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Both the balloon-expandable (BE) Sapien XT and the self-expandable (SE) CoreValve transcatheter heart valves are approved for use in the U.S. and Europe. In this German, five-center, open-label, randomized trial, 241 patients with severe aortic stenosis and at least intermediate surgical risk underwent transcatheter aortic valve replacement with one of the two devices. The primary endpoint was device success, a procedural composite endpoint described by the Valve Academic Research Consortium.
The device success rate was higher with the BE than with the SE device (96% vs. 76%; P<0.001), primarily because of less-frequent moderate or severe aortic regurgitation (4% vs. 18%; P<0.001) and need for a second valve (0.8% vs. 5.8%; P=0.03). No signi…