Congenital heart disease affects between 1-2% of all newborn infants, making heart disease the most common birth defect. Congenital and acquired valve disease in infants and young children remains challenging despite improvements in surgical techniques. The primary limitation of pediatric valve replacement is the lack of appropriate-sized valves for the pediatric population, which have appropriate durability and biocompatibility.
Valve replacement in children is often necessary, but it the surgery may be risky and the new valve suboptimal. The primary limitation of pediatric valve replacement is the lack of appropriate-sized valves . Commonly used surgical valves are designed for adults. Adult-sized tissue valves are more available; yet, these valves have significant limitations in their durability. Once implanted, these valves tend to become stenotic (tight) and regurgitant (leaky) over the first few years. Indeed, replacement of the new valve is common, and is usual within 2-5 years of implantation. Each replacement involves an open-heart surgical procedure which carries significant risk of morbidity and mortality.