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    Does the Person You Care For Have Severe Aortic Stenosis?

    If they're high-risk or too sick for open heart surgery, transcatheter aortic valve replacement (TAVR) is a less invasive procedure that could be an option.

    Only a qualified TAVR Heart Team can determine if TAVR is an appropriate option for the person you care for.

    Find a TAVR Center Below:

    Click Here

    Help the Person You Care For Get the Treatment That Is Right for Them

    There are a few treatment options for aortic stenosis. When the stenosis is severe, the doctor will probably suggest replacing the aortic valve. Most people think that means open heart surgery. But it's important to know that open heart surgery is not the only way to replace the aortic valve.

    Transcatheter aortic valve replacement, or TAVR, is a less invasive procedure for people who are high-risk or too sick for open heart surgery. With the TAVR procedure, there are multiple approaches. The most common is where an incision is made either in the leg, in the chest between the ribs, or in the upper chest. The new valve is placed in the heart via a flexible tube, known as a catheter. Ultimately, only the Heart Team can decide if TAVR is the best treatment option.

    TAVR involves risks, the most serious of which include death, stroke, bleeding, and vascular complications.

    Please see Important Safety Information below for a more complete description of risks and other important information.

    Your Role

    As a caregiver, you serve many important roles in the life of the person you care for. First and foremost, you are their trusted partner and health care advocate. Making treatment decisions isn't easy. As an advocate, you can help sort through all the different questions, concerns, and options along the treatment journey.

    Here Are Ways You Can Help

    Here Are Ways You Can Help
    +Be a Voice of Reason

    Many people think symptoms of aortic stenosis are just normal signs of aging. If you're worried about their symptoms (chest pain, fatigue, shortness of breath, lightheadedness, feeling dizzy and/or fainting, or difficulty when exercising) , encourage them to see a doctor to confirm if there is an underlying serious medical issue/condition.

    When it's time for the next step, you can be there to look at all the options and how the after care will affect you.

    +Track Symptoms

    Keep an eye on the symptoms of aortic stenosis (chest pain, fatigue, shortness of breath, lightheadedness, difficulty with exercise). Are they worsening? Is it time to check with a doctor about what is the next step in the treatment plan?

    +Attend Appointments

    It can help to have someone at each appointment to get information first-hand and make sure all questions are answered. Keep a folder with appointment notes, medication lists, doctors' contact information, and calendar, and bring it with you to all appointments. Make a list of questions before the appointment and take notes during the discussion. If you are not nearby, ask if you can participate in appointments by phone.

    +Consider a Second Opinion

    Part of being an advocate might mean getting a second opinion. The goal should always be for the patient to feel empowered about the treatment plan. If you're not sure about one doctor's recommendation, consult a Heart Team.

    +Talk About the Treatment Plan

    Different treatment paths may need to be considered. The treatment paths will depend on how severe the disease is as well as other factors. Treatment options may include medications to relieve symptoms. You can help your loved one by asking questions and discussing these options both during the doctor's appointment and at home.

    Make the Most of the Next Doctor Visit

    Use our Doctor Discussion Guide to help organize and remember questions you may have.

    IMPORTANT:
    WebMD and Edwards Lifesciences Corporation respect your privacy choices. By completing the form below you will transfer your information to Edwards Lifesciences Corporation and its designated parties in order to fulfil your request. Edwards Lifesciences Corporation and its designated parties will use your information as outlined in the Edwards Lifesciences Corporation Privacy Policy. Entry of the below information indicates your agreement with the Edwards Lifesciences Corporation Terms and Conditions.

    Only a qualified TAVR Heart Team can determine if TAVR is an appropriate option for the person you care for.

    Find a TAVR Center Below:

    Click Here

    Indications:

    The Edwards SAPIEN XT transcatheter heart valve, model 9300TFX, systems are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ≤ 1.0 cm² or aortic valve area index ≤ 0.6 cm²/m², a mean aortic valve gradient of ≥ 40 mmHg, or a peak aortic-jet velocity of ≥ 4.0 m/s), and with native anatomy appropriate for the 23, 26, or 29 mm valve system, who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥ 8% or at a ≥ 15% risk of mortality at 30 days).

    Contraindications (Who should not use):

    The Edwards SAPIEN XT transcatheter heart valve and delivery systems should not be used in patients who:

    • Cannot tolerate medications that thin the blood or prevent blood clots from forming.
    • Have an active infection in the heart or elsewhere.

