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.
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).



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).



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.



URL: http://www.clinicaltrials.gov. Unique identifier: NCT01240902.
From the Departments of Cardiology (S.H.L.) and Cardiac Surgery (M.J.R.), Houston Methodist DeBakey Heart & Vascular Center, TX; Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (J.K.O., S.S.A.), and Jacksonville, FL (A.W.P.); Department of Cardiovascular Medicine, Morristown Medical Center, NJ (L.G.); Departments of Cardiology (P.P.S.) and Cardiovascular Surgery (D.H.A.), Mount Sinai Medical Center, NY; Department of Cardiac Surgery, The Ohio State University, Columbus (D.A.O.); Vascular Medicine Institute, Division of Cardiology, University of Pittsburgh Medical Center, PA (J.L.C.); Cardiovascular Research Institute, Department of Cardiothoracic Surgery, University of Kansas Hospital, Kansas City (G.L.Z.); Coronary and Structural Heart Disease Management Clinical Department, Medtronic, Minneapolis, MN (H.Q.); and Department of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, MA (J.D.C., J.J.P.). SHLittle@houstonmethodist.org.
Stephen H
SH
Little
From the Departments of Cardiology (S.H.L.) and Cardiac Surgery (M.J.R.), Houston Methodist DeBakey Heart & Vascular Center, TX; Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (J.K.O., S.S.A.), and Jacksonville, FL (A.W.P.); Department of Cardiovascular Medicine, Morristown Medical Center, NJ (L.G.); Departments of Cardiology (P.P.S.) and Cardiovascular Surgery (D.H.A.), Mount Sinai Medical Center, NY; Department of Cardiac Surgery, The Ohio State University, Columbus (D.A.O.); Vascular Medicine Institute, Division of Cardiology, University of Pittsburgh Medical Center, PA (J.L.C.); Cardiovascular Research Institute, Department of Cardiothoracic Surgery, University of Kansas Hospital, Kansas City (G.L.Z.); Coronary and Structural Heart Disease Management Clinical Department, Medtronic, Minneapolis, MN (H.Q.); and Department of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, MA (J.D.C., J.J.P.).
Jae K
JK
Oh
From the Departments of Cardiology (S.H.L.) and Cardiac Surgery (M.J.R.), Houston Methodist DeBakey Heart & Vascular Center, TX; Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (J.K.O., S.S.A.), and Jacksonville, FL (A.W.P.); Department of Cardiovascular Medicine, Morristown Medical Center, NJ (L.G.); Departments of Cardiology (P.P.S.) and Cardiovascular Surgery (D.H.A.), Mount Sinai Medical Center, NY; Department of Cardiac Surgery, The Ohio State University, Columbus (D.A.O.); Vascular Medicine Institute, Division of Cardiology, University of Pittsburgh Medical Center, PA (J.L.C.); Cardiovascular Research Institute, Department of Cardiothoracic Surgery, University of Kansas Hospital, Kansas City (G.L.Z.); Coronary and Structural Heart Disease Management Clinical Department, Medtronic, Minneapolis, MN (H.Q.); and Department of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, MA (J.D.C., J.J.P.).
Linda
L
Gillam
From the Departments of Cardiology (S.H.L.) and Cardiac Surgery (M.J.R.), Houston Methodist DeBakey Heart & Vascular Center, TX; Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (J.K.O., S.S.A.), and Jacksonville, FL (A.W.P.); Department of Cardiovascular Medicine, Morristown Medical Center, NJ (L.G.); Departments of Cardiology (P.P.S.) and Cardiovascular Surgery (D.H.A.), Mount Sinai Medical Center, NY; Department of Cardiac Surgery, The Ohio State University, Columbus (D.A.O.); Vascular Medicine Institute, Division of Cardiology, University of Pittsburgh Medical Center, PA (J.L.C.); Cardiovascular Research Institute, Department of Cardiothoracic Surgery, University of Kansas Hospital, Kansas City (G.L.Z.); Coronary and Structural Heart Disease Management Clinical Department, Medtronic, Minneapolis, MN (H.Q.); and Department of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, MA (J.D.C., J.J.P.).
Partho P
PP
Sengupta
From the Departments of Cardiology (S.H.L.) and Cardiac Surgery (M.J.R.), Houston Methodist DeBakey Heart & Vascular Center, TX; Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (J.K.O., S.S.A.), and Jacksonville, FL (A.W.P.); Department of Cardiovascular Medicine, Morristown Medical Center, NJ (L.G.); Departments of Cardiology (P.P.S.) and Cardiovascular Surgery (D.H.A.), Mount Sinai Medical Center, NY; Department of Cardiac Surgery, The Ohio State University, Columbus (D.A.O.); Vascular Medicine Institute, Division of Cardiology, University of Pittsburgh Medical Center, PA (J.L.C.); Cardiovascular Research Institute, Department of Cardiothoracic Surgery, University of Kansas Hospital, Kansas City (G.L.Z.); Coronary and Structural Heart Disease Management Clinical Department, Medtronic, Minneapolis, MN (H.Q.); and Department of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, MA (J.D.C., J.J.P.).
