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Trial to test aortic valve technique in lower-risk patients

Oct. 27, 2016, 9:28 AM

In 2011, doctors at the Vanderbilt Heart and Vascular Institute performed the state’s first transcatheter valve-replacement (TAVR) procedure for high-risk patients suffering from aortic stenosis, the most common valvular heart disease in the United States.

Now, five years later, Vanderbilt University Medical Center is participating in a new trial investigating the use of the non-surgical procedure in low-risk patients. Previous trials testing efficacy in both high-risk and intermediate-risk groups have shown success.

“TAVR is transformational technology,” said Joseph Fredi, M.D., assistant professor of Medicine at Vanderbilt. “It’s continually evolving and has completely transformed the way we treat aortic valve stenosis. Both the technology and patient population that can be served are advancing significantly. We are now able to treat a lot of patients who would have never been considered for any form of treatment.

“This is a lethal disease if left untreated. Although we are moving toward TAVR as a first-line therapy for aortic valve stenosis, it won’t apply to every single patient because there are certain situations that require surgery.”

Nearly 300,000 people each year are diagnosed with aortic valve stenosis, a narrowing of the main valve allowing blood to leave the heart. One-third of those diagnosed are deemed high risk or ineligible for open-heart surgery, long considered the standard therapy.

According to Fredi, with more than 600 TAVR procedures performed, Vanderbilt is the region’s leader in the technique.

The minimally invasive procedure channels a catheter with an artificial valve through the femoral artery in the groin to reach the heart. There are two types of valves — balloon expandable and self-expandable. The type of valve used is determined based on patient evaluation.

Compared to the four to six hours typical for open-heart surgeries, this procedure calls for a smaller incision, requires less than a 24-hour stay for most patients and takes about two hours to complete.

Low-risk patients seeking valve replacement will have the option of surgical replacement or to participate in the current, randomized trial.

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