Matthew Emmerling was just three days old and barely home from the hospital when his mother noticed his feet were unusually cold to the touch. Hours later, doctors determined that he was born with a critically narrowed aortic valve that prevented his heart from getting an adequate supply of blood to the rest of his body. He was in shock, and without quick intervention, his life was in danger.
To avoid risky open-heart surgery on the infant, doctors figured they could thread a tiny balloon into his heart and inflate it to stretch open the obstructed valve. The problem was that a balloon designed and approved to treat heart defects in patients as tiny as Matthew didn't exist. Instead, Robert Beekman, a pediatric cardiologist at Cincinnati Children's Hospital Medical Center, chose an angioplasty balloon that normally serves a different function: opening up clogged kidney arteries in adults.
The adult kidney balloon "is the right size for a newborn's aortic valve, so we use it," Dr. Beekman says. But, he adds, using a device in small children that wasn't designed for that purpose puts them at heightened risk for procedural complications and medical errors.
Matthew's situation highlights an enduring reality for children born with life-threatening heart defects: Hardly any of the myriad drugs and devices developed for the multibillion-dollar market for cardiovascular disease are designed with kids in mind. Children with heart disease represent too small a segment of that market to justify companies' investing the time and resources needed to develop specialized products. Litigation worries over products intended for children--and the challenge of conducting clinical trials for treatments often administered to newborns--are other impediments.
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