• Understand Aortic Stenosis
    • About Heart Valve Disease
    • 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
    • FAQs
    • Helpful Websites
    • Glossary
  • Search Close
  • US
      × Select a country
    • AustraliaAustralia
    • BrazilBrazil
    • 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

Waiting Isn’t an Option. Get Evaluated for TAVR

Don’t let a severe aortic stenosis diagnosis hold you back. Nothing else ever has. If your doctor has recommended getting your aortic valve replaced, it is time to put yourself in the driver’s seat of your health.

Be proactive by talking to your doctor about all of your treatment options, especially if you are experiencing symptoms such as fatigue and shortness of breath. Instead of waiting for your severe aortic stenosis to get worse, take control of your disease by getting treatment now.

Transcatheter aortic valve replacement (TAVR) gives you a way to live your best life without open heart surgery. Studies have shown that this less invasive procedure may shorten recovery time, reduce time spent at the hospital and get patients home quicker.1

Start your golden years off right by asking your doctor if you are eligible for TAVR.

Don’t Wait

Take control of your future by learning if TAVR is right for you. You can start by ordering your Free Info Kit to learn more about the benefits of TAVR.

Free Info Kit
http://Mario's%20TAVR%20Eligibility

Slowing Down? Not for Mario

Getting back to life quickly made TAVR the right option for Mario.

Play Video

All Patients Should Ask for a TAVR Evaluation

A severe aortic stenosis diagnosis doesn’t mean it’s time to slow down. TAVR can help you take control of your disease – and your life.

Luckily, the less invasive TAVR procedure is an option for more patients than ever before.

Any severe aortic stenosis patients who are experiencing symptoms can be considered for TAVR. The American College of Cardiology and American Heart Association have recently updated the guidelines for treatment of severe aortic stenosis. If you were told that TAVR was not an option for you in the past, you may be eligible now. Talk to your TAVR Heart Team about your options.

TAVR may be an option for bicuspid patients. Open heart surgery is not their only option (although it may be the best option for their unique situation). Bicuspid patients should seek an evaluation with a TAVR Heart Team to see all their treatment options.

The TAVR procedure may also be an option for people at high risk for surgery who had their aortic valve replaced in the past, but need a new one because the replacement valve may no longer work.

As more people discover the benefits of TAVR, more people are treating their severe aortic stenosis with this less invasive option. These benefits may include:

  • Improved quality of life following the procedure, including the ability to return to normal daily activities

  • Shorter hospital stay

  • Relief of symptoms

  • Less pain and anxiety

  • Minimal scarring

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.

icon-caregiver-tip-hands

Part of being an advocate means evaluating all treatment options for severe aortic stenosis, including TAVR. The goal should always be for your loved one to feel empowered about their treatment plan. If you’re not sure about one doctor’s recommendation, seek an evaluation at a TAVR Hospital.

Find a TAVR Hospital
http://David's%20TAVR%20Eligibility

Why TAVR was the Clear Choice for David

David's life changed when he developed symptoms from severe aortic stenosis. Hear why TAVR was the best option to help him get his life back.

Play Video

How to Get a TAVR Evaluation

It takes courage to take charge of your severe aortic stenosis. Take the first step by seeking out a TAVR Heart Team who will evaluate you for all treatment options.

Your TAVR Doctor will run several tests to determine the best treatment plan for you and to evaluate if you are a TAVR candidate. Some of these tests include:

  • An angiogram to examine how blood is flowing through your heart’s arteries
  • An echocardiogram to take pictures of your heart
  • Other diagnostic tests which can be explored in our FAQs section

In some cases, you may have already taken some of these tests. However, it may be important that the tests be taken again at the request of your TAVR Doctor.

Although it may feel like a lot of appointments, it’s important because your TAVR Doctor wants to make sure they are recommending the best treatment option for you.

Find a TAVR Hospital

Only a TAVR Doctor 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. Use our Find a TAVR Hospital tool to locate one near you.

Find a TAVR Hospital

Your life belongs to you, not severe aortic stenosis. Take it back, with TAVR. Learn what you can expect before, during and after the TAVR procedure.

TAVR: What to Expect
Stay Informed
Get Updates
Find a TAVR Hospital
Search Now
Reference

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

  • About the TAVR Procedure
  • Is TAVR Right for You?
Request Your Free TAVR Info Kit

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...
  • Privacy Policy
  • Legal Terms
  • Site Map
  • Contact Us
  • Important Risk Information
  • Stay Informed
  • Do not sell my information
© 2021 Edwards Lifesciences Corporation. All rights reserved.
edwards-logo