Find a TAVR Center
Free Info Kit
Doctor Discussion Guide

Share with friends

Close

what you need to know

Most people are not prepared to be caregivers. There is no special training, you learn as you go and, most of the time, you have more questions than answers. There are daily challenges—emotional, physical, and financial. Put simply: it’s not easy. But remember this: without caregivers like you, many people wouldn’t get the help they need.


According to the Caregiver Action Network and the National Alliance for Caregiving, more than 65 million Americans take care of someone with a chronic condition, disability, disease, or frailties of old age.

If someone you know has been diagnosed with severe aortic stenosis, you may find yourself among those millions. Whether you’re near or far, you can play an important, active role in support. This website is a good place to start your journey of taking care of your aortic stenosis patient—and yourself.

AT THE HEART OF THEIR
support IS…YOU

What you need to know about aortic stenosis

Millions of people in the United States have aortic stenosis, yet many people have never heard of it. As a caregiver, you may be asked to help navigate the road ahead with the person you care for. This may include scheduling and transporting the patient to and from medical appointments, discussing the treatment options, relaying the doctor's observations to family members, and ultimately helping the person you care for make the best treatment decision possible.

Get educational materials about aortic stenosis. Order a Free Info Kit.

Below is some basic information about aortic stenosis you will want to be familiar with.

What causes aortic stenosis?

Aortic stenosis is often caused by age-related calcium build-up on the valve, but can also be caused by rheumatic fever or radiation therapy.

What are the symptoms?

Because aortic stenosis reduces oxygen-rich blood flow, it may cause symptoms like severe shortness of breath and extreme fatigue. However, it's important to know that heart valve disease may occur with no outward symptoms.

The symptoms of aortic disease are commonly misunderstood by patients as “normal” signs of aging. Many patients initially appear asymptomatic, but on closer examination, up to 32% exhibit symptoms.

What are some of the signs of aortic stenosis?
The person you care for may notice symptoms like:

  • Chest pain
  • Fatigue
  • Shortness of breath
  • Lightheadedness, feeling dizzy, and/or fainting
  • Difficulty when exercising

If the person you care for experiences any of these signs of symptoms, consult a doctor right away.

How is it diagnosed?

The first thing the doctor will probably do is listen to their heart with a stethoscope. This is called auscultation. If the doctor suspects a heart murmur, they may refer them to a doctor who specializes in heart conditions, called a cardiologist. The cardiologist will more than likely require that an echocardiogram, also known as an “echo,” be performed. This test will confirm a diagnosis of aortic stenosis.

Note

Echocardiography
A transthoracic echo, also known as a TTE, is another test performed to detect aortic stenosis. This is a noninvasive test where the patient lies down while a probe is placed on the chest wall. The probe uses sound waves to make detailed pictures of the heart.

Next, the cardiologist, as well as other members of the Heart Team, will ask for a number of specialized tests to assess if the TAVR procedure is the best option. In some cases, the patient may have already taken some of these tests. However, it is vitally important that they take these tests again at the request of the Heart Team. There are special angles and measurements used that the Heart Team will specifically request. These tests may include:

Note

Auscultation
The doctor will use a stethoscope to listen for a murmur, click, or other abnormal sounds in the heart.

Note

Cardiac catheterization (angiography)
Under X-ray guidance, small hollow tubes (catheters) are advanced to the aortic valve and into the left ventricle. The rate of blood flow across the aortic valve and pressures can be measured.

Note

Chest X-ray
A chest X-ray usually shows a normal heart shadow. If heart failure is present, fluid in the lung tissue and larger blood vessels in the upper lung regions are often seen.

Note

Electrocardiography (also EKG)
An EKG is a recording of the heart's electrical activity using electrodes attached to your skin. An EKG can show the heart’s rhythm, the heart’s rate, and the strength and timing of the electrical currents.

What are the treatment options?

Treatment for aortic stenosis depends on how far the disease has progressed. If the stenosis is mild, medication may be prescribed to temporarily relieve symptoms, but is not effective long term. As the severity of the stenosis progresses, the doctor may recommend replacing the diseased aortic valve.

No medical treatments have been proven to delay the progression of severe aortic stenosis or to improve survival.

Eventually, most people will need to have their heart valve replaced.

Today, there are 2 ways to replace diseased aortic valves:

Note

1. Transcatheter Aortic Valve Replacement

For people who have been diagnosed with severe aortic stenosis and are at intermediate or greater risk for open heart surgery, TAVR (sometimes called transcatheter aortic valve implantation, or TAVI), may be an alternative. This less invasive procedure allows a new valve to be inserted within the native, diseased aortic valve.

The TAVR procedure can be performed through multiple approaches, however the most common approach is the transfemoral approach (through an incision in the leg). Only a Heart Team can decide which approach is best, based on a person’s medical condition and other factors.

Please consult a Heart Team for more information on TAVR and its associated risks.

Learn more about Edwards transcatheter heart valves here.

To see associated risks with TAVR, click here.

Note

2. Open Heart Surgery

Open heart surgery is the most common treatment for aortic stenosis, and has been performed for many years.

During open heart surgery, the surgeon removes the diseased aortic valve and replaces it with either a mechanical valve (made from man-made materials) or a biological valve (made from animal or human tissue).

Aortic valve replacement can also be performed through minimal incision valve surgery (MIVS). In MIVS, the surgeon can replace the diseased valve through a smaller incision while looking directly at the heart or through a small, tube-shaped camera. MIVS may be an option for some patients.

Please consult a Heart Team for more information on open heart surgery and its associated risks.

How is the treatment plan decided?

