The Institute under the leadership of Harvey S. Borovetz, Ph.D has been awarded a five-year $4.5 million contract from the National Heart, Lung, and Blood Institute to develop a heart assist device for infants. Working with Children's Hospital of Pittsburgh, Carnegie Mellon University and industry partners, the Pitt researchers envision the pediatric ventricular assist device (PVAD) to be about the size of a quarter, with features designed to meet the special needs of patients with congenital and acquired heart defects who are as young or small as a newborn baby.
The only means of mechanical support currently available in the United States for infants and children up to age 2 is ECMO, or extracorporeal membrane oxygenation, which can only be applied for up to several weeks and completely immobilizes patients with its elaborate network of tubes and medical equipment. Despite it being standard practice for nearly 30 years for pediatric patients of all ages who are in heart failure, its use is associated with a high death rate. Less than half of children and infants survive the therapy. Larger children sometimes have the option of being supported by ventricular assist devices (VADs) that have been designed with the adult patient in mind, but no devices currently approved by the U.S. Food and Drug Administration are small enough to be implanted in infants.
To develop the PVAD, Dr. Borovetz has assembled a multidisciplinary team of bioengineers, surgeons and researchers from Pitt's schools of Engineering and Medicine and the McGowan Institute for Regenerative Medicine. Working as subcontractors will be pediatric cardiologists from Children's Hospital of Pittsburgh, bioengineers from Carnegie Mellon University and research teams from MedQuest Products, Inc., of Salt Lake City, which hopes to manufacture and commercialize the device, and LaunchPoint Technologies of Goleta, Calif. Researchers from Primary Children's Medical Center and LDS Hospital, both in Salt Lake City, also are involved.
The goal of the contract is to develop a miniature centrifugal pump utilizing suspended magnetic levitation technology for use in babies between 5 and 35 pounds. It's conceived that the device could be used for up to six months as a bridge to heart transplantation. In some babies, the device may allow the heart to recover. As such, the team plans to develop a smart control system that will indicate patterns consistent with a recovering heart. Since the device will be fully implantable with a small lead to an external power supply, children supported by the device will be able to be mobile and active.
The technology being applied to the development of the PVAD builds on the innovative work of James F. Antaki, Ph.D., associate professor of biomedical engineering and computer science at Carnegie Mellon University and associate professor of bioengineering and surgery at the University of Pittsburgh. Dr. Antaki is a co-investigator and the project director for the contract.
"Our primary objective is to develop a highly reliable circulatory assist device for infants who would otherwise perish from heart failure," said Dr. Antaki. "This contract will enable our collaborative research team to apply over two decades of experience with cardiovascular support to design a novel device for this high-risk population. We aim to perform our first clinical trials within five years."
"As surgeons, physicians, bioengineers and bench scientists, we have different perspectives to the challenge at hand. But then, this interdisciplinary PVAD effort exemplifies the kind of collaboration that has existed for nearly 30 years at the University of Pittsburgh. We happen to believe it's the best way to solve problems in the clinical setting," added Dr. Kormos, medical director of the McGowan Institute, where much of the research and development of the PVAD will occur.
Additional Information:
UPMC News Bureau: University of Pittsburgh Receives NIH Funding to Develop Heart Assist Device for Infants
Pittsburgh Post Gazette: Five Teams Working on Pumps for Kids' Hearts
Pittsburgh Tribune Review: Infant Heart-Assist Device in Works