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

项目总结 迫切需要一种长期的机械热支持装置，用于终末期死亡儿童 心力衰竭。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，开发足够小的儿童设备是困难的，因为 有很多不同的原因。儿童在年龄、体型和发育方面各有不同，每个变量都需要不同的 心血管方面的要求。心力衰竭的原因也可能有很大的不同，临床上可用的泵有 不适合这些患者中的许多，包括患有复杂先天性心脏病的患者，如单纯性心脏病 心腔。此外，开发一种专门用于儿童的设备在经济上可能并不可行 对于设备开发公司来说。为了使儿童心力衰竭的治疗选择进一步复杂化，有 没有足够的供体心脏可用于心脏移植，通常会导致在等待期间过早死亡 才能获得合适的捐献器官。考虑到心脏移植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，显然迫切需要的是一种 替代整个心脏功能的装置(所谓的“完全人工心脏”)。在NIH的资助下，取得了长足的进步 为了开发一种小到足以让孩子支撑衰竭的左心的装置，然而，仍然存在一个缺口， 为患有完全心力衰竭的儿童提供可行和长期的支持。BiVACOR全人工心脏 多年来一直在为成年人口发展，并准备提供完整的心脏 更换，在休息和运动时，几乎不会造成血液损伤。此外，没有任何部件会 磨损，因此几乎永久使用该装置在理论上是可能的。BiVACOR显著地 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的功能足够强大 支持儿童进入成年年龄，在他们成长过程中不再需要更换设备。因此，我们 目的通过了解儿童可以受益的大小，将BiVACOR技术用于儿童 从整个人工心脏，如果在心血管系统中看到的较低的心脏流量和压力 儿童在保持最小的血液损伤的同时，没有血栓形成，并提供良好的 所有器官的灌流。患者群体特有的侧支循环特征，如支气管壁增加 还将对Flow进行调查。BiVACOR将通过计算机植入进行评估，以了解 大小的胸腔适合于计算机化的流动动力学、模拟循环、血液循环和动物模型。快速- 正在寻求轨道资金，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 没有一颗完全人工心脏是无法生存的。

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.