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Unprecedented Study shows Berlin Heart device provides life-saving "bridge" for young children and babies
Date:8/8/2012

d the device is used to assist its activities. However, in a few instances, two devices are used to replace both chambers of the heart. This pump is available in a variety of sizes.

Without the assistance of the device, children awaiting a transplant would become increasingly sick as their heart failed. The device improves their circulation and keeps them alive until they receive a heart transplant. In some rare instances, patients recover enough to come off the device and maintain blood flow on their own.

Fraser first used pump seven years ago

Fraser first used the pump in an infant – tiny Brady Burch of Corpus Christi – seven years ago. Brady, now 7, went on to receive a transplant and enters first grade this fall. The success with Brady stimulated Fraser to push for a study of the device to determine its effectiveness.

Fraser said a major limitation of the study is that it is not truly randomized – a method by which patients are assigned an experimental treatment or currently accepted treatment by chance, as in the flip of the coin.

"There was no way we were going to randomize patients. Even using ECMO as a comparison was difficult," Fraser said. They drew their comparison patients from the Extracorporeal Life Support Organization registry based in Ann Arbor, Michigan. They matched each patient who received the Berlin Heart to two closely comparable individuals in the registry. While using these historical control patients was difficult, it was the only ethical method of obtaining comparison, Fraser said. He believes the study will provide important information for the future.

"I don't think we are far from a small, implantable VAD in children," he said. "The implantable devices will be less cumbersome. There are approved, fully implantable devices already available for adults. This gives us the drive to push even further for more devices like this that can be life-saving options for these children who
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SOURCE Texas Children's Hospital
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