Talking With Your Doctor

Your journey to treating your severe aortic stenosis starts with understanding the benefits of Edwards transcatheter aortic valve replacement (TAVR)—and the fact that not all heart valves are the same.

Talk to your doctor about Edwards TAVR, the valve with better outcomes than open heart surgery in low-risk patients after one year- and is equally effective after 5 years, so life doesn’t have to skip a beat.*

Without valve replacement, up to 50% of people with severe aortic stenosis will die within an average of 2 years once symptoms appear. The only way to treat severe aortic stenosis is with a heart valve replacement.1

*The PARTNER 3 Trial, SAPIEN 3 TAVR proven superior to surgery on the primary endpoint of all-cause death, all stroke, and re-hospitalization (valve-related or procedure-related and including heart failure) at one year, and multiple pre-specified secondary endpoints in low risk patients.

PARTNER 3 Trial 5-Year Results in low-risk patients – Low rates of cardiovascular mortality through five years (5.5% SAPIEN 3 TAVR to 5.1% SAVR). Low rates of all-cause mortality through five years (10.0% SAPIEN 3 TAVR vs. 8.2% with SAVR). Low rates of disabling stroke through five years (2.9% SAPIEN 3 TAVR to 2.7% SAVR). Low rates of stroke through five years (5.85% SAPIEN 3 TAVR vs. 6.4% SAVR). Lower rates of rehospitalization with SAPIEN 3 TAVR through five years (13.7% vs. 17.4%).

Get Improved Clinical Outcomes with Edwards TAVR

TAVR is the clear choice to treat severe aortic stenosis. Not only do people who had TAVR with an Edwards valve regain independence quicker, but low-risk patients are also 3× less likely than open heart surgery patients to die or have a disabling stroke within 1 year.2 In addition to this short-term effectiveness, TAVR was also proven equally as effective as open heart surgery after 5 years.**

TAVR gives you a way to live your best life without open heart surgery. With TAVR, you are more likely to go directly home after the procedure. In contrast, open heart surgery patients spend an average of 7 days in the hospital.3

That extra time can mean a lot when it comes to your quality of life. It can mean more time with friends, family, and loved ones.

It can also mean getting back to your golden years quickly. Patients who had Edwards TAVR show health improvements within 30 days and resume normal activities quickly. In contrast, patients who had open heart surgery for heart valve replacement are 3 times more likely to need to stay in a care facility after the procedure.

Edwards TAVR has better clinical outcomes than open-heart surgery in low-risk patients after one year—and is equally effective after 5 years.**

Patients considering heart valve replacement deserve to know the benefits of Edwards TAVR compared to open heart surgery, including4:

Low rate of serious complications

Shorter recovery time

Less pain and discomfort

Short hospital stay
(3 days vs 7 days after surgery)

Improved quality of life


**The PARTNER 3 Trial, SAPIEN 3 TAVR proven superior to surgery on the primary endpoint of all-cause death, all stroke, and re-hospitalization (valve-related or procedure-related and including heart failure) at one year, and multiple pre-specified secondary endpoints in low risk patients.

PARTNER 3 Trial 5-Year Results in low-risk patients – Low rates of cardiovascular mortality through five years (5.5% SAPIEN 3 TAVR to 5.1% SAVR). Low rates of all-cause mortality through five years (10.0% SAPIEN 3 TAVR vs. 8.2% with SAVR). Low rates of disabling stroke through five years (2.9% SAPIEN 3 TAVR to 2.7% SAVR). Low rates of stroke through five years (5.85% SAPIEN 3 TAVR vs. 6.4% SAVR). Lower rates of rehospitalization with SAPIEN 3 TAVR through five years (13.7% vs. 17.4%).

Which Valve Is Right for You?

With more people eligible for TAVR than ever before, it is important to know the different treatment options and valves that are available to you.

Not all valves are the same, so feel empowered to talk to your doctor about which one is right for you.

You have the power to live life on your own terms. That’s why making the best decisions about your heart health begins with you.

Edwards TAVR valve

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.

It is important to understand the benefits and risks of your treatment options. You can use our Informed Discussion Guide to prepare for your talk with your doctor about treatment for your severe aortic stenosis.

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References

1. Otto C. Timing of aortic valve surgery [Valve Disease]. Heart. 2000;84(2):211-218.

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

3. Based on PARTNER 3 low-risk cohort trial outcomes.

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

Important Risk Information

Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, and Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System

Indications:
The Edwards SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA 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, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA 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, a surgical bioprosthetic mitral valve, or a native mitral valve with an annuloplasty ring 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, Edwards SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA 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.
  • Have a mitral ring that is damaged and can no longer support the valve.

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 anesthesia, contrast media, cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or plastics.
  • The Edwards SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA 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. Patients who do not may be at increased risk of a stroke. Blood-thinning medication may increase the risk of bleeding in the brain (stroke).
  • Transcatheter valve replacement is not recommended in previous mitral valve rings that are damaged or have become too rigid.

Precautions:
The long-term durability of the Edwards SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA 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. A patient’s anatomical characteristics should be considered by their physicians when using the valve in this patient population. In addition, patient age should be considered as long-term durability of the valve has not been established. Patients who need a dental procedure should talk to their doctor about risk of infection and needing antibiotics. Patients should be treated post-procedure for heart infection as a precaution.

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.
  • Who have a prosthetic ring in the tricuspid position.
  • 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 the delivery devices, or a large amount of calcification at the point of entry.
  • Allergies to blood-thinning medications or dye injected during the procedure.
  • Whose previously implanted artificial valve or ring is not securely in place or is damaged that could cause it to leak.
  • Whose previously implanted valve or ring could block a blood vessel caused from the leaflet partially detaching.

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, sudden loss of heart function, 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, dizziness, 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, serious damage to the arteries, severe bleeding in the heart or in the body that could require a transfusion or surgery.
  • 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 or emergency heart surgery and possible removal of the Edwards SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA and SAPIEN 3 valves, a blood clot that requires treatment, damage to the valve (e.g., wear, breakage, recurring aortic stenosis), valve issues not related to structure (e.g., leakage, inappropriate sizing or positioning, blockage, excess tissue in growth, blood cell damage) 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.