Multinational Clinical and Community-based Validation of PRESENT-SHD, an Ensemble Deep Learning Approach for the Detection of Multiple Structural Heart Disorders Using Electrocardiographic Images
Abstract Body (Do not enter title and authors here): Background: Screening for structural heart disorders (SHDs) requires cardiac imaging, which has limited accessibility and requires clinical expertise. We report the multinational validation of PRESENT-SHD, an artificial intelligence-based approach for detecting multiple SHDs from a single image of a 12-lead electrocardiogram (ECG) across clinical settings in the US and a community-based cohort from Brazil.
Methods: Using paired ECG images and transthoracic echocardiograms (TTEs) from the Yale New Haven Hospital (2015-2023) from 110,228 patients, we developed PRESENT-SHD, an ensemble deep learning approach combining CNN probabilities for individual SHDs with a person’s age and sex, as a single screen for multiple SHDs. SHD was defined as any LV systolic dysfunction (LVEF < 40%), moderate-or-severe left-sided valve disease, or severe LVH (IVSd > 15mm and LV diastolic dysfunction). We validated PRESENT-SHD across patients from 4 distinct hospitals and an outpatient medical network (Northeast Medical Group [NEMG]) in the US and in a large prospective population-based cohort study, the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil), who underwent protocolized ECGs and TTEs concurrently.
Results: We evaluated the model on a single ECG drawn from 8921 individuals at Bridgeport Hospital, 2507 at Greenwich Hospital, 17,856 at Lawrence + Memorial Hospital, 3638 at Westerly Hospital, 21,055 at NEMG, and 3014 in ELSA-Brasil. SHD prevalence ranged from 20-23% at the hospital sites and 22% at the outpatient NEMG. It was 3% in the population-based ELSA-Brasil. In the hospital-based sites, PRESENT-SHD had an AUROC ranging 0.847-0.899, with sensitivities and specifities of 81-85% and 72-80%, respectively. In the outpatient NEMG, the performance was also consistent (AUROC, 0.815 [95% CI, 0.808-0.822], sensitivity 61%, specificity 84%). In ELSA-Brasil, the model had an AUROC of 0.853 (95% CI: 0.808-0.890) with sensitivity and specificity of 63% and 90%, respectively. Model performance was consistent across demographic subgroups.
Conclusion: PRESENT-SHD maintained excellent performance in identifying SHD on ECG images across diverse populations and clinical settings in the US and Brazil. This demonstrates strong potential as a scalable and accessible tool for SHD screening using digital or printed versions of 12-lead ECGs.
Dhingra, Lovedeep
( Yale School Of Medicine
, New Haven
, Connecticut
, United States
)
Khera, Rohan
( Yale School of Medicine
, New Haven
, Connecticut
, United States
)
Aminorroaya, Arya
( Yale School of Medicine
, New Haven
, Connecticut
, United States
)
Pedroso, Aline
( Yale School of Medicine
, New Haven
, Connecticut
, United States
)
Sangha, Veer
( Yale Universty
, New Haven
, Connecticut
, United States
)
Brant, Luisa
( FEDERAL UNIVERSITY of MINAS GERAIS
, Belo Horizonte
, Brazil
)
Barreto, Sandhi
( FEDERAL UNIVERSITY of MINAS GERAIS
, Belo Horizonte
, Brazil
)
Ribeiro, Antonio Luiz
( FEDERAL UNIVERSITY of MINAS GERAIS
, Belo Horizonte
, Brazil
)
Krumholz, Harlan
( Yale University
, New Haven
, Connecticut
, United States
)
Oikonomou, Evangelos
( Yale School of Medicine
, New Haven
, Connecticut
, United States
)
Author Disclosures:
Lovedeep Dhingra:DO NOT have relevant financial relationships
| Rohan Khera:DO have relevant financial relationships
;
Research Funding (PI or named investigator):Bristol-Myers Squibb:Active (exists now)
; Ownership Interest:Ensight-AI, Inc:Active (exists now)
; Ownership Interest:Evidence2Health LLC:Active (exists now)
; Research Funding (PI or named investigator):BridgeBio:Active (exists now)
; Research Funding (PI or named investigator):Novo Nordisk:Active (exists now)
| Arya Aminorroaya:DO NOT have relevant financial relationships
| Aline Pedroso:DO NOT have relevant financial relationships
| Veer Sangha:DO have relevant financial relationships
;
Royalties/Patent Beneficiary:63/346,610, 63/484,426, 63/428,569:Active (exists now)
; Ownership Interest:Ensight-AI:Active (exists now)
| Luisa Brant:DO NOT have relevant financial relationships
| Sandhi Barreto:No Answer
| Antonio Luiz Ribeiro:DO NOT have relevant financial relationships
| Harlan Krumholz:DO have relevant financial relationships
;
Individual Stocks/Stock Options:Element Science:Active (exists now)
; Research Funding (PI or named investigator):Pfizer:Active (exists now)
; Research Funding (PI or named investigator):Kenvue:Active (exists now)
; Research Funding (PI or named investigator):Janssen:Active (exists now)
; Ownership Interest:Ensight-AI:Active (exists now)
; Ownership Interest:Refactor Health:Active (exists now)
; Ownership Interest:Hugo Health:Active (exists now)
; Advisor:F-Prime:Active (exists now)
; Individual Stocks/Stock Options:Identifeye:Active (exists now)
| Evangelos Oikonomou:DO have relevant financial relationships
;
Ownership Interest:Evidence2Health, LLC:Active (exists now)
; Consultant:Caristo Diagnostics Ltd:Past (completed)
; Royalties/Patent Beneficiary:University of Oxford:Past (completed)
; Consultant:Ensight-AI, Inc:Active (exists now)