Start 
Find A TAVR Hospital

Treatment Options

Treatment for aortic stenosis depends on how far your disease has progressed. If your stenosis is mild, medication may be prescribed to help regulate your heartbeat and prevent blood clots. However, as the severity of your stenosis progresses, your doctor may recommend replacing the diseased aortic valve.

Severe aortic stenosis cannot be treated with medication. The only effective treatment is to replace your aortic valve.

Today there are 2 options to replace diseased aortic valves:

Surgical Aortic Valve Replacement (AVR)

1. Surgical aortic valve replacement (AVR)
Aortic Valve Replacement (AVR) through open-heart surgery is a common treatment for severe aortic stenosis.  Surgical AVR has been performed for many years on patients who can undergo surgery and has lengthened patients lives.

Surgical AVR is an open-heart procedure. During surgical AVR, the surgeon removes the diseased aortic valve and replaces it with either a mechanical valve (made from man-made materials) or a biological valve (made from animal or human tissue).

Aortic valve replacement can also be performed through minimal incision valve surgery (MIVS). In MIVS, the surgeon can replace the diseased valve through a smaller incision while looking directly at the heart or through a small, tube-shaped camera.  MIVS may be an option for some patients.

Please consult your Cardiothoracic Surgeon for more information on surgical aortic valve replacement and its associated risks.

To learn more information about AVR or MIVS, click here.

Transcatheter Aortic Valve Replacement (TAVR)

2. Transcatheter aortic valve replacement (TAVR)
For people who have been diagnosed with severe symptomatic calcified native aortic valve stenosis and who are high-risk or too sick for open-heart surgery, transcatheter aortic valve replacement (TAVR) may be an alternative, and results in lengthening patients lives.

If a Heart Team determines that you are at high-risk or too sick for open-heart surgery, TAVR may be an alternative.  This less invasive procedure allows a new valve to be inserted within your native, diseased aortic valve.  The TAVR procedure can be performed through two different approaches - transfemoral (through an incision in the leg) or transapical (through an incision in the chest between the ribs).  Your Heart Team (Interventional Cardiologist & Cardiothoracic Surgeon) will decide which approach is best for you based on your medical condition and other factors.

Please consult a TAVR Heart Team (Interventional Cardiologist & Cardiothoracic Surgeon) for more information on TAVR and its associated risks.

To see associated risks with TAVR, click here.

 

Please talk to a TAVR Heart Team (Interventional Cardiologist & Cardiothoracic Surgeon) about which treatment is right for you.

Medication
If you are diagnosed with heart valve disease, medication may be prescribed by your cardiologist to help relieve symptoms.  However, no medication exists for curing severe aortic stenosis.

Although helpful in managing some symptoms, medications cannot reverse damage to your heart valve. In some cases the damage continues to progress even with medications, and further action must be taken. Talk with your cardiologist about your options.

Balloon Aortic Valvuloplasty (BAV)
Balloon aortic valvuloplasty may relieve symptoms associated with severe aortic stenosis.  However, balloon valvuloplasty is not a lasting solution, as the valve tends to narrow again.  BAV is the repair of a stenotic aortic valve using a balloon catheter inside the valve. The balloon is placed into the aortic valve that has become stiff from calcium buildup. The balloon is then inflated in an effort to increase the opening size of the valve and improving blood flow.

 

Doctor discussion guide

Aortic Valve Replacement Options

Aortic Valve Replacement Option

For patients who are at high-risk or not suitable for surgical AVR, TAVR may be an alternative.

Please remember, this information is not meant to tell you everything you need to know about your treatment options for aortic stenosis. Please talk to a TAVR Heart Team for more information.

The Heart Team Approach
When you are referred, it's important to have a full team composed of several medical specializations engaged in your care. This combines the expertise of collaborative Heart Teams that include Interventional Cardiologists, Cardiothoracic Surgeons, Echocardiographers, Anesthesiologists, and/or cardiac cath lab staff.

If you go to a TAVR center, a dedicated TAVR Heart Team will conduct a thorough evaluation to determine whether you are an appropriate TAVR candidate.

Make the most of your doctor visit
Your doctor plays a crucial role in diagnosis and can provide valued advice during treatment decisions. You may have questions and concerns about your condition and treatment options.  It can be hard to organize and remember your questions before and during your doctor visit. The Doctor Discussion Guide can help guide you.

Doctor discussion guide

The TAVR Procedure

Transcatheter aortic valve replacement (TAVR)
If your Heart Team determines that you are at high-risk or too sick for open-heart surgery, transcatheter aortic valve replacement (TAVR) may be an alternative. This less invasive procedure allows a new valve to be inserted within your diseased aortic valve.

In the transfemoral approach, an incision is made in the leg.

Transfemoral Procedure Overview

Transfemoral approach procedure
Transfemoral Procedure

1. You will be placed under general anesthesia (you will be in a deep sleep).

2. An incision will be made in your leg (or slightly higher up), where your doctor will put a sheath (a short hollow tube) that slightly larger than the width of a pencil.

