Not a Chance With TAVR Clinical Outcomes.
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%).
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.
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
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.
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.
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.
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:
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:
Potential risks associated with the procedure include:
Additional potential risks specifically associated with the use of the heart valves include:
CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.