| Coverage Policy Manual | |
| Policy #: | 1997229 |
| Category: | Medicine |
| Initiated: | September 1993 |
| Last Review: | September 2023 |
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| Cardiac Event Recorder, External Loop or Continuous Recorder | |
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| Description: |
Various devices are available for outpatient cardiac rhythm monitoring. These devices differ in the types of monitoring leads used, the duration and continuity of monitoring, the ability to detect arrhythmias without individual intervention, and the mechanism of delivering the information from individual to clinician. These devices may be used to evaluate symptoms suggestive of arrhythmias (e.g., syncope, palpitations), and may be used to detect atrial fibrillation (AF) in individuals who have undergone cardiac ablation of AF or who have a history of cryptogenic stroke.
Cardiac monitoring is routinely used in the inpatient setting to detect acute changes in heart rate or rhythm that may need urgent response. For some conditions, a more prolonged period of monitoring in the ambulatory setting is needed to detect heart rate or rhythm abnormalities that may occur infrequently. These cases may include the diagnosis of arrhythmias in individuals with signs and symptoms suggestive of arrhythmias as well as the evaluation of paroxysmal atrial fibrillation (AF).
Cardiac arrhythmias may be suspected because of symptoms suggestive of arrhythmias, including palpitations, dizziness, or syncope or presyncope, or because of abnormal heart rate or rhythm noted on exam.
Arrhythmias are an important potential cause of syncope or near syncope, which in some cases may be described as dizziness. An electrocardiogram (ECG) is generally indicated whenever there is suspicion of a cardiac cause of syncope. Some arrhythmic causes will be apparent on ECG. However, for individuals in whom an ECG is not diagnostic, longer monitoring may be indicated. The 2009 joint guidelines from the European Society of Cardiology and 3 other medical specialty societies suggested that, in individuals with clinical or ECG features suggesting an arrhythmic syncope, ECG monitoring is indicated; the guidelines also stated that the "duration (and technology) of monitoring should be selected according to the risk and the predicted recurrence rate of syncope (Moya, 2009)." Similarly, guidelines from the National Institute for Health and Care Excellence on the evaluation of transient loss of consciousness, have recommended the use of an ambulatory ECG in individuals with a suspected arrhythmic cause of syncope. The type and duration of monitoring recommended is based on the individual's history, particularly the frequency of transient loss of consciousness (NICE, 2014). The Holter monitor is recommended if transient loss of consciousness occurs several times a week. If the frequency of transient loss of consciousness is every 1 to 2 weeks, an external event recorder is recommended; and if the frequency is less than once every 2 weeks, an implantable event recorder is recommended.
Similar to syncope, the evaluation and management of palpitations is individual-specific. In cases where the initial history, examination, and ECG findings are suggestive of an arrhythmia, some form of ambulatory ECG monitoring is indicated. A position paper from the European Heart Rhythm Association indicated that, for individuals with palpitations of unknown origin who have clinical features suggestive of arrhythmia, referral for specialized evaluation with consideration for ambulatory ECG monitoring is indicated (Raviele, 2011).
Atrial Fibrillation Detection
AF is the most common arrhythmia in adults. It may be asymptomatic or be associated with a broad range of symptoms, including lightheadedness, palpitations, dyspnea, and a variety of more nonspecific symptoms (e.g., fatigue, malaise). It is classified as paroxysmal, persistent, or permanent based on symptom duration. Diagnosed AF may be treated with antiarrhythmic medications with the goal of rate or rhythm control. Other treatments include direct cardioversion, catheter-based radiofrequency- or cryo-energy-based ablation, or one of several surgical techniques, depending on the individual's comorbidities and associated symptoms.
Stroke in AF occurs primarily as a result of thromboembolism from the left atrium. The lack of atrial contractions in AF leads to blood stasis in the left atrium, and this low flow state increases the risk of thrombosis. The area of the left atrium with the lowest blood flow in AF, and therefore the highest risk of thrombosis, is the left atrial appendage. Multiple clinical trials have demonstrated that anticoagulation reduces the ischemic stroke risk in individuals at moderate- or high-risk of thromboembolic events. Oral anticoagulation in patients with AF reduces the risk of subsequent stroke and is recommended by American Heart Association, American College of Cardiology, and Heart Rhythm Society joint guidelines on individuals with a history of stroke or transient ischemic attack (January, 2014).,
Ambulatory ECG monitoring may play a role in several situations in the detection of AF. In individuals who have undergone ablative treatment for AF, if ongoing AF can be excluded with reasonable certainty, including paroxysmal AF which may not be apparent on ECG during an office visit, anticoagulation therapy could potentially be stopped. In some cases where identifying paroxysmal AF is associated with potential changes in management, longer term monitoring may be considered. There are well-defined management changes that occur in individuals with AF. However, until relatively recently the specific role of long-term (i.e., >48 hours) monitoring in AF was not well-described.
Individuals with cryptogenic stroke are often monitored for the presence of AF because AF is estimated to be the cause of cryptogenic stroke in more than 10% of individuals, and AF increases the risk of stroke (Mittal, 2011; Christensen. 2014). Paroxysmal AF confers an elevated risk of stroke, just as persistent and permanent AF does. In individuals with a high risk of stroke, particularly those with a history of ischemic stroke that is unexplained by other causes, prolonged monitoring to identify paroxysmal AF has been investigated.
Cardiac Rhythm Ambulatory Monitoring Devices
Ambulatory cardiac monitoring with a variety of devices permits the evaluation of cardiac electrical activity over time, in contrast to a static ECG, which only permits the detection of abnormalities in cardiac electrical activity at a single point in time.
A Holter monitor is worn continuously and records cardiac electrical output continuously throughout the recording period. Holter monitors are capable of recording activity for 24 to 72 hours. Traditionally, most Holter monitors have 3 channels based on 3 ECG leads. However, some currently available Holter monitors have up to 12 channels. Holter monitors are an accepted intervention in a variety of settings where a short period (24 to 48 hours) of comprehensive cardiac rhythm assessment is needed (e.g., suspected arrhythmias when symptoms [syncope, palpitations] are occurring daily). These devices are not the focus of this review.
Various classes of devices are available for situations where longer monitoring than can be obtained with a traditional Holter monitor is needed. Devices vary in how data are transmitted to the location where the ECG output is interpreted. Data may be transmitted via cellular phone or landline, or by direct download from the device after its return to the monitoring center.
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Noncontinuous devices with memory (event recorder)
Devices not worn continuously but rather activated by individual and applied to the skin in the precordial area when symptoms develop. Device Examples:
Continuous recording devices with longer recording periods
Devices continuously worn and continuously record via 1 or more cardiac leads and store data longer than traditional Holter (14 days). Device Examples:
External memory loop devices (individual- or autotriggered)
Devices continuously worn and store a single channel of ECG data in a refreshed memory. When the device is activated, the ECG is then recorded from the memory loop for the preceding 30-90 seconds and for next 60 seconds or so. Devices may be activated by a individual when symptoms occur (individual-triggered) or by an automated algorithm when changes suggestive of an arrhythmia are detected (auto-triggered). Device Examples:
Implantable memory loop devices (individual- or auto-triggered)
Devices similar in design to external memory loop devices but implanted under the skin in the precordial region. Device Examples:
Mobile cardiac outpatient telemetry (MCOT) (See policy 2008007)
Continuously recording or auto-triggered memory loop devices that transmit data to a central recording station with real-time monitoring and analysis. Device Examples:
There are also devices that combine features of multiple classes. For example, the LifeStar ACT Ex Holter (LifeWatch Services) is a 3-channel Holter monitor, but it is converted to a mobile cardiac telemetry system if a diagnosis is inconclusive after 24 to 48 hours of monitoring. The BodyGuardian® Heart Remote Monitoring System (Preventice Services) is an external auto-triggered memory loop device that can be converted to a real-time monitoring system. The eCardio Verité™ system (eCardio) can switch between a patient-activated event monitor and a continuous telemetry monitor. The Spiderflash-T (LivaNova) is an example of an external auto-triggered or individual-triggered loop recorder, but like the Zio Patch, can record 2 channels for 14 to 40 days.
Coding
The interpretation of the EKGs recorded with ambulatory event monitors (AEMs) may be variably coded as follows:
93268: External 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 transmission, physician review, and interpretation
The above CPT code represents a bundled CPT code including all components of AEM monitoring, including EKG analysis of all the recorded strips during a 30-day period.
Other CPT codes that can be used for AEM monitoring represent unbundling of the 93268 code. For example, CPT code 93270 describes the connection, recording and disconnection of an external device; CPT code 93271 describes the transmission download and analysis; and 93272 describes the physician review and interpretation of the EKG strips. AEM monitoring services may supply the monitoring, receipt of transmissions and analysis of the EKGs (i.e., CPT codes 93271 and 93272), but the provider supplies the hook-up and disconnection of the device (i.e., CPT code 93270). If this is the case, the unbundled codes may be used. It should also be noted that CPT code 93272 (physician review and interpretation) applies to all EKGs transmitted during a 30-day period; therefore, billing for each individual transmitted strip is not warranted.
