Coverage Policy Manual
Policy #: 2008007
Category: Medicine
Initiated: January 2008
Last Review: February 2019
  Cardiac Event Recorder, Mobile Telemetry

Description:
Ambulatory Holter electrocardiography (EKG) is a widely used noninvasive test in which EKG is continuously recorded over an extended period of time, typically 24 to 48 hours, to evaluate symptoms suggestive of cardiac arrhythmias, i.e., palpitations, dizziness, or syncope. However, Holter monitoring will be ineffective if a patient experiences infrequent symptoms. Ambulatory event monitors (AEMs) were developed to provide longer periods of monitoring. In this technique the recording device is either worn continuously and activated only when the patient experiences symptoms or is carried by the patient and applied and activated when symptoms are present. The recorded EKGs are then stored for future analysis or transmitted by telephone to a receiving station, e.g., a doctor's office, hospital, or cardiac monitoring service, where the EKGs can then be analyzed. AEMs can be used for extended periods of time, typically up to a month until the patient experiences symptoms. Since the EKGs are recorded only during symptoms, there is good correlation with any underlying arrhythmia. Conversely, if no EKG abnormality is noted, a noncardiac etiology of the patient's symptoms can be sought.
 
Mobile Cardiac Outpatient Telemetry
Ambulatory event monitors store the recorded data, which are ultimately transmitted either to a physician’s office or to a central recording station. In contrast, outpatient cardiac telemetry provides real-time monitoring and analysis. For example, CardioNet Inc. is a company that offers mobile cardiac outpatient telemetry. In this system, the patient wears a 3-lead sensor, which constantly communicates with the CardioNet monitor, a lightweight unit that can be carried in a pocket or a purse. When an arrhythmia is detected according to preset parameters, the EKG is automatically transmitted to a central CardioNet service center, where the EKG is immediately interpreted, with results sent to the referring physician. The referring physician can request the level and timing of response, ranging from daily reports to stat results.
 
Other systems for outpatient cardiac telemetry include the HEARTLink II system (Cardiac Telecom Corp.), the Vital Signs Transmitter (VST, Biowatch Medical, Columbia, SC), the Lifestar Ambulatory Cardiac Telemetry (ACT) system (Card Guard Scientific Survival Ltd., Israel) and the Heartrak External Cardiac Ambulatory Telemetry (ECAT). The Heartrak ECAT is patient activated, auto-triggered, records up to 30 days of continuous monitoring and has 2-way voice communication between patient and Monitoring Center.
 
The VectraplexECG System is a real-time continuous Mobile Cardiac Outpatient Telemetry device to measure ischemic ECG changes that can be indicative of a myocardial infarction (MI). This device utilizes the Internet to communicate real-time ECG changes to the physician. The patient is hooked up to a mini-tablet by either 5 electrodes, which communicate 15-lead ECG data, or 10 electrodes that communicate 12-lead ECG data. While this system is primarily intended to monitor for ischemia, the continuous ECG monitoring would presumably detect rhythm disturbances, as well as ischemic changes.
  
Coding
 
Effective January 1, 2009, there are specific CPT codes for mobile outpatient cardiac telemetry:
 
93228: External mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real-time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; physician review and interpretation with report
 
93229 ; technical support for connection and patient instructions for use, attended surveillance, analysis and physician prescribed transmission of daily and emergent data reports.
 
Effective April 1, 2006, three HCPCS S codes were added for the mobile outpatient cardiac telemetry:
 
S0345: Electrocardiographic monitoring utilizing a home computerized telemetry station with automatic activation and real-time notification of monitoring station, 24-hour attended monitoring, including recording, monitoring, receipt of transmissions, analysis, and physician review and interpretation; per 24-hour period
 
S0346: Electrocardiographic monitoring utilizing a home computerized telemetry station with automatic activation and real-time notification of monitoring station, 24-hour attended monitoring, including recording, monitoring, receipt of transmissions, and analysis; per 24-hour period
 
S0347: Electrocardiographic monitoring utilizing a home computerized telemetry station with automatic activation and real-time notification of monitoring station, 24-hour attended monitoring, including physician review and interpretation; per 24-hour period.
 
 
For coverage of other cardiac event recorders please see the following policies:
Cardiac Event Recorder Continuous 24 hr (Holter) - policy number 1997130;
Cardiac Event Recorder Insertable Loop Recorder - policy number 1998153;
Cardiac Event Recorder External Loop Recorder - policy number 1997229.

Policy/
Coverage:
Effective February 2019
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of outpatient cardiac telemetry, also known as mobile cardiac outpatient telemetry or MCOT, as a diagnostic alternative to ambulatory event monitors (AEMs) in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (ie, palpitations, dizziness, presyncope, syncope) does not meet primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, the use of outpatient cardiac telemetry, also known as mobile cardiac outpatient telemetry or MCOT, as a diagnostic alternative to ambulatory event monitors (AEMs) in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (ie, palpitations, dizziness, presyncope, syncope) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Other uses of outpatient cardiac telemetry or MCOT, including but not limited to monitoring asymptomatic patients with risk factors for arrhythmia, monitoring the effectiveness of antiarrhythmic medications, and detection of myocardial ischemia by detecting ST-segment changes does not meet primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, other uses of outpatient cardiac telemetry or MCOT, including but not limited to monitoring asymptomatic patients with risk factors for arrhythmia, monitoring the effectiveness of antiarrhythmic medications, and detection of myocardial ischemia by detecting ST-segment changes is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior To February 2019
The use of outpatient cardiac telemetry (also known as mobile cardiac outpatient telemetry or MCOT) as a diagnostic alternative in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope) does not meet Primary Coverage Criteria for cost-effectiveness.  There is a lack of data indicating this testing is more effective than other cardiac event recorders (e.g. 30 day recording) and the procedure is more costly.  
 
