Roughly 1 in 5 patients undergoing
surgical aortic valve replacement in the U.S. are estimated to be intermediate - risk; so together, intermediate - and high - risk patients comprise the top quartile of all patients needing an aortic valve replacement.
«The first year results from the CoreValve US Pivotal Trial support the safety and efficacy of this therapy in patients unsuitable for
surgical aortic valve replacement,» said lead investigator Steven Yakubov, MD..
Degenerative aortic stenosis is a progressive disease with a poor prognosis in the absence of
surgical aortic valve replacement.
Of 795 patients randomly assigned to valve replacement by catheter or surgery, 747 patients underwent one of the procedures: 390 in the transcatheter aortic valve replacement (TAVR) arm and 357 in
the surgical aortic valve replacement arm.
Not exact matches
TAVR was first approved by the U.S. Food and Drug Administration (FDA) in 2011 to treat patients with severe
aortic valve stenosis — a problem that occurs when the
valve in the heart's main artery doesn't open fully and forces the heart to work harder to pump blood — for whom standard
surgical valve replacement is too risky.
Transcatheter
aortic valve replacement with a self - expanding
valve prosthesis for the first time has demonstrated significantly lower death rates at one year compared with conventional
surgical valve replacement in high - risk patients with severe
aortic stenosis, according to research presented at the American College of Cardiology's 63rd Annual Scientific Session.
Their analysis involved approximately 300,000 patients who had undergone 11 major
surgical procedures, including coronary artery bypass grafting,
aortic valve replacement and appendectomy.