Study examines the effects of TAVR with balloon-expandable valve for low-risk patients

For patients with aortic stenosis that cannot be treated with medication, surgical (SAVR) and transcatheter (TAVR) aortic valve replacement can offer effective treatment. A new study, one of two on the topic released today at the American Association for Thoracic Surgery's 99th Annual Meeting, examines, for the first time, the effects of TAVR with a balloon-expandable valve for low-risk patients.

950 patients with severe symptomatic aortic stenosis and low surgical risk participated in the randomized trial. At 30 days, results favored TAVR with a balloon-expandable valve, with fewer deaths (0.4 percent vs. 1.1 percent); fewer strokes (0.6 percent vs. 2.4 percent); and fewer re-hospitalizations (3.4 percent vs. 6.5 percent.) These differences were maintained at one year. In addition, 30-day rates of life-threatening bleeding were lower (3.6 percent vs. 24.5 percent), as was new onset atrial fibrillation (5.0 percent vs. 29.5 percent.)

Patients treated with TAVR also experienced other benefits. Length of stay in the ICU and duration of hospital stay were both significantly decreased, with 96 percent of those treated with TAVR discharged to home or self-care vs. 73 percent of SAVR patients.

"While previous studies have focused on patients with higher surgical risk, almost 80 percent of patients who are operated upon for aortic stenosis fall into the low risk category," explained lead author Martin Leon, Director, Center for Interventional Vascular Therapy at New York-Presbyterian/ Columbia University Medical Center and Founder and Chairman Emeritus of the Cardiovascular Research Foundation (CRF). "Significantly, the data shows that for low risk patients, the two therapies - SAVR and TAVR - are at least equivalent, and in many cases, TAVR may be the preferred alternative. The study will continue to follow patients to 10 years, which will also provide important data on the durability of these balloon expandable valves."



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