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Take Control of Your Options. Get Evaluated for TAVR

Receiving news that you’ve been diagnosed with severe aortic stenosis and may need your aortic valve replaced can be scary. You may wonder if you will be able to participate in your favorite activities, eat the same foods, or approach life in the same way.

Although these feelings can be overwhelming, it is important to talk to your doctor about all of your treatment options, especially if you are experiencing symptoms such as fatigue and shortness of breath. These symptoms of aortic stenosis may mean your condition is getting worse and you need to seek treatment right away.

The good news is, open heart surgery is not the only way to replace an aortic heart valve. There is a less invasive option called transcatheter aortic valve replacement, or TAVR for short. This procedure used to only be available for people who were too weak to undergo open heart surgery. But now, any severe aortic stenosis patients who are experiencing symptoms can be considered for TAVR. Only a TAVR Team can tell you if it is right for you.

TAVR may be an option for bicuspid patients. Open heart surgery is not their only option (although it may be the best option for their unique situation). Bicuspid patients should seek an evaluation with a TAVR Team to see all their treatment options.

The TAVR procedure may also be an option for people at high risk for surgery who had their aortic valve replaced in the past, but need a new one because the replacement valve may no longer work.

Don’t Wait

Take control of your future by learning if TAVR is right for you. You can start by ordering your Free Info Kit to learn more about the benefits of TAVR.

Free Info Kit
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Evaluating Mario for TAVR

Learn what factors made TAVR the right option for Mario.

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All Patients Should Ask for a TAVR Evaluation

The idea of a heart valve replacement can be scary. Luckily, the less invasive TAVR procedure is an option for more patients than ever before.

Unlike open heart surgery, in which an incision is made across the full length of your chest to remove the unhealthy valve, TAVR uses a catheter to implant a new valve within your diseased valve. TAVR can be performed in multiple ways but the most common is through an incision in the leg.

TAVR is proven to have lower instances of death, stroke and rehospitalization compared to open heart surgery.1

Other TAVR benefits may include:

  • Improved quality of life following the procedure, including the ability to return to normal daily activities

  • Shorter hospital stay

  • Relief of symptoms

  • Less pain and anxiety

  • Minimal scarring

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Part of being an advocate means evaluating all treatment options for severe aortic stenosis, including TAVR. The goal should always be for your loved one to feel empowered about their treatment plan. If you’re not sure about one doctor’s recommendation, seek an evaluation at a TAVR Hospital.

Find a TAVR Hospital
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Why TAVR was a Great Choice for David

David's life changed when he developed symptoms from severe aortic stenosis. Hear why TAVR was the best option to help him get his life back.

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How to Get a TAVR Evaluation

TAVR is available for even more patients than ever before. TAVR is no longer just for patients who are too sick for open heart surgery. Any severe aortic stenosis patients who are experiencing symptoms can be considered for TAVR. Even if you were previously told that TAVR wasn’t an option for you, consult with a TAVR Team to find out if you are now eligible.

Your TAVR Doctor will run several tests to determine the best treatment plan for you and to evaluate if you are a TAVR candidate. Some of these tests include:

  • An angiogram to examine how blood is flowing through your heart’s arteries
  • An echocardiogram to take pictures of your heart
  • Other diagnostic tests which can be explored in our FAQs section

In some cases, you may have already taken some of these tests. However, it may be important that the tests be taken again at the request of your TAVR Doctor.

Although it may feel like a lot of appointments, it’s important because your TAVR Doctor wants to make sure they are recommending the best treatment option for you.

Find a TAVR Hospital

Only a TAVR Doctor can evaluate you for both TAVR and open heart surgery to determine what the best treatment option is for you. Not all hospitals perform TAVR. Use our Find a TAVR Hospital tool to locate one near you.

Find a TAVR Hospital

Sometimes having additional information about a procedure is helpful in determining if it is right for you. Learn what you can expect before, during and after the TAVR procedure.

TAVR: What to Expect
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Reference

  1. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019:380(18):1695-1705.

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Edwards SAPIEN 3 THV System and Edwards SAPIEN 3 Ultra THV System

Indications:
The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.

The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications (Who should not use):
The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System 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 may be an increased risk of stroke in transcatheter aortic valve replacement procedures, compared to other standard treatments for aortic stenosis in the high or greater risk population.
  • 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 sensitive to cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or polymeric materials.
  • The Edwards SAPIEN 3 Ultra and SAPIEN 3 valves may not last as long in younger patients, or patients with a disease that results in more calcium in their blood.
  • 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.
  • Patient’s creatinine level should be measured prior to the procedure.
  • Patients who have already had a valve replaced should be carefully assessed by their physician prior to receiving a new valve to ensure proper placement of the new valve.
  • Injury can occur if the delivery system is not used properly.
  • Transcatheter heart valve patients should talk to their physicians about the potential need for medications that thin the blood or prevent blood clots from forming.

Precautions:
The long-term durability of the Edwards SAPIEN 3 Ultra and SAPIEN 3 transcatheter heart valves are not known at this time. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing. Limited clinical data are available for transcatheter aortic valve replacement in patients who are born with an aortic heart valve that has only two leaflets and who are determined to be at low risk for open heart surgery. Long-term durability of the valve has not been established.

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

  • An aortic heart valve that is not calcified, contains only one leaflet, 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 prosthetic ring in any position.
  • Previous atrial septal occlude.
  • 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, abnormal or irregularly shaped vessels leading to the heart. Vessels which are heavily diseased or too small for associated delivery devices, or a large amount of calcification at the point of entry.
  • Allergies to blood-thinning medications or dye injected during the procedure.
  • For a valve in valve procedure, there is a risk of leakage if the previously implanted tissue valve is not securely in place or if it is damaged. There is also the possibility that a partially detached valve leaflet from the previously implanted valve could block a blood vessel.
  • Additional pre-procedure imaging will be completed to evaluate proper sizing.

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 pacemaker, chest pain, heart murmur, false aneurysm, recurring aortic stenosis (narrowing), too much fluid around the heart, injury to the structure of 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 valves include:

  • Valve movement after deployment, blockage or disruption of blood flow through the heart, need for additional heart surgery and possible removal of the Edwards SAPIEN 3 Ultra and SAPIEN 3 valves, 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 in growth, blood cell damage, etc.) or mechanical failure of the delivery system and/or accessories.

CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.

Important Risk Information
The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System are indicated for relief of aortic stenosis...
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