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    Edwards SAPIEN® Transcatheter
    Aortic Valve Replacement (TAVR)

    What is the Edwards SAPIEN® transcatheter aortic valve replacement (TAVR) procedure with the RetroFlex3® delivery system?

    The Edwards SAPIEN® TAVR procedure allows physicians to replace a diseased aortic valve while the heart is still beating. The Edwards SAPIEN® transcatheter heart valve is introduced into the femoral artery in the upper thigh using a very thin tube known as the RetroFlex3® delivery system, which is threaded through the circulatory system to the patient’s beating heart.

    The Edwards SAPIEN® transcatheter heart valve is introduced into the femoral artery in the upper thigh using a very thin tube known as the RetroFlex3® delivery system, which is threaded through the circulatory system to the patient’s beating heart.
    Images are the property of Edwards Lifesciences LLC.

    Why is the procedure necessary?

    The heart has four valves with paper-thin flaps of tissue (leaflets) that constantly open and close to regulate blood flow. Sometimes, these valves become diseased, hindering the flow of blood.

    The Edwards SAPIEN® TAVR procedure allows doctors to replace a diseased aortic valve and its leaflets with a new heart valve made of a balloon-expandable, stainless steel frame and three very thin leaflets, constructed from the tissue sac surrounding the heart of a cow.

    How is it performed?

    Edwards SAPIEN® transcatheter aortic valve replacement (TAVR) with the RetroFlex3® delivery system is performed in the hospital under general anesthesia and takes about four to five hours.

    During the procedure, a doctor makes a small incision in the femoral artery of the leg and inserts a pencil-thin tube called a sheath. Through the sheath, a doctor introduces a balloon catheter—a very thin tube with a deflated balloon—and guides it to the aortic valve using imaging guidance while the heart is beating. The balloon is inflated to open the diseased valve, and then deflated and removed.

    Once positioned in the aortic valve, the balloon is inflated, expanding the new valve within the diseased one. The balloon is then deflated and the RetroFlex3® delivery system is removed.
    Images are the property of Edwards Lifesciences LLC.

    Edwards SAPIEN® transcatheter heart valve over a deflated balloon on a very thin tube or catheter called the RetroFlex3® delivery system. Inserting this delivery system through the sheath in the femoral artery, the doctor threads it to the aortic valve using imaging guidance.

    Once positioned in the aortic valve, the balloon is inflated, expanding the new valve within the diseased one. The balloon is then deflated and the RetroFlex3® delivery system is removed. The new Edwards SAPIEN® transcatheter heart valve begins to work immediately.

    What are the advantages?

    • Improvement in symptoms and quality of life for many patients, including high-risk, inoperable patients with symptomatic severe calcific-degenerative aortic valve stenosis
    • Elimination of cardiopulmonary bypass (heart–lung machine)
    • Minimally invasive
    • Optimal delivery and placement of the valve through imaging guidance
    • Construction of the Edwards SAPIEN® transcatheter heart valve using the Carpentier-Edwards ThermaFix® tissue process to prevent calcification of valve tissue

    What are the risks?

    Talk to your doctor to determine if this procedure is right for you. As with any medical procedure, there are risks. Some of them include:

    • Device may not open properly
    • Infection of the heart (endocarditis)
    • Leakage
    • Clots
    • Abnormal bleeding
    • Abnormal heart sounds

    Why choose Alta Bates Summit Medical Center?

    Our Cardiovascular Center of Excellence delivers the most advanced diagnostic and treatment techniques, using the latest state-of-the-art technology. To find a physician with expertise in TAVR, please call our Heart Valve Clinic at 510-869-6700.