Download Ambulatory Event Monitors and Mobile Cardiac Outpatient Telemetry

Ambulatory Event Monitors and Mobile Cardiac
Outpatient Telemetry
Protocol
(20208)
Medical Benefit
Preauthorization
No
Effective Date: 07/01/16
Next Review Date: 05/17
Review Dates: 05/07, 07/08, 09/09, 09/10, 01/11, 01/12, 01/13, 01/14, 09/14,
05/15, 05/16
This Protocol considers mobile cardiac outpatient telemetry investigational. If the physician
feels this service is medically necessary, preauthorization is recommended.
The following Protocol contains medical necessity criteria that apply for this service. The criteria
are also applicable to services provided in the local Medicare Advantage operating area for those
members, unless separate Medicare Advantage criteria are indicated. If the criteria are not met,
reimbursement will be denied and the patient cannot be billed. Please note that payment for
covered services is subject to eligibility and the limitations noted in the patient’s contract at the
time the services are rendered.
Populations
Patients/individuals with:
• Symptoms suggestive of
arrhythmia
Patients/individuals with:
• Symptoms suggestive of
arrhythmia
Patients/individuals with:
• Symptoms suggestive of
arrhythmia
Interventions
Interventions of interest are:
• Patient-activated or autoactivated external AEMs
Interventions of interest are:
• Outpatient cardiac telemetry
Patients/individuals with:
• AF following ablation
Interventions of interest are:
• Patient-activated or autoactivated external AEMs
• Outpatient cardiac telemetry
• CAMs storing information
greater than 48 h
Interventions of interest are:
• Patient-activated or autoactivated external AEMs
• Outpatient cardiac telemetry
• CAMs storing information
greater than 48 h
• Patient-activated or autoactivated implantable AEMs
Interventions of interest are:
• Patient-activated or autoactivated implantable AEMs
Patients/individuals with:
• Cryptogenic stroke with
negative standard workup for AF
Patients/individuals with:
• Symptoms suggestive of
arrhythmia with infrequent symptoms
Interventions of interest are:
• CAMs storing information
greater than 48 h
Comparators
Comparators of interest are:
• ECG only or 24-48 h Holter
monitoring
Comparators of interest are:
• Patient-activated or autoactivated external AEMs
Comparators of interest are:
• 24-48 h Holter monitoring
• Patient-activated or autoactivated external AEMs
Comparators of interest are:
• Management with 24-48 h
Holter monitoring
Outcomes
Relevant outcomes include:
• Overall survival
• Morbid events
Relevant outcomes include:
• Overall survival
• Morbid events
Relevant outcomes include:
• Overall survival
• Morbid events
Comparators of interest are:
• Standard evaluation for
stroke, including ECG and
24-h Holter monitor
Relevant outcomes include:
• Overall survival
• Medication use
• Treatment-related morbidity
• Morbid events
Comparators of interest are:
• No additional evaluation/
standard care
• Management with patientactivated or auto-activated
external AEMs
Relevant outcomes include:
• Overall survival
• Treatment-related morbidity
• Morbid events
Relevant outcomes include:
• Medication use
• Morbid events
Page 1 of 11
Protocol
Ambulatory Event Monitors and Mobile Cardiac Outpatient
Telemetry
Populations
Patients/individuals with:
• Risk factors for AF
Interventions
Interventions of interest are:
• CAMs storing information
greater than 48 h
Comparators
Comparators of interest are:
• No additional evaluation/
standard care
Last Review Date: 05/16
Outcomes
Relevant outcomes include:
• Overall survival
• Medication use
• Morbid events
AEM: ambulatory event monitor; AF: atrial fibrillation; CAM: continuous ambulatory monitor; ECG: electrocardiogram.
Description
There are a wide variety of devices available for outpatient cardiac rhythm monitoring. The primary purpose of
these devices is the evaluation of suspected arrhythmias that have not been detected by office- or hospitalbased monitoring. These devices differ in the types of monitoring leads used, the duration and continuity of
monitoring, the ability to detect arrhythmias without patient intervention, and the mechanism of delivery of the
information from patient to clinician. These devices may be used for the evaluation of symptoms suggestive of
arrhythmias, such as syncope or palpitations, but also may be used in the detection of atrial fibrillation (AF) in
patients who have undergone cardiac ablation of AF or who have a history of cryptogenic stroke.