3. Your doctor will take a balloon and put it through the sheath into your blood vessel to reach your aortic valve. The balloon will be inflated with fluid to break open your narrowed valve, deflated, and then removed.

4. The Edwards SAPIEN transcatheter heart valve will be placed on the delivery system (long tube with a balloon on the end), and compressed on the balloon (using a crimper) to make it small enough to fit through the sheath. It will be about the width of a pencil.

5. The delivery system carrying the valve will be placed through the sheath and pushed up to your aortic valve, guided by a type of X-ray.

6. The balloon of the delivery system carrying the valve will be inflated with fluid, expanding this new valve within your diseased valve. During valve expansion, the heart is stabilized by temporarily speeding up the heartbeat. The new valve will push the leaflets of your diseased valve aside. The frame of the new valve is very strong and it will use the leaflets of your diseased valve to secure in place. Next, the balloon will be deflated.

7. Your doctor will make sure that your new valve is working properly before removing the delivery system and closing the incision in your leg (or slightly higher up). If your new valve is not working properly, your doctor may need to do something else which may include open-heart surgery or other additional surgery.



Watch the Transfemoral Procedure
This animated video shows an anatomical overview of what happens during the transfemoral approach, which is performed through an incision in your leg or slightly higher.

Transapical procedure

In the transapical approach, an incision is made in your chest between your ribs to access the apex (lowest part) of your heart.

Transapical approach procedure
Transapical procedure

1. You will be placed under general anesthesia (you will be in a deep sleep).

2. An incision will be made in your chest between your ribs to access to the apex (the lowest part) of your heart. Your doctor will place a sheath (a short hollow tube) that is slightly larger than the width of a pencil through the apex and into the left ventricle.

3. Your doctor will take a balloon and put it through the sheath to reach your aortic valve. The balloon will be inflated with fluid to break open your narrowed valve, deflated, and removed.

4. The Edwards SAPIEN transcatheter heart valve will be placed on the delivery system (long tube with a balloon on the end), and compressed on the balloon (using a crimper) to make it small enough to fit through the sheath. It will be about the width of a pencil.

5. The delivery system carrying the valve will be placed through the sheath and pushed up to your aortic valve, guided by a type of X-ray.

6. The balloon of the delivery system carrying the valve will be inflated with fluid, expanding this new valve within your diseased valve. During valve expansion, the heart is stabilized by temporarily speeding up the heartbeat. The new valve will push the leaflets of your diseased valve aside. The frame of the new valve is very strong and it will use the leaflets of your diseased valve to secure in place. Next, the balloon will be deflated.

7. Your doctor will make sure that your new valve is working properly before removing the delivery system and closing the chest incision between your ribs. If your new valve is not working properly, your doctor may need to do something else which may include open-heart surgery or other additional surgery.





Watch the Transapical Procedure
This animated video shows an anatomical overview of what happens during the transapical approach, which is performed through an incision in your chest between your ribs.

Your TAVR Heart Team will recommend a treatment option for you based on your overall health.


Aortic Stenosis and TAVR Brochure

Download the TAVR Patient Guide
Click the button below to download an informative brochure that goes into detail about aortic stenosis and the TAVR procedure.



English Brochure

Spanish Brochure

Important Safety Information for Patients

EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND THE RETROFLEX 3 DELIVERY SYSTEM (LONG ACCESS) and/or THE ASCENDRA 3 DELIVERY SYSTEM (SHORT ACCESS)

Who Is It For?
Transcatheter Aortic Valve Replacement with the Edwards SAPIEN transcatheter heart valve is indicated for patients with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction >20% who have been examined by a heart team including an experienced heart surgeon and a cardiologist and found to either be: 1) inoperable and in whom existing comorbidities would not preclude the expected benefit from correction of the aortic stenosis; or 2) be operative candidates for aortic valve replacement but who have a Society of Thoracic Surgeons predicted operative risk score ≥8% or are judged by the heart team to be at a ≥15% risk of mortality for surgical aortic valve replacement.

Contraindications
The Edwards SAPIEN transcatheter heart valve and delivery system should not be used by patients who: 

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

Warnings for Long and/or Short Access

  • There is a higher risk of stroke in transcatheter aortic valve replacement procedures, compared to other standard treatments for aortic stenosis.
  • The artificial valve may not last as long in patients whose bodies process calcium abnormally.
  • Patients should talk to their doctor if they are allergic to chromium, nickel, molybdenum, manganese, copper, silicon, and/or polymeric materials.
  • X-ray guidance is used during the procedure and may cause radiation injury to the skin. These injuries may be painful, damaging, and long-lasting.
  • Your doctor should be aware of the following pre-existing conditions or other artificial medical devices before performing a Transcatheter Aortic Valve Replacement: 
    • significant heart disease
    • AV low flow 
    • low gradient and mitral valve devices 

Warnings Specific to the Transapical Access (in the chest between the ribs) 

  • The safety and effectiveness of the transapical procedure has only been evaluated in patients for whom the transfemoral aortic valve replacement procedure is not suitable.

