National Medical Policy

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1 National Medical Policy Subject: Policy Number: Implantable Cardiac Event Monitors NMP495 Effective Date*: November 2009 Update: May 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for coverage guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Electrocardiographic Services (20.15): National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* X Other Decision Memo for Electrocardiographic Services: dver=2&ncaname=electrocardiographic+servic es&ispopup=y&bc=aaaaaaaaeaaa& None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) Implantable Cardiac Event Monitor May 15 1

2 If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. 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 cardiac event monitors (i.e., FDA approved Reveal Insertable Loop Recorders, including Reveal XT, DX and LINQ) 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 both of the following criteria are met: 1. A cardiac arrhythmia is suspected as the cause of the symptoms; and 2. A prior trial of Holter Monitor and other external ambulatory event monitors have been unsuccessful in determining a definitive diagnosis, or a diagnostic ECG. 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. Investigational Health Net, Inc. considers the use of implantable loop recorder cardiac event monitors (i.e., FDA approved Reveal Insertable Loop Recorders, including Reveal XT, DX and LINQ) for detection of atrial fibrillation following cryptogenic stroke investigational. Peer review literature is limited and although the prevention of recurrent strokes in patients with cryptogenic stroke is feasible through enhanced detection provided by ICM, additional randomized trials are needed to assess whether the information yielded by ILR monitoring improves clinical management and influences the rate of secondary stroke and overall morbidity and mortality in patients who have experienced a cryptogenic stroke. In addition, the patient population most likely to benefit from monitoring needs to be better defined. Definitions ICD Implantable cardioverter defibrillator CIED Cardiac implantable electronic devices AECG Ambulatory electrocardiography ECG/EKG Electrocardiogram AHRQ Agency for Healthcare Research and Quality ACC American College of Cardiology AHA American Heart Association ILR Insertable memory loop recorder TEE Transesophageal echocardiography ESC European Society of Cardiology Committee MCOT Mobile Cardiac Outpatient Telemetry MCT Mobile cardiovascular telemetry EPS Electrophysiology studies PPM Permanent pacemakers CRT Cardiac resynchronization therapy Implantable Cardiac Event Monitor May 15 2

3 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 will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date. ICD-9 Codes 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 Angina pectoris I21.01-I21.4 ST elevation (STEMI) and non-st elevation (NSTEMI) myocardial infarction I25.5 Ischemic cardiomyopathy I25.89 Other forms of chronic ischemic heart disease I25.9 Chronic ischemic heart disease, unspecified I42.5 Other restrictive cardiomyopathy I42.8 Other cardiomyopathies I44.0-I44.7 Atrioventricular and left bundle-branch block I45.0-I45.9 Other conduction disorders I47.0-I47.9 Paroxysmal tachycardia I47.0-I47.9 Paroxysmal tachycardia I48.0-I48.9 Atrial fibrillation and flutter I49.0-I49.9 Other cardiac arrhythmias R00.0 Tachycardia, unspecified R00.2 Palpitations R42 Dizziness and giddiness R55 Syncope and collapse Implantable Cardiac Event Monitor May 15 3

4 CPT Codes 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 symptom-related 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 symptom-related memory loop with remote download capability up to 30 days, 24-hour attended monitoring; transmission and analysis Implantable Cardiac Event Monitor May 15 4

5 93285 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 Event recorder, cardiac (implantable) E0616 Implantable cardiac event recorder with memory, activator and programmer 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) 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 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. Implantable Cardiac Event Monitor May 15 5

6 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, ) among those who subsequently had AF detected versus 45 (interquartile range, ) 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 24- hour 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 ideal candidates for prolonged ECG monitoring for AF detection. CLINICAL TRIAL REGISTRATION: URL: Unique identifier: NCT Sanna et al (2014) states the current guidelines recommend at least 24 hours of Implantable Cardiac Event Monitor May 15 6

7 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, NCT ). 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 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 Implantable Cardiac Event Monitor May 15 7

8 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: 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. 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 Implantable Cardiac Event Monitor May 15 8

9 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 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 Implantable Cardiac Event Monitor May 15 9

10 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. 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. Implantable Cardiac Event Monitor May 15 10

11 The Reveal LINQ insertable cardiac monitoring system (ICM) was just FDA approved with approval number K on February 14, 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, K on November 21, The Reveal XT (Model 9529) and Reveal DX (Model 9528) most recent modifications submission were cleared via K on May 4, 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, 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 device allows the cardiologist to assess the history of treated and untreated episodes of ventricular arrhythmias. Scientific Rationale Update April 2013 Implantable Cardiac Event Monitor May 15 11

12 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 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 inoffice 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 Implantable Cardiac Event Monitor May 15 12

13 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. 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: Implantable Cardiac Event Monitor May 15 13

14 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 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 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. Implantable Cardiac Event Monitor May 15 14

15 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 = ). 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 /- 0.2 episodes per patient/year) compared with 41% (burden / 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 / 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 15 15