David A
DA
Orsinelli
From the Departments of Cardiology (S.H.L.) and Cardiac Surgery (M.J.R.), Houston Methodist DeBakey Heart & Vascular Center, TX; Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (J.K.O., S.S.A.), and Jacksonville, FL (A.W.P.); Department of Cardiovascular Medicine, Morristown Medical Center, NJ (L.G.); Departments of Cardiology (P.P.S.) and Cardiovascular Surgery (D.H.A.), Mount Sinai Medical Center, NY; Department of Cardiac Surgery, The Ohio State University, Columbus (D.A.O.); Vascular Medicine Institute, Division of Cardiology, University of Pittsburgh Medical Center, PA (J.L.C.); Cardiovascular Research Institute, Department of Cardiothoracic Surgery, University of Kansas Hospital, Kansas City (G.L.Z.); Coronary and Structural Heart Disease Management Clinical Department, Medtronic, Minneapolis, MN (H.Q.); and Department of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, MA (J.D.C., J.J.P.).
João L
JL
Cavalcante
From the Departments of Cardiology (S.H.L.) and Cardiac Surgery (M.J.R.), Houston Methodist DeBakey Heart & Vascular Center, TX; Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (J.K.O., S.S.A.), and Jacksonville, FL (A.W.P.); Department of Cardiovascular Medicine, Morristown Medical Center, NJ (L.G.); Departments of Cardiology (P.P.S.) and Cardiovascular Surgery (D.H.A.), Mount Sinai Medical Center, NY; Department of Cardiac Surgery, The Ohio State University, Columbus (D.A.O.); Vascular Medicine Institute, Division of Cardiology, University of Pittsburgh Medical Center, PA (J.L.C.); Cardiovascular Research Institute, Department of Cardiothoracic Surgery, University of Kansas Hospital, Kansas City (G.L.Z.); Coronary and Structural Heart Disease Management Clinical Department, Medtronic, Minneapolis, MN (H.Q.); and Department of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, MA (J.D.C., J.J.P.).
James D
JD
Chang
From the Departments of Cardiology (S.H.L.) and Cardiac Surgery (M.J.R.), Houston Methodist DeBakey Heart & Vascular Center, TX; Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (J.K.O., S.S.A.), and Jacksonville, FL (A.W.P.); Department of Cardiovascular Medicine, Morristown Medical Center, NJ (L.G.); Departments of Cardiology (P.P.S.) and Cardiovascular Surgery (D.H.A.), Mount Sinai Medical Center, NY; Department of Cardiac Surgery, The Ohio State University, Columbus (D.A.O.); Vascular Medicine Institute, Division of Cardiology, University of Pittsburgh Medical Center, PA (J.L.C.); Cardiovascular Research Institute, Department of Cardiothoracic Surgery, University of Kansas Hospital, Kansas City (G.L.Z.); Coronary and Structural Heart Disease Management Clinical Department, Medtronic, Minneapolis, MN (H.Q.); and Department of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, MA (J.D.C., J.J.P.).
David H
DH
Adams
From the Departments of Cardiology (S.H.L.) and Cardiac Surgery (M.J.R.), Houston Methodist DeBakey Heart & Vascular Center, TX; Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (J.K.O., S.S.A.), and Jacksonville, FL (A.W.P.); Department of Cardiovascular Medicine, Morristown Medical Center, NJ (L.G.); Departments of Cardiology (P.P.S.) and Cardiovascular Surgery (D.H.A.), Mount Sinai Medical Center, NY; Department of Cardiac Surgery, The Ohio State University, Columbus (D.A.O.); Vascular Medicine Institute, Division of Cardiology, University of Pittsburgh Medical Center, PA (J.L.C.); Cardiovascular Research Institute, Department of Cardiothoracic Surgery, University of Kansas Hospital, Kansas City (G.L.Z.); Coronary and Structural Heart Disease Management Clinical Department, Medtronic, Minneapolis, MN (H.Q.); and Department of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, MA (J.D.C., J.J.P.).
George L
GL
Zorn
From the Departments of Cardiology (S.H.L.) and Cardiac Surgery (M.J.R.), Houston Methodist DeBakey Heart & Vascular Center, TX; Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (J.K.O., S.S.A.), and Jacksonville, FL (A.W.P.); Department of Cardiovascular Medicine, Morristown Medical Center, NJ (L.G.); Departments of Cardiology (P.P.S.) and Cardiovascular Surgery (D.H.A.), Mount Sinai Medical Center, NY; Department of Cardiac Surgery, The Ohio State University, Columbus (D.A.O.); Vascular Medicine Institute, Division of Cardiology, University of Pittsburgh Medical Center, PA (J.L.C.); Cardiovascular Research Institute, Department of Cardiothoracic Surgery, University of Kansas Hospital, Kansas City (G.L.Z.); Coronary and Structural Heart Disease Management Clinical Department, Medtronic, Minneapolis, MN (H.Q.); and Department of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, MA (J.D.C., J.J.P.).
