New VADs Offer Hope for Children With Heart Defects

April 19, 2011 – Promising new devices for mechanical circulatory support of children with heart defects or heart failure, and related research, will be revealed this week at the International Society for Heart and Lung Transplantation (ISHLT) 31st Annual Meeting and Scientific Sessions. An update from the Pumps for Kids, Infants and Neonates (PumpKIN) Program will be presented during the meeting in San Diego. PumpKIN is supported by the National Heart, Lung, and Blood Institute (NHLBI), a branch of the National Institutes of Health (NIH). Despite rapid advances in the technology of sophisticated mechanical devices for adults, the options for infants and children in need of mechanical circulatory support are very limited. Close to 1,800 children with congenital heart defects die each year in the United States alone, and 25 percent of the 36,000 babies born with these malformations require invasive treatment within the first year of life. Currently, there are no U.S. Food and Drug Administration (FDA)-approved devices designed specifically for patients younger than 5 years old, and the available options are even more limited for newborns and infants up to 2 years old. "Tremendous advances have been made in assist devices for adults, but there really are no devices for infants and children. The driving force of this program is encouraging development of such devices and sharing of information among developers," said J. Timothy Baldwin, Ph.D. Baldwin is deputy chief, advanced technologies and surgery branch and program director, basic and early technology research program in the Division of Cardiovascular Sciences at the National Heart, Lung, and Blood Institute, and the program officer who supervises the PumpKIN consortium. Acknowledging this need, the NHLBI awarded four contracts in January 2010 to fund preclinical testing of these pediatric devices, including both miniature ventricular assist devices (VADs) and integrated compact ECMO (extracorporeal membrane oxygenator) devices. The PumpKIN program builds on the NHLBI Pediatric Circulatory Support Program, which initiated funding for the development of novel circulatory support devices in 2004. The PumpKIN Program will support the realization of the most promising devices in order to gain FDA approval to begin clinical testing, which is anticipated by 2013. The four PumpKIN contractors are Harvey S. Borovetz, Ph.D., University of Pittsburgh; Mark Gartner, Ph.D., Ension, Pittsburgh; Bartley P. Griffith, M.D., University of Maryland School of Medicine; and Robert Jarvik, M.D., Jarvik Heart, New York. Griffith presented an update on his research during the Mid-Day Symposium 4: Update on Pediatric MCS Therapy. According to Baldwin, the contractors are on schedule and making good progress. He said the miniature pediatric devices are based on the latest technology for VAD and ECMO devices. Preliminary data presented at this meeting, and in other forums, suggest that these devices and technology have great promise to perform well in future pediatric patients, based on work ongoing at the PumpKIN study centers. For more information: www.ishlt.org, www.nhlbi.nih.gov