Other uses of outpatient cardiac telemetry, including but not limited to monitoring effectiveness of antiarrhythmic therapy and detection of myocardial ischemia by detecting ST segment changes, does not meet Primary Coverage Criteria.
 
Published guidelines of national and/or international workgroups of medical experts, widely used medical compendia, or technology assessments published by independent technology assessment organizations have classified non-covered uses as investigational or as questionable or of unknown benefit.
 
For any contract without Primary Coverage Criteria, the use of outpatient cardiac telemetry (also known as mobile cardiac outpatient telemetry or MCOT)  as a diagnostic alternative in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope) or for any other reason,  including but not limited to monitoring effectiveness of antiarrhythmic therapy and detection of myocardial ischemia by detecting ST segment changes, is considered not medically necessary.  Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Effective prior to January 2012
The use of outpatient cardiac telemetry (also known as mobile cardiac outpatient telemetry or MCOT) as a diagnostic alternative in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope) does not meet Primary Coverage Criteria for cost-effectiveness.  There is a lack of data indicating this testing is more effective than other cardiac event recorders (e.g. 30 day recording) and the procedure is more costly.  
 
Other uses of outpatient cardiac telemetry, including but not limited to monitoring effectiveness of antiarrhythmic therapy and detection of myocardial ischemia by detecting ST segment changes, does not meet Primary Coverage Criteria.
 
Published guidelines of national and/or international workgroups of medical experts, widely used medical compendia, or technology assessments published by independent technology assessment organizations have classified non-covered uses as investigational or as questionable or of unknown benefit.
 
For any contract without Primary Coverage Criteria, the use of outpatient cardiac telemetry (also known as mobile cardiac outpatient telemetry or MCOT)  as a diagnostic alternative in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope) or for any other reason,  including but not limited to monitoring effectiveness of antiarrhythmic therapy and detection of myocardial ischemia by detecting ST segment changes, is considered investigational and is not covered.  Investigational services are an exclusion in the member benefit certificate.

Rationale:
AEMs are a well-established technology that are most typically used to evaluate episodes of cardiac symptoms (palpitations, dizziness, syncope), which, due to their infrequency, would escape detection on a standard 24- to 48-hour Holter monitor. Other proposed uses include monitoring the efficacy of antiarrhythmic therapy and evaluating ST segment changes as an indication of myocardial ischemia. However evidence is inadequate to validate these uses of AEMs. Although serial EKG monitoring has often been used to guide antiarrhythmic therapy in patients with symptomatic sustained ventricular arrhythmias or survivors of near sudden cardiac death, it is not known what level of reduction of arrhythmic events constitute successful drug therapy. Furthermore, the patient’s cardiac activity must be evaluated before and during treatment, such that the patient can serve as his or her own control. The routine monitoring of asymptomatic patients after myocardial infarction is additionally controversial, especially after the Cardiac Arrhythmia Suppression Trial (CAST) showed that patients treated with encainide or flecainide actually had a higher mortality. While Holter monitoring has been used to detect ST segment changes, it is unclear whether ST segment changes can be reliably detected by an AEM. The interpretation of ST segment change is limited by instability of the isoelectric line, which is in turn dependent on meticulous attention to skin preparation, electrode attachment, and measures to reduce cable movement.
 
The published literature regarding outpatient cardiac telemetry was reviewed, with a specific focus on whether or not outpatient cardiac telemetry was associated with incremental benefit compared to the use of ambulatory event monitors. Of specific interest was the benefit of real-time monitoring in an ambulatory population, presumably considered to be at a lower level of risk from significant arrhythmia such that an electrophysiologic study or inpatient telemetry was not required. One published study was identified that described the outcomes of a consecutive case series of 100 patients.  Patients with a variety of symptoms were included, including most commonly palpitations (47%), efficacy of drug treatment (25%), dizziness (24%), or syncope (19%). Clinically significant arrhythmias were detected in 51% of patients, but half of these patients were asymptomatic. The authors comment that the automatic detection results in an increased diagnostic yield, but there was no discussion of its unique feature, i.e., the real-time analysis, transmission, and notification of arrhythmia.
 
One recent study reported on the potential role of mobile telemetry in the follow-up of patients who have ablation procedures for atrial fibrillation.  Studies presented as meeting abstracts suggest that mobile cardiac outpatient telemetry (MCOT) can detect more significant arrhythmias than standard loop recordings, but the impact of these findings on clinical outcomes is uncertain. In addition, the role of this device in the diagnosis and treatment strategy of patients with possible cardiac arrhythmias is unknown.
 
Rothman and colleagues recently reported results comparing MCOT to standard loop recording.  This study involved 305 patients who were randomized to the LOOP recorder or MCOT and who were monitored for up to 30 days. The unblinded study enrolled patients at 17 centers for whom the investigators had a strong suspicion of an arrhythmic cause of symptoms including those with symptoms of syncope, presyncope, or severe palpitations occurring less frequently than once per 24 hours and a nondiagnostic 24-hour Holter or telemetry monitor within the prior 45 days. Test results were read in a blinded fashion by an electrophysiologist. Study exclusions were Class IV heart failure, myocardial infarction within the prior 3 months, unstable angina, history of sustained ventricular tachycardia or ventricular fibrillation, and complex ectopy with an ejection fraction less than 35%.
 
While 305 patients were randomized, results from 266 were analyzed using patients who completed at least 25 days of monitoring, 132 in the LOOP group and 134 in the MCOT group. Of the 39 patients who did not complete the protocol, 20 (13 MCOT and 7 LOOP) did not complete the study due to non-compliance (non-wearing) with the device. Patients were predominantly female with a mean age of 56 years. Approximately 20% had a history of heart disease, 50% hypertension, and 5% heart failure.
 
