Harold L Dauerman1, Michael J Reardon2, Jeffrey J Popma2, Stephen H Little2, João L Cavalcante2, David H Adams2, Neil S Kleiman2, Jae K Oh2. 1. From the University of Vermont College of Medicine, Burlington (H.L.D); Houston DeBakey Heart and Vascular Center, The Houston Methodist Hospital, TX (M.J.R., S.H.L., N.S.K.); Beth Israel Deaconess Medical Center, Boston, MA (J.J.P.); University of Pittsburgh Medical Center, PA (J.L.C.); Mount Sinai School of Medicine, New York, NY (D.H.A.); and Mayo Clinic, Rochester, MN (J.K.O.). harold.dauerman@uvmhealth.org. 2. From the University of Vermont College of Medicine, Burlington (H.L.D); Houston DeBakey Heart and Vascular Center, The Houston Methodist Hospital, TX (M.J.R., S.H.L., N.S.K.); Beth Israel Deaconess Medical Center, Boston, MA (J.J.P.); University of Pittsburgh Medical Center, PA (J.L.C.); Mount Sinai School of Medicine, New York, NY (D.H.A.); and Mayo Clinic, Rochester, MN (J.K.O.).
Abstract
BACKGROUND: Approximately one third of patients with symptomatic aortic stenosis have reduced left ventricular ejection fraction (LVEF) before transcatheter aortic valve replacement. The incidence, predictors, and significance of early LVEF recovery after CoreValve transcatheter aortic valve replacement have not been described. METHODS AND RESULTS: We studied 156 patients from the CoreValve Extreme and High-Risk trials with LVEF ≤40% at baseline who had 30-day LVEF data. All patients underwent core laboratory echocardiographic assessment of LVEF at baseline, post procedure, discharge, 30 days, 6 months, and 1 year. Early LVEF recovery was defined as an absolute increase of ≥10% in EF at 30 days. One-year outcomes were compared between patients with and without early recovery. Multivariable analysis was performed to determine independent predictors of early recovery. Early LVEF recovery occurred in 62% of patients, generally before discharge. By 30 days LVEF increased >17% compared with baseline in the early recovery group with minimal increase in the no-early recovery group (48.9±8.8% versus 31.5±6.9%; P<0.001). One-year all-cause mortality was numerically (but not statistically) higher in the no-early recovery group (24% versus 12%; P=0.07). Absence of previous myocardial infarction (odds ratio, 0.44; 95% confidence interval, 0.19-1.03) and baseline mean gradient ≥40 mm Hg (odds ratio, 4.59; 95% confidence interval, 1.76-11.96) were identified as predictors of early LVEF recovery. CONCLUSIONS: Nearly two thirds of patients with reduced LVEF will have a marked early improvement after transcatheter aortic valve replacement. Early LVEF recovery is associated with improved clinical outcomes and is most likely among patients with higher baseline aortic valve gradients and no previous myocardial infarction. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01240902.
RCT Entities:
BACKGROUND: Approximately one third of patients with symptomatic aortic stenosis have reduced left ventricular ejection fraction (LVEF) before transcatheter aortic valve replacement. The incidence, predictors, and significance of early LVEF recovery after CoreValve transcatheter aortic valve replacement have not been described. METHODS AND RESULTS: We studied 156 patients from the CoreValve Extreme and High-Risk trials with LVEF ≤40% at baseline who had 30-day LVEF data. All patients underwent core laboratory echocardiographic assessment of LVEF at baseline, post procedure, discharge, 30 days, 6 months, and 1 year. Early LVEF recovery was defined as an absolute increase of ≥10% in EF at 30 days. One-year outcomes were compared between patients with and without early recovery. Multivariable analysis was performed to determine independent predictors of early recovery. Early LVEF recovery occurred in 62% of patients, generally before discharge. By 30 days LVEF increased >17% compared with baseline in the early recovery group with minimal increase in the no-early recovery group (48.9±8.8% versus 31.5±6.9%; P<0.001). One-year all-cause mortality was numerically (but not statistically) higher in the no-early recovery group (24% versus 12%; P=0.07). Absence of previous myocardial infarction (odds ratio, 0.44; 95% confidence interval, 0.19-1.03) and baseline mean gradient ≥40 mm Hg (odds ratio, 4.59; 95% confidence interval, 1.76-11.96) were identified as predictors of early LVEF recovery. CONCLUSIONS: Nearly two thirds of patients with reduced LVEF will have a marked early improvement after transcatheter aortic valve replacement. Early LVEF recovery is associated with improved clinical outcomes and is most likely among patients with higher baseline aortic valve gradients and no previous myocardial infarction. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01240902.
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