Computer-Enhanced Frequency-Domain and 12-Lead Electrocardiography Accurately Detect Abnormalities Consistent With Obstructive and Nonobstructive Coronary Artery Disease

Abstract

Noninvasive methods of identifying coronary artery disease are not consistently accurate. To identify abnormalities associated with angiographically determined coronary artery disease, the authors sought to quantify the utility of a new device, a digital database-driven multiphase electrocardiograph system (3DMP), which produces a computer-enhanced frequency/time-domain resting electrocardiogram, in conjunction with a 12-lead electrocardiogram. The authors compared resting 3DMP results from those of coronary angiograms to identify abnormalities associated with coronary artery disease in a random sample of 136 patients. Using a discrete-Fourier transform signal-averaging variant and a series of mathematic transformations, the computer-expert system analyzed signals in the 0.1- to 50-Hz range. The system identified abnormalities by comparing results with a 21,000-patient database culled from predicate research. The system detected abnormalities in 96.0% of patients subsequently found to have 70% or greater stenosis by angiography. For patients with a 40% or less times a more than 50% occlusion, the system detected abnormalities in 75% of cases. For patients with a 50% or less times a 70% or less occlusion, it detected abnormalities in 90% of cases. Overall sensitivity for the study was 93.3% (positive predictive value, 91.2%; specificity, 83%; negative predictive value, 86.7%). No gender differences were detected. A 3DMP electrocardiograph system combined with 12-lead electrocardiography appears to have measurable, diagnostic utility in identifying 3DMP abnormalities associated with coronary artery disease, and warrants further study.

A Paired-Comparision of the MultiFunction CardioGramsm (MCG) and Sestamibi SPECT Myocardial Perfusion Imaging (MPI) to Quantitative Coronary Angiography for the Detection of Relevant Coronary Artery Obstruction (≥70%) - A Single-Center Study of 116 Consecutive Patients Referred for Coronary Angiography

“…The study only permitted patients with an abnormal SPECT MPI test, significant VHD with/without a normal SPECT MPI test, or patients with persistent coronary symptoms and a normal SPECT MPI test to undergo cardiac catheterization. While the MCG findings were consistent with the prior published data 6-10, SPECT MPI was associated with a high number of false positives (46%) that led to angiography in 54 patients whose management did not change based on the results, therefore, arguably making the angiogram medically unnecessary.…”

“…Stress MPI studies were all performed using standard SPECT techniques and VHD was defined using ASE guideline-based recommendations for severity assessment with TTE. Based on data from previously conducted trials 6-10, an MCG CO score of ≥ 4.0 was considered abnormal and indicative of the presence of relevant CO (≥70%) in one or more coronary arteries or bypass grafts. 49 patients with either normal or equivocal stress MPI results, and insignificant VHD, and no persistent chest pain were not recommended for CA, and, thus were excluded from analysis in the trial.…”

“…The Multifunction Cardiogram™ (MCG) has been studied as an innovative computational electro-physiologic signal analysis tool for the non-invasive diagnosis of relevant CO/ischemia (≥70%) 6-10. In three previous double-blind, controlled, clinical trials of patients scheduled to undergo elective coronary angiography 6-9 MCG accurately identified 88% of the patients finally found to either have or not have relevant CO (≥70%).…”

“…In three previous double-blind, controlled, clinical trials of patients scheduled to undergo elective coronary angiography 6-9 MCG accurately identified 88% of the patients finally found to either have or not have relevant CO (≥70%). Limitations of these studies included the lack of a standardized non-invasive diagnostic testing algorithm prior to angiography making it difficult to compare the predictive value of MCG to that of SPECT MPI or other non-invasive diagnostic testing modalities, and that the indications for angiography varied among patients.…”

Computerized two-lead resting ECG analysis for the detection of coronary artery stenosis after coronary revascularization

“…The database against which the incoming ECG results are compared originated from data gathering trials conducted from 1978 to 2000 in more than 30 institutions in Europe, Asia, and North America on individuals of varying ages and degrees of disease state including normal populations 20,21. All ECG analyses in this database have been validated against the final medical diagnosis of at least two independent expert diagnosticians in the field, including results of angiography and enzyme tests.…”