A diagnostic endpoint (confirmation/exclusion of arrhythmic cause of symptoms) was found in 88% of MCOT patients and 75% of LOOP patients (p = 0.008). The difference in rates was due primarily to detection of asymptomatic (not associated with simultaneous symptoms) arrhythmias in the MCOT group consisting of rapid atrial fibrillation and/or flutter (15 patients vs. 1 patient) and ventricular tachycardia defined as more than 3 beats and rate greater than 100 (14 patients vs. 2 patients). These were thought to be clinically significant rhythm disturbances and the likely causes of the patients’ symptoms. The paper does not comment on the clinical impact (changes in management) of these findings in patients for whom the rhythm disturbance did not occur simultaneously with symptoms. In this study, the median time to diagnosis in the total study population was 7 days in the MCOT group and 9 days in the LOOP group. Of note, prior studies of the autotrigger loop recorder have also shown similar findings that are viewed as improvements over traditional LOOP recordings that require patient activation.
 
A subset of only 50 patients (related to device availability) received the newer autotrigger loop recorders. This study protocol does not allow for adequate comparisons between the autotrigger and the MCOT device.
 
The autotrigger loop recorders have become a part of the standard diagnostic approach to patients who have infrequent symptoms that are thought likely to be due to arrhythmias. Therefore, this is the test to which newer technologies must be compared. Currently, the literature does not provide any adequate comparative data for the autotrigger device compared to mobile cardiac telemetry. Further study of MCOT is needed to replicate the Rothman study and to compare MCOT with the autotrigger loop recorder.
 
There are limited data to show any potential value for the continuous monitoring aspects of MCOT.
 
2012 Update
The published literature concerning mobile cardiac outpatient telemetry was reviewed.  One study was identified that was published since the last policy updated. Kadish et al. evaluated the frequency with which events transmitted by MCOT represented emergent arrhythmias, thereby indirectly assessing the clinical utility of real-time outpatient monitoring (Kadish, 2010).  A total of 26,438 patients who had undergone MCOT during a 9-month period were retrospectively examined. Of these patients, 21% (5,459) had an arrhythmic event requiring physician notification, and 1% (260) had an event that could be considered potentially emergent. These potentially emergent events included 120 patients with wide-complex tachycardia, 100 patients with sinus pauses 6 seconds or longer, and 42 with sustained bradycardia at less than 30 beats per minute.
 
MCOT is another option for long-term cardiac monitoring. The current evidence on MCOT establishes that it does record cardiac electric signals, without patient activation, for subsequent analysis. Currently, the literature does not provide any adequate comparative data for MCOT compared to the autotrigger device. One retrospective, uncontrolled study reported that only a small minority of events (1%) detected by MCOT were potentially emergent. None of the available studies have clearly shown an improvement in clinical utility as a result of using MCOT. Further study of MCOT is needed to compare MCOT with the autotrigger loop recorder in order to determine whether the faster response possible with real-time monitoring leads to improved outcomes.  Thus, mobile cardiac outpatient telemetry  would be considered not medically necessary.
 
2013 Update
This policy is being updated with a literature review through January 2013. There was no new information that would prompt a change in the coverage statement.
 
2014 Update
A literature search was conducted using the MEDLINE database through January 2014. No new prospective trials were identified assessing the outcomes of MCOT compared to autotrigger loop recorders. Two retrospective analyses were identified and reviewed (Tsang J, 2014;  Miller DJ, 2012). Results of these analyses did not prompt a change in the coverage statement.
 
2016 Update
A literature search conducted through January 2016 did not reveal any new randomized controlled trials. No new information was identified that would prompt a change in the coverage statement.
 
In 2015, Favilla et al reported results of a retrospective cohort study of 227 patients with cryptogenic stroke or TIA who underwent 28 days of monitoring with mobile cardiac outpatient telemetry (Favilla, 2015).  AF was detected in 14% of patients (31/227), of whom 3 reported symptoms at the time of AF. Oral anticoagulation was initiated in 26 patients (84%) diagnosed with AF. Of the remaining 5 (16%) who were not anticoagulated, 1 had a prior history of gastrointestinal bleeding, 3 were not willing to accept the risk of bleeding, and 1 failed to follow up.
 
The available published evidence is considered insufficient to determine that MCOT improves the net health outcome for patients with suspected arrhythmias or for the detection of AF in patients following catheter ablation or following cryptogenic stroke.    
 
2017 Update
A literature search conducted through January 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2016, Solomon and colleagues evaluated the diagnostic yield for potentially high-risk arrhythmias with 14 days of continuous recording with the Zio Patch among 122,454 patients (122,815 recordings) included in a manufacturer registry (Solomon, 2016). Patients included in the series all underwent monitoring with the device from November 2011 to December 2013. Mean wear time was 9.6 days. Overall, there were 22,443 (18%) patients with sustained ventricular tachycardia, 1766 (1.4%) patients with sinus pauses of 3 seconds or more, 521 (0.4%) patients with AF pauses of 3 seconds or more, 249 (0.2%) patients with symptomatic pauses, and 1468 (0.4%) with high-grade heart block, which were considered potentially high-risk arrhythmias. After 24 and 48 hours of monitoring, 52.5% and 65.5%, respectively, of potentially high-risk arrhythmias were detected. Seven days of monitoring identified 92.9% of potentially high-risk arrhythmias.
 
