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You may have questions about your diagnosis, symptoms, and treatment options for either your failing RVOT conduit or previously implanted surgical tissue valve. Explore our frequently asked questions below and get the information you need to take control of your health.

What is congenital heart disease?

Congenital Heart Disease, also known as CHD, is one of the most common birth defects in the United States. CHD is a defect or abnormality of the heart that is usually present from birth. It results when the heart or blood vessels near the heart do not develop normally before birth.

Types of congenital pulmonary valve defects or diseases
  • Tetralogy of Fallot
  • Pulmonary valve stenosis
  • Aortic stenosis requiring a Ross Procedure
  • Pulmonary atresia
  • Transposition of the Great Arteries requiring a Rastelli Repair
  • Truncus arteriosus
  • Double outlet right ventricle (DORV)
What is the pulmonary valve?

The pulmonary valve (sometimes referred to as the pulmonic valve) is a one-way valve that lies between the right ventricle and the pulmonary artery and has three cusps. It controls blood flow from the right lower chamber (right ventricle) to the pulmonary artery and sends blood to the lungs to pick up oxygen. People with a congenital heart defect may need to have their pulmonic valve replaced due to disease.

What is right ventricular outflow tract?

The right ventricular outflow tract, also known as the RVOT, is a tunnel-like structure in the heart below the pulmonary valve. When working properly, blood will pass from the heart through the RVOT and pulmonary valve to the pulmonary artery and out to the lungs.

What is a RVOT conduit?

A conduit is for reconstruction or replacement of the natural right ventricular outflow tract (RVOT) to create a pathway from the right ventricle to the pulmonary arteries. Conduits can be homograft material, Dacron or animal tissue.

Initial Treatment for Failing RVOT or Pulmonary Valve

If someone has a heart defect involving the right ventricular outflow tract also know as RVOT or with their pulmonary valve, it is sometimes addressed with reconstructive open heart surgery to help restore blood to correctly flow to the lungs. To repair the RVOT, a prosthetic conduit is surgically implanted to connect the right ventricle to the main pulmonary artery. If the pulmonary valve needs to be replaced, the failing valve is usually removed and a new surgical tissue valve is inserted. Over time both of these options are often not the final solution for CHD patients, as conduits and/or tissue valves will need to be replaced later in life.

Symptoms of a failing RVOT conduit or previously implanted pulmonic valve
  • Fatigue and exertional intolerance
  • Shortness of breath
  • Chest pain
  • Dizziness or fainting from exercise
  • Irregular heartbeat
  • Too weak for normal activities
Treatment options for a failing RVOT conduit or previously implanted pulmonic valve
  • Transcatheter pulmonic valve (TPV) therapy
  • Open heart surgery
  • Balloon angioplasty/valvuloplasty
  • Stenting
What is transcatheter pulmonic valve therapy?

During this minimally invasive procedure, a small tube called a catheter holding a new heart valve is inserted through a small tube and guided to the intended location in your heart. Once the valve has reached the correct location, it is expanded with the help of a balloon. The valve should immediately begin to work and help control blood flow. Once the valve is deployed, the balloon and tube are removed.

Who is transcatheter pulmonic valve therapy indicated for?

The Edwards SAPIEN 3 pulmonic valve is for people who want a less invasive option to replace their failing pulmonary surgical valve or failing RVOT conduit. It is approved for use in adults and children who have a narrowed (stenosis) and/or leaky (regurgitation) RVOT conduit or previously implanted surgical valve.

Who should not have transcatheter pulmonic valve therapy?

TPV therapy with the Edwards SAPIEN 3 pulmonic valve should not be performed on anyone who cannot tolerate medications that thin the blood or prevent blood clots from forming or who have an active infection in the heart or elsewhere.

How long will I need to stay in the hospital after the procedure?

After the procedure, most people stay one to two days.

How long is the transcatheter pulmonic valve procedure?

Depending on your health, the average procedure lasts between 2-3 hours.

How long has transcatheter pulmonic valve therapy been performed?

Transcatheter pulmonic valve (TPV) therapy has been commercially available in the United States since 2016.

What is the Edwards SAPIEN 3 valve made from?

The Edwards SAPIEN 3 valve is made up of three leaflets of tissue from a cow’s heart. The leaflets are sewn to a fabric skirt on a metal frame.

What are the major risks associated with the Edwards SAPIEN 3 transcatheter pulmonic valve procedure?

As with open-heart surgery, there are risks. The major risks associated with the TPV procedure, although rare, include heart damage potentially requiring surgery, bleeding, blood vessel complications, irregular heartbeat, and possible death. Talk to your doctor about all the risks associated with TPV therapy.

How long does the Edwards SAPIEN 3 valve last?

How long your tissue valve will last depends on many patient factors and medical conditions. Follow all care instructions to ensure the best possible results. The Edwards SAPIEN 3 pulmonic valve has been tested in a laboratory to mimic 5 years of use without failure. Regular follow-ups will help your doctor know how your valve is working.