Download National Medical Policy

National Medical Policy
Subject:
Implantable Cardiac Event Monitors
Policy Number:
NMP495
Effective Date*: November 2009
Update:
May 2016
This National Medical Policy is subject to the terms in the
IMPORTANT NOTICE
at the end of this document
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Transmittal 173. September 4, 2014:
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Instructions
Implantable Cardiac Event Monitor May 16
1
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Current Policy Statement
(Refer to Medical Policy on Mobile Outpatient Cardiac Telemetry (e.g. CardioNet for
additional information)
Health Net, Inc. considers the use of implantable loop recorder (ILR), cardiac event
monitors (i.e., FDA approved Reveal Insertable Loop Recorders, including Reveal XT,
DX, LINQ and LINQ11) medically necessary only in a limited role, in a very small
subset of patients, who experience at least two episodes of recurrent, infrequent*,
unexplained symptoms of pre-syncope, syncope, or tachycardia with severe
symptoms of hemodynamic instability, when the following criteria are met:
1.
2.
A cardiac arrhythmia is suspected as the cause of the symptoms; and
A prior trial of Holter Monitor and other external ambulatory event monitors have
been unsuccessful in determining a definitive diagnosis, or a diagnostic ECG.
OR
3.
To be used on a case by case basis only in a small subset of individuals with
severely significant and suspected paroxysmal atrial fibrillation as a cause of
cryptogenic stroke when other less invasive diagnostic modalities (eg, external
ambulatory event monitors or Holter monitors) have been used with inconclusive
results.
Note*: An infrequent but recurrent symptom of pre-syncope, syncope, or
tachycardia with severe symptoms of hemodynamic instability would be indicative of
frequency of at least two episodes within six months.
Implantable Cardiac Event Monitor May 16
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Definitions
ICD
CIED
AECG
ECG/EKG
AHRQ
ACC
AHA
ILR
TEE
ESC
MCOT
MCT
EPS
PPM
CRT
Implantable cardioverter defibrillator
Cardiac implantable electronic devices
Ambulatory electrocardiography
Electrocardiogram
Agency for Healthcare Research and Quality
American College of Cardiology
American Heart Association
Insertable memory loop recorder
Transesophageal echocardiography
European Society of Cardiology Committee
Mobile Cardiac Outpatient Telemetry
Mobile cardiovascular telemetry
Electrophysiology studies
Permanent pacemakers
Cardiac resynchronization therapy
Codes Related To This Policy
NOTE:
The codes listed in this policy are for reference purposes only. Listing of a code in
this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and
medical necessity criteria. This list of codes may not be all inclusive.
On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and
inpatient procedures have been replaced by ICD-10 code sets.
ICD-9 Codes
410.00410.92
411.1
413.0-413.9
414.8
414.9
425.4
426.0-426.9
427.0-427.9
780.2
780.4
785.0
785.1
Acute myocardial infarction
Intermediate coronary syndrome, unstable angina
Angina pectoris
Other specified forms of chronic ischemic heart disease
Unspecified chronic ischemic heart disease
Other primary cardiomyopathies
Conduction disorders
Cardiac arrhythmias
Syncope and collapse
Dizziness and giddiness
Tachycardia
Palpitations
ICD-10 Codes
I20.0–I20.9
I21.01-I21.4
I25.5
I25.89
I25.9
I42.5
I42.8
I44.0-I44.7
I45.0-I45.9
I47.0-I47.9
I47.0-I47.9
Angina pectoris
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial
infarction
Ischemic cardiomyopathy
Other forms of chronic ischemic heart disease
Chronic ischemic heart disease, unspecified
Other restrictive cardiomyopathy
Other cardiomyopathies
Atrioventricular and left bundle-branch block
Other conduction disorders
Paroxysmal tachycardia
Paroxysmal tachycardia
Implantable Cardiac Event Monitor May 16
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I48.0-I48.9
I49.0-I49.9
R00.0
R00.2
R42
R55
Atrial fibrillation and flutter
Other cardiac arrhythmias
Tachycardia, unspecified
Palpitations
Dizziness and giddiness
Syncope and collapse
CPT Codes
33282
33284
93224
93225
93226
93227
93228
93229
93268
93270
93271
93272
Implantation of patient-activated cardiac event recorder
Removal of an implantable, patient-activated cardiac event recorder
External electrocardiographic recording up to 48 hours by
continuous rhythm recording and storage; includes recording,
scanning analysis with report, review and interpretation by a
physician or other qualified health care professional
External electrocardiographic recording up to 48 hours by
continuous rhythm recording and storage; (includes connection,
recording, and disconnection)
External electrocardiographic recording up to 48 hours by
continuous rhythm recording and storage; (includes scanning
analysis with report)
External electrocardiographic recording up to 48 hours by
continuous rhythm recording and storage; review and interpretation
by a physician or other qualified health care professional
External mobile cardiovascular telemetry with electrocardiographic
recording, concurrent computerized real time data analysis and
greater than 24 hours of accessible ECG data storage (retrievable
with query) with ECG triggered and patient selected events
transmitted to a remote attended surveillance center for up to 30
days; review and interpretation with report interpretation by a
physician or other qualified health care professional
External mobile cardiovascular telemetry with electrocardiographic
recording, concurrent computerized real time data analysis and
greater than 24 hours of accessible ECG data storage (retrievable
with query) with ECG triggered and patient selected events
transmitted to a remote attended surveillance center for up to 30
days; technical support for connection and patient instructions for
use, attended surveillance, analysis and transmission of daily and
emergent data reports as prescribed by a physician or other
qualified health care professional
External patient and, when performed, auto activated
electrocardiographic rhythm derived event recording with symptomrelated memory loop with remote download capability up to 30
days, 24-hour attended monitoring; includes transmission, review
and interpretation by a physician or other qualified health care
professional
External patient and, when performed, auto activated
electrocardiographic rhythm derived event recording (includes
connection, recording and disconnection)
External patient and, when performed, auto activated
electrocardiographic rhythm derived event recording (includes
transmission download and analysis)
External patient and, when performed, auto activated
electrocardiographic rhythm derived event recording with symptomrelated memory loop with remote download capability up to 30
days, 24-hour attended monitoring; transmission and analysis
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93285
93291
93298
Programming device evaluation (in person) with iterative
adjustment of the implantable device to test the function of the
device and select optimal permanent programmed values with
physician analysis, review and report; by a physician or other
qualified health care professional; implantable loop
recorder system
Interrogation device evaluation (in person) with analysis review and
report, includes connection, recording and disconnection per patient
encounter; implantable loop recorder system, including heart
rhythm derived data analysis
Interrogation device evaluation(s), (remote) up to 30 days;
implantable loop recorder system, including analysis of recorded
heart rhythm data, analysis, review(s) and report(s)by a physician
or other qualified health
care professional
HCPCS Codes
C1764
E0616
Event recorder, cardiac (implantable)
Implantable cardiac event recorder with memory, activator and
programmer
Scientific Rationale – Update May 2016
Insertable or implantable cardiac monitors (ICMs) continuously monitor the heart
rhythm and record irregularities over 3 years, enabling the diagnosis of infrequent
rhythm abnormalities associated with syncope and stroke. The enhanced recognition
capabilities of recent ICM models are able to accurately detect atrial fibrillation (AF)
and have led to new applications of ICMs for the detection and monitoring of AF.
Cryptogenic stroke describes stroke without an identifiable cause, specifically a
cardioembolic source, such as a patent foramen ovale or AF. When potential
cardiovascular etiologies have been ruled out during an initial workup consisting of
various imaging studies and ECGs, then it's considered to be a ‘Cryptogenic’ stroke.
Studies on Implantable Cardiac Monitors with Suspected Atrial Fibrillation
After Cryogenic Stroke
Burkowitz et al. (2016) Based on a systematic literature search, two indications were
identified for ICMs for which considerable evidence, including randomized studies,
exists: diagnosing the underlying cardiac cause of unexplained recurrent syncope
and detecting AF in patients after cryptogenic stroke (CS). Three randomized
controlled trials (RCTs) were identified that compared the effectiveness of ICMs in
diagnosing patients with unexplained syncope (n=556) to standard of care. A metaanalysis was conducted in order to generate an overall effect size and confidence
interval of the diagnostic yield of ICMs versus conventional monitoring. In the
indication CS, one RCT and five observational studies were included in order to
assess the performance of ICMs in diagnosing patients with AF (n=1129). Based on
these studies, there is strong evidence that ICMs provide a higher diagnostic yield for
detecting arrhythmias in patients with unexplained syncope and for detection of AF in
patients after CS compared to conventional monitoring. Prolonged monitoring with
ICMs is an effective tool for diagnosing the underlying cardiac cause of unexplained
syncope and for detecting AF in patients with CS. In all RCTs, ICMs have a superior
diagnostic yield compared to conventional monitoring.
Poli et al. (2015) completed a study with the goals to assess if an atrial fibrillation
(AF) risk factor based pre-selection of implantable cardiac monitor (ICM) candidates
would enhance the rate of AF detection and to determine AF risk factors with
significant predictive value for (AF) detection. Seventy-five patients with cryptogenic
IS/TIA were consecutively enrolled if at least one of the following AF risk factors was
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present: a CHA2 DS2 -VASc score ≥4, atrial runs, left atrium (LA) size >45 mm, left
atrial appendage (LAA) flow ≤0.2 m/s, or spontaneous echo contrast in the LAA. The
electrocardiographic and echocardiographic criteria were chosen as they have been
repeatedly reported to predict AF; the same applies for four of the six items of
the CHA2 DS2 -VASc score. The study end-point was the detection of one or more
episodes of AF (≥2 min). Seventy-four patients underwent implantation of an ICM;
one patient had AF at the date of implantation. After 6 months, AF was detected in
21/75 patients (28%), after 12 months in 25/75 patients (33.3%). 92% of AF
episodes were asymptomatic. LA size >45 mm and the presence of atrial runs were
independently associated with AF detection [hazard ratio 3.6 (95% confidence
interval 1.6-8.4), P = 0.002, and 2.7 (1.2-6.7), P = 0.023, respectively]. The
detection rate of AF is one-third after 1 year if candidates for an ICM after
cryptogenic IS/TIA are selected by AF risk factors. LA dilation and atrial runs
independently predict AF.
