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MP 2.02.23 Electrocardiographic Body Surface Mapping

Medical Policy    
Section
Medicine 
Original Policy Date
6:2007 
Last Review Status/Date
Reviewed with literature review/8:2013
Issue
8:2013
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. 


Description

Electrocardiographic (ECG) body surface mapping (BSM) is a technique that uses multiple (generally 80 or more) electrocardiography leads to detect cardiac electrical activity. The use of multiple leads may result in improved diagnostic accuracy, compared to that of the standard 12-lead ECG. One potential use of this device is in the early evaluation of occult ischemia in patients who do not meet the current definition of ST elevation myocardial infarction (STEMI). Another potential use is a more rapid stratification of low-risk chest pain patients who present to the emergency department.

Background

Electrocardiographic body surface mapping (BSM) 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 5 minutes. This system displays clinical data in 3 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 myocardial ischemia, 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 is being considered 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. The negative predictive value of the test, which has the potential to identify patients who do not require further evaluation with serial cardiac enzymes and clinical observation, is not currently receiving attention as a research topic.

Regulatory Status

In March 2002, the device “PRIME ECG®” (Verathon, Bothell, WA) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that the device was substantially equivalent to existing devices for use in recording of ECG signals on the body surface.

Note: This policy only addresses use of this technique in the diagnosis or management of acute myocardial infarction or acute coronary syndrome and not the diagnosis or management of coronary artery disease (CAD).


Policy

Electrocardiographic body surface mapping is considered investigational for the diagnosis or management of cardiac disorders including acute coronary syndrome.


Policy Guidelines

Beginning July 1, 2007, there are 3 CPT category III codes specific to this procedure:

0178T: Electrocardiogram, 64 leads or greater, with graphic presentation and analysis; with interpretation and report

0179T: tracing and graphics only, without interpretation and report

0180T: interpretation and report only


Benefit Application

BlueCard/National Account Issues

Some state or federal mandates (e.g., FEP) prohibit Plans from denying FDA-approved technologies as investigational. In these instances, Plans may have to consider the coverage eligibility of FDA-approved technologies on the basis of medical necessity alone.


Rationale

This policy was originally created in 2007 and was regularly updated with searches of the MEDLINE database. The most recent literature search was performed for the period of June 2012 through June 27, 2013. Following is a summary of the key literature to date:

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.

TechnicalPerformance

The investigation of additional leads in electrocardiography and body surface mapping (BSM) is not new. Patterns of electric potentials in normal subjects have been established, and the significance of abnormal signals has been explored over past decades. (1, 2)

A 2006 publication describes the use of the 80-lead technique in the evaluation of patients with chest pain in the emergency department. (3) The authors comment that use of this approach has been hampered by slow acquisition time and the complexity of interpretation but that technologic advances are overcoming these limitations. However, they add that the future of BSM in emergency medicine is unclear and that more research is needed to define its benefits and limitations.

In 2007, Lefebvre and Hoekstra described the improvements in technical performance and ease of use in recent modifications to BSM technologies. A standardized vest improves lead placement, and changes to software direct clinicians’ attention to locations on the body mapping that may be significant, possibly reducing the amount of training needed. (4)

DiagnosticAccuracy

For patients with suspected ischemia, does electrocardiographic body surface mapping (BSM) improve the accuracyof diagnosis for acute myocardial infarction (AMI) and/or acute coronary syndrome (ACS), compared to standard12-lead ECG?

