The Heart Institute at Nicklaus Children's Hospital is now offering pulmonary valve replacement via cardiac catheterization with the recently FDA-approved Harmony valve. The Harmony Transcatheter Pulmonary Valve (TPV) from Medtronic is a first-of-its-kind option available to patients with a specific type of congenital heart defect that affects the right ventricle of the heart.

According to the Centers for Disease Control and Prevention (CDC), congenital heart disease (CHD) is the most common type of birth defect in the United States, affecting an estimated 40,000 infants each year. Approximately one in five of those born with CHD have an abnormality of their right ventricular outflow tract (RVOT) and pulmonary valve, which makes it difficult for blood to travel from the heart to the lungs. These patients require open-heart surgery or other interventions early in life to address these malformations and provide them with a functioning pulmonary valve. As time goes on, these pulmonary valves often become dysfunctional and need to be replaced. There are currently two FDA approved transcatheter pulmonary valves, however only about a quarter of patients needing pulmonary valve replacement are candidates for the currently approved valves.

The unique design of the Harmony TPV allows it to adapt to a wide variety of patient anatomies, significantly increasing the number of patients who can undergo transcatheter pulmonary valve replacement. The Harmony TPV provides patients that meet criteria with an alternative to open-heart surgery. Instead, the valve is loaded onto a catheter and delivered via a small incision in the femoral vein, or in the neck, and placed directly inside the heart.

“This is a significant step in our ongoing efforts to offer patients the least invasive approaches to treating heart defects,” said Dr. Lourdes Prieto, Director of the Cardiac Catheterization lab at Nicklaus Children's and director of the Division of Cardiology.

The Harmony valve is primarily used to treat patients who have severe pulmonary valve regurgitation by re-establishing efficient blood flow from the right ventricle to the lungs, where blood is re-oxygenated and carried to the rest of the body.

The Food and Drug Administration (FDA) recently approved the therapy, which is now being offered by the Heart Institute at Nicklaus Children's Hospital.