Thijs et al. (2016) assessed predictors of atrial fibrillation (AF) cryptogenic stroke
(CS) or transient ischemic attack (TIA) patients who received an
implantable cardiac monitor (ICM). The authors studied patients with CS/TIA who
were randomized to ICM within the CRYSTAL AF study. Age, sex, race, body mass
index, type and severity of index ischemic event were assessed. CHADS2 score, PR
interval, and presence of diabetes, hypertension, congestive heart failure, or patent
foramen ovale and premature atrial contractions predicted AF development within
the initial 12 and 36 months of follow-up using Cox proportional hazards models.
Among 221 patients randomized to ICM (age 61.6 ± 11.4 years, 64% male), AF
episodes were detected in 29 patients within 12 months and 42 patients at 36
months. Significant univariate predictors of AF at 12 months included age (hazard
ratio [HR] per decade 2.0 [95% confidence interval 1.4-2.8], p = 0.002), CHADS2
score (HR 1.9 per one point [1.3-2.8], p = 0.008), PR interval (HR 1.3 per 10
milliseconds [1.2-1.4], p < 0.0001), premature atrial contractions (HR 3.9 for
>123 vs 0 [1.3-12.0], p = 0.009 across quartiles), and diabetes (HR 2.3
[1.0-5.2], p < 0.05). In multivariate analysis, age (HR per decade 1.9 [1.3-2.8],
p = 0.0009) and PR interval (HR 1.3 [1.2-1.4], p < 0.0001) remained significant
and together yielded an area under the receiver operating characteristic curve of
0.78 (0.70-0.85). The same predictors were found at 36 months. Increasing age and
a prolonged PR interval at enrollment were independently associated with an
increased AF incidence in CS patients. However, they offered only moderate
predictive ability in determining which CS patients had AF detected by the ICM.
Kitsiou et al. (2016) The embolic stroke of unknown source concept was introduced
as a more rigid analysis of patients with cryptogenic stroke representing a super
selection of patients with cardioembolic stroke. These patients are particularly
candidates for intermittent AF. As long as AF has not been documented, current
concepts do not recommend oral anticoagulation. Implantable loop recorders (ILR) in
patients with ESUS may detect AF and establish the indication for oral
anticoagulation. The aim of this study was to prospectively assess and predict AF
occurrence in patients with ILR after ESUS. In patients with ESUS (MR imaging based
cardioembolic stroke, exclusion of structural cardiac stroke source by TEE, no AF
detectable by 72h Stroke Unit monitoring and 24h holter ECG, exclusion of other
stroke causes such as symptomatic carotid stenosis) an ILR was implanted and AF
detection assessed by daily remote monitoring. The ILR was implanted on average
20 days after stroke. We analyzed the predictive value of different clinical and
imaging characteristics for AF detection. By daily remote monitoring of 124 Patients
over a period of 12.7±5.5 months, AF was documented and manually confirmed in
29 of 124 patients (23.4%). First AF detection occurred on average after 3.6±3.4
months of monitoring. Characteristics of patients with and without AF detection are
Implantable Cardiac Event Monitor May 16
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shown in the table. Patients with ESUS and asymptomatic AF detected only by longterm continuous monitoring with an ILR were on average older, had a higher
CHA2DS2-VASc score and had more often microangiopathy. Other clinical
parameters and features of cerebral imaging in ESUS did not increase the probability
of AF detection in these preselected patients with ESUS. Importantly, ESUS selection
almost doubled AF detection rate compared to recent studies such as the ILR group
of the Crystal-AF trial (23.4% in 12.7±5.5 months compared to 12.4% in 12
months).
Choe et al. (2015) Ischemic stroke cause remains undetermined in 30% of cases,
leading to a diagnosis of cryptogenic stroke. Paroxysmal atrial fibrillation (AF) is a
major cause of ischemic stroke but may go undetected with short periods of ECG
monitoring. The Cryptogenic Stroke and Underlying Atrial Fibrillation trial (CRYSTAL
AF) demonstrated that long-term electrocardiographic monitoring with insertable
cardiac monitors (ICM) is superior to conventional follow-up in detecting AF in the
population with cryptogenic stroke. We evaluated the sensitivity and negative
predictive value (NPV) of various external monitoring techniques within a cryptogenic
stroke cohort. Simulated intermittent monitoring strategies were compared to
continuous rhythm monitoring in 168 ICM patients of the CRYSTAL AF trial. Shortterm monitoring included a single 24-hour, 48-hour, and 7-day Holter and 21-day
and 30-day event recorders. Periodic monitoring consisted of quarterly monitoring
through 24-hour, 48-hour, and 7-day Holters and monthly 24-hour Holters. For a
single monitoring period, the sensitivity for AF diagnosis was lowest with a 24-hour
Holter (1.3%) and highest with a 30-day event recorder (22.8%). The NPV ranged
from 82.3% to 85.6% for all single external monitoring strategies. Quarterly
monitoring with 24-hour Holters had a sensitivity of 3.1%, whereas quarterly 7-day
monitors increased the sensitivity to 20.8%. The NPVs for repetitive periodic
monitoring strategies were similar at 82.6% to 85.3%. Long-term continuous
monitoring was superior in detecting AF compared to all intermittent monitoring
strategies evaluated (p <0.001). Long-term continuous electrocardiographic
monitoring with ICMs is significantly more effective than any of the simulated
intermittent monitoring strategies for identifying AF in patients with previous
cryptogenic stroke.
Atrial fibrillation (AF) can be a cause of previously diagnosed cryptogenic stroke.
However, AF can be paroxysmal and asymptomatic, thereby making detection with
routine ECG methods difficult. Oral anticoagulation is highly effective in reducing
recurrent stroke in patients with AF, but its initiation is dependent on the detection of
AF. Cryptogenic Stroke and Underlying Atrial Fibrillation (CRYSTAL AF) is the first
randomized study to report the detection of AF in cryptogenic stroke patients using
continuous long-term monitoring via insertable cardiac monitors (ICM). Brachman et
al. (2016) completed a clinical trial with identifier of NCT00924638. Patients with
prior cryptogenic stroke were randomized to control (n=220) or ICM (n=221) and
followed for ≤36 months. Cumulative AF detection rates in the ICM arm increased
progressively during this period (3.7%, 8.9%, 12.4%, and 30.0% at 1, 6, 12, and
36 months, respectively), but remained low in the control arm (3.0% at 36 months).
This resulted in oral anticoagulation prescription in 94.7% of ICM patients with AF
detected at 6 months, 96.6% at 12 months, and 90.5% at 36 months. Among ICM
patients with AF detected, the median time to AF detection was 8.4 months, 81.0%
of first AF episodes were asymptomatic, and 94.9% had at least 1 day with >6
minutes of AF. Three-year monitoring by ICM in cryptogenic stroke patients
demonstrated a significantly higher AF detection rate compared with routine care.
Given the frequency of asymptomatic first episodes and the long median time to
detection, these findings highlight the limitations of using traditional AF detection
Implantable Cardiac Event Monitor May 16
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methods. The majority of patients with AF were prescribed oral anticoagulation
therapy.
Afzal et al. (2015) Recent studies have suggested that prolonged outpatient rhythm
monitoring results in increased detection of atrial fibrillation (AF) in patients
with cryptogenic stroke (CS). However, the best monitoring strategy and its
clinical utility is debatable. The goal of this study was to compare the effectiveness of
implantable loop recorder (ILR) versus wearable devices in identifying AF in patients
with CS. Three randomized controlled trials (RCTs) and 13 observational studies
were identified by database searches. Seven studies (enrolling 774 patients)
employed ILR for AF detection for a median duration of 365 days (range 50-569
days). Ten studies (enrolling 996 patients) employed continuous monitoring with
wearable devices for a median duration of 21 days (range 4-30 days). One study
performed 7 days of monitoring with wearable device followed by implantation of
ILR, thus included in both groups. Pooled odds ratio (OR) of identifying AF in RCTs
showed increased detection of AF with prolonged monitoring (OR 4.54, 95%
confidence interval [CI] 2.92, 7.06; P < 0.00001) compared to routine outpatient
follow-up. Overall detection of AF with outpatient monitoring was 17.6% (CI: 12.522.7). There was significantly higher AF detection with ILR (23.3%; CI: 13.83-32.29)
compared to wearable devices (13.6%; CI: 7.91-19.32; P < 0.05). Patients with AF
were older in age compared to patients without AF. AF detection in patients with CS
is improved with prolonged rhythm monitoring and is better with ILR compared to
wearable devices. AF was more common in older patients. The clinical significance of
these findings is unknown at this point.
Ziegler et al. (2015) The characteristics of atrial fibrillation (AF) episodes in
cryptogenic stroke patients have recently been explored in carefully selected
patient populations. However, the incidence of AF among a large, real-world
population of patients with an insertable cardiac monitor (ICM) placed for the
detection of AF following a cryptogenic stroke has not been investigated.
Patients in the Medtronic DiscoveryLink database who received an ICM (Reveal LINQ)
for the purpose of AF detection following a cryptogenic stroke were included. AF
detection rates (episodes ≥2 min) were quantified using Kaplan-Meier survival
estimates at 1 and 6 months and compared to the CRYSTAL AF study at 6 months.
The time to AF detection and maximum duration of AF episodes were also analyzed.
A total of 1,247 patients (age 65.3 ± 13.0 years) were followed for 182 (IQR 182182) days. A total of 1,521 AF episodes were detected in 147 patients, resulting in
AF detection rates of 4.6 and 12.2% at 30 and 182 days, respectively, and
representing a 37% relative increase over that reported in the CRYSTAL AF trial at 6
months. The median time to AF detection was 58 (IQR 11-101) days and the median
duration of the longest detected AF episode was 3.4 (IQR0.4-11.8) h. The real-world
incidence of AF among patients being monitored with an ICM after a cryptogenic
stroke validates the findings of the CRYSTAL AF trial and suggests that continuous
cardiac rhythm monitoring for periods longer than the current guideline
recommendation of 30 days may be warranted in the evaluation of patients with
cryptogenic stroke.
The Reveal LINQ Model LNQ11 was given premarket notification by the U.S. FDA on
August 5, 2015, with the 510K clearance number of K150614. It is a small, leadless
implantable device that is typically implanted under the skin, in the chest. It is an
automatically-activated and patient-activated monitoring system that records
subcutaneous ECG and is indicated in the following cases:

Patients with clinical syndromes or situations at increased risk of cardiac
arrhythmias
Implantable Cardiac Event Monitor May 16
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

Patients who experience transient symptoms such as dizziness, palpitation,
syncope, and chest pain that may suggest a cardiac arrhythmia
The device has not been tested specifically for pediatric use.
