prior authorization review panel mco policy submission a ... · saecg for risk assessment after mi...

Prior Authorization Review PanelMCO Policy Submission

A separate copy of this form must accompany each policy submitted for review.Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health Submission Date: 11/01/2018

Policy Number: 0664 Effective Date: Revision Date:

Policy Name: Signal-Averaged Electrocardiography(SAECG)

Type of Submission – Check all that apply: New Policy* Revised Policy Annual Review – No Revisions

*All revisions to the policy must be highlighted using track changes throughout the document. Please provide any clarifying information for the policy below:

CPB 0664 Signal-Averaged Electrocardiography (SAECG)

Policy is new to Aetna Better Health of Pennsylvania.

Name of Authorized Individual (Please type or print):

Dr. Bernard Lewin, M.D.

Signature of Authorized Individual:

http://aetnet.aetna.com/mpa/cpb/600_699/0664.html 10/23/2018

Signal-Averaged Electrocardiography (SAECG) - Medical Clinical Policy Bulletins | Aetna Page 1 of 17

Signal-Averaged Electrocardiography (SAECG)

Policy History

Last Review: 11/16/2017

Effective: 05/02/2003

Next Review: 07/12/2018

Review History

Definitions

Additional

Information

Clinical Policy Bulletin

Notes

Number: 0664

Policy

*Please see amendment forPennsylvaniaMedicaid

at theend of this CPB.

Aetna considers signal-averaged electrocardiography

experimental and investigational because no prospective

clinical studies have demonstrated the utility of this testing in

improving clinical outcomes.

Aetna considers remote algorithmic analysis of

electrocardiographic-derived data (Premier

Heart's Multifunction Cardiogram (MCG); also known as 3DMP

Computerized EKG System) experimental and investigational

because the clinical value of the system in managing persons

suspected of having significant coronary artery disease has

not been established.

See

also CPB 0579 - T-Wave Alternans (../500_599/0579.html).

Background

Signal-Averaged Electrocardiography (SAECG):

http://aetnet.aetna.com/mpa/cpb/600_699/0664.html

10/23/2018 http://aetnet.aetna.com/mpa/cpb/600_699/0664.html


Signal-averaged electrocardiography (SAECG) is a technique

involving computerized analysis of segments of a standard

electrocardiogram that allows the detection of ventricular late

potentials. Ventricular late potentials in patients with cardiac

abnormalities, especially coronary artery disease or following

an acute myocardial infarction (MI), have been associated with

an increased risk of ventricular tachyarrhythmias and sudden

cardiac death. Proponents of SAECG claim that it can obviate

the need for invasive techniques commonly used to identify

high-risk patients for interventions that treat or prevent

ventricular tachyarrhythmia and sudden death.

An Agency for Healthcare Policy and Research's assessment

(AHCPR, 1998) found that the current data on SAECG show

relatively consistent high negative-predictive values, poor

positive-predictive values, and variable sensitivity and

specificity when the technique is used on patients with

cardiomyopathy or following a MI. However, the high

negative- predictive value of SAECG is largely due to the fact

that the incidence of fatal arrhythmic events among post-MI

patients is now below 10 %. The incidence of fatal

arrhythmias has declined among post-MI patients, a large

percentage of whom are on anti-thrombotic therapy, most

likely following the trend of decreased mortality rate following

MI.

In 1996, an American College of Cardiology (ACC) consensus

statement on SAECG concluded that SAECG has “established

value” in assessing the risk of development of sustained

ventricular arrhythmias in patients recovering from MI.

However, subsequently published guidelines from the ACC on

management of acute MI (1999) stated that the usefulness of

SAECG for risk assessment after MI is less well-established by

evidence/opinion. In addition, subsequently published ACC

guidelines on implantable anti-arrhythmia devices (1998) do

not recommend SAECG for selecting patients for automated

implantable cardioverter defibrillators (AICDs).




Although it has been proposed that SAECG may be used to

select post-MI patients for anti-arrhythmic drugs or AICD

implantation, there are no prospective clinical studies

demonstrating the clinical utility of SAECG in selecting patients

for these therapies. In addition, there are no prospective

clinical studies proving that SAECG can be used successfully

to select patients for electrophysiologic studies or Holter

monitoring, or to use SAECG for risk stratification in lieu of

these other tests.

Grimm et al (2003) studied arrhythmia risk stratification with

regard to prophylactic implantable cardioverter-defibrillator

patients with in idiopathic dilated cardiomyopathy (IDC).