Summary of Evidence
For the use of autoactivated event monitors for arrhythmia detection in patients with suspected arrhythmias, a
number of studies have indicated that autotrigger event monitors detect additional episodes of arrhythmias
compared with Holter monitoring or patient-triggered devices. This evidence has led to the acceptance of
autotrigger event monitors as the criterion standard for detecting arrhythmias that occur infrequently.
For the use of autoactivated event monitors for detection of atrial fibrillation (AF) in patients who have been
treated with catheter ablation, there is evidence that autotrigger devices can pick up asymptomatic episodes of
AF in patients treated with catheter ablation and that identifying asymptomatic episodes may lead to
modifications in treatment.
For the use of autoactivated event monitors for the detection of AF in patients with cryptogenic stroke, the most
direct evidence consists of one well-designed and well-controlled randomized controlled trial (RCT) which
demonstrated improved AF detection rates for patients managed with 30 days of autotriggered event monitoring compared with those managed with 24-hour Holter monitoring. Observational studies support this
finding. There are recognized management changes which lead to improved outcomes for patients with stroke
and AF (i.e., initiation of oral anticoagulation). Therefore, the published evidence is sufficient to determine that
autotrigger event monitors improve the net health outcome for patients with suspected arrhythmia, for patients
who have undergone catheter ablation for AF and in whom discontinuation of systemic anticoagulation is being
considered, and for patients with cryptogenic stroke.
Similarly, for the use of implantable event monitors for the detection of AF in patients with cryptogenic stroke,
the most direct evidence consists of an RCT comparing the use of an autotriggered implantable monitor with
routine care in patients with cryptogenic stroke. This study demonstrated improvements in AF detection rate
with event monitoring, compared with routine care. The published evidence is sufficient to determine that
implantable event monitors for AF detection improve the net health outcome for patients with cryptogenic
stroke.
For the evaluation of patients with infrequent symptoms who have not had arrhythmias detected with standard
Holter monitoring or external event monitors, there is little direct evidence regarding outcomes associated with
implantable loop recorders. Implantable loop recording devices likely have greater sensitivity in detecting
arrhythmias in patients presenting with symptoms suggestive of arrhythmia. The available evidence does not
Page 2 of 11
Protocol
Ambulatory Event Monitors and Mobile Cardiac Outpatient
Telemetry
Last Review Date: 05/16
clearly define the indications for an implantable loop recorder; however, given the small but higher risk associated with an implantable device, for patients presenting with signs or symptoms suggestive of an arrhythmia,
it would be reasonable to consider the use of an implantable loop recorder after a trial of an external loop
recorder does not yield a definitive diagnosis.
Newer continuous monitoring devices are available that use novel technology and record information for longer
periods than a Holter monitor (e.g., up to two weeks). The available evidence for these devices consists of crosssectional studies that show they typically detect greater numbers of arrhythmias during extended follow-up
than 24- or 48-hour Holter monitoring. However, the appropriate comparison group would be patient- or autotriggered event monitors, and no studies were identified that compared longer recording devices with patientor autotriggered event monitors. Direct evidence for improved outcomes with the use of these types of monitors is lacking. The evidence for a significant incremental improvement in outcomes when continuous monitoring devices are used is lacking. Therefore, the available published evidence is considered insufficient to determine that continuous monitoring devices with longer recording periods improve the net health outcome for
patients with suspected arrhythmias.
Mobile cardiac outpatient telemetry (MCOT) is another option for long-term cardiac monitoring. For the use of
MCOT for the evaluation of patients with suspected arrhythmias, evidence from one RCT and uncontrolled case
series suggests that MCOT is likely to be as effective at detecting arrhythmias as autotriggered event monitors.