In June 2012, the Agency for Healthcare Research and Quality (AHRQ) published a technology assessment on the diagnostic utility of electrocardiographic (ECG)-based signal analysis technologies for patients at low to intermediate risk of coronary artery disease (CAD). (5) This was an update of a 2010 technology assessment. (6) Findings of the updated review were summarized in a 2013 publication by Leisy and colleagues. (7) The AHRQ literature review focused on studies evaluating U.S. Food and Drug Administration (FDA)-approved or cleared devices that are commercially available in the United States and can feasibly be used in most medical facilities. The 2012 assessment combined data from 10 studies on the PRIME ECG that involved patients with chest pain. Six of these were published by the same research group in Northern Ireland. The studies from Northern Ireland may have included a patient population that was higher risk than average, since some patients were treated in mobile cardiac care centers. Using a bivariate, random-effects model, the summary estimate for sensitivity was 71.1% (95% confidence interval [CI]: 45.6-87.8%), and for specificity was 90.2% (95% CI: 83.2-94.4%). The summary estimate for the positive likelihood ratio was 6.3 (95% CI: 3.3-12.1), and the summary negative likelihood ratio negative was 0.30 (95% CI: 0.16-0.56). These combined summary estimates were compared to estimates compiled from 10 studies reporting 12-lead ECG performance. (Eight of these 10 studies were also included in the analysis of PRIME ECG sensitivity, above). The pooled sensitivity was 43.1% (95% CI: 25.8-62.2%) and the pooled specificity was 94.4% (95% CI: 88.4-97.4%). The difference in sensitivity between the PRIME ECG and the 12-lead ECG were not significantly different, p<0.078. In addition, differences in specificity did not differ significantly, p<0.234.

Many of the individual studies have shown higher sensitivity for BSM and some have shown lower specificity. For example, in a retrospective study conducted at 4 centers, Ornato and colleagues reviewed the cardiac enzyme-confirmed cases of acute myocardial infarction (MI) against results of 12-lead ECG and BSM. (8) Due to a change in standard practice during the study, AMI was defined by either elevated troponin or heart-specific creatinine kinase (CK-MB). Of 647 patients, 58 (8.9%) were not analyzed due to lack of enzyme data. Sensitivity comparison between BSM and 12-lead ECG in the CK-MB group favored BSM (100% vs. 72.7%, respectively, p=0.031; n=364), and also in the troponin group (92.9% vs. 60.7%, respectively, p=0.022; n=225). Specificity for BSM was not significantly different from 12-lead ECG in either group (96.5% vs. 97.1 and 94.9 vs. 96.4, both respectively).

A 2013 study from Northern Ireland retrospectively reported on 645 consecutive patients with sudden out-of-hospital cardiac arrest initially attended by a mobile cardiac care unit. (9) Eighty patients survived initial resuscitation and 59 of these underwent ECG BSM and 12-lead ECG analysis by the physician leading the mobile unit. Twenty-four of the patients died pre-hospital and 35 were admitted to the hospital and underwent coronary angiography. Twenty-six of the 35 patients (75%) who received angiography had acute occlusion of a main coronary artery. Electrocardiographic BSM post-resuscitation showed ST-segment elevation in 23 of 35 patients (66%) and had had 88% sensitivity and 100% specificity for diagnosing acute coronary occlusion in these 35 patients. In contrast, the combination of either ST elevation myocardial infarction (STEMI) or ST segment depression on 12-lead ECG had a sensitivity of 46% and specificity of 100% for diagnosing acute coronary occlusion. A 2008 retrospective study from Northern Ireland included 755 patients presenting to the emergency department, mobile cardiac care, or in hospital with symptoms of ischemic chest pain. (10) Each patient’s clinical course was guided by standard American College of Cardiology 12-lead ST segment criteria and subsequent cardiac enzymes, if electrocardiographically negative. A cardiologist blinded to the clinical details measured BSM retrospectively. AMI was defined by elevated cardiac troponin levels. The standard 12-lead electrocardiograph demonstrated a sensitivity of 45% and a specificity of 92% for detecting troponin-positive ischemia. When non-ST electrographic changes were permitted as part of the criteria for AMI, sensitivity increased (51% to 68%), but specificity decreased (71% to 89%). In this study, BSM performed with a sensitivity of 76% and specificity of 92%.

