Pediatric researchers report that a recently introduced surgical procedure offers infants with severely underdeveloped hearts a better chance at surviving during their first year of life, in comparison to the standard surgery.
Heart surgeons from 15 centers in the federally sponsored Pediatric Heart Network studied the outcomes in 549 newborns who received a complex series of surgeries for hypoplastic left heart syndrome (HLHS).
"This landmark study is the largest clinical trial ever performed in congenital heart surgery, and the first randomized trial comparing two surgical procedures for congenital heart defects," said senior author J. William Gaynor, M.D., a pediatric cardiothoracic surgeon at The Children's Hospital of Philadelphia, and co-principal investigator of the study. As one of the nation's leading programs in pediatric cardiology, the Cardiac Center at Children's Hospital enrolled 101 subjects in this study.
The study results appear in the May 27 issue of the New England Journal of Medicine, published today.
The lead author and principal investigator of this study, called the Single Ventricle Reconstruction (SVR) Trial, was Richard G. Ohye, M.D., head of the Pediatric Cardiovascular Surgery Division of the University of Michigan.
Occurring about once in every 100 live births, congenital heart disease is the most common birth defect. It includes a broad variety of structural abnormalities, but HLHS is among the most severe forms. In HLHS, affecting 1 in 5,000 live births, the left ventricle, one of the heart's two pumping chambers, is small and unable to function. Without treatment, HLHS is fatal in the first few days of life.
Starting in the 1980s, surgeons developed surgical procedures for HLHS that have allowed increasingly more children born with a single functioning ventricle to survive. The intervention involves three planned surgeries, beginning in the newborn period and extendin
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Children's Hospital of Philadelphia