• Understand Aortic Stenosis
    • What is Aortic Stenosis
    • Dangers of Severe Aortic Stenosis
    • Treatment Options
  • Explore TAVR
    • About the TAVR Procedure
    • Is TAVR Right for You?
  • TAVR: What to Expect
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    • During the Procedure
    • After the Procedure
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Have Questions About Aortic Stenosis? We Have Answers.

You may have questions about diagnosis, symptoms, and treatment options for aortic stenosis. Explore our frequently asked questions below and get the information you need to take control of your health.

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About Heart Valve Disease

What is heart valve disease?

Heart valve disease occurs when one or more of the 4 valves in your heart doesn’t work properly. This can disrupt blood flow between your heart and your body, which can lead to many health problems. There are many types of heart valve disease, including the most common among elderly patients—aortic stenosis.1

Where can I find information on pulmonic congenital heart disease?

Please see https://www.pulmonicvalvetherapy.com to learn more about congenital heart disease and treatment options available.

What does it mean if you have heart valve disease with a bicuspid aortic valve?

A normal aortic valve has three thin leaflets that open and close when the heart beats to regulate blood flow. But about 1% to 2% of people are born with a bicuspid aortic valve, meaning it only has two leaflets. Bicuspid only refers to the number of leaflets within your heart valve and not to the disease itself.

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About Aortic Stenosis

What is aortic stenosis?

Aortic stenosis is a progressive condition caused by a narrowing of the aortic valve, which prevents normal blood flow. Because the condition will get worse with time, doctors will measure it as mild, moderate, or severe (depending on how damaged the valve is). The condition affects more than 2.5 million people over the age of 75 in the United States.1,2

What causes aortic stenosis?

There are 4 main causes of aortic stenosis: calcium build-up on the valve leaflets, birth defects that may impact the structure of the aortic valve, rheumatic fever which can cause scar tissue to form in the heart, and radiation therapy.

What is severe aortic stenosis?

If aortic stenosis goes untreated, it will progress to the severe stages of the disease. Severe aortic stenosis means the aortic valve has a severe build-up of calcium and has a difficult time opening and closing. Your heart may need to work harder to pump blood throughout your body.

What is severe symptomatic aortic stenosis?

Once your aortic stenosis progresses to the severe stages, symptoms may start to occur, such as shortness of breath, chest pain, fatigue, or lightheadedness. This is called symptomatic severe aortic stenosis. It is important to tell your doctor right away if you experience symptoms or if your symptoms worsen.

What are the symptoms of severe aortic stenosis?

Symptoms of severe aortic stenosis include shortness of breath, chest pain, fatigue, lightheadedness, rapid or irregular heartbeat, swollen ankles/feet or difficulty exercising. These symptoms may indicate your aortic stenosis has progressed to a life-threatening point.

How serious is severe aortic stenosis (also known as severe aortic valve stenosis)?

Up to 50% of people who develop severe aortic stenosis symptoms will die within an average of 2 years if they do not have their aortic valve replaced.3 If you have been diagnosed with severe aortic stenosis and have symptoms, talk to your doctor right away about your treatment options.

Is aortic stenosis different if you have a bicuspid aortic valve?

No. The only difference is the number of leaflets the aortic valve has. Aortic stenosis is the stiffening of your aortic valve (regardless if you have two or three leaflets), which causes a narrowing of the aortic valve opening. This means the valve cannot fully open and close like it should. The amount of blood pumped with each beat of your heart is reduced, so it’s forced to work harder to supply your body with the blood it needs.

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Diagnosis and Treatment of Aortic Stenosis

How is aortic stenosis diagnosed?

Your doctor will perform a few tests to determine if you have aortic stenosis. This is primarily done by listening to the sounds of your heart with a stethoscope. Diagnosis may also be done through a test called echocardiogram, which uses ultrasound waves to obtain images of the heart chambers and valves.

What are the treatment options for aortic stenosis?

Depending on how far your aortic stenosis has progressed, your doctor may prescribe medication to help control your symptoms. However, it’s important to know the only effective way to treat aortic stenosis is by replacing your valve. This can be done through transcatheter aortic valve replacement (TAVR) or open heart surgery.