Although MCOT has the theoretical advantage of allowing a rapid response to a potentially emergent
arrhythmia, none of the available studies have clearly shown an improvement in clinical utility as a result of
using MCOT. Further studies are needed to compare MCOT with the autotrigger loop recorder to determine
whether the faster response possible with real-time monitoring leads to improved outcomes. Direct evidence
for improved health outcomes with the use of MCOT for the evaluation of suspected arrhythmias is lacking, and
evidence for a significant incremental improvement in outcomes with MCOT, compared with standard management, is lacking. Therefore, the available published evidence is considered insufficient to determine that MCOT
improves the net health outcome for patients with suspected arrhythmias.
Similarly, for the use of MCOT for the detection of AF either in patients following catheter ablation of AF or
following cryptogenic stroke, there is no direct evidence comparing MCOT with other detection methods. Singlearm studies report relatively high rates of AF detection with MCOT in patients with cryptogenic stroke. Direct
evidence for improved health outcomes with the use of MCOT for the evaluation of AF and evidence for a significant incremental improvement in outcomes with MCOT, compared with standard management, is lacking.
Therefore, the available published evidence is considered insufficient to determine that MCOT improves the net
health outcome for patients who require evaluation for AF.
Policy
The use of patient activated or auto-activated external ambulatory event monitors may be considered medically
necessary as a diagnostic alternative to Holter monitoring in the following situations:
•
Patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac
arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope).
•
Patients with atrial fibrillation who have been treated with catheter ablation, and in whom discontinuation
of systemic anticoagulation is being considered.
•
Patients with cryptogenic stroke who have a negative standard work-up for atrial fibrillation including a 24hour Holter monitor (see Policy Guidelines).
Page 3 of 11
Protocol
Ambulatory Event Monitors and Mobile Cardiac Outpatient
Telemetry
Last Review Date: 05/16
The use of implantable ambulatory event monitors, either patient activated or auto-activated, may be considered medically necessary in the following situations:
•
In the small subset of patients who experience recurrent symptoms so infrequently that a prior trial of other
external ambulatory event monitors has been unsuccessful.
•
In patients with cryptogenic stroke who have had a negative standard work-up for atrial fibrillation including
a 24-hour Holter monitor (see Policy Guidelines).
The use of outpatient cardiac telemetry (also known as mobile cardiac outpatient telemetry [MCOT]) as a
diagnostic alternative to ambulatory event monitors in patients who experience infrequent symptoms (less
frequently than every 48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope, or
syncope) is considered investigational.
The use of continuous ambulatory monitors that record and store information for periods longer than 48 hours
may be considered medically necessary as a diagnostic alternative to Holter monitoring or patient-activated or
auto-activated external ambulatory event monitors in the following situations:
•
Patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac
arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope).
•
Patients with atrial fibrillation who have been treated with catheter ablation, and in whom discontinuation
of systemic anticoagulation is being considered.
•
Patients with cryptogenic stroke who have a negative standard work-up for atrial fibrillation including a 24hour Holter monitor (see Policy Guidelines).
Other uses of ambulatory event monitors, including outpatient cardiac telemetry, are considered investigational, including but not limited to monitoring effectiveness of antiarrhythmic medications and detection of
myocardial ischemia by detecting ST segment changes.
Policy Guidelines
For the evaluation of patients with cryptogenic stroke who have had a negative standard work-up for atrial
fibrillation including 24-hour Holter monitoring, the use of long-term monitoring with an external event monitor,
OR a continuous ambulatory monitor that records and stores information for periods longer than 48 hours, OR
an implantable ambulatory monitor may be considered medically necessary for patients who meet the criteria
outlined above.
Medicare Advantage
Except for this additional medically necessary statement, the above policy statements and guidelines apply for
Medicare Advantage.
Telephonic EKG transmissions are considered medically necessary as a diagnostic service for the indications
below:
1. Detection, characterization, and documentation of symptomatic transient arrhythmias;
2. Initiate, revise, or discontinue arrhythmic drug therapy; or,
3. Carry-out early post-hospital monitoring of patients discharged after myocardial infarction (MI); (only if 24hour coverage is provided).