Eisenbert and colleagues reported on a single center study on the diagnostic yield and timing of detection of arrhythmias in patients monitored with the Zio Patch for a variety of arrhythmias. 524 consecutive patients were evaluated in an academic EP practice. Monitoring indications were surveillance of unspecified arrhythmia or palpitations (47%), known/suspected AF (30%), syncope (8%), bradycardia surveillance (4%), tachycardia surveillance (5%), and chest pain (2%). The main findings were significant arrhythmias were detected in 297 (57%), 66% had 1st arrhythmia detected within 2 days of monitoring, 25% of patients-triggered events associated with clinically significant arrhythmias.
 
Another report by Schreiber and colleagues reported on a single center study on the diagnostic yield and timing of detection of arrhythmias in patients monitored with the Zio Patch for a variety of arrhythmias. (Schreiber, 2014).174 patients with symptoms suggestive of arrhythmia seen in the emergency department (ED) were evaluated. The monitoring indications were as follows: palpitations (44%), syncope (24.1%), unspecified arrhythmias detected in the ED (11.5%). The main findings were >1 significant arrhythmia other than chronic AF (≥4 beats VT, paroxysmal AF, (≥4 beats SVT, ≥3-second pause, 2nd degree Mobitz II or 3rd degree AV block, or symptomatic bradycardia detected in 83 (47.7%), median time to arrhythmia detection: any arrhythmia 1.0 day interquartile range, VT 3.1 d, sinus pause 4.2 d; significant heart block 5.8 d.
 
A prospective study that evaluated the incidence of asymptomatic AF episodes following AF ablation (using an implantable cardiac monitoring) followed 50 patients with cardiac monitoring over 18 months postablation (Verma, 2013). Based on symptoms alone, 29 (58%) of 50 patients were arrhythmia-free after ablation; based on occurrence of symptoms or the detection of AF on intermittent (every 3 month) ECG or Holter monitor, 28 (56%) patients were arrhythmia-free postablation. Six (12%) patients had arrhythmias detected on implantable monitoring alone.
 
Brachmann and colleagues reported on 3-year follow-up from the CRYSTAL-AF trial in 2016 (Brachmann, 2016). At the closure of the trial, 48 subjects had completed 3 years of follow-up (n=24 in each treatment group). By 3 years, the HR for detecting AF for ICM-monitored versus control patients was 8.8 (95% CI, 3.5 to 22.2; p<0.001).
 
Giada and colleagues conducted an RCT of 2 diagnostic strategies in 50 patients with infrequent (≤1 episode per month) unexplained palpitations: an ILR strategy (n=26) vs a conventional strategy (n=24) including 24-hour Holter, 4 weeks of ambulatory ECG monitoring with an external recorder, and an electrophysiologic study if the 2 prior evaluations were negative) (Giada, 2007). Prior cardiac evaluation in eligible patients included standard ECG and echocardiography. Rhythm monitoring was considered diagnostic when a symptom-rhythm correlation was demonstrated during spontaneous palpitations that resembled pre-enrollment symptoms. In the conventional strategy group, a diagnosis was made in 5 (21%) subjects, after a mean time to diagnosis of 36 (±25) days, based on external ECG monitoring in 2 subjects and electrophysiologic studies in 3 subjects. In the ILR group, a diagnosis was made in 19 subjects (73%; vs conventional group, p<0.001) after a mean time to diagnosis of 279 (±228) days.
 
In 2004, Farwell and colleagues reported results of an RCT comparing the diagnostic yield of an ILR (Reveal Plus, Medtronic) with a conventional diagnostic strategy in 201 patients with unexplained syncope (Farwell, 2004). Eligible patients were evaluated at a single institution for recurrent syncope and had no definitive diagnosis after a basic initial workup (including 12-lead ECG, Holter monitoring in patients with suspected cardiac syncope, upright cardiac sinus massage, and tilt-table testing). At last follow-up, more loop recorder patients (33%) had an ECG diagnosis than control patients (4%; HR for ECG diagnosis; 8.93; 95% CI, 3.17 to 25.19; p<0.001).Seven of the loop recorder patients had a diagnosis made with the device’s auto-trigger feature. In the loop recorder group, 34 patients had an ECG-directed therapy initiated (vs 4 in the control group; HR=7.9; 95% CI, 2.8 to 22.3). No device-related adverse events were reported.
 
An earlier (2001) RCT reported by Krahn and colleagues with a similar design compared a conventional monitoring strategy (external loop recorder monitoring for 2-4 weeks, followed by tilt-table and electro-physiologic testing) with at least 1 year of monitoring to an ILR in 60 subjects with unexplained syncope (n=30 per group) (Krahn, 2001). Eligible patients had previously undergone clinical assessment, at least 24 hours of continuous ambulatory monitoring or inpatient telemetry, and a transthoracic echocardiogram. A diagnosis was made in 20% of those in the conventional monitoring arm versus 52% of those in the ILR arm (p=0.012).
 
In a report from an observational registry of patients who received or were about to receive an ILR (the Reveal Plus, DX, or XT device) because of unexplained syncope, Edvardsson and colleagues described the yield of monitoring in 570 patients who were implanted and followed for at least a year or until diagnosis (Edvardsson, 2014). Most (97.5%) patients had a standard ECG before initiation of the ILR, 11.8% had prior external loop recorder, and 54.6% had in-hospital ECG monitoring. During the monitoring period, 218 (38%) patients had recurrent syncope. The proportion of specific diagnoses based on the ILR is not reported, but of subjects who had a recurrence, 42.2% had a pacemaker implanted, 4.6% had an implantable cardioverter defibrillator implanted, 4.1% received antiarrhythmic drug therapy, and 3.7% underwent catheter ablation.
 
Other observational studies have reported on the yield of arrhythmia diagnosis in patients with symptoms monitored with ILRs. Bhangu and colleagues reported on the diagnostic yield of ILRs in a series of 70 elderly patients with unexplained falls (Bhangu, 2016).
 
