Children's Hospital leads projects to develop nation's first heart assist devices for young children

Children's Hospital of Pittsburgh of UPMC Heart Center experts helping to develop first implantable and external pediatric heart pumps

Children’s Hospital of Pittsburgh of UPMC — a national leader in the use of lifesaving ventricular assist devices (VADs) for children in heart failure — is part of a collaboration that recently has been awarded a $2.3 million grant from the National Institutes of Health (NIH) to develop an external heart pump designed specifically for small children.

VADs are mechanical devices that take over the pumping action of the heart and offer lifesaving support, most often acting as a bridge to keep patients alive until a donor heart becomes available for transplantation. There are VADs approved by the U.S. Food and Drug Administration (FDA) for use in adults and larger adolescents in the United States, but none are designed and approved for use in infants and toddlers.

Cardiac experts in Children’s Hospital’s Heart Center currently are involved in two separate projects to develop external and implantable VADs. It is estimated that as many as 1,000 children annually may benefit from these technologies, according to Peter D. Wearden, MD, PhD, a pediatric cardiothoracic surgeon and director of Pediatric Mechanical Cardiopulmonary Support at Children’s.

“Unfortunately, because this is a relatively small market, companies that make medical devices historically have not focused their attention on pediatric VADs,” Dr. Wearden said. “Because of this, our options for treating young children in heart failure have been extremely limited. Our hope is that these two projects will lead to the first pediatric devices being approved by the FDA for use in the United States.”

Children’s and medical device manufacturer Levitronix® LLC received a $2.3 million National Heart Lung and Blood Institute Small Business Innovation Research (SBIR) grant to complete development of, and to clinically test, the first external centrifugal pump designed specifically for infants and small children in heart failure.

The team currently is finalizing tests of this device in the laboratory and hopes to begin the clinical trial in the coming year. The device, known as the PediVAS (ventricular assist system), would be an external pump designed to support pediatric patients in heart failure for days to four weeks.

Dr. Wearden also is spearheading efforts to develop the first totally implantable pediatric VAD in the United States that could be used for longer periods of time than the external pump.

In the development of an implantable pediatric VAD known as PediaFlow, Children’s team is partnering with two pioneers in cardiac support, Harvey S. Borovetz, PhD, deputy director, Artificial Organs and Medical Devices, McGowan Institute for Regenerative Medicine, and chair, Department of Bioengineering, University of Pittsburgh; and James Antaki, professor, Department of Biomedical Engineering, Carnegie Mellon University.