Current treatment of many forms of congenital heart disease requires multiple surgical procedures starting shortly after birth, with attendant high morbidity and potential mortality. A promising alternative treatment calls for placing a stent in te patent ductus arteriosus (PDA), in order to delay definitive repair until the child is older and wil have a lower risk. A novel stent specifically designed for implantation in the neonate PDA is proposed, in order to overcome the difficulties that clinicians have experienced with this new procedure in newborns, complications arising from the fact that the stents used were not designed for this purpose. An interdisciplinary team of engineers and pediatric cardiologists will (1) identify/document the requirements for a stent to be implanted in the newborn PDA, including removal;(2) perform analytical and in vitro studies with phantoms to identify the most promising candidate designs for the stent and removal instrumentation;(3) conduct an in vivo pilot study in a suitable animal model to evaluate deployment, recaptureability, trackability and radiopacity;and (4) conduct a pilot long-term animal study to assess safety and efficacy. In this latter study, proposed stent designs will be compared with stents currently being used, in regard to maintenance of patency of the PDA, tissue inflammation, and safe removal from the PDA in the presence of adherent endothelial tissue. These studies will form a compelling foundation for completing development of a PDA stent for treatment of Cyanotic Congenital Heart Disease in neonates.
While significant improvement in treatment of CHD has already been made, including a 30% reduction in mortality over the past decade, there is a still a long way to go and as a whole this area has been significantly underfunded. Successful development of a new stent, specifically designed for implantation in the PDA in neonates, would represent a major contribution toward this end, providing a safer and less invasive means for treating cyanotic congenital heart disease, including hypoplastic left heart syndrome (HLHS), the deadliest of all congenital heart diseases during the first year of life. Currently, the survivl of these neonates requires that they undergo invasive and highly risky open-heart procedures shortly after birth, whereas the availability of a safe and effective PDA stent for would permit delay of invasive surgery until an age when the child is at much lower risk.