TEXAS -- For patients awaiting a heart transplant, it is a race against the clock.
Now, a new device is buying doctors more time, especially for the smallest patients.
Adult heart failure patients in the United States can get heart pumps as they wait for an organ transplant, but helping children is more difficult.
For mother Bonnie Fraga to see her son, Derek, have a little fun is a relief.
"He's had to mature a lot quicker than a lot of 13-year-olds," said Bonnie.
When Derek was 10 years old, doctors diagnosed him with an enlarged heart.
" I took him in for his stomach pain and we found out that the stomach pain was coming from the fact that his heart was failing," said Bonnie.
Dr. Charles Fraser used the Berlin Heart to keep Derek alive.
"Prior to this device, we didn't have much to offer children with acutely failing circulation," said Dr. Fraser.
The Berlin Heart takes over the patient's heart and allows it to rest. This lets the patient's body gain strength, usually making them a better candidate for heart transplantation.
"One of the very attractive features of the Berlin Heart is that it comes in different sizes," said Dr. Fraser.
The heart is small enough to treat a six pound baby and large enough for a growing teen. It actually strengthened Derek's body before his heart transplant.
Before the transplant, Derek was 60 pounds underweight. After four months on the Berlin Heart, he had gained 22 pounds.
"I think Derek was a better transplant patient. He was able to eat and have good nutrition. He was ambulatory, off a ventilator," said Dr. Fraser.
"Me and my physical therapist and my mom would go to the basement and would walk all around," said Derek.
77% of patients who get the Berlin Heart survive to their transplant surgery.
Texas Children's Hospital and nine others in the United STats are researching the Berlin Heart for FDA approval.
The FDA is expected to evaluate the information from the trial in about three years.
The Berlin Heart has been used successfully in Europe since 1992.
FOR MORE INFORMATION, PLEASE CONTACT:
Texas Children's Hospital
U.S. Clinical Trials
BACKGROUND: 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 German-based company 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," Dr. Fraser told Ivanhoe.
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.
HOW IT WORKS: 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. To 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," Dr. Fraser explained. "It's driven by a pneumatic compressor and it pumps the blood." Children who have the device are able to move around.
SEEKING FDA APPROVAL: The FDA appointed Texas Children's Hospital as the lead center in a three-year clinical trial of the Berlin heart. Dr. 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.