Clinical UM Guideline


Subject:  Holter Monitors
Guideline #:  CG-MED-44Current Effective Date:  10/08/2013
Status:RevisedLast Review Date:  08/08/2013

Description

Holter monitors are ambulatory, noninvasive, unattended electrocardiography (ECG) devices that provide continuous recordings of the heart for a minimum of 24 or 48 hours.  Ambulatory ECG (AECG) devices may be used as a diagnostic tool for individuals with specified symptoms and/or to assess response to specified therapies.  This document addresses the use of the standard external ambulatory Holter monitor.

This document does not address attended, real time ECG monitoring and ambulatory event monitors.
Note:  For additional information, please see:

Clinical Indications

Medically Necessary:

Continuous 24- to 48- hour ambulatory ECG Holter monitor use is considered medically necessary for adults with any of the following indications:

  1. As a diagnostic tool to evaluate frequent, unexplained symptoms suggestive of cardiac arrhythmias such as palpitations, unexplained dizziness or syncope or near syncope;
  2. As a diagnostic tool for detecting ventricular arrhythmias, QT interval changes, or ST changes, to evaluate risk;
  3. As a method to assess treatment response to antiarrhythmic therapy (efficacy; proarrhythmic effect);
  4. Evaluation of idiopathic hypertrophic cardiomyopathy or dilated cardiomyopathies;
  5. Assessment of the function of pacemakers or implantable cardioverter defibrillators (ICD) in individuals:
    1. with frequent symptoms of palpitation, syncope, or near syncope to assess device function to exclude myopotential inhibition and pacemaker mediated tachycardia; or
    2. to assist in programming parameters such as rate-responsivity and automatic mode switching; or
    3. to evaluate suspected component failure or malfunction when device interrogation is not definitive; or
    4. to assess response to adjunctive pharmacologic therapy in individuals receiving frequent ICD therapy;
  6. Suspected variant angina;
  7. As a method to assess for asymptomatic atrial fibrillation three or more months after ablation of arrhythmogenic foci for atrial fibrillation.

Continuous 24- to 48- hour ambulatory ECG Holter monitor use is considered medically necessary for children with any of the following indications:

  1. As a diagnostic tool to evaluate frequent symptoms suggestive of cardiac arrhythmias such as palpitations, unexplained dizziness or syncope or near syncope;
  2. Evaluation of hypertrophic cardiomyopathy or dilated cardiomyopathies;
  3. Evaluation of possible or documented long QT syndromes;
  4. Palpitations in children with prior surgery for congenital heart disease and significant residual hemodynamic abnormalities;
  5. As a method to assess treatment response to antiarrhythmic therapy (efficacy; proarrhythmic effect);
  6. Asymptomatic, unpaced, congenital complete atrioventricular (AV) block;
  7. Evaluation of cardiac rhythm after transient (AV) block associated with heart surgery or catheter ablation;
  8. Evaluation of rate-responsive or physiological pacing function in children with persistent or recurrent cardiac symptoms.

Not Medically Necessary:

Ambulatory ECG Holter monitor use is considered not medically necessary when the above criteria are not met. 

Ambulatory ECG Holter monitor use is considered not medically necessary for all other indications including, but not limited to:

Coding

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes.  A draft of future ICD-10 Coding (effective 10/01/2014) related to this document, as it might look today, is included below for your reference. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT 
93224External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation by a physician or other qualified health care professional
93225External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; recording (includes connection, recording and disconnection)
93226External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; scanning analysis with report
93227External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; review and interpretation by a physician or other qualified health care professional
  
ICD-9 Diagnosis 
411.0-411.89Other acute and subacute forms of ischemic heart disease
413.1Prinzmetal angina
425.11-425.18Hypertrophic cardiomyopathy
425.4Other primary cardiomyopathies
426.0-426.9Conduction disorders
427.0-427.9Cardiac dysrhythmias
429.9Heart disease, unspecified
746.84Obstructive anomalies of heart, NEC
746.86Congenital heart block
746.89Other specified anomalies of heart
780.2Syncope and collapse
780.4Dizziness and giddiness
785.0Tachycardia, unspecified
785.1Palpitations
786.50Chest pain, unspecified
V45.01-V45.02Cardiac device in situ; cardiac pacemaker, automatic implantable cardiac defibrillator
V53.31-V53.32Fitting and adjustment of cardiac pacemaker, automatic implantable cardiac defibrillator
  
