Microvolt T-Wave Alternans Testing for Cardiac Arrhythmias
DESCRIPTION
Microvolt T-wave alternans testing is a non-invasive provocative diagnostic test designed to detect minute beat-to-beat variability in the amplitude of the T-wave on electrocardiogram (EKG) known as T-wave alternans. The presence of T-wave alternans has been investigated as a risk factor for fatal arrhythmias and sudden cardiac death for individuals with a history of myocardial infarction, congestive heart failure, or cardiomyopathy. The investigation has involved the utilization of this technology in an attempt to identify candidates who could benefit from implantable cardioverter defibrillator (ICD) placement for primary prevention of sudden death. Primary prevention refers to individuals that have not experienced a life-threatening arrhythmia. Secondary prevention refers to individuals that have experienced a life threatening arrhythmia.
POLICY
Microvolt T-wave alternans testing to identify risk stratification for primary or secondary prevention of fatal arrhythmias and sudden cardiac death when there is a history of myocardial infarction, congestive heart failure, cardiomyopathy or other cardiac disorders such as long-QT syndrome (e.g., Brugada syndrome) is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
See also:
Automatic Implantable Cardioverter Defibrillator for the Prevention of Sudden Death
Wearable Cardioverter Defibrillator for the Prevention of Sudden Death
IMPORTANT REMINDER
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.
ADDITIONAL INFORMATION
Published evidence of well-designed studies in peer review journals is insufficient to determine whether the use of microvolt T-wave alternans testing improves net health outcome, whether it is as beneficial as any established alternatives, or whether a normal MTWA safely indicates withholding an ICD.
SOURCES
Bloomfield, D. M., Bigger, J. T., Steinman, R. C., Namerow, P. B., Parides, K. P., Curtis, A. B., et al. (2006). Microvolt t-wave alternans and the risk of death or sustained ventricular arrhythmias in patients with left ventricular dysfunction. Journal of the American College of Cardiology, 47 (2), 456-463. (Level 1 Evidence - Industry sponsored)
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2011). T-wave alternans (2.02.13). Retrieved June 14, 2011 from BlueWeb. (18 articles and/or guidelines reviewed)
Chan, P. S., Bartone, C., Booth, T., Kereiakes, D., & Chow, T. (2007). Prognostic implications of redefining indeterminate microvolt t-wave alternans studies as abnormal or normal. American Heart Journal, 153 (4), 523-529. (Level 1 Evidence - Industry sponsored)
Chan, P. S., Kereiakes, D. J., Bartone, C. & Chow, T. (2008). Usefulness of microvolt t-wave alternans to predict outcomes in patients with ischemic cardiomyopathy beyond one year. American Journal of Cardiology, 102 (3), 280-284. (Level 1 Evidence - Industry sponsored)
Chan, P. S., Stein, K., Chow, T., Fendrick, M., Bigger, J. T., & Vijan, S. (2006). Cost-effectiveness of a microvolt t-wave alternans screening strategy for implantable cardioverter-defibrillator placement in the MADIT-II-eligible population. Journal of the American College of Cardiology, 48 (1), 112-121.
Chow, T., Kereiakes, D. J., Bartone, C., Booth, T., Schloss, E. J., Waller, T. (2006). Prognostic utility of microvolt t-wave alternans in risk stratification of patients with ischemic cardiomyopathy. Journal of the American College of Cardiology, 47 (9), 1820-1827. (Level 1 Evidence - Industry sponsored)
Chow, T., Kereiakes, D. J., Onufer, J., Woelfel, A., Gursoy, S., Peterson, B. J., et al. (2008). Does microvolt T-wave alternans testing predict ventricular tachyarrhythmias in patients with ischemic cardiomyopathy and prophylactic defibrillators? The MASTER (Microvolt T Wave Alternans Testing for Risk Stratification of Post-Myocardial Infarction Patients) trial. Journal of the American College of Cardiology, 52 (20), 1607-1615. (Level 1 Evidence - Industry sponsored)
Chow, T., Saghir, S., Bartone, C., Goebel, M., Schneider, J., Booth, T, et al. (2007). Usefulness of microvolt t-wave alternans on predicting outcomes in patients with ischemic cardiomyopathy with and without defibrillators. American Journal of Cardiology, 100 (4), 598-604. (Level 1 Evidence - Industry sponsored)
Complete Guide to Medicare Coverage Issues. [Computer software]. (2011, April). Microvolt t-wave alternans (MTWA) (NCD 20.30, p. 2-28). Ingenix.
