Clinical UM Guideline


Subject:  Ambulatory Event Monitors to Detect Cardiac Arrhythmias
Guideline #:  CG-MED-40Current Effective Date:  11/17/2014
Status:RevisedLast Review Date:  11/13/2014

Description

This document addresses the use of both standard external and implantable ambulatory event monitors (AEMs) for the detection of abnormal heart rhythms that cannot be detected by other means.  This document does not address the use of AEMs equipped with cellular telecommunications equipment for real time physician notification.  For information related to these devices, refer to MED.00051 Real-Time Remote Heart Monitors.  Also, this document does not address continuous 24-48 hour Holter monitoring.

Clinical Indications

Medically Necessary:

The use of external ambulatory event monitors (AEM) is considered medically necessary when EITHER of the following criteria are met:

  1. As a diagnostic alternative to Holter monitoring, in individuals who experience infrequent symptoms (less frequently than once every 48 hours) suggestive of cardiac arrhythmias; OR
  2. Following cryptogenic stroke, for the detection of suspected paroxysmal atrial fibrillation (AF) when prior testing with Holter monitoring has yielded inconclusive results and when AEM is intended to guide medical management with anticoagulants.

The use of implantable ambulatory event monitors is considered medically necessary only in the small subset of individuals who experience recurrent symptoms so infrequently that a prior trial of Holter monitor or an external ambulatory event monitor are not likely to be successful.

Not Medically Necessary:

Other uses of ambulatory event monitors and telemetry are considered not medically necessary including, but not limited to, the following clinical situations:

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. 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 
0295TExternal electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation
0296TExternal electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; recording (includes connection and initial recording)
0297TExternal electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; scanning analysis with report
0298TExternal electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; review and interpretation
33282Implantation of patient-activated cardiac event recorder
93268-93272External patient and, when performed, auto activated electrocardiographic rhythm derived event recording with symptom-related memory loop with remote download capability up to 30 days, 24-hour attended monitoring [includes codes 93268, 93270, 93271, 93272]
93285Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified healthcare professional; implantable loop recorder system
  
HCPCS 
E0616Implantable cardiac event recorder with memory, activator, and programmer
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2015]
 All diagnoses
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2015]
 All diagnoses
  
Discussion/General Information

Ambulatory event monitors (AEMs) were developed to provide longer periods of EKG monitoring, compared to ambulatory Holter electrocardiography, which is limited to 24 to 48 hours.  With AEM, the recording device is either worn continuously or activated only when the individual experiences symptoms.  The recorded EKGs are then either stored for future analysis or transmitted over telephone lines to a receiving station, that is, a doctor's office, hospital, or to a cardiac monitoring service.

Newer AEM devices have the capacity to transmit data to a monitoring station via cellular telephone connections in real time. These devices are not addressed in this document and are the subject of MED.00051 Real-Time Remote Heart Monitors.

Implantable AEMs are also available for those instances where individuals experience such infrequent symptoms that extended monitoring is needed.  These devices are inserted just under the skin in the chest area during an outpatient surgical procedure.  The device may remain implanted for over one year.  Implantable loop recorders (ILR) have the ability to record events either automatically (auto-activated) or by manual activation (self-activated). An example of an ILR is the Reveal® Insertable Loop Recorder (Medtronic, Inc., Minneapolis, MN) which received clearance through the 510(k) premarket approval process from the U.S. Food and Drug Administration (FDA) in February 2001 as a Class II device. 

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 (HM); self-activated event recorders; auto-triggered event recorders; and ILRs. The yield varied among devices, with the auto-trigger devices offering the highest range of detection (72-80%), followed by the self-activated devices (17-75%), and HM (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 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 (Hoefman, 2010).

In 1999, the American College of Cardiology (ACC), in conjunction with other organizations, published clinical guidelines for ambulatory electrocardiography with the following Class I recommendations (Crawford, 1999):

There were two Class IIa recommendations as follows: 

These guidelines describe both HM and AEM devices, but the recommendations do not distinguish between the different types of monitors.  These guidelines also predate the commercial availability of external loop recorders with auto-triggered capability or ILR.  However, these guidelines are helpful to define the indications for ambulatory ECG in general, with the choice of specific device to be based on the frequency of symptoms.  Of the Class I and IIa recommendations listed above, only the assessment of unexplained symptoms, such as syncope and palpitation, would occur infrequently enough to warrant the use of an AEM.  The other indications could be adequately assessed with short term monitoring with a HM.  Additionally, in 2001, the ACC published a clinical competence statement on ECG and ambulatory ECG (Kadish, 2001) which reiterated that the indications for ambulatory ECG had been addressed in the 1999 clinical guidelines (Crawford, 1999).  The competence statement noted:

There are no specific guidelines that distinguish patients for whom it is appropriate to perform continuous monitoring, (i.e., Holter monitor) from those for whom intermittent ambulatory monitoring is adequate. However, when monitoring is performed to evaluate the cause of intermittent symptoms, the frequency of the symptoms should dictate the type of recording (Kadish, 2001).