Position Statements
Sheldon et al. (2015) The Heart Rhythm Society (HRS), along with the American
Autonomic Society (AAS), the American College of Cardiology (ACC), the American
Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), the
European Heart Rhythm Association (EHRA), the Pediatric and Congenital
Electrophysiology Society (PACES), and the Sociedad Latinoamericana de
Estimulacion Cardiacay Electrofisiologia (SOLAECE) (Latin American Society of
Cardiac Pacing and Electrophysiology), released a consensus statement on the
diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus
tachycardia, and vasovagal syncope. Implantable loop recording (ILR) is
recommended for the assessment of recurrent syncope with unclear origin in older
patients that are at low risk of a fatal outcome (Class IIa evidence*, level of
evidence B-R). In addition, ILR monitoring is considered reasonable if an inheritable
arrhythmia, cardiomyopathy, or severe bradycardia is suggested in the patient’s
clinical history, or if the patient is unresponsive to medical treatment.
*Note: Class IIa evidence- Weight of evidence/opinion is in favor of usefulness
/efficacy. Level of Evidence – B - Limited evidence from single randomized trial or
other nonrandomized studies.
Scientific Rationale – Update May 2015
Regarding implantable recorders, a report of the American College of
Cardiology/American Heart Association Task Force and the European Society of
Cardiology Committee Guideline for Management of Patients with Ventricular
Arrhythmias and the Prevention of Sudden Cardiac Death made the following
recommendations regarding ambulatory electrocardiography (ECG): “Implantable
recorders are useful in patients with sporadic symptoms suspected to be related to
arrhythmias such as syncope when a symptom-rhythm correlation cannot be
established by conventional diagnostic techniques. (Level of Evidence: B).”
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” report:
“Arrhythmia monitoring can be performed with the use of noncontinuous or
continuous ECG monitoring tools. Choice of either method depends on individual
need and consequence of arrhythmia detection. Basically, more intensive monitoring
is associated with a greater likelihood of detecting both symptomatic and
asymptomatic AF. They state further in the guidelines that a four-week autotrigger
event monitor, mobile cardiac outpatient telemetry system, or implantable
subcutaneous monitor may identify less frequent AF.”
Cryptogenic stroke (or stroke of undetermined origin in TOAST terminology) is
defined as brain infarction that is not attributable to a source of definite
cardioembolism, large artery atherosclerosis, or small artery disease despite
extensive vascular, cardiac, and serologic evaluation. Cryptogenic stroke accounts
for 30 to 40 percent of ischemic strokes in most modern stroke registries and
databases.
Per the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial
Fibrillation:Executive Summary, “ Atrial fibrillation (AF) may be described by the
Implantable Cardiac Event Monitor May 16
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duration of the episode. Implanted loop recorders, pacemakers, and
defibrillators offer the possibility of reporting frequency, rate, and duration
of abnormal atrial rhythms, including atrial fibrillation (AF). Episodes often increase
in frequency and duration over time.
Per the American Academy of Neurology, summary of evidence-based guideline
Update on prevention of stroke in nonvalvular atrial fibrillation (2014), “In patients
with recent cryptogenic stroke, cardiac rhythm monitoring probably detects occult
nonvalvular atrial fibrillation (NVAF).” Per the guideline, In patients with recent
cryptogenic stroke, cardiac rhythm monitoring probably detects previously
unidentified NVAF at a rate ranging from 0% to 23% (weighted average of 10.7%
[95% CI 7.9%–14.3%]) (2 Class II studies, 15 Class III studies10,–,24). The
detection rate is probably related to the duration of monitoring.” The guideline notes
further, “Many of the NVAF episodes that are detected are clinically asymptomatic,
and thus monitoring devices with continuous recording or automatic detection
algorithms, rather than patient-triggered recording, are preferred. The risk of
recurrent stroke is uncertain in patients with very brief (e.g., <30 seconds) or very
infrequent episodes of NVAF; however, previous studies have demonstrated that
NVAF tends to occur for progressively longer periods, and the stroke risk in patients
with paroxysmal NVAF is similar to that in patients with persistent NVAF.”
AAN Practice Recommendations include the following:

Clinicians might obtain outpatient cardiac rhythm studies in patients with
cryptogenic stroke without known NVAF, to identify patients with occult NVAF
(Level C).

Clinicians might obtain cardiac rhythm studies for prolonged periods (e.g., for 1
or more weeks) instead of shorter periods (e.g., 24 hours) in patients with
cryptogenic stroke without known NVAF, to increase the yield of identification of
patients with occult NVAF (Level C).
Gladstone et al (2015) reported many ischemic strokes or transient ischemic attacks
are labeled cryptogenic but may have undetected AF. They sought to identify those
most likely to have subclinical AF. The investigators prospectively studied patients
with cryptogenic stroke or transient ischemic attack aged ≥55 years in sinus rhythm,
without known AF, enrolled in the intervention arm of the 30 Day Event Monitoring
Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event (EMBRACE) trial.
Participants underwent baseline 24-hour Holter ECG poststroke; if AF was not
detected, they were randomly assigned to 30-day ECG monitoring with an AF autodetect external loop recorder. Multivariable logistic regression assessed the
association between baseline variables (Holter-detected atrial premature beats
[APBs], runs of atrial tachycardia, age, and left atrial enlargement) and subsequent
AF detection. Among 237 participants, the median baseline Holter APB count/24 h
was 629 (interquartile range, 142-1973) among those who subsequently had AF
detected versus 45 (interquartile range, 14-250) in those without AF (P<0.001). APB
count was the only significant predictor of AF detection by 30-day ECG (P<0.0001),
and at 90 days (P=0.0017) and 2 years (P=0.0027). Compared with the 16% overall
90-day AF detection rate, the probability of AF increased from <9% among patients
with <100 APBs/24 h to 9% to 24% in those with 100 to 499 APBs/24 h, 25% to
37% with 500 to 999 APBs/24 h, 37% to 40% with 1000 to 1499 APBs/24 h, and
40% beyond 1500 APBs/24 h. The authors concluded among older cryptogenic
stroke or transient ischemic attack patients, the number of APBs on a routine 24hour Holter ECG was a strong dose-dependent independent predictor of prevalent
subclinical AF. Those with frequent APBs have a high probability of AF and represent
Implantable Cardiac Event Monitor May 16
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ideal candidates for prolonged ECG monitoring for AF detection. CLINICAL TRIAL
REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00846924.
Sanna et al (2014) states the current guidelines recommend at least 24 hours of
electrocardiographic (ECG) monitoring after an ischemic stroke to rule out AF.
However, the most effective duration and type of monitoring have not been
established, and the cause of ischemic stroke remains uncertain despite a complete
diagnostic evaluation in 20 to 40% of cases (cryptogenic stroke). Detection of AF
after cryptogenic stroke has therapeutic implications. The investigators conducted a
randomized, controlled study of 441 patients to assess whether long-term monitoring
with an insertable cardiac monitor (ICM) is more effective than conventional followup (control) for detecting AF in patients with cryptogenic stroke. Patients 40 years of
age or older with no evidence of AF during at least 24 hours of ECG monitoring
underwent randomization within 90 days after the index event. The primary end
point was the time to first detection of AF (lasting >30 seconds) within 6 months.
Among the secondary end points was the time to first detection of AF within 12
months. Data were analyzed according to the intention-to-treat principle. By 6
months, AF had been detected in 8.9% of patients in the ICM group (19 patients)
versus 1.4% of patients in the control group (3 patients) (hazard ratio, 6.4; 95%
confidence interval [CI], 1.9 to 21.7; P<0.001). By 12 months, AF had been detected
in 12.4% of patients in the ICM group (29 patients) versus 2.0% of patients in the
control group (4 patients) (hazard ratio, 7.3; 95% CI, 2.6 to 20.8; P<0.001). The
investigators concluded ECG monitoring with an ICM was superior to conventional
follow-up for detecting AF after cryptogenic stroke. (Funded by Medtronic; CRYSTAL
AF ClinicalTrials.gov number, NCT00924638.).
Jorfida et al (2014) reported that AF is responsible for up to one-third of ischemic
strokes, and is also associated with silent cerebral infarctions and transient ischemic
attacks (TIAs). The self-terminating and often asymptomatic nature of paroxysmal
atrial fibrillation (PAF) may lead to its under diagnosis. A continuous and long-term
heart rhythm monitoring can be useful in unmasking PAF episodes. Prevalence of
asymptomatic PAF in patients suffering a cryptogenic stroke, at risk for AF but
without any history of arrhythmia or palpitations, using a continuous
electrocardiographic monitoring. One hundred and forty-two consecutive patients
were admitted to the Stroke Unit of ' a single center between June 2010 and March
2013 and discharged with the diagnosis of ischemic cryptogenic stroke. Sixty fulfilled
predefined inclusion criteria. Follow-up was carried on and completed for the 54
patients who consented to implantable loop recorder (ILR) implantation. After ILR
implantation, trans-telephonic data were collected monthly. AF episodes lasting
more than 5min were recorded in 25 patients (46%), median detection time was 5.4
months (range 1-18) and median duration of AF episodes was 20h (range 7min-8
days) with 19 patients (76%) remaining asymptomatic and the others experiencing
weakness and dyspnoea but not palpitations. The authors concluded long-term heart
rhythm monitoring is successful in unmasking silent AF in 46% of patients suffering a
cryptogenic stroke with concomitant atrial fibrillation risk factors, but without history
of arrhythmia or palpitations.
Christensen et al (2014) reported that AF increases the risk of stroke fourfold and is
associated with a poor clinical outcome. Despite work-up in compliance with
guidelines, up to one-third of patients have cryptogenic stroke (CS). The prevalence
of asymptomatic paroxysmal atrial fibrillation (PAF) in CS remains unknown. The
SURPRISE project aimed at determining this rate using long-term cardiac monitoring.
