A head-to-head trial of two widely used TAVR devices in patients with small aortic annuli, mostly women, showed differences in performance at 1 year in the SMART trial.
trial demonstrated that a self-expanding device performs better on multiple prognostically important measures of valve function at 1 year than a balloon-expandable device.and a small aortic annulus, TAVR using the self-expanding valve was noninferior to the balloon-expandable device on clinical outcomes and superior on bioprosthetic valve dysfunction at 12 months.
He explained that the decision to test this potential difference in a study primarily enrolling women is based on evidence that good hemodynamics might be especially important when the aortic annulus is small. The postmarketing study with a planned 5-year follow-up was conducted in North America and Europe. The all-comer design permitted entry to those with bicuspid aortic valves.
In addition to the fact that it is the largest randomized trial to directly compare two TAVR devices, she called the number of women included in this trial"astounding."
Cardiac Surgery Congenital Heart Disease Thromboembolism Hemodynamics Hemodynamic Monitoring Stroke Cerebrovascular Accident CVA - Cerebrovascular Accident Heart Failure Transcatheter Aortic Valve Replacement TAVR Transcatheter Aortic Valve Implantation TAVI Percutaneous Aortic Valve Replacement Aortic Valve Aortic Insufficiency Aortic Valve Insufficiency
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