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Transcatheter aortic-valve replacement with a self-expanding prosthesis.
N. Engl. J. Med..May 08, 2014;370(19):1790-8.
Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK, Byrne T.
From Mount Sinai Medical Center, New York (D.H.A.), and St. Francis Hospital, Roslyn (N.R., G.P.) - both in New York; Beth Israel Deaconess Medical Center, Boston (J.J.P.); Houston Methodist DeBakey Heart and Vascular Center (M.J.R., N.S.K.), and Texas Heart Institute at St. Luke's Medical Center (J.S.C.) - both in Houston; Riverside Methodist Hospital, Columbus, OH (S.J.Y.); University of Michigan Medical Center, Ann Arbor (G.M.D., S. Chetcuti), and Spectrum Health Hospitals, Grand Rapids (J.H., W.M.) - both in Michigan; University of Pittsburgh Medical Center, Pittsburgh (T.G.G.); Palo Alto Veterans Affairs Medical Center, Palo Alto, CA (M.B.); St. Vincent Medical Center, Indianapolis (J.H.); University of Kansas Hospital, Kansas City (G.Z., P.T.); Duke University Medical Center, Durham, NC (G.C.H., J.K.H.); Johns Hopkins Hospital, Baltimore (J.C.); Pinnacle Health, Harrisburg, PA (B.M., M.M.); and Medtronic, Minneapolis (S. Chenoweth), and Mayo Clinical Foundation, Rochester (J.K.O.) - both in Minnesota.
We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery.
We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing.
A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, -0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke.
In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement. (Funded by Medtronic; U.S. CoreValve High Risk Study ClinicalTrials.gov number, NCT01240902.).