Patients with CS after protocolled work-up including electrocardiography (ECG) and
telemetry were included after informed consent. An implantable loop recorder (ILR)
was implanted subcutaneously. PAF was defined by events of atrial arrhythmia >2
Implantable Cardiac Event Monitor May 16
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min with a correlating one-lead ECG confirming the diagnosis. Eighty-five patients
were monitored for a mean of 569 days (SD ±310). PAF was documented in 18
patients (20.7%) during the study period and detected by ILR in 14 patients
(16.1%). In three patients PAF was detected by other methods before or after
monitoring and was undiscovered due to device sensitivity in one case. The first
event of PAF was documented at a mean of 109 days (SD ±48) after stroke onset.
PAF was asymptomatic in all cases and occurred in episodes lasting predominantly
between 1 and 4 h. Four recurrent strokes were observed, three in patients with
PAF; all three patients were on oral anticoagulation (OAC). The authors concluded
one in five patients with CS had PAF, which occurred at low burden and long after
stroke. Future studies should determine the role of implantable cardiac monitors
after stroke and determine the potential therapeutic benefit of OAC treatment of
patients with PAF.
Cotter et al (2013) investigated the usefulness of the ILR with improved AF detection
capability (Reveal XT) and the factors associated with AF in the setting of
unexplained stroke. A cohort study is reported of 51 patients in whom ILRs were
implanted for the investigation of ischemic stroke for which no cause had been found
(cryptogenic) following appropriate vascular and cardiac imaging and at least 24
hours of cardiac rhythm monitoring. The patients were aged from 17 to 73 (median
52) years. Of the 30 patients with a shunt investigation, 22 had a patent foramen
ovale (73.3%; 95% confidence interval [CI] 56.5%-90.1%). AF was identified in 13
(25.5%; 95% CI 13.1%-37.9%) cases. AF was associated with increasing age (p =
0.018), interatrial conduction block (p = 0.02), left atrial volume (p = 0.025), and
the occurrence of atrial premature contractions on preceding external monitoring (p
= 0.004). The median (range) of monitoring prior to AF detection was 48 (0-154)
days. The authors concluded in patients with unexplained stroke, AF was detected
by ILR in 25.5%. Predictors of AF were identified, which may help to target
investigations. ILRs may have a central role in the future in the investigation of
patients with unexplained stroke.
Rojo-Martinez et al (2013) reported that ILR’s may allow detection of occult
paroxysmal atrial fibrillation (PAF) in patients with cryptogenic ischemic stroke.
However, optimal selection algorithm and ideal duration of monitoring remain
unclear. AIM. To determine the incidence and time-profile of PAF in patients with
cryptogenic ischemic stroke studied with Reveal XT ILR, who were selected based on
a high suspicion of cerebral embolism. Selection criteria include the absence of
stroke etiology after complete study including vascular imaging, transesophageal
echocardiography and at least 24 hours of cardiac rhythm monitoring, and
confirmation of acute embolic occlusion of intracranial artery by transcranial duplex
or characteristics of acute ischemic lesion on neuroimaging suggesting embolic
mechanism of ischemia. After implanting Reveal XT ILR, patients were trained to
perform transmissions monthly or when symptoms occurred. We reviewed the
information online each month and patients underwent clinical visits at 3rd and 6th
month and then every six months. The authors included 101 patients with
cryptogenic ischemic stroke and at least one month of follow-up after ILR implant.
Mean age was 67 years, 54 women (53.5%). Mean follow-up after implantation was
281 ± 212 days. Occult PAF was detected in 34 patients (33.7%). Frequency of false
positives: 22.8%. Median time from implant to arrhythmia detection was 102 days
(range: 26-240 days). 24 (70%) patients with PAF had several arrhythmic episodes
detected with ILR. The majority of events (75%) were detected during the first six
months of monitoring. The authors concluded in their patients with probably embolic
cryptogenic ischemic stroke, PAF was detected by Reveal XT ILR in 33.7%. One in
four events occurred after the first six months of monitoring.
Implantable Cardiac Event Monitor May 16
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Ziegler et al (2012) reported the detection of undiagnosed atrial tachycardia/atrial
fibrillation (AT/AF) among patients with stroke risk factors could be useful for
primary stroke prevention. The authors analyzed newly detected AT/AF (NDAF) using
continuous monitoring in patients with stroke risk factors but without previous stroke
or evidence of AT/AF. NDAF (AT/AF >5 minutes on any day) was determined in
patients with implantable cardiac rhythm devices and ≥1 stroke risk factors
(congestive heart failure, hypertension, age ≥75 years, or diabetes). All devices
were capable of continuously monitoring the daily cumulative time in AT/AF. Of
1,368 eligible patients, NDAF was identified in 416 (30%) during a follow-up of 1.1 ±
0.7 years and was unrelated to the CHADS(2) score (congestive heart failure,
hypertension [blood pressure consistently >140/90 mm Hg or hypertension treated
with medication], age ≥75 years, diabetes mellitus, previous stroke or transient
ischemic attack). The presence of AT/AF >6 hours on ≥1 day increased significantly
with increased CHADS(2) scores and was present in 158 (54%) of 294 patients with
NDAF and a CHADS(2) score of ≥2. NDAF was sporadic, and 78% of patients with a
CHADS(2) score of ≥2 with NDAF experienced AT/AF on <10% of the follow-up days.
The median interval to NDAF detection in these higher risk patients was 72 days
(interquartile range 13 to 177). The authors concluded, continuous monitoring
identified NDAF in 30% of patients with stroke risk factors. In patients with NDAF,
AT/AF occurred sporadically, highlighting the difficulty in detecting paroxysmal AT/AF
using traditional monitoring methods. However, AT/AF also persisted for >6 hours on
≥1 days in most patients with NDAF and multiple stroke risk factors. Whether
patients with CHADS(2) risk factors but without a history of AF might benefit from
implantable monitors for the selection and administration of anticoagulation for
primary stroke prevention merits additional investigation
Dion et al (2010) hypothesized that AF was involved in ischemic stroke but
underdiagnosed by standard methods. They sought to determine the incidence of
AF in cryptogenic ischemic stroke by using continuous monitoring of the heart rate
over several months. The secondary objective was to test the value of atrial
vulnerability assessment in predicting spontaneous AF. The investigators
prospectively enrolled 24 patients under 75 years of age, 15 men and 9 women of
mean age 49 years, who within the last 4 months had experienced cryptogenic
stroke diagnosed by clinical presentation and brain imaging and presumed to be of
cardioembolic mechanism. All causes of stroke were excluded by normal 12-lead
ECG, 24-h Holter monitoring, echocardiography, cervical Doppler, hematological, and
inflammatory tests. All patients underwent electrophysiological study. Of the
patients, 37.5% had latent atrial vulnerability, and 33.3% had inducible sustained
arrhythmia. Patients were secondarily implanted with an implantable loop recorder to
look for spontaneous AF over a mean follow-up interval of 14.5 months. No
sustained arrhythmia was found. Only one patient had non-significant episodes of
AF. The authors concluded, symptomatic AF or AF with fast ventricular rate has not
been demonstrated by the implantable loop recorder in patients under 75 years with
unexplained cerebral ischemia. The use of this device should not be generalized in
the systematic evaluation of these patients. In addition, this study attests that the
assessment of atrial vulnerability is poor at predicting spontaneous arrhythmia in
such patients.
Schlingloff et al (2013) Recent data suggest continuous monitoring by ILR to be the
criterion standard for rhythm surveillance after atrial ablation. Studies describing
patient compliance and pitfalls in the perioperative period are lacking. It was the aim
of this study to evaluate patient compliance and time invested by physicians for
obtaining data during the follow-up period after implanting an ILR. The authors
prospectively collected data of 70 consecutive patients undergoing concomitant
cardiac surgery, atrial ablation, and implantation of an ILR. Patient compliance was
Implantable Cardiac Event Monitor May 16
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calculated as the ratio of incoming/expected data transmission. The authors
documented total time spent by physicians with preoperative and postoperative
supervision. Between February 2012 and February 2013, a total of 70 patients had
an ILR implanted; 49 of 70 patients were eligible for evaluation of data at 3-month
follow-up. The ratio of incoming/expected data transmission was 12/49 (24%). The
mean ± SD time spent with ILR-related issues during hospital stay was 88 ± 19
minutes. Assessment of incoming data and information of the patient and the
general practitioner took 132 ± 13 minutes per patient. Overall, a mean ± SD of 220
± 16 minutes per patient was needed for appropriate data acquisition, from
implantation to first data transmission. The authors concluded in the patients having
an ILR after surgical atrial ablation, initial compliance regarding data transmission
was low. A substantial time effort was necessary to obtain sufficient data on cardiac
rhythm. Device-related complications were observed. Patient selection should
therefore be handled with care. Beneficial therapeutic decisions can be expected only
when reliable data are obtained by efficient management.
Kapa et al (2013) reported arrhythmia monitoring in patients undergoing AF ablation
is challenging. Transtelephonic monitors (TTMs) are cumbersome to use and
provide limited temporal assessment. ILRs may overcome these limitations. The
authors sought to evaluate the utility of ILRs versus conventional monitoring (CM) in
patients undergoing AF ablation. Forty-four patients undergoing AF ablation received
ILRs and CM (30-day TTM at discharge and months 5 and 11 postablation). Over the
initial 6 months, clinical decisions were made based on CM. Subjects were then
randomized for the remaining 6 months to arrhythmia assessment and management
by ILR versus CM. The primary endpoint was arrhythmia recurrence. The secondary
endpoint was actionable clinical events (change of antiarrhythmic drugs [AADs],
anticoagulation, non-AF arrhythmia events, etc.) due to either monitoring strategy.
Over the study period, 6 patients withdrew. In the first 6 months, AF recurred in 18
patients (7 noted by CM, 18 by ILR; P = 0.002). Five patients in the CM (28%) and 5
in the ILR arm (25%; P = NS) had AF recurrence during the latter 6 months. AF was
falsely diagnosed frequently by ILR (730 of 1,421 episodes; 51%). In more patients
in the ILR compared with the CM arm, rate control agents (60% vs 39%, P = 0.02)
and AADs (71% vs 44%, P = 0.04) were discontinued. The authors concluded in AF
ablation patients, ILR can detect more arrhythmias than CM. However, false
detection remains a challenge. With adequate oversight, ILRs may be useful in
monitoring these patients after ablation.
Clinical trials continue to evaluate implantable loop recorders. Numerous trials
were identified on the Clinical trials.gov webpage.
