The Edwards SAPIEN 3 Valve With the Alterra Adaptive Prestent System

The Edwards SAPIEN 3 Valve
With the Alterra Adaptive
Prestent System

Transcatheter Pulmonary Valve Replacement (TPVR) With the Edwards SAPIEN 3 Valve and Alterra Adaptive Prestent System

TPVR is a less invasive treatment option for patients who typically face the burden of multiple open-heart surgeries, often beginning at birth. The Edwards SAPIEN 3 valve with the Alterra adaptive prestent system, could help people with congenital heart disease (CHD) who have pulmonary regurgitation due to a prior procedure to fix their pulmonary valve or right ventricular outflow tract (RVOT).

Most CHD patients will typically require multiple open-heart surgeries throughout their lifetimes. With each open-heart surgery, your surgical risk increases. However, with the less invasive option of TPVR with the Edwards SAPIEN 3 valve and Alterra adaptive prestent system, it is possible that you will need fewer repeat surgeries, as well as return home sooner to the activities you love.

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Patients who receive the Edwards SAPIEN 3 pulmonic valve and Alterra adaptive prestent may experience the following:

TPVR could delay your next open-heart surgery

TPVR patients experience improved heart function within the first year of treatment

The Edwards SAPIEN 3 Pulmonary Valve With the Alterra Adaptive Prestent System

This technology is a part of Edwards’ long-standing leadership in patient-focused innovations for structural heart disease. Edwards has been helping critically ill patients for over 60 years.

Alterra Adaptive Prestent

The prestent is designed to help make your RVOT suitable for implanting the Edwards SAPIEN 3 transcatheter heart valve. The Alterra adaptive prestent works as a landing zone for the Edwards SAPIEN 3 pulmonary valve within the RVOT. The prestent frame is made from metal and has a fabric covering with designated inflow and outflow ends.

Edwards SAPIEN 3 Valve

The valve is designed to work like your pulmonary heart valve and help make your valve and heart work as it is intended. The Edwards SAPIEN 3 transcatheter heart valve is made up of three main components: three leaflets made from the tissue of a cow’s heart, a metal frame, and a fabric skirt. Together with the Alterra adaptive prestent, the Edwards SAPIEN 3 pulmonary valve should begin working immediately after it is implanted.

TPVR With the Edwards SAPIEN 3 Valve and Alterra Adaptive Prestent System

Who Should Have the Procedure?

The Edwards SAPIEN 3 valve with the Alterra adaptive prestent system is a minimally invasive treatment option, designed to help treat severe pulmonary regurgitation in children, adolescents, and adults with a native or surgically repaired RVOT.

Who Should Not Have the Procedure?

The Edwards SAPIEN 3 valve with the Alterra adaptive prestent system should not be used with 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.

Steps of the TPVR Procedure With the Edwards SAPIEN 3 Pulmonary Valve and Alterra Adaptive Prestent System

Be sure to tell your doctor if you are taking any medications or have any allergies. Your doctor will also explain the procedure and answer any questions you might have.

Steps of the TPVR procedure

1. Before your procedure, you may be placed under general anesthesia or light sedation.

2. Your doctor will make a small incision in your leg to access your vein. Once the doctor has access to the vein, a short, hollow tube called a sheath, which is inserted into the vein and used as a tunnel to deliver the Alterra adaptive prestent to your heart.

3. When the sheath is in place, your doctor will take the Alterra adaptive prestent and insert the delivery catheter into the leg and guide it up the vein to reach the heart. Your doctor will begin to deploy the self-expanding prestent into the RVOT. Once it is fully expanded, your doctor will remove the delivery catheter leaving the prestent as a landing zone, making your RVOT ready for the new transcatheter pulmonary valve.

4. Now that you have a docking station for your new valve, your doctor will use a different delivery system catheter with the Edwards SAPIEN 3 transcatheter pulmonary valve squeezed into a balloon on the tip. This makes the valve small enough to fit into a catheter.

5. Your doctor will insert the delivery system into the leg and guide the new valve up to the heart. Once it reaches the Alterra Adaptive Prestent, your doctor will expand the balloon on the catheter, opening up the Edwards SAPIEN 3 pulmonary valve and securing it in place.

6. Your doctor will make sure your Edwards SAPIEN 3 pulmonary valve works properly before removing the delivery catheter from the leg and closing the small incision in your leg.

On Average, the TPVR Procedure Takes Approximately 2-3 Hours

On Average, the TPVR Procedure
Takes Approximately 2-3 Hours

Watch a Video of TPVR with the Edwards SAPIEN 3 Valve and the Alterra Adaptive Prestent System

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Life After Your TPVR Procedure

It is important to understand that every patient is different in how they recover. You can expect to spend a day or two in the hospital after your procedure. Most patients should begin walking soon after their procedure. Before you leave the hospital, your doctor will explain your aftercare plan. You will be given specific instructions to help with your recovery, including when to return to exercise, as well as any medicine you need to take.

It is important to carefully follow your doctor’s directions, especially if you need to take any blood-thinning medication. You should start feeling better soon after TPVR. It can take about a week before you return to normal, everyday activities. Regular checkups with your doctor are essential. Take your medications as instructed and be sure to keep all follow-up appointments with your doctor.

Potential Benefits of the Edwards SAPIEN 3 Pulmonary Valve

Clinical data has shown signs of improvement in health up to six months. That means a lot in terms of improved quality of life, including:

Delay of next open-heart surgery

Improved heart function

Ability to care for yourself

Return to everyday activities

Average length of stay for patients who received TPVR with the Edwards SAPIEN 3 Valve:
1-2 days

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.

Watch Real Patient Stories

See how TPVR helped patients to delay their next open-heart procedure