What treatment options are available for severe aortic stenosis if you have a bicuspid aortic valve?

Both TAVR and open heart surgery may be treatment options for bicuspid patients. However, only a TAVR Heart Team can determine which treatment option is best for the patient. Those with bicuspid severe aortic stenosis should seek an evaluation with a TAVR Heart Team to see all treatment options available for them.

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About Transcatheter Aortic Valve Replacement (TAVR)

What is TAVR (Transcatheter Aortic Valve Replacement)?

TAVR (also known as transcatheter aortic valve implantation or TAVI for short) is a less invasive procedure for replacing a diseased aortic valve. During the procedure, your TAVR Doctor will use a catheter to implant a new valve within your diseased valve. TAVR can be performed through multiple approaches; however, the most common is through a small incision in the leg. TAVR procedures can be performed under conscious sedation, rather than general anesthesia.

What are the different approaches used to perform TAVR?

TAVR can be performed in different ways depending on each individual’s anatomy.

Some approaches include:

  • The transfemoral approach (the most common approach and is through an incision in the leg).
  • The subclavian approach (through an incision near the shoulder).
  • The transapical approach (through an incision in the chest between the ribs).
  • The transaortic approach (through an incision in the upper chest).
Does my heart have to be stopped for TAVR?

No, unlike open heart surgery, TAVR does not require stopping the heart.

How could I benefit from a transcatheter valve replacement?

With the less invasive TAVR procedure, people may return to daily activities sooner than with open heart surgery. People who undergo TAVR report improved quality of life following the procedure. Other TAVR benefits may include: short hospital stay, relief of symptoms (sometimes immediately), improved heart function, and reduced pain and anxiety.4

How long is the TAVR procedure?

Depending on your health and the procedural approach recommended by your doctor, the average TAVR procedure lasts approximately 1 hour. In comparison, the average open heart surgery lasts approximately 4 hours.4

What is TAVI, and is it different from TAVR?

TAVI stands for transcatheter aortic valve implantation. The procedure and its approaches are the same as TAVR. Your doctor may use the terms interchangeably when discussing your treatment options.

How long have TAVR procedures been performed?

TAVR has been commercially available in Europe since 2007 and in the United States since 2011.

How many people have had the TAVR procedure?

More than 450,000 people worldwide have had a TAVR procedure.

Are there different types of transcatheter heart valves and can I ask for a specific valve?

Transcatheter heart valves are made by different manufacturers. You can check which valves are used and available at your hospital. Although you can ask for a specific valve, your TAVR Doctor will recommend the best valve for you.

Learn More About Edwards Transcatheter Heart Valves

Does my insurance cover TAVR and do I need a referral?

You should contact your insurance carrier directly prior to your first appointment with your TAVR Doctor to determine if your TAVR evaluation and TAVR procedure are covered, and if a referral is required.

The Centers for Medicare and Medicaid Services (CMS) cover TAVR under certain conditions. You can learn more by visiting our Helpful Websites page.

Learn More on Our Helpful Websites Page

What are the potential risks or complications of TAVR?

As with any medical procedure, there is a possibility of risks. The most serious risks of TAVR include death, stroke, serious damage to the arteries, or serious bleeding.

Is TAVR approved to treat patients who have bicuspid severe aortic stenosis?

Yes, TAVR is approved to treat patients who have severe aortic stenosis and a bicuspid aortic valve. However, it may not always be the best option due to a patient’s individual needs. Only a TAVR Heart Team can determine which treatment option is best for the patient. Those with bicuspid severe aortic stenosis should seek an evaluation with a TAVR Heart Team to see all treatment options available for them.

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Getting a TAVR Evaluation

How do I know if TAVR is right for me?

TAVR used to only be available for people who were too weak to undergo open heart surgery. But now, any person who has been diagnosed with severe aortic stenosis experiencing symptoms can be considered. It is also an option for people who previously had their aortic valve replaced.

You need to consult an interventional cardiologist at a TAVR Hospital to determine if TAVR is an option for you. You can use our Find a TAVR Hospital tool to identify the nearest location to you.

What tests will my doctor perform to determine if TAVR is right for me?

Your doctor may use one or more of these tests to determine if TAVR is the best option for you.