Page 4 of 11
Protocol
Ambulatory Event Monitors and Mobile Cardiac Outpatient
Telemetry
Last Review Date: 05/16
24-hour attended coverage used as early post-hospital monitoring of patients discharged after MI is only
covered if provision is made for such 24-hour attended coverage in the manner described below:
24-hour attended coverage means there must be, at a monitoring site or central data center, an EKG
technician or other non-physician, receiving calls and/or EKG data; tape recording devices do not meet
this requirement. Further, such technicians should have immediate, 24-hour access to a physician to
review transmitted data and make clinical decisions regarding the patient. The technician should also be
instructed as to when and how to contact available facilities to assist the patient in case of emergencies.
Background
A variety of cardiac monitors are available for the evaluation of patients with potential arrhythmias. Signs and
symptoms potentially suggestive of arrhythmias include palpitations, dizziness, syncope, or presyncope, or
abnormal heart rate or rhythm noted on exam. In addition, because of the association between atrial fibrillation
(AF) and stroke or transient ischemic attack (TIA), monitoring for asymptomatic AF is often part of the evaluation
for the cause of a stroke or TIA.
A brief description of the major categories of devices is given next. There has been a trend in recent years
toward using novel technology to increase the efficiency, comfort, and convenience of these devices. These
technologic advances include the development of devices that are smaller and more convenient to use, as well
as novel ways to rapidly transmit information, such as by use of mobile devices. These advances in technology
may present challenges in categorizing new devices.
Some of the newer devices are described next for informational purposes in assigning them to the most relevant
category. However, because there may be many devices within each category, a comprehensive description of
individual devices is beyond the scope of this review.
Continuous Monitoring Devices (Holter Monitors and Similar Devices)
Ambulatory Holter electrocardiography (ECG) is a widely used noninvasive test in which ECG is continuously
recorded over an extended period of time, typically 24 to 48 hours, to evaluate symptoms suggestive of cardiac
arrhythmias (i.e., palpitations, dizziness, syncope). However, Holter monitoring will be ineffective in detecting
arrhythmias if a patient experiences infrequent symptoms. Therefore, the sensitivity of Holter monitoring is low
for detection of arrhythmias that are intermittent.
Continuous Monitoring Devices With Longer Recording Periods
Some newer devices are continuous monitors that are similar to traditional Holter monitoring in concept, but
offer other advantages such as the ability to monitor for longer periods of time.
•
The Zio® Patch system (iRhythm Technologies, San Francisco, CA) is a long-term continuous monitoring
system that is most analogous to a Holter monitor that records and stores information for longer time
periods. It is primarily used for asymptomatic monitoring. This system consists of a patch worn over the left
pectoral region of the body that records continuously for up to 14 days, while the patient keeps a symptom
log. At the end of the recording period, the patient mails back the recorder in a prepaid envelope to a
central station and a full report is provided to the physician within a few days.
•
The BodyGuardian Remote Monitoring System™ (Preventice®, Minneapolis, MN) continuously detects and
records a variety of physiologic data including ECG tracing, respiratory rate, and activity level for up to 30
days. The data can be transmitted to the physician’s office via a cellular telephone, and information can be
viewed by the patient and physician through the Internet.
Page 5 of 11
Protocol
Ambulatory Event Monitors and Mobile Cardiac Outpatient
Telemetry
Last Review Date: 05/16
Noncontinuous Monitoring Devices (AEMs and Similar Devices)
Ambulatory event monitors (AEMs) were developed to provide longer periods of monitoring by using noncontinuous monitoring. In this technique, the recording device is either worn continuously and activated only when
the patient experiences symptoms or is carried by the patient and applied and activated when symptoms are
present. The recorded ECGs are then stored for future analysis or transmitted by telephone to a receiving
station (e.g., a doctor’s office; hospital; cardiac monitoring service) where the ECGs can then be analyzed. AEMs
can be used for extended periods of time, typically up to one month or until the patient experiences symptoms.
Because the ECGs are recorded only during symptoms, there is good correlation with any underlying arrhythmia.
Conversely, if no ECG abnormality is noted, a noncardiac etiology of the patient’s symptoms can be sought.
