Multinational Validation of Fully Automated Diagnostic Reports using Artificial Intelligence-enabled Application for ECG Images
Abstract Body (Do not enter title and authors here): Background: Accurate ECG interpretation is critical for triaging, diagnosis, and managing patients with cardiovascular conditions. Current computerized methods have limited accuracy and are often proprietary algorithms based on raw signal data. We sought to evaluate ECG-GPT, a novel vision-text transformer model capable of generating free-text diagnosis statements from images of ECGs.
Methods: ECG-GPT was developed with 3 million ECGs at Yale and validated in 2 large and geographically distinct populations: (1) 1.4 million ECG images with diagnosis statements from Mount Sinai Health System (MSHS), NY, and (2) 45,389 ECG images with 6 diagnostic labels from UK Biobank (UKB). We employed 2 metrics: (A) a rule-based approach to evaluate diagnostic accuracy for 19 rhythm and conduction disorders on MSHS ECGs and 6 key conditions on UKB ECGs, and (B) semantic similarity (similar meaning) using a fine-tuned DistilBERT model. Using semantic similarity methods, we assessed the quality of generated text across the full range of ECG diagnoses by computing similarity both for all model-generated and reference statements and for subsets specific to ECGs flagged for each of the 19 extracted conditions. To establish baseline similarities, we also computed semantic similarities between random combinations of model-generated and reference statements within each of these sets.
Results: The model performed well across multiple key labels, spanning rhythm and conduction disorders, including an AUROC of 0.92 for atrial fibrillation, 0.95 for left bundle branch block, and 0.90 for atrioventricular block (Table A). More importantly, in addition to the labels, ECG-GPT identified the full context of the diagnosis statements with allied conditions. It had a median pairwise cosine similarity of 0.86 (IQR 0.78-0.94), significantly greater than the median baseline similarity of 0.73 (IQR 0.66-0.79, p<0.001) (Table B). This separation between median pairwise and baseline similarity remained consistent across all 19 condition-specific subsets. Results were comparable in the UKB dataset, with AUROCs of 0.95, 0.92, and 0.95 for AF, ST, and SB, and AUROCs of 0.99, 0.99, and 0.95 for LBBB, RBBB, and AVb (Table C).
Conclusion: Our model represents a scalable and accessible strategy for generating accurate, expert-level reports from photos of ECGs, validated across large, multinational datasets using both individual diagnostic labels and the comprehensiveness of the diagnostic statement.
Khunte, Akshay
( Yale University
, New Haven
, Connecticut
, United States
)
Krumholz, Harlan
( Yale University
, New Haven
, Connecticut
, United States
)
Nadkarni, Girish
( Icahn Sch. of Medicine at Mt. Sinai
, New York City
, New York
, United States
)
Vaid, Akhil
( Icahn Sch. of Medicine at Mt. Sinai
, New York City
, New York
, United States
)
Khera, Rohan
( Yale School Of Medicine
, New Haven
, Connecticut
, United States
)
Sangha, Veer
( Yale University
, New Haven
, Connecticut
, United States
)
Oikonomou, Evangelos
( Yale School Of Medicine
, New Haven
, Connecticut
, United States
)
Dhingra, Lovedeep
( Yale School Of Medicine
, New Haven
, Connecticut
, United States
)
Aminorroaya, Arya
( Yale School Of Medicine
, New Haven
, Connecticut
, United States
)
Coppi, Andreas
( Yale School Of Medicine
, New Haven
, Connecticut
, United States
)
Vasisht Shankar, Sumukh
( Yale University
, New Haven
, Connecticut
, United States
)
Mortazavi, Bobak
( Yale School Of Medicine
, New Haven
, Connecticut
, United States
)
Bhatt, Deepak
( Mount Sinai Fuster Heart Hospital
, Scarsdale
, New York
, United States
)
Author Disclosures:
Akshay Khunte: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)
| Girish Nadkarni:No Answer
| Akhil Vaid:DO have relevant financial relationships
;
Consultant:Verily Life Sciences:Active (exists now)
| 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)
| 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)
| 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)
| Lovedeep Dhingra:DO NOT have relevant financial relationships
| Arya Aminorroaya:DO NOT have relevant financial relationships
| Andreas Coppi:DO NOT have relevant financial relationships
| Sumukh Vasisht Shankar:DO NOT have relevant financial relationships
| Bobak Mortazavi:No Answer
| Deepak Bhatt:DO have relevant financial relationships
;
Advisor:Angiowave, Bayer, Boehringer Ingelheim, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Stasys:Active (exists now)
; Other (please indicate in the box next to the company name):Trustee: American College of Cardiology; Unfunded Research: FlowCo:Active (exists now)
; Other (please indicate in the box next to the company name):Site Co-Investigator: Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, Vascular Solutions;:Active (exists now)
; Royalties/Patent Beneficiary:Royalties: Elsevier (Editor, Braunwald’s Heart Disease):Active (exists now)
; Researcher:Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Alnylam, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CinCor, Cleerly, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Otsuka, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, Youngene, 89Bio;:Active (exists now)
; Royalties/Patent Beneficiary:Patent: Sotagliflozin (named on a patent for sotagliflozin assigned to Brigham and Women's Hospital who assigned to Lexicon; neither I nor Brigham and Women's Hospital receive any income from this patent);:Active (exists now)
; Other (please indicate in the box next to the company name):Honoraria: Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Oakstone CME (Course Director, Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), WebMD (CME steering committees), Wiley (steering committee);:Active (exists now)
; Other (please indicate in the box next to the company name):Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), CSL Behring (AHA lecture), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum):Active (exists now)
; Other (please indicate in the box next to the company name):Data Monitoring Committees: Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic, Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY-DM trial, funded by Concept Medical; for ALLAY-HF, funded by Alleviant Medical), Novartis, Population Health Research Institute; Rutgers University (for the NIH-funded MINT Trial);:Active (exists now)
; Consultant:Broadview Ventures, GlaxoSmithKline, Hims, SFJ, Youngene:Active (exists now)
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