Implantable Loop Recorders in the Detection of Atrial Fibrillation
As noted in the preceding section on the detection of AF, some trials that have demonstrated improved outcomes with monitoring strategies (ie, the CRYSTAL AF) used ILRs. Auto-trigger ILRs have also been developed specifically to detect AF through the use of AF detection algorithms. Several nonrandomized studies have evaluated the accuracy of auto-triggered ILRs for the diagnosis of AF.
 
Hindricks and colleagues evaluated the accuracy of auto-triggered ILRs in 247 patients at high risk for paroxysmal AF (Hindricks, 2010). All patients underwent simultaneous 46-hour continuous Holter monitoring, and the authors calculated the performance characteristics of the loop recorder using physician-interpreted Holter monitoring as the criterion standard. The sensitivity of the loop recorder for detecting AF episodes of 2 minutes or more in duration was 88.2%, rising to 92.1% for episodes of 6 minutes or more. AF was falsely identified by the loop recorder in 19 of 130 patients who did not have AF on Holter monitoring, for a false-positive rate of 15%. AF burden was accurately measured by the loop recorder, with the mean absolute difference between the loop recorder and Holter monitor of 1.4% (±6.4%).
 
Hanke and colleagues compared an auto-trigger ILR with 24-hour Holter monitoring done at 3-month intervals in 45 patients who had undergone surgical ablation for AF (Hanke, 2009). After a mean follow-up of 8.3 months, the ILR identified AF in 19 (42%) patients in whom Holter monitoring recorded sinus rhythm.
 
In 2015, Afzal and colleagues reported on a systematic review and meta-analysis of studies comparing ILRs with wearable AEMs for prolonged outpatient rhythm monitoring after cryptogenic stroke (Afzal, 2015). The review included 16 studies (total N=1770 patients): 3 RCTs and 13 observational studies. For ILR-monitored patients, the median monitoring duration was 365 days (range, 50-569 days), while for wearable device-monitored patients, the median monitoring duration was 14 days (range, 4-30 days). Compared with wearable device AEMs, ILRs were associated with significantly higher rates of AF detection (23.3% vs 13.6%; odds ratio, 4.54; 95% CI, 2.92 to 7.06; p<0.05).
 
In 2015, Ziegler and colleagues reported on a large (N=1247) set of patients undergoing ILR monitoring for AF detection after a cryptogenic stroke who were identified from the manufacturer’s registry (Ziegler, 2015). Over a median follow-up of 182 days, a total of 1521 episodes of AF were detected in 147 patients. Overall, 42 (29%) patients had a single episode of AF and 105 (71%) patients had multiple episodes. The overall detection rate 12.2% (at 182 days) was somewhat higher than that reported in CRYSTAL AF.
 
Sanders and colleagues reported on the diagnostic yield for AF with the Reveal Linq device, a miniaturized ILR with a detection algorithm designed to detect AF in a nonrandomized, prospective trial (Sanders, 2016). The study included 151 patients, most of whom (81.5%) were undergoing monitoring for AF ablation or AF management. Compared with Holter-detected AF, the ILR had a diagnostic sensitivity and specificity for AF of 97.4% and 97.0%.
 
Safety of Implantable Loop Recorders
In 2015, Mittal and colleagues reported on safety outcomes related to the use of an ILR, the Reveal LINQ device, based on data from 2 studies, the Reveal LINQ Usability study and the Reveal LINQ Registry (Mittal, 2015). The Usability study enrolled 151 patients at 16 European and Australian centers; adverse events were reported for the first month of follow-up. The Registry is a multicenter post-marketing surveillance registry, with a planned enrollment of at least 1200. At the time of analysis, 161 patients had been enrolled. For Registry patients, all adverse events were recorded when they occurred. The device version used in these studies measures 7 × 45 × 4 mm3, and is inserted with a preloaded insertion tool via a small skin incision. In the Usability study, 1 serious adverse event was recorded (insertion site pain); in the Registry study, 2 serious adverse events were recorded (1 case each of insertion site pain and insertion site infection). The rates of infection and procedure-related serious adverse events in the Usability study were 1.3% and 0.7%, respectively, and were 1.6% and 1.6%, respectively, in the Registry study.
 
In an uncontrolled case series, Tayal and colleagues retrospectively analyzed patients with cryptogenic stroke who had not been diagnosed with AF by standard monitoring (Tayal, 2008). In this study, 13 (23%) of 56 patients with cryptogenic stroke had AF with MCOT. Twenty-seven asymptomatic AF episodes were detected in the 13 patients; 23 of these were less than 30 seconds in duration. In contrast, Kalani and colleagues reported a diagnostic yield for AF of 4.7% (95% CI, 1.5% to 11.9%) in a series of 85 patients with cryptogenic stroke (Kalani, 2015). In this series, 82.4% of patients had completed transesophageal echocardiography, cardiac magnetic resonance imaging (cMRI), or both, with negative results; the authors proposed that the use of advanced cardiac imaging may alter the underlying prevalence of AF in patients labeled as having cryptogenic stroke.
 
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in December 2016 did not identify any ongoing or unpublished trials that would likely influence this review.
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
AF DETECTION IN ASYMPTOMATIC PATIENTS
Screening for AF in asymptomatic patients has been proposed to reduce burden of stroke. Evaluating the net benefits of screening for AF in unselected patients requires considering the potential risk of stroke in absence of screening, the incremental benefit of earlier versus later treatment for stroke resulting from
earlier detection of AF, and the potential harms of  overdiagnosis.
 
