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 对于长期的机械热支撑装置，终于终于末期的儿童有紧急卸载 心力衰竭。 然而，随着末期心力衰竭的开发，适合儿童的设备的开发是差不多的。 不同的原因。 心血管衰竭的原因也可能有所不同，临床上可用的泵 不适用于许多患者，包括复杂的先天性心脏病患者，例如单身 心脏室。 为了进一步的公司开发公司。 Nough Hearts是否可用于心脏移植 为了使合适的供体器官可用。 作为当前机械心脏支撑设备的局限 替换整个心脏功能的设备（所谓的“人造心脏”）。 为了开发一个足够小的设备，以使孩子支持左心脏，仍然存在差距， 对Comprete心力衰竭的儿童有可行的长期支持。 成年人口正在开发多年，并且已经准备好了 更换，休息和运动过程中，几乎没有血液损伤。 磨损，因此几乎永久使用该设备。 比目前可用的任何人工头饰的心脏小，但是尽管尺寸很小，但TAH的功能足够强大 为了支持儿童成年时代，消除了随着设备的生长而需要更换设备的需求。 旨在利用双虎技术在儿童中使用，了解哪些尺寸的孩子可以受益 从总人工心脏，下心流动和压力如心血管系统所见 儿童疼痛，同时保持最小的血液损伤，没有血栓形成并提供良好 所有器官的灌注。 还将通过计算机植入来评估双子 大小的箱子是合适的，计算机流动动力学，模拟循环，血环和动物模型中的。 正在寻求追踪资金，以确保及时使用临床用途，以挽救许多孩子的生命 没有人造心脏就无法生存。