Effective in 2012, category III codes were added for continuous rhythm recording devices with longer recording capabilities:
0295T External 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
0296T ;recording (includes connection and initial recording)
0297T ;scanning analysis with report
0298T ;review and interpretation
0295T-0298T should not be reported in conjunction with 93224-93272 for the same monitoring period.
Effective 1/1/2021, CPT codes were added for continuous rhythm recording devices with longer recording capabilities:
93241 External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation
93242 External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; recording (includes connection and initial recording)
93243 External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; scanning analysis with report
93244 External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; review and interpretation
93245 External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation
93246 External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; recording (includes connection and initial recording)
93247 External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; scanning analysis with report
93248 External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; review and interpretation
Related policies include:
1997130 Cardiac Event Recorder, Continuous 24-Hr (Holter)
2008007 Cardiac Event Recorder, Mobile Telemetry
1998153 Cardiac Event Recorder, Insertable Loop Recorder
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Policy/ Coverage: |
Effective October 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Continuous Monitoring for Periods Longer than 48 Hours
The use of a continuous ambulatory monitor that records and stores information for periods longer than 48 hours meets member benefit certificate primary coverage criteria and will be covered for 2-14 days as a diagnostic alternative to Holter monitoring or event recording in the following situations, for members who are 18 years of age or older and only in the absence of an implantable defibrillator.
A continuous ambulatory monitor that records and stores information for periods longer than 48 hours is limited to one every 6 months, except for a single additional test for evaluation of a new symptom(s).
Pre-Symptom Memory Loop Recorder
A pre-symptom memory loop cardiac event recorder meets primary coverage criteria for effectiveness and is covered based on a 30-day period of observation for individuals whose symptoms are considered infrequent enough that it would be unlikely that a cardiac arrhythmic event would be captured by a rhythm strip or 24-hour continuous EKG waveform recording and storage or computerized monitoring device.
To properly bill for CPT 93268 or any of the components (CPT 93270, 93271, or 93272), a monitoring service must be available 24-hours per day, 7 days a week, to allow the individual to report any activation of the monitor. Twenty-four hour coverage means that there must be, at the monitoring site (or sites) an experienced EKG technician receiving calls; tape recording devices do not meet this requirement. Further, such technicians should have immediate access to a physician, and have been instructed in when and how to contact available facilities to assist the individual in cases of emergencies.
This form of EKG monitoring is ordered only by the individual's physician as part of an overall plan of treatment. This monitoring is used to record symptomatic episodes of rate disturbance. Following an event and transmission by the individual, the physician or physiological lab receives the transmission. The lab or physician may then bill for CPT 93271. When the physician ordering the test actually interprets the rhythm strip, the physician may bill for the physician component, CPT 93272. If the physician receives the transmission (TC) and reads the rhythm strip (PC), the physician should bill for the global CPT 93268.
A presymptom memory loop cardiac event recorder is covered for diagnosis of:
Use of the external loop recording monitoring is limited to the detection, characterization, and documentation of symptomatic transient arrhythmias.
The individual's physician must order the monitoring service. The individual must have seen that physician within one month of initiating of monitoring. The individual must be symptomatic.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of the external loop recording device when used in, nursing homes, hospitals, ambulatory surgery centers, or other facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of individuals does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of this device when used in clinics, nursing homes, hospitals, ambulatory surgery centers, or other facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of individuals is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
* Therefore, the claim form must indicate that the place of service of the technical component of CPT 93271, when billed separately from the professional component, is in the home.
The use of the external loop recording device to diagnose and treat suspected arrhythmias as a routine substitute for a more conventional method of diagnosis such as careful history, physical examination, and standard EKG and rhythm strip does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of the external loop recording device to diagnose and treat suspected arrhythmias as a routine substitute for a more conventional method of diagnosis such as careful history, physical examination, and standard EKG and rhythm strip is considered not medically necessary. Services that are medically necessary are specific contract exclusions in most member benefit certificates of coverage.
The use of continuous ambulatory monitors that record and store information for periods longer than 48 hours (for example, monitors which record for 14-21 days) in patients “at risk” (asymptomatic individuals) or not meeting the criteria indicated above does not meet member benefit certificate primary coverage criteria.
For members with contracts without primary coverage criteria, the use of continuous ambulatory monitors that record and store information for periods longer than 48 hours (for example, monitors which record for 14-21 days) in individuals “at risk” (asymptomatic individuals) or not meeting the criteria indicated above is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
Any other use of ambulatory cardiac event recording with or without external loop monitoring does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, any other use of cardiac event recording is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Cardiac resynchronization therapy with wireless left ventricular endocardial pacing does not meet member benefit certificate primary coverage criteria.
For members with contracts without primary coverage criteria, cardiac resynchronization therapy with wireless left ventricular endocardial pacing is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective August 2022 through September 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Continuous Monitoring for Periods Longer than 48 Hours
The use of a continuous ambulatory monitor that records and stores information for periods longer than 48 hours meets member benefit certificate primary coverage criteria and will be covered for 2-14 days as a diagnostic alternative to Holter monitoring or event recording in the following situations, for members who are 18 years of age or older and only in the absence of an implantable defibrillator.
A continuous ambulatory monitor that records and stores information for periods longer than 48 hours is limited to one every 6 months, except for a single additional test for evaluation of a new symptom(s).
Pre-Symptom Memory Loop Recorder
A pre-symptom memory loop cardiac event recorder meets primary coverage criteria for effectiveness and is covered based on a 30-day period of observation for patients whose symptoms are considered infrequent enough that it would be unlikely that a cardiac arrhythmic event would be captured by a rhythm strip or 24-hour continuous EKG waveform recording and storage or computerized monitoring device.
To properly bill for CPT 93268 or any of the components (CPT 93270, 93271, or 93272), a monitoring service must be available 24-hours per day, 7 days a week, to allow the patient to report any activation of the monitor. Twenty-four hour coverage means that there must be, at the monitoring site (or sites) an experienced EKG technician receiving calls; tape recording devices do not meet this requirement. Further, such technicians should have immediate access to a physician, and have been instructed in when and how to contact available facilities to assist the patient in cases of emergencies.
This form of EKG monitoring is ordered only by the patient's physician as part of an overall plan of treatment. This monitoring is used to record symptomatic episodes of rate disturbance. Following an event and transmission by the patient, the physician or physiological lab receives the transmission. The lab or physician may then bill for CPT 93271. When the physician ordering the test actually interprets the rhythm strip, the physician may bill for the physician component, CPT 93272. If the physician receives the transmission (TC) and reads the rhythm strip (PC), the physician should bill for the global CPT 93268.
A presymptom memory loop cardiac event recorder is covered for diagnosis of:
Use of the external loop recording monitoring is limited to the detection, characterization, and documentation of symptomatic transient arrhythmias.
The patient's physician must order the monitoring service. The patient must have seen that physician within one month of initiating of monitoring. The patient must be symptomatic.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of the external loop recording device when used in, nursing homes, hospitals, ambulatory surgery centers, or other facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of patients does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of this device when used in clinics, nursing homes, hospitals, ambulatory surgery centers, or other facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of patients is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
* Therefore, the claim form must indicate that the place of service of the technical component of CPT 93271, when billed separately from the professional component, is in the home.
The use of the external loop recording device to diagnose and treat suspected arrhythmias as a routine substitute for a more conventional method of diagnosis such as careful history, physical examination, and standard EKG and rhythm strip does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of the external loop recording device to diagnose and treat suspected arrhythmias as a routine substitute for a more conventional method of diagnosis such as careful history, physical examination, and standard EKG and rhythm strip is considered not medically necessary. Services that are medically necessary are specific contract exclusions in most member benefit certificates of coverage.
The use of continuous ambulatory monitors that record and store information for periods longer than 48 hours (for example, monitors which record for 14-21 days) in patients “at risk” (asymptomatic patients) or not meeting the criteria indicated above does not meet member benefit certificate primary coverage criteria.
For members with contracts without primary coverage criteria, the use of continuous ambulatory monitors that record and store information for periods longer than 48 hours (for example, monitors which record for 14-21 days) in patients “at risk” (asymptomatic patients) or not meeting the criteria indicated above is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
Any other use of ambulatory cardiac event recording with or without external loop monitoring does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, any other use of cardiac event recording is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Cardiac resynchronization therapy with wireless left ventricular endocardial pacing does not meet member benefit certificate primary coverage criteria.
For members with contracts without primary coverage criteria, cardiac resynchronization therapy with wireless left ventricular endocardial pacing is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective January 2021 through July 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Continuous Monitoring for Periods Longer than 48 Hours
The use of a continuous ambulatory monitor that records and stores information for periods longer than 48 hours meets member benefit certificate primary coverage criteria and will be covered for 2-14 days as a diagnostic alternative to Holter monitoring or event recording in the following situations, for members who are 18 years of age or older and only in the absence of an implantable defibrillator.
