DESCRIPTION
Electrocardiographic body surface mapping (BSM) is an electrocardiographic (ECG) technique that uses multiple (generally 80 or more) electrocardiography leads to detect cardiac electrical activity. It is suggested that 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.
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 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 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.
An example of a device used for electrocardiographic body surface mapping is the “PRIME ECG®” (Verathon, Bothell, WA). This device was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process.
POLICY
Electrocardiographic body surface mapping for the diagnosis or management of cardiac disorders, including acute coronary syndrome is considered investigational.
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ADDITIONAL INFORMATION
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, but under ideal conditions it is possible that body surface mapping has a higher sensitivity than 12-lead ECG alone. Data on the effect of specificity are unclear, 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 serial cardiac enzymes. The clinical utility of the body surface mapping technique, both in terms of benefits and risks and burdens, has not been demonstrated.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2010). Electrocardiographic body surface mapping (2.02.23). Retrieved December 28, 2010 from BlueWeb. (13 articles and / or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 4/4/2011
MOST RECENT REVIEW DATE: 4/4/2011
ID_EBA
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