“When we compare transthoracic TAVR patients to those having surgery, they are about the same, so whatever benefit achieved related to lower rates of death and strokes was clearly in the transfemoral group,” Leon said.
Researchers also found significant differences in secondary clinical endpoints looking at time in the hospital, valve function and major complications, some favoring TAVR, some surgery. For example, TAVR patients spent less time in the hospital overall—the average time in the ICU was two days with TAVR versus four days with surgery, and the average hospitalization for TAVR was six days compared to nine days with surgery. TAVR also appeared to improve the aortic valve areas more than surgery, meaning that the quality of the valve’s performance was better as measured by echocardiography during follow-up points through two years.
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Compared to surgery, TAVR also yielded significantly lower rates of acute kidney injury, severe bleeding events and new onset atrial fibrillation, a heart rhythm problem that is a common complication of open procedures. The surgery group, on the other hand, had fewer major vascular complications and leakage around the valve (para-valvular regurgitation).
The heart team discussed each individual case to determine if patients were indeed intermediate-risk. Baseline characteristics were comparable. All patients were followed for at least two years and will continue to be followed for five years. “The two-year follow-up allows enough time to accurately assess the relative performance of these two valve replacement therapies,” Leon said, adding that he suspects these findings will potentially affect clinical guidelines for TAVR in the future. “We know surgery is good, but it is still a major procedure and for many patients, a less-invasive approach may be the preferred alternative. As we continue to evolve the procedure and technology, it’s important to know whether TAVR is an effective alternative in these lower risk patients.”
Aortic stenosis happens when the aortic valve narrows or is blocked and therefore does not open fully. As a result, the amount of blood that can flow through the valve into the aorta and out to the body is restricted. If the condition is untreated, which usually involves valve replacement, the risk of death is 25 percent the first year after symptoms appear, and the risk rises to 50 percent the second year.
Roughly 1 in 5 patients undergoing surgical aortic valve replacement in the U.S. are estimated to be intermediate-risk; so together, intermediate- and high-risk patients comprise the top quartile of all patients needing an aortic valve replacement.
