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Randomized Controlled Trial
. 2018 Aug 3;1(4):e181456.
doi: 10.1001/jamanetworkopen.2018.1456.

Variability in Ejection Fraction Measured By Echocardiography, Gated Single-Photon Emission Computed Tomography, and Cardiac Magnetic Resonance in Patients With Coronary Artery Disease and Left Ventricular Dysfunction

Affiliations
Randomized Controlled Trial

Variability in Ejection Fraction Measured By Echocardiography, Gated Single-Photon Emission Computed Tomography, and Cardiac Magnetic Resonance in Patients With Coronary Artery Disease and Left Ventricular Dysfunction

Patricia A Pellikka et al. JAMA Netw Open. .

Abstract

Importance: Clinical decisions are frequently based on measurement of left ventricular ejection fraction (LVEF). Limited information exists regarding inconsistencies in LVEF measurements when determined by various imaging modalities and the potential impact of such variability.

Objective: To determine the intermodality variability of LVEF measured by echocardiography, gated single-photon emission computed tomography (SPECT), and cardiovascular magnetic resonance (CMR) in patients with left ventricular dysfunction.

Design, setting, and participants: International multicenter diagnostic study with LVEF imaging performed at 127 clinical sites in 26 countries from July 24, 2002, to May 5, 2007, and measured by core laboratories. Secondary study of clinical diagnostic measurements of LVEF in the Surgical Treatment for Ischemic Heart Failure (STICH), a randomized trial to identify the optimal treatment strategy for patients with LVEF of 35% or less and coronary artery disease. Data analysis was conducted from March 19, 2016, to May 29, 2018.

Main outcomes and measures: At baseline, most patients had an echocardiogram and subsets of patients underwent SPECT and/or CMR. Left ventricular ejection fraction was measured by a core laboratory for each modality independent of the results of other modalities, and measurements were compared among imaging methods using correlation, Bland-Altman plots, and coverage probability methods. Association of LVEF by each method and death was assessed.

Results: A total of 2032 patients (mean [SD] age, 60.9 [9.6] years; 1759 [86.6%] male) with baseline LVEF data were included. Correlation of LVEF between modalities was r = 0.601 (for biplane echocardiography and SPECT [n = 385]), r = 0.493 (for biplane echocardiography and CMR [n = 204]), and r = 0.660 (for CMR and SPECT [n = 134]). Bland-Altman plots showed only moderate agreement in LVEF measurements from all 3 core laboratories with no substantial overestimation or underestimation of LVEF by any modality. The percentage of observations that fell within a range of 5% ranged from 43% to 54% between different imaging modalities.

Conclusions and relevance: In this international multicenter study of patients with coronary artery disease and reduced LVEF, there was substantial variation between modalities in LVEF determination by core laboratories. This variability should be considered in clinical management and trial design.

Trial registration: Clinicaltrials.gov Identifier: NCT00023595.

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Conflict of interest statement

Conflict of Interest Disclosures: Drs She, Panza, and Lee reported grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Dr Berman reported grants from the National Heart, Lung, and Blood Institute during the conduct of the study and personal fees from Cedars-Sinai Medical Center outside the submitted work. Dr Prior reported grants from the National Institutes of Health during the conduct of the study; and personal fees from Novartis and nonfinancial support from Bayer outside the submitted work. Drs Borges-Neto and Al-Khalidi reported grants from Duke University during the conduct of the study. Dr Grayburn reported grants from the National Institutes of Health during the conduct of the study; and grants from Abbott Vascular, Edwards Lifesciences, Medtronic, and Boston Scientific outside the submitted work. Dr Velazquez reported grants from the National Heart, Lung, and Blood Institute during the conduct of the study; and grants and personal fees from Novartis, Philips, and Amgen, grants from Pfizer and Alnylam, personal fees from Merck and Abiomed, and grants from General Electric outside the submitted work. Dr Oh reported grants from the National Institutes of Health during the conduct of the study. No other disclosures were reported.

Figures

Figure.
Figure.. Bland-Altman Plots for Left Ventricular Ejection Fraction (EF)
Plots are compared for biplane Simpson method and visual estimation for echocardiography (A), biplane Simpson method by echocardiography and gated single-photon emission computed tomography (SPECT) (B), biplane Simpson method by echocardiography and cardiovascular magnetic resonance (CMR) (C), and gated SPECT and CMR (D).

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