    Warnings:

    • There is a higher risk of stroke in transcatheter aortic valve replacement procedures, compared to other standard treatments for aortic stenosis.
    • If an incorrect valve size for your anatomy is used, it may lead to heart injury, valve leakage, movement, or dislodgement.
    • Patients should talk to their doctor if they have significant heart disease, a mitral valve device or are allergic to chromium, nickel, molybdenum, manganese, copper, silicon, and/or polymeric materials.
    • The SAPIEN XT valve may not last as long in patients whose bodies do not process calcium normally.
    • During the procedure, your doctors should monitor the dye used in the body; if used in excess it could lead to kidney damage. X-ray guidance used during the procedure may cause injury to the skin, which may be painful, damaging, and long-lasting.
    • Transcatheter aortic heart valve patients should take medications that thin the blood or prevent blood clots from forming, except when likely to have an adverse reaction, as determined by their physician. The Edwards SAPIEN XT transcatheter heart valve has not been tested for use without medications that thin the blood or prevent blood clots from forming.

    Precautions

    The long-term durability of the Edwards SAPIEN XT transcatheter heart valve is not known, at this time. Regular medical follow-up is recommended to evaluate how well a patient's heart valve is performing. For patients who have previously had aortic valve replacement, the safety, effectiveness, and durability of putting a transcatheter valve in an already implanted artificial valve are not known at this time.

    The safety and effectiveness of the transcatheter heart valve is also not known for patients who have:

    • An aortic heart valve that is not calcified, contains only one or two leaflets, has leaflets with large pieces of calcium that may block the vessels that supply blood to the heart or in which the main problem is that the valve leaks
    • Previous heart valve replacement or repair
    • A heart that does not pump well, has thickening of the heart muscle, with or without blockage, unusual ultrasound images of the heart that could represent irregularities such as a blood clot, a diseased mitral valve that is calcified or leaking, or Gorlin syndrome, a condition that affects many areas of the body and increases the risk of developing various cancers and tumors
    • Low white, red or platelet blood cell counts, or history of bleeding because the blood does not clot properly
    • Diseased or irregularly shaped vessels leading to the heart. Vessels in the legs which are heavily diseased or too small for associated delivery devices, or a large amount of calcification at the point of entry to the heart, depending on delivery method
    • Allergies to blood-thinning medications or dye injected during the procedure

    Potential risks associated with the procedure include:

    • Death, stroke, paralysis (loss of muscle function), permanent disability, or severe bleeding
    • Risks to the heart, including heart attack or heart failure, a heart that does not pump well, irregular heartbeat that may result in a need for a permanent pace maker, chest pain, heart murmur, false aneurysm, recurring aortic stenosis(narrowing), too much fluid around the heart
    • Risks to your lungs or breathing, including difficulty breathing, fainting, buildup of fluid in or around the lungs, weakness or inability to exercise
    • Risks involving bleeding or your blood supply, including formation of a blood clot, high or low blood pressure, limited blood supply, a decrease in red blood cells, or abnormal lab values, bleeding in the abdominal cavity, collection of blood under the skin
    • Additional risks, including life-threatening infection, dislodgement of calcified material, air embolism (air bubbles in the blood vessels), poor kidney function or failure, nerve injury, fever, allergic reaction to anesthesia or dye, reoperation, pain, infection or bleeding at incision sites, or swelling

    Additional potential risks specifically associated with the use of the heart valve include:

    • Valve movement after deployment, blockage or disruption of blood flow through the heart, need for additional heart surgery and possible removal of the SAPIEN XT valve, a blood clot that requires treatment, damage to the valve (e.g., wear, breakage, recurring aortic stenosis), nonstructural valve dysfunction (e.g., leakage, inappropriate sizing or positioning, blockage, excess tissue ingrowth, blood cell damage, etc.) or mechanical failure of the delivery system and/or accessories

    Edwards, Edwards Lifesciences, Edwards SAPIEN, Edwards SAPIEN XT, SAPIEN, SAPIEN XT, NewHeartValve.com and design logo are trademarks of Edwards Lifesciences. All other trademarks are the property of their respective owners.

    ©2015 Edwards Lifesciences Corporation. All rights reserved. AR12564


    WebMD does not endorse any specific product, service, or treatment.

