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TAVR Approved for Intermediate-Risk Aortic Stenosis Patients: What to Know


Erin Azuse

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Your heart is pretty amazing. It beats approximately 100,000 times each day and pumps 2,000 gallons of blood through your body. Your heart sends oxygenated blood to all of its tissues via the largest artery, the aorta. So you can imagine if the connection between your heart and aorta was narrowed, your heart would have to work harder, and it would be difficult for blood to flow as it should. This is called aortic stenosis, and when blood flow is significantly reduced, it can lead to serious complications.

Previously, aortic stenosis could only be corrected using open-heart surgery to replace the valve that connects the heart and aorta. More recently, a less invasive procedure known as transcatheter aortic valve replacement (TAVR) was developed; it was originally only approved for those who couldn’t have open-heart surgery due to other medical issues or were at high risk for complications. However, the U.S. Food and Drug Administration (FDA) has now also given the green light for TAVR to be performed on intermediate-risk aortic stenosis patients after clinical trials showed positive outcomes.

What does it mean to be an intermediate-risk patient?

Surgeons must do their best to determine whether a patient’s benefit from having a particular procedure outweighs the risks involved. Different risk models can be used to help make this decision. In the case of the TAVR clinical trials, patients who had a 4 to 8% risk of death within 30 days of the procedure were labeled “intermediate.”  Now with the FDA approval, a much larger group of patients are eligible for TAVR than in the past.

How does TAVR work?

Your doctor will make a small skin incision either in your groin area, your chest, or between your ribs to access an artery. Then, while using special imaging techniques, he or she will insert a narrow, flexible tube called a catheter into the incision, and thread a new folded-up valve through the catheter until it reaches your aortic valve. The replacement valve is then expanded, often using a small balloon, so that it opens up on top of your damaged aortic valve, covering it and assuming its functions. Then, the catheter is removed. This new valve takes over from the old valve, widening the connection between the heart and aorta, while also ensuring blood flows in the correct direction and does not back up into the heart.

There are three places that can be used as points of entry for the procedure:

  • Through a large artery in your leg: Your doctor can insert the catheter through your femoral artery in your groin.

  • Through your chest: A small incision can be made in your upper chest, and the catheter can be inserted into a large artery or into the left ventricle of your heart.

  • Between your ribs: The catheter can be inserted into your chest between your ribs to reach your aortic valve.

How does TAVR compare to open-heart surgery?

Intermediate-risk patients in clinical trials were assigned to receive either TAVR or surgical aortic valve replacement (SAVR). These studies found that TAVR was similar to surgery in terms of safety and effectiveness in the two years following the procedure. The benefit to TAVR is that it does not require a major incision and opening of the chest cavity. Patients generally spend only 3 to 5 days in the hospital post-TAVR.

Yet, as with any major medical procedure, there are potential risks associated with TAVR. These include:

  • Bleeding

  • Stroke

  • Heart attack

  • Infection

  • Abnormal heart rhythm

  • Complications with blood vessels

  • Kidney injury

  • Death

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Medical Reviewers: William C. Lloyd III, MD, FACS Last Review Date: Jan 9, 2017

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Medical References

  1. FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery. U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517281.htm
  2. Heart Facts. Cleveland Clinic. http://my.clevelandclinic.org/health/articles/heart-blood-vessels-facts
  3. Problem: Aortic Valve Stenosis. American Heart Association. http://www.heart.org/HEARTORG/Conditions/More/HeartValveProblemsandDisease/Problem-Aortic-Valve-Sten...
  4. Sapien 3 TAVR Superior to Surgery in Intermediate-Risk Aortic-Stenosis Patients, Says Study. Medscape. http://www.medscape.com/viewarticle/861469#vp_2
  5. Transcatheter Aortic Valve Replacement (TAVR)- What You Can Expect. Mayo Clinic. http://www.mayoclinic.org/tests-procedures/transcatheter-aortic-valve-replacement/details/what-you-c...
  6. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patient. New England Journal of Medicine. http://www.nejm.org/doi/full/10.1056/NEJMoa1514616#t=article

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