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    • What is Aortic Stenosis
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Your Aortic Stenosis Treatment Options

Taking the next step to find out about aortic stenosis treatment may feel overwhelming, but it is important to talk to your doctor about the options available to you.

Once your aortic stenosis becomes severe and you start to have symptoms, treatment right away is important. Your doctor may recommend balloon valvuloplasty (BAV) to relieve symptoms of severe aortic stenosis. However, it is not a lasting solution as the valve will eventually narrow again.

The only effective way to treat severe aortic stenosis is by replacing your valve. This can be done through transcatheter aortic valve replacement (TAVR) or open heart surgery.

Can Medication Treat Aortic Stenosis?

Depending on how far your aortic stenosis has progressed, your doctor may prescribe medication at first to help control your symptoms. But it is important to remember that eventually your valve will likely need to be replaced.

Explore Aortic Valve Replacement Options

Transcatheter Aortic Valve Replacement (TAVR)

  • TAVR is for people who have been diagnosed with severe aortic stenosis who are experiencing symptoms.
  • TAVR is a less invasive way to replace your aortic valve without opening the chest.
  • During the TAVR procedure, a small tube is used to insert a bioprosthetic valve inside your diseased valve.
  • TAVR may shorten your recovery time so you can resume normal activities.
  • Talk to your doctor about questions you may have about TAVR and/or its associated risks.
tavr

What is TAVR?

Learn how the less invasive TAVR procedure is performed.

Play Video

Open Heart Surgery
(Also Known as Surgical Aortic Valve Replacement)

  • Typically during open heart surgery, the surgeon will make an incision across the full length of your chest to access your valve.
  • Sometimes open heart surgeries can be performed through smaller incisions (called minimal incision valve surgery).
  • Your old aortic valve will be taken out and a new one will be placed in your body.
  • The new valve can either be a mechanical valve or a bioprosthetic valve.
  • Talk to your doctor about questions you may have about open heart surgery and/or its associated risks.
SAVR

What is Open Heart Surgery?

Explore how open heart surgery is performed and what you can expect from the procedure.

Play Video

All patients requiring aortic valve replacement should be evaluated for TAVR. Learn more about the benefits of the TAVR procedure.

About the TAVR Procedure
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  • What is Aortic Stenosis
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Edwards SAPIEN 3 THV System and Edwards SAPIEN 3 Ultra THV System

Indications:
The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System are 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 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System are indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or 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 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 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 is not known at this time. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing. Safety, performance, and durability of the SAPIEN 3 Ultra and SAPIEN 3 valve have not been established for placement inside a previously implanted transcatheter valve.

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, two leaflets in low surgical risk patients, 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 SAPIEN 3 Ultra or 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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