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Dec 05, 2013

Update on Transcatheter Aortic Valve Replacements in the U.S.

National registry helps assess safety and efficacy of minimally-invasive procedure used to treat aortic valve stenosis.

Until recently, treatment options for high-risk patients with aortic valve stenosis (narrowed heart valve) were limited. Aortic valve surgery is often used to fix faulty heart valves but this surgery is not safe for all patients, especially those with other medical conditions that increase risk of complications. Fortunately, a minimally-invasive procedure called transcatheter aortic valve replacement (TAVR) was recently approved for high-risk patients and according to a recent study, this new procedure is relatively safe and effective.

Published in the Journal of the American Medical Association, this study analyzed data from a national registry (Transcatheter Valve Therapy Registry), which was started in 2011 by the American College of Cardiology and Society of Thoracic Surgeons. Since its launch, the registry currently tracks TAVR procedures at more than 250 clinical sites across the country, collecting a wealth of information on patient outcomes.

Through this registry, researchers identified a total of 7,710 TAVR procedures that took place between 2011 and 2013. Patients included in the study were either considered high-risk for traditional surgery or chose TAVR over surgery. Most patients ranged in age from 78–88 years old and about half were women.

After looking at patient outcomes, researchers found that the procedure was considered successful in 92% of cases and risk of complications was relatively low. Among high-risk patients undergoing TAVR, risk of stroke was 2% and risk of death during their hospital stay was 5.5%.

Experts are encouraged by this recent report, especially since the real-world statistics mirror past findings from clinical trials. Data on the safety and efficacy of TAVR from this registry is similar to what was expected based on past research and also similar to findings in other countries. However, authors note that longer follow-up is needed to better assess the safety and efficacy of TAVR in high-risk patients. The data analyzed only captures data from the last few years and experts hope to revisit it in the near future to look at long-term outcomes for patients.

Questions for You to Consider

  • What is aortic stenosis and how does it progress over time?

  • Aortic stenosis occurs when the aortic valve does not open fully, which can obstruct normal blood flow and put extra stress on the heart. Aortic stenosis can start out mild, but worsen over time as the area of the aortic valve decreases lessening the amount of blood flowing from the heart. Patients with aortic stenosis should be continually monitored by a cardiologist to track the progression of this condition, and strenuous activity should be avoided in those with moderate to severe aortic stenosis.
  • What are the symptoms of aortic stenosis?
  • Aortic valve stenosis is a slow process. For many years, even decades, you will not feel any symptoms. But at some point, the valve will likely become so narrow (often one-fourth of its normal size) that you start having problems. Symptoms are often brought on by exercise, when the heart has to work harder.

    As aortic valve stenosis gets worse, you may have symptoms such as:

    • Chest pain or pressure (angina). You may have a heavy, tight feeling in your chest.
    • Feeling dizzy or faint.
    • Feeling tired and being short of breath.
    • A feeling that your heart is pounding, racing, or beating unevenly (palpitations).

    If you start to notice any of these symptoms, let your doctor know right away. If you have symptoms, you need treatment. By the time you have symptoms, your condition probably is serious. If you have symptoms, you also have a high risk of sudden death.


Minimally Invasive Procedure for Replacing Surgical Aortic Valves

TAV-in-SAV procedure safe and effective in high-risk patients.

Treatment Options for Patients with Severe Aortic Stenosis

Minimally-invasive procedure, TAVI, is promising for patients with severe aortic stenosis.

Update on Transcatheter Aortic Valve Replacements in the U.S.

National registry helps assess safety and efficacy of minimally-invasive procedure used to treat aortic valve stenosis.

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