Fermann and colleagues found very different performance characteristics of BSM in comparison to 12-lead ECG from other studies. (11) A convenience sample of 150 patients with chest pain presenting to the emergency department had BSM measured within 30 minutes of the standard ECG. Emergency physicians, who had been trained in BSM, interpreted both the BSM and the ECGs at the time of presentation. Both were stored electronically for review by a BSM expert over read; after the study had ended, a convenience sample of 135 BSMs were over read. Of 43 patients, 10 (23.3%) judged to have normal BSM by the emergency physicians were found to have abnormal findings or frank infarction by the expert interpreter. Overall correlation between the emergency physicians and expert reviewer was only fair (correlation coefficient κ=0.627; 95% CI: 0.530-0.724). Sensitivity of both standard ECG and BSM were low at 10.5 (95% CI: 1.8-34.5) and 15.8 (95% CI: 4.2-40.5), respectively. This low sensitivity likely reflects the spectrum of patients in the study. Specificities were also comparable between the 2 groups at 90.1 (95% CI: 83.3-94.4) and 86.3 (95% CI: 78.9-91.4), respectively.

In 2010, O’Neil and colleagues published results from a secondary analysis of the Optimal Cardiovascular Diagnostic Evaluation Enabling Faster Treatment of Myocardial Infarction (OCCULT-MI) trial. (12) A multicenter (10-site), prospective, observational study, the OCCULT-MI trial enrolled 1,830 subjects presenting to the emergency department with moderate- to high-risk chest pain. Patients were simultaneously tested with 12-lead and 80-lead ECGs, with clinicians able to access the 12-lead results only. The patients were treated by standard care based on 12-lead result or clinical suspicion. Off-site clinicians, who were not involved in the patients’ care, reviewed the 80-lead ECG and made a diagnostic determination, validated through multiple reviewers.

In this publication, 12-lead ECG was compared to 80-lead ECG mapping for detecting high-risk ECG abnormalities. Patients diagnosed with STEMI by 12-lead ECG (n=91), and patients with missing data (n=255) were excluded from the analysis on specificity and sensitivity. When detecting myocardial infarction (MI) and acute coronary syndrome (ACS), the 80-lead ECG mapping sensitivity was significantly higher than the 12-lead ECG for MI (19.4% vs. 10.7%, p=0.0014) and for ACS (12.3% vs. 7.1%, p=0.0025). The authors attributed these low sensitivity rates to the exclusion of STEMI patients in this analysis. Specificity for the 80-lead ECG mapping was significantly lower than the 12-lead ECG for MI (93.9% vs. 96.4%, p=0.0005) and for ACS (93.7% vs. 96.4%, p=0.0005). Positive and negative predictive values and negative and positive likelihood ratios were not statistically different between the 12-lead and 80-lead groups. The 80-lead ECG mapping resulted in the identification of 18 additional MI patients and 21 additional ACS patients who could potentially have benefited from more aggressive treatment. However, the 80-lead ECG mapping results were not incorporated into treatment decision making, and thus, no conclusions can be made from this study on the impact of this technology on patient outcomes. Also, the authors did not explore the impact of decreased specificity, and increased false-positive rates, on patient outcomes. Other limitations of this study include lack of enrollment of low-risk emergency department patients and the lack of power to detect differences in ACS diagnosis.

In 2012, Daly et al. also compared 12-lead ECG to 80-lead ECG mapping in a retrospective review of 2,810 consecutive patients admitted with ischemic-type chest pain. (13) All patients included in the study had coronary angiography and cardiac troponin levels during admission. The analysis was confined to patients with significant left main stem (LMS) coronary stenosis (greater than 70%), which was found in 116 (4.1%) patients. Of these 116 patients with LMS coronary stenosis, 92 (79%) had AMI, diagnosed when cardiac troponin levels were 0.03 µg/L or higher. BSM was found to be more sensitive for diagnosing AMI in patients with LMS coronary stenosis compared to 12-lead ECG. BSM detected STEMI in 85/92 patients for an 88% sensitivity, 83% specificity, 95% positive predictive value, and 65% negative predictive value. Twelve-lead ECG (using Minnesota 9-2 criteria) detected STEMI in 13 patients (11%), for a 12% sensitivity and 92% specificity. The c-statistic for the diagnosis of AMI in patients with LMS stenosis by 12-lead ECG was 0.580 (95% CI: 0.460–0.701, p=0.088) compared to 0.800 [95% CI: 0.720–0.881; p<0.001] using physician interpretation of BSM or 0.792 (95% CI: 0.690–0.894, p<0.001) using the “PRIME ECG®” algorithm.

