BETHESDA, MD – The National Heart, Lung, and Blood Institute, part of the National Institutes of Health, has awarded four contracts totaling $23.6 million to begin preclinical testing of devices to help children born with congenital heart defects or those who develop heart failure. The four-year program is called Pumps for Kids, Infants, and Neonates.

Each year in the United States, nearly 1,800 infants die as a result of congenital heart defects and another 350 develop heart disease, which leads to heart failure for many. Approximately 60 infants and children under 5 years old who are placed on the heart transplant waiting list die each year before receiving one. Mechanically assisted circulatory support could be used to sustain these young patients as they seek to recover or wait to receive a heart transplant.

“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 National Heart, Lung, and Blood Institute Acting Director Susan B. Shurin, M.D., a pediatrician. “The National Heart, Lung, and Blood Institute is committed to saving the lives of our youngest patients. Well-designed circulatory support devices are expected to substantially improve the outcomes of the infants and young children who need them as they seek to recover or wait to receive a heart transplant.”

The options for chronic circulatory support devices for infants and young children are limited, and all have substantial risks for serious adverse events such as infection, stroke, and device failure. With this in mind, the National Heart, Lung, and Blood Institute launched the Pediatric Circulatory Support Program in 2004 by funding the development of five novel circulatory support devices for infants and young children with congenital and acquired cardiovascular disease.

The Pumps for Kids, Infants, and Neonates program is the next phase of National Heart, Lung, and Blood Institute support for the development and clinical realization of these devices. The program’s goal is to complete the needed animal studies and other tests in artificial environments for the most promising devices in order to gain approval from the FDA to begin clinical testing.

Devices in the program will provide suitable circulatory support for newborns, older infants, and children less than 55 pounds who experience heart failure due to congenital and acquired cardiovascular disease. They are designed to supply adequate blood flow to prevent organ damage while minimizing the risk of blood vessel damage, infection, breakdown of red blood cells, excessive bleeding, brain damage, and dangerous blood clots. The devices are intended to support circulation in pediatric patients for one to six months, be sufficiently small and reasonably portable, and be able to be routinely positioned and functioning in less than one hour, among other specifications.

“Similar devices are used in adults,” Shurin noted. “As an adult, your heart is normally about the size of your fist; devices for small children require radically different designs from adult devices to adapt to the differences in the size of the patients.”

The program will test ventricular assist devices and advanced extracorporeal membrane oxygenator devices. The ventricular assist devices in the Pumps for Kids, Infants, and Neonates program are very small rotary pumps which are implanted to provide circulatory support for extended periods of use. They work by drawing blood from the heart and pumping it to the body. Extracorporeal membrane oxygenator devices circulate and supply oxygen to the blood, and are commonly used for patients who need both heart and lung support. For extracorporeal membrane oxygenator devices, tubes connecting the patient to the device are placed directly into large blood vessels near the base of the neck. Blood is drawn from the right side of the heart, pumped through the oxygenator, and then returned to the body on the left side of the heart so the oxygen-rich blood can be delivered throughout the body.

- MFP Wire Services
- 02-05-2010