Have questions about TAVR?

Click or call 1-877-209-8638

Caregiver Corner

TAVR Procedure

There are a few treatment options for aortic stenosis. When the stenosis is severe, the doctor will probably suggest replacing the aortic valve. Most people think that means open heart surgery.

Open heart surgery is not the only way to replace the aortic valve.

“I have just heard about the TAVR procedure, but I don’t know too much about it. Is it an option for the person I care for?”

– Caregiver

MULTIPLE APPROACHES OF TAVR

Transcatheter aortic valve replacement, or TAVR, is a less invasive procedure for patients who are at intermediate or greater risk for open heart surgery. You might hear this procedure referred to as TAVI. With the TAVR procedure, there are multiple approaches, however the most common is the transfemoral approach. TAVR uses a catheter to replace the heart valve instead of opening up the chest and completely removing the diseased valve. The valve used during TAVR is inserted within the diseased aortic valve. The valve is crimped onto a balloon that is expanded, pushing the leaflets of the diseased valve aside. Once the balloon is deflated, the valve begins working immediately. Only a specialized Heart Team can decide which approach is best for each person.

Transfemoral

Through an incision in the leg

Transfemoral aortic valve replacement procedure

Transapical

Through an incision between the ribs

Transapical aortic valve replacement procedure

Transaortic

Through an incision in the chest

Learn more about the history of this procedure and the valve that may be used by visiting TAVRbyEdwards.com.

Request a free information kit about TAVR.

WHAT’S IN A NAME?

Transcatheter aortic valve replacement, or TAVR, can sometimes be written as “TAVI.” TAVI stands for transcatheter aortic valve implantation. Whether your doctor calls it TAVR or TAVI, the procedure approaches remain exactly the same.

Preparing for TAVR

Before
the procedure

Day of
the procedure

During
the procedure

After
the procedure

THERE ARE USUALLY A NUMBER OF TESTS THAT NEED TO BE DONE BEFORE THE TAVR PROCEDURE.

They can be done in one day or over weeks, depending on the TAVR Heart Team. You may need to go with your loved one to some of these tests. You can also help organize the appointment schedule and ensure medications are taken as prescribed. If you have questions, ask the Valve Clinic Coordinator on the Heart Team.

WHAT SHOULD YOU DO BEFORE THE PROCEDURE?

Before the TAVR procedure, the Heart Team may want to do a number of different tests to check heart function and confirm the treatment plan. These tests are very important, and it may be helpful to the person you care for to have you there. You can help organize the appointment schedule and make sure medications are taken as prescribed.

Leading up to the TAVR procedure, if you notice any symptoms (e.g., tiredness, shortness of breath, etc.), call your Heart Team right away. As the caregiver, take note of any changes you see, make sure the Heart Team stays informed of changes, and keep in close touch with the Heart Team.

HELPING THE PERSON YOU CARE FOR PREPARE FOR TAVR.

Activity Level

Ask the Heart Team what level of activity is appropriate. Exercise, even for short periods of time, will be extremely difficult if the aortic stenosis is extremely severe. Be very watchful of the person you care for while he or she is exercising, and make sure they slow down if they get short of breath, have chest pain, or feel faint.

Monitor Medication

Keep all medications organized and help make sure they're taken as prescribed by your Heart Team.

Driving

Typically, people with severe aortic stenosis will be extremely winded and will probably not be able to drive. Every person is different. Please talk to the Heart Team if the person you care for should be driving or if they need a driver.

Healthy Eating

It's important for the person you care for to eat as well as possible and for you to be encouraging throughout this process. The Heart Team may have put restrictions on how much liquid and salt the person you care for can have. Help make sure the recommendations are followed.

Recovery Plan

Have an open discussion about the care after TAVR. Some people can be released from the hospital within a few days of the procedure, but everyone is different. The main questions are: What will happen after they're released from the hospital? Where will they go? Who will take them? And who will stay with them?

TALK TO YOUR TAVR HEART TEAM ABOUT WHETHER THE PERSON YOU CARE FOR SHOULD STOP EATING BEFORE THE PROCEDURE AND FOR HOW LONG.

Make sure a bag is packed for the hospital stay. Your Valve Clinic Coordinator will provide specific instructions.

WHAT SHOULD YOU DO THE DAY OF THE PROCEDURE?

