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Myocardial Strain Imaging

Policy Number: MP-726

 

Latest Review Date:  June 2021

Category:  Radiology

Policy Grade:  C

 

POLICY:

Myocardial strain imaging is considered  investigational.

 

DESCRIPTION OF PROCEDURE OR SERVICE:

Myocardial strain refers to the deformation (shortening, lengthening, or thickening) of the myocardium through the cardiac cycle. Myocardial strain can be measured by tissue Doppler imaging, or more recently, speckle-tracking echocardiography. Speckle-tracking echocardiography uses imaging software to assess the movement of specific markers in the myocardium that are detected in standard echocardiograms. It is proposed that a reduction in myocardial strain may indicate sub-clinical impairment of the heart and can be used to inform treatment before development of symptoms and irreversible myocardial dysfunction.

The term strain indicates dimensional or deformational change under force.  When used in echocardiography, the term ‘strain’ is used to describe the magnitude of shortening, thickening and lengthening of the myocardium through the cardiac cycle. The most frequent measure of myocardial strain is the deformation of the left ventricle (LV) in the long axis, termed global longitudinal strain (GLS).  During systole, ventricular myocardial fibers shorten with movement from the base to the apex. GLS is used as a measure of global LV function, and provides a quantitative myocardial deformation analysis of each LV segment. Myocardial strain imaging is intended to detect subclinical changes in left ventricle function in patients with a preserved LV ejection fraction, allowing for early detection of systolic dysfunction.  Potential applications of speckle-tracking echocardiography are coronary artery disease, ischemic cardiomyopathy, valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathies, stress cardiomyopathy, and chemotherapy-related cardiotoxicity.

Myocardial Strain Imaging

Myocardial strain can be measured by either cardiac magnetic resonance imaging (MRI), tissue Doppler imaging or by speckle-tracking echocardiography (STE). Tissue Doppler strain imaging has been in use since the 1990's but has limitations that include angle dependency and significant noise. Smiseth et al (2016), reported that the most widely used method of measuring myocardial strain at the present time is STE. In STE, natural acoustic markers generated by the interaction between the ultrasound beam and myocardial fibers form interference patterns (speckles). These markers are stable, and STE analyzes the spatial dislocation (tracking) of each point (speckle) on routine 2-dimensional sonograms. Echocardiograms are processed using specific acoustic-tracking software on dedicated workstations, with offline semi-automated analysis of myocardial strain. The 2-dimentional displacement is identified by a search with image processing algorithms for similar patterns across two frames. When tracked frame-to-frame, the spatiotemporal displacement of the speckles provides information about myocardial deformation across the cardiac cycle. GLS provides a quantitative analysis of each LV segment, which is expressed as a percentage. In addition to GLS, STE allows evaluation of LV rotational and torsional dynamics.

 

KEY POINTS:

This evidence review was developed using a search of the MEDLINE database through March 18, 2021.

Summary of Evidence

For individuals who receive myocardial strain imaging, the evidence includes systematic reviews of observational studies. Relevant outcomes include symptoms, morbid events, quality of life, treatment-related mortality, and treatment-related morbidity. Although myocardial strain imaging may detect sub-clinical myocardial changes, the value of these changes in predicting clinical outcomes or guiding therapy is uncertain. No studies were identified that compared the diagnostic accuracy of myocardial strain imaging to left ventricle ejection fraction. A study that compares clinical outcomes when therapy is guided by myocardial strain imaging or left ventricle ejection fraction is in progress, and will provide direct evidence on the clinical utility of myocardial strain imaging. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American College of Cardiology et al.

In 2019, the American College of Cardiology, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and the Society of Thoracic Surgeons published appropriate use criteria for multimodality imaging in the assessment of cardiac structure and function in nonvalvular heart disease (see Table 1).

Using a modified Delphi approach, the panel rated indications as “appropriate”, “may be appropriate”, and “not appropriate”. The specific studies that formed the basis of the ACC guidelines are not cited, however, they note that they used ACC/American Heart Association clinical practice guidelines whenever possible.

Of 81 indications considered for strain rate imaging, the panel rated only 4 as “appropriate” (Table 1). Three of the four “appropriate indications”, concerned evaluation (initial or follow-up) in patients prior to and following exposure to potentially cardiotoxic agents. The other indication was follow-up testing to clarify initial diagnostic testing for patients with suspected hypertrophic cardiomyopathy. The guidelines did not separate out imaging with speckle tracking and tissue Doppler, and did not make recommendations related to the comparative effectiveness of these imaging modalities.

The panel rated 14 other indications as “may be appropriate” (Table 1). According to the panel, interventions in this category should be performed depending on individual clinical patient circumstances and patient and provider preferences, including shared decision making.

