laboratories; Left; Left ventricular structure; Light; Lung; Mechanics; Membrane; Metabolic; Modeling; Moderate Exercise; New York; Organ; Output; Patients; Perfusion; Peripheral; Physiologic pulse; Physiological; Physiology; Positioning Attribute; Prosthesis; Pulmonary Circulation; Pulse Pressure; Pump; Quality of life; Recording of previous events; Research; Resources; Skeletal Muscle; Speed; Staging; System; Talents; Techniques; Technology; Testing; United States; Vascular resistance; Venous; Ventricular; Work; blood pump; clinical application; design; experience; flexibility; implantable device; implantation; improved; in vivo; innovation; meetings; methionylmethionine; next generation; premature; pressure; research study; response; time interval; total artificial heart; ventricular assist device

PROJECT SUMMARY A simple, safe, reliable mechanical replacement for the failing human heart would dramatically impact health care. Over the past four decades, substantial effort has been expended to develop a cardiac replacement device (CRD), but technical hurdles have been prohibitive. The introduction of the constant-flow (CF) rotary blood pump over the last 7 years has revolutionized the field of cardiac support. These pumps are smaller, more energy efficient, and less expensive to produce than their pulsatile predecessors, and their lack of valves and flexible membranes makes them impervious to mechanical wear. More than 1,000 patients have been treated with CF pumps; one of the first such pumps to be implanted functions well more than 6 years later. The goal of the proposed BRP project is to show that a next-generation CRD comprising two integrated CF (HeartMate III) rotary pumps can provide adequate pulmonary and systemic circulation to meet physiologic demands. The specific aims of this project are (1) to refine and improve the CRD for total cardiac replacement using combined engineering and in vivo experiments, such that the device allows calves to thrive for up to 3 months after implantation, and to compare the physiology of the calves using the CRD in constant-flow (pulseless) mode or actuated to impart a physiologic pulse pressure at 40 pulses/min; (2) to observe the effects of pulseless and reduced-pulse perfusion at the microvascular level in the lungs and other organs; and (3) to evaluate the exercise capacity of CRD-implanted calves and the ability of the CRD to respond to increased metabolic demands during exercise. This study should provide the necessary evidence to shift global efforts at CRD development from volume-displacement to CF technology and will hasten the day when "management of end-stage heart failure" can be crossed off the list of unmet clinical needs. The assemblage of pioneers in the field, innovative talent, experienced institutions, and resources proposed for this work-as well as the longstanding collaboration between the participating institutions that has culminated in pioneering clinical trials-uniquely positions this BRP team to successfully achieve its stated goals.

项目摘要 简单，安全，可靠的机械替代人为失败的人心脏会极大地影响健康 关心。在过去的四十年中，已经花费了大量精力来发展心脏替代品 设备（CRD），但技术障碍却是艰难的。引入恒定流量（CF）旋转 在过去的7年中，血泵彻底改变了心脏支持领域。这些泵很小， 比脉动的前辈更节能，生产价格便宜，而且缺乏阀门 柔性膜使它们不受机械磨损的影响。超过1,000名患者 用CF泵处理；超过6年后，最早的植入功能的此类泵之一。这 拟议的BRP项目的目标是表明，下一代CRD包括两个集成CF （心友III）旋转泵可以提供足够的肺和全身循环以满足生理 需求。该项目的具体目的是（1）完善和改善CRD的总替代品 使用组合的工程和体内实验，使该设备允许犊牛蓬勃发展至3 植入后的几个月，并在恒定流中使用CRD比较犊牛的生理 （无脉冲）模式或以40脉冲/min的速度赋予生理脉冲压力； （2）观察 在肺和其他器官微血管水平上无脉冲和减少脉冲灌注的影响；和 （3）评估CRD植入犊牛的运动能力和CRD的能力 运动过程中的代谢需求增加。这项研究应提供必要的证据来转移 全球CRD开发的努力从量置换到CF技术，并将加快这一天 可以将“终末期心力衰竭的管理”纳入未满足的临床需求清单。组合 该领域的开拓者，创新的人才，经验丰富的机构和为这项工作提出的资源 - 作为最终达到开拓的参与机构之间的长期合作 临床试验 - 唯一地定位了这个BRP团队，以成功实现其既定目标。