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What is TAVR?

Is TAVR (or TAVI) right for you?

TAVR STANDS FOR TRANSCATHETER AORTIC VALVE REPLACEMENT

This procedure is for people who have been diagnosed with severe symptomatic aortic stenosis and are at intermediate or greater risk for open heart surgery. Your physician might also refer to the TAVR procedure as TAVI.

image of transcatheter valve (TAVR) in heart image of transcatheter valve (TAVR) in heart

The TAVR procedure allows a new valve to be inserted within your diseased aortic valve. The new valve will push the leaflets of your diseased valve aside. The frame will use the leaflets of your diseased valve to secure it in place.

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.

Learn about the history of this procedure and the valve that may be used by visiting TAVRbyEdwards.com.

What’s in a name?

Transcatheter aortic valve replacement, or TAVR, can sometimes be written as “TAVI.” TAVI stands for transcatheter aortic valve implantation. Whether your doctor calls it TAVR or TAVI, the procedure approaches remain exactly the same.

Is TAVR right for you?

If you have been diagnosed with severe aortic stenosis and your physician says you are either at intermediate or greater risk for open heart surgery, TAVR may be an option for you.

To request an information kit about severe aortic stenosis or TAVR, click below.

Please remember this information is educational only, and is not meant to diagnose or tell you everything you need to know about your treatment options for severe aortic stenosis. Talk to a TAVR Heart Team physician about this procedure and its associated risks. Learn the risks.

Are you considered an intermediate or greater-risk surgical patient?

5 Major Factors

There are several factors your doctor and/or specialized Heart Team will take into consideration when deciding whether or not you are at intermediate or greater risk for open heart surgery, and therefore, a possible candidate for TAVR.

  1. AGE
  2. CURRENT HEALTH STATUS
  3. MEDICAL HISTORY
  4. YOUR FRAILTY
  5. CONDITION OF YOUR HEART

QUESTIONS YOUR DOCTOR MAY ASK OR EVALUATE

If you need your aortic valve replaced and are at intermediate or greater risk for open heart surgery, your doctors may consider TAVR.

  • Have you had a stroke?
  • Do you have a history of fainting/passing out?
  • Have you had bypass surgery?
  • Have you had prior chest radiation?
  • Have you been diagnosed with coronary artery disease, or CAD?
  • Have you been diagnosed with chronic or obstructive pulmonary disease, or COPD?
  • Do you have cardiac arrhythmias?

Of course, each patient is unique. Talk to your Heart Team about what is right for you.

How will the heart team decide if TAVR is an option for you?

YOUR HEART TEAM WILL DO A NUMBER OF ASSESSMENTS

Confirm your aortic stenosis is SEVERE

If symptoms or signs suggest aortic stenosis, your doctor may do a complete assessment to diagnose your condition and to evaluate the severity of your aortic stenosis. This is usually done by the doctor performing auscultation (listening to your heart via a stethoscope) and an echocardiogram.

Determine if you are at intermediate or greater risk for open heart surgery

TAVR is only an option for patients who are at intermediate or greater risk for open heart surgery. All potential patients will be assessed by a specially-trained Heart Team, including a cardiothoracic surgeon and interventional cardiologist.

Decide on the best treatment

Together, the specialized Heart Team will conduct a comprehensive evaluation to determine whether the TAVR procedure is an appropriate option for you.

Some of the tests and procedures mentioned below are quick and painless. Others take more time and may require you to take medication.

Even if you’ve had one or several of these procedures before, your TAVR Heart Team may request that they be done again in order to take special measurements and specific images that will determine the best TAVR approach. In some cases, you may have all of the necessary tests done in one day or you may need to take these tests over the course of several days. Speak with your Heart Team to arrange a schedule that works best for you and your caregiver.

TESTS AND PROCEDURES THAT HELP DETERMINE IF TAVR IS THE BEST OPTION FOR YOU

Non-Invasive

Chest X-ray

TTE

(Transthoracic echocardiogram)

MRI

(Magnetic resonance imaging)

Moderately Invasive

PFT

(Pulmonary function test)

CT Scan

(Computerized tomography)

More Invasive

Angiogram

(Cardiac cath)

TEE

(Transesophageal echocardiogram)

QUESTIONS TO ASK
YOUR DOCTOR

Your doctor will help determine if your severe aortic stenosis should be evaluated by a Heart Team. Watch this video to learn more about talking with your doctor.

QUESTIONS TO ASK
YOUR DOCTOR

Your doctor will help determine if your severe aortic stenosis should be evaluated by a Heart Team. Watch this video to learn more about talking with your doctor.

Important Risk Information

Important Risk Information for Patients

EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

Indications: The Edwards SAPIEN 3 transcatheter heart valve, model 9600TFX, and accessories 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 at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% 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 and delivery 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 allergic to chromium, nickel, molybdenum, manganese, copper, silicon, and/or polymeric materials.
  • The SAPIEN 3 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 3 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 3 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
  • 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 pacemaker, 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 3 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 in growth, blood cell damage, etc.) or mechanical failure of the delivery system and/or accessories
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

Indications: The Edwards SAPIEN XT transcatheter heart valve, model 9300TFX, and accessories 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 at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

The Edwards SAPIEN XT transcatheter heart valve and accessories are also indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic 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., STS 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 balloon aortic valvuloplasty and other standard treatments for aortic stenosis in the high or greater risk population.
  • Implanting a valve that is too small may cause blood leakage and valve movement. Implanting a valve that is too large can cause a buildup of pressure in the valve or a rupture of blood vessels in or around your heart. Your Heart Team will do tests to determine the best valve size for you.
  • The SAPIEN XT valve may not last as long in patients whose bodies do not process calcium normally.
  • 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.
  • 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.

The safety and effectiveness of implanting:

  • A transcatheter valve inside a transcatheter valve is not known
  • A transcatheter valve inside a surgical tissue valve is not known in the intermediate-risk population

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
  • 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. The safety and effectiveness of the transcatheter heart valve has not been determined when the valve is implanted:
    • Inside a stented previously implanted valve smaller than 21 mm
    • Inside an unstented previously implanted aortic tissue valve
  • Your Heart Team will do tests to determine the exact size of the new valve you should receive and communicate what to expect.

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, sudden loss of heart function, heart failure, 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

Be sure to ask your Heart Team to explain your treatment options and the possible benefits and risks of the procedure.

CAUTION: Federal law (USA) restricts these devices to sale by or on the order of a physician. This information is not a substitute for talking with your doctor.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN XT, Edwards SAPIEN 3, NewHeartValve.com, NewHeartValve.com design logo, SAPIEN, SAPIEN XT, and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.