Children with heart failure survived longer while awaiting a heart transplant when they received therapy with Berlin Heart’s Excor pediatric ventricular assist device than when treated with the current standard of care, according to a new study.
The Excor PAD device was not without risks, but survival rates for children on the device were "significantly higher" than those in the control group, according to the study’s authors.
The study included 48 patients aged 16 and younger, split into 2 groups according to body size. Each group received the Excor implant while awaiting a donor heart, and results were compared with historical data from children who had been placed on heart-lung support machines, known as extracorporeal membrane oxygenation .
Among the smaller children, those weighing less than 10 pounds, more than half survived at least 174 days on the Excor system. The average survival rate among a similar group of children supported by ECMO was only 13 days, according to the study, which was sponsored by Berlin Heart.
The larger children survived an average of 144 days with the pump, compared with 10 days on ECMO. Overall 88% of the smaller children and 92% of the larger children survived long enough on Excor to receive a transplant, the study found.
The average wait time for an infant donor heart is 119 days, according to the FDA. Heart failure in children is less common than in adults, but there are far fewer pediatric donor hearts available.
"The Excor Pediatric Ventricular Assist Device represents a major medical advance in the treatment of children who need a heart transplant," lead author Dr. Charles Fraser said in prepared remarks. "Most of these babies and children would not otherwise survive without the support of Excor while awaiting donor hearts. I know that I speak for all of the medical professionals who participated that we are tremendously gratified to have been a part of this ground-breaking study."
The Excor system in December 2011 won FDA humanitarian device exemption after a unanimous recommendation from the federal watchdog agency’s Circulatory System Devices Advisory Panel.
The pediatric VAD is a mechanical cardiac assist device for critically ill pediatric patients suffering from severe heart failure. The system supports patients from newborns to teenagers, helping to keep them alive while they’re awaiting heart transplantation.
Berlin Heart’s pediatric VAD consists of 1 or 2 external air-driven blood pumps connected to the heart chambers and arteries by multiple tubes.
The device represents a "new era" in treating childhood heart disease, the company said, but the procedure wasn’t without complications. Most of the children in the Excor study experienced infections, strokes or bleeding, the Chicago Tribune reported.