For patients with aortic stenosis that cannot be treat with medication; so surgical (SAVR) and transcatheter (TAVR) aortic valve replacement can offer effective treatment. A new study, one of two on the topic release 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.
High risk for death with surgery
Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk.
They randomly assign patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a pre specify margin of 6% age points) and superiority testing were perform in the as treat population.
950 patients with severe symptomatic aortic stenosis and low surgical risk participate in the randomize trial. At 30 days, results favor TAVR with a balloon-expandable valve, with fewer deaths; fewer strokes (0.6% vs. 2.4%); and fewer re-hospitalizations (3.4% vs. 6.5%.) These differences were maintain at one year. In addition, 30-day rates of life-threatening bleeding were lower (3.6% vs. 24.5% ), as was new onset atrial fibrillation (5.0% vs. 29.5%).
Duration of hospital stay
Patients treat with TAVR also experience other benefits. Length of stay in the ICU and duration of hospital stay were both significantly decrease; so with 96% of those treat with TAVR discharge to home or self-care vs. 73% of SAVR patients. Among patients with severe aortic stenosis who were at low surgical risk; so the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery.
While previous studies have focus on patients with higher surgical risk; so almost 80% of patients who are operate upon for aortic stenosis fall into the low risk category,” explain 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; so the two therapies SAVR and TAVR are at least equivalent; also 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.