Download Medical Policy Microvolt T

Medical Policy
Microvolt T-Wave Alternans
(MTWA)
Effective Date: February 8, 2017
Subject: Microvolt T-Wave Alternans (MTWA)
Background: Microvolt T-wave alternans (MTWA) testing is intended to risk-stratify patients who are
candidates for an implantable cardioverterdefibrillator (ICD). MTWA is proposed as a noninvasive means
to predict the likelihood of subsequent ventricular tachyarrhythmic events (VT, e.g., sudden cardiac
death, sustained ventricular tachycardia, ventricular fibrillation) and is utilized as primary prevention in
patients with left-ventricular dysfunction.
Authorization: Prior authorization is not required.
Policy and Coverage Criteria:
Harvard Pilgrim Health Care (HPHC) covers Microvolt T-wave alternans testing (MTWA) for the
evaluation of members who are candidates for implantable cardioverter defibrillator placement.
Exclusions: Harvard Pilgrim Health Care considers Microvolt T-wave alternans testing (MTWA)
experimental/investigational for all other indications.
Supporting Information:
Microvolt T-wave alternans (MTWA) is a subtle, beat-to-beat oscillation in the morphology, amplitude,
and/or polarity of the T-wave portion of the heartbeat on ECG. The T wave reflects electrical recovery
(repolarization) for the ventricles, and TWA represents anomalies in ventricular repolarization and is
linked with arrhythmogenesis. TWA rarely is visible on standard ECGs but can be detected at the
microvolt level by using specialized ECG electrodes and computer processing techniques. Standard MTWA
testing involves gradual elevation of the heart rate, which is achieved by exercise, drugs, or, rarely, atrial
and/or ventricular pacing.
Peer-reviewed literature suggests the presence of MTWA is associated with increased disease severity
and reduced functional status in patients with certain types of heart disease and patients who test
positive for MTWA are at increased risk for ventricular arrhythmias and sudden death.
HPHC Medical Review Criteria
Microvolt T-Wave Alternans (MTWA)
Page 1 of 5
HPHC policies are based on medical science, and written for the majority of people with a given condition.
Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group.
Please reference appropriate member materials (e.g., Benefit Handbook, Certificate of Coverage) for member-specific benefit
information.
There are several non-invasive tests proposed to identify patients at high risk for developing ventricular
arrhythmias. One of the non-invasive tests is routine surface ECG monitoring with emphasis on
observation of premature ventricular complexes and their morphology and number.
Several studies find these non-invasive tests have limited sensitivity and specificity as well as low
predictive value for stratifying patients at risk for SCD (Barron 2000, Costantini et al. 2000, Adachi et al.
2001, Gold et al. 2003, Verrier et al. 2003, Kunavarapu et al. 2004).
MWTA uses special multi-segment high-resolution electrodes, noise-reduction software, and a spectral
method of alternans analysis for accurate measurements. Spectral analysis during controlled heart rate
acceleration is the most widely used MTWA technique.
Aro et al. (2016) evaluated the role of T-wave alternans testing to guide therapy in clinical practice. The
American Heart Association/American College of Cardiology Foundation asserted that TWA may be useful
for SCD risk stratification, but further information is needed on how to implement this test in clinical
practice. The authors concluded that there is not enough clinical evidence to support the use of TWA
testing in routine clinical practice to guide therapy.
Danilowicz-Szymanowicz et al (2014) studied the utility of MTWA testing, characterized by high negative
predictive value, in scheduling ICD implantation. A total of 152 patients were included who qualified for
ICD implantation for the primary prevention of SCD. The negative predictive value of the MTWA test was
100% over 12 months of observation. Therefore, it was concluded that MTWA is useful in determining
who is at greater risk in SCD and malignant ventricular arrhythmias and should receive ICD implantation
first.
A 2012 review by Merchant et al. evaluated the utility of MTWA testing for SCD risk stratification in
patients without ICDs. The study found positive, negative and indeterminate MTWA results. The most
common cause of indeterminacy was excessive ventricular ectopy during exercise (59%), followed by
inadequate HR (21%), noise (11%) and unsustained alternans (6%). The authors concluded that these
“findings may have important implications for refining primary prevention ICD treatment algorithms and
improving resource allocation.”
A 2012 study by Trojnarska et al. determined the incidence of MTWA in 179 subjects with congenital
heart defects compared with a control group of 43 subjects. The subjects were classified into MTWA (+),
MTWA (-), or MTWA indeterminate (ind). MTWA (+) and MTWA (ind) were combined to a classification of
MTWA (non-). The results showed significant increase in frequency of abnormal MTWA among the study
group compared to the control group. Trojnarska et al. concluded that abnormal MTWA is more frequent
in adults with congenital heart diseases than in the healthy population and the probability increases in
patients who show clinical findings conducive to lethal arrhythmia like heart failure and pulmonary
hypertension.