 

Table 1. Summary of ACC Appropriate Use Criteria for Myocardial Strain Imaging

Clinical Scenario and Indication

Rating

Initial evaluation in an asymptomatic patient:

 

Initial evaluation prior to exposure to medications/radiation that could result in cardiotoxicity/heart failure

Appropriate

Initial cardiac evaluation of a known systemic, congenital, or acquired disease that could be associated with structural heart disease

May be appropriate

Screening evaluation for structure and function in first-degree relatives of a patient with an inherited cardiomyopathy

May be appropriate

Pre-participation assessment of an asymptomatic athlete with 1 or more of the following: abnormal examination, abnormal ECG, or definite (or high suspicion for) family history of inheritable heart disease)

May be appropriate

Initial evaluation of a patient with clinical signs and/or symptoms of heart disease:

 

Initial evaluation when symptoms or signs suggest heart disease

May be appropriate

Arrhythmias or conduction disorders

  • Newly diagnosed LBBB
  • Non-sustained VT

May be appropriate

Palpitations/Presyncope/Syncope

  • Clinical symptoms or signs consistent with a cardiac diagnosis  known to cause presyncope/syncope (including but not limited to hypertrophic cardiomyopathy and heart failure)

May be appropriate

Respiratory failure/exertional shortness of breath

  • Exertional shortness of breath/dyspnea or hypoxemia of uncertain etiology

May be appropriate

Heart failure/cardiomyopathy

  • Initial evaluation of known or suspected heart failure (systolic or diastolic) based on symptoms, signs, or abnormal test results to assess systolic or diastolic function and to assess for possible etiology (CAD, valvular disease)
  • Suspected inherited or acquired cardiomyopathy (e.g., restrictive, infiltrative, dilated, hypertrophic)

May be appropriate

Device therapy

  • Known implanted pacing/ICD/CRT device with symptoms possibly due to suboptimal device settings

May be appropriate

Cardiac Transplantation

  • Monitoring for rejection or coronary arteriopathy in a cardiac transplant recipient

May be appropriate

Other

  • Suspected pericardial diseases

May be appropriate

Sequential or follow-up testing to clarify initial diagnostic testing:

 

Evaluation of suspected hypertrophic cardiomyopathy

Appropriate

Re-evaluation (1 year) in a patient previously or currently undergoing therapy with potentially cardiotoxic agents

Appropriate

Periodic reevaluation in a patient undergoing therapy with cardiotoxic agents and worsening symptoms

Appropriate

Pulmonary hypertension in the absence of severe valvular disease

May be appropriate

Comprehensive further evaluation of undefined cardiomyopathy

May be appropriate

Evaluation of suspected cardiac amyloidosis

May be appropriate

Sequential or follow-up testing: New or Worsening Symptoms or to Guide Therapy

 

Re-evaluation of known structural heart disease with change in clinical status or cardiac examination or to guide therapy

May be appropriate

Re-evaluation of known cardiomyopathy with a change in clinical status or cardiac examination or to guide therapy

May be appropriate

Re-evaluation of known HF (systolic or diastolic) with a change in clinical status or cardiac examination without a clear precipitating change in medication or diet

May be appropriate

Re-evaluation for CRT device optimization in a patient with worsening HF

May be appropriate

Source: Adapted from Doherty et al 2019

 

The American Society of Clinical Oncology

The American Society of Clinical Oncology(2017) noted that measurement of strain has been demonstrated to have some diagnostic and prognostic use in patients with cancer receiving cardiotoxic therapies but that there have been no studies demonstrating that early intervention based on changes in strain alone can result in changes in risk and improved outcomes. The American Society of Clinical Oncology also notes that screening for asymptomatic cardiac dysfunction using advanced imaging could lead to added distress in cancer survivors.

U.S. Preventive Services Task Force Recommendations

Not applicable.

 

KEY WORDS:

Myocardial strain, cardiovascular, cardiac, Myostrain, 2D Cardiac Performance Analysis, EchoInsight, Echo1nsight, Q-lab, Vivid, Aplio

 

APPROVED BY GOVERNING BODIES:

A number of image analysis systems have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Examples of these are shown in Table 2. For example, the Echolnsight software system (Epsilon Imaging) "enables the production and visualization of 2D tissue motion measurements (including tissue velocities, strains, strain rates) and cardiac structural measurement information derived from tracking speckle in tissue regions visualized in any B-mode (including harmonic) imagery loops as captured by most commercial ultrasound systems" ( K110447). The FDA determined that this device was substantially equivalent to existing devices (e.g., syngo US Workplace, Siemens, K091286) for analysis of ultrasound imaging of the human heart.

 

Table 2. FDA Clearances

Brand Name

Manufacturer

510(k) Number

FDA Product Code

Clearance Date

Myostrain

Myocardial Solutions

K182756

LNH

02/14/2019

2D CARDIAC PERFORMANCE ANALYSIS

Tomtec

K120135

LLZ

04/13/2012

Echolnsight

Epsilon Imaging

K110447

LLZ

05/27/2011

Q-lab

Phillips

K023877

LLZ

12/23/2002

Vivid

GE

K181685

IYN

10/25/2018

Aplio

Toshiba

 

IYN

01/11/2018

FDA: Food and Drug Administration.

 

BENEFIT APPLICATION:

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 and will be reviewed for medical necessity.