  • Chest X-ray: A type of imaging to view images of the organs and structures inside your chest. You will be placed between a metal plate and the X-ray machine. The X-ray technician will take several images of your chest in a variety of positions. This may take up to 30 minutes to perform.
  • Transthoracic echocardiogram (TTE): This diagnostic test (also known as an echo) uses ultrasound to obtain 3D images of the heart. While you are lying on a table, a probe will be placed on your chest wall and will use sound waves to provide detailed pictures of your heart. This usually takes 30-60 minutes.
  • Magnetic resonance imaging (MRI): A diagnostic test that uses magnetic and radio waves to take detailed pictures of your heart. You will be asked to lie down on a bed that moves into a large tube. You won’t feel anything but will hear a noise as the images are acquired. You will be asked to lie very still for duration of test.  This usually takes 30-90 minutes.
  • Pulmonary function test (PFT): A group of tests, using special breathing equipment, that will measure how well your lungs are moving oxygen to the blood. These can take 60-120 minutes.
  • Computerized tomography (CT) scan: An imaging test that uses X-rays to obtain detailed pictures of your heart and blood vessels. You will be injected with contrast dye through an IV. You will be asked to lie down on a bed that passes through a donut-shaped X-ray scanner to take clear images of your heart. This takes up to 60 minutes.
  • Angiogram (cardiac cath): An imaging test that uses X-ray and dye to see how blood flows through your arteries and veins. You will lie on your back on an X-ray table. A small incision will be made and a small tube, called a catheter, will be inserted either in your groin or near your elbow. Dye will be injected into the vessel to make the area show clearly on the X-ray pictures. This takes up to 60 minutes.
  • Transesophageal echocardiogram: A test that obtains detailed pictures of your heart by inserting a probe down the esophagus (throat). While lying on a table, a technician will spray your throat with medicine to numb and suppress your gag reflex. A thin flexible tube will be guided down your throat. The probe will send and receive sound waves which will become pictures on a video screen. This may take up to 60 minutes.
Is TAVR only for people who are too sick or for whom surgery is too risky?

TAVR is an option for more people than ever before. TAVR may be an option for anyone with severe aortic stenosis who is experiencing symptoms. Only a specialized Heart Team can tell you if TAVR is right for you.

How can I get evaluated for TAVR?

To see if the TAVR procedure is right for you, you need to seek out expert care from a specialized heart doctor called an interventional cardiologist at a TAVR Hospital. Only a TAVR Hospital 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, but you can find the nearest TAVR Hospital using the Find a TAVR Hospital Tool.

What is a Heart Team?

You may have heard the term Heart Team while researching your aortic stenosis treatment options. A Heart Team is a specialized care team that includes interventional cardiologists, cardiothoracic surgeons, imaging specialists, anesthesiologists, cardiac cath lab staff, and a cardiologist. Together, the specialized Heart Team will conduct a comprehensive evaluation to determine whether the TAVR procedure is appropriate for you.

What is a Valve Clinic Coordinator (VCC)?

A VCC is usually your first point of contact at a TAVR Hospital. They are in charge of coordinating all activities regarding TAVR. The VCC provides support to patients from referral to a TAVR Doctor through follow-up from the TAVR procedure. They will help you navigate through the process of evaluation, possible treatment, insurance coverage, and financial needs.

What if my doctor doesn’t know about TAVR or perform TAVR?

If your doctor doesn’t perform TAVR, you should ask for a referral to a TAVR Hospital. The doctors at a TAVR Hospital are experts in valvular disease and valve replacement and are able to determine the best treatment option for you. Find the nearest TAVR Hospital.

What if my doctor does not think I am a good candidate for TAVR?

TAVR is becoming an option for more and more people with severe aortic stenosis. If your doctor does not think you are a good candidate for TAVR, you may still contact a TAVR Hospital to receive a second opinion.

Find a TAVR Hospital

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Recovery from TAVR

What should I expect directly after my TAVR procedure?

Typically following a TAVR procedure, you may be taken to the intensive care unit (ICU) for a little while or moved directly to a recovery room. Your doctor will update your caregiver or loved ones on how you are doing.

