Transcatheter pulmonic valve (TPV) therapy with the Edwards SAPIEN 3 valve provides a less invasive treatment option for a group of patients who typically face the burden of multiple open-heart surgeries, often times beginning at birth. As surgical risk increases with each open-heart surgery, minimally invasive options can help patients recover and return to normal activities sooner.
TPV therapy with the Edwards SAPIEN 3 valve is meant to restore the function of the pulmonary valve in hopes to delay the need for an additional open-heart surgery. The Edwards SAPIEN 3 pulmonic valve treats a failing right ventricular outflow tract (RVOT) conduit or previously implanted surgical tissue valve because it has either become narrowed (stenosis) and/or leaky (regurgitation).
The Edwards SAPIEN 3 Transcatheter Heart Valve
The SAPIEN 3 valve 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.
The Edwards SAPIEN 3 pulmonic valve is part of the latest technology of heart valves from Edwards Lifesciences. The Edwards SAPIEN 3 pulmonic valve is a bioprosthetic, balloon-expandable valve. The frame of the valve is made from cobalt chromium to help with strength and durability. The leaflets in the valves are made from the same bovine pericardial tissue (from a cow’s heart) as Edwards long standing surgical valves. An outer sealing skirt surrounds the bottom of the valve to help stop any possible leakage around the valve.
The valve is available in four sizes: 20, 23, 26, and 29 mm in diameter. Your doctor will determine which valve size is right for you.
TPV Therapy with the Edwards SAPIEN 3 Valve
Who Should Have the Procedure?
The Edwards SAPIEN 3 pulmonic valve is for people who want a less invasive option to replace their failing pulmonary surgical tissue 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 the Procedure?
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.
Clinical Data for the Edwards SAPIEN 3 Pulmonic Valve
TPV therapy with the Edwards SAPIEN 3 valve has been demonstrated for the treatment of pediatric and adult patients. There are complications that may occur during this transcatheter procedure with the Edwards SAPIEN 3 pulmonic valve that may be serious and could include death. To see a list of all complications, please download the patient brochure.
It is important to talk with your doctor about your procedure, the product you will receive, and the literature on clinical studies using that product.
Patients who received the Edwards SAPIEN 3 Pulmonic Valve experienced the following:
Patients were able to delay their next open-heart surgery
Generally, patients experienced improved heart valve function within the first year of treatment
Life After the Procedure
After your procedure, you may spend a day or two in the hospital. Every patient is different in how they recover. Most patients should begin walking very soon after their procedure. Before you leave the hospital, your doctor will discuss your aftercare plan with you. They will give you specific instructions to help you with your recovery. This may include a special diet, when to return to exercise, and any medicine you may 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 TPV therapy. It can take about a week before you can return to normal activities. Regular checkups with your doctor are important. Take your medications as instructed, and be sure to keep all follow-up appointments with your doctor.
Quality of Life Improvements
TPV therapy clinical data have shown signs of improvement in health in six months. That means a lot in terms of improved quality of life, including:
Reduction in symptoms
Ability to care for yourself
Improved heart function
Return to everyday activities
Watch Mia’s Journey with Transcatheter Pulmonic Valve Therapy
Mia, a student nurse, was born with a congenital heart defect (CHD). Her twin sister Tia however has a healthy heart. Growing up, Mia was always concerned about her next open-heart procedure. Mia’s journey with transcatheter pulmonic valve (TPV) therapy, she was able to postpone her next open-heart procedure.