Several different types of AEMs are available:
Noncontinuous Devices With Memory
These devices are carried by the patient and applied to the precordial area via nongel electrodes when the
symptoms are occurring or, alternatively, a recording device may be worn on the wrist and then activated when
symptoms are present. The limitation of these devices is that an arrhythmia of very short duration would be
difficult to record. In addition, noncontinuous devices require reasonable dexterity on the part of the patient to
apply the device correctly during a symptomatic period. This is a particular limitation if the patient is incapacitated during symptomatic periods.
•
The Zio® Event Card (iRhythm Technologies, San Francisco, CA) is a noncontinuous real-time recording
device that can be worn up to 30 days. This device can be worn comfortably under clothing (including during
sleep), as it weighs less than two ounces and is similar in size to a standard credit card. On activation by the
patient, the card is able to record the previous 45 seconds of ECG activity into memory plus the first 15
seconds after the button is pushed. This is made possible because this device continuously scans for ECG
activity but only records on symptom activation. After the device is activated, the patient is responsible for
calling the iRhythm National Clinical Center, which then instructs the patient on sending the event over the
phone line.
•
The REKA E100™ system is a noncontinuous single-lead cardiac event monitor. This device is the size of a
hockey puck and weighs no more than a few ounces. There are two options, depending on the patient’s
circulation: (1) a zero-lead device that is separate from the body and may be carried in a purse or coat
pocket; or if a patient’s circulation is determined to be inadequate, (2) a single electrode lead that the
patient connects to the device at the time of an event. The zero-lead device records an event by patient
activation and can record and store up to 2000 readings. Patients have the option of sending stored event
information to the physician across a free-of-charge phone app or the Internet in their computer. Internet
transmission requires one of the following systems: Android, Blackberry, iPhone 3, 3S, 4, and 4S, iPad, iPod
Touch®, Microsoft, or Windows.
Continuous “Memory Loop” Devices
These devices are able to continuously store a single channel of ECG data in a refreshed memory. If the patient
activates the device, the ECG is then recorded from the memory loop for the preceding 30 to 90 seconds and for
the next minute or so. Therefore, these types of devices permit recording of the onset of arrhythmias and/or
transient or incapacitating events. They obviously must be worn continuously.
Implantable Continuous “Memory Loop” Devices
An implantable loop recorder device is inserted just under the patient’s skin in the chest area during an outpatient surgical procedure. When symptoms are felt, the patient places a hand-held activator over the recorder
to activate the storage of cardiac rhythms. This device can be used for more than one year.
Page 6 of 11
Protocol
Ambulatory Event Monitors and Mobile Cardiac Outpatient
Telemetry
Last Review Date: 05/16
Autotrigger Devices
All of the previously described devices require activation by the patient. More recently, autotriggering technology has become available, which can be adapted to memory loop devices. For example, event monitors can be
programmed to detect heart rates greater than 165 beats per minute, less than 40 beats per minute, or an
asystole of greater than three seconds.
Implantable Continuous “Memory Loop” Devices With Autotrigger
These devices combine the long-term monitoring available with implantable devices with the autotriggers seen
on newer event monitors. These devices contain algorithms that are programmed to detect heart rates exceeding an upper or lower limit, asystole of greater than three seconds. They typically contain other autotriggers,
such as a variable RR interval seen with AF. For example, the Reveal® XT ICM (Medtronic, Minneapolis, MN) is an
implantable memory loop device cleared for marketing by the U.S. Food and Drug Administration (FDA) in 2008
that allows patient-activated rhythm recording, rhythm recording at prespecified time intervals, or autotriggered rhythm recording. Sizes of implantable devices are decreasing: in February 2014, FDA cleared for marketing
the Reveal LINQ™, a miniaturized implantable memory loop device that is approximately 1 mL that includes
autotriggered or patient-activated rhythm recording.