In 2006, the American Heart Association (AHA), in conjunction with the ACC, the American College of Cardiology Foundation (ACCF) and other organizations, published a scientific statement on the evaluation of syncope (Strickberger, 2006).  This scientific statement did not provide specific recommendations, but reviewed the role of "non-invasive ECG monitoring" in different clinical situations.  AEM use was specifically identified as an accepted technique in individuals with syncope with an otherwise normal history and physical exam, as follows:

The type and duration of ambulatory ECG monitoring is dictated by the frequency of symptoms.  A Holter monitor is appropriate for episodes that occur at least every day.  Event monitoring is ideal for episodes that occur at least once a month.  An implantable loop monitor allows the correlation of symptoms with the cardiac rhythm in patients in whom the symptoms are infrequent (Strickberger, 2006).

In 2011, a small study was published that investigated subjects with unexplained recurrent syncope due to idiopathic paroxysmal atrioventricular (AV) block, in the absence of structural heart disease and normal standard EKG and electrophysiological findings.  This observational study, which followed 18 subjects for a total timeframe of 12 ± 8 years, included prolonged EKG monitoring with ILRs, as well as with HM and in-hospital telemetry, to confirm the common clinical and electrophysiological features of this distinct form of syncope.  The authors acknowledged the need for larger prospective study to confirm their findings (Brignole, 2011).   

In 2011, the ACC/ACCF published Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy (HCM) within which only the following recommendation is made regarding cardiac event monitors: "Twenty-four-hour ambulatory (Holter) electrocardiographic monitoring or event recording is recommended in patients with HCM who develop palpitations or lightheadedness (Level of Evidence: B)" (Gersh, 2011).

Monitoring for Atrial Fibrillation (AF) in the post-cryptogenic stroke setting:

There has also been interest in the use of AEM devices to further characterize atrial fibrillation (AF) in the following clinical situations:

Cryptogenic stroke describes stroke without an identifiable cause, specifically a cardioembolic source, such as a patent foramen ovale or AF.  When potential cardiovascular etiologies have been ruled out during an initial workup consisting of various imaging studies and ECGs, then it's considered to be a "Cryptogenic" stroke.  It is estimated that some 36% of stroke survivors have cryptogenic stroke.  It has been suggested that additional monitoring may identify AF in stroke initially categorized as cryptogenic (Tayal, 2008).  The presence or absence of AF has a significant impact on post-stroke management.  For example, the AHA and the American Stroke Association (ASA) jointly published Guidelines for the Prevention of Stroke in Individuals with a prior Ischemic Stroke or Transient Ischemic Attack (TIA) (Sacco, 2006).  These guidelines recommend that individuals with cryptogenic stroke take aspirin for secondary stroke prevention, while the ACC guidelines addressing AF recommend careful consideration of warfarin, due to its superior efficacy for stroke prevention (Fuster, 2006).  Guidelines published by the American College of Chest Physicians (ACCP) also recommend anti-platelet therapy, (for example, aspirin) in individuals with cryptogenic stroke, while anticoagulation therapy is recommended in individuals with AF (Albers, 2008).  However, none of these guidelines specifically recommend extended ECG monitoring in individuals with cryptogenic stroke.

In 2007, Liao conducted a systematic review of noninvasive cardiac monitoring in the post-stroke setting where the authors specifically sought to determine the frequency of occult AF detected by noninvasive methods of continuous cardiac rhythm monitoring in consecutive individuals with ischemic stroke; a total of five prospective case series were included in the analysis.  Five studies evaluated HM for 24 to 72 hours in the inpatient setting and are not considered further.  The two studies that focused on loop recorders, following a negative HM finding, are relevant to this discussion (Barthelemy, 2003; Jaboudon, 2004).  New AF was identified in 5.7% and 7.7% of subjects, respectively (Liao, 2007).  In the study by Jaboudon, oral anticoagulation was started in 2 of the 7 subjects with new onset AF.  The authors concluded that increased duration of monitoring appears to be associated with increased rates of detection of AF; however, the authors also comment that it is uncertain whether any type of monitoring, including HM, should be routinely performed given the low incidence of AF.