Scientific Rationale – Update May 2014
Per the manufacturer, Medtronic, "The Reveal LINQ Insertable Cardiac Monitoring
System (ICM), also known as an insertable loop recorder (ILR), is designed to help
the doctor quickly diagnose and treat arrhythmias that may be related to
unexplained syncope. The Reveal LINQ ICM is 1cc, the smallest heart monitor on the
market; it automatically detects and records abnormal heart rhythms for up to 3
years; is safe for use in an MRI setting; is placed just under the skin of your chest in
an outpatient procedure; and is not visible in most patients". Medtronic also notes
that The LINQ ICM system has 20% more memory than the Reveal XT ICM,
improved AF algorithms, and provides remote monitoring through the Carelink
Network. This allows physicians to receive alerts about patients who are experiencing
cardiac events. The Reveal LINQ includes the new MyCareLink Patient Monitor, a
monitoring system using global cellular technology to transmit a patient’s diagnostic
data to their clinician from nearly any location in the world.
Implantable Cardiac Event Monitor May 16
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Medtronics has developed and manufactured various types of 'Reveal implantable
cardiac monitors' including the Revel DX and XT Insertable Loop Recorders that have
previously been noted within this policy statement and the scientific rationale.
The Reveal LINQ insertable cardiac monitoring system (ICM) was just FDA approved
with approval number K132649 on February 14, 2014. On the FDA site it states:
Summary of Substantial Equivalence:
The intended use, design, materials and performance of the Reveal LINQ ICM (Model
LNQI I) and Reveal Patient Assistant (Model 9538) are substantially equivalent to the
following predicate devices:

The Reveal XT (Model 9529) and Reveal DX (Model 9528) were initially cleared
via separate 510(k) applications, reference numbers K071641, K071655 on
November 21, 2007. The Reveal XT (Model 9529) and Reveal DX (Model 9528)
most recent modifications submission were cleared via K103764 on May 4, 2011.

Per the FDA site, Medtronic has demonstrated that the Reveal LINQ device
described in this submission result in a substantially equivalent device because
the fundamental scientific principle, operating principle, design features and
intended use are unchanged from the predicate device(s).
Per the FDA: The Reveal LINQ Insertable Cardiac Monitor is an implantable patientactivated and automatically-activated monitoring system that records subcutaneous
ECG and is indicated in the following cases:



Patients with clinical syndromes or situations at increased risk of cardiac
arrhythmias;
Patients who experience transient symptoms such as dizziness, palpitation,
syncope and chest pain that may suggest a cardiac arrhythmia;
The Patient Assistant is intended for unsupervised patient use away from a
hospital or clinic. The Patient Assistant activates the data management features
in the Reveal LINQ ICM to initiate recording of cardiac event data in the
implanted device memory.
Scientific Rationale – Update April 2014
As significant cardiac diseases increase, permanent pacemakers (PPMs), implantable
cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT)
devices are being inserted more frequently. There has also been an expansion in the
indications for cardiac implantable electronic devices (i.e., CIEDs, a term which
includes PPMs, ICDs, and CRT devices, as well as other devices such as implantable
loop recorders and left ventricular assist devices), and device therapy has become
more commonplace.
The S-ICD System (Subcutaneous Implantable Cardioverter Defibrillator) received
U.S. FDA approval on September 28, 2012. It is a defibrillator that is implanted
subcutaneously and provides an electric shock to the heart for the treatment of
ventricular tachyarrhythmias and to reduce the risks of sudden cardiac arrest (SCA)
and sudden cardiac death (SCD). The S-ICD system electrode is inserted under the
skin and implanted outside of the rib cage. The S-ICD System includes an
implantable lead, an implantable pulse generator, a lead insertion tool, and a
programming device that communicates wirelessly with the pulse generator. The
pulse generator is placed in a subcutaneous pocket along the sixth rib in the left
axillary area. When the device detects an arrhythmia, it confirms the finding,
charges, and delivers 1 or more 80-Joule shocks to the heart. Interrogation of the
Implantable Cardiac Event Monitor May 16
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device allows the cardiologist to assess the history of treated and untreated episodes
of ventricular arrhythmias.
Scientific Rationale – Update April 2013
Merlos et al (2013) sought to determine the outcome of patients with syncope of
unknown origin in whom a diagnosis is not reached during the lifetime of the device
in terms of syncope recurrence and survival. An implantable loop recorder (ILR) was
implanted to 97 patients with syncope of unknown origin. Patients were classified in
groups A and B depending on their high or low risk, respectively, of having
arrhythmic syncope. Diagnosis had not been reached in 60 patients (62%) when the
ILR battery reached end operational life. Five patients were lost to follow up. During
a median follow-up of 48 months after ILR explantation (interquartile range 36-56),
22 patients (40%) had recurrence of syncope (32% in group A vs. 48% in group B, P
= 0.3). Syncopes with no neurally mediated profile were more frequent in group A
(18 vs. 0%, P = 0.05) and neurally mediated profile syncopes were more frequent in
group B (44 vs. 11%, P = 0.007). Five patients died, four of them in group A and 1
in group B (P = 0.4). No sudden or cardiac deaths were detected during follow-up.
All deaths were due to non-cardiac causes. Investigators concluded recurrent
syncope is common in patients in whom a diagnosis is not established after the full
battery life of an ILR. The prognosis of these patients seems to be good, without
observed sudden or cardiac death.
Salih et al (2012) reported a single center experience with implantable loop
recorders (ILR), in patients with unexplained syncope. A device (Medtronic Reveal
DX or XT) was implanted in 31 patients between January 2009 and January 2012.
During a mean follow-up of 10.5±8.5 months, loop recording definitively determined
that an arrhythmia was the cause of symptoms in 10 patients (32%). Fourteen
patients (45%) experienced syncope or pre-syncope. In eight of the 14 patients with
syncope, during follow-up, no arrhythmic diagnosis could be made (one patient has
been diagnosed as presenting epilepsy and seven as having hypotensive vasovagal
syncope). In six patients, the ILR showed an arrhythmic etiology. Four other patients
presented an abnormal ILR result without symptoms. Diagnosis included sinusal
arrest in four patients, bradycardia in one patient, advanced atrioventricular block in
two patients, ventricular arrythmias in two patients, and supraventricular tachycardia
of 180/min in one patient. Therapy was instituted in all patients, in whom an
arrhythmic cause was found except one who refused the therapy (six pacemaker,
two implantable cardioverter-defibrillator implantations, and one cryoablation of
atrioventricular nodal reentrant tachycardia confirmed by an invasive exploration).
Authors reported in this survey, implantable loop recorder implantation led to the
diagnosis of an arrhythmic cause in 32% of patients and excluded an arrhythmic
cause in 26% of patient with a mean follow-up of 10.5 months.
Scientific Rationale Update – April 2012
Furukawa et al. (2011) completed a study with the goal to evaluate the effectiveness
and acceptance of remote monitoring in the clinical management of syncope and
palpitations in patients with implantable loop recorders (ILR). Consecutive patients
implanted with ILR (Reveal DX/XT Medtronic, Inc.) and followed up by means of
remote monitoring (CareLink)) were included. The patients were requested to
transmit the data stored in the ILR every week, via the CareLink system, or more
frequently during the first period. Patient acceptance of ILR was evaluated by means
of a questionnaire concerning physical and mental components. Forty-seven patients
(27 males, average age 64 ± 19 years) were enrolled and followed up for 20 ± 13
weeks. Thirty-two patients (68%) had at least one ECG recording of a true relevant
event. The mean time from ILR implantation to the first true relevant ECG was 28 ±
49 days, which was 71 ± 17 days less than in the clinical practice of 3-monthly inImplantable Cardiac Event Monitor May 16
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office follow-up examinations. Thirty-eight patients (81%) had at least one false
arrhythmic event, mainly false asystole and false fast ventricular tachycardia. In the
absence of Carelink transmission, at least one episode of memory saturation of ILR
would have occurred in 21 patients (45%) that would have limited the diagnostic
yield. Patient compliance was good even though one-fifth had some minor
psychological concern regarding the ILR implant. CareLink was well accepted and
judged easy to use. Remote monitoring enhances the diagnostic effectiveness of
Reveal, limiting the risk of memory saturation due to the high number of false
detections and reducing the time to diagnosis. Both ILR and CareLink were well
accepted and well tolerated by the patients, as they were considered useful.
Scientific Rationale – Initial
Most patients with cardiac arrhythmias present with infrequent or episodic
symptoms. These symptoms may include chest pain, palpitations, syncope, and
presyncope. Transtelephonic electrocardiographic event monitors (TTMs) may yield
documentation of the arrhythmia because they are portable and patient activated.
Long –Term ECG Recording (Holter Monitor)
Long-term ECG recording is a very useful method to document and quantitate the
frequency of arrhythmias, correlate the arrhythmia with the patient's symptoms, and
evaluate the effect of antiarrhythmic therapy. There are several different types of
long-term ECG recorders, which detect arrhythmias for a varying length of time. The
Holter monitor is used to record events occurring in 24 (or up to 72) hours.
The American College of Cardiology (ACC), the American Heart Association (AHA),
and the European Society of Cardiology (ESC) guidelines for the management of
patients with supraventricular arrhythmias states, “Ambulatory 24-hour Holter
recording can be used in patients with frequent (i.e., several episodes per week) but
transient tachycardias. An event or wearable loop recorder is often more useful than
a 24-hour recording in patients with less frequent arrhythmias. Implantable loop
recorders may be helpful in selected cases with rare symptoms (i.e., fewer than two
episodes per month) associated with severe symptoms of hemodynamic instability.”
Mobile Cardiovascular Telemetry (MCT) or Mobile Cardiac Outpatient
Telemetry (MCOT)
Biowatch
(2008) Biowatch Medical (Columbia, SC) offers an MCT service called "Vital Signs
Transmitter (VST)", similar to other MCT services. According to the manufacturer,
VST provides continuous, real-time, wireless ambulatory patient monitoring of two
ECG channels plus respiration and temperature. The VST has an integrated
microprocessor and wireless modem to automatically detect and transmit abnormal
ECG waveforms, when activated by the patient or by the monitor’s real-time analysis
software. This is sent to a central monitoring station, where technicians analyze the
tracing. The monitoring center also provides daily reports that can be accessed by
the patient's physician over the Internet. The VST was cleared by the FDA based on
a 510(k) premarket notification.
