Babies born with certain types of congenital heart conditions not only need heart surgery after birth and as infants, but again years later as adults.

As a result of neonatal heart surgery, some may experience chronic leaky pulmonary valves and develop enlarged right hearts, which can cause heart failure and abnormal heart rhythms. These patients will often require pulmonary valve replacements and numerous open-heart surgeries throughout their lives.

Now, a new minimally invasive approach will allow some of these patients to reduce the risks and long recovery associated with recurring invasive surgeries.

University of Michigan Health C.S. Mott Children's Hospital has become the first center in the state of Michigan and among a select few in the country to offer the Harmony transcatheter pulmonary valve, a breakthrough catheter-based treatment for patients with dysfunctional pulmonary valves.

"Open-heart surgery is the current standard of care for replacing the pulmonary valve in patients with severe pulmonary valve regurgitation," said Mott pediatric cardiologist Jeffrey Zampi, M.D.  

"Using our current technology we're able to avoid surgical valve replacements in only a small percentage of congenital heart patients as they enter their adult years. This new method will allow us to significantly expand minimally invasive options to more patients with pulmonary valve disease."

The procedure, which usually takes one to two hours, involves inserting the Harmony valve within a thin, hollow tube (catheter) into a vein in the groin or neck, which is then guided to the heart. The collapsed valve is then released in the region where the pulmonary valve typically is and begins to function immediately.

"These valves are expected to last as long as surgical valves, with patients likely to spend one night at the hospital compared to a week with traditional open heart surgery," Zampi said. "This approach requires less anesthesia, helps us reduce surgery risks like bleeding complications and infections and gets patients back to resuming regular activities much more quickly."

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Among people who benefit from the procedure are those born with tetralogy of fallot, a rare condition caused by a combination of four heart defects including a hole in the heart that leads to inadequate blood flow to the lungs.

These patients often undergo at least one surgery as a baby, but eventually need more interventions to address a leaky pulmonary valve.

That was the case for Lauren Boyce, 28, who was the first patient to receive the Harmony valve in the state of Michigan at Mott in June.

Boyce, of Canton, underwent open heart surgery for tetralogy of fallot as a newborn. She routinely sees a cardiologist but hasn't needed any interventions since then, she said.

Last winter, however, she began experiencing severe shortness of breath.

"I've been having a lot of trouble breathing and a lot more sleepiness and fatigue," she said. "I definitely haven't been able to be as active recently, not doing things I like to do like roller blading and bike riding. But it's sometimes hard to breathe even when I'm walking and talking."

MRI results showed that increased pulmonary valve regurgitation was the culprit. Her cardiologist, Daniel Turner, M.D., Beaumont Children's chief of pediatric cardiology, told her Mott was expected to offer the new Harmony valve soon and she decided to wait for the surgery alternative.

Boyce said the shorter recovery will mean taking less time off work at her job as a medical assistant in an orthopedic office and worrying about the risks of having an invasive surgery.

"It will make recovery a lot easier," she said. "I'm glad I didn't have to travel far to get this procedure."

The FDA approved Medtronic's Harmony valve in March, 2021 after a 70-patient clinical study, which will continue observing patients for 10 years.

The Harmony valve, which is a self-expanding transcatheter valve, is distinct from other currently available transcatheter pulmonary valves which are balloon-expandable, Zampi noted. Because of this design, the number of patients who can be treated for severe pulmonary leakage and enlarged right hearts will drastically improve, he said.

"While this new catheter-based approach doesn't necessarily replace open heart surgery, it may delay or reduce the number of surgeries patients need to treat pulmonary valve disease," Zampi said.

"We're committed to providing our patients with congenital heart disease innovative strategies to improve their quality of life over their entire lifetime while minimizing the stress and disruptions that come with big surgeries." 

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