A continuous ambulatory monitor that records and stores information for periods longer than 48 hours is limited to one every 6 months, except for a single additional test for evaluation of a new symptom(s).
Pre-Symptom Memory Loop Recorder
A pre-symptom memory loop cardiac event recorder meets primary coverage criteria for effectiveness and is covered based on a 30-day period of observation for patients whose symptoms are considered infrequent enough that it would be unlikely that a cardiac arrhythmic event would be captured by a rhythm strip or 24-hour continuous EKG waveform recording and storage or computerized monitoring device.
To properly bill for CPT 93268 or any of the components (CPT 93270, 93271, or 93272), a monitoring service must be available 24-hours per day, 7 days a week, to allow the patient to report any activation of the monitor. Twenty-four hour coverage means that there must be, at the monitoring site (or sites) an experienced EKG technician receiving calls; tape recording devices do not meet this requirement. Further, such technicians should have immediate access to a physician, and have been instructed in when and how to contact available facilities to assist the patient in cases of emergencies.
This form of EKG monitoring is ordered only by the patient's physician as part of an overall plan of treatment. This monitoring is used to record symptomatic episodes of rate disturbance. Following an event and transmission by the patient, the physician or physiological lab receives the transmission. The lab or physician may then bill for CPT 93271. When the physician ordering the test actually interprets the rhythm strip, the physician may bill for the physician component, CPT 93272. If the physician receives the transmission (TC) and reads the rhythm strip (PC), the physician should bill for the global CPT 93268.
A presymptom memory loop cardiac event recorder is covered for diagnosis of:
Use of the external loop recording monitoring is limited to the detection, characterization, and documentation of symptomatic transient arrhythmias.
The patient's physician must order the monitoring service. The patient must have seen that physician within one month of initiating of monitoring. The patient must be symptomatic.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of the external loop recording device when used in, nursing homes, hospitals, ambulatory surgery centers, or other facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of patients does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of this device when used in clinics, nursing homes, hospitals, ambulatory surgery centers, or other facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of patients is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
* Therefore, the claim form must indicate that the place of service of the technical component of CPT 93271, when billed separately from the professional component, is in the home.
The use of the external loop recording device to diagnose and treat suspected arrhythmias as a routine substitute for a more conventional method of diagnosis such as careful history, physical examination, and standard EKG and rhythm strip does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of the external loop recording device to diagnose and treat suspected arrhythmias as a routine substitute for a more conventional method of diagnosis such as careful history, physical examination, and standard EKG and rhythm strip is considered not medically necessary. Services that are medically necessary are specific contract exclusions in most member benefit certificates of coverage.
The use of continuous ambulatory monitors that record and store information for periods longer than 48 hours (for example, monitors which record for 14-21 days) in patients “at risk” (asymptomatic patients) or not meeting the criteria indicated above does not meet member benefit certificate primary coverage criteria.
For members with contracts without primary coverage criteria, the use of continuous ambulatory monitors that record and store information for periods longer than 48 hours (for example, monitors which record for 14-21 days) in patients “at risk” (asymptomatic patients) or not meeting the criteria indicated above is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
Any other use of ambulatory cardiac event recording with or without external loop monitoring does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, any other use of cardiac event recording is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Cardiac resynchronization therapy with wireless left ventricular endocardial pacing does not meet member benefit certificate primary coverage criteria.
For members with contracts without primary coverage criteria, cardiac resynchronization therapy with wireless left ventricular endocardial pacing is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to January 2021
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of a continuous ambulatory monitor that records and stores information for periods longer than 48 hours meets member benefit certificate primary coverage criteria and will be covered for 2-14 days as a diagnostic alternative to Holter monitoring or event recording in the following situations, for members who are 18 years of age or older and only in the absence of an implantable defibrillator.
A continuous ambulatory monitor that records and stores information for periods longer than 48 hours is limited to one every 6 months, except for a single additional test for evaluation of a new symptom(s).
A pre-symptom memory loop cardiac event recorder meets primary coverage criteria for effectiveness and is covered based on a 30-day period of observation for patients whose symptoms are considered infrequent enough that it would be unlikely that a cardiac arrhythmic event would be captured by a rhythm strip or 24-hour continuous EKG waveform recording and storage or computerized monitoring device.
To properly bill for CPT 93268 or any of the components (CPT 93270, 93271, or 93272), a monitoring service must be available 24-hours per day, 7 days a week, to allow the patient to report any activation of the monitor. Twenty-four hour coverage means that there must be, at the monitoring site (or sites) an experienced EKG technician receiving calls; tape recording devices do not meet this requirement. Further, such technicians should have immediate access to a physician, and have been instructed in when and how to contact available facilities to assist the patient in cases of emergencies.
This form of EKG monitoring is ordered only by the patient's physician as part of an overall plan of treatment. This monitoring is used to record symptomatic episodes of rate disturbance. Following an event and transmission by the patient, the physician or physiological lab receives the transmission. The lab or physician may then bill for CPT 93271. When the physician ordering the test actually interprets the rhythm strip, the physician may bill for the physician component, CPT 93272. If the physician receives the transmission (TC) and reads the rhythm strip (PC), the physician should bill for the global CPT 93268.
A presymptom memory loop cardiac event recorder is covered for diagnosis of:
Use of the external loop recording monitoring is limited to the detection, characterization, and documentation of symptomatic transient arrhythmias.
The patient's physician must order the monitoring service. The patient must have seen that physician within one month of initiating of monitoring. The patient must be symptomatic.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of the external loop recording device when used in, nursing homes, hospitals, ambulatory surgery centers, or other facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of patients does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of this device when used in clinics, nursing homes, hospitals, ambulatory surgery centers, or other facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of patients is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
* Therefore, the claim form must indicate that the place of service of the technical component of CPT 93271, when billed separately from the professional component, is in the home.
The use of the external loop recording device to diagnose and treat suspected arrhythmias as a routine substitute for a more conventional method of diagnosis such as careful history, physical examination, and standard EKG and rhythm strip does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of the external loop recording device to diagnose and treat suspected arrhythmias as a routine substitute for a more conventional method of diagnosis such as careful history, physical examination, and standard EKG and rhythm strip is considered not medically necessary. Services that are medically necessary are specific contract exclusions in most member benefit certificates of coverage.
The use of continuous ambulatory monitors that record and store information for periods longer than 48 hours (for example, monitors which record for 14-21 days) in patients “at risk” (asymptomatic patients) or not meeting the criteria indicated above does not meet member benefit certificate primary coverage criteria.
For members with contracts without primary coverage criteria, the use of continuous ambulatory monitors that record and store information for periods longer than 48 hours (for example, monitors which record for 14-21 days) in patients “at risk” (asymptomatic patients) or not meeting the criteria indicated above is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
Any other use of ambulatory cardiac event recording with or without external loop monitoring does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, any other use of cardiac event recording is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Cardiac resynchronization therapy with wireless left ventricular endocardial pacing does not meet member benefit certificate primary coverage criteria.
For members with contracts without primary coverage criteria, cardiac resynchronization therapy with wireless left ventricular endocardial pacing is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
EFFECTIVE PRIOR TO FEBRUARY 2020
The use of ZioPatch (continuous ambulatory monitor that records and stores information for periods longer than 48 hours) meets member benefit certificate primary coverage criteria and will be covered for 2-14 days as a diagnostic alternative to Holter monitoring or event recording in the following situations, for members who are 18 years of age or older and only in the absence of an implantable defibrillator.
The ZioPatch is limited to one every 6 months, except for a single additional test for evaluation of a new symptom(s).
A pre-symptom memory loop cardiac event recorder meets primary coverage criteria for effectiveness and is covered based on a 30-day period of observation for patients whose symptoms are considered infrequent enough that it would be unlikely that a cardiac arrhythmic event would be captured by a rhythm strip or 24-hour continuous EKG waveform recording and storage or computerized monitoring device.
To properly bill for CPT 93268 or any of the components (CPT 93270, 93271, or 93272), a monitoring service must be available 24-hours per day, 7 days a week, to allow the patient to report any activation of the monitor. Twenty-four hour coverage means that there must be, at the monitoring site (or sites) an experienced EKG technician receiving calls; tape recording devices do not meet this requirement. Further, such technicians should have immediate access to a physician, and have been instructed in when and how to contact available facilities to assist the patient in cases of emergencies.
This form of EKG monitoring is ordered only by the patient's physician as part of an overall plan of treatment. This monitoring is used to record symptomatic episodes of rate disturbance. Following an event and transmission by the patient, the physician or physiological lab receives the transmission. The lab or physician may then bill for CPT 93271. When the physician ordering the test actually interprets the rhythm strip, the physician may bill for the physician component, CPT 93272. If the physician receives the transmission (TC) and reads the rhythm strip (PC), the physician should bill for the global CPT 93268.