These researchers concluded that reduced left ventricular

ejection fraction (LVEF) and lack of beta-blocker use are

important arrhythmia risk predictors in IDC, whereas SAECG,

baroreflex sensitivity, heart rate variability, and T-wave

alternans do not seem to be helpful for arrhythmia risk

stratification. Furthermore, in a review on electrocardiographic

arrhythmia risk testing, Engel et al (2004) evaluated the

various electrocardiographic (ECG) techniques that appear to

have potential in assessment of risk for arrhythmia. The

resting ECG (premature ventricular contractions, QRS

duration, damage scores, QT dispersion, and ST segment and

T wave abnormalities), T-wave alternans, late potentials

identified on SAECG, and heart rate variability were explored.

The authors stated that unequivocal evidence to support the

widespread use of any single non-invasive technique is

lacking; further research in this area is needed.

Guidelines from the European Society for Cardiology

(Brignole, et al., 2004) concluded that the systematic use of

SAECG in syncope is “not recommended.”

Tamaki and colleagues (2009) prospectively compared the

predictive value of cardiac iodine-123

metaiodobenzylguanidine (MIBG) imaging for sudden cardiac

death (SCD) with that of the SAECG, heart rate variability




(HRV), and QT dispersion in patients with chronic heart failure

(CHF). At entry, cardiac MIBG imaging, SAECG, 24-hr Holter

monitoring, and standard 12-lead ECG were performed in 106

consecutive stable CHF outpatients with a radionuclide

LVEF less than 40 %. The cardiac MIBG washout rate (WR)

was obtained from MIBG imaging. Furthermore, the time and

frequency domain HRV parameters were calculated from 24-hr

Holter recordings, and QT dispersion was measured from the

12-lead ECG. During a follow-up period of 65 +/- 31 months,

18 of 106 patients died suddenly. A multi-variate Cox analysis

revealed that WR and LVEF were significantly and

independently associated with SCD, whereas the SAECG,

HRV parameters, or QT dispersion were not. Patients with an

abnormal WR (greater than 27 %) had a significantly higher

risk of SCD (adjusted hazard ratio: 4.79, 95 % confidence

interval: 1.55 to 14.76). Even when confined to the patients

with LVEF greater than 35 %, SCD was significantly more

frequently observed in the patients with than without an

abnormal WR (p = 0.02). The authors concluded that cardiac

MIBG WR, but not SAECG, HRV, or QT dispersion, is a

powerful predictor of SCD in patients with mild-to-moderate

CHF, independently of LVEF.

Park and colleagues (2009) examined the correlation between

parameters of 2-dimensional ECG and SAECG in patients with

arrhythmogenic right ventricular cardiomyopathy (ARVC). A

total of 33 patients (13 females, 40.3 +/- 14.4 years old) were

included in this study. Both the right and left ventricular

dimensions and systolic function were assessed with

2-dimensional ECG. The SAECG was performed with high-

gain amplification and filtered using bi-directional Butterworth

filters between 40 and 250 Hz. The right ventricular (RV)

outflow tract was the most frequently (n = 18, 54 %) involved

segment. Six (18 %) patients had only mildly decreased RV

systolic function. All the other patients had normal RV systolic

function. Although localized left ventricular wall motion

abnormalities were observed in 14 (42 %) patients, the LVEF

was normal in most (n = 32, 97 %). Late potentials were




positive in 22 (63 %) patients. There was no significant

correlation between parameters of the SAECG and

2-dimensional ECG for the entire patient population. The

authors concluded that the SAECG parameters exhibited no

correlation to any of 2-dimensional ECG parameters in the

patients with ARVC. Fragmented electrical activity may

develop with no significant relation to the anatomical changes

in the patients with ARVC.

The Agency for Healthcare Research and Quality's systematic

review of ECG-based signal analysis technologies for

evaluating patients with acute coronary syndrome (Coeytaux

et al, 2012) concluded that “Existing research is largely

insufficient to confidently inform the appropriate use of ECG-

based signal analysis technologies in diagnosing CAD and/or

ACS. Further research is needed to better describe the

performance characteristics of these devices to determine in

what circumstances, if any, these devices might precede,

replace, or add to the standard ECG in test strategies to

identify clinically significant CAD in the patient population of

interest. To fully assess the impact of these devices on

diagnostic strategies for patients with chest pain, test

performance needs to be linked to clinically important

outcomes through modeling or longitudinal studies”.

