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COVID-2019 Alert

The latest information about the 2019 Novel Coronavirus, including vaccine clinics for children ages 5 years old and older.

La información más reciente sobre el nuevo Coronavirus de 2019, incluidas las clínicas de vacunación para niños de 5 años en adelante.

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The Harmony™ Transcatheter Pulmonary Valve (TPV)—a New, Nonsurgical Solution to Severe Pulmonary Valve Regurgitation

As 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 program (Cath Lab) use leading-edge research and technology to provide the very latest, minimally invasive treatment options for children with heart problems. We’re pleased to add a transcatheter pulmonary valve (TPV) therapy to the suite of minimally invasive heart valve replacements performed in our Cath Lab.

The Harmony™ TPV is the first pulmonary valve to be approved for use in the United States by the FDA. It serves as a solution to specific right ventricle heart defects. While transcatheter pulmonary valves have been available in other countries, the Harmony™ TPV is the first of its kind in the world, and Stanford Children’s Health is the first of just two hospitals nationwide to provide it to children.

Undergoing a Cath Lab procedure rather than open heart surgery—the only solution for severe pulmonary valve regurgitation until now—means a quicker recovery for your child and improved quality of life.

About pulmonary valve regurgitation

Pulmonary valve regurgitation 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.

Lucile Packard Children’s Hospital Stanford is one of the first hospitals in the country to offer TPV to children. Learn more, call today (650) 597-7267.

Benefits of a transcatheter pulmonary valve (TPV) 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 TPV is placed

  1. The nonsurgical procedure is performed in the Cath Lab.
  2. 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.
  3. Once placed, the artificial valve expands to fill the space; the catheter is removed.
  4. Images and tests ensure that the valve is working properly and pumping blood from the heart to the lungs without backflow.

Facts about the Harmony™ TPV

  • The first transcatheter pulmonary valve to be approved by the FDA for use in the United States, and the first of its kind in the world to treat pulmonary valve regurgitation nonsurgically.
  • Achieved 89% effectiveness during clinical trials of both children and adults, including here at Stanford Children’s Health.
  • Granted breakthrough device designation by the FDA due to its success, allowing it to be put to use quickly.
  • Side effects may include irregular heartbeat, leaking, bleeding, a narrowed pulmonary valve, and implant movement, among others.

To learn more, talk to your child’s cardiologist at Stanford Children’s Health.

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