Babies born with certain types of congenital heart conditions need heart surgery as infants and 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.
“Open-heart surgery is the current standard of care for replacing the pulmonary valve in patients with severe pulmonary valve regurgitation,” says Jeffrey Zampi, M.D, pediatric cardiologist at University of Michigan C.S. Mott Children’s Hospital in Ann Arbor, Michigan. “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.”
Now, a new minimally invasive approach will allow some of these patients to reduce the risks and long recovery associated with recurring invasive surgeries. 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 catheter-based treatment for patients with dysfunctional pulmonary valves.
“This new method will allow us to significantly expand minimally invasive options to more patients with pulmonary valve disease,” Zampi says.
How it works
The procedure, which usually takes one to two hours, involves inserting the valve into a vein in the groin or neck through a catheter, which is then guided to the heart. The collapsed valve is then released in the region of the pulmonary valve 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.”
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.
The FDA approved the valve in March 2021 after a 70-patient clinical study, which will continue observing patients for 10 years. It is a self-expanding transcatheter valve, which is distinct from other currently available transcatheter pulmonary valves that are balloon-expandable, Zampi notes. Because of this design, the number of patients who can be treated for severe pulmonary leakage and enlarged right hearts will drastically improve. “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 says.
“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.”