If the person you care for goes to a specialized Heart Team, you will make an appointment to visit their valve clinic where they can run a number of tests and evaluations to help determine the best treatment plan. The Heart Team will ask for a number of specialized tests and assessments to help them make the best decision for the person you care for.

In some cases, they may have already taken some of these tests. However, it may be important that the tests be taken again at the request of the Heart Team. There are special angles and measurements used that the Heart Team will specifically request.

The Heart Team will make the best decision for the person you care for based on their medical condition and other factors, which means that after being screened for TAVR, open heart surgery may still be the best option.

Print our TAVR Guide for important information, which you may need when speaking to your doctor

Only a qualified Heart Team can determine if TAVR is an appropriate option for the person you care for.

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

Important Risk Information

Indications: The Edwards SAPIEN 3 transcatheter heart valve (THV), model 9600TFX, and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease...

  • Important Risk Information for Patients

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    Indications: The Edwards SAPIEN 3 transcatheter heart valve, model 9600TFX, and accessories 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 at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% 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 and delivery 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 allergic to chromium, nickel, molybdenum, manganese, copper, silicon, and/or polymeric materials.
    • The SAPIEN 3 valve may not last as long in patients whose bodies do not process calcium normally.
    • 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.
    • Transcatheter aortic heart valve patients should take medications that thin the blood or prevent blood clots from forming, except when likely to have an adverse reaction, as determined by their physician. The Edwards SAPIEN 3 transcatheter heart valve has not been tested for use without medications that thin the blood or prevent blood clots from forming.

    Precautions: The long-term durability of the Edwards SAPIEN 3 transcatheter heart valve is not known, at this time. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing. For patients who have previously had aortic valve replacement, the safety, effectiveness, and durability of putting a transcatheter valve in an already implanted artificial valve are not known at this time.

    The safety and effectiveness of the transcatheter heart valve is also not known for patients who have:

    • An aortic heart valve that is not calcified, contains only one or two leaflets, 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 heart valve replacement or repair
    • 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 or irregularly shaped vessels leading to the heart. Vessels in the legs which are heavily diseased or too small for associated delivery devices, or a large amount of calcification at the point of entry to the heart
    • Allergies to blood-thinning medications or dye injected during the procedure

    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
    • 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 valve 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 valve, 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
  • EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    Indications: The Edwards SAPIEN XT transcatheter heart valve, model 9300TFX, and accessories 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 at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

    The Edwards SAPIEN XT transcatheter heart valve and accessories are also indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic 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., STS operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).

    Contraindications (Who should not use): The Edwards SAPIEN XT transcatheter heart valve and delivery systems 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 is a higher risk of stroke in transcatheter aortic valve replacement procedures, compared to balloon aortic valvuloplasty and other standard treatments for aortic stenosis in the high or greater risk population.
    • Implanting a valve that is too small may cause blood leakage and valve movement. Implanting a valve that is too large can cause a buildup of pressure in the valve or a rupture of blood vessels in or around your heart. Your Heart Team will do tests to determine the best valve size for you.
    • The SAPIEN XT valve may not last as long in patients whose bodies do not process calcium normally.
    • Patients should talk to their doctor if they have significant heart disease, a mitral valve device or are allergic to chromium, nickel, molybdenum, manganese, copper, silicon, and/or polymeric materials.
    • 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.
    • Transcatheter aortic heart valve patients should take medications that thin the blood or prevent blood clots from forming, except when likely to have an adverse reaction, as determined by their physician. The Edwards SAPIEN XT transcatheter heart valve has not been tested for use without medications that thin the blood or prevent blood clots from forming.

    Precautions: The long-term durability of the Edwards SAPIEN XT transcatheter heart valve is not known, at this time. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing.

    The safety and effectiveness of implanting:

    • A transcatheter valve inside a transcatheter valve is not known
    • A transcatheter valve inside a surgical tissue valve is not known in the intermediate-risk population

    The safety and effectiveness of the transcatheter heart valve is also not known for patients who have:

    • An aortic heart valve that is not calcified, contains only one or two leaflets, 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 heart valve replacement or repair
    • 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 or irregularly shaped vessels leading to the heart. Vessels in the legs which are heavily diseased or too small for associated delivery devices, or a large amount of calcification at the point of entry to the heart, depending on delivery method
    • Allergies to blood-thinning medications or dye injected during the procedure

    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 pace maker, chest pain, heart murmur, false aneurysm, recurring aortic stenosis(narrowing), too much fluid around 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
    • 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. The safety and effectiveness of the transcatheter heart valve has not been determined when the valve is implanted:
      • Inside a stented previously implanted valve smaller than 21 mm
      • Inside an unstented previously implanted aortic tissue valve
    • Your Heart Team will do tests to determine the exact size of the new valve you should receive and communicate what to expect.

    Additional potential risks specifically associated with the use of the heart valve include:

    • Valve movement after deployment, blockage or disruption of blood flow through the heart, sudden loss of heart function, heart failure, need for additional heart surgery and possible removal of the SAPIEN XT valve, 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 ingrowth, blood cell damage, etc.) or mechanical failure of the delivery system and/or accessories

    Be sure to ask your Heart Team to explain your treatment options and the possible benefits and risks of the procedure.

    CAUTION: Federal law (USA) restricts these devices to sale by or on the order of a physician. This information is not a substitute for talking with your doctor.

    Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN XT, Edwards SAPIEN 3, NewHeartValve.com, NewHeartValve.com design logo, SAPIEN, SAPIEN XT, and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

    © 2016 Edwards Lifesciences Corporation. All rights reserved.