mp-318 - Medical Policies - Alabama
Policy Number: MP-318
Latest Review Date: October 2019
Policy Grade: Effective January 2, 2013, this remains an active policy but no longer scheduled for regular literature reviews and updates.
Signal-averaged electrocardiography is considered not medically necessary and investigational for any of the following indications, including, but not limited to:
its use as a technique of risk stratification for arrhythmias after prior myocardial infarction; or
in patients with cardiomyopathy; or
in patients with syncope; or
as an assessment of success after surgery for arrhythmia; or
in the detection of acute rejection of heart transplants; or
as an assessment of efficacy of antiarrhythmic drug therapy; or
in the assessment of success of pharmacological, mechanical, or surgical interventions to restore coronary artery blood flow.
Description of Procedure or Service:
Signal-averaged electrocardiography (SAECG) is a technique involving computerized analysis of small segments of a standard ECG to detect abnormalities, termed ventricular late potentials (VLPs), that would be otherwise obscured by “background” skeletal muscle activity. VLPs reflect aberrant, asynchronous electrical impulses arising from viable isolated cardiac muscle bordering an infarcted area and are thought to be responsible for ventricular tachyarrhythmias. Therefore, VLPs, as measured by SAECG, have been investigated as a risk factor for arrhythmic events in patients with a variety of cardiac conditions, including cardiomyopathy and prior history of myocardial infarction (MI). Patients considered at high risk of ventricular arrhythmias and thus sudden death may be treated with drugs to suppress the emergence of arrhythmias or implantable cardiac defibrillators (ICD) to promptly detect and terminate tachyarrhythmias when they occur. Because sudden cardiac death, whether from arrhythmias or pump failure, is one of the most common causes of death after a previous myocardial infarction, there is intense interest in risk stratification to target therapy. Patient groups are divided into those who have not experienced a life-threatening arrhythmia (i.e., primary prevention) and those who have (i.e., secondary prevention). SAECG is just one of many risk factors that have been investigated. Others include left ventricular ejection fraction (LVEF), arrhythmias detected on Holter monitor or electrophysiologic studies, heart rate variability, and baroreceptor sensitivity. T-wave alternans is another technique for risk stratification; it measures beat-to-beat variability, while SAECG measures beat-averaged conduction.
The most recent update of this policy includes a literature review through October 31, 2019.
For individuals receiving signal averaged electrocardiography, the evidence includes prospective studies, small comparative studies, and retrospective reviews. Relevant outcomes are overall survival, morbid events, and treatment related morbidity. Signal-averaged ECG has some ability to risk-stratify patients at risk for ventricular arrhythmias. However, this predictive ability is modest, and this technique has not been used to stratify patients into clinically relevant categories of risk. Some RCTs have used signal-averaged ECG for selection of patients at high risk of ventricular arrhythmias, but these studies have not demonstrated outcome benefits for the treatments under study. Signal-averaged ECG has also been tested as a diagnostic test for a variety of cardiac-related disorders, but the evidence is insufficient to demonstrate clinical utility for any of the conditions tested. The evidence is insufficient to determine the effects of the technology on health outcomes.
Practice Guidelines and Position Statements
American Heart Association
The 2006 ACC, American Heart Association (AHA), and European Society of Cardiology (ESC) guidelines for management of patients with ventricular arrhythmias and prevention of sudden death list SAECG with a Class IIb recommendation (Class IIb noted as usefulness/efficacy is less well established by evidence/opinion). The report notes that SAECG may be useful to improve the diagnosis and risk stratification of patients with ventricular arrhythmias or of those at risk for life-threatening ventricular arrhythmias.
A recent consensus document from the AHA, ACC Foundation, and Heart Rhythm Society indicates the SAECG may identify patients with prior MI at risk for sudden cardiac death and that further studies are required to assess the utility of this test.
Electrocardiography, Signal-Averaged, SAECG, Signal-Averaged Electrocardiography
Approved by Governing Bodies:
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved. Will be reviewed for medical necessity
Signal-Averaged Electrocardiography (SAECG), With or without ECG
Bailey JJ, Berson AS, Handelsman H et al. Utility of current risk stratification tests for predicting major arrhythmic events after myocardial infarction. J Am Coll Cardiol 2001; 38(7):1902-11.
Bauer A, Guzik P, Barthel P et al. Reduced prognostic power of ventricular late potential in post-infarction patients of the reperfusion era. Eur Heart J 2005; 26(8):755-61.
Bigger JT. Prophylactic use of implanted cardiac defibrillators in patients at high risk for ventricular arrhythmias after coronary artery bypass graft surgery. Coronary Artery Bypass Graft (CABG) Patch Trial Investigators. N Engl J Med 1997; 337(22):1569-75.
Cain ME, Anderson JL, Arnsdorf MF et al. ACC expert consensus document. Signal-averaged electrocardiography. J Am Coll Cardiol 1996; 27(1):238-49.
