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What is Aortic Stenosis?

Human heart valves are remarkable structures. These tissue-paper thin membranes attached to the heart wall constantly open and close to regulate blood flow (causing the sound of a heartbeat). When there is a narrowing of your heart's aortic valve opening, this is known as aortic stenosis. This narrowing does not allow normal blood flow. It is most often caused by age-related calcification, but can be caused by a birth defect, rheumatic fever, or radiation therapy.

There are four valves that control the flow of blood through your heart, one of which is called the aortic valve

Progression from Healthy to Mild Aortic Stenosis

Healthy Aortic Valve

Open

Closed

Mildly Diseased Valve

Open

Closed

With aortic stenosis, your heart needs to work harder and may not pump enough oxygen-rich blood to your body.

What causes Aortic Stenosis?

In elderly patients, aortic stenosis is sometimes caused by the build-up of calcium (mineral deposits) on the aortic valve's leaflets. Over time, the leaflets become stiff, reducing their ability to fully open and close. When the leaflets don't fully open, a person's heart must work harder to push blood through the aortic valve to the rest of the body. Eventually, the heart gets weaker, increasing the risk of heart failure (heart cannot supply enough blood to the body).

How is it diagnosed?

Your doctor will perform a few tests to detirmine your diagnosis. This is primarily done through:

  • Auscultation

    Your cardiologist will use a stethoscope to listen to the sounds of your heart.

  • Echocardiography

    This test uses ultrasound waves to obtain images of the heart chambers and valves.

What are the treatment options?

Treatment for aortic stenosis depends on how far the disease has progressed.

Medication: If you are diagnosed with aortic stenosis, medication may be prescribed to help relieve symptoms. However, if your aortic stenosis becomes severe, medication will not fix your failing aortic valve. Your doctor may recommend that your aortic valve be replaced.

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 improve blood flow.

Long-Term Monitoring: Your diagnosis will determine how often you need to see your doctor for follow up. Below are recommended guidelines for follow up, but you should always talk with your doctor about your best treatment plan.

People with mild aortic stenosis should have a yearly physical exam and an echocardiogram every 3-5 years, or as determined by your doctor.

People with moderate or severe aortic stenosis should be examined twice yearly and whenever they develop symptoms of aortic stenosis.

Reference:
1. Stewart BF, Siscovick D, Lind BK, et al. Clinical factors associated with calcific aortic valve disease. Cardiovascular Health Study. J Am Coll Cardiol. 1997;29:630-634.

Important Risk Information

Indications: The Edwards SAPIEN 3 transcatheter heart valve (THV), model 9600TFX, and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease...

  • Important Risk Information for Patients

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    Indications: The Edwards SAPIEN 3 transcatheter heart valve (THV), 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 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 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 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 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 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 and delivery systems are indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioproshtetic aortic valve who 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 cannot use): The Edwards SAPIEN XT transcatheter heart valve and delivery systems cannot 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.
    • 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 transfemoral 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, effectiveness, and durability of implanting a new valve inside a previously implanted surgical tissue valve has not been established. 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 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
    • 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.
    • © 2016 Edwards Lifesciences Corporation. All rights reserved.