• Understand Aortic Stenosis
    • What is Aortic Stenosis
    • Dangers of Severe Aortic Stenosis
    • Treatment Options
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Have a Question About Aortic Stenosis and Treatment Options?

Figuring out the next steps in treating your severe aortic stenosis may feel overwhelming. Our Edwards PatientConnect team is here to support you and help guide you through your journey towards a healthier life. Additionally, it is sometimes helpful to talk with patients who have been through the same treatment and know what you are going through.

Contact a PatientConnect Team Member

Call 1-877-209-8638

Or, simply fill out the form below and a team member will reach out to help you get started.

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Our PatientConnect Support Team is Ready to Help You:

  • Understand Aortic Stenosis

    Our specialists can provide information on symptoms, progression and treatment options for aortic stenosis.

  • Connect with a TAVR Patient

    Our TAVR patient ambassadors will share their TAVR treatment experience and provide support when you need it the most.

  • Find a TAVR Hospital

    We can help you locate a TAVR Hospital near you for evaluation for the best treatment option for you.

  • Make the Most of Your Doctor’s Appointments

    Not sure of what to expect during your next doctor’s appointment? Let us help you prepare for your upcoming appointments and doctor discussions.

Sign Up For Edwards PatientConnect Program

Please fill out the fields below to receive support from a PatientConnect team member.

  • Edwards PatientConnect Program Consent Terms & Conditions: I understand that the Edwards PatientConnect program does not offer medical advice and is not intended to replace my or my loved one’s relationship with our doctor(s), whom we will contact if we have any questions related to medical care and treatment.
    I hereby consent to participate in the Edwards PatientConnect program, which I understand is sponsored by Edwards Lifesciences. I authorize Edwards Lifesciences LLC, its affiliates, and agents/contractors ("Edwards Partners") to use, access, disclose, and transfer my personal information to provide me with the requested support, resources, informational and marketing materials via text, email, direct mail, telephone, and/or video chat ("Services").
    I also understand that Edwards and/or Edwards Partners may de-identify my personal information and use or disclose the de-identified data to help improve, develop, and evaluate products, services, materials, programs, and treatments related to aortic stenosis, as well as for health economic outcomes research, market research, or any other purpose permitted by law.
    Edwards and Edwards Partners may not sell or rent my personal information or otherwise use my personal information for any purpose not authorized above without additional consent from me.
    I understand that this Consent to Participate is voluntary and will expire in, at most, 6 years, unless I cancel it sooner. I may cancel or opt out at any time by calling 1-844-413-2092 or clicking "Unsubscribe" on any Edwards PatientConnect program email.
    I expressly agree to enter into this Consent to Participate in electronic format and my checkmark in the box below is my electronic signature. By signing, I agree to the statements above and that I am currently 18 years of age or older.
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From Patient to TAVR Ambassador

Larry had the TAVR procedure to replace his aortic valve and now he shares his TAVR experience over the phone with those who are considering their treatment options.

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* Edwards PatientConnect program does not offer medical advice or involve the practice of medicine. This program is not intended to replace your relationship with your doctor. Please contact your doctor if you have any questions related to your medical care and treatment.

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  • Overview
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  • Glossary

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...
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