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

日益增加的儿童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: 10687110
• 负责人: Iki Adachi
• 金额: $ 56.47万
• 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/10687110
• 关键词: 15 year old; 5 year old; Address; Adult; Age; Anatomy; Animal Model; Artificial Heart; Award; Blood; Cardiac; Cardiac Surgery procedures; Cardiovascular system; Cessation of life; Characteristics; Chest; Child; Child Support; Childhood; Chronic; Circulation; Clinical; Complex; Computer software; Data; Destinations; Development; Device or Instrument Development; Devices; Diagnosis; Ensure; Ethics; Exercise; Family; Freezing; Frustration; Funding; Graft Survival; Health Care Costs; Heart; Heart Diseases; Heart Transplantation; Heart failure; Hospitals; Housing; Implant; 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; Specific qualifier value; System; Techniques; Technology; Testing; Texas; Thrombosis; Thrombus; Transplantation; Trauma; Treatment Failure; United States National Institutes of Health; Update; Variant; Ventricular; 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; manufacture; 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.

项目概要 对于终末期死亡的儿童来说，对长期机械热支持装置的需求迫切且未得到满足 心力衰竭的改进手术技术和机械设备改善了儿童的生活质量。 然而，对于终末期心力衰竭，开发足够小的儿童设备是困难的，因为 儿童的年龄、体型和发育情况各不相同，并且每个变量都需要不同的原因。 心力衰竭的原因也有很大差异，临床上可用的泵有多种。 不适合其中许多患者，包括患有复杂先天性心脏病的患者，例如单发性心脏病患者 此外，开发专门针对儿童的设备在经济上可能不可行。 对于设备开发公司来说，儿童心力衰竭的治疗选择进一步复杂化。 没有足够的供体心脏用于心脏移植，常常导致等待期间过早死亡 考虑到心脏移植的这一令人沮丧的现实，也需要找到合适的供体器官。 由于现有机械心脏支持装置的局限性，显然迫切需要的是 在 NIH 的资助下，替代整个心脏功能的设备（所谓的“全人工心脏”）取得了长足的进步。 旨在开发一种足够小的装置，供儿童支撑衰竭的左心，然而，差距仍然存在， BiVACOR 全人工心脏为患有完全心力衰竭的儿童提供可行的长期支持。 多年来一直在为成年人开发，并准备提供完整的心脏 此外，在休息和运动时更换，不会造成任何血液损伤。 因此，理论上 BiVACOR 几乎可以永久使用。 比目前可用的任何其他人造心脏都要小，但尽管尺寸很小，TAH 的功能却足够强大 支持儿童进入成年阶段，消除他们成长过程中更换设备的需要。 旨在通过了解哪些体型的儿童可以受益，将 BiVACOR 技术用于儿童 来自全人造心脏，如果下层心脏的流量和压力如心血管系统所示 实现了儿童的成功，同时保持了最小的血液损伤，没有血栓形成，并提供了良好的 所有器官的灌注。患者群体特定的侧支血流特征，例如支气管增加。 BiVACOR 也将通过计算机植入进行评估，以了解具体情况。 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。 正在寻求跟踪资金，以确保及时进行临床使用，以挽救许多儿童的生命，否则他们将 没有完全的人造心脏就无法生存。