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HEART VALVE DISEASE

AORTIC STENOSIS

Aortic stenosis is a serious and progressive heart valve disease. It is one of the most common heart valve diseases, affecting more than 20% of older people.1
 
If left untreated, aortic stenosis can lead to heart failure and death.1
 
Download the Aortic Stenosis Treatment Guide to learn more about aortic stenosis symptoms and a treatment option for severe aortic stenosis.

Your heart has four valves that direct blood flow between the chambers of the heart. These valves act like one-way doors, allowing blood to flow forward into the next chamber. The valves close to prevent backflow. 

On the left side of the heart, blood flows through the left ventricle into the aorta—the main artery of the body—through the aortic valve. The aortic valve has three flaps of tissue, called leaflets, that open and close to ensure that blood flows in only one direction. 

Aortic stenosis, or AS, occurs when the leaflets become thick or stiff, which causes a narrowing of the aortic valve. Because of this, the valve doesn’t open and close properly, which restricts the flow of blood out of the left ventricle into the aorta.1,2 This makes it harder for your heart to pump oxygen-rich blood to your body, which can affect your health.
 

Aortic Stenosis Aortic Valve
  • Healthy Aortic Valve vs. Aortic Stenosis

    Normal

    Mild-to-moderate aortic stenosis

    Severe aortic stenosis

What causes
Aortic Stenosis?

Aortic stenosis most commonly occurs in people 65 and older as a result of scarring and calcium buildup on the valve leaflets. Scarring and calcium build up may be from a normal sign of aging or from prior chest radiation, it may also result from having rheumatic fever during childhood, which is now rare in the United States.1,3

Aortic stenosis may be present in young people due to a birth defect, the most common being a bicuspid aortic valve. This is where only two leaflets grow instead of the normal three.1,3
 

Aortic Stenosis
symptoms

Aortic stenosis symptoms may not be noticeable during the mild-to-moderate stages of the disease when blood flow is not significantly reduced. As damage to the leaflets worsens, the valve further narrows and blood flow is greatly reduced.1 Once the disease progresses to this severe stage, aortic stenosis symptoms may include1:

Shortness of Breath

SHORTNESS OF BREATH

Dizziness

DIZZY

Difficulty in Walking

DIFFICULTY WALKING SHORT DISTANCES

Reduced Ability

DECLINE IN ACTIVITY LEVEL OR REDUCED ABILITY TO DO NORMAL ACTIVITIES

Chest Pain

CHEST PAIN

Heart Palpitations

RAPID, FLUTTERING HEARTBEAT

Ankles and Feet swelling

SWOLLEN FEET OR ANKLES

Difficulty in Sleeping

DIFFICULTY SLEEPING OR NEEDING TO SLEEP SITTING UP


The symptoms of aortic stenosis can be misunderstood as “normal” signs of aging—if you or a loved one experience any of these symptoms, see a doctor right away.

Patients diagnosed with mild-to-moderate aortic stenosis who have no symptoms should receive regular clinical and echocardiography exams to monitor the progression of their valve disease.4 Echocardiography is a test that uses sound waves to produce live images of your heart that allows your doctor to monitor how your heart and its valves are functioning.  

Aortic Stenosis is
progressive and life threatening

If you are diagnosed with severe aortic stenosis, it is important to get treatment right away. Call your doctor as soon as you notice these symptoms or if your symptoms worsen.

Aortic stenosis is a progressive disease, which means that it will become more severe over time. As your leaflets become more damaged, the heart must work harder to pump blood through the narrowed valve opening. This causes the wall of the left ventricle to enlarge and thicken and the heart to weaken, reducing the amount of blood supplied to the body. In time, this may lead to heart failure and death.1,3


From the onset of symptoms, risk of death from severe aortic stenosis is as high as 25% at 1 year and 50% at 2 years in patients who do not undergo aortic valve replacement.5

AORTIC STENOSIS TREATMENT

If you or a loved one has been diagnosed with aortic stenosis, it’s important to seek timely treatment since the condition gets worse over time. Your doctor will discuss the best treatment option for you. Learn about aortic stenosis treatment options.

TREATMENT OPTIONS

The information provided is not intended for medical diagnosis or treatment as a substitute for professional medical advice. Consult with a physician or qualified healthcare provider for appropriate medical advice.

MAT-2304819 v3.0 | Item approved for U.S. use only.

References
  1. American Heart Association. Aortic stenosis overview.  Accessed March 15, 2023. www.heart.org/en/health-topics/heart-valve-problems-and-disease/heart-valve-problems-and-causes/problem-aortic-valve-stenosis. Reviewed October 26, 2020.
  2. Satter Y, Rauf H, Bareeqa S, et al. Transcatheter aortic valve replacement versus surgical aortic valve replacement: A review of aortic stenosis management. Cureus. 2019;11(12):e6431. doi: 10.7759/cureus.6431
  3. Carita P, Coppola G, Novo G, et al. Aortic stenosis: Insights on pathogenesis and clinical implications. J Geriatr Cardiol. 2016;13:489-498. doi:10.11909/j.issn.1671-5411.2016.06.001
  4. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC Guideline for the management of patients with valvular heart disease. Circulation. 2014;129(23):2240-2492. doi: 10.1161/CIR.0000000000000029
  5. Ren X. Aortic stenosis. Medscape. Accessed March 15, 2023. emedicine.medscape.com/article/150638-overview. Updated November 18, 2021.
Important Safety Information
  • Navitor

  • WHAT IS THE NAVITOR™ TAVI SYSTEM APPROVED FOR?
    Available by prescription only.