The Cryptogenic Stroke and underlying Atrial Fibrillation (CRYSTAL-AF) trial was a large, prospective, randomized controlled study that utilized parallel-group design to evaluate the time to first episode of AF by means of 6 months of continuous rhythm monitoring versus control treatment in subjects with a recent cryptogenic stroke or TIA but without a personal history of AF.  Trial participants at 50 centers in the U.S., Canada and Europe were randomized in a 1:1 fashion to standard arrhythmia monitoring (in the control arm) or to implantation of a long-term, insertable, subcutaneous cardiac monitor (ICM), the Reveal XT (Medtronic, Inc., Minneapolis, MN) (in the continuous monitoring arm).  The purpose of this trial was to assess whether a long-term ECG monitoring strategy with an ICM is superior to conventional follow-up for the detection of AF in subjects with cryptogenic stroke.  The primary endpoint was time to detection of AF within 6 months after stroke, and the clinical follow-up period was at least 12 months.  Secondary endpoints included the time to first detection of AF at 12 months of follow-up, recurrent stroke or TIA, and the change in use of oral anticoagulant drugs.  AF was defined as an episode of irregular heart rhythm, without detectable P waves, lasting more than 30 seconds, with events qualifying for analysis adjudicated by an independent committee.  During the study period, 447 trial participants were enrolled and 441 were randomly assigned to either the ICM group (n=221) or the control group (n=220).  The mean (± standard deviation [SD]) time between the index event and randomization was 38.1 ± 27.6 days.  In 2014, results of the CRYSTAL-AF trial were published.  The rate of detection of AF at 6 months was 8.9% among the subjects assigned to the ICM group (n=19), as compared with 1.4% among subjects assigned to the control group (n=3) (hazard ratio [HR], 6.4; 95% confidence interval [CI], 1.9 to 21.7; P<0.001).  The median time from randomization to detection of AF was 41 days (interquartile range, 14 to 84) in the ICM group and 32 days (interquartile range, 2 to 73) in the control group.  Asymptomatic AF was noted in 14 of 19 first episodes in the ICM group (74%) and in 1 of 3 first episodes in the control group (33%).  The yield of 3 detected episodes in the control group was from a total of 88 conventional ECG studies in 65 subjects, 20 occurrences of 24-hour HM in 17 subjects, and monitoring with an event recorder in 1 trial subject.  The rate of detection of AF at 12 months was 12.4% (29 subjects) in the ICM group, as compared with 2.0% (4 subjects) in the control group (HR, 7.3; 95% CI, 2.6 to 20.8; P<0.001).  The median time from randomization to detection of AF was 84 days (interquartile range, 18 to 265) in the ICM group and 53 days (interquartile range, 17 to 212) in the control group.  Asymptomatic AF was noted in 23 of 29 first episodes in the ICM group (79%) and in 2 of 4 first episodes in the control group (50%).  When monitoring continued from 6 through 12 months, an additional 10 first episodes of AF were detected in the ICM group versus 1 in the control group, despite 34 conventional ECG studies in 33 subjects and 12 occurrences of HM in 10 subjects.  Ischemic stroke or TIA occurred in 11 subjects (5.2%) in the ICM group, as compared with 18 (8.6%) in the control group, during the first 6 months after randomization and in 15 subjects (7.1%) versus 19 (9.1%) during the first 12 months.  The rate of oral anticoagulant use was 10.1% in the ICM group versus 4.6% in the control group at 6 months (P=0.04) and 14.7% versus 6.0% at 12 months (P=0.007).  By 12 months, 97.0% of trial participants in whom AF had been detected were receiving oral anticoagulants.