A 2012 study by Jackson et al. profiled MTWA in 1003 patients hospitalized with heart failure. The
patients with decompensated heart failure were scheduled to be tested with MTWA 1 month post
discharge. 648 of the 1003 returned for MTWA. Of the MTWA tests, 100 (30%) were positive, 78 (24%)
were negative, and 152 (46%) were indeterminate; 112/152 indeterminate tests (74%) occurred because
of failure to achieve target heart rate (HR) due to chronotropic incompetence or physical limitations.
There were differences in patient characteristics according to MTWA result. Independent predictors of a
negative result included younger age and higher left ventricular ejection fraction (LVEF). Independent
predictors of a positive result included higher HR during MTWA testing and lower LVEF. Independent
predictors of an indeterminate result included older age and history of previous/paroxysmal AF. Jackson
HPHC Medical Review Criteria
Microvolt T-Wave Alternans (MTWA)
Page 2 of 5
HPHC policies are based on medical science, and written for the majority of people with a given condition.
Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group.
Please reference appropriate member materials (e.g., Benefit Handbook, Certificate of Coverage) for member-specific benefit
information.
et al. concluded MTWA treadmill testing is not widely applicable in typical HF patients and is unlikely to
refine risk stratification for sudden death on a population level.
Shizuta et al. (2012) published results of the PREVENT-SCD study, a multicenter, prospective
observational study of patients with LV ejection fraction ≤40% due to ischemic or non-ischemic
cardiomyopathies, designed to evaluate the prognostic value of TWA for lethal ventricular
tachyarrhythmia. Study results found TWA showed high negative predictive ability for lethal ventricular
tachyarrhythmia in patients with LV dysfunction, although the TWA-negative patients accounted for only
18% of the entire population. Those ineligible for the TWA test had the highest risk for lethal ventricular
tachyarrhythmia.
Yu et al. (2012) assessed the value of TWA in prediction of sudden cardiac death in patients with acute
MI. Their results found T-wave alternans (≥47 ΜV) monitored at 1 to 15 days after AMI-predicted
heightened risk of SCD. Prediction is improved when the frequency of TWA episodes (≥47 ΜV) is
analyzed.
A 2005 review by Gehi et al. evaluated the predictive value of MTWA in determining risk stratification of
ventricular tachyarrhythmic events (VTE) across a variety of subjects. The study found that the presence
of significant MTWA predicted nearly a fourfold risk of VTE compared to the absence of MTWA. The
absence of MTWA carries a % risk of arrhythmic events during follow up. The authors concluded if the
MTWA test is negative; the patient would be at low risk for arrhythmic events. If the MTWA test is
positive, this would reinforce the decision for an implantable cardioverter defibrillator. Another review by
Armoundas et al. (2005) evaluated MTWA testing as a predictor of VTEs in patients with a reduced
ejection fraction who were not selected on the basis of history of ventricular tachyarrhythmias. The
average annual rate of fatal and nonfatal VTEs among patients who tested negative for MTWA was
around 1%. The authors concluded that testing patients with a low ejection faction being considered for
ICD therapy should undergo MTWA testing as part of their evaluation. Another review on the utility of
MTWA to predict SCD in patients with cardiomyopathy, the authors state that risk stratification with
MTWA has the potential to guide prophylactic ICD therapy in patients with cardiomyopathy. Chauhan et
al. (2007), concluded that “future research to optimize MTWA testing will include improving signal
processing, incorporating quantitative analysis, and defining disease-specific thresholds applicable to
lower risk cardiomyopathic patients without prior arrhythmic events.”
Although there remains a need to examine MTWA in well-conducted randomized controlled trials as well
as the ability of MTWA to predict long-term outcomes, there seems to be potential for routine clinical use
of TWA for prediction of ventricular arrhythmias following myocardial infarction in patients with reduced
left ventricular ejection fraction (LVEF) and in symptomatic patients with dilated cardiomyopathy.
Coding: Codes are listed below for informational purposes only, and do not
guarantee member coverage or provider reimbursement. The list may not be
all-inclusive. Deleted codes and codes which are not effective at the time the
service is rendered may not be eligible.
93025: Microvolt T-wave alternans for assessment of ventricular arrhythmias
HPHC Medical Review Criteria
Microvolt T-Wave Alternans (MTWA)
Page 3 of 5
HPHC policies are based on medical science, and written for the majority of people with a given condition.
Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group.
Please reference appropriate member materials (e.g., Benefit Handbook, Certificate of Coverage) for member-specific benefit
information.
References:
1. Technology Evaluation Center. BCBS Associations. Microvolt T-wave Alternans testing to risk stratify
patients being considered for ICD therapy for primary prevention of sudden death. May 2007.
2. Hayes, Inc. Medical Technology Directory. Microvolt T-Wave Alternans to Identify Risk of Ventricular
Arrhythmias and Sudden Cardiac Death. Lansdale, PA: Hayes, Inc.; Sept 2013.
3. Barron, HV. T-wave alternans and serious ventricular arrhythmias: a tale of two T-waves. J Am Coll
Cardiol. 2000; 36(7): 2254-6.
4. Costantini, O., Drabeck, C., Rosenbaum, DS. Can sudden cardiac death be predicted from the Twave of the ECG? A critical examination of T-wave alternans and QT interval dispersion. Pacing Clin
Electrophysiol. 2000; 23(9): 1407-16.
