The Harmony™ Transcatheter Pulmonary Valve (TPV)

A new, nonsurgical solution to severe pulmonary valve regurgitation

For a parent, the idea of your child needing open heart surgery can be daunting, even when it’s necessary to save your child’s life. Our pediatric heart experts in our cardiac catheterization laboratories at Stanford Medicine Children’s Health use leading-edge research and technology to provide the very latest, minimally invasive treatment options for children with heart problems. We’re pleased to offer transcatheter pulmonary valve (TPV) therapy as part of our suite of minimally invasive heart valve replacements. TPVs serve as a solution to specific right ventricle heart defects.

The Harmony™ transcatheter pulmonary valve was an early pulmonary valve to be approved for use in the United States by the FDA. It was one of the first of its kind in the world, and Stanford Medicine Children’s Health was one of just three hospitals nationwide to provide it to children. Soon after, other large pediatric heart centers followed suit to offer the Harmony™ TPV. It achieved 89% effectiveness during clinical trials of both children and adults, including here at Stanford Medicine Children’s Health.

We also offer several other models of transcatheter pulmonary valves, always ensuring that we are providing the very latest solutions tailored to each child’s needs. In this way, we provide exceptional outcomes for our young heart-lung patients with right ventricle heart defects.

Undergoing an interventional cardiac catheterization procedure rather than open heart surgery—the only solution for severe pulmonary valve regurgitation before 2021—has been shown to likely mean a quicker recovery for your child and improved quality of life.

About pulmonary valve regurgitation

Pulmonary valve regurgitation occurs when there is a leak in the heart valve that controls blood flow from the lower right pumping chamber (ventricle) of the heart to blood vessels connected to the lungs. The condition is a result of congenital heart disease—when the heart of a developing baby does not form correctly. There are many types of congenital heart defects that require repair of the pulmonary valve and adjacent right ventricular outflow tract (RVOT).

Pulmonary valve regurgitation creates a backflow of blood from the lungs into the heart, wearing down the heart over time. When severe, it may cause symptoms of fatigue, shortness of breath, dizziness, chest pain, irregular heartbeat, swelling, and cyanosis (blue discoloration of lips and nails). When symptoms advance, your doctor may recommend open heart surgery or a transcatheter pulmonary valve replacement. Mild to moderate pulmonary valve leaking may not cause symptoms and is often treated with medicines to help the heart work better.

The Betty Irene Moore Children’s Heart Center team at Lucile Packard Children’s Hospital Stanford was one of the first hospital teams in the country to offer transcatheter pulmonary valve to children. 

Benefits of a transcatheter pulmonary valve replacement

• Replaces open heart surgery, which has been the only answer for patients with severe pulmonary valve regurgitation in the United States.
• Results in a faster recovery, less pain, less anesthesia, and a shorter hospital stay.
• Improves blood flow from the heart to the lungs and decreases leaky valve symptoms.
• Restores valve function quickly.
• Delays need for more open heart surgeries.

How the transcatheter pulmonary valve (TPV) is placed

• The nonsurgical procedure is performed in one of our cardiac catheterization laboratories.
• Heart doctors insert a catheter—a thin, hollow tube—through a very small incision into a vein in your child’s groin or neck. The end of the catheter holds the collapsed TPV, which is transported to the right side of the heart.
• Once placed, the artificial valve expands to fill the space; the catheter is removed.
• Images and tests ensure that the valve is working properly and pumping blood from the heart to the lungs without backflow.