ICD-10 DiagnosisICD-10-CM draft codes; effective 10/01/2014:
I20.1Angina pectoris with documented spasm
I20.9Angina pectoris, unspecified [chest pain]
I24.0-I24.9Other acute ischemic heart diseases
I42.0Dilated cardiomyopathy
I42.1Obstructive hypertrophic cardiomyopathy
I42.2Other hypertrophic cardiomyopathy
I44.0-I45.9Atrioventricular and left bundle-branch block, other conduction disorders
I47.0-I49.9Paroxysmal tachycardia, atrial fibrillation and flutter, other cardiac arrhythmias
Q24.6Congential heart block
Q24.8Other specified congenital malformations of heart
R00.0-R00.9Abnormalities of heart beat
R42Dizziness and giddiness
R55Syncope and collapse
Z45.010-Z45.018Encounter for adjustment and management of cardiac pacemaker
Z45.02Encounter for adjustment and management of automatic implantable cardiac defibrillator
Z95.0Presence of cardiac pacemaker
Z95.810Presence of automatic (implantable) cardiac defibrillator
  
Discussion/General Information

Holter monitors are self-contained recording devices that provide a graphic representation of electrical activity within the heart.  Electrodes are placed externally in predetermined locations on an individual's chest to detect and record the electrical activity of the heart.  Individuals maintain a diary of activities and symptoms while wearing the Holter monitor.  The information from the Holter ECG is reviewed and interpreted by a physician to determine a diagnosis and a treatment plan. 

Holter AECG utilizing the traditional Holter monitoring devices has been in use for many years to diagnose a wide range of heart disease and other conditions that manifest themselves by abnormal cardiac electrical activity (Centers for Medicare & Medicaid Services, 2004).  Holter monitors have a low sensitivity for detecting intermittent arrhythmias.  Therefore, Holter monitors are utilized to evaluate frequently occurring symptoms (for example, daily or multiple occurrences during the day) and ECG events.  

The practice of AECG using a Holter monitor over 24-48 hours has been based on clinical practice guidelines reviewed and published by the American College of Cardiology (ACC), American Heart Association (AHA) and the European Society of Cardiology (ESC). 

The ACC/AHA Task Force on Practice Guidelines, in collaboration with the North American Society for Pacing and Electrophysiology, provided guidelines and recommendations for AECG (Crawford, 1999).  The Class I – IIa recommendations included the common and accepted use of AECG Holter monitoring to determine the relationship of transient, unexplainable symptoms that may be suggestive of cardiac arrhythmias (for example, palpitations, dizziness or syncope), as well as unexplained, recurrent palpitations.  For individuals with idiopathic hypertrophic cardiomyopathy, AECG is indicated to detect arrhythmias and to assess risk for future cardiac events.  Holter AECG monitoring can assess response to antiarrhythmic drugs, as well as detect proarrhythmic responses to antiarrhythmic therapy in high-risk individuals.  AECG has also been recommended to evaluate and assess ICDs and pacemakers, including the response to adjunctive pharmacological therapy.  The guidelines included recommendations for AECG Holter monitoring in the pediatric population.  

Recommendations from the ACC/AHA Task Force guidelines that were based on lower levels of evidence included Holter monitor use to measure heart rate variability as a risk assessment for future cardiac events in individuals who had ventricular dysfunction after a myocardial infarction (class II, level of evidence B) and as an evaluation for diabetic neuropathy in individuals with diabetes (class III level of evidence) (Crawford, 1999). 

Ole and colleagues (2012) investigated if cardiovascular autonomic neuropathy (CAN) could be detected by simple function tests compared to heart rate variability (HRV) from 24-hour AECG recordings in individuals with type 1 and type 2 diabetes.  Randomly selected individuals with diabetes were monitored for 24 hours with a Holter monitor.  The participants were then put through a series of five function tests to assess the autonomic nervous system.  The trained technician who edited the 24-hour AECG recordings was blinded to the participants' information.  Data from participants with acceptable 24-hour AECG recordings and had completed all five function tests were analyzed.  The investigators assessed all of the variables and determined that the Valsalva ratio (p=0.002), the 30:15 ratio (p=0.037), and the handgrip (p=0.037) function tests were significant predictors for all-cause mortality and CAN, as compared to 24-hour AECG Holter monitor recordings.