A presymptom memory loop cardiac event recorder is covered for diagnosis of:
Use of the external loop recording monitoring is limited to the detection, characterization, and documentation of symptomatic transient arrhythmias.
The patient's physician must order the monitoring service. The patient must have seen that physician within one month of initiating of monitoring. The patient must be symptomatic.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary
Coverage Criteria
The use of the external loop recording device when used in, nursing homes, hospitals, ambulatory surgery centers, or other facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of patients does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of this device when used in clinics, nursing homes, hospitals, ambulatory surgery centers, or other facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of patients is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
* Therefore, the claim form must indicate that the place of service of the technical component of CPT 93271, when billed separately from the professional component, is in the home.
The use of the external loop recording device to diagnose and treat suspected arrhythmias as a routine substitute for a more conventional method of diagnosis such as careful history, physical examination, and standard EKG and rhythm strip does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of the external loop recording device to diagnose and treat suspected arrhythmias as a routine substitute for a more conventional method of diagnosis such as careful history, physical examination, and standard EKG and rhythm strip is considered not medically necessary. Services that are medically necessary are specific contract exclusions in most member benefit certificates of coverage.
The use of continuous ambulatory monitors that record and store information for periods longer than 48 hours (for example, monitors which record for 14-21 days) (ZioPatch) in patients “at risk” (asymptomatic patients) or not meeting the criteria indicated above does not meet member benefit certificate primary coverage criteria.
For members with contracts without primary coverage criteria, the use of continuous ambulatory monitors that record and store information for periods longer than 48 hours (for example, monitors which record for 14-21 days) (ZioPatch) in patients “at risk” (asymptomatic patients) or not meeting the criteria indicated above is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
Any other use of ambulatory cardiac event recording with or without external loop monitoring does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, any other use of cardiac event recording is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Cardiac resynchronization therapy with wireless left ventricular endocardial pacing does not meet member benefit certificate primary coverage criteria.
For members with contracts without primary coverage criteria, cardiac resynchronization therapy with wireless left ventricular endocardial pacing is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
EFFECTIVE PRIOR TO FEBRUARY 2019
The use of ZioPatch (continuous ambulatory monitors that records and stores information for periods longer than 48 hours) meets member benefit certificate primary coverage criteria and will be covered for 1-14 days as a diagnostic alternative to Holter monitoring in the following situations:
A pre-symptom memory loop cardiac event recorder meets primary coverage criteria for effectiveness and is covered based on a 30-day period of observation for patients whose symptoms are considered infrequent enough that it would be unlikely that a cardiac arrhythmic event would be captured by a rhythm strip or 24-hour continuous EKG waveform recording and storage or computerized monitoring device.
To properly bill for CPT 93268 or any of the components (CPT 93270, 93271, or 93272), a monitoring service must be available 24-hours per day, 7 days a week, to allow the patient to report any activation of the monitor. Twenty-four hour coverage means that there must be, at the monitoring site (or sites) an experienced EKG technician receiving calls; tape recording devices do not meet this requirement. Further, such technicians should have immediate access to a physician, and have been instructed in when and how to contact available facilities to assist the patient in cases of emergencies.
This form of EKG monitoring is ordered only by the patient's physician as part of an overall plan of treatment. This monitoring is used to record symptomatic episodes of rate disturbance. Following an event and transmission by the patient, the physician or physiological lab receives the transmission. The lab or physician may then bill for CPT 93271. When the physician ordering the test actually interprets the rhythm strip, the physician may bill for the physician component, CPT 93272. If the physician receives the transmission (TC) and reads the rhythm strip (PC), the physician should bill for the global CPT 93268.
A presymptom memory loop cardiac event recorder is covered for diagnosis of:
Use of the external loop recording monitoring is limited to the detection, characterization, and documentation of symptomatic transient arrhythmias.
The patient's physician must order the monitoring service. The patient must have seen that physician within one month of initiating of monitoring. The patient must be symptomatic.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary
Coverage Criteria
The use of the external loop recording device when used in, nursing homes, hospitals, ambulatory surgery centers, or other facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of patients does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of this device when used in clinics, nursing homes, hospitals, ambulatory surgery centers, or other
facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of patients is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
* Therefore, the claim form must indicate that the place of service of the technical component of CPT 93271, when billed separately from the professional component, is in the home.
The use of the external loop recording device to diagnose and treat suspected arrhythmias as a routine substitute for a more conventional method of diagnosis such as careful history, physical examination, and standard EKG and rhythm strip does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of the external loop recording device to diagnose and treat suspected arrhythmias as a routine
substitute for a more conventional method of diagnosis such as careful history, physical examination, and standard EKG and rhythm strip is considered not medically necessary. Services that are medically necessary are specific contract exclusions in most member benefit certificates of coverage.
The use of continuous ambulatory monitors that record and store information for periods longer than 48 hours (for example, monitors which record for 14-21 days) (ZioPatch) in patients “at risk” (asymptomatic patients) does not meet member benefit certificate primary coverage criteria.
For members with contracts without primary coverage criteria, the use of continuous ambulatory monitors that record and store information for periods longer than 48 hours is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
Any other use of ambulatory cardiac event recording with or without external loop monitoring does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, any other use of cardiac event recording is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Cardiac resynchronization therapy with wireless left ventricular endocardial pacing does not meet member benefit certificate primary coverage criteria.
For members with contracts without primary coverage criteria, cardiac resynchronization therapy with wireless left ventricular endocardial pacing is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
EFFECTIVE PRIOR TO MAY 2018
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
A pre-symptom memory loop cardiac event recorder meets primary coverage criteria for effectiveness and is covered based on a 30-day period of observation for patients whose symptoms are considered infrequent enough that it would be unlikely that a cardiac arrhythmic event would be captured by a rhythm strip or 24-hour continuous EKG waveform recording and storage or computerized monitoring device.
To properly bill for CPT 93268 or any of the components (CPT 93270, 93271, or 93272), a monitoring service must be available 24-hours per day, 7 days a week, to allow the patient to report any activation of the monitor. Twenty-four hour coverage means that there must be, at the monitoring site (or sites) an experienced EKG technician receiving calls; tape recording devices do not meet this requirement. Further, such technicians should have immediate access to a physician, and have been instructed in when and how to contact available facilities to assist the patient in cases of emergencies.
This form of EKG monitoring is ordered only by the patient's physician as part of an overall plan of treatment. This monitoring is used to record symptomatic episodes of rate disturbance. Following an event and transmission by the patient, the physician or physiological lab receives the transmission. The lab or physician may then bill for CPT 93271. When the physician ordering the test actually interprets the rhythm strip, the physician may bill for the physician component, CPT 93272. If the physician receives the transmission (TC) and reads the rhythm strip (PC), the physician should bill for the global CPT 93268.
A presymptom memory loop cardiac event recorder is covered for diagnosis of:
Use of the external loop recording monitoring is limited to the detection, characterization, and documentation of symptomatic transient arrhythmias.
The patient's physician must order the monitoring service. The patient must have seen that physician within one month of initiating of monitoring. The patient must be symptomatic.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of the external loop recording device when used in, nursing homes, hospitals, ambulatory surgery centers, or other facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of patients does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of this device when used in clinics, nursing homes, hospitals, ambulatory surgery centers, or other facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of patients is considered not medically necessary. Services that are medically necessary are specific contract exclusions in most member benefit certificates of coverage.
* Therefore, the claim form must indicate that the place of service of the technical component of CPT 93271, when billed separately from the professional component, is in the home.
The use of the external loop recording device to diagnose and treat suspected arrhythmias as a routine substitute for a more conventional method of diagnosis such as careful history, physical examination, and standard EKG and rhythm strip does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of the external loop recording device to diagnose and treat suspected arrhythmias as a routine substitute for a more conventional method of diagnosis such as careful history, physical examination, and standard EKG and rhythm strip is considered not medically necessary. Services that are medically necessary are specific contract exclusions in most member benefit certificates of coverage.
The use of continuous ambulatory monitors that record and store information for periods longer than 48 hours (for example, monitors which record for 14-21 days) (ZioPatch) does not meet member benefit certificate primary coverage criteria because there is a lack of data indicating that this intervention is more effective than other interventions that are less costly.
For members with contracts without primary coverage criteria, the use of continuous ambulatory monitors that record and store information for periods longer than 48 hours is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
Any other use of ambulatory cardiac event recording with or without external loop monitoring does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, any other use of cardiac event recording is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
EFFECTIVE PRIOR TO APRIL 2015
A pre-symptom memory loop cardiac event recorder meets primary coverage criteria for effectiveness and is covered based on a 30-day period of observation for patients whose symptoms are considered infrequent enough that it would be unlikely that a cardiac arrhythmic event would be captured by a rhythm strip or 24-hour continuous EKG waveform recording and storage or computerized monitoring device. To properly bill for CPT 93268 or any of the components (CPT 93270, 93271, or 93272), a monitoring service must be available 24-hours per day, 7 days a week, to allow the patient to report any activation of the monitor. Twenty-four hour coverage means that there must be, at the monitoring site (or sites) an experienced EKG technician receiving calls; tape recording devices do not meet this requirement. Further, such technicians should have immediate access to a physician, and have been instructed in when and how to contact available facilities to assist the patient in cases of emergencies.