Proclemer et al (2013) examined the current clinical practice of

screening and risk evaluation for SCD in ischemic and non-

ischemic cardiomyopathy with a focus on selection of

candidates for ICD therapy, timing of ICD implantation, and

use of non-invasive and invasive diagnostic tests across

Europe. A systematic screening program for SCD existed in

19 out of 31 centers (61.3 %). Implantation of ICDs according

to the inclusion criteria of MADIT-II and SCD-HeFT trials was

reported in 30 and 29 % of centers, respectively, followed by

MADIT-CRT (18 %), COMPANION (16 %), and combined

MADIT and MUSTT (7 %) indications. In patients with severe

renal impairment, ICD implantation for primary prevention of

SCD was always avoided in 8 centers (33.3%), was not used




only if creatinine level was greater than 2.5 mg/dL in 10

centers (32.2 %), and in patients with permanent dialysis in 8

centers (33.3 %). Signal-averaged electrocardiography and

heart rate variability were never considered as risk

stratification tools in 23 centers (74.2 %). Implantation of a

loop recorder was performed in patients with borderline

indications for ICD therapy in 6 centers (19.4 %), for research

purposes in 5 (16.1 %), and was never performed in 20 (64.5

%) centers. The authors concluded that the majority of

participating European centers have a screening program for

SCD and the selection of candidates for ICD therapy was

mainly based on the clinical risk stratification and not on non-

invasive and invasive diagnostic tests or implantable loop

recorder use.

Furthermore, an UpToDate review on “Clinical applications of

the signal-averaged electrocardiogram: Overview” (Narayan

and Cain, 2014) states that “Guideline Recommendations --

We agree with the 2008 American Heart Association

(AHA)/American College of Cardiology (ACC)/Heart Rhythm

Society (HRS) scientific statement on noninvasive risk

stratification and the 2006 ACC/AHA/European Society of

Cardiology (ESC) guidelines for management of patients with

ventricular arrhythmias, which concluded that the SAECG may

be useful to identify patients at low risk for SCD, but its routine

use to identify patients at high risk for SCD is not yet

adequately supported. Similarly, the 2006 AHA/ACC scientific

statement on syncope concluded that routine use of T-wave

alternans combined with signal-averaged ECG and

assessment of heart rate variability in patients with syncope

and a negative initial evaluation is not yet established and

currently is not indicated”.

An UpToDate review on “Use of the signal-averaged

electrocardiogram in nonischemic heart disease and cardiac

transplantation” (Narayan and Cain, 2015) concludes that:




▪ Data are conflicting on the efficacy of SAECG in

predicting clinical outcome or ventricular arrhythmias in

patients with non-ischemic dilated cardiomyopathy.

▪ There are insufficient data to recommend the use of the

SAECG for risk stratification of patients with non-

ischemic cardiomyopathy.

▪ Although small studies have identified SAECG

alterations in patients with cardiac transplant rejection,

the utility of SAECG for detection of rejection has not

been established.

Dinov and colleagues (2016) correlated SAECG with the

endocardial scar characteristics in patients with ischemic

ventricular tachycardia (VT). These researchers suggested

that successful catheter ablation (CA) can result in

normalization of the SAECG. A total of 50 patients (42 men;

aged 67 ± 10 years, EF 34 ± 12 %) with ischemic VTs were

prospectively enrolled; SAECG was performed before and after

CA. Patients with at least 2 abnormal criteria (filtered

QRS greater than or equal to 114 ms; root mean square 40

less than 20 μV, and low-amplitude potentials 40 greater than

38 ms) were defined as having positive SAECG. There was a

linear correlation between endocardial scar area (less than 1.5

mV) and filtered QRS (r = 0.414; p = 0.003); CA resulted in

normalization of the SAECG in 6 patients. In patients with

filtered QRS less than or equal to 120 ms, 13 (40.6 %) patients

had normal SAECG after CA compared with 7 (21.9 %) before

ablation (p = 0.034). Patients with normal or normalized

SAECG after CA had better VT-free survival compared with

those whose SAECG remained abnormal. Abnormal SAECG

after CA was a predictor for VT recurrence: hazard ratio (HR)

= 3.64; p = 0.039 for the overall population, and HR = 5.80; p =

1.22 for patients having QRS less than or equal to 120 ms.

The authors concluded that there was a significant correlation

between the surface SAECG and endocardial scar size in




patients with ischemic VTs. A successful CA could result in

normalization of SAECG that was associated with more

favorable long-term outcomes.