Constantini, O., Hohnloser, S. H., Kirk, M. M., Lerman, B. B., Baker, J. H., Bethuraman, B., et al. (2009). The ABCD (Alternans Before Cardioverter Defibrillator) trial. Journal of the American College of Cardiology, 53 (6), 471-479. (Level 1 Evidence - Industry sponsored)
Cutler, M. J., & Rosenbaum, D. S. (2009). Risk stratification for sudden cardiac death: Is there a clinical role for T wave alternans? Heart Rhythm, 6 (8 Suppl), S56-S61.
De Ferrari, G. M. & Sanzo, A. (2009). T-wave alternans in risk stratification of patients with nonischemic dilated cardiomyopathy: Can it help to better select candidates for ICD implantations? Heart Rhythm, 6 (35), S29-S34.
Gold, M. R., Ip, J. H., Costantini, O., Poole, J. E., McNulty, S., Mark, D. B., et al. (2008). Role of microvolt T-wave alternans in assessment of arrhythmia vulnerability among patients with heart failure and systolic dysfunction: Primary results from the T-wave alternans sudden cardiac death in heart failure trial substudy. Circulation, 118 (20), 2022-2028. (Level 1 Evidence - Industry sponsored)
Hohnloser, S. H. (2008). Risk factor assessment: Defining populations and individuals at risk. Cardiology Clinics, 26 (3), 355-366.
Hohnloser, S. H., Ikeda, T., & Cohen, R. J. (2008). Evidence regarding clinical use of microvolt T-wave alternans. Heart Rhythm, 6 (35), S36-S44.
Ikeda, T., Yoshino, H., Sugi, K., Tanno, K., Himizu, H., Watanabe, J. et al. (2006). Predictive value of microvolt t-wave alternans for sudden cardiac death in patients with preserved cardiac function after acute myocardial infarction. Journal of the American College of Cardiology, 48 (11), 2268-2274. (Level 1 Evidence - Independent study)
Kusumoto, F. (2008). A comprehensive approach to management of ventricular arrhythmias. Cardiology Clinics, 26 (3), 481-496.
Lo, R. & Hsia, H. H. (`2008). Ventricular arrhythmias in heart failure patients. Cardiology Clinics, 26 (3), 381-403.
Salerno-Uriatrte, J. A., De Ferrari, G. M., Klersy, C., Pedretti, R. F., Tritto, M., Sallusti, L., et al. (2007). Prognostic value of t-wave alternans in patient with heart failure due to nonischemic cardiomyopathy. Journal of the American College of Cardiology, 50 (19), 1898-1904. (Level 1 Evidence - Independent study)
Technology Evaluation Center. (2007, May). Microvolt t-wave alternans testing to risk stratify patients being considered for ICD therapy for primary prevention of sudden death (Vol. 21, No. 14). Chicago: BlueCross BlueShield Association. (22 articles and/or guidelines reviewed)
U. S. Food and Drug Administration. (2003, October). Center for Devices and Radiological Health. 510(k) Notification Database. K032513. Retrieved October 2, 2009 from http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K032513.
U. S. Food and Drug Administration. (2005, April). Center for Devices and Radiological Health. 510(k) Notification Database. K050225. Retrieved October 2, 2009 from http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K050225.
U. S. Food and Drug Administration. (2010, April). Center for Devices and Radiological Health. 510(k) Notification Database. K100362. Retrieved June 14, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf10/K100362.pdf.
Winifred S. Hayes, Inc. Medical Technology Directory. (2009, September). Microvolt t-wave alternans to identify risk of ventricular arrhythmias and sudden cardiac death. Retrieved June 14, 2011 from www.Hayesinc.com/subscribers. (38 articles and/or guidelines reviewed)
Zipes, D. P., Camm, A. J., Borggrefe, M., Buxton, A. E., Chaitman, B., Fromer, M., et al. (2006). 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, 114 (10), e385-e484.
ORIGINAL EFFECTIVE DATE: 10/14/2006
MOST RECENT REVIEW DATE: 7/14/2011
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