This form of EKG monitoring is ordered only by the patient's physician as part of an overall plan of treatment. This monitoring is used to record symptomatic episodes of rate disturbance.
Following an event and transmission by the patient, the physician or physiological lab receives the transmission. The lab or physician may then bill for CPT 93271. When the physician ordering the test actually interprets the rhythm strip, the physician may bill for the physician component, CPT 93272. If the physician receives the transmission (TC) and reads the rhythm strip (PC), the physician should bill for the global CPT 93268.
A presymptom memory loop cardiac event recorder is covered for diagnosis of:
Use of the external loop recording monitoring is limited to the detection, characterization, and documentation of symptomatic transient arrhythmias.
This device is not covered when used in clinics, nursing homes, hospitals, ambulatory surgery centers, or other facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of patients. Therefore, the claim form must indicate that the place of service of the technical component of CPT 93271, when billed separately from the professional component, is in the home. The use of these devices to diagnose and treat suspected arrhythmias as a routine substitute for a more conventional method of diagnosis such as careful history, physical examination, and standard EKG and rhythm strip is not covered.
The patient's physician must order the monitoring service. The patient must have seen that physician within one month of initiating of monitoring. The patient must be symptomatic.
Any other use of cardiac event recording with or without external loop monitoring does not meet Primary Coverage Criteria and is not covered. Guidelines published by national and/or international workgroups of medical experts recommend only those medical situations listed as "covered".
For members with contracts without primary coverage criteria any use of transtelephonic EKG monitoring, other than those listed as covered, would be considered not medically necessary. Medically unnecessary services are an exclusion in the member benefit certificate.
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| Rationale: |
Cardiac event recording is a well-established technique for evaluating symptoms compatible with arryhthmia when symptoms occur too infrequently to be captured on 24-hour Holter monitoring.
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 (DiMarco, 1990), 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.
In 1999, the American College of Cardiology (ACC) in conjunction with the American Heart Association (AHA) published guidelines for the use of ambulatory electrocardiography. These guidelines did not make an explicit distinction between continuous (i.e., Holter monitor) and intermittent (i.e., ambulatory event monitor) monitoring. Regarding the effectiveness of antiarrhythmic therapy, the ACC guidelines list one Class I* indication: “To assess antiarrhythmic drug response in individuals in whom baseline frequency of arrhythmia has been well characterized as reproducible and of sufficient frequency to permit analysis.” The guidelines do not specify whether Holter monitoring or ambulatory event monitors are most likely to be used. However, the accompanying text notes that intermittent monitoring may be used to confirm the presence of an arrhythmia during symptoms. This indication is addressed in the first policy statement above, i.e., evaluation of symptomatic patients. There were no Class I indications for detection of myocardial ischemia. In addition, there were no Class I indications for ambulatory monitoring to assess risk for future cardiac events in patients without symptoms of arrhythmia. This latter category would suggest that routine monitoring of patients after myocardial infarction to detect nonsustained ventricular tachycardia as a risk factor for sudden cardiac death is not routinely recommended. As noted in a review article by Zimetbaum and Josephson, 1999, there is a paucity of data to document the impact on the final health outcomes, and, furthermore, it is not clear at what point after a myocardial infarction such monitoring would be optimal.
2005 Update
A focused review of auto-activated ambulatory event monitors was done. Several studies, including an analysis of a database of 100,000 patients, compared the diagnostic yield of automatic and patient-activated arrhythmia recordings, and reported an improved yield with auto-triggering devices. (Ermis C, 2003; Reiffel JA, 2005; Balmelli N, 2003) One comparative study of 50 patients noted that auto-activation may result in a large number of inappropriately stored events. (Ng E , 2004) The policy statement does not distinguish whether the device used is auto- or patient-activated.
2007 Update
Rothman and colleagues recently reported results comparing MCOT to standard loop recording. (10 Rothman SA, 2007) 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.
2008 Update
The autotrigger loop recorder is considered the current standard for evaluating patients with infrequent symptoms; and there are no comparative studies between MCOT and the autotrigger device.
2012 Update
Several studies, including an analysis of a database of 100,000 patients, compared the diagnostic yield of automatic and patient-activated arrhythmia recordings and reported an improved yield with autotriggering devices (Balmelli, 2003) (Ermis, 2003) (Reiffel, 2005). One comparative study of 50 patients noted that auto-activation may result in a large number of inappropriately stored events (Ng, 2004). The policy statement does not distinguish whether the device used is auto or patient activated.
Implantable autotrigger loop recorders have also been developed that are specifically geared toward detection of atrial fibrillation through the use of atrial fibrillation detection algorithms. Hindricks et al. evaluated the accuracy of an implantable autotriggered loop recorder in 247 patients at high risk for paroxysmal atrial fibrillation (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 gold standard. The sensitivity of the loop recorder for detecting atrial fibrillation episodes of 2 minutes or more in duration was 88.2%, rising to 92.1% for episodes of 6 minutes or more. Atrial fibrillation was falsely identified by the loop recorder in 19 of 130 patients who did not have atrial fibrillation on Holter monitoring, for a false-positive rate of 15%. The atrial fibrillation 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 et al. compared an implantable autotrigger device with 24-hour Holter monitoring done at 3-month intervals in 45 patients who had undergone surgical ablation for atrial fibrillation (Hanke, 2009). After a mean follow-up of 8.3 months, the implantable loop recorder identified atrial fibrillation in 19 patients (42%) in whom Holter monitoring recorded sinus rhythm.
The most recent generation of event recorders has incorporated transmission using cellular phone technology (Leshem-Rubinow, 2011) (Sankari, 2011). These devices incorporate a cell phone into the event monitor, allowing patients or autotrigger to transmit data directly from the device. This modification is intended to simplify the transmission of data, thus minimizing the proportion of transmissions that are not successful. Leshem-Rubinow et al. performed an observational study of 604 patients with palpitations, presyncope, and/or chest pain. This study demonstrated that the Cardio R® device (SHL-Medical, Tel Aviv, Israel) was able to diagnose and transmit heart rhythm information efficiently. Out of 604 patients, a rhythm disturbance that could account for symptoms was found in 49% of cases. The information was transmitted within 7 minutes in 93% of cases.
In summary, there is evidence that auto-trigger devices can pick up asymptomatic episodes of atrial fibrillation in treated patients and that identifying asymptomatic episodes may lead to modifications in treatment. Therefore, the coverage statement has been changed to include this indication.
2014 Update
A literature search was conducted using the MEDLINE database through February 2014. There was no new information identified that would prompt a change in the coverage statement.
2015 Update
This policy is being updated with a focus on the newer devices that record cardiac rhythms continuously, but for longer periods of time than traditional Holter monitors. For example, the Zio® Patch continuously records and stores information for up to 2 weeks. In addition to recording information for longer periods of time, this device uses “near-field” recording electrodes that differ from most other devices.
Several studies have evaluated the diagnostic yield of continuous monitoring for greater than 48 hours, either directly through comparison to Holter monitoring or indirectly through determination of the proportion of arrhythmias detected in the first 48 hours of monitoring.
Tuakhia et al published a study in 2013 evaluating the diagnostic yield of the Zio Patch (Turakhia, 2013). Data from the manufacturer was used to identify 26,751 first-time users of the device. The most common clinical indications were palpitations (40.3%), atrial fibrillation (AF) (24.3%), and syncope (15.1%). The mean duration of use was 7.6±3.6 days, and 95.9% of patients wore the device for more than 48 hours. At least 1 episode of arrhythmia was detected in 16,142 patients (60.3%). The authors compared the detection rate in the first 48 hours with the detection rate over the entire time period that the device was worn, with 70.1% of patients having their arrhythmia detected within the first 48 hours and 29.9% having their first arrhythmia detected after the first 48 hours. The overall yield was significantly higher when comparing the total monitored period with the first 48 hours (62.2% vs 43.9%, p<0.001). These data confirm previous studies that have shown that a substantial proportion of arrhythmias in symptomatic patients can be detected with a 48-hour period of monitoring and that longer monitoring periods increase the detection rate.
