Electrocardiographic body surface mapping (BSM) is an electrocardiographic (ECG) technique that uses multiple (generally 80 or more) leads to detect cardiac electrical activity. The disposable electrode array (e.g. PRIME ECG®) is in the form of a vest that includes a conducting gel applied to the patient’s chest and back. The vest can be affixed to the patient in less than 5 minutes.
This system displays clinical data in three forms; a colored 3-D torso image, an 80-lead single beat view, and the 12-lead electrocardiograph (ECG). The colored torso images are said to allow the practitioner to rapidly scan the heart for significant abnormalities. It has been suggested that the use of multiple leads may result in improved diagnostic accuracy compared to that of the standard 12-lead ECG.
Proposed uses for this device are the early evaluation and rapid identification of individuals who would benefit from earlier coronary artery intervention than is achieved utilizing current standard of care.
Electrocardiographic body surface mapping for the diagnosis or management of all disorders, including but not limited to acute coronary syndrome is considered investigational.
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.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
The 2012 AHRQ technology assessment did not find a statistically significant difference in the diagnostic accuracy of BSM compared with a standard 12-lead ECG. There are no studies that demonstrate how BSM can be used to change clinical management in ways that improve health outcomes Therefore, this technology remains investigational.
Agency for Healthcare Research and Quality (2012, June) Technology Assessment Program: Systemic review of ECG based signal analysis technologies for evaluating patients with acute coronary syndrome. Retrieved June 23, 2017 from http://www.ahrq.gov.
Aryana, A., O’Neill, P., & d’Avila, A. (2015). Noninvasive electrocardiographic mapping: are we ready for prime time? Journal of the American Heart Association, 4 (10), e002655.
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2015). Electrocardiographic body surface mapping (2.02.23). Retrieved June 23, 2017 from BlueWeb. (16 articles and / or guidelines reviewed)
Huebner, T., Goernig, M., Scheupback, M., Sanz, E., Pilgram, R., Seeck, A., Voss, A., et.al. (2010) Electrocardiologic and related methods of non-invasive detection and risk stratification in myocardial ischemia: state of the art and perspectives. German Medical Science 2010, Vol. 8, ISSN 1612-3174. (Level 5 evidence)
Leisy, P., Coeytaux, R., Wagner, G., Chung, E., McBroom A., Green C. et. al., (2013, March-April) ECG-based signal analysis technologies for evaluating patients with acute coronary syndrome: a systematic review. Journal of Electro cardiology ;46(2):92-7. Abstract retrieved June 23, 2017 from PubMed database.
National Government Services, Inc. (2016, February) Local Coverage Determination (LCD): Category III CPT® Codes (L33392). Retrieved July 25, 2016 from https://www.cms.gov.
O'Neil, B., Hoekstra, J., Pride, Y., Lefebvre, C., Diercks, D., Frank-Peacock, W., et. al. (2010, September) Incremental benefit of 80-lead electrocardiogram body surface mapping over the 12-lead electrocardiogram in the detection of acute coronary syndromes in patients without ST-elevation myocardial infarction: Results from the Optimal Cardiovascular Diagnostic Evaluation Enabling Faster Treatment of Myocardial Infarction (OCCULT MI) trial. Academy of Emerging Medicine; 17(9):932-9. Abstract retrieved June 23, 2017 from PubMed database.
Revishvili, A., Wissner, E., Lebedev, D., Lemes, C., Deiss, S., Metzner, A., et al. (2015). Validation of the mapping accuracy of a novel non-invasive epicardial and endocardial electrophysiology system. Europace, 17 (8), 1282-1288. (Level 5 evidence)
U. S. Food and Drug Administration. (2002, March). Center for Devices and Radiologic Health. 510(k)Premarket Notification Database K012414 (PRIME™ ECG). Retrieved September 2, 2015 from http://www.fda.gov.
U. S. Food and Drug Administration. (2014, November). Center for Devices and Radiologic Health. 510(k) Premarket Notification Database K140497 (InSight™). Retrieved July 25, 2016 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2015, July). Center for Devices and Radiologic Health. 510(k) Premarket Notification Database K150990 (ECVUE™ Mapping System). Retrieved July 25, 2016 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Medical Technology Directory. (2011, December; Archived January 2017) Electrocardiogram signal analysis for diagnosis of coronary artery disease: body surface mapping. Retrieved June 23, 2017 from www.Hayesinc.com/subscribers. (88 guidelines and/or articles reviewed)
Zhou, Z., Jin, Q., Yu, L., Wu, L., and He, B.(2016, October) Noninvasive imaging of human atrial activation during atrial flutter and normal rhythm from body surface potential maps. PLOS ONE. Article #0163445. (Level 3 evidence)
ORIGINAL EFFECTIVE DATE: 4/4/2011
MOST RECENT REVIEW DATE: 8/10/2017
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.