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

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.