Cited by 424Artificial Intelligence in Healthcare and EducationECG Monitoring and AnalysisArtificial Intelligence in Healthcare

Artificial intelligence–enabled electrocardiograms for identification of patients with low ejection fraction: a pragmatic, randomized clinical trial

Yao, Xiaoxi, Rushlow, David R., Inselman, Jonathan W., McCoy, Rozalina G., Thacher, Thomas D., Behnken, Emma M., Bernard, Matthew E., Rosas, Steven L. +14 more·2021·Nature Medicine

Abstract

We have conducted a pragmatic clinical trial aimed to assess whether an electrocardiogram (ECG)-based, artificial intelligence (AI)-powered clinical decision support tool enables early diagnosis of low ejection fraction (EF), a condition that is underdiagnosed but treatable. In this trial ( NCT04000087 ), 120 primary care teams from 45 clinics or hospitals were cluster-randomized to either the intervention arm (access to AI results; 181 clinicians) or the control arm (usual care; 177 clinicians). ECGs were obtained as part of routine care from a total of 22,641 adults (N = 11,573 intervention; N = 11,068 control) without prior heart failure. The primary outcome was a new diagnosis of low EF (≤50%) within 90 days of the ECG. The trial met the prespecified primary endpoint, demonstrating that the intervention increased the diagnosis of low EF in the overall cohort (1.6% in the control arm versus 2.1% in the intervention arm, odds ratio (OR) 1.32 (1.01-1.61), P = 0.007) and among those who were identified as having a high likelihood of low EF (that is, positive AI-ECG, 6% of the overall cohort) (14.5% in the control arm versus 19.5% in the intervention arm, OR 1.43 (1.08-1.91), P = 0.01). In the overall cohort, echocardiogram utilization was similar between the two arms (18.2% control versus 19.2% intervention, P = 0.17); for patients with positive AI-ECGs, more echocardiograms were obtained in the intervention compared to the control arm (38.1% control versus 49.6% intervention…

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Crossref · 10.1038/s41591-021-01335-4

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  • The EAGLE trial increased new diagnoses of low EF from 1.6% in the control arm to 2.1% in the intervention arm (OR 1.32, 95% CI 1.01-1.61; P = 0.007), equivalent to a 32% relative increase over usual care.

    “The trial met this endpoint, increasing new diagnoses from 1.6% in the control arm to 2.1% in the intervention arm (OR 1.32, 95% CI 1.01–1.61; P = 0.007), equivalent to a 32% relative increase over usual care.14”
  • In EAGLE, only 49.6% of intervention-arm patients with a positive AI-ECG result underwent echocardiography.

    “In EAGLE, only 49.6% of intervention-arm patients with a positive AI-ECG result underwent echocardiography, indicating that follow-up imaging still did not occur in roughly half of AI-positive outpatients even when the result was visible to clinicians.14”
  • Unlike low-LVEF AI-ECG, broad SHD screening is still supported mainly by retrospective multicenter validation and nonrandomized prospective or population-based cohorts, and randomized implementation data, hard downstream outcome trials, and validated gatekeeper protocols for safely deferring echocardiography remain unavailable.

    “Even so, unlike low-LVEF AI-ECG—which already has pragmatic randomized trial evidence—broad SHD screening is still supported mainly by retrospective multicenter validation and nonrandomized prospective or population-based cohorts, and randomized implementation data, hard downstream outcome trials, and validated gatekeeper protocols for safely deferring echocardiography remain unavailable.14,34”
  • AI-enabled detection improved case finding without materially increasing overall echocardiography utilization.

    “Importantly, AI-enabled detection improved case finding without materially increasing overall echocardiography utilization, suggesting referral redirection rather than indiscriminate imaging expansion.”
  • The main contribution of EAGLE was to elevate the evidentiary level from model-performance literature to pragmatic care-pathway evidence.

    “The main contribution of EAGLE was not to re-establish that AI-ECG can detect low LVEF, which had already been shown in earlier derivation and validation studies, but to elevate the evidentiary level from model-performance literature to pragmatic care-pathway evidence.14”

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Authors
Yao, X., Rushlow, D. R., Inselman, J. W., McCoy, R. G., Thacher, T. D., Behnken, E. M., Bernard, M. E., Rosas, S. L., Akfaly, A., Misra, A., Molling, P. E., Krien, J. S., Foss, R. M., Barry, B. A., Siontis, K. C., Kapa, S., Pellikka, P. A., Lopez-Jimenez, F., Attia, Z. I., Shah, N. D., Friedman, P. A., & Noseworthy, P. A.
Affiliations
  • Mayo Clinic (US)
  • Mayo Clinic Health System (US)
Corresponding author
Yao, Xiaoxi
Venue
Nature Medicine
Published
2021-05
Volume
27
Issue
5
Pages
815-819
ISSN
  • 1078-8956 (ISSN-L)
  • 1546-170X
OpenAlex
W3159560336
Cited by
424
References
27
Citations by year
2026: 90 · 2025: 93 · 2024: 93 · 2023: 65 · 2022: 68 · 2021: 15
FWCI
13.52
Type
journal article
Language
en
Open access
closed
Locations
  • Nature Medicine (publishedVersion)
  • PubMed (publishedVersion)
Funders
Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery
Topics
  • Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › ECG Monitoring and Analysis
  • Health Sciences › Health Professions › Health Information Management › Artificial Intelligence in Healthcare
Keywords
artificial intelligence, electrocardiogram, reduced ejection fraction, heart failure, clinical decision support, early diagnosis, primary care
MeSH terms
Adolescent, Adult, Aged, Algorithms, Artificial Intelligence, Echocardiography, Electrocardiography, Female, Heart Failure, Humans, Male, Middle Aged, Stroke Volume, Decision Support Systems, Clinical, Early Diagnosis, Young Adult

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