The main drawbacks of this study were its small sample size

(n = 50) and the relatively short follow-up (median of 12

months). The authors stated that this study should be

considered as a hypothesis-generating one. The presented

results are valid for patients with ischemic heart disease and

must be confirmed in other clinical conditions (e.g., dilated

cardiomyopathy, and arrhythmogenic right ventricular

dysplasia). They noted that as long as the post-ablation

SAECGs were recorded before the hospital discharge, it

remained unclear if the VT recurrences during the follow-up

were accompanied by perturbations in the SAECG. The

localization of the scar may influence the sensitivity of the

method because the abnormal low-amplitude potentials less

than 40 μV and root mean square voltage in the last 40 ms of

the filtered QRS were less pronounced in patients with anterior

or septal MIs.

Multifunction Cardiogram:

The Premier Heart digital database-driven multi-phase (3DMP)

electrocardiograph (EKG) System provides a computer

analysis of digitalized 12-lead EKG waveforms in the frequency

domain (power spectral estimate) to aid in the

detection of significant coronary artery disease. The 3DMP

system was cleared by the Food and Drugs Administration

(FDA) based on a 510(k) application. Weiss et al (2002)

reported on a cross-sectional analysis of the use of the 3DMP

system in 136 patients with symptoms of potential coronary

artery disease who were scheduled for angiography.

Originally, 200 patients were selected for the study, but 64 of

the patients were not included in the study because of various

technical problems in their 3DMP readings.




Although the 3DMP system was positive for coronary artery

disease (CAD) in 76 of 78 patients with greater than 60 %

narrowing by angiography, the 3DMP system also read

positive in 8 of 12 patients with 40 to 60 % narrowing. None of

the 10 patients with greater than 0 to 40 % narrowing read as

positive by the 3DMP system, but 8 of 36 patients with 0 %

narrowing read as positive for CAD.

As a significant number (2 of 78) of patients with significant

angiographic lesions were missed by the 3DMP system, it is

not clear that the device is sufficiently accurate to either be

used in lieu of angiography or to select patients for

angiography.

There are no evidence-based guidelines from national

professional organizations that address the clinical utility of

3DMP in evaluating patients suspected of having coronary

artery disease. Prospective clinical studies are necessary to

demonstrate the clinical utility of the 3DMP system in

managing patients suspected of having significant coronary

artery disease.

A technology assessment prepared for the AHCPR on ECG-

based signal analysis technologies (Coeytaux et al, 2010)

stated that the reliability and test performance of 3DMP in

subjects at high-risk or with known CAD is promising. The

horizon scan identified 7 potentially relevant devices,

including 3 that use body surface mapping and 1 that uses

mathematical signal analysis. Of the 7 devices, only the

PRIME ECG by Heartscape Technologies (body surface

mapping) and the 3DMP/MCG/ mfEMT by Premier Heart

(mathematical signal analysis; referred to as the 3DMP) are

cleared for marketing by the FDA and commercially available.

One body surface mapping device (Visual ECG/Cardio3KG by

NewCardio) is commercially available but not cleared; the

other devices are not commercially available. The assessment

concluded: "There is currently little available evidence that

pertains to the utility of ECG-based signal analysis



Signal-Averaged Electrocardiography (SAECG) - Medical Clinical Policy Bulletins | A... Page 10 of 17

technologies as a diagnostic test among patients at low to

intermediate risk of CAD who present in the outpatient setting

with the chief complaint of chest pain. The limited evidence

that is available demonstrates proof of concept, particularly for

the PRIME ECG and 3DMP devices. Further research is

needed to better characterize the performance characteristics

of these devices to determine in what circumstances, if any,

these devices might precede, replace, or add to the standard

ECG for the diagnosis of CAD among patients who present

with chest pain in the outpatient setting. The randomized

controlled trial (RCT) study design is best suited for evaluating

the impact that ECG-based signal analysis technologies may

have on clinical decision-making and patient outcomes, but

there are indirect approaches that might be applied to answer

these questions".

Kawaji and colleagues (2015) stated that multifunction

cardiogram (MCG) is a computer-enhanced, resting

electrocardiogram analysis developed to detect

hemodynamically relevant CAD. Based on data from previous

studies suggesting excellent diagnostic accuracy in detecting

CAD, MCG (approved by the FDA) received a Current

Procedure Terminology (CPT) code in 2010 in United States.

However, there is no previous study validating MCG by using

fractional flow reserve (FFR) as the reference standard.

Multifunction cardiogram Evaluation in Diagnosis of Functional

coronary Ischemia sTudy (MED-FIT) was designed as a

single-center, prospective study enrolling 100 stable patients

with suspected CAD scheduled for coronary angiography. The

primary and secondary analyses evaluated the diagnostic

performance of the MCG severity score to detect functional

myocardial ischemia by FFR less than or equal to 0.80, and

angiographically significant coronary stenosis (percent

diameter stenosis greater than or equal to 50 %) by

quantitative coronary angiography. The current analysis set

consisted of 91 patients in whom MCG data with adequate

quality was obtained. The prevalence of positive functional

myocardial ischemia and angiographically significant stenosis




in the current study was 42.7 % and 41.8 %, respectively.