Section summary: Numerous published studies compare the accuracy of BSM with standard 12-lead electrocardiography for the diagnosis of ACS. These studies are mostly retrospective and did not enroll the ideal clinical populations, i.e., consecutive patients presenting with clinical signs/symptoms of ischemia. They also tended to compare the accuracy of BSM alone with 12-lead EKG alone. This is less clinically relevant because 12-lead EKG is not used alone to diagnose ACS, but rather is combined with the clinical presentation and results of cardiac enzymes.

The 2012 AHRQ technology assessment did not find a statistically significant difference in the diagnostic accuracy of BSM compared to a standard 12-lead EKG. Among the individual studies, the difference in sensitivity is variable, and there is uncertainty around whether there is higher sensitivity that is clinically significant. The specificity of BSM may be lower than 12-lead EKG, as some studies report lower specificity but others do not. Because of the uncertainty in the sensitivity and specificity in the available studies, it is not possible to estimate the tradeoff between additional cases of ACS detected and false-positive results leading to further unnecessary testing. Further prospective studies are needed that include relevant clinical populations and that compare the incremental value of BMS when used as part of the overall diagnostic workup for ACS.

ClinicalUtility

Does electrocardiographic body surface mapping lead to changes in management that improve health outcomes?

The 2012 AHRQ assessment, noted above, (5) did not identify any studies in patients at low to intermediate risk of CAD that provided evidence on the question of whether findings from ECG-based technologies other than the standard 12-lead ECG had an impact on patient management decisions or health outcomes. One study, the OCCULT-MI trial, was identified that addressed the issue of patient outcomes in a population of patients at moderate to high risk for CAD. This study is discussed above in the section on diagnostic accuracy. Primary outcome in the OCCULT-MI trial was door-to-sheath time in 12-lead STEMI patients versus door-to-sheath time in patients with ST elevations noted on 80-lead testing. (12, 14) Secondary outcomes were clinical outcomes at 30 days and angiographic data. Of the 1,830 subjects, 91 had a discharge diagnosis of STEMI, 84 of whom underwent cardiac catheterization with a mean door-to-sheath time of 54 minutes. Twenty-five subjects (1.4% of the study population) met criteria for ST elevation in the 80-lead alone, 14 of whom underwent cardiac catheterization with a mean door-to-sheath time of 1,002 minutes (estimated treatment difference: 881; 95% CI: 181 to 1,079 minutes, respectively). Neither 30-day clinical outcomes, nor adverse events, differed significantly in the identified at-risk groups. These 25 patients were in addition to the 91 STEMI patients identified on 12-lead, leading the authors to conclude that the additional leads identified 27.5% more acute MI patients than 12-lead alone (25/91).

An editorial accompanying the publication of the OCCULT-MI trial acknowledged the limitation of 12-lead ECG in identifying patients with acute MI. However, a distinction was made between those patients for whom it is well established that early intervention is beneficial (i.e., STEMI on standard 12-lead ECG) and those for whom BSM is positive but 12-lead is not. It is not known whether these patients benefit from early intervention. The editorial suggested that the patients identified thusly are more similar to the non-ST elevation myocardial infarction (NSTEMI) patients based on peak troponin levels found in the OCCULT-MI trial and that identification of these patients should not lead to a change in treatment. (15)

Section summary: There are no studies that demonstrate how BSM can be used to change clinical management in ways that improve health outcomes. Indirect evidence suggests that BSM might be used in a subset of patients presenting with suspected ACS to reduce the time to diagnosis and thereby provide revascularization more expediently. Whether this strategy improves outcomes has yet to be demonstrated. In order to demonstrate clinical utility, the ideal study design is a randomized controlled trial in which patients are randomized to BSM or standard 12-lead EKG, and patients are followed for changes in management and clinical outcomes.