In subgroup analysis, the higher rate of detection of AF with ICM, than with conventional follow-up, was consistent across all the prespecified subgroups, defined by age, sex, race or ethnic group, type of index event, presence or absence of patent foramen ovale, and CHADS2 score at 6 months, with no significant interactions.  The results of subgroup analyses at 12 months were consistent with those at 6 months.  At study closure, 277 subjects had completed the scheduled 18-month follow-up visit, 177 had completed the 24-month visit, 94 had completed the 30-month visit, and 48 had completed the 36-month visit (total follow-up, 815.5 subject years).  A relatively small number of subjects were followed for more than 24 months, but at 36 months of follow-up, the rate of detection of AF was 30.0% in the ICM group (42 subjects) versus 3.0% in the control group (5 subjects) (HR, 8.8; 95% CI, 3.5 to 22.2; P<0.001).  The most common adverse events associated with the ICM were infection (3 subjects [1.4%]), pain (3 subjects [1.4%]), and irritation or inflammation (4 subjects [1.9%]) at the insertion site.  The ICM remained inserted in 98.1% of subjects at 6 months and in 96.6% of subjects at 12 months.  The authors concluded that results of this manufacturer sponsored trial, despite study limitations, demonstrated that AF was more frequently detected with an ICM than with conventional follow-up in subjects with a recent cryptogenic stroke.  Study results also showed that AF after cryptogenic stroke was most often asymptomatic and paroxysmal and, thus, unlikely to be detected by strategies based on symptom-driven monitoring or intermittent short-term recordings (Sanna, 2014).

Similar results were noted from another open-label, multi-center, randomized controlled trial, the 30-Day Cardiac Event Monitor Belt for Recording Atrial Fibrillation after a Cerebral Ischemic Event (EMBRACE) trial that enrolled 572 subjects with cryptogenic stroke or TIA of undetermined cause within the previous 6 months and no history of AF.  Trial subjects were randomized to receive noninvasive ambulatory ECG monitoring with either a 30-day event-triggered loop recorder (intervention group) or a conventional 24-hour HM (control group). The primary outcome was newly detected AF lasting 30 seconds or longer within 90 days after randomization.  Secondary outcomes included episodes of AF lasting 2.5 minutes or longer and anticoagulation status at 90 days.  At 30 days, results indicated that AF lasting 30 seconds or longer was detected in 45 of 280 subjects (16.1%) in the intervention group, as compared with 9 of 277 (3.2%) in the control group (absolute difference, 12.9 percentage points; 95% CI, 8.0 to 17.6; P<0.001; number needed to screen, 8).  Episodes of AF lasting 2.5 minutes or longer were present in 28 of 284 subjects (9.9%) in the intervention group, as compared with 7 of 277 (2.5%) in the control group (absolute difference, 7.4 percentage points; 95% CI, 3.4 to 11.3; P<0.001).  By 90 days, oral anticoagulant therapy had been prescribed for more individuals in the intervention group than in the control group (52 of 280 [18.6%] vs. 31 of 279 [11.1%]; absolute difference, 7.5 percentage points; 95% CI, 1.6 to 13.3; P=0.01).  Despite remaining questions regarding the clinical relevance of subclinical AF and what therapeutic benefit is associated with anticoagulation therapy in this population, the trial results have demonstrated that noninvasive ambulatory ECG monitoring for 30 days is superior to short-term 24 hour monitoring for the detection of AF in individuals with a history of stroke or TIA labeled as cryptogenic (Gladstone, 2014).

Additional published evidence includes a systematic review and meta-analysis which was conducted by Kishore to determine the frequency of newly detected AF using noninvasive or invasive cardiac monitoring after ischemic stroke or TIA.  Prospective observational studies or randomized controlled trials of individuals with ischemic stroke, TIA, or both, who underwent any cardiac monitoring for a minimum of 12 hours, were included after electronic searches of multiple databases.  The primary outcome was detection of any new AF during the monitoring period.  A total of 32 studies were analyzed.  The overall detection rate of any AF was 11.5% (95% CI, 8.9%-4.3%), although the timing, duration, method of monitoring, and reporting of diagnostic criteria used for paroxysmal AF varied.  Results showed that detection rates were higher in selected subjects (13.4%; 95% CI, 9.0%-18.4%), as compared to unselected subjects (6.2%; 95% CI, 4.4%-8.3%).  The authors noted the presence of substantial heterogeneity even within specified subgroups and concluded that detection of AF was highly variable.  This review was limited by small sample sizes and marked heterogeneity (Kishore, 2014). 

In 2014, a report of the Guideline Development Subcommittee of the American Academy of Neurology (AAN) issued updated Guidelines on the Prevention of Stroke in Patients with Nonvalvular Atrial Fibrillation (NVAF).  This update to the former 1998 AAN practice parameter on stroke prevention in NVAF focuses on medical strategies to reduce risk of ischemic stroke but also provided the following regarding identification of individuals with occult NVAF:

Levels of Evidence are provided as follows for the AAN guideline recommendations above:
**B:    Data derived from a single randomized trial or nonrandomized studies;
***C:  Low confidence in evidence, small benefit relative to harm (AAN, 2014).