Barrett et al published a comparison of arrhythmia detection rates in 146 patients who underwent simultaneous monitoring with a 24-hour Holter monitor and a 14-day Zio Patch monitor (Barrett, 2014). Included were patients referred for evaluation of a suspected cardiac arrhythmia at single institution. For the detection of atrioventricular block, pause, polymorphic ventricular tachycardia, supraventricular tachycardia, or AF. Holter monitoring detected 61 arrhythmias, while the Zio Patch detected 96 (p<0.001). Over the course of the monitoring period, 60 arrhythmias were detected by both devices, with 36 detected by the Zio Patch that were not detected by Holter monitoring and 1 detected by the Holter that was not detected by the Zio Patch. The investigators conducted within-subject comparisons of arrhythmia detection for the 24-hour period during which both devices were worn. Holter monitoring detected 61 arrhythmia events, compared with 52 detected by the Zio Patch (p=0.013). This study further suggests that extended monitoring may increase the diagnostic yield of cardiac monitoring. However, a relatively large number of missed events occurred with the Zio Patch during the period of simultaneous monitoring, which may have clinical significance if its performance is similar in non-research settings.
The available evidence on continuously worn cardiac monitors that can store data for longer periods of time than standard Holter monitoring indicates that such devices typically detect greater numbers of arrhythmias during extended follow-up than 24- or 48-hour Holter monitoring. However, a more appropriate comparison group for such monitors is AEMs, and evidence on this comparison is lacking.
2016 Update
A literature search conducted through February 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2015, Bolourchi and colleagues evaluated the diagnostic yield of 14 days of monitoring with the Zio Patch in a cross-sectional study of 3,209 children who were included in a manufacturer registry (Bolourchi, 2015). Patients’ age ranged from 1 month to 17 years. Indications for monitoring included palpitations (n=1138 [95.5%[), syncope (n=450 [14.0%]), unspecified tachycardia (n=291 [ 9.1%]), paroxysmal supraventricular tachycardia (SVT) (n=264 [ 8.2%]) and chest pain (n=261 [8.1%]). The overall prevalence of any arrhythmia was 12.1%, with 44.1% of arrhythmias occurring after the first 48 hours of monitoring. Arrhythmias were detected in 10.0% of patients who were referred for palpitations, 6.7% of patients referred for syncope, 14.8% of patients referred for tachycardia, 22.7% of patients referred for paroxysmal SVT, and 6.5% of patients referred for chest pain.
Section Summary
The available evidence on continuously worn cardiac monitors that can store data for longer periods of time than standard Holter monitoring indicates that such devices typically detect greater numbers of arrhythmias during extended follow-up than 24- or 48-hour Holter monitoring. However, a more appropriate comparison group for such monitors is AEMs, and evidence on this comparison is lacking.
In 2015, Sposato and colleagues reported results of a systematic review and meta-analysis of studies reporting rates of new AF diagnosis after cryptogenic stroke or TIA based on cardiac monitoring, stratified into 4 sequential phases of screening: phase 1 (emergency room) consisted of admission ECG; phase 2 (in hospital) comprised serial ECG, continuous inpatient ECG monitoring, continuous inpatient cardiac telemetry, and in-hospital Holter monitoring; phase 3 (first ambulatory period) consisted of ambulatory Holter; and phase 4 (second ambulatory period) consisted of mobile cardiac outpatient telemetry, external loop recording, and implantable loop recording (Sposato, 2015). In total, 50 studies with 11,658 patients met the inclusion criteria. Studies were mixed in their patient composition: 22 (28%) included only cryptogenic stroke cases, 4 (5%) stratified events into cryptogenic and non-cryptogenic, and 53 (67%) included unselected patient populations. The summary proportion of patients diagnosed with post-stroke AF was 7·7% (95% CI, 5.0 to 10.8) in phase 1, 5.1% (95% CI, 3.8% to 6.5%) in phase 2, 10.7% (95% CI, 5.6% to 17.2%) in phase 3, and 16.9% (95% CI, 13.0% to 21.2%) in phase 4. The overall AF detection yield after all phases of sequential cardiac monitoring was 23.7% (95% CI, 17.2% to 31.0%). In phase 4, there were no differences between the proportion of patients diagnosed with poststroke AF by MCOT (15.3%; 95% CI, 5.3% to 29.3%), external loop recording (16.2%; 95% CI, 0.3% to 24.6%), and implantable loop recording (16.9%; 95% CI, 10.3% to 24.9%; p=0.97).
Plas and colleagues reported the results of a prospective study of 94 patients with cryptogenic stroke who underwent 24 hours of monitoring with an external loop recorder with an automated AF detection algorithm (Plas, 2015). The 24-h automated loop recorder revealed paroxysmal AF in 4 patients (4 %) and paroxysmal atrial flutter in 1 patient (1 %).
Turakhia and colleagues reported results of a single-center non-comparative study evaluating the feasibility and diagnostic yield of a continuously recording device with longer recording period (the Zio® Patch) for AF screening in patients with risk factors for AF (Turakhia, 2015). The study included 75 patients over 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 to be at moderate to high risk of stroke (CHA2DS2-VASc ≥2 in 97% of subjects). Atrial fibrillation was detected in 4 subjects (5.3%), all of whom had CHA2DS2-VASc scores of greater than or equal to 2. All patients with AF detected had an initial episode within the 1st 48 hours of monitoring. Five patients had episodes of atrial tachyarrhythmias lasting at least 60 seconds detected.
Section Summary
For the use of ambulatory monitoring for the diagnosis of AF in asymptomatic but higher risk patients, a small non-comparative study demonstrated that 14 day monitoring with the Zio Patch is feasible. The use of population-based screening for asymptomatic patients is not well-established, and several studies are underway to evaluate population-based screening are currently underway and may influence the standard of care for AF detection in patients without symptoms or a history of stroke or TIA. To determine whether outcomes are improved for ambulatory monitoring for AF in patients without a history of stroke/TIA or treated AF, studies comparing the outcomes for various outpatient diagnostic screening strategies for AF would be needed.
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through March 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; Page1994). 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 large‐cluster RCT of opportunistic pulse taking versus systematic screening with 12‐lead 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.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2019. No new literature was identified that would prompt a change in the coverage statement.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Wineinger et al reported on 13,293 individuals with paroxysmal AF who were referred for extended cardiac rhythm evaluation based on a clinical indication and wore the Zio Patch as part of standard clinical care (Wineinger, 2020). The median time to the first detected paroxysmal AF event was 24.9 hours (IQR 2.7 to 83.9 hours). After 24 hours of monitoring, 49.4% of individuals had experienced a paroxysmal AF event, increasing to 63.1% after 48 hours of monitoring and to 89.7% after 7 days of monitoring.
In a retrospective cohort study using data from two integrated health care delivery systems in California, Go et al examined the association of AF burden with the risk of stroke in patients with paroxysmal AF who were not receiving anticoagulants (Go, 2018). The analysis included data from 1965 patients who were receiving monitoring with the Zio Patch. The highest tertile of AF burden (11.4% or higher), as measured by up to 14 days of continuous monitoring, was associated with a more than 3-fold higher risk of ischemic stroke compared to the lower 2 tertiles, even after controlling for known stroke risk factors.
Multiple single-center studies have reported on the diagnostic yield and timing of arrhythmia detection in patients monitored with the Zio Patch for a variety of arrhythmias. These studies generally have reported high rates of arrhythmia detection. One was conducted by Mullis et al who monitored premature ventricular contractions (PVCs) in 59 consecutive patients seen in an outpatient electrophysiology clinic. The results are as follows: median of minimum 24-hour PVC burden: 4.5% (IQR 2.6% to 11.2%); median of maximum 24-hour PVC burden: 16.2% (IQR 11.7% to 26.2%); mean 24-hour PVC burden: 9.0% (IQR 6.4% to 17.9%): median difference between maximum 24-hour PVC burden and minimum 24-hour burden: 2.45-fold (IQR 1.68- to 5.55-fold) (Mullis, 2019). Another study by Reed et al evaluated 86 patients in an emergency room who had syncope and found that 9 of the 86 patients (10.5%) had a symptomatic significant arrhythmia endpoint (95% CI 4.0 to 16.9) (Reed, 2018).
Kaura et al compared monitoring with the Zio Patch to short-term Holter monitoring in 120 patients following TIA or ischemic stroke (Kaura, 2019). Patch-based monitoring was superior to standard monitoring for the detection of paroxysmal AF over the 90-day follow-up period (16.3% vs 2.1%; odds ratio 8.0; 95% CI 1.1 to 76.0; P =.026).
Heckbert et al reported results of an ancillary study of the Multi-Ethnic Study of Atherosclerosis (MESA), designed to determine the prevalence of AF, atrial flutter, and other arrhythmias in participants 45–84 years of age and free of clinically-recognized cardiovascular disease (Heckbert, 2018). A total of 1122 participants completed one or two monitoring episodes using the Zio Patch. The mean age of participants at the time of monitoring was 75 (SD 8) years. Among the 804 participants with no prior history of clinically recognized AF/flutter, 32 (4.0%) had AF/flutter detected during the monitoring period, representing a new diagnosis. Among the 32 individuals with AF/flutter detected, the arrhythmia was detected at device activation or during the initial 24 hours in 15 (47%), during the second 24 hours in 5 (16%), and during days 3 to 12 of monitoring in 12 (38%).