    IMPORTANT SAFETY INFORMATION

    Indications:

    The Edwards SAPIEN XT transcatheter heart valve, model 9300TFX, systems are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ≤ 1.0 cm² or aortic valve area index ≤ 0.6 cm²/m², a mean aortic valve gradient of ≥ 40 mmHg, or a peak aortic-jet velocity of ≥ 4.0 m/s), and with native anatomy appropriate for the 23, 26, or 29 mm valve system, who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥ 8% or at a ≥ 15% risk of mortality at 30 days).

    Contraindications (Who should not use):

    The Edwards SAPIEN XT transcatheter heart valve and delivery systems should not be used in patients who:

    • Cannot tolerate medications that thin the blood or prevent blood clots from forming.
    • Have an active infection in the heart or elsewhere.

    Warnings:

    • There is a higher risk of stroke in transcatheter aortic valve replacement procedures, compared to other standard treatments for aortic stenosis.
    • If an incorrect valve size for your anatomy is used, it may lead to heart injury, valve leakage, movement, or dislodgement.
    • Patients should talk to their doctor if they have significant heart disease, a mitral valve device or are allergic to chromium, nickel, molybdenum, manganese, copper, silicon, and/or polymeric materials.
    • The SAPIEN XT valve may not last as long in patients whose bodies do not process calcium normally.
    • During the procedure, your doctors should monitor the dye used in the body; if used in excess it could lead to kidney damage. X-ray guidance used during the procedure may cause injury to the skin, which may be painful, damaging, and long-lasting.
    • Transcatheter aortic heart valve patients should take medications that thin the blood or prevent blood clots from forming, except when likely to have an adverse reaction, as determined by their physician. The Edwards SAPIEN XT transcatheter heart valve has not been tested for use without medications that thin the blood or prevent blood clots from forming.

    Precautions

    The long-term durability of the Edwards SAPIEN XT transcatheter heart valve is not known, at this time. Regular medical follow-up is recommended to evaluate how well a patient's heart valve is performing. For patients who have previously had aortic valve replacement, the safety, effectiveness, and durability of putting a transcatheter valve in an already implanted artificial valve are not known at this time.

    The safety and effectiveness of the transcatheter heart valve is also not known for patients who have:

    • An aortic heart valve that is not calcified, contains only one or two leaflets, has leaflets with large pieces of calcium that may block the vessels that supply blood to the heart or in which the main problem is that the valve leaks
    • Previous heart valve replacement or repair
    • A heart that does not pump well, has thickening of the heart muscle, with or without blockage, unusual ultrasound images of the heart that could represent irregularities such as a blood clot, a diseased mitral valve that is calcified or leaking, or Gorlin syndrome, a condition that affects many areas of the body and increases the risk of developing various cancers and tumors
    • Low white, red or platelet blood cell counts, or history of bleeding because the blood does not clot properly
    • Diseased or irregularly shaped vessels leading to the heart. Vessels in the legs which are heavily diseased or too small for associated delivery devices, or a large amount of calcification at the point of entry to the heart, depending on delivery method
    • Allergies to blood-thinning medications or dye injected during the procedure

    Potential risks associated with the procedure include:

    • Death, stroke, paralysis (loss of muscle function), permanent disability, or severe bleeding
    • Risks to the heart, including heart attack or heart failure, a heart that does not pump well, irregular heartbeat that may result in a need for a permanent pace maker, chest pain, heart murmur, false aneurysm, recurring aortic stenosis(narrowing), too much fluid around the heart
    • Risks to your lungs or breathing, including difficulty breathing, fainting, buildup of fluid in or around the lungs, weakness or inability to exercise
    • Risks involving bleeding or your blood supply, including formation of a blood clot, high or low blood pressure, limited blood supply, a decrease in red blood cells, or abnormal lab values, bleeding in the abdominal cavity, collection of blood under the skin
    • Additional risks, including life-threatening infection, dislodgement of calcified material, air embolism (air bubbles in the blood vessels), poor kidney function or failure, nerve injury, fever, allergic reaction to anesthesia or dye, reoperation, pain, infection or bleeding at incision sites, or swelling

    Additional potential risks specifically associated with the use of the heart valve include:

    • Valve movement after deployment, blockage or disruption of blood flow through the heart, need for additional heart surgery and possible removal of the SAPIEN XT valve, a blood clot that requires treatment, damage to the valve (e.g., wear, breakage, recurring aortic stenosis), nonstructural valve dysfunction (e.g., leakage, inappropriate sizing or positioning, blockage, excess tissue ingrowth, blood cell damage, etc.) or mechanical failure of the delivery system and/or accessories