Monitoring for AF in the post-ablation setting:

Ablation, as a treatment of AF, is an option in individuals with symptomatic AF, in individuals who are refractory or intolerant to pharmacologic management, and in selected individuals with heart failure (HF) and/or reduced left ventricular ejection fraction (LVEF).  Catheter ablation of AF is addressed in MED.00064 Transcatheter Ablation of Arrhythmogenic Foci in the Pulmonary Veins as a Treatment of Atrial Fibrillation (Radiofrequency and Cryoablation).  In 2007, the Heart Rhythm Society (HRS), in conjunction with other organizations, published a consensus statement addressing the follow-up of individuals undergoing ablative therapy for AF (HRS, 2007).  This consensus statement pointed out that careful attention to anticoagulation therapy is needed, both before and after the ablative procedure, to avoid the occurrence of a thromboembolic event, which is considered one of the most serious complications of both AF and AF ablation procedures.  For example, early recurrences of AF are common during the first 1 to 3 months following ablation, due to remodeling and healing.  For this reason, monitoring to assess the efficacy of catheter ablation is typically delayed for at least 3 months, following the ablation.  The consensus statement notes that monitoring options include intermittent sampling using a standard ECG, or the use of an AEM.  However, the consensus does not indicate how this information can be used in the management of the individual, specifically whether or not to discontinue anticoagulation therapy.  For example, the consensus statement provided the following recommendations for anticoagulation after ablation (these indications are not based on the presence or absence of AF):

The ACC/AHA/ESC Guidelines on the Management of AF address the role of ablation techniques, and note:

The long term efficacy of catheter ablation to prevent recurrent AF requires further study.  Available data demonstrate 1 year or more free from recurrent AF in most (albeit, carefully selected) patients. It is important to bear in mind, however, that AF can recur without symptoms and be unrecognized by the patient or the physician.  Therefore, it remains uncertain whether apparent cures represent elimination of AF or transformation into an asymptomatic form of paroxysmal AF. The distinction has important implications for the duration of anticoagulation treatment (Fuster, 2006).

A 2011 ACCF/AHA/HRS focused update to the ACC/AHA/ESC Guidelines on the Management of AF includes HM and longer term event recording in its recommendations for initial clinical evaluation if the diagnosis or type of arrhythmia is in question and also in subsequent treatment monitoring as a means of evaluating rate control and individual risk for thromboembolic events.  This document reviews the major clinical trials of various treatment strategies for AF and notes, "The optimum method for monitoring antiarrhythmic drug treatment varies with the agent involved, as well as with patient factors."  The following is excerpted:

Ambulatory ECG recordings and device-based monitoring have revealed that an individual may experience periods of both symptomatic and asymptomatic AF…Prolonged or frequent monitoring may be necessary to reveal episodes of asymptomatic AF, which may be a cause of cryptogenic stroke (Fuster, 2011).

In 2014, the AHA/ACC/HRS updated its Guidelines on the Management of Patients with Atrial Fibrillation which referred to ILR, pacemakers and defibrillators as, "Offer the possibility to report the frequency, rate, and duration of abnormal atrial rhythms including AF" (January, 2014).  No additional information or recommendations for use of ILRs were provided in this document.

Based on the currently available published evidence, there is inadequate data to support the use of AEMs in post-ablation therapy to determine the need for continued anticoagulation therapy (Kapa, 2013; Themistoclakis, 2010).

Monitoring in other study populations:

The CARISMA study (Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction) investigated the incidence and prognostic significance of arrhythmias, documented by use of an ILR, in individuals following acute myocardial infarction (MI) with left ventricular systolic dysfunction.  A total of 1393 of 5869 individuals (24%) screened in the acute phase (3 to 21 days) of an acute MI had an LVEF ≤ 40%.  After exclusions, 297 subjects (21%) (mean ± SD age 64.0 ± 11.0 years; LVEF 31 ± 7%) received an ILR within 11 ± 5 days of the acute MI and were followed up every 3 months for an average of 1.9 ± 0.5 years.  Predefined bradyarrhythmias and tachyarrhythmias were recorded in 137 subjects (46%); 86% of these were asymptomatic.  The ILR documented a 28% incidence of new-onset AF with fast ventricular response (≥ 125 bpm), a 13% incidence of nonsustained ventricular tachycardia (≥ 16 beats), a 10% incidence of high-degree atrioventricular block (≤ 30 bpm lasting  ≥ 8 seconds), a 7% incidence of sinus bradycardia (≤ 30 bpm lasting  ≥ 8 seconds), a 5% incidence of sinus arrest (≥ 5 seconds), a 3% incidence of sustained ventricular tachycardia, and a 3% incidence of ventricular fibrillation.  Cox regression analysis with time-dependent covariates revealed that high-degree atrioventricular block was the most powerful predictor of cardiac death (HR, 6.75; 95% CI, 2.55 to 17.84; P<0.001).  In this first study to report on long-term cardiac arrhythmias, recorded by an ILR in individuals with an LVEF ≤ 40% after MI, the authors concluded that clinically significant bradyarrhythmias and tachyarrhythmias were documented in a substantial proportion of study subjects with depressed LVEF after acute MI and that intermittent high-degree atrioventricular block was associated with a very high risk of cardiac death (Bloch, 2010). 

