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22 October 2017

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Int J Med Sci 2009; 6(4):143-155. doi:10.7150/ijms.6.143

Research Paper

Comparison of a Two-Lead, Computerized, Resting ECG Signal Analysis Device, the MultiFunction-CardioGramsm 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

John E. Strobeck, Joseph T. Shen, Binoy Singh, Kotaro Obunai, Charles Miceli, Howard Sacher, Franz Ritucci, Michael Imhoff

The Valley Hospital, Ridgewood, NJ and Columbia University College of Physicians and Surgeons, New York, NY, USA

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.

Keywords: coronary artery disease, ECG analysis, Coronary Artery Stenosis

This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY-NC) License. See http://ivyspring.com/terms for full terms and conditions.
How to cite this article:
Strobeck JE, Shen JT, Singh B, Obunai K, Miceli C, Sacher H, Ritucci F, Imhoff M. Comparison of a Two-Lead, Computerized, Resting ECG Signal Analysis Device, the MultiFunction-CardioGramsm 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. Int J Med Sci 2009; 6(4):143-155. doi:10.7150/ijms.6.143. Available from http://www.medsci.org/v06p0143.htm