Cardiac Event Monitors
Event monitors are devices that are used by patients over a longer period (weeks to
months, typically 1 month). The monitor is used when symptoms suggestive of an
arrhythmia occur infrequently. A drawback of this device is that the patient must be
able to press the event button to begin recording.
Implantable Cardiac Event Monitor May 16
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Portable External Loop or Patient-Activated ECG Cardiac Event Monitors
Two general types of portable external loop or patient-activated ECG cardiac event
monitors are available. These “event recorders” are designed with replaceable
electrodes so that patients can be monitored for prolonged periods (typically up to 2
weeks) as they go about their usual activities. These include the following:
1.
Looping memory (presymptom) event monitor. Two electrodes are
attached on the chest. The monitor is always on but stores the patient's rhythm
only when the patient or caregiver pushes the button, when they experience
symptoms (e.g., light-headedness, palpitations, chest discomfort). The saved
ECG includes a continuous rhythm strip just before the button was pressed (e.g.,
45 sec), as well as a recording after the event mark (e.g., 15 sec). The stored
ECGs can be transmitted by phone to an analysis station for immediate
diagnosis.
2.
Postsymptom event monitor. This monitor does not have electrodes that are
attached to the chest. One type is worn on the wrist like a watch. When
symptoms occur, a button is pressed to start the recording. The other type is a
small device that has small metal disks that function as the electrodes. When
symptoms occur, the device is pressed against the chest to start the recording.
There are numerous manufacturers of portable external loop or patient-activated
ECG cardiac event monitors, which can be found on the FDA Center for Devices and
Radiologic Health 510(k) database (FDA, 2009).
Implantable/Insertable Loop Recorder
For patients with very infrequent symptoms, such as once every 6 months, neither
Holter recorders nor 30-day event recorders may yield diagnostic information. In
such patients, implantable loop recorders, about the size of a pack of chewing gum,
are implanted subcutaneously beneath the skin in the upper left chest, with a battery
life of 15-18 months. This device allows continuous rhythm monitoring that is stored
either when manually activated by a patient/parent or automatically when high or
low rate parameters are met. This device was shown to be instrumental in
establishing the diagnosis in patients with infrequent syncope, in whom other
recording devices failed to document the cause of syncope. Examples of implantable
memory loop recorders include the Reveal Insertable Loop Recorder (Medtronic, Inc.,
Minneapolis, MN) which received 510(k) premarket approval from the FDA in
February 2001 as a Class II device, and the Sleuth System (Transoma Medical, Inc.,
Arden Hills, MN) received 510(k) premarket approval from the FDA in October 2007
as a Class II device.
(2006) The American Heart Association (AHA) / American College of Cardiology
(ACC) scientific statement on the evaluation of syncope states: “In patients with
unexplained syncope, use of an ‘Insertable memory loop recorder’ (ILR) for one year
yielded diagnostic information in more than 90% of patients. This approach is more
likely to identify the mechanism of syncope than is a conventional approach that
uses Holter or event monitors and electrophysiological testing”.
Centers for Medicare & Medicaid Services (CMS)
(12/10/2004) The Centers for Medicare & Medicaid Services (CMS) has a national
coverage determination for electrocardiographic (EKG) services (20.15), publication
number 100-3, which states that an implantable or insertable loop recorder (ILR) is
another type of pre-symptom memory loop recorder (MLR), that is implanted
subcutaneously in a patient’s upper left chest and may remain implanted for many
months. An ILR is used when syncope is thought to be cardiac-related, but is too
Implantable Cardiac Event Monitor May 16
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infrequent to be detected by either a Holter Monitor or a traditional pre-symptom
MLR.
Studies
Moya et al. (2008) completed the ‘International Study on Syncope of Uncertain
Origin –2’, that included > 2 events recorded by implantable loop recorders.
The objective of this study was to analyse the reproducibility of the ECG findings
recorded with implantable loop recorders in 41 patients with suspected neurallymediated syncope. The ECG obtained with the first documented syncope (index
syncope) was compared with other recorded events. Twenty-two patients had >2
syncope episodes, and their ECGs were reproducible in 21 (95%): 15 with sinus
rhythm, 5 with asystole, and 1 with ventricular tachycardia; 1 had asystole at first
syncope and sinus rhythm at recurrent syncope. In 32 patients with nonsyncopal
episodes, an arrhythmia was documented in 9, and all of them had the same
arrhythmia during the index syncope (100% reproducibility); conversely, when sinus
rhythm was documented (23 patients) during nonsyncopal episodes, an arrhythmia
was still documented in 6 during the index syncope (70% reproducibility; p =
0.0004). In conclusion, the ECG findings during the first syncope are highly
reproducible in subsequent syncopes. The presence of an arrhythmia during
nonsyncopal episodes is also highly predictive of the mechanism of syncope, but the
presence of sinus rhythm does not rule out the possibility of arrhythmia during
syncope. Therefore the finding of an arrhythmia during a nonsyncopal episode allows
the etiologic diagnosis of syncope, and eventually to anticipate treatment, without
waiting for syncope.
Brignole et al. (2006) performed a prospective multicentre observational study to
assess the efficacy of specific therapy based on implantable loop recorder (ILR)
diagnostic observations in patients with recurrent suspected neurally mediated
syncope (NMS). Patients with >3 clinically severe syncopal episodes in the last 2
years without significant electrocardiographic and cardiac abnormalities were
included. Orthostatic hypotension and carotid sinus syncope were excluded. After ILR
implantation, patients were followed until the first documented syncope (Phase I).
The ILR documentation of this episode determined the subsequent therapy and
commenced Phase II follow-up. Among 392 patients, the 1-year recurrence rate of
syncope during Phase I was 33%. One hundred and three patients had a
documented episode and entered Phase II: 53 patients received specific therapy [47
a pacemaker because of asystole of a median 11.5 s duration and six antitachyarrhythmia therapy (catheter ablation: four, implantable defibrillator: one, antiarrhythmic drug: one)] and the remaining 50 patients did not receive specific
therapy. The 1-year recurrence rate in 53 patients assigned to a specific therapy was
10% (burden 0.07 +/- 0.2 episodes per patient/year) compared with 41% (burden
0.83 +/- 1.57 episodes per patient/year) in the patients without specific therapy
(80% relative risk reduction for patients, P = 0.002, and 92% for burden, P =
0.002). The 1-year recurrence rate in patients with pacemakers was 5% (burden
0.05 +/- 0.15 episodes per patient/year). Severe trauma secondary to syncope
relapse occurred in 2% and mild trauma in 4% of the patients. A strategy based on
early diagnostic ILR application, with therapy delayed until documentation of syncope
allows a safe, specific, and effective therapy in patients with neurally mediated
syncope (NMS).
Implantable Cardiac Event Monitor May 16
19
Review History
November 2009
April 2011
April 2012
April 2013
April 2014
May 2014
May 2015
May 2016
Medical Advisory Council Initial Approval
Update. Added Medicare Table with link to NCD, Article and
decision memo. No Revisions. Added 2011 CPT Code revisions.
Update. No revisions.
Update – no revisions. Code updates
Update – no revisions. Code updates
Update - Added Reveal LINQ Insertable Cardiac Monitor (ICM)
as medically necessary. Code updates.
Update - Added as investigational, implantable loop recorder
cardiac event monitors to evaluate individuals following
cryptogenic stroke.
Update – Added implantable cardiac event monitor as medically
necessary to be used on a case by case basis only in a small
subset of individuals with severely significant and suspected
paroxysmal atrial fibrillation as a cause of cryptogenic stroke
when other less invasive diagnostic modalities (eg, external
ambulatory event monitors or Holter monitors) have been used
with inconclusive results. Codes reviewed.
This policy is based on the following evidence-based guidelines:
1.
2.
3.
4.
5.
6.
Calkins H, Brugada J, Packer DL, et al. European Heart Rhythm Association
(EHRA); European Cardiac Arrhythmia Society (ECAS); American College of
Cardiology (ACC); American Heart Association (AHA); Society of Thoracic
Surgeons (STS). HRS/EHRA/ECAS expert Consensus Statement on catheter and
surgical ablation of atrial fibrillation: recommendations for personnel, policy,
procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task
Force on catheter and surgical ablation of atrial fibrillation. Heart Rhythm.
2007;4 (6):816-861. Available at: http://www.or-live.com/hrs/2216/HR-andEuro-AF-Consensus-Stmt.pdf.
Cardiac arrhythmias. Washington (DC): American College of Cardiology (ACC);
2007
Zipes DP, Camm AJ, Borggrefe M, et al. ACC/AHA/ESC 2006 guidelines for
management of patients with ventricular arrhythmias and the prevention of
sudden cardiac death: a report of the American College of Cardiology/American
Heart Association Task Force and the European Society of Cardiology Committee
for Practice Guidelines (Writing Committee to develop guidelines for
management of patients with ventricular arrhythmias and the prevention of
sudden cardiac death). Circ. 2006; 114:1088-1132. Available at:
http://circ.ahajournals.org/cgi/reprint/114/10/e385.
Blomström-Lundqvist C, Scheinman MM, Aliot EM, et al. ACC/AHA/ESC
guidelines for the management of patients with supraventricular arrhythmias-executive summary: a report of the American College of Cardiology/American
Heart Association Task Force on Practice Guidelines and the European Society of
Cardiology Committee for Practice Guidelines (Writing Committee to Develop
Guidelines for the Management of Patients With Supraventricular Arrhythmias).
Circulation. 2003 Oct 14;108(15):1871-909.
Tracy C, Epstein A, Darbar D, et al. 2012 ACCF/AHA/HRS Focused Update
Incorporated Into the ACCF/AHA/HRS 2008 Guidelines for Device-Based Therapy
of Cardiac Rhythm Abnormalities: A Report of the American College of
Cardiology Foundation/American Heart Association Task Force on Practice
Guidelines and the Heart Rhythm Society. Available at:
http://content.onlinejacc.org/article.aspx?articleid=1486116
Roger VL, Go AS, Lloyd-Jones DM, et al.; American Heart Association Statistics
Committee and Stroke Statistics Subcommittee. Heart disease and stroke
Implantable Cardiac Event Monitor May 16
20
7.
8.
9.
10.
11.
12.
13.
14.
15.
statistics--2012 update: a report from the American Heart Association
[correction appears in Circulation. 2012;125(22):e1002]. Circulation.