A substudy of the CARISMA investigated the incidence and risk associated with new-onset AF occurring after discharge in subjects following an acute MI.  This study included 271 post-MI subjects with an LVEF ≤ 40% and no history of previous AF.  All trial subjects were implanted with an ILR and followed up every 3 months for 2 years.  Major cardiovascular events were defined as reinfarction, stroke, hospitalization for HF, or death.  Results showed the risk of new-onset AF is highest during the first 2 months after the acute MI (16% event rate) and decreases until month 12 post-MI, after which the risk for new-onset AF is stable.  The risk of major cardiovascular events was increased in subjects with AF events ≥ 30 seconds (HR [95% CI]=2.73 [1.35 to 5.50], P=0.005), but not in subjects with AF events lasting < 30 seconds (HR [95% CI]=1.17 [0.35 to 3.92], P=0.80).  More than 90% of all recorded AF events were asymptomatic.  The authors concluded that, through use of an ILR, the incidence of new-onset AF was found to be 4-fold higher than earlier reported.  In the study population in which treatment with beta-blockers was optimized, the vast majority of AF events were asymptomatic, and a duration of 30 seconds or more identified clinically important AF episodes (Jons, 2011).

Newer devices are becoming available with enhanced recording capability, such as the Zio®Patch (iRhythm Technologies, Inc., San Francisco, CA) which obtained FDA clearance in 2012 for, "Prescription only single patient use, continuous recording EGG monitor that can be worn for up to 14 days.  It is indicated for use on patients who experience transient symptoms, such as syncope, palpitations, shortness of breath, or chest pains" (FDA, 2012).  To date, the published evidence regarding these newer devices is limited regarding safety/efficacy and impact on clinical outcomes.

 *The CHADS (cardiac failure, hypertension, age, diabetes, stroke) score is a risk assessment tool that is based on a point system, in which 2 points are assigned for a history of stroke or TIA, and 1 point each is assigned for age over 75 and a history of hypertension, diabetes or recent HF.  The adjusted stroke rate can be assessed based on the CHADS score.  For example, a CHADS score of 2 is associated with an adjusted stroke rate of 4% per year (Fuster, 2006).

