According to the American Heart Association, cardiomyopathy, an enlarged heart, causes the heart to become inflamed, preventing it from properly pumping blood.

The condition may be a result of high blood pressure, heart valve disease, artery diseases, congenital heart defects or, as in Derek Hernandez's case, a viral infection. But thanks to Berlin Heart's ventricular assist device EXCOR Pediatric, there is now hope for children like Derek.

According to Charles D. Fraser, chief of pediatric and congenital heart surgery at Texas Children's Hospital in Houston, the device is a large step for children who have failing circulation. Adult heart failure patients in the United States can get heart pumps as they wait for an organ transplant, but helping children has been more difficult.

"Prior to this device becoming available, or potentially available, we didn't have much to offer children with acutely failing circulations," Fraser said.

Since 1992, the device has been successfully used in Europe. Although not yet FDA approved, the association has allowed pediatric hospitals across the United States to use the Berlin heart pump since 2000 under emergency or "compassionate use" regulations. No other heart pumps are currently available to children in the United States.

Thanks to a variety of pumps, the device can be used on newborns to teens. According to Berlin Heart, pump volume ranges from 10 milliliters to 60 milliliters. Pump size is determined by a patient's weight or body surface. Tubes are implanted to transport blood into and out of the device and the pumping mechanism sits outside the chest.

"It sits outside the body and is connected to the heart and the great blood vessels through canals or tubes," Fraser explained. "It's driven by a pneumatic compressor and it pumps the blood."

Children who have the device are able to move around.

The FDA appointed Texas Children's Hospital as the lead center in a three-year clinical trial of the Berlin heart.

Fraser is serving as the study's national principal investigator. Ten other hospitals in the United States and two hospitals in Canada are also participating in the study. Previously, if the pump was approved to be used in the United States, it would have to be flown from Germany. When not in use, the device had to be returned to the European country because it was not permitted to be stored here.

Additional Information:

Texas Children's Hospital
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