TY - JOUR
T1 - Self-expanding transcatheter aortic valve replacement versus surgical valve replacement in patients at high risk for surgery
T2 - A study of echocardiographic change and risk prediction
AU - Little, Stephen H.
AU - Oh, Jae K.
AU - Gillam, Linda
AU - Sengupta, Partho P.
AU - Orsinelli, David A.
AU - Cavalcante, João L.
AU - Chang, James D.
AU - Adams, David H.
AU - Zorn, George L.
AU - Pollak, Amy W.
AU - Abdelmoneim, Sahar S.
AU - Reardon, Michael J.
AU - Qiao, Hongyan
AU - Popma, Jeffrey J.
N1 - Publisher Copyright:
© 2016 American Heart Association, Inc.
PY - 2016/6/1
Y1 - 2016/6/1
N2 - Background - The CoreValve US High-Risk Clinical Study compared clinical outcomes and serial echocardiographic findings in patients with severe aortic valve stenosis after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis or surgical aortic valve replacement (SAVR). Methods and Results - Eligible patients were randomly assigned 1:1 to TAVR with a self-expanding bioprosthesis or SAVR (N=747). Echocardiograms were obtained at baseline, discharge, 30 days, 6 months, and 1 year after the procedure and were analyzed at a central core laboratory. Compared with SAVR patients (N=357), TAVR patients (N=390) had a lower mean aortic valve gradient, larger valve area, and less patient-prosthesis mismatch (all P<0.001), but more paravalvular regurgitation at discharge, which decreased at 1 year. SAVR patients experienced significant right ventricular systolic dysfunction at discharge and 1 month with normal right ventricular function at 1 year. One-year all-cause mortality was 14.2% for TAVR and 19.1% for SAVR patients. Preimplantation aortic regurgitation ≥mild was associated with reduced mortality hazard for both the TAVR (hazard ratio 0.48, 95% confidence interval 0.27-0.85; P=0.01) and the SAVR groups (hazard ratio 0.53, 95% confidence interval 0.32-0.87; P=0.01). Aortic regurgitation ≥mild after TAVR was associated with increased risk for all-cause mortality (hazard ratio 1.95, 95% confidence interval 1.08-3.53; P=0.03). Conclusions - In patients with severe aortic stenosis at increased surgical risk, TAVR was associated with better systolic valve performance, similar left ventricular remodeling, more paravalvular regurgitation, and less right ventricular systolic dysfunction compared with SAVR. Despite an overall mortality reduction for the TAVR group, ≥mild aortic valve regurgitation after TAVR was associated with an increased mortality hazard.
AB - Background - The CoreValve US High-Risk Clinical Study compared clinical outcomes and serial echocardiographic findings in patients with severe aortic valve stenosis after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis or surgical aortic valve replacement (SAVR). Methods and Results - Eligible patients were randomly assigned 1:1 to TAVR with a self-expanding bioprosthesis or SAVR (N=747). Echocardiograms were obtained at baseline, discharge, 30 days, 6 months, and 1 year after the procedure and were analyzed at a central core laboratory. Compared with SAVR patients (N=357), TAVR patients (N=390) had a lower mean aortic valve gradient, larger valve area, and less patient-prosthesis mismatch (all P<0.001), but more paravalvular regurgitation at discharge, which decreased at 1 year. SAVR patients experienced significant right ventricular systolic dysfunction at discharge and 1 month with normal right ventricular function at 1 year. One-year all-cause mortality was 14.2% for TAVR and 19.1% for SAVR patients. Preimplantation aortic regurgitation ≥mild was associated with reduced mortality hazard for both the TAVR (hazard ratio 0.48, 95% confidence interval 0.27-0.85; P=0.01) and the SAVR groups (hazard ratio 0.53, 95% confidence interval 0.32-0.87; P=0.01). Aortic regurgitation ≥mild after TAVR was associated with increased risk for all-cause mortality (hazard ratio 1.95, 95% confidence interval 1.08-3.53; P=0.03). Conclusions - In patients with severe aortic stenosis at increased surgical risk, TAVR was associated with better systolic valve performance, similar left ventricular remodeling, more paravalvular regurgitation, and less right ventricular systolic dysfunction compared with SAVR. Despite an overall mortality reduction for the TAVR group, ≥mild aortic valve regurgitation after TAVR was associated with an increased mortality hazard.
KW - aortic stenosis
KW - echocardiography
KW - mortality
KW - paravalvular regurgitation
KW - surgical aortic valve replacement
KW - transcatheter aortic valve replacement
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U2 - 10.1161/CIRCINTERVENTIONS.115.003426
DO - 10.1161/CIRCINTERVENTIONS.115.003426
M3 - Article
C2 - 27313280
AN - SCOPUS:84975760719
SN - 1941-7640
VL - 9
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
IS - 6
M1 - e003426
ER -