A SOLUTION FOR INFANT HEART DISEASEinfant heart disease

Each year, over 35,000 children are born with congenital heart disease. Circulatory support of these pediatric patients under the age of two is currently limited to short-term extracorporeal devices whose use is often complicated by infection, bleeding and thromboembolism. Currently, 25% of babies born with congenital heart defects in the United States each year require invasive treatment (including mechanical cardiac support) in order to survive their first year of life.

Acquired heart disease also affects this vulnerable infant population. Based on National Heart, Lung, and Blood Institute-sponsored Pediatric Cardiomyopathy Registry data, each year nearly 350 children under one year of age in the U.S. develop cardiomyopathy, many of whom die or require mechanical cardiac support (MCS) as a bridge-to-cardiac transplantation.

Current MCS options for infants are quite limited, particularly in regard to the duration of support. Extracorporeal membrane oxygenation (ECMO), which remains the only form of mechanical circulatory support available at most pediatric tertiary care centers in the U.S., is only capable of providing support for a few weeks at most. This becomes a critical limitation when ECMO is used for the youngest patients, who often require a significant amount of circulatory support until a suitable donor can be found. In addition, an ECMO system is an external device approximately the size of a fax machine, leaving the child completely immobilized during treatment. These drawbacks all contribute to the low ECMO survival rates of only around 38%.

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