Self-expanding transcatheter aortic valve replacement versus surgical valve replacement in patients at high risk for surgery

A study of echocardiographic change and risk prediction

Stephen H. Little, Jae Kuen Oh, Linda Gillam, Partho P. Sengupta, David A. Orsinelli, João L. Cavalcante, James D. Chang, David H. Adams, George L. Zorn, Amy W. Pollak, Sahar S. Abdelmoneim, Michael J. Reardon, Hongyan Qiao, Jeffrey J. Popma

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Article numbere003426
JournalCirculation: Cardiovascular Interventions
Volume9
Issue number6
DOIs
StatePublished - Jun 1 2016

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Surgical Instruments
Aortic Valve
Aortic Valve Insufficiency
Mortality
Right Ventricular Dysfunction
Bioprosthesis
Aortic Valve Stenosis
Confidence Intervals
Transcatheter Aortic Valve Replacement
Right Ventricular Function
Ventricular Remodeling
Prostheses and Implants

Keywords

  • aortic stenosis
  • echocardiography
  • mortality
  • paravalvular regurgitation
  • surgical aortic valve replacement
  • transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Self-expanding transcatheter aortic valve replacement versus surgical valve replacement in patients at high risk for surgery : A study of echocardiographic change and risk prediction. / Little, Stephen H.; Oh, Jae Kuen; Gillam, Linda; Sengupta, Partho P.; Orsinelli, David A.; Cavalcante, João L.; Chang, James D.; Adams, David H.; Zorn, George L.; Pollak, Amy W.; Abdelmoneim, Sahar S.; Reardon, Michael J.; Qiao, Hongyan; Popma, Jeffrey J.

In: Circulation: Cardiovascular Interventions, Vol. 9, No. 6, e003426, 01.06.2016.

Research output: Contribution to journalArticle

Little, SH, Oh, JK, Gillam, L, Sengupta, PP, Orsinelli, DA, Cavalcante, JL, Chang, JD, Adams, DH, Zorn, GL, Pollak, AW, Abdelmoneim, SS, Reardon, MJ, Qiao, H & Popma, JJ 2016, 'Self-expanding transcatheter aortic valve replacement versus surgical valve replacement in patients at high risk for surgery: A study of echocardiographic change and risk prediction', Circulation: Cardiovascular Interventions, vol. 9, no. 6, e003426. https://doi.org/10.1161/CIRCINTERVENTIONS.115.003426
Little, Stephen H. ; Oh, Jae Kuen ; Gillam, Linda ; Sengupta, Partho P. ; Orsinelli, David A. ; Cavalcante, João L. ; Chang, James D. ; Adams, David H. ; Zorn, George L. ; Pollak, Amy W. ; Abdelmoneim, Sahar S. ; Reardon, Michael J. ; Qiao, Hongyan ; Popma, Jeffrey J. / Self-expanding transcatheter aortic valve replacement versus surgical valve replacement in patients at high risk for surgery : A study of echocardiographic change and risk prediction. In: Circulation: Cardiovascular Interventions. 2016 ; Vol. 9, No. 6.
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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 Kuen

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.

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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