Latest Review Date: February 2024

Category:  Medicine                                                              

POLICY:

Electrocardiographic body surface mapping is considered investigational for all indications including, but not limited to, acute coronary syndrome.

DESCRIPTION OF PROCEDURE OR SERVICE:

Electrocardiographic body surface mapping (BSM) is an electrocardiographic (ECG) technique that uses multiple electrocardiography leads to detect cardiac electrical activity. It is suggested that the use of multiple leads may result in improved diagnostic accuracy of acute myocardial infarction (AMI) or acute coronary syndrome (ACS), compared with that of the standard 12-lead ECG.  No BSM ECG devices with 80 or more leads are currently commercially available in the United States.

Electrocardiographic body surface mapping consists of an 80-lead disposable electrode array in the form of a vest and includes a conducting gel that is applied to the patient’s chest and back. The vest can be affixed to the patient in less than five minutes. This system displays clinical data in three forms: a colorimetric 3-D torso image, an 80-lead single beat view, and the 12-lead electrocardiograph (ECG). The colorimetric torso images are said to allow the practitioner to rapidly scan the heart for significant abnormalities.

Currently, in patients presenting to the emergency department with symptoms suggestive of acute coronary syndrome (ACS), a standard 12-lead ECG is obtained. In the presence of ST-segment elevation on the ECG, personnel are activated to respond in a timely manner to open a presumed coronary artery occlusion, either by mechanical means through balloon angioplasty, or medically, through intravenous thrombolytic drugs. The 12-lead ECG has a specificity of 94%, leading to relatively few erroneous interventions. However, the sensitivity is approximately 50%. These patients may be further stratified by scoring systems and time-sensitive cardiac enzymes, which may require up to 24 hours of monitored observation.

BSM has been investigated as a method to assist in the rapid identification of patients who would benefit from earlier coronary artery intervention than is achieved utilizing current standard of care.

KEY POINTS:

The most recent literature search was performed through February 14, 2024.

Assessment of a diagnostic technology focuses on the following three parameters: 1) technical performance; 2) diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) in relevant clinical populations; and 3) clinical utility, i.e., demonstration that the diagnostic information can be used to improve patient outcomes.

Summary of Evidence

For individuals who have suspected or confirmed acute cardiac syndrome who receive ECG BSM, the evidence includes a number of studies on the association between ECG BSM and AMI. Relevant outcomes are overall survival, disease-specific survival, test accuracy, test validity, and morbid events. No prospective trials using BSM to guide treatment were identified. Results of published studies have been variable and an Agency for Healthcare Research and Quality review did not find statistically significant differences in the diagnostic accuracy of BSM and 12-lead ECG. Under ideal conditions, it is possible that BSM has a higher sensitivity than a 12-lead ECG for acute coronary events. However, studies have reported lower specificity with ECG BSM compared with 12-lead ECG, which may lead to false-positive results. There is no evidence demonstrating that electrocardiographic BSM leads to changes in management that improve health outcomes. The evidence is insufficient to determine the effect of the technology on health outcomes.

Practice Guidelines and Position Statements

American Heart Association, American College of Cardiology Foundation, Heart Rhythm Society

The AHA, ACC, and HRS published a scientific statement for recommendations for the standardization and interpretation of the Electrocardiogram. They recognize that while the studies of body surface maps from large electrode arrays have provided useful information about localization of ECG information on the thorax, at this time their complexity precludes their use as a substitute for the standard 12-lead ECG for routine recording purposes.

U.S. Preventive Services Task Force Recommendations

The use of 80-lead body surface mapping ECG is not a preventive service.

