Diagnostic Accuracy of a New Cardiac Electrical Biomarker for Detection of Electrocardiogram Changes Suggestive of Acute Myocardial Ischemic Injury

Abstract

ObjectiveA new cardiac “electrical” biomarker (CEB) for detection of 12-lead electrocardiogram (ECG) changes indicative of acute myocardial ischemic injury has been identified. Objective was to test CEB diagnostic accuracy.MethodsThis is a blinded, observational retrospective case-control, noninferiority study. A total of 508 ECGs obtained from archived digital databases were interpreted by cardiologist and emergency physician (EP) blinded reference standards for presence of acute myocardial ischemic injury. CEB was constructed from three ECG cardiac monitoring leads using nonlinear modeling. Comparative active controls included ST voltage changes (J-point, ST area under curve) and a computerized ECG interpretive algorithm (ECGI). Training set of 141 ECGs identified CEB cutoffs by receiver-operating-characteristic (ROC) analysis. Test set of 367 ECGs was analyzed for validation. Poor-quality ECGs were excluded. Sensitivity, specificity, and negative and positive predictive values were calculated with 95% confidence intervals. Adjudication was performed by consensus.ResultsCEB demonstrated noninferiority to all active controls by hypothesis testing. CEB adjudication demonstrated 85.3–94.4% sensitivity, 92.5–93.0% specificity, 93.8–98.6% negative predictive value, and 74.6–83.5% positive predictive value. CEB was superior against all active controls in EP analysis, and against ST area under curve and ECGI by cardiologist.ConclusionCEB detects acute myocardial ischemic injury with high diagnostic accuracy. CEB is instantly constructed from three ECG leads on the cardiac monitor and displayed instantly allowing immediate cost-effective identification of patients with acute ischemic injury during cardiac rhythm monitoring.

Diagnostic value of the cardiac electrical biomarker, a novel ECG marker indicating myocardial injury, in patients with symptoms suggestive of non‐ST‐elevation myocardial infarction

“…The findings of this large diagnostic study extend and corroborate previous pilot studies on the possible clinical utility of the CEB for the diagnosis of AMI (Schreck & Fishberg, , ). In the largest published series to date, Schreck and Fishberg used 508 ECG obtained from various ECG databases and reported a sensitivity of 85%–94% and a specificity of 93% for the CEB to automatically detect standard ECG changes suggestive of myocardial ischemia (Schreck & Fishberg, ).…”

“…The findings of this large diagnostic study extend and corroborate previous pilot studies on the possible clinical utility of the CEB for the diagnosis of AMI (Schreck & Fishberg, , ). In the largest published series to date, Schreck and Fishberg used 508 ECG obtained from various ECG databases and reported a sensitivity of 85%–94% and a specificity of 93% for the CEB to automatically detect standard ECG changes suggestive of myocardial ischemia (Schreck & Fishberg, ). These results however must not be confounded with the diagnostic accuracy of the CEB for AMI: given that the gold standard was the presence of standard ECG changes suggestive of AMI during manual ECG interpretation, a NSTEMI patient without ECG changes (which is the case in more than half of all NSTEMI patients) was classified as a non‐AMI patient in that study.…”

“…Using this cutoff value yielded sensitivity, specificity, negative predictive values (NPV), and positive predictive values (PPV) of 68%, 53%, 91%, and 19%. The diagnostic results of the previously published CEB thresholds of 65 and 95 are shown in Table (Schreck & Fishberg, ).…”

“…The cardiac electrical biomarker (CEB) has been investigated as a novel ECG marker quantifying the multipolar versus dipolar activity of the heart with higher levels possibly indicating acute myocardial ischemic injury (Schreck & Fishberg, ). Multipolar activity rises from myocardial ischemic injury altered polarization behavior of affected myocardial cells.…”

“…Multipolar activity rises from myocardial ischemic injury altered polarization behavior of affected myocardial cells. Two pilot studies showed a high diagnostic accuracy of the CEB for the detection of AMI when compared to standard ST‐segment analysis (Schreck & Fishberg, , ). A third study found an association between increased CEB values and increased high‐sensitive cardiac troponin I (hs‐cTnI) levels (Tereshchenko, Gatz, Feeny, & Korley, ).…”