2012;125(1):e2-e220.
Hayes. Health Technology Brief. S-ICD (Subcutaneous Implantable Cardioverter
Defibrillator; Boston Scientific Corp.) for Prevention of Sudden Cardiac Death.
December 6, 2013.
Hayes Prognosis. Reveal LINQ Leadless Miniaturized Insertable Cardiac Monitor.
April 2014.
Hayes Search and Summary. Implantable Cardiac Loop Recorders for Syncope.
March 2015.
Hayes Health Technology Brief. Implantable Cardiac Loop Recorders for
Detection of Atrial Fibrillation Following Cryptogenic Stroke. February 2015.
Updated January 27, 2016.
Heart Rhythm Society. Technologies for Arrhythmia Diagnosis/Management.
January CT, Wann LS, Alpert JS, et al.; ACC/AHA Task Force Members. 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. 2014;130(23):2071-2104. Available at:
http://circ.ahajournals.org/content/early/2014/04/10/CIR.0000000000000040.l
ong
Culebras A, Messé SR. Summary of evidence-based guideline update:
Prevention of stroke in nonvalvular atrial fibrillation: Report of the Guideline
Development Subcommittee of the American Academy of Neurology. Neurology.
2014 Sep 23;83(13):1220. Available at:
http://www.neurology.org/content/82/8/716.full
Hayes. Medical Technology Directory. Implantable Cardiac Loop Recorders for
Diagnosis and Management of Syncope in Adults. March 10, 2016.
Albers GW, Bernstein RA, Brachmann A, et al. Heart Rhythm Monitoring
Strategies for Cryptogenic Stroke: 2015 Diagnostics and Monitoring Stroke Focus
Group Report. Journal of the American Heart Association. Available at:
http://jaha.ahajournals.org/content/5/3/e002944.full#sec-3
References – Update May 2016
1.
2.
3.
4.
5.
6.
Afzal MR, Gunda S, Waheed S, et al. Role of Outpatient Cardiac Rhythm
Monitoring in Cryptogenic Stroke: A Systematic Review and Meta-Analysis.
Pacing Clin Electrophysiol. 2015 Oct;38(10):1236-45. Epub 2015, Aug 27.
Brachman Brachmann J, Morillo CA, Sanna T, et al. 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. 2016 Jan;9(1):e003333.
Burkowitz J, Merzenich C, Grassme K, et al. Insertable cardiac monitors in the
diagnosis of syncope and the detection of atrial fibrillation: a systematic review
and meta-analysis. Eur J Prev Cardiol. 2016. Epub ahead of print. February 10,
2016. Available at: http://www.ncbi.nlm.nih.gov/pubmed/26864396.
Choe WC, Passman RS, Brachmann J, et al. A Comparison of Atrial Fibrillation
Monitoring Strategies After Cryptogenic Stroke (from the Cryptogenic Stroke and
Underlying AF Trial). Am J Cardiol. 2015. Sep 15;116(6):889-93. doi:
10.1016/j.amjcard.2015.06.012. Epub 2015 Jun 24.
Gladstone DJ, Dorian P, Spring M, et al. Atrial premature beats predict atrial
fibrillation in cryptogenic stroke: results from the EMBRACE trial. Stroke. 2015;
46(4):936-941.
Kitsiou A, Kalyani M, Ejanjue LE, et al. Atrial Fibrillation Detection in Patients
With an Implantable Loop Recorder After Acute Embolic Stroke of Unknown
Source (ESUS). Stroke. American Heart association. 2016.
Implantable Cardiac Event Monitor May 16
21
7.
8.
9.
10.
11.
12.
13.
Pürerfellner H. Sanders P, Pokushalov E, et al. Miniaturized Reveal LINQ
insertable cardiac monitoring system: First-in-human experience. Heart Rhythm.
2015 Jun;12(6):1113-9. doi: 10.1016/j.hrthm.2015.02.030. Epub 2015 Feb 26.
Poli S, Diedler J, Härtig F, et al. Insertable cardiac monitors after cryptogenic
stroke - a risk factor based approach to enhance the detection rate for
paroxysmal atrial fibrillation. Eur J Neurol. 2016 Feb;23(2):375-81. doi:
10.1111/ene.12843. Epub 2015 Oct 16.
Sheldon RS, Grubb BP II, Olshansky B, et al. 2015 heart rhythm society expert
consensus statement on the diagnosis and treatment of postural tachycardia
syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart
Rhythm. 2015;12(6):e41-e63.
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. 2015 Apr;14(4):377-87. Epub 2015 Mar 4.
Thijs VN, Brachmann J, Morillo CA, et al. Predictors for atrial fibrillation
detection after cryptogenic stroke: Results from CRYSTAL AF. Neurology. 2016
Jan 19;86(3):261-9. Epub 2015 Dec 18.
U.S. FDA. Reveal LINQ Insertable Cardiac Monitor (Model LNQ11). August 6,
2015. Available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf15/k150614.pdf
Ziegler PD, Rogers JD, Ferreira SW, et al. Real-World Experience with Insertable
Cardiac Monitors to Find Atrial Fibrillation in Cryptogenic Stroke. Cerebrovascular
Dis. 2015;40(3-4):175-81. Epub 2015 Aug 28.
References – Update May 2015
1.
Amara W, Sileu N, Salih H, et al. Long term results of implantable loop recorder
in patients with syncope: results of a French survey. Ann Cardiol Angeiol
(Paris). 2014 Nov;63(5):327-30.
2. Andrade JG, Field T, Khairy P. Detection of occult atrial fibrillation in patients
with embolic stroke of uncertain source: a work in progress. Front Physiol. 2015
Apr 1;6:100.
3. Bartoletti A, Bocconcelli P, De Santo T, et al. Implantable loop recorders for
assessment of syncope: increased diagnostic yield and less adverse outcomes
with the latest generation devices. Minerva Med. 2013 Aug;104(4):421-9.
4. Christensen LM, Krieger DW, Højberg S, et al. Paroxysmal atrial fibrillation
occurs often in cryptogenic ischaemic stroke. Final results from the SURPRISE
study. Eur J Neurol. 2014 Jun;21(6):884-9.
5. Cotter PE, Martin PJ, Ring L, et al. Incidence of atrial fibrillation detected by
implantable loop recorders in unexplained stroke. Neurology. 2013 Apr
23;80(17):1546-50
6. Dion F, Saudeau D, Bonnaud I,, et al. Unexpected low prevalence of atrial
fibrillation in cryptogenic ischemic stroke: a prospective study. J Interv Card
Electrophysiol. 2010 Aug;28(2):101-7.
7. 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. 2014
Oct;37(10):618-25.
8. Gladstone DJ, Dorian P, Spring M, et al. Atrial Premature Beats Predict Atrial
Fibrillation in Cryptogenic Stroke: Results From the EMBRACE Trial. Stroke.
2015 Apr;46(4):936-41
9. Houmsse M, Ishola A, Daoud EG. Clinical utility of implantable loop recorders.
Postgrad Med. 2014 Mar;126(2):30-7
10. Jorfida M, Antolini M, Cerrato E, et al. Cryptogenic ischemic stroke and
prevalence of asymptomatic atrial fibrillation: a prospective study. J Cardiovasc
Med (Hagerstown). 2014 Nov 15
Implantable Cardiac Event Monitor May 16
22
11. 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. 2013 Aug;24(8):875-81
12. Lilli A1, Di Cori A. The cold facts of long-term ECG monitoring. Expert Rev
Cardiovasc Ther. 2015 Feb;13(2):125-7
13. Martínez P, Pilar Sáez M, Rubio JA, et al. Experience with the use of an
implantable loop recorder in a series of older people with falls and suspected
arrhythmic syncopes]. Rev Esp Geriatr Gerontol. 2014 May-Jun;49(3):121-4.
14. 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. 2014 Oct;107(10):54652.
15. Rojo-Martinez E, Sandín-Fuentes M, Calleja-Sanz AI, et al. High performance of
an implantable Holter monitor in the detection of concealed paroxysmal atrial
fibrillation in patients with cryptogenic stroke and a suspected embolic
mechanism. Rev Neurol. 2013 Sep 16;57(6):251-7.
16. Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying
atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86
17. Schlingloff F, Oberhoffer MM, Quasdorff I, et al. Implantable loop recorders after
atrial ablation: patient compliance and data surveillance in clinical practice.
Innovations (Phila). 2013 Sep-Oct;8(5):337-40
18. Sciaraffia E, Chen J, Hocini M, et al. Use of event recorders and loop recorders
in clinical practice: results of the European Heart Rhythm Association Survey.
Europace. 2014 Sep;16(9):1384-6
19. Somlói M, Toldy-Schedel E, Nényei Z, et al. Role of implantable loop recorder in
the clinical diagnosis of syncope: Results of the introduction of an effective
diagnostic tool] Orv Hetil. 2015 Apr 1;156(15):609-13
20. Ziegler PD, Glotzer TV, Daoud EG, et al. Detection of previously undiagnosed
atrial fibrillation in patients with stroke risk factors and usefulness of continuous
monitoring in primary stroke prevention. Am J Cardiol. 2012 Nov
1;110(9):1309-14
References – Update May 2014
1.
2.
Medtronic. Insertable Cardiac Monitors (ICM). February 19, 2014. Available at:
http://www.medtronic.com/patients/fainting/device/our-insertable-cardiacmonitors/reveal-linq-icm/index.htm
U.S. FDA. 510K Summary. Reveal LINQ Insertable Cardiac Monitor. K132649.
February 14, 2014. Available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf13/k132649.pdf
References – Update April 2014
1.
2.
3.
4.
2.
Akerström F, Arias MA, Pachón M, et al. Subcutaneous implantable defibrillator:
State-of-the art 2013. World J Cardiol. 2013;5(9):347-354. Available at:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3783987
Ganz LI, Hayes DL. Cardiac implantable electronic devices: Patient follow-up.
UpToDate. February 13, 2014.
Guédon-Moreau L, Lacroix D, Sadoul N, et al. A randomized study of remote
follow-up of implantable cardioverter defibrillators: safety and efficacy report of
the ECOST trial. Eur Heart J 2013; 34:605
Pettit SJ, McLean A, Colquhoun I, Connelly D, McLeod K. Clinical experience of
subcutaneous and transvenous implantable cardioverter defibrillators in children
and teenagers. Pacing Clin Electrophysiol. Epub ahead of print. September 13,
2013.