    Transcatheter Aortic Valve Implantation (TAVI) with the Navitor™ TAVI System provides an alternative, minimally invasive treatment option for people living with severe aortic stenosis, a condition where the aortic valve does not fully open or close, who are not candidates for open-heart surgery due to age, frailty, or other conditions that make surgery too risky.

    WHO SHOULD NOT RECEIVE TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE NAVITOR™ TAVI SYSTEM?

    You should not receive the Navitor valve if you have any of the following conditions: any kind of infection, including an active infection in the heart; cannot tolerate medication that thins the blood or prevents blood clots from forming; have a reaction or allergy to nitinol, an alloy of nickel and titanium.

    The Navitor™ TAVI System has not been studied in the following patient populations and therefore should not be used in patients who: have any evidence of a blood clot (thrombus), intracardiac mass or vegetation in, on or around the heart; have narrow veins or arteries with calcification that make insertion of the delivery sheath and access to the aortic valve impossible; have stenotic (narrowed) aortic valve without calcium deposits; have a heart valve defect from birth with either one or two leaflets vs. the normal three leaflets; are pregnant or breastfeeding; are age 21 or younger at the time of diagnosis or treatment; have an ejection fraction, or volume of blood fluid, less than 20%; have unstable heart function requiring mechanical assistance or drug therapy to support the normal function of the heart; are low or intermediate surgical risk; have had a previous heart valve or ring in any position in the heart; have mixed aortic valve disease (stenosis and regurgitation); have severe mitral valve disease (calcification, stenosis or inefficiency); have a medical condition that affects the cellular or plasma components of the blood; have significant coronary artery disease that requires treatment; have abnormally thick heart muscle (hypertrophic cardiomyopathy); are on dialysis, have kidney failure or inefficiency; have known allergy or sensitivity to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media/dye; have bulky calcium build up on the valve leaflets close to the coronary ostia which are the main arteries delivering blood from the heart to the rest of the body; have significant aortic disease, including abdominal aorta, thoracic aneurysm or any other folding, bending or narrowing which would make access to the aortic valve impossible.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE NAVITOR™ TAVI SYSTEM?

    There are risks with any heart valve implantation procedure. The most serious risks are: death, stroke, serious damage to the arteries and serious bleeding. Additional risks include, but are not limited to: access site complications (e.g., pain, bleeding, infection, blood vessel damage); buildup of deposits (plaque) in and on the walls of coronary arteries; heart attack - blockage of blood flow to the heart muscle; allergic reaction to medication or products/devices used during the procedure (medication to prevent blood clotting, x-ray die, components of the valve delivery process); tear or burst of the aorta; irregular heart rate; disruption or injury of electrical system in your heart leading to the need for a permenant pacemaker implant; tear or separation of the layers of the wall of an artery; obstruction of an artery, typically by a clot of blood or an air bubble; inflammation of the lining of your heart; failure of your heart to pump enough blood to the body’s organs; unstable blood flow; rupture or destruction of blood cells; blood cell damage; low red blood cell count; bleeding, infection, clotting in or on the valve or tissue of the valve; loose clots in the bloodstream that may block an artery in your arms, legs, or brain; escape of blood from a ruptured blood vessel; blood pressure changes above or below the normal levels; infection; reduced blood flow to your heart, preventing the heart muscle from receiving enough oxygen; changes to the Mitral valve where it doesn’t close tightly; multi-organ failure - inflammation from a severe infection or injury causes dysfunction in two or more organ systems; wrong sizing or positioning of the implanted valve; collection of fluid or blood around your heart; perforation or tear of the heart muscle, ventricle or blood vessel; formation of scar tissue that may cover or block the valve from functioning normally; leakage of blood around the edge of the valve; valves in your heart don’t close tightly, allowing blood to flow backward in your heart; kidneys lose the ability to remove waste and balance fluids; blood doesn’t have enough oxygen or has too much carbon dioxide; sepsis; structural deterioration of the implanted valve (i.e., calcification, leaflet tear); having an abnormal particle (air or blood clots) floating in the bloodstream or attached to an object, including the valve; when extra fluid builds up in the space around the heart; when the transcatheter valve moves or is dislodged from the deployment position/location; permanent disability; the need for additional medical procedures to include blood transfusions, operation to remove the valve, use of a balloon to adjust the valve (valvuloplasty), and catheter insertion into coronary arteries to treat blockages.

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MAT-2302755 v4.0  |   Item approved for U.S. use only.

Step 1

To implant the device, your doctor inserts a narrow tube into a vein in your upper leg.

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