The pediatric cardiac team at the Hospital of the Oregon Health & Science University Doernbecher Children's is the first in the region and one of the few in the country to establish a pulmonary heart valve without open heart surgery.
To date, four patients have undergone valve milestone in the OHSU Pediatric and Adult Congenital Cardiac Catheterization Laboratory. All reported immediate improvement in your energy level and stamina.
The device, called the Medtronic Melody ® Percutaneous pulmonary valve, was recently approved by the Food and Drug Administration. The valve is used to replace a narrow or leaky pulmonary valve "pipeline" - a tube that connects the heart to the lungs - in children and adults who have previously undergone surgery to correct a congenital heart defect. So far, the pulmonary valve replacements have required open heart surgery.
The Melody valve is inserted into a small opening in the leg and guided by a catheter through blood vessels in the heart. Once the valve is correctly positioned, a balloon at the end of the catheter is inflated, the valve delivery and immediately correct the flow of blood.
"Children born with blocked heart valves or leaks may be subject to a maximum of four open heart surgeries before reaching adulthood to replace the tubes that have been carried out or has been overcome, and each time the risk of surgery increases, "said Grant Burch, MD, director of the OHSU Pediatric and Adult Congenital Cardiac Catheterization Laboratory and associate professor of pediatric cardiology at OHSU Doernbecher Children's Hospital. "The melody extends the life of a pipeline valve implanted and is likely to reduce the number of open-heart surgery, a patient may need during a lifetime."
"This device will not remove the need for open heart surgery, but it offers a safe and effective alternative to surgery for many children and young adults with congenital heart disease," said Burch.
"The most remarkable thing about this procedure is that the valve is placed on the beating heart through a vein in the patient's leg. After the procedure, patients spend one night in the hospital room and are discharged The next morning, "said Laurie Armsby, MD, associate professor of pediatric cardiology at OHSU Doernbecher Burch and partner in the OHSU Pediatric and Adult Congenital Cardiac Catheterization Laboratory. "This device brings us closer to the goal of providing alternatives for children less invasive surgery for the treatment of congenital heart disease."
More than 1,700 patients have been implanted worldwide since the valve has been approved for commercial use in Europe in 2006. According to the FDA, an estimated 1,000 U.S. children and adults with congenital heart disease will qualify for the new valve year.
Drs. Burch and Armsby are pediatric cardiologists in Oregon only with advanced training in interventional cardiology. Together hold more than 300 cardiac catheterizations in infants, children and adults with congenital heart disease each year.
The FDA approved the Melody valve in providing humanitarian device exemption, which allows the use of certain devices that are safe and whose health benefits outweigh the risks of injury or illness. A Humanitarian Use Device (HUD) is designed to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States each year. The exemption is only given when no comparable device available to treat or diagnose disease or condition.
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