The use of dedicated pulsatile ventricular support devices (VAD) for circulatory support is becoming an accepted treatment modality for adult patients requiring support due to post-cardiotomy pump failure or post- AMI cardiogenic shock, and as bridge to transplant. Although temporary circulatory support in pediatric patients is being performed with ECMO or centrifugal pumps, no dedicated pulsatile VAD have been developed for pediatric application. The proposed pediatric VAD addresses this need with the goal of developing an inexpensive pulsatile device. The device is tubular in construction with integrally formed inflow valve, pump chamber, and outflow valve. The inflow valve and pump are actuated pneumatically. The outflow valve is passively operated. The designed stroke volume is l0cc suitable for neonates and infants weighing up to l0kg. The device is designed to have minimal surface area and is small in size to minimize hemodilution, heat loss and bleeding complications. Phase I in vitro studies demonstrated the good filling characteristics of the pump, while the in vivo studies verified the hemodynamic function and the hematologic compatibility of the device. The Phase II program will focus on the completion of a portable console with a close-loop control sensitive to filling pressures. In vitro reliability testing and in vivo studies will be conducted to qualify for a 7-day intended use. Additional in vivo characterization studies will be conducted for uni- and bi-ventricular support.
The potential application of the proposed device is in the approximately 20,000 pediatric cardiac surgery cases performed in the United States annually. Initial application will be in cases involving post-cardiotomy support subsequent to the correction of congenital heart defect or in patients with cardiopulmonary compromise secondary to myocarditis and/or cardiomyopathy.