In 2011, the ACCF/AHA Foundation published Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy (HCM) that included recommendations for AECG Holter monitoring.  Twenty-four–hour AECG Holter monitoring was recommended in the initial evaluation of individuals with HCM to detect ventricular tachycardia (VT) and to identify candidates for ICD therapy and in individuals with HCM who developed palpitations or lightheadedness (Gersh, 2011). 

In the 2006 (Zipes) report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology (ACC/AHA/ESC) Committee for Practice Guidelines, continuous 24- and 48-hour AECG Holter recording was deemed, "Appropriate whenever the arrhythmia is known or suspected to occur at least once a day."  Conventional standard external and implantable ambulatory event monitors were considered more appropriate for sporadic episodes of palpitations, dizziness or syncope.  The need to clarify the diagnosis by detecting arrhythmias, such as QT-interval changes or ST changes, to evaluate cardiac risk for arrhythmic events or to assess the therapeutic response to anti-arrhythmic medications was a class I recommendation (level of evidence A) for AECG with Holter monitoring.

The 2012 Heart Rhythm Society/ European Heart Rhythm Association/ European Cardiac Arrhythmia Society Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation (Calkins, 2012) notes there are early recurrences of atrial fibrillation during the first one to three months following a catheter ablation procedure for treatment of atrial fibrillation.  Therefore, a three month blanking period after ablation therapy is typically used when reporting efficacy outcomes.  Asymptomatic atrial fibrillation commonly occurs after ablation therapy and Holter monitoring is useful in detecting the asymptomatic episodes and determining efficacy of the ablative therapy.

In 2010, Hoefman published a systematic review on diagnostic tools for detecting cardiac arrhythmias.  This analysis included studies of subjects presenting with palpitations and compared the yield of remote monitoring for several classes of devices: Holter monitors; patient-activated event recorders; auto-triggered event recorders; and implantable loop recorders.  The yield varied among devices, with the autotrigger devices offering the highest range of detection (72-80%), followed by the patient-activated devices (17-75%), and Holter monitors (33-35%).  No combined analysis was performed due to the heterogeneity of the study population and study design.  Limitations in the evidence base precluded any specific recommendations on the selection of devices.  The authors concluded that the choice of device should be driven largely by the presence, type, and frequency of symptoms experienced by each individual.

The ACC/AHA practice guidelines and published peer reviewed literature support the clinical utility of standard Holter AECG monitors in the specified clinical indications. 

There are multiple cardiovascular monitoring devices (Holter monitors) that have received U.S. Food & Drug Administration 510(k) clearances as Class II devices.  Some newer devices are continuous monitors that are similar to traditional AECG Holter monitoring in concept, but offer other features such as the ability to monitor for longer periods of time.  However, there is a lack of published, peer-reviewed evidence to support the clinical utility of long-term (greater than 48 hours), continuous, external, unattended cardiac monitoring with a Holter monitor.

Definitions

Arrhythmia:  Abnormal heart rhythms which may be classified as either atrial or ventricular, depending on the origin in the heart.  Individuals with arrhythmias may experience a wide variety of symptoms ranging from palpitations to fainting.

Atrial fibrillation:  A quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications.

Myopotential:  The electric signal originating from skeletal muscle (usually the pectoralis major), close to a pacemaker, which may be sensed by the pacemaker during activity and falsely interpreted as a depolarization.

Physiological pacing:  A dual chamber or atrium-based pacing device used to maintain atrioventricular synchrony.

Rate-responsive pacing:  A pacemaker that can vary the pacing rate, depending on the immediate needs of the individual using sensors of body motion or respiratory rate.

Syncope:  An episode where the individual experiences loss of consciousness lasting at least several seconds.  If extreme dizziness is experienced without actual loss of consciousness, this is termed "pre- syncope."

Tachycardia:  An abnormally rapid heartbeat.