KEY WORDS:

Electrocardiography, Heartscape, PRIME ECG, 80-lead electrocardiogram, multi-lead electrocardiogram, electrocardiographic body surface mapping, electrocardiographic body surface potential mapping

APPROVED BY GOVERNING BODIES:

In March 2002, the device “PRIME ECG®” (Verathon, Bothell, WA) was cleared for marketing by FDA through the 510(k) process. FDA determined that the device was substantially equivalent to existing devices for use in recording of ECG signals on the body surface. As of April 2016, neither the PRIME ECG device nor its successor, the Heartscape™ 3D ECG System are being marketed in the United States. Product code: DPS.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT Codes:

There are no specific codes for this procedure.  Use unlisted code 93799 to report.

REFERENCES:

1. Bai B, Li X, Yang C, et al. Prediction of atrial fibrillation using the recurrence complex network of body surface potential mapping signals.  Technol Health Care. 2019;27(S1):287-300.
2. Coeytaux RR WJ, Chung E, Gharacholou M. Technology Assessment. ECG-based signal analysis technologies. Prepared for the Agency for Healthcare Research and Quality (AHRQ) by the Duke Evidence-based Practice Center. 2010. Available online at: www.cms.gov/determinationprocess/downloads/id73TA.pdf.
3. Coeytaux RM, Leisy PJ, Wagner GS et al. Systematic review of ECG-based signal analysis technologies for evaluating patients with acute coronary syndrome. Agency for Healthcare Research and Quality Technology Assessment Report. Project ID: CRDD0311. June 2012. Available online at: www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id83TA-1.pdf. Last accessed December, 2013.
4. Daly MJ, Adgey JA, Harbinson MT.  Improved detection of acute myocardial infarction in patients with chest pain and significant left main stem coronary stenosis. QJM. Feb 2012; 105(2): 127-135.
5. Daly MJ, Finlay DD, Scott PJ et al. Pre-hospital body surface potential mapping improves early diagnosis of acute coronary artery occlusion in patients with ventricular fibrillation and cardiac arrest. Resuscitation 2013; 84(1):37-41.
6. Fermann GJ, Lindsell CJ, O'Neil BJ et al. Performance of a body surface mapping system using emergency physician real-time interpretation. Am J Emerg Med 2009; 27(7):816-22.
7. Gulrajani RM. The forward and inverse problems of electrocardiography. IEEE Eng Med Biol Mag 1998; 17(5):84-101, 122.
8. Hoekstra JW, O'Neill BJ, Pride YB et al. Acute detection of ST-elevation myocardial infarction missed on standard 12-Lead ECG with a novel 80-lead real-time digital body surface map: primary results from the multicenter OCCULT MI trial. Ann Emerg Med 2009; 54(6):779-88 e1.
9. Hollander JE. The 80-lead ECG: more expensive NSTEMI or Occult STEMI. Ann Emerg Med 2009; 54(6):789-90.
10. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
11. Kligfield P, Gettes LS, Bailey JJ et al. Recommendations for the standardization and interpretation of the electrocardiogram: part I: the electrocardiogram and its technology a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society endorsed by the International Society for Computerized Electrocardiology. J Am Coll Cardiol 2007; 49(10):1109-27.
12. Konrad T, Theis C, Mollnau H, et al. Body surface potential mapping for mapping and treatment of persistent atrial fibrillation. Herzschrittmacherther Elektrophysiol 2014 Dec; 25(4):226-9.
13. Lau J, Ioannidis JP, Balk EM et al. Diagnosing acute cardiac ischemia in the emergency department: a systematic review of the accuracy and clinical effect of current technologies. Ann Emerg Med 2001; 37(5):453-60.
14. Lefebvre C and Hoekstra J. Early detection and diagnosis of acute myocardial infarction: The potential for improved care with next-generation, user-friendly electrocardiographic body surface mapping. Am J Emerg Med, November 2007; 25(9): 1063-1072.
15. Leisy PJ, Coeytaux RR, Wagner GS et al. ECG-based signal analysis technologies for evaluating patients with acute coronary syndrome: a systematic review. J Electrocardiol 2013; 46(2):92-7.
16. Menown IB, Allen J, Anderson JM, et al. Early diagnosis of right ventricular or posterior infarction associated with inferior wall left ventricular acute myocardial infarction. American Journal of Cardiology 2000; 85(8): 934-938.
17. O'Neil BJ, Hoekstra J, Pride YB et al. 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. Acad Emerg Med 2010; 17(9):932-9.
18. Ornato JP, Menown IB, Peberdy MA et al. Body surface mapping vs 12-lead electrocardiography to detect ST-elevation myocardial infarction. Am J Emerg Med 2009; 27(7):779-84.
19. Owens CG, McClelland AJ, Walsh SJ, et al. Prehospital 80-LAD mapping: Does it add significantly to the diagnosis of acute coronary artery syndromes? J Electrocardiol 2004; 37(Suppl): 223-232.
20. Owens C, McClelland A, Walsh S et al. Comparison of value of leads from body surface maps to 12-lead electrocardiogram for diagnosis of acute myocardial infarction. Am J Cardiol 2008; 102(3):257-65.
21. Self WH, Mattu A, Martin M, et al. Body surface mapping in the ED evaluation of the patient with chest pain:  Use of the 80-lead electrocardiogram system. Am J Emerg Medicine 2006; 24(1): 87-112.
22. Thivierge M, Gulrajani RM, Savard P. Effects of rotational myocardial anisotropy in forward potential computations with equivalent heart dipoles. Ann Biomed Eng 1997; 25(3):477-98.
23. Zeb M, Mahmoudi M, Garty F, et al. Detection of regional myocardial ischemia by a novel 80-electrode body surface Delta map in patients presenting to the emergency department with cardiac-sounding chest pain. Eur J Emerg Med. Apr 2014; 21(2): 89-97.

