PMcardio Launches World’s First Certified AI-Powered Medical Device to Detect Acute Coronary Occlusion From the ECG

Published December 6, 2023

New York, United States, 5. December 2023

PMcardio announces the launch of the Queen of Hearts, a certified medical device AI algorithm that represents a landmark moment in detecting and consequently timely treatment of acute obstructive heart attacks, termed acute Occlusion Myocardial Infarction (OMI). With 50 million patients worldwide presenting to emergency departments with chest pain annually, the current standard of care often misidentifies and delays treatment in 50% of OMI patients who urgently need intervention. On the other hand, most hospitals also suffer from 20-40% false positive cath lab activation rates due to false positive ST elevation criteria.

The OMI Paradigm has been pioneered by Prof. Dr. Stephen W. Smith and Dr. H. Pendell Meyers. It addresses the limitations of the traditional dichotomous STEMI/NSTEMI model, which neglects dynamic ECG changes throughout the evolution of occlusive myocardial infarction requiring emergent reperfusion. The OMI identification at the time of the first point of contact is challenging and may require sequential ECG evaluations, leading to unnecessary and potentially harmful delays in myocardial revascularization.

Recognizing subtle and complex patterns on ECGs, the OMI AI Model was found to be twice as sensitive compared to the current standard of care and detected acute coronary obstructed heart attacks (STEMI equivalents) three hours earlier.

“When treating patients with symptoms potentially indicating Acute Coronary Syndrome (ACS), immediate and accurate diagnosis is crucial for timely intervention. The Queen of Hearts leverages decades of our ECG morphology research to accurately distinguish acute occlusions from patterns which mimic them, going beyond mere ST-elevation analysis”, states Dr. Smith,faculty physician at the Emergency Medicine Residency, Hennepin County Medical Center, Professor of Emergency Medicine at the University of Minnesota, and founder of Dr. Smith’s ECG Blog.

Specifically targeting acute OMI, the Queen of Hearts was developed using a comprehensive dataset of 18,616 ECGs from 10,543 patients suspected of ACS, sourced from an international database with angiographically validated outcomes. 

Its performance was rigorously evaluated in an international cohort and compared to the conventional STEMI criteria and assessments by ECG experts. The AI model demonstrated an impressive area under the curve (AUC) of 0.938 for identifying OMI. It exhibited superior performance with an accuracy of 90.9%, sensitivity of 80.6%, and specificity of 93.7%, surpassing the STEMI criteria and aligning with the proficiency of ECG experts. These published findings are detailed in the European Heart Journal – Digital Health.

“The OMI AI Model demonstrates unparalleled promise in treating acute coronary patients with acute occlusive coronary lesions. The rapid and accurate identification of such patients often presents without typical ST-elevation at first medical contact – either in the ambulance or emergency triage. From a single ECG, the tool immediately provides the pivotal clinical solution to prevent increased risk for heart failure or mortality due to delayed revascularization of large myocardial infarctions”, states Dr. Jozef Bartunek, Co-Director of Cardiovascular Center Aalst, OLV Hospital in Belgium.

Serving as a critical link between emergency physicians and cardiologists, the OMI AI Modelensures that both specialties align in the swift and accurate diagnosis of acute coronary occlusions. This ensures that patients receive immediate and appropriate care and are quickly prioritized upon arrival at the emergency department.

“The impact of our technology is not limited to the immediate treatment of heart attacks; it extends into the future well-being of patients. Our AI models in development focus on ECG-based screening for heart failure as early as asymptomatic patients presenting for a routine check-up to their GP and early recognition of sudden cardiac death, such as Brugada and Hypertrophic Cardiomyopathy, ensuring patients have the best chance for a healthier, longer life”, concludes Dr. Robert Herman, Research, Digital, and Innovation Committee Member at the European Society of Cardiology and Chief Medical Officer at Powerful Medical, the deep-tech company behind PMcardio.

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 diagnose up to 40 cardiovascular diseases with the precision of a cardiologist. 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 the Queen of Hearts:

PMcardio’s OMI AI Model, also known as the Queen of Hearts, enables physicians to detect Occlusion Myocardial Infarction (OMI) from any 12-lead ECG regardless of typical ST-elevation. The current gold standard misidentifies half of patients in urgent need of treatment for Acute Coronary Occlusion. The Queen of Hearts was developed and clinically validated to improve the early diagnosis of acute obstructive heart attacks in order to improve patient referral and outcomes.

Collaboration contact:

Media Contact:
Lucia Bojkovska

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