Miniaturized Heart Pump Keeps Kids Alive Until Transplant

A miniaturized version of the heart pump has helped to keep eight out of nine severely ill children alive long enough for them to receive a heart transplant. Heart-assisted devices are widely available for use in adults that have severely damaged hearts while waiting for a heart transplant. However, the devices that are approved for sale in the U.S. are too large for use in many children. The smaller versions, tailored for a child's anatomy, are approved in Europe and in other parts of the world, but not currently so in the United States.

Dr. Sanjiv Gandhi from the Saint Louis Children’s Hospital in Missouri says, “Research and development on pediatric pumps has been woefully lacking…. Up until now there were no available pumps for children who are in end stage of heart failure and in need of some sort of bridge while waiting for a suitable donor organ to come along.”

Gandhi and his colleagues tested one such device called the Excor pediatric ventricular assist device that was made by Berlin Heart GmbH. This device was used in two boys and seven girls with ages ranging from 12 days to 17 years. All of these children had severe heart failure and weighed less than 88 pounds. One of the children died from kidney failure before they received a heart transplant. After approximately 19 months of follow up, the other eight children were alive and had new hearts.

Gandhi said that the potential benefits of this device are huge. A lot of the children in whom these devices were implanted would probably not have survived with conventional therapy while they were waiting for a suitable heart. Gandhi said, however, there were some complications along the way but they were all managed easily, and the children that survived and received a heart transplant were faring well.

Because there are less than 100 children in the U.S. that need a heart-assisted device annually, the pediatric market has been too small to attract the attention of the U.S. makers of the adult heart pumps.

Gandhi’s hospital is now among several centers that are taking part in a three-year, U.S. Food and Drug Administration-approved clinical trial to test the Excor device in children that are in need of heart transplants. Before the start of this trail, many pediatric hospitals in the U.S. used the Berlin Heart under the FDA’s emergency or “compassionate use” regulation. However, this means that each case had to be approved by the FDA prior to use and the device could not be stored in the United States. If the study validates the use and success of the miniature pumps, it is the hope that they will become approved and available in the United States.