MADERA — Children's Hospital Central California broke ground this week when doctors there replaced heart valves in two teenagers without cracking open a chest.
"This is the next big technology leap" in cardiac care, said Dr. Carl Owada, medical director of the hospital's cardiac catheterization laboratory.
In the past, children with narrowed pulmonary arteries and defects in their pulmonary valves, which regulate the flow of blood into the lungs, had to have open-heart surgery for a valve replacement.
The open-heart surgery meant weeks and sometimes months of recovery.
Now instead of opening the chest to replace the valve, the new Melody Transcatheter Pulmonary Valve is threaded into the heart through a catheter inserted into a vein in the patient's leg. The valve is inside a wire stent, which is mounted to the outside of an angioplasty balloon at the end of the catheter. The balloon is inflated to deliver the valve, then the balloon is deflated and removed.
"It's a delivery system for the valve that we didn't have before," Owada said.
The Melody Valve was approved by the federal Food and Drug Administration in 2010 for children and adults. Children's is the first hospital in the Central Valley with approval to use it in patients.
It's so new that Children's is negotiating reimbursement for the procedure with California Children's Services, a program that provides medical care to children with chronic medical conditions such as heart disease, cystic fibrosis, hemophilia, cerebral palsy and cancer. The program is administered as a partnership between county health departments and the California Department of Health Care Services.
Payment not settled
Children's has been told it needs to perform six of the valve procedures before California Children's Services will pay. It wasn't clear Tuesday whether the hospital will receive even a partial payment for any of the first six procedures.
It's not the first time the hospital has not been reimbursed for state-of-the-art advancements, said Beverly Hayden-Pugh, vice president and chief nursing officer. Hayden-Pugh watched one of the surgeries Monday and said she's convinced that it's worthwhile for patients and the hospital.
"It was awe-inspiring," she said.
The procedure takes a few hours and can save patients from several open-heart surgeries over the course of their lives, said Dr. Paolo Aquino who implanted the valves in two boys Monday.
Aquino and his team did the two procedures in about four hours each. The patients, boys 17 and 13, went home Tuesday.
That shortened recovery is what makes patients giddy, Aquino said. In open-heart surgery cases, children typically must spend a few days in an intensive care unit and several more in the hospital, he said.
Devon Robinson, 13, of Fresno, was all smiles in photos the hospital showed of him Tuesday, the day after his procedure. Back at home, he was having a hard time minding his watchful mother, Monica Paez, who said, "he's walking around and I'm trying to keep him laying down."
That's a different experience than in the past, Paez said. Devon had his first open-heart valve surgery at 7 months. When he was 6, he had open-heart surgery to replace the valve. He missed half of kindergarten because of that surgery, Paez said.
Devon, who will be a Central Unified eighth-grader this year, said Tuesday that he wants to play soccer.
"Before, I couldn't do too much," he said. "Now, they're saying I can do more stuff. I can run more, run farther."
The Melody Valve has the potential to help a lot of children, Aquino and Owada said. Typically in a year, doctors at the hospital replace valves in 15 to 20 children. About 200 current patients at Children's could be candidates for the Melody Valve, Owada said.
Adults could be next
Children's also could be putting the Melody Valve in adults. The hospital is working with the University of California at San Francisco-Fresno Medical Education program to bring adult patients to the hospital for the procedure, Owada said.
It wouldn't be the first adult heart surgery for Children's doctors.
Valley Children's Hospital performed its first open-heart surgery on a 9-year-old girl in 1958, and did its first open-heart surgery on an adult the next year. The hospital, which at that time was in central Fresno, had an adult cardiac unit until 1980 when it was closed to make room for more pediatric patients. The hospital moved to Madera County in 1998 and the name changed to Children's Hospital Central California in 2002.
Aquino said he is ready to do the valve procedure on more patients, including adults.
He was trained at Children's Hospital of Michigan, and Monday was his first anniversary at Children's Hospital Central California. The Melody Valve is why he came to the valley hospital, he said. "I really wanted to bring it to a place that didn't have it."