Amy W
AW
Pollak
From the Departments of Cardiology (S.H.L.) and Cardiac Surgery (M.J.R.), Houston Methodist DeBakey Heart & Vascular Center, TX; Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (J.K.O., S.S.A.), and Jacksonville, FL (A.W.P.); Department of Cardiovascular Medicine, Morristown Medical Center, NJ (L.G.); Departments of Cardiology (P.P.S.) and Cardiovascular Surgery (D.H.A.), Mount Sinai Medical Center, NY; Department of Cardiac Surgery, The Ohio State University, Columbus (D.A.O.); Vascular Medicine Institute, Division of Cardiology, University of Pittsburgh Medical Center, PA (J.L.C.); Cardiovascular Research Institute, Department of Cardiothoracic Surgery, University of Kansas Hospital, Kansas City (G.L.Z.); Coronary and Structural Heart Disease Management Clinical Department, Medtronic, Minneapolis, MN (H.Q.); and Department of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, MA (J.D.C., J.J.P.).
Sahar S
SS
Abdelmoneim
From the Departments of Cardiology (S.H.L.) and Cardiac Surgery (M.J.R.), Houston Methodist DeBakey Heart & Vascular Center, TX; Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (J.K.O., S.S.A.), and Jacksonville, FL (A.W.P.); Department of Cardiovascular Medicine, Morristown Medical Center, NJ (L.G.); Departments of Cardiology (P.P.S.) and Cardiovascular Surgery (D.H.A.), Mount Sinai Medical Center, NY; Department of Cardiac Surgery, The Ohio State University, Columbus (D.A.O.); Vascular Medicine Institute, Division of Cardiology, University of Pittsburgh Medical Center, PA (J.L.C.); Cardiovascular Research Institute, Department of Cardiothoracic Surgery, University of Kansas Hospital, Kansas City (G.L.Z.); Coronary and Structural Heart Disease Management Clinical Department, Medtronic, Minneapolis, MN (H.Q.); and Department of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, MA (J.D.C., J.J.P.).
Michael J
MJ
Reardon
From the Departments of Cardiology (S.H.L.) and Cardiac Surgery (M.J.R.), Houston Methodist DeBakey Heart & Vascular Center, TX; Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (J.K.O., S.S.A.), and Jacksonville, FL (A.W.P.); Department of Cardiovascular Medicine, Morristown Medical Center, NJ (L.G.); Departments of Cardiology (P.P.S.) and Cardiovascular Surgery (D.H.A.), Mount Sinai Medical Center, NY; Department of Cardiac Surgery, The Ohio State University, Columbus (D.A.O.); Vascular Medicine Institute, Division of Cardiology, University of Pittsburgh Medical Center, PA (J.L.C.); Cardiovascular Research Institute, Department of Cardiothoracic Surgery, University of Kansas Hospital, Kansas City (G.L.Z.); Coronary and Structural Heart Disease Management Clinical Department, Medtronic, Minneapolis, MN (H.Q.); and Department of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, MA (J.D.C., J.J.P.).
Hongyan
H
Qiao
From the Departments of Cardiology (S.H.L.) and Cardiac Surgery (M.J.R.), Houston Methodist DeBakey Heart & Vascular Center, TX; Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (J.K.O., S.S.A.), and Jacksonville, FL (A.W.P.); Department of Cardiovascular Medicine, Morristown Medical Center, NJ (L.G.); Departments of Cardiology (P.P.S.) and Cardiovascular Surgery (D.H.A.), Mount Sinai Medical Center, NY; Department of Cardiac Surgery, The Ohio State University, Columbus (D.A.O.); Vascular Medicine Institute, Division of Cardiology, University of Pittsburgh Medical Center, PA (J.L.C.); Cardiovascular Research Institute, Department of Cardiothoracic Surgery, University of Kansas Hospital, Kansas City (G.L.Z.); Coronary and Structural Heart Disease Management Clinical Department, Medtronic, Minneapolis, MN (H.Q.); and Department of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, MA (J.D.C., J.J.P.).
Jeffrey J
JJ
Popma
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000000981:diagnostic imaging / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging* / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D015150:Echocardiography, Doppler; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D008297:Male; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016896:Treatment Outcome; D014481:United States; D016277:Ventricular Function, Left; D016278:Ventricular Function, Right; D020257:Ventricular Remodeling
aortic stenosis; echocardiography; mortality; paravalvular regurgitation; surgical aortic valve replacement; transcatheter aortic valve replacement