Urgent and unmet need for a long-term solution for increasing pediatric heart-failure population: BiVACOR Rotary Total Artificial Heart

日益增加的儿科心力衰竭人群对长期解决方案的迫切且未满足的需求：BiVACOR 旋转式全人工心脏

• 批准号: 10462481
• 负责人: Iki Adachi
• 金额: $ 114.56万
• 依托单位: BIVACOR, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-05 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10462481
• 关键词: 15 year old; 5 year old; Address; Adult; Age; Anatomy; Animal Model; Artificial Heart; Award; Blood; Blood Circulation; Cardiac; Cardiovascular system; Cessation of life; Characteristics; Chest; Child; Child Support; Childhood; Chronic; Clinical; Complex; Computer software; Data; Destinations; Development; Device or Instrument Development; Devices; Diagnosis; Ensure; Ethics; Exercise; Family; Freezing; Funding; Graft Survival; Health Care Costs; Heart; Heart Diseases; Heart Transplantation; Heart failure; Hospitals; Housing; Implantable Pump; In Vitro; Left; Life Expectancy; Liquid substance; Magnetism; Mechanics; Medicine; Methods; Operative Surgical Procedures; Organ; Organ Donor; Outcome; Patients; Pediatric Hospitals; Performance; Perfusion; Phase; Physiological; Population; Pump; Quality of life; Recovery; Replacement Therapy; Rest; Risk; Small Business Innovation Research Grant; Solid; System; Techniques; Technology; Testing; Texas; Thrombosis; Thrombus; Time; Transplantation; Trauma; Treatment Failure; United States National Institutes of Health; Update; Variant; Waiting Lists; age group; biomaterial compatibility; blood damage; blood pump; cohort; college; commercialization; computerized; congenital heart disorder; design; heart function; hemocompatibility; implantation; improved; in vivo; innovation; mechanical circulatory support; mechanical device; mortality; operation; patient population; pediatric heart failure; pediatric patients; premature; pressure; programs; research and development; response; sheep model; success; total artificial heart; virtual

PROJECT SUMMARY There is an urgent and unmet need for long-term mechanical heat support device for children dying of end-stage heart failure. Improved surgical techniques and mechanical devices have improved the quality of life children with end-stage heart failure, however, the development of devices small enough for children is difficult due to many different reasons. Children vary in age, size and development, and each of those variables require different cardiovascular requirements. The cause of heart failure can also vary greatly, and clinically available pumps are not suitable for many of these patients, including patients with complex congenital heart disease such as single heart chamber. Additionally, the development of a device specifically for children may not be financially feasible for device development companies. To further complicate the heart failure treatment options for children, there are not enough donor hearts available for heart transplant, oftentimes resulting in premature death while waiting for a suitable donor organ to become available. Given such a frustrating reality of heart transplantation as well as the limitations of current mechanical heart support devices, it is clear that what is urgently necessary is a device to replace the entire heart function (so-called ‘total artificial heart’). With NIH funding, strides have been made to develop a device small enough for a child to support the failing left heart, however, a gap still exists, with viable and long-term support for children with complete heart failure. The BiVACOR total artificial heart has been under development for the adult population for many years and is poised to provide complete heart replacement, at rest and during exercise, with very little blood damage. Additionally, there are no parts that will wear and therefore nearly permanent use of the device is theoretically possible. The BiVACOR is significantly smaller than any other artificial heart currently available, but despite the small size, the TAH is powerful enough to support children into the adult age eliminating the need for device replacements as they grow. Therefore, we aim to utilize the BiVACOR technology for use in children, by understanding what size children could benefit from the total artificial heart, and if the lower heart flows and pressure as seen in the cardiovascular system of children are achieved, while maintaining minimal blood damage, no thrombus formation and providing good perfusion of all organs. Patient population specific collateral flow characteristics, such as an increased bronchial flow will also be investigated. The BiVACOR will be assessed via computerized implantation to understand what size chests are suitable, computerized flow dynamics, mock-circulation, blood loops and in animal models. Fast- track funding is being sought to ensure timely clinical use to save lives of many children who otherwise would not survive without a total artificial heart.

项目摘要 对于临终儿童的长期机械热支持装置的需求是迫切而未满足的 心衰改进的手术技术和机械装置提高了儿童的生活质量 然而，对于终末期心力衰竭，由于 很多不同的原因。儿童在年龄、体型和发育方面各不相同，每一个变量都需要不同的 心血管需求。心力衰竭的原因也可能变化很大，临床上可用的泵是 不适合许多这类患者，包括单胎等复杂先天性心脏病患者。 心室此外，开发专门针对儿童的设备在经济上可能不可行 设备开发公司。为了进一步复杂化儿童心力衰竭的治疗选择， 没有足够的供体心脏可用于心脏移植，经常导致在等待期间过早死亡 等待合适的捐赠器官考虑到心脏移植也是如此令人沮丧的现实， 由于目前机械心脏支持装置的局限性，很明显，迫切需要的是一种 这是一种替代整个心脏功能的设备（所谓的“全人工心脏”）。在NIH的资助下， 为了开发一种小到足以让孩子支撑衰竭的左心脏的设备，然而，仍然存在差距， 为患有完全心力衰竭的儿童提供可行的长期支持。BiVACOR全人工心脏 多年来一直在为成年人开发，并准备提供完整的心脏 在休息和运动期间，很少有血液损伤。此外，没有部件会 磨损并因此几乎永久使用该装置在理论上是可能的。BiVACOR显著 比目前可用的任何其他人工心脏都要小，但尽管体积小，TAH却足够强大。 以支持儿童进入成年年龄，从而在他们成长时无需更换设备。所以我们 旨在通过了解多大尺寸的儿童可以受益，将BiVACOR技术用于儿童 从整个人工心脏，如果较低的心脏流量和压力，如在心血管系统中看到的， 实现了儿童，同时保持最小的血液损伤，没有血栓形成，并提供良好的 所有器官的灌注。患者人群特异性侧支血流特征，例如支气管扩张增加。 流量也将进行调查。将通过计算机植入评估BiVACOR，以了解 尺寸合适的胸部，计算机化的流动动力学，模拟循环，血液循环和动物模型。快- 正在寻求跟踪资金，以确保及时的临床使用，以挽救许多儿童的生命，否则他们将 没有人造心脏就活不下去