Precautions
Long-term durability of the Edwards SAPIEN transcatheter heart valve has not been established at this time. Regular medical follow-up is recommended to evaluate how well your heart valve is performing. Transcatheter heart valve patients should stay on blood-thinning medicine for 6 months after the procedure and aspirin for the rest of their lives, unless otherwise instructed by their doctor.

The safety of the transcatheter heart valve has not been established in patients who have:

  • A previously implanted artificial aortic heart valve or a valve repair device in any position
  • A ventricle that does not pump efficiently
  • Thickening of the heart muscle, with or without a blockage

For patients who have previously had aortic valve replacement, the safety, effectiveness, and durability of putting a transcatheter valve in an already implanted tissue valve are not known at this time.

The safety and effectiveness of the transcatheter heart valve has not been established for patients who have:

  • An aortic heart valve that is not calcified
  • An aortic heart valve that only has one or two leaflets
  • A diseased aortic valve in which the main problem is valve leakage
  • A previously implanted ring or artificial heart valve
  • A diseased mitral valve that is calcified or leaking, or Gorlin syndrome
  • Low white blood cell count, low red blood cell count, low platelet count, or a history of bleeding because the blood does not clot properly
  • Thickening of the heart muscle, with or without a blockage
  • Unusual ultrasound images of the heart that could represent abnormalities such as a blood clot
  • Allergies to blood-thinning medications or dye injected during the procedure
  • An aortic valve that is too small or too big to fit the transcatheter heart valve
  • Diseased or abnormally shaped vessels leading to the heart 
  • Femoral vessels that are heavily diseased or too small for the delivery device
  • Aortic valve leaflets with large pieces of calcium that may block the vessels that supply blood to the heart

Precautions Specific to the Transfemoral Access (in the leg)

  • Access site characteristics that would rule out the safe placement of 22F or 24F introducer sheath, such as: 
    • A severe buildup of calcium that blocks the artery
    • Abnormal artery shape or artery size less than 7 mm in diameter 

Potential risks associated with the procedure include: 

  • death
  • stroke
  • paralysis
  • permanent disability
  • difficulty breathing
  • severe bleeding
  • injury to the right side of the heart
  • cardiovascular injury that may require repair
  • annular tear or rupture
  • too much fluid in the tissue sac around the heart
  • calcified valve material, clots in the blood vessels, chambers of the heart, and/or limbs, clot formation, dislodgment of material/air and blockage that may lead to heart attack, stroke, and/or death
  • life-threatening infection
  • heart failure
  • heart attack 
  • valve leaflet tearing 
  • poor kidney function or kidney failure 
  • injury or defect to the heart that may require a permanent pacemaker 
  • irregular heartbeat 
  • bleeding in the abdominal cavity 
  • false aneurysm 
  • reoperation 
  • restricted blood supply or nerve injuries 
  • stenosis returning 
  • fluid in the lungs 
  • buildup of fluid around the lungs 
  • bleeding 
  • catheter balloon rupture and separation 
  • a decrease in red blood cells
  • abnormal lab values
  • high blood pressure or low blood pressure
  • allergic reaction to anesthesia or dye
  • collection of blood under the skin
  • fainting
  • pain or changes at the incision site
  • weakness or inability to exercise
  • swelling
  • chest pain
  • heart murmur
  • fever
  • mechanical failure of the valve delivery system and/or accessories
  • tearing or injury to the Edwards SAPIEN valve

Potential Risks associated with short access procedures include:

  • Suturing of the peripheral coronary artery

Additional potential risks specifically associated with the use of the heart valve include, but may not be limited to:

  • the heart stops beating or there is severe damage to the heart
  • emergency heart surgery
  • heart failure
  • blockage or disruption of blood flow through the heart
  • blood clot caused by the device that requires treatment
  • blood clot in the heart valve
  • dislodgement
  • movement or improper positioning of the Edwards SAPIEN valve tbat must be treated
  • placing the valve in an unintended location
  • valve stenosis
  • damage to the Edwards SAPIEN valve including wear and breakage or reduced effectiveness
  • valve leakage
  • breakdown of red blood cells
  • removing the Edwards SAPIEN valve
  • nonstructural dysfunction
  • non-emergent reoperation

Additional potential risks for short access procedures include:

  • Injury to the mitral valve

All listed risks may include symptoms associated with the medical conditions.


CAUTION:  Federal (United States) law restricts these devices to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions, and adverse events.

Edwards, Edwards Lifesciences, the stylized E logo, Ascendra, Ascendra 3, Edwards SAPIEN, RetroFlex, RetroFlex 3 and SAPIEN are trademarks of Edwards Lifesciences Corporation. 

© 2013 Edwards Lifesciences Corporation. All rights reserved.