Area under the receiver operating characteristics curve (AUC)

of the MCG severity score for functional myocardial ischemia

and angiographically significant stenosis was low (AUC 0.51,

95 % confidence interval [CI]: 0.38 to 0.63, and AUC 0.58, 95

% CI: 0.46 to 0.70, respectively). Sensitivity, and specificity of

the MCG severity score for functional myocardial ischemia and

angiographically significant stenosis was also low (32 %/67 %,

and 37 %/72 %) using a cut-off value of 4.0. The authors

concluded that diagnostic performance of the MCG severity

score was poor for both functional myocardial ischemia, and

angiographically significant stenosis.

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

Code Code Description

CPT codes not covered for indications listed in the CPB:

0206T Computerized database analysis of multiple

cycles of digitized cardiac electrical data from

two or more ECG leads, including transmission

to a remote center, application of multiple

nonlinear mathematical transformations, with

coronary artery obstruction severity assessment

93278 Signal-averaged electrocardiography (SAECG)

with or without ECG

Other CPT codes related to the CPB:

93000 -

93010

Electrocardiogram, routine ECG with at least 12

leads; with interpretation and report, tracing

only, without interpretation and report, or

interpretation and report only

ICD-10 codes not covered for indications listed in the CPB :




Code Code Description

I05.0 - I52 Chronic rheumatic heart disease, hypertensive

disease, ischemic heart disease, diseases of

pulmonary circulation, and other forms of heart

disease

The above policy is based on the following references:

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3. Gregoratos G, Cheitlin MD, Conill A, et al. ACC/AHA

guidelines for implantation of cardiac pacemakers and

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Practice Guidelines (Committee on Pacemaker

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electrocardiography accurately detect abnormalities

consistent with obstructive and nonobstructive coronary

artery disease. Heart Dis. 2002;4(1):2-12.




6. U.S. Food and Drug Administration (FDA), Center for

Devices and Radiologic Health (CDRH). Cardiotron

multi-phase EKG information analysis system. 510(k) no.

K992703. Rockville, MD: FDA; March 21, 2000.

7. 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):2883-2891.

8. Engel G, Beckerman JG, Froelicher VF, et al.

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9. Hunt SA, Baker DW, Chin MH, et al. ACC/AHA guidelines

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management (diagnosis and treatment) of syncope--

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signal-averaged electrocardiography in the young

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coronary artery stenosis after coronary revascularization.

Int J Med Sci. 2008;5(2):50-61.

20. Tamaki S, Yamada T, Okuyama Y, et al. Cardiac iodine-

123 metaiodobenzylguanidine imaging predicts sudden

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comparative study with signal-averaged

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cardiomyopathy: Results of the European Heart Rhythm

Association survey. Europace. 2013;15(7):1059-1062.

27. Proclemer A, Lewalter T, Bongiorni MG, et al. Screening

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and non-ischaemic cardiomyopathy: Results of the

European Heart Rhythm Association survey. Europace.

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28. Narayan SM, Cain ME. Clinical applications of the signal-

averaged electrocardiogram: Overview. UpToDate [online

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29. Bae MH, Kim JH, Jang SY, et al. Changes in follow-up

ECG and signal-averaged ECG in patients with

arrhythmogenic right ventricular cardiomyopathy. Pacing

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30. Liao YC, Lin YJ, Chung FP, et al. Risk stratification of

arrhythmogenic right ventricular cardiomyopathy based




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electrocardiogram in nonischemic heart disease and

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Waltham, MA: UpToDate; reviewed May 2015.

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detection of functional myocardial ischemia: Multifunction

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Electrocardiol. 2015;20(5):446-453.

33. 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).



Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan

benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,

general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care

services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors

in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely

responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is

subject to change.

Copyright © 2001-2018 Aetna Inc.

http://aetnet.aetna.com/mpa/cpb/600_699/0664.html 10/23/2018


AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0664 Signal-Averaged

Electrocardiography (SAECG)

For the Pennsylvania Medical Assistance plan: Signal-averaged electrocardiography (SAECG) w ith or without ECG may be considered for coverage on a case by case basis based on medical necessity.

www.aetnabetterhealth.com/pennsylvania new 11/01/2018

http://www.aetnabetterhealth.com/pennsylvania

prior authorization review panel mco policy submission a ... · saecg for risk assessment after mi...

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