5. Adachi, K., Ohnishi, Y., Yokoyama, M. Rish stratification for sudden cardiac death in dilated
cardiomyopathy using microvolt-level T-wave alternans. Jpn Circ J. 2001; 65(2): 76-80.
6. Gold, MR., Spencer, W. T-wave alternans for ventricular arrhythmia risk stratification. Curr Opin
Cardiol. 2003; 18(1): 1-5.
7. Verrier, RL., Tolat, AV. Jospehson, ME. T-wave alternans for arrhythmia risk stratification in patients
with idiopathic dilated cardiomyopathy. J Am Coll Cardiol. 2003; 41(12): 2225-7.
8. Kunavarapu, C., Bloomfield, DM. Role of noninvasive studies in risk stratification for sudden cardiac
dealth. Clin Cardiol. 1004; 27(3): 192-7.
9. Gehi, AK., Stein, RH., Metz, LD., Gomes, JA. Microvolt T-wave alternans for the risk stratification of
ventricular tacharrhythmic events: a meta-analysis. J Am Coll Cardiol. 2005; 46(1): 75-82.
10. Armoundas, AA., Hohnloser, SH., Ikeda, T., Cohen, RJ. Can Microvolt T-wave alternans testing
reduce unnecessary defibrillator implantation? Nat Clin Pract Cardiovasc Med. 2005; 2(10): 522-8.
11. Chauhan, VS., Selvaraj, RJ., Utility of microvolt T-wave alternans to predict sudden cardiac death in
patients with cardiomyopathy. Curr Opin Cardiol. 2007; 22(1): 25-32.
12. Jackson, CE., Myles, RC., Tsorlalis, IK., et al. Profile of microvolt T-wave alternans testing in 1003
patients hospitalized with heart failure. Eur J Heart Fail. 2012; 14(4): 377-86.
13. Shizuta, S., Ando, K., Nobuyoshi, M., et al. Prognostic utility of T-wave alternans in a real-world
population of patients with left ventricular dysfunction: the PREVENT-SCD study. Clin Res Cardiol.
2012; 101(2): 89-99.
14. Yu, H., Pi-Hua, F., Yuan, W., et al. Prediction of sudden cardiac death in patients after acute
myocardial infarction using T-wave alternans: a prospective study. J Electrocardiol. 2012; 45(1): 605.
15. Calo, L., DeSanto, T., Nuccio, F., et al. Predictive value of microvolt T0wave alternans for cardiac
death or ventricular tachyarrhythmic events in ischemic and nonischemic cardiomyopathy patients: a
meta-analysis. Ann Noninvasive Electrocardiol. 2011; 16(4): 388-402.
16. Verrier, RL., Klingenheben, T., Malik, M., El-Sharif, N., et al. Microvolt T-wave alternanas
physiological basis, methods of measurement, and clinical utility – consensus guideline by
International Society for Holder and Noninvasive Electrocardiology. J Am Coll Cardiol. 2011; 58(13):
1309-24.
17. Danilowicz-Szymanowicz, L., Suchecka, J., Zagozdzon, P., Szwoch, M., Kempa, M., Raczak, G.
Application of microvolt T- wave alternans testing in scheduling implantable cardioverter-defibrillator
placement for the primary prevention of sudden cardiac death in patients with left ventricular
dysfunction. Kardiol Pol. 2014.
HPHC Medical Review Criteria
Microvolt T-Wave Alternans (MTWA)
Page 4 of 5
HPHC policies are based on medical science, and written for the majority of people with a given condition.
Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group.
Please reference appropriate member materials (e.g., Benefit Handbook, Certificate of Coverage) for member-specific benefit
information.
18. Trojnarska, O., Cieplucha, A., Bartczak, A., Kramer, L., Grajek, S. Microvolt T-wave alternans in adults
with complex congenital heart diseases. Cardiol J. 2014; 21(2):144-51.
19. Van der Avoort, C., Filion KB., Dendukuri, N., Brophy, JM. Microvolt T-wave alternans as a predictor
of mortality and severe arrhythmias in patients with left-ventricular dysfunction: a systematic review
and meta-analysis. BMC Cardiovascular Disorder. 2009; 9(5).
20. Aro, Aapo L, Tuomas V Kenttä, and Heikki V Huikuri. "Microvolt T-Wave Alternans: Where Are We
Now?". Arrhythmia & Electrophysiology Review 5.1 (2016): 37.
21. Centers for Medicare and Medicaid,. NCD20.30 Microvolt T-Wave Alternans (MTWA). 2015.
Summary of Changes:
Date
Change
01/17
Reference and supporting evidence revised
Approved by UMCPC: 01/25/17
 Reviewed/Revised: 12/08, 12/10, 12/12, 1/15, 1/17
 Initiated: 12/08
HPHC Medical Review Criteria
Microvolt T-Wave Alternans (MTWA)
Page 5 of 5
HPHC policies are based on medical science, and written for the majority of people with a given condition.
Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group.
Please reference appropriate member materials (e.g., Benefit Handbook, Certificate of Coverage) for member-specific benefit
information.