Doctors Perform Breakthrough Non-Surgical Heart Valve Replacement in Children with Congenital Heart Defects
October 13, 2008
One of only five pediatric hospitals in the U.S. to offer this alternative to open-heart surgery.
One of only five pediatric hospitals in the U.S. to offer this alternative to open-heart surgery
Seattle Children’s Hospital announced today that is has successfully performed its third minimally-invasive pulmonary valve replacement in congenital heart patients, signaling a new frontier in the use of non-surgical technology for the treatment of complex congenital heart defects.
Traditionally, patients with defective pulmonary valves require open-heart surgery to insert a valved-conduit, a two-inch tube with a valve inside, that opens the connection between the right ventricle of the heart and the artery that leads to the lungs. Due to a limited life span of the conduit, it is not unusual for patients to need repeat open-heart surgeries every ten years or so. When these conduits fail, they cause the child to tire very easily as the heart overexerts itself trying to get oxygenated blood throughout the body. Left untreated, heart function would deteriorate to the point of life-threatening complications.
With the availability of new transcatheter valve technology, physicians now have a far less invasive means to treat heart-valve disease, allowing them to deliver replacement valves via a catheter inserted through a vein in the leg - thus eliminating the need to open the chest and perform repeat open-heart surgery. The procedures at Children’s were done using Medtronic’s MelodyÂ® Transcatheter Pulmonary Valve. The MelodyÂ® Valve is currently available only to patients participating in a U.S. Food and Drug Administration (FDA) approved clinical trial. Five pediatric hospitals in the U.S. are participating in the study that will implant up to a total of 70 valves.
“For many children who may not be able to tolerate another open-heart procedure, this new therapy offers tremendous hope,” said Dr. Thomas K. Jones, director of Children’s Cardiac Catheterization Laboratories. “The alternative of open-heart surgery comes with significant risk and is followed by a long recovery, with the potential for many complications. By providing less invasive options for patients and eliminating even one open-heart procedure during their lifetime, we believe we can improve our patients’ quality of life immeasurably.”
Cindy Foster, whose 12-year-old daughter was one of the first to receive the MelodyÂ® Valve at Children’s said there was “no comparison” between her daughter’s recovery from open-heart surgery and her recovery from the transcatheter replacement.
“After my daughter’s open-heart surgery, there were tubes everywhere and there was such a big incision that needed to heal,” said Foster. “She was in the hospital for three weeks. Recovery was a long, slow process.” In contrast, after her daughter’s transcatheter procedure, Foster said, “My daughter spent only one night in the hospital and was tired for just a day or two, but was then ready to get back to all of her activities. You wouldn’t even know she just received a new pulmonary valve two weeks ago. She is riding her bike, jumping on the trampoline, playing with friends and getting ready for soccer camp.”
The MelodyÂ® Valve is a device made from the jugular vein of a cow. There is a naturally occurring valve in these jugular veins that can function just like a human pulmonary valve. The jugular vein valve is sewn inside a large diameter metallic stent. The stent is then crimped onto an angioplasty balloon within the delivery catheter. The delivery catheter is inserted through a vein in the groin and guided into the old conduit. The valve is delivered by inflating an angioplasty balloon that opens up the stent inside the old conduit. As soon as the balloon is deflated and the catheter removed, the valve starts working immediately.
Although the valve and transcatheter system is available in Europe and Canada, the FDA has not yet approved it for commercial use in the United States. To date, over 400 patients worldwide have received a MelodyÂ® Valve. According to MedtronicÂ®, most of these patients are children.
The American Heart Association states that congenital heart defects are the No. 1 birth defect worldwide. In the United States, approximately 35,000 babies are born with a heart defect each year.
About Seattle Children's Hospital
Consistently ranked as one of the best children’s hospitals in the country by U.S. News & World Report, Children’s serves as the pediatric and adolescent academic medical referral center for the largest landmass of any children’s hospital in the country (Washington, Alaska, Montana and Idaho). For more than 100 years, Children’s has been delivering superior patient care and advancing new treatments through pediatric research. Children’s serves as the primary teaching, clinical and research site for the Department of Pediatrics at the University of Washington School of Medicine. The hospital works in partnership with Seattle Children’s Research Institute and Seattle Children’s Hospital Foundation. For more information, visit http://www.seattlechildrens.org.