Taking the Lead
-U-M to Conduct Landmark Surgical Study in Congenital Heart Disease
The University of Michigan Health System is one of 14 centers participating in the first multi-center surgical study for congenital heart disease. The study will compare two different kinds of surgical procedures that are used to correct a fatal congenital birth defect called hypoplastic left heart syndrome, or HLHS. Babies born with HLHS are often referred to as having "half a heart."
The Most Procedures Worldwide
"Michigan does more Norwood procedures than any other center in the world about 60 a year," says Richard G. Ohye, M.D., assistant professor of surgery. "We're one of the two biggest congenital heart centers in the country. It’s important for us to take the lead."
U-M uses either the traditional Norwood procedure or a modified Norwood procedure that uses a new variation called the Sano Shunt, depending on different factors such as the patient's anatomy. That is an important aspect of this clinical trial.
Surgeons involved in the study will make the final decisions on whether to use the traditional Norwood procedure or the Sano Shunt. "If the surgeon doesn't think there's any difference or benefit using one or the other, he will use the one that the patient was randomized for," the surgeon says.
"In the operating room, we're always making that kind of call," Ohye notes.
"While both procedures are reliable and effective, this study will uncover which procedure might be better for the patient's heart, lungs, pulmonary system, valves or mental development," says Ohye.
The First Randomized Study
"This study is crucial because there has never been a randomized prospective study in heart surgery," Ohye says. "While Michigan does the most Norwood procedures, no given center does enough procedures to run a study. It's a great way to pool knowledge."
HLHS is the most common fatal congenital heart disease in newborns. Without treatment, more than 95% of newborns with the defect die before one month of age. In HLHS, the left side of the heart, which pumps blood to the body, fails to develop properly. The Norwood procedure is the first step in a three-step procedure to rebuild the heart so that the right side becomes the main pumping chamber.
Before the Norwood procedure was developed in the 1980s, there was no hope for newborns diagnosed with HLHS. Today, the only alternative to the three-stage procedure is a heart transplant. Most parents of babies with HLHS opt for the procedure instead of waiting for a donor heart.
"Some form of congenital heart failure occurs in .8 to .9 percent of the population about 1 in 100 children. It's much more common than people think," Ohye says. "It's even more common than childhood cancer. The results of this study will be far-reaching."
"This is important evidence-based medicine, basing what you do in medicine on objective criteria and outcomes," says Ohye, who notes that clinical evaluations such as this one are strictly controlled. Safety and ethics are monitored by an independent board.
Ohye has been chosen as the chairperson for the study and has primary responsibility for the overall conduct of the trial and for providing scientific, technical and administrative leadership. "The buck stops here," he says.
As for next steps, Ohye says, "We are looking for future funding to follow these children for a lifetime."
The study is conducted under the auspices of the Pediatric Heart Network, a cooperative network of pediatric cardiovascular clinical research centers. The National Heart, Lung and Blood Institute is funding the study.