Mobile Cardiac Outpatient Telemetry
AEMs store the recorded data, which are ultimately transmitted either to a physician’s office or to a central
recording station. In contrast, outpatient cardiac telemetry provides real-time monitoring and analysis. For
example, CardioNet® now owned by BioTelemetry (Malvern, PA), offers MCOT. In this system, the patient wears
a three-lead sensor, which constantly communicates with the CardioNet monitor, a lightweight unit that can be
carried in a pocket or a purse. When an arrhythmia is detected according to preset parameters, the ECG is
automatically transmitted to a central CardioNet service center, where the ECG is immediately interpreted, with
results sent to the referring physician. The referring physician can request the level and timing of response,
ranging from daily reports to stat results. Other systems for outpatient cardiac telemetry include the HEARTLink
II™ system (Cardiac Telecom), the Vital Signs Transmitter (VST™; Biowatch Medical, Columbia, SC), the LifeStar™
Ambulatory Cardiac Telemetry (ACT) system (Card Guard Scientific Survival, Israel), and the SEEQ™ Mobile
Cardiac Telemetry System (Medtronic, Minneapolis, MN). The eCardio Verité™ system (eCardio, Houston, TX) is
a multifunctional model that can be changed between a patient-activated event monitor and a continuous
telemetry monitor.
The VectraplexECG™ System is a real-time continuous MCOT device to measure ischemic ECG changes that can
be indicative of a myocardial infarction. This device uses the Internet to communicate real-time ECG changes to
the physician. The patient is hooked up to a mini-tablet by either five electrodes, which communicate 15-lead
ECG data, or 10 electrodes that communicate 12-lead ECG data. While this system is primarily intended to
monitor for ischemia, the continuous ECG monitoring would presumably detect rhythm disturbances, as well as
ischemic changes.
Regulatory Status
Some of the newer devices are described in the Background section for informational purposes. However,
because there may be many devices within each category, a comprehensive description of individual devices is
beyond the scope of this review.
Page 7 of 11
Protocol
Ambulatory Event Monitors and Mobile Cardiac Outpatient
Telemetry
Last Review Date: 05/16
Services that are the subject of a clinical trial do not meet our Technology Assessment Protocol criteria and are
considered investigational. For explanation of experimental and investigational, please refer to the Technology
Assessment Protocol.
It is expected that only appropriate and medically necessary services will be rendered. We reserve the right to
conduct prepayment and postpayment reviews to assess the medical appropriateness of the above-referenced
procedures. Some of this Protocol may not pertain to the patients you provide care to, as it may relate to
products that are not available in your geographic area.
References
We are not responsible for the continuing viability of web site addresses that may be listed in any references
below.
1. DiMarco JP, Philbrick JT. Use of ambulatory electrocardiographic (Holter) monitoring. Ann Intern Med. Jul 1
1990; 113(1):53-68. PMID 2190517
2. Hoefman E, Bindels PJ, van Weert HC. Efficacy of diagnostic tools for detecting cardiac arrhythmias: systematic literature search. Neth Heart J. Nov 2010; 18(11):543-551. PMID 21113379
3. Turakhia MP, Hoang DD, Zimetbaum P, et al. Diagnostic utility of a novel leadless arrhythmia monitoring
device. Am J Cardiol. Aug 15 2013; 112(4):520-524. PMID 23672988
4. Barrett PM, Komatireddy R, Haaser S, et al. 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
5. Bolourchi M, Batra AS. 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
6. Balmelli N, Naegeli B, Bertel O. Diagnostic yield of automatic and patient-triggered ambulatory cardiac event
recording in the evaluation of patients with palpitations, dizziness, or syncope. Clin Cardiol. Apr 2003;
26(4):173-176. PMID 12708623
7. Ermis C, Zhu AX, Pham S, et al. 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
8. Reiffel JA, Schwarzberg R, Murry M. Comparison of autotriggered memory loop recorders versus standard
loop recorders versus 24-hour Holter monitors for arrhythmia detection. Am J Cardiol. May 1, 2005;
