Development of an Infant VAD System for Long Term Uni- and Bi-ventricular Support

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DESCRIPTION (provided by applicant): Development of an Infant VAD System for Long Term Uni- and Bi-ventricular Support Project Summary This objective of the project is to develop a Ventricular Assist System (VAS) for supporting infants with severe heart failure. The VAS consists of an Infant-sized Ventricular Assist Device (VAD) which can be used to support the left ventricle or right ventricle, or both ventricles (biventricular support), and a portable BiVAD driver which can power left and right VADs. Although VADs have been successfully used for adult heart-failure patients for over 30 years, their introduction to pediatrics has been slow to evolve. The pneumatically-actuated, pulsatile VAD is well-suited to the pediatric application, especially in infants. It may be utilized for right, left, or bi-ventricular support. Penn State and Minnetronix have developed a pulsatile pneumatic sac-type pediatric Ventricular Assist System based on the design of the adult-sized Pierce-Donachy (Thoratec(R)) VAD. The Infant VAD has a dynamic stroke volume of 14 ml, and is capable of supporting the circulation for periods up to one year. This work extends that development to a portable pneumatic driver and control system which will complete the development of the infant VAS in preparation for pre-clinical testing. The driver will incorporate innovative features to automatically optimize the pump operation to achieve maximum flow rate under all preload conditions, and minimize thrombembolic risk, including during weaning. Special emphasis will be placed on usability in pediatric heart centers unfamiliar with VAD systems. PUBLIC HEALTH RELEVANCE: The pediatric Ventricular Assist Device (VAD) will provide a currently-unavailable option for safe, long term support for infants with failing hearts or congenital heart defects. Because it will be able to safely replace the function of both pumping chambers of the heart for extended periods of time, this system will provide a valuable new care option.