جهت دسترسی به کاربرگه ی زیر، از این لینک استفاده کنید. http://dl.kums.ac.ir/handle/Hannan/333790
Title: 2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement
Authors: Reardon, Michael J.;Adams, David H.;Kleiman, Neal S.;Yakubov, Steven J.;Coselli, Joseph S.;Deeb, G. Michael;Gleason, Thomas G.;Lee, Joon Sup;Hermiller, James B.;Chetcuti, Stan;Heiser, John;Merhi, William;Zorn, George L.;Tadros, Peter;Robinson, Newell;Petr
Keywords: TAVR;aortic stenosis;outcomes
Year: 2018
Publisher: Elsevier
Abstract: Background The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis. Objectives Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained. Methods Patients with severe aortic stenosis who were at increased surgical risk were recruited. Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve (transcatheter aortic valve replacement [TAVR] group) or to aortic valve replacement with a surgical bioprosthesis (surgical group). The 2-year clinical and echocardiographic outcomes were evaluated in these patients. Results A total of 797 patients underwent randomization at 45 centers in the United States. The rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2%) than in the surgical group (28.6%; log-rank test p < 0.05) in the as-treated cohort, with an absolute reduction in risk of 6.5 percentage points. Similar results were found in the intention-to-treat cohort (log-rank test p < 0.05). The rate of 2-year death or major stroke was significantly lower in the TAVR group (24.2%) than in the surgical group (32.5%; log-rank test p = 0.01). Conclusions In patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
URI: https://doi.org/10.1016/j.jacc.2018.08.2146
http://dl.kums.ac.ir/handle/Hannan/333790
ISSN: 0735-1097
volume: Volume 72
Issue: Issue 22
month: December
More Information: VOLUME : 66 ISSUE : 2 START PAGE : 113 END PAGES : 121
Appears in Collections:Journal of the American College of Cardiology

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