Most people who have TAVR come to the hospital the morning of the procedure. Sometimes, people may be asked to come to the hospital the night before. Follow the instructions from your Heart Team.

THINGS TO CONSIDER FOR THE HOSPITAL BAG:

  • Toothbrush and toothpaste
  • Comb or brush
  • Slippers (with non-slip soles)
  • Glasses
  • Hearing aid(s)
  • Reading materials
  • Pajamas
  • Comfortable clothes to go home in

DO NOT PACK CASH OR VALUABLES

Patients may be moved at least twice during their stay and it's possible for things to be misplaced during these moves. Also, it may be best if you keep their clothes until the day they leave the hospital, if possible.

WHAT HAPPENS DURING THE PROCEDURE?

The TAVR procedure will be performed in the hospital, under anesthesia.

  1. Depending on the approach, the doctor will make a small incision, either in the leg, in the chest between the ribs, or in the upper chest.
  2. At the incision area, the Heart Team will insert a short, hollow tube called a sheath.
  3. Next, it is important to open the diseased valve and prepare it for the new valve. This is done with a procedure called balloon aortic valvuloplasty, or BAV.
  4. With BAV, a thin, flexible tube called a catheter is inserted through the sheath to gain access to the aortic valve. Once it reaches the valve, a balloon at the end of the tube is inflated. The balloon presses against the hardened tissue, which opens the valve leaflets. The balloon is then deflated and removed through the sheath.
  5. Now that the diseased valve leaflets have been opened, the new valve is ready for placement. A new catheter carrying the artificial valve is inserted through the sheath and guided to the heart valve.
  6. Once it reaches the heart valve, the balloon on the catheter is inflated, expanding the new valve within the diseased valve. The new valve pushes the leaflets of the diseased valve aside. The frame of the new valve will use the leaflets of the diseased valve to secure it into place.
  7. The balloon is deflated and removed. Once the Heart Team has made sure that the new valve is functioning properly, they will close the incision area.

Depending on the TAVR approach, the average total procedure time varies from 1 to 2 hours.

PEOPLE WHO HAVE THE TAVR PROCEDURE PROBABLY WILL NEED HELP AT HOME—THOUGH HOW MUCH AND FOR HOW LONG VARIES FROM PERSON TO PERSON.

Before they leave the hospital, make sure you ask specific questions about eating, sleeping, activity level, medications, and follow-up appointments.

WHAT IS YOUR ROLE AFTER TAVR?

Every person's recovery with TAVR is different—from how long they stay in the hospital to how long it takes to feel normal again. Some people leave the hospital needing only minimal support at home. Some leave the hospital needing a month or more of active caregiving support. It's best to talk to the Heart Team about what to expect in regards to your particular situation.

SOME THINGS YOU MAY NEED TO HELP WITH:

  • Managing medication
  • Preparing meals
  • Keeping up the house—cleaning, laundry, getting the mail, watering plants, etc.
  • Running errands
  • Driving and attending follow-up appointments

In cases of slow recovery, you may need extra caregiving help. The Heart Team and a social worker can assist you on where to get help.

If you need help finding caregivers to help the person you care for after their TAVR procedure, you can also visit the National Alliance for Caregiving website.

Before the procedure

THERE ARE USUALLY A NUMBER OF TESTS THAT NEED TO BE DONE BEFORE THE TAVR PROCEDURE.

They can be done in one day or over weeks, depending on the TAVR Heart Team. You may need to go with your loved one to some of these tests. You can also help organize the appointment schedule and ensure medications are taken as prescribed. If you have questions, ask the Valve Clinic Coordinator on the Heart Team.

WHAT SHOULD YOU DO BEFORE THE PROCEDURE?

Before the TAVR procedure, the Heart Team may want to do a number of different tests to check heart function and confirm the treatment plan. These tests are very important, and it may be helpful to the person you care for to have you there. You can help organize the appointment schedule and make sure medications are taken as prescribed.

HELPING THE PERSON YOU CARE FOR PREPARE FOR TAVR.

Activity Level

Ask the Heart Team what level of activity is appropriate. Exercise, even for short periods of time, will be extremely difficult if the aortic stenosis is extremely severe. Be very watchful of the person you care for while he or she is exercising, and make sure they slow down if they get short of breath, have chest pain, or feel faint.

Monitor Medication

Keep all medications organized and help make sure they're taken as prescribed by your Heart Team.