95(9):1055-1059. PMID 15842970
9. Ng E, Stafford PJ, Ng GA. Arrhythmia detection by patient and auto-activation in implantable loop recorders.
J Interv Card Electrophysiol. Apr 2004; 10(2):147-152. PMID 15014215
10. Locati ET, Vecchi AM, Vargiu S, et al. Role of extended external loop recorders for the diagnosis of unexplained syncope, pre-syncope, and sustained palpitations. Europace. Jun 2014; 16(6):914-922. PMID 24158255
11. Da Costa A, Defaye P, Romeyer-Bouchard C, et al. 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
12. Podoleanu C, DaCosta A, Defaye P, et al. 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
Page 8 of 11
Protocol
Ambulatory Event Monitors and Mobile Cardiac Outpatient
Telemetry
Last Review Date: 05/16
13. Edvardsson N, Garutti C, Rieger G, et al. 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
14. Hindricks G, Pokushalov E, Urban L, et al. Performance of a new leadless implantable cardiac monitor in
detecting and quantifying atrial fibrillation: Results of the XPECT trial. Circ Arrhythm Electrophysiol. Apr
2010; 3(2):141-147. PMID 20160169
15. Hanke T, Charitos EI, Stierle U, et al. Twenty-four-hour holter monitor follow-up does not provide accurate
heart rhythm status after surgical atrial fibrillation ablation therapy: up to 12 months experience with a novel
permanently implantable heart rhythm monitor device. Circulation. Sep 15 2009; 120(11 Suppl):S177-184.
PMID 19752365
16. Leshem-Rubinow E, Berger M, Shacham J, et al. New real-time loop recorder diagnosis of symptomatic
arrhythmia via telemedicine. Clin Cardiol. Jul 2011; 34(7):420-425. PMID 21618252
17. Sankari Z, Adeli H. HeartSaver: a mobile cardiac monitoring system for auto-detection of atrial fibrillation,
myocardial infarction, and atrio-ventricular block. Comput Biol Med. Apr 2011; 41(4):211-220. PMID
21377149
18. Rothman SA, Laughlin JC, Seltzer J, et al. 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
19. Kadish AH, Reiffel JA, Clauser J, et al. Frequency of serious arrhythmias detected with ambulatory cardiac
telemetry. Am J Cardiol. May 1, 2010; 105(9):1313-1316. PMID 20403485
20. Joshi AK, Kowey PR, Prystowsky EN, et al. 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
21. Olson JA, Fouts AM, Padanilam BJ, et al. 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
22. Saarel EV, Doratotaj S, Sterba R. Initial experience with novel mobile cardiac outpatient telemetry for
children and adolescents with suspected arrhythmia. Congenital heart disease. Jan-Feb 2008; 3(1):33-38.
PMID 18373747
23. Tayal AH, Tian M, Kelly KM, et al. Atrial fibrillation detected by mobile cardiac outpatient telemetry in
cryptogenic TIA or stroke. Neurology. Nov 18 2008; 71(21):1696-1701. PMID 18815386
24. Dagres N, Kottkamp H, Piorkowski C, et al. 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
25. Pokushalov E, Romanov A, Corbucci G, et al. Ablation of paroxysmal and persistent atrial fibrillation: 1-year
follow-up through continuous subcutaneous monitoring. J Cardiovasc Electrophysiol. Apr 2011; 22(4):369375. PMID 20958836
26. Chao TF, Lin YJ, Tsao HM, et al. 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
Page 9 of 11
Protocol
Ambulatory Event Monitors and Mobile Cardiac Outpatient
Telemetry
Last Review Date: 05/16
27. Kapa S, Epstein AE, Callans DJ, et al. 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
28. Themistoclakis S, Corrado A, Marchlinski FE, et al. The risk of thromboembolism and need for oral anticoagulation after successful atrial fibrillation ablation. J Am Coll Cardiol. Feb 23 2010; 55(8):735-743. PMID
20170810
29. Mittal S, Movsowitz C, Steinberg JS. Ambulatory external electrocardiographic monitoring: focus on atrial
fibrillation. J Am Coll Cardiol. Oct 18 2011; 58(17):1741-1749. PMID 21996384
30. Christensen LM, Krieger DW, Hojberg S, et al. 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
31. January CT, Wann LS, Alpert JS, et al. 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. Apr 10 2014. PMID
24682348
32. Gumbinger C, Krumsdorf U, Veltkamp R, et al. Continuous monitoring versus HOLTER ECG for detection of
atrial fibrillation in patients with stroke. Eur J Neurol. Feb 2012; 19(2):253-257. PMID 21895885
33. Lazzaro MA, Krishnan K, Prabhakaran S. 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
34. Cotter PE, Martin PJ, Ring L, et al. Incidence of atrial fibrillation detected by implantable loop recorders in
unexplained stroke. Neurology. Apr 23 2013; 80(17):1546-1550. PMID 23535493
35. Miller DJ, Khan MA, Schultz LR, et al. 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
36. Sposato LA, Cipriano LE, Saposnik G, et al. 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
37. Kishore A, Vail A, Majid A, et al. 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
38. Kamel H, Navi BB, Elijovich L, et al. Pilot randomized trial of outpatient cardiac monitoring after cryptogenic
stroke. Stroke. Feb 2013; 44(2):528-530. PMID 23192756
39. Higgins P, MacFarlane PW, Dawson J, et al. Noninvasive cardiac event monitoring to detect atrial fibrillation
after ischemic stroke: a randomized, controlled trial. Stroke. Sep 2013; 44(9):2525-2531. PMID 23899913