Ongoingclinical trials

A search of online Clinicaltrials.gov database in July 2013 did not identify any ongoing trials comparing the diagnostic accuracy of electrocardiographic BSM to standard 12-lead ECG or investigating the clinical utility of electrocardiographic BSM.

Summary

Electrocardiographic body surface mapping (BSM) is an electrocardiographic (ECG) technique that uses multiple (generally 80 or more) electrocardiography leads to detect cardiac electrical activity. The use of multiple leads may result in improved diagnostic accuracy, compared to that of the standard 12-lead ECG.

A number of studies have examined the association between electrocardiographic body surface mapping and acute myocardial infarction, but no prospective trials using body surface mapping to guide treatment have been conducted. Results of published studies have been variable and an Agency for Healthcare Research and Quality (AHRQ) review did not find statistically significant differences in the diagnostic accuracy of BSM and 12-lead ECG. Under ideal conditions, it is possible that body surface mapping has a higher sensitivity than 12-lead ECG alone for acute coronary events. However, the data also suggest that the specificity may be lower, highlighting concerns regarding false-positive results. In clinical practice, patients with symptoms suspicious for ischemia are not diagnosed with 12-lead ECG alone but in combination with clinical presentation and serial cardiac enzymes. There is no evidence demonstrating that electrocardiographic body surface mapping leads to changes in management that improve health outcomes. Therefore, clinical utility of the body surface mapping technique, both in terms of benefits and risks and burdens, has not been demonstrated. Due to insufficient evidence that diagnostic accuracy is improved with BSM and the lack of evidence on clinical utility, this technique is considered investigational.

Practice Guidelines and Position Statements

The American College of Cardiology Foundation guidelines for electrocardiography standardization and interpretation 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. (16)

Medicare National Coverage

There is no national coverage determination.

References:

  1. Gulrajani RM. The forward and inverse problems of electrocardiography. IEEE Eng Med Biol Mag 1998; 17(5):84-101, 22.
  2. 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.
  3. 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 Med 2006; 24(1):87-112.
  4. Lefebvre C, 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 2007; 25(9):1063-72.
  5. 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: http://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id83TA-1.pdf. Last accessed July, 2013.
  6. 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: http://www.cms.gov/determinationprocess/downloads/id73TA.pdf. Last accessed July 2013.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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 2012; 105(2):127-35.
  14. 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.
  15. Hollander JE. The 80-lead ECG: more expensive NSTEMI or Occult STEMI. Ann Emerg Med 2009; 54(6):789-90.
  16. 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.

Codes

Number

Description

CPT  0178T Electrocardiogram, 64 leads or greater, with graphic presentation and analysis; with interpretation and report
  0179T  tracing and graphics only, without interpretation and report
  0180T interpretation and report only
ICD-9 Diagnosis   Investigational for all diagnoses 
ICD-10-CM (effective 10/1/14)    Investigational for all diagnoses
ICD-10-PCS (effective 10/1/14)    ICD-10-PCS codes are only used for inpatient services.
   4A02X4Z Measurement, physiological systems, cardiac, external, electrical activity


Index

Electrocardiography, 64 leads or greater
Heartscape
PRIME ECG


Policy History

Date Action Reason
06/14/07 Add to Medicine section, Cardiology subsection New policy
07/10/08 Replace policy  Policy updated with literature search, reference number 5 added. No change in policy statement.
07/09/09 Replace policy Policy updated with literature search, reference number 6 added. No change in policy statement
08/12/10 Replace policy Policy updated with literature search, reference 1, 2, 5, 7-12 added. No change in policy statement.
8/11/11 Replace policy Policy updated with literature search, references 6 and 11 added. No change in policy statement.
08/09/12 Replace policy Policy updated with literature search, reference 12 added. No change in policy statement.
8/8/13 Replace policy Policy updated with literature search through June 27, 2013; references 5, 7 and 9 added. No change in policy statement.
9/12/13 Replace policy-correction only Corrections made to references in the Rationale