• 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
    • Before the Procedure
    • During the Procedure
    • After the Procedure
  • Talking with Your Doctor
  • Patient Resources
    • Overview
    • Free Info Kits
    • Patient Stories
    • Aortic Stenosis and Treatment Videos
    • Brochures
    • Patient Support
    • FAQs
    • Helpful Websites
    • Glossary
  • Search Close
  • US
      × Select a country
    • AustraliaAustralia
    • Canada - EnglishCanada - English
    • Canada - FrenchCanada - French
    • TaiwanChina - Taiwan
    • DenmarkDenmark
    • FinlandFinland
    • GermanyGermany
    • ItalyItaly
    • NetherlandsNetherlands
    • New ZealandNew Zealand
    • NorwayNorway
    • South KoreaSouth Korea
    • Southeast AsiaSoutheast Asia
    • SwedenSweden
    • United KingdomUnited Kingdom

Dangers of Severe Aortic Stenosis

The dangerous thing about severe aortic stenosis is that it prevents blood from flowing easily throughout your body. Your heart may need to work harder to pump blood throughout your body, and many times, it can’t do so effectively. When that happens, some people may notice uncomfortable symptoms such as shortness of breath and fatigue as the heart becomes weaker.

1 in 8 Affected with Aortic Stenosis

Aortic stenosis is a common condition—affecting about 1 out of 8 people over the age of 75.1

Here are some of the top reasons severe aortic stenosis is dangerous:

  • By the time it is found in many patients, the disease has progressed to an advanced stage. This is why doctors call it severe aortic stenosis. The aortic valve has a severe build-up of calcium and it has a difficult time opening and closing.

  • Patients with severe aortic stenosis may find it hard to participate in regular activities like walking to get the mail or climbing up the stairs.

  • When this happens, your risk for heart failure increases significantly. This is why the outlook for severe aortic stenosis is poorer than many cancers that have metastasized in the body, such as metastatic breast cancer and even lung cancer.2

Severe Aortic Stenosis Has a Worse Prognosis Than Many Metastatic Cancers2

Survival Rates For Severe Aortic Stenosis Compared To Metastatic Cancers [% = survival rate after 5 years]

3%
Severe Inoperable Aortic Stenosis
4%
Lung Cancer
12%
Colorectal Cancer
23%
Breast Cancer
28%
Ovarian Cancer
30%
Prostate Cancer

 

Without aortic valve replacement, only a few people with the disease survive past 5 years. The good news is, there is hope and a less invasive treatment option available for severe aortic stenosis. If you are experiencing symptoms, or if you think you have severe aortic stenosis, talk to your doctor.

Recognize Severe Aortic Stenosis Symptoms

If aortic stenosis is so serious, why aren’t more people aware of it?

Many simply confuse these aortic valve stenosis symptoms with normal signs of aging. But actually, these symptoms may mean your body is not getting enough oxygen. Over time, you may feel tired and weak. These may be signs that your severe aortic stenosis has reached a life-threatening point.

Studies have shown that while many patients initially report no symptoms, after closer examination, 32% do have symptoms.4 That is why it’s so important to talk to your doctor about your symptoms.

People may notice symptoms like:

  • Shortness of breath
  • Chest pain
  • Fatigue (low energy)
  • Lightheadedness, feeling dizzy, and/or fainting
  • Difficulty when exercising
  • Swollen ankles and feet
  • Rapid or irregular heartbeat

Up to 50% of people who develop severe aortic stenosis symptoms will die within an average of two years if they do not have their aortic valve replaced.3

icon-caregiver-tip-hands

The symptoms of aortic valve disease are commonly misunderstood by patients as normal signs of aging. If the person you care for is experiencing symptoms such as lack of energy, or they can’t do things like they used to, they should talk to a doctor right away.

http://Jake

Jake's "New Normal"

Listen to Jake describe his aortic stenosis symptoms and how they impacted his life.

Play Video

Don't Wait to Treat Your Severe Aortic Stenosis

If you have been told you have severe aortic stenosis and have symptoms, it is important to remember that medication cannot stop or cure the disease, it can only treat the symptoms. Valve replacement is the only effective treatment option.