References

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  24. Mittal S, Movsowitz C, Steinberg JS. Ambulatory external electrocardiographic monitoring: focus on atrial fibrillation. J Am Coll Cardiol. 2011; 58(17):1741-1749.
  25. Ritter MA, Kochhauser S, Duning T, et al. Occult atrial fibrillation in cryptogenic stroke: detection by 7-day electrocardiogram versus implantable cardiac monitors. Stroke. 2013; 44(5):1449-1452.
  26. Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014; 370(26):2478-2486.
  27. Sinha AM, Diener HC, Morillo CA, et al. Cryptogenic stroke and underlying atrial fibrillation (CRYSTAL AF): design and rationale. Am Heart J. 2010; 160(1):36-41.e1.
  28. Tayal AH, Tian M, Kelly KM, et al. Atrial fibrillation detected by mobile cardiac outpatient telemetry in cryptogenic TIA or stroke. Neurology. 2008; 71(21):1696-1701.
  29. Themistoclakis S, Corrado A, Marchlinski FE, et al. The risk of thromboembolism and need for oral anticoagulation after successful atrial fibrillation ablation. J Am Coll Cardiol. 2010; 55(8):735-743.
  30. Ziegler PD, Glotzer TV, Daoud EG, et al. Detection of previously undiagnosed atrial fibrillation in patients with stroke risk factors and usefulness of continuous monitoring in primary stroke prevention. Am J Cardiol. 2012; 110(9):1309-1314.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Agency for Healthcare Research and Quality (AHRQ).  Research Protocol:  Treatment of Atrial Fibrillation.  EPC Version 11. 2012.  Available at:  http://effectivehealthcare.ahrq.gov/ehc/products/358/946/AtrialFibrillationTreatment_AmendedProtocol_20120530.pdf. Accessed on October 24, 2014.
  2. Agency for Healthcare Research and Quality (AHRQ). Remote cardiac monitoring. Technology Assessment. ECRI Evidence-based Practice Center (EPC). Contract No. 290-02-0019. Rockville, MD: AHRQ; December 12, 2007. Available at: http://www.cms.hhs.gov/determinationprocess/downloads/id51TA.pdf. Accessed on October 24, 2014.
  3. Albers GW, Amarenco P, Easton JD, et al. Antithrombotic and thrombolytic therapy for ischemic stroke: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest. 2008; 133(6 Suppl):630S-669S.
  4. Blomstrom-Lundqvist C, Scheinman MM, Aliot EM, et al. European Society of Cardiology Committee, NASPE-Heart Rhythm Society. ACC/AHA/ESC guidelines for the management of patients with supraventricular arrhythmias--executive summary. 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 develop guidelines for the management of patients with supraventricular arrhythmias) developed in collaboration with NASPE-Heart Rhythm Society. J Am Coll Cardiol. 2003; 42(8):1493-1531.
  5. Brignole M, Vardas P, Hoffman E, et al. European Society of Cardiology (EHRA). Position Paper: Indications for the use of diagnostic implantable and external ECG loop recorders.  Europace. 2009; 11(5):671-687. 
  6. Calkins H, Kuck KH, 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. J Interv Card Electrophysiol. 2012; 33(2):171-257.
  7. 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 October 24, 2014.
  8. 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.
  9. Culebras A, Messe SR, Chaturvedi S, et al. Summary of evidence-based guideline update: prevention of stroke in nonvalvular atrial fibrillation: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2014; 82(8):716-724.
  10. Fuster V, Rydén LE, Cannom DS, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: executive summary: 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 and Policy Conferences (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Association and the Heart Rhythm Society. Circulation. 2006; 114(7):e257-e354. Available at: http://circ.ahajournals.org/cgi/reprint/114/7/e257. Accessed on October 24, 2014.
  11. Fuster V, Ryden LE, Cannom DS, et al. 2011 ACCF/AHA/HRS focused updates incorporated into the 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. J Am Coll Cardiol. 2011; 57(11):101-198. Available at: http://circ.ahajournals.org/content/123/10/e269.full.pdf+html. Accessed on October 24, 2014.
  12. Gersh BJ, Maron BJ, Bonow RO, et al.  American College of Cardiology/American Heart Association (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. J Am Coll Cardiol. 2011; 58(25):e212-260. Available at: http://content.onlinejacc.org/article.aspx?articleid=1147838. Accessed on October 24, 2014.
  13. HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task Force on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2007; 4(6):816-861.
  14. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation: Executive Summary. J Am Coll Cardiol. 2014. Available at:  https://content.onlinejacc.org/article.aspx?articleid=1854230. Accessed on October 24, 2014. 
  15. Kadish AH, Buxton AE, Kennedy HL, et al. 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). Circulation. 2001; 38(7):2091-2100. Available at:  http://content.onlinejacc.org/cgi/content/full/38/7/2091. Accessed on October 24, 2014.
  16. Khairy P, Van Hare GF, Balaji S, et al. PACES/HRS Expert Consensus Statement on the Recognition and Management of Arrhythmias in Adult Congenital Heart Disease. Heart Rhythm. 2014; 11(10):e102-165.
  17. Medtronic Bakken Research Center. CARISMA: Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction. NCT00145119. Last updated January 20, 2014. Available at:  http://www.clinicaltrials.gov/ct2/show/NCT00145119?term=NCT00145119.&rank=1. Accessed on October 24, 2014.
  18. Medtronic Cardiac Rhythm Disease Management/Medtronic Bakken Research Center. Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke (CRYSTAL-AF). NCT 00924638.  Last updated June 26, 2014. Available at:  http://clinicaltrials.gov/show/NCT00924638. Accessed on October 24, 2014.
  19. Moya A, Sutton R, Ammirati F, et al.; European Society of Cardiology (ESC); European Heart Rhythm Association (EHRA); Heart Failure Association (HFA); Heart Rhythm Society (HRS), Task Force for the Diagnosis and Management of Syncope.  Guidelines for the diagnosis and management of syncope.  Updated 2009.  Eur Heart J. 2009; 30(21):2631-2671.
  20. 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. Available at:  http://europace.oxfordjournals.org/content/13/7/920.full.pdf. Accessed on October 24, 2014.
  21. Sacco RL, Adams R, Albers G, et al. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: a statement for healthcare professions from the American Heart Association and the American Stroke Association Council on Stroke. Circulation. 2006; 113(10):e409-e449. Available at: http://stroke.ahajournals.org/content/37/2/577.full.pdf+html. Accessed on October 24, 2014.
  22. Strickberger SA, Benson DW, Biaggioni I, et al. ACC/ACCF scientific statement on the evaluation of syncope: from the American Heart Association Councils on Clinical Cardiology, Cardiovascular Nursing, Cardiovascular Disease in the Young, and Stroke, and the Quality of Care and Outcomes Research Interdisciplinary Working Group; and the American College of Cardiology Foundation in collaboration with the Heart Rhythm Society. J Am Coll Cardiol. 2006; 47(2):473-484.
  23. Sunnybrook Health Sciences Centre. 30-Day Cardiac Event Monitor Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event (EMBRACE). NCT 00846924. Last updated September 14, 2014. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00846924?term=30-Day+Cardiac+
    Event+Monitor+Belt+for+Recording+Atrial+Fibrillation+After+a+Cerebral+Ischemic+Event&rank=1. Accessed on October 24, 2014.
  24. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health. Medtronic® Reveal® Plus Insertable Loop Recorder (ILR) System. No. K003667. Rockville, MD: FDA. February 14, 2001. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/k071641.pdf. Accessed on October 24, 2014.
  25. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health. Sleuth Implantable ECG Monitoring System. No. K063035. Rockville, MD: FDA. October 1, 2007. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063035.pdf?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=K063035&utm_content=1. Accessed on October 24, 2014.
  26. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health. Zio® Patch. No. K113862. Rockville, MD: FDA. February 6, 2012. Available at:  http://www.accessdata.fda.gov/cdrh_docs/pdf11/K113862.pdf. Accessed on October 24, 2014.
  27. Zipes DP, Camm AJ, Borggrefe M, et al. 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). Circulation. 2006; 114(10):1088-1132. Available at:http://www.escardio.org/guidelines-surveys/esc-guidelines/GuidelinesDocuments/guidelines-VASCD-FT.pdf. Accessed on October 24, 2014.
Index