40. Sinha AM, Diener HC, Morillo CA, et al. Cryptogenic Stroke and underlying Atrial Fibrillation (CRYSTAL AF):
design and rationale. Am Heart J. Jul 2010; 160(1):36-41 e31. PMID 20598970
41. Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. Jun
26 2014; 370(26):2478-2486. PMID 24963567
42. Gladstone DJ, Spring M, Dorian P, et al. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med.
Jun 26 2014; 370(26):2467-2477. PMID 24963566
43. Ritter MA, Kochhauser S, Duning T, et al. Occult atrial fibrillation in cryptogenic stroke: detection by 7-day
electrocardiogram versus implantable cardiac monitors. Stroke. May 2013; 44(5):1449-1452. PMID 23449264
Page 10 of 11
Protocol
Ambulatory Event Monitors and Mobile Cardiac Outpatient
Telemetry
Last Review Date: 05/16
44. Etgen T, Hochreiter M, Mundel M, et al. Insertable cardiac event recorder in detection of atrial fibrillation
after cryptogenic stroke: an audit report. Stroke. Jul 2013; 44(7):2007-2009. PMID 23674523
45. Plas GJ, Bos J, Velthuis BO, et al. Diagnostic yield of external loop recording in patients with acute ischemic
stroke or TIA. J Neurol. Mar 2015; 262(3):682-688. PMID 25557280
46. Tung CE, Su D, Turakhia MP, et al. Diagnostic Yield of Extended Cardiac Patch Monitoring in Patients with
Stroke or TIA. Front Neurol. 2014; 5:266. PMID 25628595
47. Favilla CG, Ingala E, Jara J, et al. Predictors of finding occult atrial fibrillation after cryptogenic stroke. Stroke.
May 2015; 46(5):1210-1215. PMID 25851771
48. Turakhia MP, Ullal AJ, Hoang DD, et al. 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
49. January CT, Wann LS, Alpert JS, et al. 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. J Am Coll Cardiol. Mar 28 2014.
PMID 24685668
50. Culebras A, Messe SR, Chaturvedi S, et al. Summary of evidence-based guideline update: prevention of
stroke in nonvalvular atrial fibrillation: report of the Guideline Development Subcommittee of the American
Academy of Neurology. Neurology. Feb 25 2014; 82(8):716-724. PMID 24566225
51. Crawford MH, Bernstein SJ, Deedwania PC, et al. ACC/AHA Guidelines for Ambulatory Electrocardiography. A
report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines
(Committee to Revise the Guidelines for Ambulatory Electrocardiography). Developed in collaboration with
the North American Society for Pacing and Electrophysiology. J Am Coll Cardiol. Sep 1999; 34(3):912-948.
PMID 10483977
52. Zimetbaum PJ, Josephson ME. The evolving role of ambulatory arrhythmia monitoring in general clinical
practice. Ann Intern Med. May 18, 1999; 130(10):848-856. PMID 10366376
53. Calkins H, Kuck KH, Cappato R, et al. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and
surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient
management and follow-up, definitions, endpoints, and research trial design. J Interv Card Electrophysiol.
Mar 2012; 33(2):171-257. PMID 22382715
54. NGS, Inc. National Coverage Determination (NCD) for Electrocardiographic Services (20.15), Effective Date of
this Version 8/26/2004.
Page 11 of 11