Newer Heart Surgery For Infants Offers First-Year Survival Benefit Over Traditional Procedure
Thursday, May 27th, 2010Infants born with a severely underdeveloped heart who undergo a newer surgical procedure are more likely to survive their first year and not require a heart transplant than those who have a more traditional surgical procedure, according to a report by researchers supported by the National Heart, Lung, and Blood Institute (NHLBI), which is part of the National Institutes of Health. The study of 549 newborns, however, suggests that after the first year, the two surgical procedures for the relatively rare condition yield similar results.
The Single Ventricle Reconstruction (SVR) Trial is the largest clinical trial to compare treatments for congenital heart disease, and the first North American, multi-center, randomized trial of surgical therapy for congenital heart disease patients. Results are published in the May 27, 2010, issue of the New England Journal of Medicine. An editorial accompanies the article.
Congenital heart disease is the most common birth defect. Every year, about 1 percent of babies are born with abnormally formed hearts. The normal heart has two pumping chambers called ventricles. The right ventricle pumps blood to the lungs, and the left ventricle pumps blood to the body. This trial studied babies born with a severe form of congenital heart disease in which babies are born with a functioning right ventricle and a small, underdeveloped, nonfunctioning left ventricle. The condition is sometimes referred to as hypoplastic left heart syndrome. Without treatment, these babies usually die shortly after birth.
The SVR Trial compared for the first time two surgical procedures that are commonly used to treat babies born with only the functioning right ventricle to determine whether one procedure improves outcomes more than the other. The SVR Trial was conducted at 15 North American clinical sites that are part of the NHLBI’s Pediatric Heart Network
“Rigorous comparison of patient outcomes is critical to fully understanding the risks and benefits of different interventions,” said NHLBI Acting Director Susan B. Shurin, M.D., a board-certified pediatrician. “To conduct meaningful clinical research on rare conditions, however, we need collaboration among multiple study sites. This study demonstrates that through consortia such as the NHLBI’s Pediatric Heart Network, we can accelerate our ability to provide needed evidence on the best ways to care for some of our most vulnerable patients.”
In general, three surgeries are needed to treat a single right ventricle. The first procedure, called the Norwood procedure, is usually performed within the first two weeks of life and is one of the highest risk procedures in congenital heart surgery. A shunt, or small tube, is implanted to provide a connection for blood to flow from the heart to the blood vessels in the lungs, or pulmonary arteries, so that blood can pick up oxygen and release carbon dioxide. Children later undergo a second surgery at 4 to 6 months of age, and a third procedure, known as the Fontan procedure, at 18 to 36 months. The operations are staged to allow the child to grow large enough that the corrective procedures can be performed. Heart transplantation may be required for children with single ventricles when surgery and other treatments fail…. (more…)

