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.
Public Health Relevance Statement: NARRATIVE Pediatric heart failure is complex, and the patient population is heterogeneous in age, size and diagnosis, with limited treatment options available for children. Although heart transplant serves as a final option in children with end-stage heart failure, this mode of therapy is inherently limited due to the limited organ availability; and there has been an ongoing worsening of the imbalance between the increasing demand for heart transplant (i.e. the number of children awaiting transplant) and the stagnant supply (i.e. the number of donor organs available for transplant), resulting in premature deaths on the wait list. Therefore, there is an urgent and unmet need for a mechanical heart device that is durable and can replace the heart completely (so-called total artificial heart), as nothing yet exists for pediatric patients, and the BiVACOR total artificial heart is small enough to provide a long- term solution for the pediatric end-stage heart failure population, reducing morbidly, mortality and healthcare cost; and increasing quality of life for children and their families.
Project Terms: Adult; 21+ years old; Adult Human; adulthood; Age; ages; Anatomy; Anatomic; Anatomic Sites; Anatomic structures; Anatomical Sciences; Award; Blood; Blood Reticuloendothelial System; Blood Circulation; Bloodstream; Circulation; Cardiovascular system; Cardiovascular; Cardiovascular Body System; Cardiovascular Organ System; Heart Vascular; circulatory system; Child; 0-11 years old; Child Youth; Children (0-21); youngster; Cessation of life; Death; Diagnosis; Ethics; ethical; Exercise; Family; Freezing; Graft Survival; Heart; Heart Diseases; Cardiac Diseases; Cardiac Disorders; heart disorder; Heart failure; cardiac failure; Heart Transplantation; Cardiac Transplantation; Heart Grafting; cardiac graft; cardiovascular transplantation; heart transplant; Artificial Heart; cardiac prosthesis; heart prosthesis; mechanical heart; prosthetic heart; Hospitals; Pediatric Hospitals; Children's Hospital; Housing; In Vitro; Life Expectancy; Medicine; Methods; mortality; United States National Institutes of Health; NIH; National Institutes of Health; Organ Donor; Patients; Perfusion; pressure; Quality of life; QOL; research and development; Development and Research; R & D; R&D; Rest; Risk; Computer software; Software; Technology; Testing; Texas; Thrombosis; thrombotic disease; thrombotic disorder; Time; Transplantation; transplant; Waiting Lists; waitlist; Child Support; Destinations; Health Care Costs; Health Costs; Healthcare Costs; Thrombus; congenital heart disorder; congenital cardiac abnormality; congenital cardiac disease; congenital cardiac disorder; congenital cardiac malformation; congenital heart abnormality; congenital heart anomaly; congenital heart disease; congenital heart malformation; Treatment Failure; therapy failure; Organ; blood pump; total artificial heart; Pump; improved; Left; Chronic; Solid; Clinical; premature; prematurity; Phase; Variant; Variation; Physiological; Physiologic; Ensure; Childhood; pediatric; heart function; cardiac function; function of the heart; Recovery; Funding; Replacement Therapy; fluid; liquid; Liquid substance; programs; mechanical; Mechanics; Complex; Techniques; System; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Operative Surgical Procedures; collegiate; college; magnetic; Magnetism; age group; biocompatibility; biomaterial compatibility; Performance; success; cohort; Animal Models and Related Studies; model of animal; model organism; Animal Model; Devices; Thorace; Thoracic; Thorax; Chest; response; Address; Data; device development; instrument development; Device or Instrument Development; Implantable Pump; in vivo; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Update; Characteristics; Cardiac; Development; developmental; virtual; computerized; design; designing; Outcome; Population; Trauma; innovation; innovate; innovative; 5 year old; 5 years of age; age 5 years; five year old; five years of age; 15 year old; 15 years of age; age 15 years; fifteen year old; fifteen years of age; implantation; commercialization; patient population; operation; pediatric patients; child patients; pediatric heart failure; childhood heart failure; hemocompatibility; blood damage; mechanical device; sheep model; ovine animal model; ovine model
