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Glossary

This glossary is available to help you understand complicated terms you will see on this website and may hear from your TAVR Doctor. Be sure to check with your doctor if you have any questions.

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A
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Anesthesia

Temporary loss of feeling or awareness induced by a medical professional during a surgical procedure.

Angina

Chest pain caused by poor blood supply to the heart.

Angiogram

A medical imaging test that uses x-rays and dyes to see how blood flows through an artery or a vein.

Angioplasty

A procedure that uses an inflatable balloon on a thin tube to internally widen a narrowed blood vessel.

Aortic Stenosis

Narrowing of the aortic valve that prevents normal blood flow and makes the heart work harder.

Aortic Valve

The valve that controls blood flow from the heart to the aorta (largest artery that carries blood to the rest of the body).

Artery

Blood vessel that carries oxygen-rich blood to the body.

Atrial Fibrillation (AFib)

Irregular heart rhythm caused by abnormal electrical signals throughout the upper chambers of the heart.

Auscultation

Listening to the sounds of your heart using a stethoscope.

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Balloon Valvuloplasty (BAV)

A procedure in which a balloon catheter is inserted through an artery into the heart. The balloon is then inflated to open the narrowed valve

Bioprosthetic Valve

Replacement heart valve made of animal tissue (cow or pig).

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Calcification

A build-up of calcium on tissue. In the aortic valve, it can reduce the ability for leaflets to open and close properly.

Cardiothoracic Surgeon

Surgeon who performs heart surgery.

Catheter

A thin, hollow tube, either flexible or non-flexible, that is used to add, remove or transfer fluids or instruments used in minimally-invasive procedures.

Catheterization

A procedure in which a slender tube is inserted into a body passage, vessel or cavity.

Chest x-ray

A type of imaging that displays images of the organs and structures inside your chest, such as your heart, lungs, and large blood vessels.

Chronic Obstructive Pulmonary Disease (COPD)

A chronic condition in which there is a slow, progressive block of airflow into or out of the lungs.

Coronary Artery Disease

A type of heart disease which happens when the arteries that supply blood to the heart muscle become hardened and narrowed due to build-up of plaque on the artery walls.

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Delivery System

A medical tool used to guide the transcatheter valve.

Diabetes

A condition in which your blood glucose, or blood sugar, is too high.

Diagnostic Tests

Tests that help your doctor confirm if you have aortic stenosis. Some of these tests include echocardiogram (also called echo), cardiac catheterization, chest x-ray, and electrocardiogram (also called EKG).

Download

To receive a copy of a file, program or document that can be saved and viewed from your computer. The downloaded file may open in a separate window, may be minimized at the bottom of the web browser, or may be located within your computer’s downloads folder.

Dyspnea

Shortness of breath.

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Echocardiogram (echo)

This diagnostic test uses sound wave technology, or ultrasound, to show three-dimensional images of the heart to better assess its function.

Electrocardiogram (EKG)

A diagnostic test that records electrical activity in the heart, such as heart rate and rhythm.

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Fatigue

A feeling of being extremely tired or having low energy.

Femoral Artery

The largest blood vessel in the leg that supplies blood to the lower part of the body.

Fluoroscopy

An x-ray procedure that makes it possible to see internal organs in motion.

Frailty

Increased physical and mental weakness that is often associated with older age.

H
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Heart and Lung Blood Machine

A device used during open heart procedures to remove blood from the body. The blood is enriched with oxygen and then returned to the body.

Heart Failure

When the heart is unable to pump blood to the body’s organs and maintain their function.

Heart Murmur

An abnormal heart sound that may indicate heart valve disease.

Heart Team

A group of qualified healthcare professionals who work together to determine the best treatment plan for each individual patient.

I
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Interventional Cardiologist

Doctor who specializes in catheter-based treatments for the heart or coronary artery diseases (in most cases this is the doctor who performs TAVR).

Invasive Procedure

A medical procedure that requires entry into the body, usually by cutting skin and inserting instruments into body.

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Leaflets

Triangular-shaped flaps of tissue within heart valves that open and close to control blood flow.

Less Invasive Procedure

A medical procedure performed with a small incision and specialized equipment.

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Magnetic Resonance Imaging (MRI)

A diagnostic test that uses magnetic and radio waves to take detailed pictures of the heart and other organs.

Mechanical Heart Valve

Replacement heart valve made of artificial materials. Once inserted in the body, lifelong blood thinning medication is required.

Metastasize

The spread of cancer cells from the place where they first formed to another part of the body. In metastasis, cancer cells break away from the original tumor, travel through the blood or lymph system, and form a new tumor in other organs or tissues of the body.

Minimal Incision Valve Surgery

A surgical technique for replacing a diseased valve that does not require a large incision or cutting through the entire breastbone.

Minimally-Invasive Procedure

A procedure that can be performed through a small incision, which typically leads to a faster recovery.

Mitral Valve

The valve that controls blood flow from the heart’s left upper chamber to the left lower chamber.

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Peripheral Vascular Disease (PVD)

A disease of the blood vessels resulting in a decrease in circulation to the legs, arms, stomach or kidneys.

Progressive

Relating to disease, a condition that will continue to get worse.

Pulmonary Valve

The valve that controls blood flow from the heart into the lungs.

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Rheumatic Fever

Inflammation that occurs throughout the body, especially in the heart, if strep throat goes untreated.

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Sheath

A tube placed in an artery or vein during a procedure to help a doctor with insertion of catheter.

Stroke

The sudden death of brain cells due to lack of oxygen, caused by blockage of blood flow to the brain.

Subclavian Approach

A way to replace your aortic valve through a small incision near the shoulder.

Syncope

Temporary loss of consciousness or fainting.

T
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TAVR Doctor

A doctor at a TAVR Hospital who can evaluate you for all of your treatment options and perform your TAVR procedure.

Transaortic Approach

A way to replace your aortic valve through a small incision in the upper chest.

Transapical Approach

A way to replace your aortic valve through a small incision in the chest between the ribs.

Transcatheter Aortic Valve Replacement

A less invasive procedure that replaces an unhealthy aortic valve.

Transfemoral Approach

A way to replace your aortic valve through a small incision in the leg.

Tricuspid Valve

The valve that controls blood flow from heart’s upper right chamber to lower right chamber.

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Ultrasound

A diagnostic test that uses sound waves to obtain images of blood flow and your body’s internal structure.

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Vein

Blood vessels that returns blood to the heart.

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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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