Implantation of the EDWARDS INTUITY Valve System is feasible, safe, and efficacious for aortic valve replacement. Aortic crossclamp and cardiopulmonary bypass times were reduced compared with those for conventional aortic valve replacement. Early hemodynamic performance was excellent and remained so up to 1 year.

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NCT01445171.

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In a large series of elderly patients with symptomatic severe aortic stenosis, rapid deployment aortic valve replacement using a subannular balloon-expandable stent frame demonstrated excellent hemodynamic performance and significant left ventricular mass regression. With continued follow-up, future studies will establish whether these favorable structural changes correlate with improvement in long-term survival and functional status.