Cairns JA, Connolly SJ, Roberts R et al. Randomized trial of outcome after myocardial infarction in patients with frequent or repetitive ventricular premature depolarization: CAMIAT. Canadian Amiodarone Myocardial Infarction Arrhythmia Trial Investigators. Lancet 1997; 349(9053):675-82.
Dinov B, Bode K, Koenig S, et al. Signal-averaged electrocardiography as a noninvasive tool for evaluating the outcomes after radiofrequency catheter ablation of ventricular tachycardia in patients with ischemic heart disease: Reassessment of an old tool. Circ Arrhythm Electrophysiol. 2016;9(9).
Furukawa Y, Yamada T, Okuyama Y et al. Increased intraatrial conduction abnormality assessed by P-wave signal-averaged electrocardiogram in patients with Brugada syndrome. Pacing Clin Electrophysiol 2011; 34(9):1138-46.
Goldberger JJ, Cain FM, Hohnloser SH et al. American Heart Association/American College of Cardiology Foundation/Heart Rhythm Society Scientific statement on noninvasive risk stratification techniques for identifying patients at risk for sudden cardiac death. J Am Coll Cardiol 2008; 52:1179-99.
Gregoratos G, Cheitlin MD, Conill A et al. ACC/AHA guidelines for implantation of cardiac pacemakers and antiarrhythmia devices: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Pacemaker Implantation). J Am Coll Cardiol 1998; 31(5):1175-209.
Grimm W, Christ M, Bach J et al. Noninvasive arrhythmia risk stratification in idiopathic dilated cardiomyopathy: results of the Marburg Cardiomyopathy Study. Circulation 2003; 108(23):2883-91.
Hohnloser SH, Klingenheben T, Zabel M. Identification of patients after myocardial infarction at risk of life-threatening arrhythmias. Eur Heart J 1999; 1(suppl C):C11-20.
Huikuri HV, Tapanainen JM, Lindgren K et al. Prediction of sudden cardiac death after myocardial infarction in the beta-blocking era. J Am Coll Cardiol 2003; 42(4):652-8.
Julian DG, Camm AJ, Frangin G et al. Randomized trial of effect of amiodarone on mortality in patients with left ventricular dysfunction after recent myocardial infarction: EMIAT. European Myocardial Infarct Amiodarone Trial Investigators. Lancet 1997; 439(9053):667-74.
Kamath GS, Zareba W, Delaney J et al. Value of the signal-averaged electrocardiogram in arrhythmogenic right ventricular cardiomyopathy/dysplasia. Heart Rhythm 2011; 8(2):256-62.
Liao YC, Chung FP, Lin YJ, et al. The application of signal average ECG in the prediction of recurrences after catheter ablation of ventricular arrhythmias in arrhythmogenic right ventricular dysplasia/cardiomyopathy. Int J Cardiol. 2017;236:168-173.
Militaru C, Donoiu I, Ionescu DD. PWave Signal-Averaged ECG in Normal Population and in Patients with Converted Atrial Fibrillation. Ann Noninvasive Electrocardiol 2011; 16(4):351-6.
Moss AJ, Hall WJ, Cannom DS et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med 1996; 335(26):1933-40.
Moss AJ, Zareba W, Hall WJ et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002; 346(12):877-83.
Nagamoto Y, Fujii Y, Morita Y, et al. Atrial electrical abnormality in patients with Brugada syndrome assessed by signal-averaged electrocardiography. Indian Heart J. 2017;69(6):714-719.
Rejdak K, Rubaj A, Glowniak A et al. Analysis of ventricular late potentials in signal-averaged ECG of people with epilepsy. Epilepsia 2011; 52(11):2118-24.
Schuller JL, Lowery CM, Zipse M et al. Diagnostic utility of signal-averaged electrocardiography for detection of cardiac sarcoidosis. Ann Noninvasive Electrocardiol 2011; 16(1):70-6.
Shturman A, Bickel A, Atar S. The predictive value of P-wave duration by signal-averaged electrocardiogram in acute ST elevation myocardial infarction. The Israel Medical Association Journal IMAJ 2012;14(8):493-7.
Toubol P. A decade of clinical trials; CAST to AVID. Eur Heart J 1999; 1(suppl C):C2-10.
U.S. Department of Health and Human Services. Health Technology Assessment. Number 11. Signal-averaged electrocardiography. 1998. Publication No. PB98-137227.
Ueno A, Kobayashi Y, Yodogawa K et al. A prospective study on the risk-stratification for patients with non-sustained ventricular tachycardia using a novel algorithm. Circ J 2007; 71(7):107-14.
Zipes DP, Camm AJ, Borggrefe M et al. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation 2006; 114(10):1088-132.
Medical Policy Group, March 2011 (1)
Medical Policy Administration Committee, March 2011
Available for comment April 4 – May 18, 2011
Medical Policy Group, February 2012 (2): 2012 Updates – Key Points, References
Medical Policy Panel, December 2012
Medical Policy Group, January 2013 (2): Policy statement unchanged. Key Points, Reference updated
Medical Policy Group, October 2019 (4): Updates to Key Points and References. No change to policy statements.
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.