POLICY HISTORY:

Medical Policy Group, June 2007 (1)

Medical Policy Administration Committee, July 2007

Available for comment July 16-September 3, 2007

Medical Policy Group, June 2009 (1)

Medical Policy Group, February 2011 (2): Description, Key Points, Key Words and References updated.

Medical Policy Group, August 2011 (1): Update to Key Points and References, no change in Policy statement

Medical Policy Group, August 2012 (1): Update to Key Points and References per MPP update; no change in Policy statement.

Medical Policy Panel, August 2013

Medical Policy Group, December 2013 (2): No change in policy statement.   Key Points and References updated with literature search through June 2013. 

Medical Policy Panel, August 2014

Medical Policy Group, August 2014 (3): 2014 Updates to Key Points, Governing Bodies & References; no change in policy statement

Medical Policy Panel, August 2015

Medical Policy Group, August 2015 (4): Updates to Key Points.  Clarified policy statement to state ECG BSM is investigational ‘for all indications’ including ‘but not limited to’ ACS.  Intent remains unchanged, still investigational.

Medical Policy Panel, July 2017

Medical Policy Group, July 2017 (4): Updates to Description, Key Points, and Approved by Governing Bodies. No change to policy statement. Policy retired.

Medical Policy Group, December 2017:  Annual Coding Update 2018.  Created previous coding section and moved deleted CPT codes 0178T – 0180T to this section.  Added existing unlisted CPT code to current coding.

Medical Policy Panel, August 2019

Medical Policy Group, August 2019 (4): Updates to Key Points. No change to Policy Statement. Reviewed by consensus. No new published peer-reviewed literature available that would alter the policy statement.

Medical Policy Group, February 2021 (4):  Updates to Key Points and References. Removed Previous Coding section with codes 0178T-0180T deleted 12/31/17. No change to policy statement. 

Medical Policy Group, February 2022 (4): Reviewed by consensus. Reference added. No new published peer-reviewed literature available that would alter the policy statement.

Medical Policy Group, February 2023 (4): Reviewed by consensus.  No new published peer-reviewed literature available that would alter the policy statement.

Medical Policy Group, February 2024 (4): Reviewed by consensus.  No new published peer-reviewed literature available that would alter the policy statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.