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Powerful Medical
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9. November 2023
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3 min to read
  • Abstract

Diagnostic Accuracy of a Smartphone Application for Artificial Intelligence-based Interpretation of 12-lead ECG in Primary Care (AMSTELHEART-1)

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Overview:

Accurately interpreting 12-lead ECGs in primary care can be challenging for clinicians due to limited training, time constraints, and variability in expertise. This study validated the PMcardio Core AI ECG Model for AI-driven ECG analysis, demonstrating 86% sensitivity and 92% specificity for major abnormalities, along with near-perfect accuracy for atrial fibrillation, highlighting its potential to enhance early case detection.

Published In: European Heart Journal
Presented Date: November 9, 2023

Background

The use of 12-lead electrocardiogram (ECG) is common in routine primary care, however it can be difficult for less experienced ECG readers to adequately interpret the ECG.

We sought to validate a novel smartphone application as a stand-alone interpretation tool for 12-lead ECG in primary care.

Methods

We recruited consecutive patients who underwent 12-lead ECG as part of routinely indicated primary care in the Netherlands. All ECGs were assessed by a smartphone application which analyses a photographed image of 12-lead ECG for automated interpretation, installed on an Android platform and an iOS platform. We validated the application for detecting: 1) any major ECG abnormality (MEA, primary outcome) defined as atrial fibrillation/flutter (AF), markers of (past) myocardial ischemia or clinically relevant impulse and/or conduction abnormalities; or 2) AF (key secondary outcome). The reference standard was a blinded expert panel.

Results

We included 290 patients from 11 Dutch general practices with median age 67 (IQR 55-74) years, 48% were female. On reference ECG, 71 patients (25%) had MEA, 35 (12%) had AF. The app’s sensitivity and specificity for MEA were 86% (95%CI:76-93) and 92% (95%CI:87-95), respectively. For AF, sensitivity and specificity were 97% (95%CI:85-100) and 99% (95%CI:97-100), respectively. Performance was comparable between Android and iOS platform (Kappa=0.95, 95%CI:0.91-0.99 and Kappa=1.00, 95%CI:1.00-1.00 for MEA and AF, respectively).

Conclusion

A smartphone application that interprets photographed 12-lead ECG images had good diagnostic accuracy in a primary care setting for major ECG abnormalities, and near-perfect properties for diagnosing AF.

Authors: J C L Himmelreich, R E Harskamp
 

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Powerful Medical leads one of the most important shifts in modern medicine by augmenting human-made clinical decisions with artificial intelligence. Our primary focus is on cardiovascular diseases, the world’s leading cause of death.

About PMcardio

PMcardio is the market leader in AI-powered diagnostics, addressing the world’s leading cause of death – cardiovascular diseases. The innovative clinical assistant empowers healthcare professionals to detect up to 40 cardiovascular diseases. In the form of a smartphone application, the certified Class IIb medical device interprets any 12-lead ECG image in under 5 seconds to provide accurate diagnoses and individualized treatment recommendations tailored to each patient.

About Powerful Medical

Established in 2017, Powerful Medical has embarked on a mission to revolutionize the diagnosis and treatment of cardiovascular diseases. We are a medical company backed by 28 world-class cardiologists and led by our expert Scientific Board with decades of experience in daily patient care, clinical research, and medical devices. The results of our research are implemented, developed, certified, and brought to market by our 50+ strong interdisciplinary team of physicians, data scientists, AI experts, software engineers, regulatory specialists, and commercial teams.

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PMcardio is CE-marked as class IIb medical device under EU MDR and only certified for marketing in the European Union and the United Kingdom. PMcardio technology has not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA. Not all modules of the PMcardio platform may be available in your region.

Prior to use, reference the Instructions for Use, for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

PMcardio is CE-marked as class IIb medical device under EU MDR and only certified for marketing in the European Union and the United Kingdom. PMcardio technology has not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA. Not all modules of the PMcardio platform may be available in your region. Prior to use, reference the Instructions for Use, for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

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