How long will I be in the hospital for my TAVR procedure?

The average hospital stay with the TAVR procedure is 3 days; however, some patients have been discharged home as early as the next day.4

What does life after TAVR look like?

Research has shown patient health improvements within 30 days, including the ability to take care of themselves and participate in everyday activities.4

How long does a transcatheter heart valve last?

How long your tissue valve will last depends on many patient factors and medical conditions. Follow all care instructions to ensure the best possible results. The Edwards transcatheter valve has been tested in a laboratory to mimic 5 years of use without failure. Regular follow-ups will help your doctor know how your valve is working.

What happens if my transcatheter heart valve fails?

Every year after TAVR you should have a follow-up appointment with your cardiologist, who will be checking your heart. During these visits, your cardiologist will likely perform an echocardiogram and complete other tests to make sure your valve and heart are still working properly. If your cardiologist determines that your valve is no longer working the way it should, your doctor will determine next steps and decide if you need an evaluation for reintervention. If it is determined that another procedure is needed to fix your failing heart valve, and you have previously had a transcatheter heart valve to fix your severe aortic stenosis, you could be eligible to get another transcatheter heart valve placed into your failed artificial valve. This procedure is known as valve-in-valve and is currently approved for patients who are deemed high risk for open heart surgery.

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About Open Heart Surgery

What is open heart surgery?

Open heart surgery for aortic valve replacement is where the doctor will open your chest and will completely remove the damaged valve and replace it with an artificial valve. You will be connected to a heart-lung machine that does the work of your heart and keeps the blood flowing throughout your body. Patients usually need to stay in the hospital for a week or more, before beginning a long period of recovery.

How long does it take to recover from open heart surgery?

After open heart surgery, it can take the body a long time to recover. Your chest needs to be opened during the operation, and it can take several months to heal completely. Cardiac care rehabilitation is recommended.

What are the potential risks or complications of open heart surgery?

As with any medical procedure, there is a possibility of complications. Serious complications, sometimes leading to re-operation or death, may be associated with open heart surgery. Other risks include stroke, infection, bleeding, abnormal heart rhythms, heart attack, kidney problems, and more.

What happens if my surgical heart valve fails?

During your routine checkups with your cardiologist, you will likely have an echocardiogram and complete other tests to make sure your valve and heart are still working properly. If your cardiologist determines that your valve is no longer working the way it should, your doctor will determine next steps and decide if you need an evaluation for reintervention. If it is determined that another procedure is needed to fix your failing surgical heart valve, you could be eligible to get a transcatheter heart valve placed into your failed surgical valve. This procedure is known as valve-in-valve and is currently approved for patients who are deemed high risk for another open heart surgery.

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Patient Resources for Aortic Stenosis and TAVR 

Are there resources available to better understand aortic stenosis and treatment options?

There are many free patient resources available to learn more about aortic stenosis and TAVR, including patient stories, TAVR brochures and procedure videos. A personalized information kit is also available to help answer your questions on aortic stenosis and TAVR.

How can I connect with other patients like me to learn about their TAVR journeys?

You can get connected with others who have gone through TAVR and ask them questions and hear their stories through the Edwards PatientConnect program. Simply call our toll-free number (1-877-209-8638) or fill out the Edwards PatientConnect program form and a dedicated team member will reach out to help you get started.

Get Support

Are there support groups or other helpful websites I can visit for more information?

There are a variety of helpful websites that may provide additional information on diagnosis and treatment of aortic stenosis as well as support services. Visit our helpful websites page to learn about these available resources.

Learn More on Our Helpful Websites Page

How can I find a TAVR Hospital near me?

You can search for TAVR Hospitals by zip code, city/state, or by hospital name using our Find a TAVR Hospital tool. Once you find a TAVR Hospital near you, you may click on the provider to view listing details.

Find a TAVR Hospital

References
  1. Osnabrugge RL, Mylotte D, Head SJ, et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013;62(11):1002-1012.

  2. US Census Bureau, Population Division. June 2015.

  3. Otto C. Timing of aortic valve surgery. Heart. 2000;84(2):211-218.

  4. PARTNER 3 trial, low-risk cohort unadjusted clinical event rates, AT population.

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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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