DESCRIPTION
Computerized 2-lead resting electrocardiogram analysis (e.g., multifunction cardiogram) is proposed for use as a diagnostic test for coronary artery disease (CAD) and is intended to improve on the performance of the standard ECG. The study device records a 2-lead EKG tracing for 82 seconds using leads II and V5 together with proprietary hardware and software. The analog EKG tracing is then amplified, digitized, down-sampled to a rate of 100Hz, and encrypted for digital transmission. The digitized information is transmitted to a central server for further analysis. At the central server, the tracings undergo a series of mathematical transformations and signal averaging. There are 6 mathematical transformations included: power spectrum, coherence, phase angle shift, impulse response, cross-correlation, and transfer function. Following these transformations, the patterns found in the tracing are compared to a large reference database collected by the manufacturer. A severity score is generated, indicating the likelihood that CAD is present. The severity score ranges from 0-20, with a score of 4.0 suggested as the cutoff for the presence of clinically significant CAD.
Stress testing, either at rest or with exercise, combined with single-photon emission computed tomography (SPECT) or echocardiographic imaging, is the most common initial test in the diagnostic work-up of chronic CAD. Sensitivities and specificities for stress testing vary, but generally fall in the 75%-90% range. Cardiac angiography is the gold standard for diagnosing CAD and is used in situations where CAD needs to be confirmed following stress testing.
There is at least one commercially available device, the Multifunction CardioGram or MCG (previously called the 3DMP device). In April 2003, the 3DMP device was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process.
POLICY
Computerized 2-lead resting electrocardiogram analysis (e.g., multifunction cardiogram) for diagnosing coronary artery disease is considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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ADDITIONAL INFORMATION
The most common method for diagnosing CAD in the non-acute setting is stress testing. There is no evidence comparing the accuracy of multifunction cardiogram with stress testing. The evidence is insufficient to determine the effects of the technology on health outcomes.
SOURCES
Amano, T., Shinoda, N., Kunimura, A., Harada, K., Uetani, T., Takashima, H., et al. (2014). Non-invasive assessment of functionally significant coronary stenoses through mathematical analysis of spectral ECG components. Openheart, 2014, e000144. (Level 3 evidence)
Kawaji, T., Shiomi, H., Morimoto, T., Nishikawa, R., Yano, M., Higami, H., et al. (2015). Noninvasive detection of functional myocardial ischemia: multifunction cardiogram evaluation in diagnosis of functional coronary ischemia study (MED-FIT). Annals of Noninvasive Electrocardiology, 20 (5), 446-453. (Level 4 evidence)
Strobeck, J.E., Mangieri, A., & Rainford, N. (2011). A paired-comparison 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 16 consecutive patients referred for coronary angiography. International Journal of Medical Sciences, 8 (8), 717-724. (Level 3 evidence)
U. S. Food and Drug Administration. (2000, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K992703. Retrieved March 10, 2014 from http://www.accessdata.fda.gov/cdrh_docs/pdf/k992703.pdf.
ORIGINAL EFFECTIVE DATE: 4/24/2011
MOST RECENT REVIEW DATE: 6/8/2023
ID_BT
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