Comparison of a Two-Lead, Computerized, Resting ECG Signal Analysis Device, the MultiFunction-CardioGram^sm or MCG (a.k.a. 3DMP), to Quantitative Coronary Angiography for the Detection of Relevant Coronary Artery Stenosis (>70%) - A Meta-Analysis of all Published Trials Performed and Analyzed in the US

Abstract

Background: Accurate, non-invasive diagnosis of, and screening for, coronary artery disease (CAD) and restenosis after coronary revascularization has been a challenge due to either low sensitivity/specificity or relevant morbidity associated with current diagnostic modalities.Methods: To assess sensitivity and specificity of a new computerized, multiphase, resting electrocardiogram analysis device (MultiFunction-CardioGramsm or MCG a.k.a. 3DMP) for the detection of relevant coronary stenosis (>70%), a meta-analysis of three published prospective trials performed in the US on patient data collected using the US manufactured device and analyzed using the US-based software and New York data analysis center from patients in the US, Germany, and Asia was completed. A total of 1076 patients from the three trials (US - 136; Germany - 751; Asia - 189) (average age 62 ± 11.5, 65 for women, 60 for men) scheduled for coronary angiography, were included in the analysis. Patients enrolled in the trials may or may not have had prior angiography and/or coronary intervention. Angiographic results in all studies were classified for hemodynamically relevant stenosis (> 70%) by two US based angiographers independently.Results: Hemodynamically relevant stenosis was diagnosed in 467 patients (43.4%). The device, after performing a frequency-domain, computational analysis of the resting ECG leads and computer-database comparison, calculated a coronary ischemia “severity” score from 0 to 20 for each patient. The severity score was significantly higher for patients with relevant coronary stenosis (5.4 ± 1.8 vs. 1.7 ± 2.1). The study device (using a cut-off score for relevant stenosis of 4.0) correctly classified 941 of the 1076 patients with or without relevant stenosis (sensitivity-91.2%; specificity-84.6%; NPV 0.942, PPV 0.777). Adjusted positive and negative predictive values (PPV and NPV) were 81.9% and 92.6%, respectively (ROC AUC = 0.881 [95% CI: 0.860-0.903]). Subgroup analysis showed no significant influence of sex, age, race/nationality, previous revascularization procedures, resting ECG morphology, or participating center on the device's diagnostic performance.Conclusions: The new computerized, multiphase, resting ECG analysis device (MultiFunction-CardioGramsm) has been shown in this meta-analysis to safely and accurately identify patients with relevant coronary stenosis (>70%) with high sensitivity and specificity and high negative predictive value. Its potential use in the evaluation of symptomatic patients suspected to suffer from coronary disease/ischemia is discussed.

Noninvasive mathematical analysis of spectral electrocardiographic components for coronary lesions of intermediate to obstructive stenosis severity–relationship with classic and functional SYNTAX score

“…Compared with the ischemia level in the previous reports , the SS and FSS in the present study have better prognostic values . Therefore, the relationship between the MCG, and the SS and FSS observed in this study might contribute not only to the reduction of unnecessary CAGs but also in providing the potential risk stratification, especially in patients who are not able to exercise and have low kidney function.…”

“…Hence, in the clinical setting, many unnecessary CAGs are often performed, resulting in increased risks of safety and economic problems. Meanwhile, the MCG has been studied as an innovative computational electrophysiological signal analysis tool for the noninvasive diagnosis of relevant ischemia . In the present study, we related the relatively high accuracy of the MCG to the FSS, therefore providing an alternative for contemporary noninvasive diagnostic modalities for the detection of relevant ischemia as a gatekeeper for CAG, especially in patients who are not able to perform exercise and have low kidney function.…”

“…The MCG reports also indicate the level of myocardial damage and severity integrated into a score; other information such as coronary damage, area of damage, and myocardial pathological and pathophysiological conditions are included in the report. An MCG score of 4 was used as the cutoff score in most published clinical trials . In this study, we used the cut‐off score of 4 but investigated the scoring method further.…”

“…The multifunction cardiogram (MCG) is a new computer‐enhanced, multiphase, resting electrocardiographic (ECG) analysis device that improves the quality of noninvasive tests. It has been used to determine the optimal decision‐making algorithm for the evaluation of suspected obstructive CAD . Recently, we reported the association between noninvasive MCG and classic coronary lesion scores .…”

Higher serum VGF protein levels discriminate bipolar depression from major depressive disorder

“…The AUC was 0.732 and the sensitivity was high, when diagnosing MDD, but the specificity was low. According to previous knowledge (Deeks & Altman, 2004;Strobeck et al, 2009), because the +LR was higher than 10 and −LR was lower than 0.1, serum VGF level was strong prediction in distinguish BD from MDD. Similarly, serum VGF level could be used to diagnose BD for the +LR and -LR were higher than 2 and lower than 0.5, respectively.…”