Assessing the prevalence of asymptomatic AF is difficult because of the lack of symptoms. Those who are asymptomatic have been estimated to constitute approximately a third of all patients with AF (Savelieva, 2000). Studies have suggested that most paroxysmal episodes of AF are asymptomatic (Israel, 2004; Page, 1994). It is uncertain whether patients with paroxysmal AF have a stroke risk comparable to those with persistent or permanent AF; some studies have suggested the risk of stroke is similar (Hart, 2000; Hohnloser, 2007) while a 2016 systematic review of 12 studies (total N=99,996 patients) suggested the risks of thromboembolism and all-cause mortality were higher with nonparoxysmal compared to paroxysmal AF (Ganesan, 2016). The clinical management of symptomatic and asymptomatic AF is the same. Anticoagulation should be initiated if reduction in risk of embolization exceeds complications due to increase bleeding risk regardless of AF symptoms.
 
Screening for AF in asymptomatic patients could be either systematic or targeted to high-risk populations. European guidelines for screening for AF are based on a 2007 largecluster RCT of opportunistic pulse taking versus systematic screening with 12lead ECG or standard care in general practice. This RCT showed that systematic and opportunistic screening detected similar rates of AF and both were superior to standard care (Fitzmaurice, 2007). The mechanisms of how and when to screen for AF in unselected populations have not been well-studied.
 
In 2015, Turakhia et al reported results for a single-center noncomparative study evaluating the feasibility and diagnostic yield of a continuous recording device with longer recording period (Zio Patch) for patients with risk factors for AF (Turakhia, 2015). The study included 75 patients older than age 55 with at least 2 of risk factors for AF (coronary disease, heart failure, hypertension, diabetes, or sleep apnea), without a history of prior AF, stroke, TIA, implantable pacemaker or defibrillator, or palpitations or syncope in the prior year. Of the 75 subjects, 32% had a history of significant valvular disease and 9.3% had prior valve replacement. Most subjects were considered at moderate to high risk of stroke (CHA2DS2-VASc scores ≥2 in 97% of subjects). AF was detected in 4 (5.3%) subjects, all of whom had CHA2DS2-VASc scores of 2 or greater. All patients with AF detected had an initial episode within the first 48 hours of monitoring. Five patients had detected episodes of atrial tachyarrhythmias lasting at least 60 seconds.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Mobile Cardiac Outpatient Telemetry
 
Arrhythmia Detection
Derkac et al retrospectively reviewed the BioTelemetry database of patients receiving ambulatory ECG monitoring, selecting patients prescribed MCOT (n=69,977) and patients prescribed AT-LER, an autotrigger looping event recorder (n=8513) (Derkac, 2017). Patients were diagnosed with palpitations, syncope and collapse, AF, tachycardia, and/or TIA. Patients given the MCOT were monitored for an average of 20 days and patients given the AT-LER were monitored an average of 27 days. The diagnostic yield using MCOT was significantly higher than that using AT-LER for several events: 128% higher for AF, 54% higher for bradycardia, 17% higher for ventricular pause, 80% higher for SVT, and 222% higher for ventricular tachycardia. Mean time to diagnosis for each asymptomatic arrhythmia was shorter for patients monitored by MCOT than by AT-LER. There was no discussion of management changes or health outcomes based on monitoring results.
 
AF Detection
In an uncontrolled case series, Tayal et al retrospectively analyzed patients with cryptogenic stroke who had not been diagnosed with AF by standard monitoring (Tayal, 2008). In this study, 13 (23%) of 56 patients with cryptogenic stroke had AF detected by MCOT. Twenty-seven asymptomatic AF episodes were detected in the 13 patients; 23 of them were less than 30 seconds in duration. In contrast, Kalani et al reported a diagnostic yield for AF of 4.7% (95% CI, 1.5% to 11.9%) in a series of 85 patients with cryptogenic stroke (Kalani, 2015). In this series, 82.4% of patients had completed transesophageal echocardiography, cardiac magnetic resonance imaging, or both, with negative results. Three devices
were used and described as MCOT devices: 34% received LifeStar ACT ambulatory cardiac telemetry, 41% received the LifeStar AF Express autodetect looping monitor, and 25% received the Cardiomedix cardiac event monitor. While the authors reported that there was a system in place to transmit the data for review, it is unclear whether data were sent in “real-time.”

CPT/HCPCS:
93228External mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; review and interpretation with report by a physician or other qualified health care professional
93229External mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; technical support for connection and patient instructions for use, attended surveillance, analysis and transmission of daily and emergent data reports as prescribed by a physician or other qualified health care professional

References: Afzal MR, Gunda S, Waheed S, et al.(2015) Role of outpatient cardiac rhythm monitoring in cryptogenic stroke: a systematic review and meta-analysis. Pacing Clin Electrophysiol. Oct 2015;38(10):1236-1245. PMID 26172621

Agency for Healthcare Research & Quality. Remote Cardiac Monitoring. http://www.cms.hhs.gov/mcd/viewtechassess.asp?where=index&tid=51; ECRI Evidence-based Practice Center, 12-12-07.

Balmelli N, Naegeli B, Bertel O.(2003) Diagnostic yield of automatic and patient-triggered ambulatory cardiac event recording in the evaluation of patients with palpitations, dizziness or syncope. Clin Cardiol 2003; 26(4):173-6.

Bhangu J, McMahon CG, Hall P, et al.(2016) Long-term cardiac monitoring in older adults with unexplained falls and syncope. Heart. May 1 2016;102(9):681-686. PMID 26822427

Brachmann J, Morillo CA, Sanna T, et al.(2016) Uncovering atrial fibrillation beyond short-term monitoring in cryptogenic stroke patients: three-year results from the Cryptogenic Stroke and Underlying Atrial Fibrillation Trial. Circ Arrhythm Electrophysiol. Jan 2016;9(1):e003333. PMID 26763225

Centers for Medicare & Medicaid Services (CMS).(2004) National Coverage Determination (NCD) for Electrocardiographic Services (20.15). 2004; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?MCDId=16&ExpandComments=n&McdName=Thomson+Micromedex+DrugDex+%C2%AE+Compendium+Revision+Request+-+CAG-00391&NCDId=179. Accessed March 19, 2018.

