Is Transcatheter Aortic Valve Replacement (TAVR) Right for You?
If you have been diagnosed with severe aortic stenosis and your physician says you are either high-risk or too sick
for open heart surgery, TAVR may be an option for you.
What is TAVR?
TAVR Stands for Transcatheter Aortic Valve Replacement
This procedure is for people who have been diagnosed with severe aortic stenosis and are considered either high-risk or too sick for open heart surgery.
This less invasive procedure is different than open heart surgery. TAVR uses a catheter to replace the heart valve instead of opening up the chest and completely removing the diseased valve. It can be performed in multiple ways.
The valve used during TAVR is inserted within your diseased aortic valve. The valve that is crimped onto a balloon is expanded and pushes the leaflets of your diseased valve aside.
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.
DOWNLOAD OR PRINT THE TAVR PATIENT GUIDE
This informative brochure goes into detail about aortic stenosis and the TAVR procedure.
Your Heart Team will help determine which option is best to treat your severe aortic stenosis.
GET TO KNOW YOUR TAVR HEART TEAM
Your TAVR heart team is made up of specialists who work together to find the best treatment for you.
Select a specialist below to learn more about their role.
Watch these videos to learn more about talking with your Heart Team.
View TAVR Procedure Animations
Only a qualified TAVR Heart Team can determine if TAVR is right for you.
FIND A TAVR CENTER BELOW:
Make the Most of the Next Doctor Visit
Use our Doctor Discussion Guide to help organize and remember questions you may have.
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.
- 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.
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
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