The heart valve that grows up with its patient

For children born with certain heart defects, the hardest question has been when to operate: wait too long and you risk harm to the child, intervene too early and they may need multiple open-heart surgeries as they grow. Now the FDA has approved the Autus Size-Adjustable Valve — the first heart valve built to be expanded after it is implanted. It goes in at about 13 millimeters wide, small enough for a toddler or preschooler, and doctors can widen it up to 22 millimeters — close to adult size — by threading a small balloon through a blood vessel, no surgery required. Its flaps are made of a synthetic material rather than animal tissue, the first FDA-approved valve of any kind to use it. In a study of 62 children at 12 U.S. hospitals, every procedure succeeded with no deaths, strokes, or clots, and two children who began outgrowing their valves had them widened without surgery. The valve went through premarket approval, the FDA's toughest review process. "Children with congenital pulmonary valve disease have long needed prosthetic valves that can account for growth over time," said trial investigator Dr. Emile Bacha of NewYork-Presbyterian/Columbia.