BlueCross BlueShield of Tennessee Medical Policy Manual

Computerized 2-lead Resting Electrocardiogram Analysis for the Diagnosis of Coronary Artery Disease

DESCRIPTION

Computerized 2-lead resting electrocardiogram analysis (e.g., multifunction cardiogram) has been proposed for use as a diagnostic test for coronary artery disease (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.

The multifunction cardiogram is intended to improve on the performance of the standard ECG for diagnosing CAD. 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.

There is a least one commercially available device, the Multifunction CardioGram or MCG (previously called the 3DMP device), manufactured by Premier Heart, LLC (Port Washington, NY). 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

IMPORTANT REMINDERS

ADDITIONAL INFORMATION  

The clinical utility of the multifunction cardiogram is uncertain. Screening for CAD has not been shown to improve outcomes. In the nonacute setting, the most common method for diagnosing CAD 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)

BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2017). Computerized 2-lead resting electrocardiogram analysis for the diagnosis of coronary artery disease (2.02.25). Retrieved August 8, 2017 from BlueWeb. (9 articles and / or guidelines reviewed)

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. Abstract retrieved October 7, 2016 from PubMed database.

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:  9/14/2017

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