 

CURRENT CODING:

93356

Myocardial strain imaging using speckle tracking-derived assessment of myocardial mechanics (List separately in addition to codes for echocardiography imaging) (Effective 01/01/20)

 

Previous Coding:

CPT Codes

0399T

Myocardial strain imaging (quantitative assessment of myocardial mechanics using image-based analysis of local myocardial dynamics) (List separately in addition to code for primary procedure) (Deleted 12/31/19)

 

REFERENCES:

  1. Armenian, SS, Lacchetti, CC, Lenihan, DD. Prevention and Monitoring of Cardiac Dysfunction in Survivors of Adult Cancers: American Society of Clinical Oncology Clinical Practice Guideline Summary. J Oncol Pract, 2016 Dec 7;13(4). 
  2. Doherty, JJ, Kort, SS, Mehran, RR, Schoenhagen, PP, Soman, PP, Dehmer, GG, Doherty, JJ, Schoenhagen, PP, Bashore, TT, Bhave, NN, Calnon, DD, Carabello, BB, Conte, JJ, Dickfeld, TT, Edmundowicz, DD, Ferrari, VV, Hall, MM, Ghoshhajra, BB, Mehrotra, PP, Naqvi, TT, Reece, TT, Starling, RR, Szerlip, MM, Tzou, WW, Wong, JJ, Doherty, JJ, Dehmer, GG, Bailey, SS, Bhave, NN, Brown, AA, Daugherty, SS, Dean, LL, Desai, MM, Duvernoy, CC, Gillam, LL, Hendel, RR, Kramer, CC, Lindsay, BB, Manning, WW, Patel, MM, Sachdeva, RR, Wann, LL, Winchester, DD, Wolk, MM. ACC/AATS/AHA/ASE/ASNC/HRS/SCAI/SCCT/SCMR/STS 2019 Appropriate Use Criteria for Multimodality Imaging in the Assessment of Cardiac Structure and Function in Nonvalvular Heart Disease: A Report of the American College of Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and the Society of Thoracic Surgeons. J Am Soc Echocardiogr, 2019 Feb 13. 
  3. Hendel, RR, Lindsay, BB, Allen, JJ, Brindis, RR, Patel, MM, White, LL, Winchester, DD, Wolk, MM. ACC Appropriate Use Criteria Methodology: 2018 Update: A Report of the American College of Cardiology Appropriate Use Criteria Task Force. J. Am. Coll. Cardiol., 2018 Feb 24;71(8). 
  4. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  5. Negishi, TT, Thavendiranathan, PP, Negishi, KK, Marwick, TT, Aakhus, SS, Murbræch, KK, Massey, RR, Bansal, MM, Fukuda, NN, Hristova, KK, Izumo, MM, La Gerche, AA, Costello, BB, Lemieux, JJ, Coté, MM, Deblois, JJ, Mottram, PP, Miyazaki, SS, Nolan, MM, Penicka, MM, Ondrus, TT, Stefanidis, EE, Seldrum, SS, Shirazi, MM, Shkolnik, EE, Amir, EE, Thampinathan, BB, Thomas, LL, Yamada, HH, Vinereanu, DD, Popescu, BB, Mihalcea, DD, Calin, AA, Cho, GG, Kurosawa, KK, Galderisi, MM, Santoro, CC. Rationale and Design of the Strain Surveillance of Chemotherapy for Improving Cardiovascular Outcomes: The SUCCOUR Trial. JACC Cardiovasc Imaging, 2018 Jun 18;11(8).
  6. Smiseth, OO, Torp, HH, Opdahl, AA, Haugaa, KK, Urheim, SS. Myocardial strain imaging: how useful is it in clinical decision making?. Eur. Heart J., 2015 Oct 29;37(15).
  7. Thavendiranathan, PP, Poulin, FF, Lim, KK, Plana, JJ, Woo, AA, Marwick, TT. Use of myocardial strain imaging by echocardiography for the early detection of cardiotoxicity in patients during and after cancer chemotherapy: a systematic review. J. Am. Coll. Cardiol., 2014 Apr 8;63(25 Pt A).
  8. Trivedi SJ, Altman M, Stanton T, et al. Echocardiographic Strain in Clinical Practice. Heart Lung Circ. 2019 Sep;28(9). 
  9. Yingchoncharoen, TT, Agarwal, SS, Popović, ZZ, Marwick, TT. Normal ranges of left ventricular strain: a meta-analysis. J Am Soc Echocardiogr, 2012 Dec 12;26(2).

 

POLICY HISTORY:

Medical Policy Panel, March 2019

Medical Policy Group, April 2019 (4): Adopted new medical policy.  Myocardial strain imaging previously considered investigational.

Medical Policy Administration Committee, April 2019

Medical Policy Group, December 2019:  2020 Annual Coding Update. Added new CPT code 93356 to Current Coding. Moved deleted CPT code 0399T to Previous Coding.

Medical Policy Panel, March 2020

Medical Policy Group, April 2020 (4): Updates to Key Points and References.  No change to policy statement.

Medical Policy Panel, May 2021

Medical Policy Group, June 2021 (4): Updates to References.  Policy statement updated to remove “not medically necessary,” no change to policy intent.

 

 

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.