That may be hard to hear if you’ve received a recent diagnosis and you are going through a range of emotions. You may feel nervous or in disbelief. You may feel hesitant. Or you may want to wait to see how things go. But if you have been told you have severe aortic stenosis and start to experience symptoms, it is important to get treatment right away. Call your doctor as soon as you notice these symptoms or if your symptoms worsen.

Did you know?

The American College of Cardiology and American Heart Association advise that a patient receive treatment as soon as they are diagnosed with severe aortic stenosis and starts to experience symptoms.5

Heart - 40% of patients with severe aortic stenosis do not receive valve replacement

At least 40% (and perhaps up to 60%) of patients with severe aortic stenosis do not receive valve replacement.6-12

Open heart surgery is not the only option for treating severe aortic stenosis. Transcatheter aortic valve replacement (TAVR) is a less invasive alternative for replacing your aortic valve. Explore your treatment options now.

Treatment Options
Talk with Your Doctor
Get the Guide
Connect with TAVR Patients
Get Support
http://Gardener
References
  1. Osnabrugge, Ruben L.J., et al. Aortic Stenosis in the Elderly. Disease Prevalence and Number Candidates for Transcatheter Aortic Valve Replacement: A Meta-Analysis and Modeling Study. J Am Coll Cardiol. 2013;62:1002-1012.

  2. Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu, MD, Cleveland Clinic. 2010.

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

  4. Das P, Rimington H, Chambers J. Exercise testing to stratify risk in aortic stenosis. Eur Heart J. 2005;26(13):1309-1313.

  5. Nishimura R, Otto C, Bonow R, et al. 2014 AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease. J AM Coll Cardiol. 2014;63(22):57-185.

  6. Bach D, Siao D, Girard S, Duvernoy C, McCallister B, Gualano S. Evaluation of Patients With Severe Symptomatic Aortic Stenosis Who Do Not Undergo Aortic Valve Replacement: The Potential Role of Subjectively Overestimated Operative Risk. Circ Cardiovasc Qual Outcomes. 2009;2(6):533-539

  7. Freed B, Sugeng L, Furlong K et al. Reasons for Nonadherence to Guidelines for Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Potential Solutions. Am J Cardiol. 2010;105(9):1339-1342

  8. Bouma B, van den Brink R, van der Meulen J, et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart. 1999;82(2):143-148.

  9. Pellikka P, Sarano M, Nishimura R, et al. Outcome of 622 adults with asymptomatic, hemodynamically significant aortic stenosis during prolonged follow-up. Circulation. 2005;111(24):3290-3295.

  10. Charlson E, Legedza A, Hamel M. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis. 2006;15(3):312-321.

  11. Varadarajan P, Kapoor N, Banscal RC, Pai RG. Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis. Ann Thorac Surg. 2006;82(6):2111-2115.

  12. Jan F, Andreev M, Mori N, Janosik B, Sagar K. Unoperated patients with severe symptomatic aortic stenosis. Circulation. 2009;120;S753.

  • What is Aortic Stenosis
  • Dangers of Severe Aortic Stenosis
  • Treatment Options
Request Your Free TAVR Info Kit

Edwards SAPIEN 3 THV System and Edwards SAPIEN 3 Ultra THV System

Indications:
The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System 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 appropriate for the transcatheter heart valve replacement therapy.

The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System are indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or 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 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 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 is not known at this time. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing. Safety, performance, and durability of the SAPIEN 3 Ultra and SAPIEN 3 valve have not been established for placement inside a previously implanted transcatheter valve.

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, two leaflets in low surgical risk patients, 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 SAPIEN 3 Ultra or 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...
  • Privacy Policy
  • Legal Terms
  • Site Map
  • Contact Us
  • Important Risk Information
  • Join Email List
© 2021 Edwards Lifesciences Corporation. All Rights Reserved.
edwards-logo

Thank You

You are now part of our email list and our patient community. To explore additional resources to help you take charge of your health, visit our Patient Resources section or request your Free Info Kit today.
powered by Typeform