Crawford MH, Berstein SJ, Deedwania PC et al.(1999) ACC/AHA Guidelines for the 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). J Am Coll Cardiol 1999; 34(3):912-45.

Derkac WM, Finkelmeier JR, Horgan DJ, et al.(2017) Diagnostic yield of asymptomatic arrhythmias detected by mobile cardiac outpatient telemetry and autotrigger looping event cardiac monitors. J Cardiovasc Electrophysiol. Dec 2017;28(12):1475-1478. PMID 28940881

DiMarco JP, Philbrick JT.(1990) Use of ambulatory electrocardiographic (Holter) monitoring. Ann Intern Med 1990; 113(1):53-68.

Edvardsson N, Garutti C, Rieger G, et al.(2014) Unexplained syncope: implications of age and gender on patient characteristics and evaluation, the diagnostic yield of an implantable loop recorder, and the subsequent treatment. Clin Cardiol. Oct 2014;37(10):618-625. PMID 24890550

Eisenberg EE, Carlson SK, Doshi RH, et al.(2014) Chronic ambulatory monitoring: results of a large single-center experience. J Innovations Cardiac Rhythm Manage. Nov 2014;5:1818-1823.

Ermis C, Zhu AX, Pham S, et al.(2003) Comparison of automatic and patient-activated arrhythmia recordings by implantable loop recorders in the evaluation of syncope. Am J Cardiol 2003; 92(7):815-9.

Excellence NIfHaC(2014) Transient loss of consciousness ('blackouts') in over 16s. NICE guidelines [CG109] 2014; https://www.nice.org.uk/guidance/cg109.

Farwell DJ, Freemantle N, Sulke AN.(2004) Use of implantable loop recorders in the diagnosis and management of syncope. Eur Heart J. Jul 2004;25(14):1257-1263. PMID 15246645

Favilla CG, Ingala E, Jara J, et al.(2015) Predictors of finding occult atrial fibrillation after cryptogenic stroke. Stroke. May 2015;46(5):1210-1215. PMID 25851771

Fitzmaurice DA, Hobbs FD, Jowett S, et al.(2007) Screening versus routine practice in detection of atrial fibrillation in patients aged 65 or over: cluster randomised controlled trial. BMJ. Aug 25 2007;335(7616):383. PMID 17673732.

Ganesan AN, Chew DP, Hartshorne T, et al.(2016) The impact of atrial fibrillation type on the risk of thromboembolism, mortality, and bleeding: a systematic review and meta-analysis. Eur Heart J. May 21 2016;37(20):1591-1602. PMID 26888184.

Giada F, Gulizia M, Francese M, et al.(2007) Recurrent unexplained palpitations (RUP) study comparison of implantable loop recorder versus conventional diagnostic strategy. J Am Coll Cardiol. May 15 2007;49(19):1951-1956. PMID 17498580

Hanke T, Charitos EI, Stierle U, et al.(2009) Twenty-four-hour holter monitor follow-up does not provide accurate heart rhythm status after surgical atrial fibrillation ablation therapy: up to 12 months experience with a novel permanently implantable heart rhythm monitor device. Circulation. Sep 15 2009;120(11 Suppl):S177-184. PMID 19752365

Hart RG, Pearce LA, Rothbart RM, et al.(2000) Stroke with intermittent atrial fibrillation: incidence and predictors during aspirin therapy. Stroke Prevention in Atrial Fibrillation Investigators. J Am Coll Cardiol. Jan 2000;35(1):183-187. PMID 10636278.

Hindricks G, Pokushalov E, Urban L, et al.(2010) Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: Results of the XPECT trial. Circ Arrhythm Electrophysiol. Apr 2010;3(2):141-147. PMID 20160169

Hohnloser SH, Pajitnev D, Pogue J, et al.(2007) Incidence of stroke in paroxysmal versus sustained atrial fibrillation in patients taking oral anticoagulation or combined antiplatelet therapy: an ACTIVE W Substudy. J Am Coll Cardiol. Nov 27 2007;50(22):2156-2161. PMID 18036454.

Israel CW, Gronefeld G, Ehrlich JR, et al.(2004) Long-term risk of recurrent atrial fibrillation as documented by an implantable monitoring device: implications for optimal patient care. J Am Coll Cardiol. Jan 07 2004;43(1):47-52. PMID 14715182.

Joshi AK, Kowey PR, Prystowsky EN, et al.(2005) First experience with a Mobile Cardiac Outpatient Telemetry (MCOT) system for the diagnosis and management of cardiac arrhythmia. Am J Cardiol 2005: 95(7):878-91.

Kadish AH, Reiffel JA, Clauser J et al.(2010) Frequency of serious arrhythmias detected with ambulatory cardiac telemetry. Am J Cardiol 2010; 105(9):1313-6.

Kalani R, Bernstein R, Passman R, et al.(2015) Low yield of mobile cardiac outpatient telemetry after cryptogenic stroke in patients with extensive cardiac imaging. J Stroke Cerebrovasc Dis. Sep 2015;24(9):2069-2073. PMID 26139455

Kalani R, Bernstein R, Passman R, et al.(2015) Low yield of mobile cardiac outpatient telemetry after cryptogenic stroke in patients with extensive cardiac imaging. J Stroke Cerebrovasc Dis. Sep 2015;24(9):2069-2073. PMID 26139455

Kamel H, Hegde M, Johnson DR, et al.(2010) Cost-effectiveness of outpatient cardiac monitoring to detect atrial fibrillation after ischemic stroke. Stroke. 2010;41:1514-1520.