Podrid PJ. Ambulatory monitoring in the assessment of cardiac arrhythmias.
UpToDate. November 27, 2013.
Implantable Cardiac Event Monitor May 16
23
3.
4.
U.S. FDA. Medical Devices. S-ICD System (Subcutaneous Implantable
Cardioverter Defibrillator). 1/17/2004. Available at:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceAppro
valsandClearances/Recently-ApprovedDevices/ucm326541.htm
Weiss R, Knight BP, Gold MR, et al. Safety and efficacy of a totally subcutaneous
implantable-cardioverter defibrillator. Circulation. 2013;128(9):944-953.
References – Update April 2013
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7.
Bovin A, Malczynski J, Dalsgaard D. Implantable loop recorder is an effective
diagnostic tool for unexplained syncope. Dan Med J. 2012 Oct;59(10):A4518.
Cronin EM, Ching EA, Varma N, et al. Remote monitoring of cardiovascular
devices: a time and activity analysis. Heart Rhythm. 2012 Dec;9(12):1947-51
Hong P, Sulke N. Implantable diagnostic monitors in the early assessment of
syncope and collapse. Prog Cardiovasc Dis. 2013 Jan;55(4):410-7.
Kadmon E, Menachemi D, Kusniec J, et al. Clinical experience of two Israeli
medical centers with the implantable loop recorder in patients with syncope:
from diagnosis to treatment. Isr Med Assoc J. 2012 Aug;14(8):488-92.
Kristjánsdóttir I, Reimarsdóttir G, Arnar DO. The usefullness of implantable loop
recorders for evaluation of unexplained syncope and palpitations. Laeknabladid.
2012 Sep;98(9):465-8.
Merlos P, Rumiz E, Ruiz-Granell R, Martínez Á, et al. Outcome of patients with
syncope beyond the implantable loop recorder. Europace. 2013 Jan;15(1):1226.
Salih H, Monsel F, Sergent J, Amara W. Long-term follow-up after implantable
loop recorder in patients with syncope: results of a French general hospital
survey. Ann Cardiol Angeiol (Paris). 2012 Nov;61(5):331-7.
References Update – April 2012
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2.
3.
Furukawa T, Maggi R, Bertolone C, et al. Effectiveness of remote monitoring in
the management of syncope and palpitations. Europace. 2011 Mar;13(3):431-7.
Epub 2011 Jan 17.
Jung W, Zvereva V, Rillig A, et al. How to use implantable loop recorders in
clinical trials and hybrid therapy. J Interv Card Electrophysiol. 2011
Dec;32(3):227-32. Epub 2011 Oct 13.
Paruchuri V, Adhaduk M, Garikipati NV, Clinical utility of a novel wireless
implantable loop recorder in the evaluation of patients with unexplained
syncope. Heart Rhythm. 2011 Jun;8(6):858-63. Epub 2011 Feb 2.
References Update – April 2011
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Paruchuri V, Adhaduk M, Garikipati NV, et al. Clinical Utility of a Novel Wireless
Implantable Loop Recorder in the Evaluation of Patients with Unexplained
Syncope. Heart Rhythm. 2011 Feb 2. Edvardsson N, Frykman V, van Mechelen
R, et al. Use of an implantable loop recorder to increase the diagnostic yield in
unexplained syncope: results from the PICTURE registry. Europace. 2011
Feb;13(2):262-9. Epub 2010 Nov 19.
Santilli RA, Ferasin L, Voghera SG, et al. Evaluation of the diagnostic value of an
implantable loop recorder in dogs with unexplained syncope. J Am Vet Med
Assoc. 2010 Jan 1;236(1):78-82.
Thomsen PE, Jons C, Raatikainen MJ, et al. Cardiac Arrhythmias and Risk
Stratification After Acute Myocardial Infarction (CARISMA) Study Group. Longterm recording of cardiac arrhythmias with an implantable cardiac monitor in
patients with reduced ejection fraction after acute myocardial infarction: The
Cardiac Arrhythmias and Risk Stratification After Acute Myocardial Infarction
(CARISMA) study. Circulation. 2010;122(13):1258-1264.
Implantable Cardiac Event Monitor May 16
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findings in patients with suspected reflex neurally-mediated syncope. Am J
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Medtronic. Reveal Plus ILR. 2008. Available at: www.medtronic.com. Plus ILR,
available at: www.fainting.com or www.seizuresandfainting.com.
Agency for Healthcare Research and Quality (AHRQ). Remote cardiac monitoring.
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Pierre B, Laurent F, Guillaume B, et al. Implantable loop recorder for recurrent
syncope: influence of cardiac conduction abnormalities showing up on resting
electrocardiogram and of underlying cardiac disease on follow-up developments.
Europace, March 5, 2008.
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Ausiello D, editors. Goldman: Cecil Medicine. 23rd ed. Philadelphia, PA: Elsevier
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Saarel EV, Doratotaj S, Sterba R. Initial experience with novel mobile cardiac
outpatient telemetry for children and adolescents with suspected arrhythmia.
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Tayal AH, Tian M, Kelly KM, et al. Atrial fibrillation detected by mobile cardiac
outpatient telemetry in cryptogenic TIA or stroke. Neurology. 2008 Nov
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monitoring system is user-friendly and effective for identifying cardiac
arrhythmias. 2008.
LifeWatch, Inc. LifeStar ACT Ambulatory Cardiac Telemetry. Rosemount, IL:
LifeWatch; 2007.
Giada F, Gulizia M, Francese M, et al. Recurrent unexplained palpitations (RUP)
study comparison of implantable loop recorder versus conventional diagnostic
strategy. J Am Coll Cardiol. 2007;49(19):1951-1956.
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. 2007;18(3):241-247.
Naccarelli GV. Ambulatory electrocardiographic monitoring: Has mobile cardiac
outpatient telemetry changed the playing field? J Cardiovasc Electrophysiol.
2007;18(3):248-249.
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. 2007;18(5):473477.
Implantable Cardiac Event Monitor May 16
25
19. Deharo JC, Jego C, Lanteaume A, et al. An implantable loop recorder study of
highly symptomatic vasovagal patients. J Am Coll Cardiol. 2006;47:587-593.
20. Farwell DJ, Freemantle N, Sulke N. The clinical impact of implantable loop
recorders in patients with syncope. Eur Heart J. 2006 Feb;27(3):351-6.
21. Brignole M, Sutton R, Menozzi C, et al. Early application of an implantable loop
recorder allows effective specific therapy in patients with recurrent suspected
neurally mediated syncope. Eur Heart J. 2006 May;27(9):1085-92. Epub 2006
Mar 28.
22. Strickberger SA, Benson DW, Biaggioni I, et al. AHA/ACCF Scientific Statement
on the Evaluation of Syncope: From the American Heart Association Councils and
the American College of Cardiology Foundation: In collaboration with the Heart
Rhythm Society. Circulation. January 17, 2006;113(2):316-327.
23. Goldberger: Clinical Electrocardiography: A Simplified Approach, 7th ed. 2006,
CARDIAC MONITORS AND MONITOR LEADS
24. Schwartzman D, Blagev DP, Brown ML, et al. Electrocardiographic events
preceding onset of atrial fibrillation: Insights gained using an implantable loop
recorder. J Cardiovasc Electrophysiol. 2006; 17 (3): 243-246.
25. Vogin G. Implantable Loop Recorders Successful for Diagnosing Syncope,
Presyncope. Medscape Medical News. May 10, 2005.
26. Brignole M, Alboni P, Benditt DG, et al. Guidelines on management (diagnosis
and treatment) of syncope, update 2004. Europace. November 2004;6(6):467537.
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(EKG) Services (20.15). Publication Number 100-3. 12/10/2004.
29. Saarel EV, Stefanelli CB, Fischbach PS, et al: Transtelephonic
electrocardiographic monitors for evaluation of children and adolescents with
suspected arrhythmias. Pediatrics 2004; 113:248-251.
30. Rossano J, Bloemers B, Sreeram N, et al: Efficacy of implantable loop recorders
in establishing symptom-rhythm correlation in young patients with syncope and
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31. Brinole M, Sutton R, Menozzi C, et al. International Study on Syncope of
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321.
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The Policies do not include
definitions. All terms are defined by Health Net. For information regarding the definitions of terms used
in the Policies, contact your provider representative.
Policy Amendment without Notice.
Health Net reserves the right to amend the Policies without notice to providers or Members.
states, prior notice or website posting is required before an amendment is deemed effective.
In some
No Medical Advice.
The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to
members. Members should consult with their treating physician in connection with diagnosis and
treatment decisions.
No Authorization or Guarantee of Coverage.
The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service
or supply. Members and providers should refer to the Member contract to determine if exclusions,
limitations, and dollar caps apply to a particular procedure, drug, service or supply.
Policy Limitation: Member’s Contract Controls Coverage Determinations.
Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize,
modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary
depending on individual need and the benefits covered under your contract. The determination of
coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is
subject to the facts of the individual clinical case, terms and conditions of the member’s contract, and
requirements of applicable laws and regulations. The contract language contains specific terms and
conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and
other relevant terms and conditions of coverage. In the event the Member’s contract (also known as the
benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member’s
contract shall govern. The Policies do not replace or amend the Member’s contract.
Policy Limitation: Legal and Regulatory Mandates and Requirements
The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable
legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal
mandates and regulatory requirements, the requirements of law and regulation shall govern.
Reconstructive Surgery
CA Health and Safety Code 1367.63 requires health care service plans to cover reconstructive surgery.
“Reconstructive surgery” means surgery performed to correct or repair abnormal structures of the body
caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do
either of the following:
(1) To improve function or
(2) To create a normal appearance, to the extent possible.
Reconstructive surgery does not mean “cosmetic surgery," which is surgery performed to alter or reshape
normal structures of the body in order to improve appearance.
Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal
improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by
physicians specializing in reconstructive surgery.
Reconstructive Surgery after Mastectomy
California Health and Safety Code 1367.6 requires treatment for breast cancer to cover prosthetic devices
or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy.
Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or
deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and
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conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for
medically necessary reasons, as determined by a licensed physician and surgeon.
Policy Limitations: Medicare and Medicaid
Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and
determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid
members shall not be construed to apply to any other Health Net plans and members. The Policies shall
not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation.
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