Pitt-led Team Gets $5.6 Million Contract to Develop Heart Assist Device for Infants and Toddlers

Researchers at the University of Pittsburgh and their collaborators have been awarded a $5.6 million federal contract to pursue the continued development of an implanted ventricular assist heart pump for infants and small children with congenital or acquired heart disease. The project aims to provide much-needed access to the sophisticated technologies that have saved the lives of older heart failure patients.

Harvey Borovetz, Ph.D., distinguished professor and chair of the Department of Bioengineering and a deputy director of the McGowan Institute for Regenerative Medicine, is the principal investigator of one of four projects that comprise the Pumps for Kids, Infants and Neonates (PumpKIN) Preclinical Program, a $23.6 million effort sponsored by the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI). He and his colleagues at Pitt, Children’s Hospital of Pittsburgh of UPMC, Carnegie Mellon University, Goleta, California-based LaunchPoint Technologies, and Salt Lake City-based WorldHeart Inc., began designing and building their device, called PediaFlow™, more than five years ago.

“We now have the opportunity to put PediaFlow through the necessary development and testing needed to proceed to clinical trials,” Dr. Borovetz explained. “The aim is to begin human studies in three to four years.”

According to the NHLBI, nearly 1,800 American infants die annually due to congenital heart defects. Another 350 develop severe cardiomyopathy leading to heart failure. Each year, approximately 60 children younger than age 5 waiting on the heart transplant list may die before a donor organ becomes available.

PediaFlow, which is made of a titanium alloy and is about the size of an AA battery, incorporates innovative mag-lev technology. Blood is drawn through it by means of a high-speed rotor that essentially floats within its housing due to magnetic levitating forces. The rotor geometry, which is designed using state-of-the-art computer models and analyses, pulls oxygenated blood from the left ventricle through the device, returning the blood to the aorta and patient circulation. The flow rate of the PediaFlow can be varied between 0.5 to 1.5 liters per minute, suitable for the very smallest infants to toddlers.

“We believe the PediaFlow will be capable of replacing the heart function of our smallest patients,” explained Peter Wearden, M.D., Ph.D., a cardiothoracic surgeon at Children’s Hospital who leads the clinical work of the project. “Left ventricular assist devices (LVADs) have been very successful in supporting older children and adults as a bridge to eventual heart transplantation, or, in some cases, as a temporary measure that allows the heart to rest and recover. But there currently are no FDA-approved LVADs for babies and toddlers.”

Extracorporeal membrane oxygenation, or ECMO, currently is the only form of support for these smallest of children, but it requires that patients be fully anesthetized, and can only be used for a few weeks before severe complications develop.

“This creates a ‘race against time’ while we and the family wait for an appropriate donor organ to become available,” Dr. Wearden noted. “To meet the NHLBI’s requirements, PediaFlow must support patients for up to six months, and our preclinical research has already shown that it works flawlessly for at least 70 days. We are very excited to have these additional resources to help bring this technology to these children.”

The other PumpKIN contractors are Mark Gartner, Ph.D., of Ension Inc., Pittsburgh, Pa.; Bartley P. Griffith, M.D., University of Maryland, Baltimore; and Robert Jarvik, M.D., Jarvik Heart Inc., New York, N.Y.

“This research seeks to develop technologies to expand life-saving options for infants and children born with congenital heart defects or those who develop heart failure,” said Susan B. Shurin, M.D., a pediatrician and acting director of the NHLBI. “Similar devices are in use in adults. Well-designed circulatory support could dramatically improve the outcomes of these young patients as they seek to recover or wait to receive a heart transplant.”