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
An RCT reported by Gladstone et al evaluated screening for AF with continuous ambulatory monitoring (the Zio XT patch worn for up to 4 weeks) compared to standard care (routine clinical follow-up plus a pulse check and heart auscultation at baseline and 6 months) in 876 asymptomatic adults over age 75 with hypertension and without known AF (Gladstone, 2021). The primary outcome was AF detected by continuous monitoring or clinically within 6 months. At 6-month follow-up, AF was detected in 23 of 434 participants (5.3%) in the screening group, compared to 2 of 422 (0.5%) in the control group (relative risk, 11.2; 95% CI, 2.7 to 47.1; p=0.001; absolute difference, 4.8%; 95% CI, 2.6% to 7.0%; p<0.001; number needed to screen, 21). Anticoagulant treatment was initiated in 4.1% of the screening group compared to 0.9% of the control group (relative risk, 4.4; 95% CI, 1.5 to 12.8; p=0.007; absolute difference, 3.2%; 95% CI, 1.1% to 5.3%; p=0.003). During the 6-month study period, 1 participant died (control group; cardiovascular death) and 2 participants had an ischemic stroke (both in the screening group). One patient had a TIA (screening group). The trial was not powered to detect clinical outcomes and was of insufficient duration to draw conclusions on health outcomes.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Svendsen et al reported results of the LOOP trial (Svendsen, 2021). This was the only RCT that was powered to detect clinical outcomes. Screening resulted in an increase in AF detection and anticoagulation initiation but no significant reduction in the risk of stroke or systemic arterial embolism. A higher-than-anticipated proportion of participants in the control group were diagnosed with atrial fibrillation (12.2% compared with anticipated 3.0%), indicating that control group participants could have been more likely to consult their physician. Additionally, atrial fibrillation episodes detected in the control group are likely to have lasted longer than atrial fibrillation detected by monitors, increasing the probability of detection and potentially decreasing the protective effect of anticoagulant treatment.
Steinhubl et al reported 3-year outcomes for the observational cohort (Steinhubl, 2021). At the end of 3 years, AF was newly diagnosed in 11.4% (n = 196) of those actively monitored versus 7.7% (n = 261) in observational controls (P <.01). The rate of the combined endpoint of death, stroke, systemic emboli and myocardial infarction was 3.6 per 100 person-years (95% CI 3.1 to 5.1) in actively monitored individuals and 4.5 (95% CI 4.0 to 5.0) in the observational cohort (adjusted Hazard Ratio 0.79, P =.02). Rates of hospitalizations for bleeding were 0.32 per 100 person-years in the actively monitored cohort versus 0.71 per 100 person-years in the control cohort with an (adjusted Incidence Rate Ratio 0.47; P <.01). Among the screened cohort with incident AF, one-third were diagnosed through screening. Clinical events were common in the 4 weeks surrounding a diagnosis, and the study authors noted that although the clinical event rate was lower in the actively monitored cohort, the difference in detection rates at 3 years indicated that screening did not diagnose AF prior to the development of complications, and so the influence of screening on health outcomes is unclear. In addition to its potential for bias in unmeasured confounders, this study was limited by its use of claims data for outcome measurement.
In 2022, the U.S. Preventive Services Task Force updated its recommendation on Screening for Atrial Fibrillation and concluded, "For adults 50 years or older who do not have signs or symptoms of atrial fibrillation: The current evidence is insufficient to assess the balance of benefits and harms of screening for AF (Grade: I statement) (Davidson, 2022).
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Diederichsen et al found that screening did not result in a significant decrease in ischemic (HR 0.76; 95% CI, 0.57-1.03; p=.07) or severe (HR 0.69; 95% CI, 0.44-1.09; p=.11) strokes compared with usual care (Diederichsen, 2022). In an exploratory subgroup analysis of participants without prior stroke, the HRs were 0.68 (95% CI, 0.48-0.97; p=.04) and 0.54 (95% CI, 0.30-0.97; p=.04), respectively, indicating a possible reduction in these outcomes among individuals without prior stroke. In another subgroup analysis of the LOOP trial also reported by Diederichsen et al, screening led to an increase in bradyarrhythmia diagnoses and pacemaker implantations compared with usual care but no change in the risk of syncope (HR, 0.83; 95% CI, 0.56-1.22; p=.34) or sudden death (HR, 1.11; 95% CI, 0.64-1.90; p=.71) (Diederichsen, 2023).
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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 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; 26:173-6. Barrett PM, Komatireddy R, Haaser S, et al.(2014) Comparison of 24-hour Holter monitoring with 14-day novel adhesive patch electrocardiographic monitoring. Am J Med. Jan 2014;127(1):95 e11-97. PMID 24384108 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 Bolourchi M, Batra AS.(2015) Diagnostic yield of patch ambulatory electrocardiogram monitoring in children (from a national registry). Am J Cardiol. Mar 1 2015;115(5):630-634. PMID 25591894 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 Burkowitz J, Merzenich C, Grassme K, et al.(2016) Insertable cardiac monitors in the diagnosis of syncope and the detection of atrial fibrillation: A systematic review and meta-analysis. Eur J Prev Cardiol. Aug 2016;23(12):1261-1272. PMID 26864396 Calkins H, Kuck KH, Cappato R, et al.(2012) 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. Mar 2012;33(2):171-257. PMID 22382715 Chao TF, Lin YJ, Tsao HM, et al.(2011) CHADS(2) and CHA(2)DS(2)-VASc scores in the prediction of clinical outcomes in patients with atrial fibrillation after catheter ablation. J Am Coll Cardiol. Nov 29 2011;58(23):2380-2385. PMID 22115643 Christensen LM, Krieger DW, Hojberg S, et al.(2014) Paroxysmal atrial fibrillation occurs often in cryptogenic ischaemic stroke. Final results from the SURPRISE study. Eur J Neurol. Jun 2014;21(6):884-889. PMID 24628954 Cotter PE, Martin PJ, Ring L, et al.(2013) Incidence of atrial fibrillation detected by implantable loop recorders in unexplained stroke. Neurology. Apr 23 2013;80(17):1546-1550. PMID 23535493 Crawford MH, Bernstein 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; 34:912-45. Culebras A, Messe SR, Chaturvedi S, et al.(2014) 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. Feb 25 2014;82(8):716-724. PMID 24566225 Da Costa A, Defaye P, Romeyer-Bouchard C, et al.(2013) Clinical impact of the implantable loop recorder in patients with isolated syncope, bundle branch block and negative workup: a randomized multicentre prospective study. Arch Cardiovasc Dis. Mar 2013;106(3):146-154. PMID 23582676 Dagres N, Kottkamp H, Piorkowski C, et al.(2010) Influence of the duration of Holter monitoring on the detection of arrhythmia recurrences after catheter ablation of atrial fibrillation: implications for patient follow-up. Int J Cardiol. Mar 18 2010;139(3):305-306. PMID 18990460 Davidson KW, Barry MJ, Mangione CM, et al.(2022) Screening for Atrial Fibrillation: US Preventive Services Task Force Recommendation Statement. JAMA. Jan 25 2022; 327(4): 360-367. PMID 35076659 DiMarco JP, Philbrick JT.(1990) Use of ambulatory electrocardiographic (Holter) monitoring. Ann Intern Med 1990; 113:53-68. 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. Oct 1 2003;92(7):815-819. PMID 14516882 Etgen T, Hochreiter M, Mundel M, et al.(2013) Insertable cardiac event recorder in detection of atrial fibrillation after cryptogenic stroke: an audit report. Stroke. Jul 2013;44(7):2007-2009. PMID 23674523 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 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 Gladstone DJ, Spring M, Dorian P, et al.(2014) Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. Jun 26 2014;370(26):2467-2477. PMID 24963566 Gladstone DJ, Wachter R, Schmalstieg-Bahr K, et al.(2021) Screening for Atrial Fibrillation in the Older Population: A Randomized Clinical Trial. JAMA Cardiol. May 01 2021; 6(5): 558-567. PMID 33625468 Go AS, Reynolds K, Yang J, et al.(2018) Association of Burden of Atrial Fibrillation With Risk of Ischemic Stroke in Adults With Paroxysmal Atrial Fibrillation: The KP-RHYTHM Study. JAMA Cardiol. Jul 01 2018; 3(7): 601-608. PMID 29799942 Gumbinger C, Krumsdorf U, Veltkamp R, et al.(2012) Continuous monitoring versus HOLTER ECG for detection of atrial fibrillation in patients with stroke. Eur J Neurol. Feb 2012;19(2):253-257. PMID 21895885 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 2009; 120(11 Suppl):S177-84. 