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Understanding the CoreValve Procedure

Patient Animation Video

simpl-pdf-icon Download the CoreValve® Transcatheter Aortic Valve Replacement (TAVR) Platform Patient Brochure

 

What You Can Expect

During the Procedure
Patients may be sedated during the 1-2 hour procedure. You may first have a test that uses sound waves to take a closer look at the inside structures of the heart. Your doctor will decide what sites are best for inserting the thin, flexible tube (catheter) required for the procedure. Additionally, your doctor will decide if performing a surgical incision to any of the sites is necessary. With CoreValve TAVR, a small incision is made and a thin, flexible tube (catheter) holding the CoreValve aortic heart valve is guided to the heart. Special imaging equipment is used to guide positioning and placement of the CoreValve aortic heart valve.

After the Procedure
Following CoreValve TAVR, you will be moved to an intensive care unit or cardiac care unit. Patients typically are able to be up and walking within 24-48 hours after their procedure. Your doctor will determine when you are ready to move to a standard hospital room. The typical hospital stay for CoreValve TAVR is approximately 8 days.

Summary of CoreValve TAVR

  • Local numbing or sedation (local or general anesthesia)
  • Heart pumps normally during procedure
  • Catheter delivers CoreValve device into the heart
  • Valve replaced during 1-2 hour procedure (typical)
  • Approximately 8 day hospital stay (typical)
 

A Typical CoreValve Transcatheter Procedure

 

  1. Patients are normally sedated during the approximately 1-2 hour procedure. Because each patient is different, your doctor may determine whether or not you should be fully asleep for the procedure.
  2. The interventional cardiologist or cardiac surgeon will make an incision and guide a long, hollow tube (sheath) into your blood vessel.
  3. Using special imaging equipment to look at your arteries, a thin, flexible tube (catheter) with a balloon on the tip is threaded through the sheath and into your heart. If you’re not fully sedated, you may have a "fluttering" feeling in your chest.
  4. When the end of the balloon is in your aortic valve, the balloon will be inflated and will force your narrowed aortic valve open to prepare it for your CoreValve aortic heart valve.
  5. Again, using the special imaging equipment, your doctor will place the CoreValve aortic heart valve in position over your own diseased aortic valve. (Figures 1 and 2)
  6. Your new CoreValve aortic heart valve will begin opening and closing; the doctor will conduct a test to confirm it is working properly. (Figure 3)
  7. The thin, flexible tube will be removed, the incision will be closed, and the procedure will be complete.

 

CoreValve Procedure Image

 

Risks You Should Know

As with any major medical procedure, there is a risk of complications after the Medtronic CoreValve transcatheter valve implantation procedure.

 

  • Death from any cause - death due to any cause, whether heart related or not.
  • Stroke - a condition when decreased blood flow to the brain causes death of the brain cells, which results in disability.
  • Major vascular complications - a condition affecting the blood vessels, including blood collecting under the skin (hematoma), or a tear or hole in a blood vessel.
  • Major bleeding - a bleeding event causing abnormal lab values or requiring blood to be put back into the body.

 

For a full list of potential risks at 30 days and 1 year post implant, please download the CoreValve Transcatheter Aortic Valve Replacement (TAVR) Platform Patient Brochure.

 

Other Potential Risks Associated with CoreValve TAVR

 

  • Cardiogenic shock - failure of the heart to pump enough blood to the body organs
  • Perforation of the myocardium or vessel - a hole in the heart muscle or a blood vessel
  • Cardiac Tamponade - the constriction or inability of the heart to pump due to build up of blood or fluid around the lining of the heart
  • Ascending aorta trauma - injury to the large blood vessel leading blood away from the heart
  • Embolism - an abnormal particle (air, blood clots) floating in the blood stream or attached to an object, including the valve
  • Thrombosis (including valve thrombosis) - blood clot, including a blood clot on the valve
  • Valve migration - upward or downward movement of the device from where it was originally placed
  • Valve dysfunctions of the CoreValve device including but not limited to:
    • Break (fracture) in the valve frame
    • Bending of the valve frame
    • The valve frame does not open (expand) all the way
    • Build up of minerals on the valve (calcification)
    • Pannus - the formation of scar tissue that may cover or block the valve from functioning normally
    • Wear, tear or movement forward (prolapse) or backward (retraction) from the normal position of the valve leaflets
    • The valve leaflets do not close together
    • A break in the stitches (sutures) of the valve frame or leaflets
    • Leakage through or around the valve or valve frame
    • Incorrect size of the valve implanted
    • Incorrect position of the valve, either too high or too low
    • Regurgitation - backward flow of blood through the valve
    • Stenosis - narrowing of the opening of the valve
  • Mitral valve regurgitation - a leaking valve between the left upper (left atrium) and left lower (left ventricle) chambers of the heart where blood flows backward through the valve
  • Hypotension or hypertension - low or high blood pressure
  • Unfavorable reaction by the body (allergic reaction) to:
    • antiplatelet agents - drugs that keep blood clots from forming
    • contrast medium - a substance used to increase the visualization of body structures such as x-ray dye
  • Bowel ischemia - decreased blood supply to the intestines
  • Complications at the area where the doctor opened the skin or related to opening the skin, including but not limited to:
    • pain
    • bleeding
    • hematoma - blood collecting under the skin
    • pseudoaneurysm - blood collecting on the outside of a vessel wall causing a balloon-like widening
    • irreversible nerve damage - permanent damage to nerves
    • compartment syndrome - squeezing of nerves and muscles in a closed space that could cause muscle or nerve damage
    • stenosis - narrowing of a vessel (artery)

 

In addition, you may experience other problems that have not been previously observed with this procedure.

 

The CoreValve Transcatheter Aortic Valve Should NOT be Used for the Following People:

 

  • Patients who have an infection in the heart or elsewhere
  • Patients who have an artificial mechanical aortic valve
  • Patients who cannot take aspirin, heparin and bivalirudin, ticlopidine (Ticlid), clopidogrel (Plavix), or have sensitivity to Nitinol (Titanium or Nickel) or contrast media (fluid used during the procedure to see internal structures)