Krahn AD, Klein GJ, Yee R, et al.(2001) Randomized assessment of syncope trial: conventional diagnostic testing versus a prolonged monitoring strategy. Circulation. Jul 3 2001;104(1):46-51. PMID 11435336

Miller DJ, Khan MA, Schultz LR, et al.(2012) Outpatient cardiac telemetry detects a high rate of atrial fibrillation in cryptogenic stroke. J Neurol Sci (2012) http://dx.doi.org/10.1016/j.jns.2012.10.001.

Mittal S, Sanders P, Pokushalov E, et al.(2015) Safety profile of a miniaturized insertable cardiac monitor: results from two prospective trials Pacing Clin Electrophysiol. Dec 2015;38(12):1464-1469. PMID 26412309

Ng E, Stafford PJ, Ng GA.(2004) Arrhythmia detection by patient and auto-activation in implantable loop recorders. J Interv Card Electrophysiol 2004; 10(2):147-52.

Olson JA, Fouts AM, Padanilam BJ, et al.(2007) Utility of mobile cardiac outpatient telemetry for the diagnosis of palpitations, presyncope, syncope and the assessment of therapy efficacy. J Cardiovasc Electrophysiol 2007; 18:473-7.

Page RL, Wilkinson WE, Clair WK, et al.(1994) Asymptomatic arrhythmias in patients with symptomatic paroxysmal atrial fibrillation and paroxysmal supraventricular tachycardia. Circulation. Jan 1994;89(1):224-227. PMID 8281651.

Prystowsky EN.(2006) Assessment of rhythm and rate control in patients with atrial fibrillation. J Cardiovasc Electrophysiol 2006; 17(suppl2):S7-S10.

Raviele A, Giada F, Bergfeldt L, et al.(2011) Management of patients with palpitations: a position paper from the European Heart Rhythm Association. Europace. Jul 2011;13(7):920-934. PMID 21697315

Reiffel JA, Schwarzbert R, Murry M.(2005) Comparison of autotriggered memory loop recorders versus standard loop recorders versus 24-hour Holter monitors for arrhythmia detection. Am J Cardiol 2005; 95(9):1055-9.

Rothman SA, Laughlin JC, Seltzer J et al.(2007) The diagnosis of cardiac arrhythmias: a prospective multi-center randomized study comparing mobile cardiac outpatient telemetry versus standard loop event monitoring. J Cardiovasc Electrophysiol 2007; 18(3):1-7.

Sanders P, Purerfellner H, Pokushalov E, et al.(2016) Performance of a new atrial fibrillation detection algorithm in a miniaturized insertable cardiac monitor: Results from the Reveal LINQ Usability Study. Heart Rhythm. Mar 4 2016. PMID 26961298

Savelieva I, Camm AJ.(2000) Clinical relevance of silent atrial fibrillation: prevalence, prognosis, quality of life, and management. J Interv Card Electrophysiol. Jun 2000;4(2):369-382. PMID 10936003.

Schreiber D, Sattar A, Drigalla D, et al.(2014) Ambulatory cardiac monitoring for discharged emergency department patients with possible cardiac arrhythmias. West J Emerg Med. Mar 2014;15(2):194-198. PMID 24672611.

Shen WK, Sheldon RS, Benditt DG, et al.(2017) 2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. Aug 1 2017;70(5):620-663. PMID 28286222

Solomon MD, Yang J, Sung SH, et al.(2016) Incidence and timing of potentially high-risk arrhythmias detected through long term continuous ambulatory electrocardiographic monitoring. BMC Cardiovasc Disord. 2016;16(1):35. PMID 26883019

Task Force for the Diagnosis Management of Syncope, European Society of Cardiology, European Heart Rhythm Association, et al. Guidelines for the diagnosis and management of syncope (version 2009). Eur Heart J. Nov 2009;30(21):2631-2671. PMID 19713422

Task Force members, Brignole M, Vardas P, et al.(2009) Indications for the use of diagnostic implantable and external ECG loop recorders. Europace. May 2009;11(5):671-687. PMID 19401342

Tayal AH, Tian M, Kelly KM, et al.(2008) Atrial fibrillation detected by mobile cardiac outpatient telemetry in cryptogenic TIA or stroke. Neurology. Nov 18 2008;71(21):1696-1701. PMID 18815386

Tsang J, Mohan S.(2014) Benefits of monitoring patients with mobile cardiac telemetry (MCT) compared with the event or holter monitors. Medical Devices: Evidence and Research 2014:7 1-5.

Vasamreddy CR, Dalal D, Dong J, et al.(2006) Symptomatic and symptomatic atrial fibrillation in patients undergoing radiofrequency catheter ablation. J Cardiovasc Electrophysiol 2006; 17(2):134-9.

Verma A, Champagne J, Sapp J, et al.(2013) Discerning the incidence of symptomatic and asymptomatic episodes of atrial fibrillation before and after catheter ablation (DISCERN AF): a prospective, multicenter study. JAMA Intern Med. Jan 28 2013;173(2):149-156. PMID 23266597

Ziegler PD, Rogers JD, Ferreira SW, et al.(2015) Real-world experience with insertable cardiac monitors to find atrial fibrillation in cryptogenic stroke. Cerebrovasc Dis. 2015;40(3-4):175-181. PMID 26314298

Zimetbaum PJ, Josephson ME.(1999) The evolving role of ambulatory arrhythmia monitoring in general clinical practice. Ann Intern Med 1999; 130(10):848-56.


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