FDA Approves New Heart Valve Procedure
For children with heart defects, it can mean many painful open heart surgeries over the years to keep things in check. But now, some kids can have their heart valves fixed with a small, nearly painless procedure.
Kunal Narula is a typical nine-year-old. You'd never know he has a heart problem.
"One of my valves wasn't working that well, so I got a surgery when I was two years old," Kunal says.
But at age seven, he was facing a second open-heart surgery to replace his pulmonary valve.
I was scared, and a little bit nervous," Kunal says.
That's when Kunal's family opted to take part in a groundbreaking clinical trial.
Kunal had a new valve implanted without open-heart surgery at New York's Stanley Children's Hospital – and he's thrived. The valve has just been approved by the FDA, so it will be available to other children as well.
A catheter is inserted into the leg to guide the valve into place. A metal stent surrounds the valve.
"When you get it to the spot where the valve has to be implanted, you just expand the stent and that valve stays in there, functions very well," Dr. William Hellenbrand, of Stanley Children's Hospital, says.
Usually, children with valve problems are subjected to multiple open-heart surgeries as they outgrow their replacement valves, but that's not the case with this new approach.
"This could easily last until he's a full adult size, and either we make this valve bigger or he might need another surgery, but we certainly avoided the need for open heart surgery at this point," Dr. Hellenbrand says.
Doctors praise Kunal's pioneering spirit, and his parents are thankful.
"We are buying time, delaying the surgery, and whatever time we get, it's better for him," mother Prerna Narula says.
Right now, the valve means less time in the hospital for Kunal, and more time for his family and friends.
The valve just received approval from the Food and Drug Administration last month, but it will be some time before it is able to be used widely. The FDA is requiring five years of post-approval studies to assess its safety and health benefits.