MONDAY, Sept. 29, 2008 (HealthDay News) -- In a small clinical trial, a miniature heart pump that's already in use in Europe helped U.S. youngsters waiting for heart transplants.
Even children at the top of the transplant waiting list can wait months before a suitable heart becomes available, and according to the current study, this small heart pump -- called the Berlin Heart Excor -- can help provide children a "bridge" to transplantation.
"We found the Berlin Heart was a very beneficial tool to have in our armamentarium," said study author Dr. Sanjiv K. Gandhi, surgical director of the heart failure program at Saint Louis Children's Hospital in Missouri.
Results of the study were published in the current Cardiovascular Surgery Supplement of Circulation.
Currently, if a child awaiting transplant gets into serious trouble, surgeons will place them on the extracorporeal membrane oxygenation (ECMO) machine. The problem with this device, however, is that children have to remain immobile, which furthers physical deterioration. And, the device carries significant risks of complications.
There are already devices approved and in use for adults called ventricular assist devices, and the small version of a biventricular assist device is available for use in Europe, though it's not yet approved in the United States. Biventricular means the device does the work of both sides of the heart. And, the benefit of this device is that it allows children to be mobile. With special preparations, they can even leave the hospital with this device.
Gandhi said the primary reason the device hasn't been approved yet in the United States is that the market is small, and clinical trials are just now under way.
Gandhi's research included nine children between the ages of 12 days to 17 years, with an average age of 1.7 years. Most of the children weighed less than 80 pounds, according to the study.
All of the children had severe heart failure from complex birth defects of the heart or cardiomyopathy, a weakening of the heart muscle that can occur as a result of an infection.
Three of the children were already on ECMO, and six were already on mechanical ventilation. All of the children were placed on the Berlin Heart Excor between April 2005 and July 2007.
One infant died of kidney failure soon after being placed on the device. The remaining children all survived to heart transplantation and were on the heart pump for an average of 35 days.
Five patients had to have additional surgery, but there were no strokes, blood clots or bleeding complications in this group of children.
"These are fantastic outcomes, better than you see in many other centers," said Dr. Peter Wearden, a pediatric cardiothoracic surgeon and director of pediatric mechanical cardiopulmonary support at Children's Hospital in Pittsburgh.
But, he cautioned, "This is not a complete panacea." There are still risks, and he said that parents often focus on the potential benefits and don't always hear that there can be complications.
Still, both Gandhi and Wearden felt this device is definitely an option for children awaiting transplant. "A significant number of children in this study would not have lived to transplant without this," said Gandhi.
The makers of the Berlin Heart Excor provided limited funding for the study; the bulk of the study funding came from Saint Louis Children's Hospital, said Gandhi.
To learn more about pediatric heart transplant, visit the American Heart Association.