References

Peer Reviewed Publications:

  1. Gumbinger C, Krumsdorf U, Veltkamp R, et al. Continuous monitoring versus holter ECG for detection of atrial fibrillation in patients with stroke. Eur J Neurol. 2012; 19(2):253-257.
  2. Hoefman E, Bindels PJ, van Weert HC. Efficacy of diagnostic tools for detecting cardiac arrhythmias: systematic literature search. Neth Heart J. 2010; 18(11):543-551.
  3. Liao J, Khalid Z, Scallan C, et al. Noninvasive cardiac monitoring for detecting paroxysmal atrial fibrillation or flutter after acute ischemic stroke: a systematic review. Stroke. 2007; 38(11):2935-2940.
  4. May O, Arildsen H.  Simple function tests for autonomic neuropathy have a higher predictive value on all-cause mortality in diabetes compared to 24-h heart rate variability.  J Diabetes Complications.  2012; 26(3):246-250.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Anderson JL, Adams CD, Antman EM, et al.; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-Elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 2002 guidelines for the management of patients with unstable angina/non-ST-elevation myocardial infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol. 2007; 50(7):e1-e157.
  2. Calkins H, Brugada J, Cappato R, et al. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow- up, definitions, endpoints, and research trial design. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society. Heart Rhythm. 2012; 9(4):632-696.
  3. Centers for Medicare and Medicaid Services. National Coverage Determination for Electrocardiographic (EKG) Services. NCD #20.15. Effective date: August 26, 2004. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=179&ncdver=2&bc=AgAAQAAAAAAA&.  Accessed on July 15, 2013.
  4. Crawford MH, Bernstein SJ, Deedwania PC, et al. ACC/AHA guidelines for ambulatory electrocardiography: executive summary and recommendations. A report of the American College of Cardiology/American Heart Association task force on practice guidelines (committee to revise the guidelines for ambulatory electrocardiography). Circulation. 1999; 100(8):886-893.
  5. Crawford MH, Bernstein SJ, Deedwania PC, et al. ACC/AHA guidelines for ambulatory electrocardiography. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the Guidelines for Ambulatory Electrocardiography). Developed in collaboration with the North American Society for Pacing and Electrophysiology. J Am Coll Cardiol. 1999; 34(3):912-948.
  6. Dewar RI, Lip GY; Guidelines Development Group for the NICE clinical guideline for the management of atrial fibrillation. Identification, diagnosis and assessment of atrial fibrillation. Heart. 2007; 93(1):252-258.
  7. Fuster V, Rydén LE, Cannom DS, et al.; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006; 114(7):e257-e354.
  8. Gersh BJ, Maron BJ, Bonow RO, et al.; American College of Cardiology/American Heart Association (ACCF/AHA) Task Force on Practice Guidelines.  2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011; 58(25):e212-e260.
  9. Kadish AH, Buxton AE, Kennedy HL, et al.; American College of Cardiology/American Heart Association/American College of Physicians-American Society of Internal Medicine Task Force; International Society for Holter and Noninvasive Electrocardiology. ACC/AHA clinical competence statement on electrocardiography and ambulatory electrocardiography: a report of the ACC/AHA/ACP-ASIM task force on clinical competence (ACC/AHA Committee to develop a clinical competence statement on electrocardiography and ambulatory electrocardiography) endorsed by the International Society for Holter and Noninvasive Electrocardiology. Circulation. 2001; 104(25):3169-3178.
  10. Moya A, Sutton R, Ammirati F, et al.; Task Force for the Diagnosis and Management of Syncope; European Society of Cardiology (ESC); European Heart Rhythm Association (EHRA); Heart Failure Association (HFA); Heart Rhythm Society (HRS). Guidelines for the diagnosis and management of syncope (version 2009). Eur Heart J. 2009; 30(21):2631-2671.
  11. Raviele A, Giada F, Bergfeldt F, et al.  Management of patients with palpitations: a position paper from the European Heart Rhythm Association. Europace. 2011; 13(7):920-934.
  12. Zipes DP, Camm AJ, Borggrefe M, et al.; American College of Cardiology/American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. 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):e385-e484.
Web Sites for Additional Information
  1. American Heart Association. Holter Monitor. Updated April 15, 2013. Available at: http://www.heart.org/HEARTORG/Conditions/HeartAttack/SymptomsDiagnosisofHeartAttack/Holter-Monitor_UCM_446437_Article.jsp. Accessed on July 15, 2013.
  2. MedlinePlus. Holter monitor (24h). Updated March 22, 2013. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/003877.htm. Accessed on July 15, 2013.
Index

Holter Monitor
Continuous cardiac recorder

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

History

Status

Date

Action

Revised08/08/2013Medical Policy & Technology Assessment Committee (MPTAC) review. Added medically necessary indication as a method to assess for asymptomatic atrial fibrillation three or more months after ablation of arrhythmogenic foci for atrial fibrillation. Updated Discussion/General Information, Definitions, References and Websites sections.
New05/09/2013MPTAC review. Initial document development.