Ambulatory Event Monitors
Cardiac Arrhythmias
Cardiac Event Monitors/Loop Recorders
iRhythm Zio Patch
Reveal Plus Insertable Loop Recorder
Sleuth Implantable ECG Monitoring System

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
StatusDateAction
Revised11/13/2014Medical Policy & Technology Assessment Committee (MPTAC) review.  The medically necessary criteria for external ambulatory event monitors were revised to add use following cryptogenic stroke for detection of suspected paroxysmal AF when criteria are met.  The Rationale and Reference sections were updated.
Reviewed05/15/2014MPTAC review. No change to criteria.  The Discussion and References sections were updated.
Reviewed05/09/2013MPTAC review. No change to criteria.  The Discussion section and References were updated.
Reviewed05/10/2012MPTAC review. No change to criteria. The Discussion section, Coding and References were updated.  The number changed from CG-DME-29 to CG-MED-40.
Reviewed05/19/2011MPTAC review. No change to criteria. References and Websites updated.
 01/01/2011Updated Coding section with 01/01/2011 CPT changes; removed CPT 93012, 93014 deleted 12/31/2010.
Reviewed05/13/2010MPTAC review. No change to criteria.  References were updated.
Revised05/21/2009MPTAC review. The indications considered not medically necessary for these devices have been expanded to add the following: following ablation procedures for atrial fibrillation and monitoring for atrial fibrillation in cryptogenic stroke. Discussion section, Coding and References were updated.
Reviewed05/15/2008MPTAC review. No change to criteria.  References were updated.
 10/01/2007Updated Coding section with 10/01/2007 ICD-9 changes.
Reviewed05/17/2007MPTAC review. No change to guideline criteria.  References and coding were updated.
Reviewed06/08/2006MPTAC review.  No change to guideline criteria.  References were updated to include scientific statements and guideline recommendations from the ACC/AHA. Guideline was renumbered to CG-DME-29 from former CG-MED-03.
 11/18/2005Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Revised07/14/2005MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.  Converted into a guideline.
Pre-Merger OrganizationsLast Review
Date
Document
Number
Title
Anthem, Inc.  No prior document
WellPoint Health Networks, Inc.06/24/20049.04.02Ambulatory Event Monitors to Detect Cardiac Arrhythmias