Kid-size Implant Holds Promise for Managing Severe Pediatric Heart Disease

A team of pediatric specialists and biomedical engineers from The Cleveland Clinic has been awarded a $4.2 million, five-year government contract to begin development of a ventricular assist device designed to support damaged hearts of infants and other small children.

The contract was awarded by the National Heart, Lung and Blood Institute, part of the National Institutes of Health. The project covers early development of the "PediPump," including basic engineering, anatomic fitting and reliability testing. The PediPump is a special device designed to assist damaged hearts by ensuring adequate blood flow throughout the body. A prototype exists, but it must undergo rigorous testing, design refinements and approval to ensure its safety and effectiveness.

"PediPump has the ability to revolutionize pediatric cardiac care," says Brian W. Duncan, M.D., principal investigator of the new project and a pediatric heart surgeon at the Cleveland Clinic Childrenís Hospital. "It is substantially smaller than any currently available device, making it suitable for providing circulatory support, even for a newborn." The device could also be used, he says, to help manage young patients who have heart failure (a lethal pumping disease involving the left ventricle of the heart) or help sustain those awaiting a heart transplant.

Dr. Duncan, who has joint appointments in the Clinicís departments of pediatric cardiac surgery and biomedical engineering, says the dime-sized PediPump will not be completed for several years, but that the NIH contract provides a stepping off point to help children who now have limited options.

"Our main objective is to design and develop an implantable pediatric ventricular assist pump that is adaptable to both the wide size range of pediatric patients and to the special needs of surgery for congenital heart diseases," Dr. Duncan says. Congenital heart disease refers to heart disease or heart disorders present at birth.

"Partnering" gives strength to effort
The PediPump team represents a partnership between the Cleveland Clinic division of pediatrics and the department of biomedical engineering. This partnership is one of the projectís main strengths, says Dr. Duncan, cultivating collaboration between experts from both fields. Pediatric specialists will work closely with biomedical engineers through all phases of the deviceís development.

"Pediatric congenital heart surgery is very complex," says William A. Smith, D.Eng., P.E., lead engineer and associate staff, department of biomedical engineering. "Collaboration is absolutely essential to fit characteristics of this device to the particular challenges that surgeons such as Dr. Duncan face when operating on infants and toddlers."

Currently, the only option for kids in need of heart support is a procedure known as extracorporeal membrane oxygenation (ECMO). But ECMO, which uses a type of artificial lung, provides only short-term support, often with a high rate of complications. And while advances have been made in device development for adults, unique features of circulatory failure in children limit their applicability.

Dr. Smith, however, says that advances in the manufacture of key device components (e.g., miniature magnetic bearings and high-speed impellers, special rotating devices that aid fluid pumping) have made possible the creation of very small but effective pumps. PediPump provides real hope for long-term development of a totally implantable system for even the smallest infants, says Dr. Smith.

Working with the Clinic to develop the PediPump is Foster-Miller Technologies, an Albany, NY-based technology company that specializes in the development of biomedical devices, machinery systems, and measurement and diagnostic tools.

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