Driving

Typically, people with severe aortic stenosis will be extremely winded and will probably not be able to drive. Every person is different. Please talk to the Heart Team if the person you care for should be driving or if they need a driver.

Healthy Eating

It's important for the person you care for to eat as well as possible and for you to be encouraging throughout this process. The Heart Team may have put restrictions on how much liquid and salt the person you care for can have. Help make sure the recommendations are followed.

Recovery Plan

Have an open discussion about the care after TAVR. Some people can be released from the hospital within a few days of the procedure, but everyone is different. The main questions are: What will happen after they're released from the hospital? Where will they go? Who will take them? And who will stay with them?

Day of the procedure

TALK TO YOUR TAVR HEART TEAM ABOUT WHETHER THE PERSON YOU CARE FOR SHOULD STOP EATING BEFORE THE PROCEDURE AND FOR HOW LONG.

Make sure a bag is packed for the hospital stay. Your Valve Clinic Coordinator will provide specific instructions.

WHAT SHOULD YOU DO THE DAY OF THE PROCEDURE?

Most people who have TAVR come to the hospital the morning of the procedure. Sometimes, people may be asked to come to the hospital the night before. Follow the instructions from your Heart Team.

THINGS TO CONSIDER FOR THE HOSPITAL BAG:

  • Toothbrush and toothpaste
  • Comb or brush
  • Slippers (with non-slip soles)
  • Glasses
  • Hearing aid(s)
  • Reading materials
  • Pajamas
  • Comfortable clothes to go home in

DO NOT PACK CASH OR VALUABLES

Patients may be moved at least twice during their stay and it's possible for things to be misplaced during these moves. Also, it may be best if you keep their clothes until the day they leave the hospital, if possible.

During the procedure

WHAT HAPPENS DURING THE PROCEDURE?

The TAVR procedure will be performed in the hospital, under anesthesia.

  1. Depending on the approach, the doctor will make a small incision, either in the leg, in the chest between the ribs, or in the upper chest.
  2. At the incision area, the Heart Team will insert a short, hollow tube called a sheath.
  3. Next, it is important to open the diseased valve and prepare it for the new valve. This is done with a procedure called balloon aortic valvuloplasty, or BAV.
  4. With BAV, a thin, flexible tube called a catheter is inserted through the sheath to gain access to the aortic valve. Once it reaches the valve, a balloon at the end of the tube is inflated. The balloon presses against the hardened tissue, which opens the valve leaflets. The balloon is then deflated and removed through the sheath.
  5. Now that the diseased valve leaflets have been opened, the new valve is ready for placement. A new catheter carrying the artificial valve is inserted through the sheath and guided to the heart valve.
  6. Once it reaches the heart valve, the balloon on the catheter is inflated, expanding the new valve within the diseased valve. The new valve pushes the leaflets of the diseased valve aside. The frame of the new valve will use the leaflets of the diseased valve to secure it into place.
  7. The balloon is deflated and removed. Once the Heart Team has made sure that the new valve is functioning properly, they will close the incision area.

Depending on the TAVR approach, the average total procedure time varies from 1 to 2 hours.

After the procedure

PEOPLE WHO HAVE THE TAVR PROCEDURE PROBABLY WILL NEED HELP AT HOME—THOUGH HOW MUCH AND FOR HOW LONG VARIES FROM PERSON TO PERSON.

Before they leave the hospital, make sure you ask specific questions about eating, sleeping, activity level, medications, and follow-up appointments.

WHAT IS YOUR ROLE AFTER TAVR?

Every person's recovery with TAVR is different—from how long they stay in the hospital to how long it takes to feel normal again. Some people leave the hospital needing only minimal support at home. Some leave the hospital needing a month or more of active caregiving support. It's best to talk to the Heart Team about what to expect in regards to your particular situation.

SOME THINGS YOU MAY NEED TO HELP WITH:

  • Managing medication
  • Preparing meals
  • Keeping up the house—cleaning, laundry, getting the mail, watering plants, etc.
  • Running errands
  • Driving and attending follow-up appointments

In cases of slow recovery, you may need extra caregiving help. The Heart Team and a social worker can assist you on where to get help.

If you need help finding caregivers to help the person you care for after their TAVR procedure, you can also visit the National Alliance for Caregiving website.

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

Important Risk Information

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.