- Multifunction cardiogram
Multifunction CardioGramTM (MCGTM) is an FDA and AMA approved diagnostic tool used to diagnose myocardial ischemia due to Coronary Artery Disease (CAD). MCG records resting ECG data between the Myocardium and intra-cardiac blood flow to accurately detect CAD without the stress, radiation, chemicals and invasiveness of the current modality set.
The MCG test consists of an 82 second test where leads II and V5 resting cardiac electrical signals are collected, digitized, encrypted and sent to Premier Heart's data center. The data is then analyzed and transformed into multiple mathematical functions. These mathematical models produce a matrix based on 166 different indices that are then compared against a database of more than 40,000 patients with a broad range of clinically verified myocardial ischemia. A summarized report is returned to the physician via internet connection to the MCG unit in less than 10 minutes.
Prospective double blind clinical trails have demonstrated MCG's diagnostic accuracies with overall sensitivity at 90+%, specificity at 83% and a negative predictive value of 93% when compared to the gold standard coronary angiography [2,3,4,5,and 6]. Recently, MCG was compared to myocardial perfusion scan or nuclear stress testing.
MCG Technology is designed and engineered to use the principles of Cybernetics or Control Theory (discovered by Norbert Wiener) applied to biological systems (see the attached introductory chapters) approach to model the entire human heart as "a whole system". This is achieved using a series of mathematical functions to deconstruct then reconstruct the information regarding the feed back embedded between the input (lead II) and the output (lead V5) or vice versa. The computational electrophysiological diagnostic system depicts the interaction between the entire myocardium and its intracardiac blood supply using the electrical signals collected from only two left ventricular leads (V5 and II), backed by a large cross sectional empirical database.
MCG Technology embodies a systems analysis approach and is the first clinically valid and commercially viable device increasingly used by physicians in their daily practices successfully to improve diagnostic accuracy for certain difficult to diagnose heart diseases, i.e. coronary ischemia.
Scientists and engineers have used similar methods to measure things such as the performance of a electrical grid in a geographic region, the predictability/interoperability/stability of a financial system, or even the presence of dark matters in the universe. MCG is the first system of this kind used to study the human heart.
Premier Heart's Multifunction CardioGram TM a.k.a. MCG is the first of its kind adopting Cybernetic principals  based on Systems Analysis. It is the marriage of computer technology, digital empirical clinical database and clinical expertise to solve modern medicine's difficult challenges , such as accurate stress, radiation and drug free non-invasive diagnosis of myocardial ischemia due to coronary artery disease.
In a recent clinical study by John Strobeck, M.D., MCG was compared directly with SPECT Nuclear MPI, and the results were verified using Coronary Angiography. In this study, hemodynamically relevant stenosis was diagnosed at cardiac catheterization in 53 of 116 patients (46%). The MCG device, after performing a computational analysis of two resting ECG leads (II and V5) in the frequency domain, calculated a “disease- severity” score from 0 to 20 for each patient. The severity score was significantly higher for patients with relevant coronary stenosis (5.4 ± 1.9 vs. 2.5 ± 1.9). The MCG (using a cut-off score for relevant stenosis of ≥ 4.0) correctly classified 103 of the 116 patients (89%) enrolled in the study as either having or not having relevant coronary stenosis (sensitivity- 91%; specificity- 87%; NPV- 92%; PPV- 86%). Subgroup analysis showed no significant influence of sex, age, history of hypertension, presence of LVH, history of diabetes, history of previous revascularization procedures (CABG or PCI), or resting ECG morphology, on the MCG device’s diagnostic performance. However, in 12 patients who were anemic at the time of their participation in the study, there was a trend toward a lower MCG specificity (71%) but this was not statistically significant due to the small number of anemic patients. SPECT nuclear myocardial perfusion imaging was abnormal in 99 of the 116 patients undergoing catheterization (85%), but only correctly classified 54 of the 116 patients (47%) entered in the study as either having or not having relevant coronary stenosis (sensitivity-85%; specificity–14%; NPV – 53%; PPV- 45%).
The new mathematical, resting ECG signal analysis Internet Based technology adopting Cybernetic principals in Systems Theory (MultiFunction-CardioGram) has been shown in this paired-comparison trial between the MCG, SPECT nuclear myocardial perfusion imaging, and coronary angiography to safely, accurately, and objectively identify patients with relevant coronary stenosis (>70%) with high sensitivity and specificity and high negative predictive value. Its overall performance was equal to, if not better, than SPECT nuclear MPI. Its potential use in the early evaluation of symptomatic coronary artery disease is present.
MCG is a completely non-traditional approach with a foundation in applied bio-mathematics based on Systems Analysis. Systems analysis is the dissection of a system into its component pieces to study how those component pieces interact and work. The MCG technology performs a systems analysis first and then subsequently a systems synthesis. Systems synthesis is the re-assembly of a system's component pieces back into a whole system-it is hoped an improved system. Through systems analysis and synthesis, we may add, delete, and modify system components toward our goal of improving the overall system. The approach of systems thinking is fundamentally different from the traditional ways of thinking and conducting business. Instead of focusing on the individual pieces of what is being studied, systems thinking focuses on the feed back relationships between the output of interest and another part of the same system. Therefore, instead of isolating smaller and smaller parts of a system, say an individual (or multiple) iron channel(s) or a protein, DNA or RNA molecule in vitro, or a segment of a single lead ECG signal analog waveform, such as S-T segment or Q-T interval, in contrast, systems analysis involves a much broader view of the system of interest, in our case the human heart as the whole organ, by looking at larger and larger interactions of at least two "life signal sources" the organ system and enabling us to understand the dynamics of the life organ better from a panoramic or the "big picture" view in vivo and in real time.
- – Multifunction Cardiogram Manufacturer's Website
- - Manufacturer's list of clinical trials and results
- - Insurance coverage determination (HighMark Medicare)
- Patel, MR, Peterson, ED, Dai, D, et al., N Engl J Med 2010;362:886-95.
- Weiss MB, Narasimhadevara SM, Feng GQ, Shen JT. Heart Dis. 2002;4:2-12.
- Grube E, Bootsveld A, Yuecel S, et al.. Int J Med Sci. 2007;7:249-263.
- Grube, E, Bootsveld, A, Buellesfeld, L, et al. Int J Med Sci. 2008 5(2):50-61.
- Hosokawa, J., Shen, JT, and Imhoff, M. Congestive Heart Failure 2008 14: pp. 251-260.
- Strobeck, JE, Shen, JT, Singh, B et al. Int J Med Sci. 2009; 6(4):143-155.
- Strobeck, Mangieri, Rainford, Imhoff J. Am. Coll. Cardiol. 2011;57;E48 doi:10.1016/S0735-1097(11)60048-X A Paired-Comparison of the MultiFunction CardioGramsm (MCG) and SPECT Myocardial Perfusion Imaging to Quantitative Coronary Angiography
- Principals of Diagnostic Machine Construction 
- Control Theory and Systems Biology 
- "Cybernetics: Or Control and Communication in the Animal and the Machine" [Paris, (Hermann & Cie) & Camb. Mass. (MIT Press) ISBN 9780262730099; 2nd revised ed. 1961]
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