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New, Less Invasive Option for Valve Replacement

First trans-catheter valve replacement at The Nebraska Medical Center

If not for the Melody Valve, Bret Larson may have spent the week after his 28th birthday preparing for open-heart surgery. Born with a congenital heart defect, it would have been his third major operation. Instead, the Johnston, IA schoolteacher and football coach spent one night in the hospital and went back home with a new pulmonary valve in his heart, and one less scar on his chest.

“I had a valve replaced when I was five and then again at 15,” Larsen said. “At 15 I can remember the recovery being painful and spending a week in the hospital.”

This time, the valve was replaced without surgery by interventional cardiologist Jeff Delaney, MD, who ran a special replacement valve called a Melody Valve through the femoral vein in Larsen’s leg and into his heart. Working closely with Dr. Delaney were his colleagues from the Pediatric Hybrid Catheterization Lab at Children’s Hospital & Medical Center, as well as cardiologists and the catheterization lab team at The Nebraska Medical Center. The collaboration allowed a former pediatric heart patient at Children’s, now an adult, to receive the most advanced treatment and care.

The FDA approved the Melody Valve under the guidelines of the Humanitarian Device Exemption. Dr. Delaney is the only cardiologist in Nebraska with permission to implant Melody valves. He received special training and is certified to perform the procedure.

He said only those patients with a rare defect in their pulmonary valve are candidates for the Melody replacement.

“About eight out of a thousand people will be born with some kind of congenital heart defect,” Dr. Delaney explained. “Twenty percent of them have anomalies in the pulmonary valve; and of those, just 15% have had prior surgeries that would make them eligible for a Melody Valve.”

The Melody Valve was first used in Europe in 2000. The first use in the United States was in 2007. Instead of naming the valve after himself, the inventor, also a violinist, gave it a name to reflect his love of music.

Dr. Delaney said there are tremendous advantages to replacing a valve using a trans-catheter approach. It carries fewer risks of complication than open-heart surgery, a significantly shorter recovery and less scar tissue – a very important advantage since replacement valves typically last 10-20 years.

“Every ten to twenty years, a patient would have to face open-heart surgery,” Dr. Delaney said. “The Melody Valve is the same valve they would use in the operating room. What’s different is the method we use to implant it. When this valve wears out, we could potentially use the same approach to put a new valve in the same place. We expect these valves to last just as long as conventionally-placed valves, but that’s one of the things we are studying.”

The procedure is done in a specialized cardiac catheterization lab, not an operating room. The cardiology team uses live x-ray to guide the catheters through the patient’s blood vessels. After carefully placing a guide wire in the blood vessel, the valve is inserted. The Melody Valve is a bovine jugular valve, almost identical in size to an adult pulmonary valve. The valve is then sewn into a balloon-expandable stent (a tiny metal mesh tube). When the balloon is inflated to expand the stent, the valve sticks in place and immediately begins working.

“The actual implantation of the valve happens very quickly,” Dr. Delaney explained. “The prep work is what takes time. We have to be very sure the implant zone for the valve is not obstructed and that the coronary arteries won’t be compressed when the stent holding the valve is deployed.”

Dr. Delaney performed Nebraska’s first Melody Valve implantation and several more on younger patients at Children’s Hospital & Medical Center. Larsen’s case was the first done at The Nebraska Medical Center. It will not be the last.

“Thanks to the expertise of Dr. Delaney and the cath lab team here, we expect we will do 10-12 of these procedures every year,” said Jorge Parodi, executive director of cardiovascular and pulmonary care at The Nebraska Medical Center. “It provides an option for patients who did not have options before. It is an important step in providing comprehensive cardiac care to all our patients.” For Bret Larsen, the difference between this procedure and the one he underwent 13 years ago is profound. Just hours after leaving the hospital, the high school football coach was at a team meeting; four days later he was on the field for the first day of summer practice.

“Had this valve been done with open heart surgery, I still would have been in the hospital,” Larsen said. “Heading home a day later feels about a million times better.”