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 Heckbert SR, Austin TR, Jensen PN, et al.(2018) Yield and consistency of arrhythmia detection with patch electrocardiographic monitoring: The Multi-Ethnic Study of Atherosclerosis. J Electrocardiol. Nov 2018; 51(6): 997-1002. PMID 30497763 Higgins P, MacFarlane PW, Dawson J, et al.(2013) Noninvasive cardiac event monitoring to detect atrial fibrillation after ischemic stroke: a randomized, controlled trial. Stroke. Sep 2013;44(9):2525-2531. PMID 23899913 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 2010; 3(2):141-7. Hoefman E, Bindels PJ, van Weert HC.(2010) Efficacy of diagnostic tools for detecting cardiac arrhythmias: systematicliterature search. Neth Heart J. Nov 2010;18(11):543-551. PMID 21113379 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 January CT, Wann LS, Alpert JS, et al.(2014) 2014 AHA/ACC/HRS guideline 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 Heart Rhythm Society. Circulation. Dec 2 2014;130(23):2071-2104. PMID 24682348 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. Apr 1 2005;95(7):878-881. PMID 15781022 Kadish AH, Buxton AE, et al.(2001) ACC/AHA clinical competence statement on electrocardiography and ambulatory electrocardiography. J Am Coll Cardioll, 2001; 38:2091-100. Kadish AH, Reiffel JA, Clauser J, et al.(2010) Frequency of serious arrhythmias detected with ambulatory cardiac telemetry. Am J Cardiol. May 1 2010;105(9):1313-1316. PMID 20403485 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, Navi BB, Elijovich L, et al.(2013) Pilot randomized trial of outpatient cardiac monitoring after cryptogenic stroke. Stroke. Feb 2013;44(2):528-530. PMID 23192756 Kapa S, Epstein AE, Callans DJ, et al.(2013) Assessing arrhythmia burden after catheter ablation of atrial fibrillation using an implantable loop recorder: the ABACUS study. J Cardiovasc Electrophysiol. Aug 2013;24(8):875-881. PMID 23577826 Kaura A, Sztriha L, Chan FK, et al.(2019) Early prolonged ambulatory cardiac monitoring in stroke (EPACS): an open-label randomised controlled trial. Eur J Med Res. Jul 26 2019; 24(1): 25. PMID 31349792 Kishore A, Vail A, Majid A, et al.(2014) Detection of atrial fibrillation after ischemic stroke or transient ischemic attack: a systematic review and meta-analysis. Stroke. Feb 2014;45(2):520-526. PMID 24385275 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 Lazzaro MA, Krishnan K, Prabhakaran S.(2012) Detection of atrial fibrillation with concurrent holter monitoring and continuous cardiac telemetry following ischemic stroke and transient ischemic attack. J Stroke Cerebrovasc Dis. Feb 2012;21(2):89-93. PMID 20656504 Leshem-Rubinow E, Berger M, Shacham J et al.(2011) New real-time loop recorder diagnosis of symptomatic arrhythmia via telemedicine. Clin Cardiol 2011; 34(7):420-5. Miller DJ, Khan MA, Schultz LR, et al.(2013) Outpatient cardiac telemetry detects a high rate of atrial fibrillation in cryptogenic stroke. J Neurol Sci. Jan 15 2013;324(1-2):57-61. PMID 23102659 Mittal S, Movsowitz C, Steinberg JS.(2011) Ambulatory external electrocardiographic monitoring: focus on atrial fibrillation. J Am Coll Cardiol. Oct 18 2011;58(17):1741-1749. PMID 21996384 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 Moya A, Sutton R, Ammirati F, et al.(2009) Guidelines for the diagnosis and management of syncope (version 2009). Eur Heart J. Nov 2009; 30(21): 2631-71. PMID 19713422 Mullis AH, Ayoub K, Shah J, et al.(2019) Fluctuations in premature ventricular contraction burden can affect medical assessment and management. Heart Rhythm. Oct 2019; 16(10): 1570-1574. PMID 31004780 National Institute for Health and Care Excellence (NICE).(2016) Transient loss of consciousness ('blackouts') in over 16s [CG109]. 2014 Available online at https://www.nice.org.uk/guidance/cg109. Accessed April 29, 2016. Ng E, Stafford PJ, Ng GA.(2004) Arrhythmia detection by patient and auto-activation in implantable loop recorders. J Interv Card Electrophysiol 2004; 10:147-52. 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. May 2007;18(5):473-477. PMID 17343724 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 Plas GJ, Bos J, Velthuis BO, et al(2015) Diagnostic yield of external loop recording in patients with acute ischemic stroke or TIA. J Neurol. Mar 2015;262(3):682-688. PMID 25557280 Podoleanu C, DaCosta A, Defaye P, et al.(2014) Early use of an implantable loop recorder in syncope evaluation: a randomized study in the context of the French Healthcare System (FRESH study). Arch Cardiovasc Dis. Oct 2014;107(10):546-552. PMID 25241220 Pokushalov E, Romanov A, Corbucci G, et al.(2011) Ablation of paroxysmal and persistent atrial fibrillation: 1-year follow-up through continuous subcutaneous monitoring. J Cardiovasc Electrophysiol. Apr 2011;22(4):369-375. PMID 20958836 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 Reed MJ, Grubb NR, Lang CC, et al.(2018) Diagnostic yield of an ambulatory patch monitor in patients with unexplained syncope after initial evaluation in the emergency department: the PATCH-ED study. Emerg Med J. Aug 2018; 35(8): 477-485. PMID 29921622 Reiffel JA, Schwarzberg 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; 95:1055-9. Remote Cardiac Monitoring. Technology Assessment. Agency for Healthcare Research and Quality. Dec 2007. Ritter MA, Kochhauser S, Duning T, et al.(2013) Occult atrial fibrillation in cryptogenic stroke: detection by 7-day electrocardiogram versus implantable cardiac monitors. Stroke. May 2013;44(5):1449-1452. PMID 23449264 Rosenberg MA, Samuel M, Thosani A, et al.(2013) Use of a noninvasive continuous monitoring device in the management of atrial fibrillation: a pilot study. Pacing Clin Electrophysiol. Mar 2013;36(3):328-333. PMID 23240827 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; 18:1-7. 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. Mar 2007;18(3):241-247. PMID 17318994 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. Jul 2016;13(7):1425-1430. PMID 26961298 Sankari Z, Adeli H.(2011) HeartSaver: a mobile cardiac monitoring system for auto-detection of atrial fibrillation, myocardial infarction, and atrio-ventricular block. Comput Biol Med 2011; 41(4):211-20. Sanna T, Diener HC, Passman RS, et al.(2014) Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. Jun 26 2014;370(26):2478-2486. PMID 24963567 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 Sinha AM, Diener HC, Morillo CA, et al.(2010) Cryptogenic Stroke and underlying Atrial Fibrillation (CRYSTAL AF): design and rationale. Am Heart J. Jul 2010;160(1):36-41 e31. PMID 20598970 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 Sposato LA, Cipriano LE, Saposnik G, et al.(2015) Diagnosis of atrial fibrillation after stroke and transient ischaemic attack: a systematic review and meta-analysis. Lancet Neurol. Apr 2015;14(4):377-387. PMID 25748102 Steinhubl SR, Waalen J, Sanyal A, et al.(2021) Three year clinical outcomes in a nationwide, observational, siteless clinical trial of atrial fibrillation screening-mHealth Screening to Prevent Strokes (mSToPS). PLoS One. 2021; 16(10): e0258276. PMID 34610049 Strickberger SA, Benson DW, et al.(2006) AHS/ACCF scientific statement on the evaluation of syncope. J Am Coll Cardiol, 2006; 47:473-84. Svendsen JH, Diederichsen SZ, Hojberg S, et al.(2021) Implantable loop recorder detection of atrial fibrillation to prevent stroke (The LOOP Study): a randomised controlled trial. Lancet. Oct 23 2021; 398(10310): 1507-1516. PMID 34469766 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 Themistoclakis S, Corrado A, Marchlinski FE, et al.(2010) The risk of thromboembolism and need for oral anticoagulation after successful atrial fibrillation ablation. J Am Coll Cardiol. Feb 23 2010;55(8):735-743. PMID 20170810 Tung CE, Su D, Turakhia MP, et al.(2014) Diagnostic Yield of Extended Cardiac Patch Monitoring in Patients with Stroke or TIA. Front Neurol. 2014;5:266. PMID 25628595 Turakhia MP, Hoang DD, Zimetbaum P, et al.(2013) Diagnostic utility of a novel leadless arrhythmia monitoring device. Am J Cardiol. Aug 15 2013;112(4):520-524. PMID 23672988 Turakhia MP, Ullal AJ, Hoang DD, et al.(2015) Feasibility of Extended Ambulatory Electrocardiogram Monitoring to Identify Silent Atrial Fibrillation in High-risk Patients: The Screening Study for Undiagnosed Atrial Fibrillation (STUDY-AF). Clin Cardiol. May 2015;38(5):285-292. PMID 25873476 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 Wineinger NE, Barrett PM, Zhang Y, et al.(2019) Identification of paroxysmal atrial fibrillation subtypes in over 13,000 individuals. Heart Rhythm. Jan 2019; 16(1): 26-30. PMID 30118885 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; 130:848-56. Zipes DP, Camm AJ, et al.(2006) ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. 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