16 Review History November 2009 April 2011 April 2012 April 2013 April 2014 May 2014 May 2015 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 Added Reveal LINQ Insertable Cardiac Monitor (ICM) as medically necessary. Code updates. Added as investigational, implantable loop recorder cardiac event monitors to evaluate individuals following cryptogenic stroke. This policy is based on the following evidence-based guidelines: 1. 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): Available at: Euro-AF-Consensus-Stmt.pdf. 2. Cardiac arrhythmias. Washington (DC): American College of Cardiology (ACC); 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: Available at: 4. 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 Oct 14;108(15): Available at: 5. Tracy C, Epstein A, Darbar D, et al 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: 6. Roger VL, Go AS, Lloyd-Jones DM, et al.; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics update: a report from the American Heart Association [correction appears in Circulation. 2012;125(22):e1002]. Circulation. 2012;125(1):e2-e220. Available at: Implantable Cardiac Event Monitor May 15 16

17 7. Hayes. Health Technology Brief. S-ICD (Subcutaneous Implantable Cardioverter Defibrillator; Boston Scientific Corp.) for Prevention of Sudden Cardiac Death. December 6, Hayes Prognosis. Reveal LINQ Leadless Miniaturized Insertable Cardiac Monitor. April Hayes Search and Summary. Implantable Cardiac Loop Recorders for Syncope. March Hayes Health Technology Brief. Implantable Cardiac Loop Recorders for Detection of Atrial Fibrillation Following Cryptogenic Stroke. February Heart Rhythm Society. Technologies for Arrhythmia Diagnosis/Management. Available at: January CT, Wann LS, Alpert JS, et al.; ACC/AHA Task Force Members 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): Available at: ong 13. 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 Sep 23;83(13):1220. Available at: References Update May 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) Nov;63(5): 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 Apr 1;6: 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 Aug;104(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 Jun;21(6): Cotter PE, Martin PJ, Ring L, et al. Incidence of atrial fibrillation detected by implantable loop recorders in unexplained stroke. Neurology Apr 23;80(17): 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 Aug;28(2): Edvardsson N, Garutti C, Rieger G,, et al. Unexplained syncope: implications of age and gender on patient characteristics and evaluation, the diagnostic yield of an implantable loop recorder, and the subsequent treatment. Clin Cardiol Oct;37(10): Gladstone DJ, Dorian P, Spring M, et al. Atrial Premature Beats Predict Atrial Fibrillation in Cryptogenic Stroke: Results From the EMBRACE Trial. Stroke Apr;46(4): Houmsse M, Ishola A, Daoud EG. Clinical utility of implantable loop recorders. Postgrad Med Mar;126(2):30-7 Implantable Cardiac Event Monitor May 15 17

18 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) Nov Kapa S, Epstein AE, Callans DJ, et al. Assessing arrhythmia burden after catheter ablation of atrial fibrillation using an implantable loop recorder: the ABACUS study. J Cardiovasc Electrophysiol Aug;24(8): Lilli A1, Di Cori A. The cold facts of long-term ECG monitoring. Expert Rev Cardiovasc Ther Feb;13(2): 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 May-Jun;49(3): Podoleanu C, DaCosta A, Defaye P, et al. Early use of an implantable loop recorder in syncope evaluation: a randomized study in the context of the French healthcare system (FRESH study). Arch Cardiovasc Dis Oct;107(10): 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 Sep 16;57(6): Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med Jun 26;370(26): Schlingloff F, Oberhoffer MM, Quasdorff I, et al. Implantable loop recorders after atrial ablation: patient compliance and data surveillance in clinical practice. Innovations (Phila) Sep-Oct;8(5): 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 Sep;16(9): 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 Apr 1;156(15): 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 Nov 1;110(9): References Update May Medtronic. Insertable Cardiac Monitors (ICM). February 19, Available at: 2. U.S. FDA. 510K Summary. Reveal LINQ Insertable Cardiac Monitor. K February 14, Available at: References Update April Akerström F, Arias MA, Pachón M, et al. Subcutaneous implantable defibrillator: State-of-the art World J Cardiol. 2013;5(9): Available at: 2. Ganz LI, Hayes DL. Cardiac implantable electronic devices: Patient follow-up. UpToDate. February 13, 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: Pettit SJ, McLean A, Colquhoun I, Connelly D, McLeod K. Clinical experience of subcutaneous and transvenous implantable cardioverter defibrillators in children Implantable Cardiac Event Monitor May 15 18

19 and teenagers. Pacing Clin Electrophysiol. Epub ahead of print. September 13, Podrid PJ. Ambulatory monitoring in the assessment of cardiac arrhythmias. UpToDate. November 27, U.S. FDA. Medical Devices. S-ICD System (Subcutaneous Implantable Cardioverter Defibrillator). 1/17/2004. Available at: valsandclearances/recently-approveddevices/ucm htm 4. Weiss R, Knight BP, Gold MR, et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation. 2013;128(9): References Update April Bovin A, Malczynski J, Dalsgaard D. Implantable loop recorder is an effective diagnostic tool for unexplained syncope. Dan Med J Oct;59(10):A Cronin EM, Ching EA, Varma N, et al. Remote monitoring of cardiovascular devices: a time and activity analysis. Heart Rhythm Dec;9(12): Hong P, Sulke N. Implantable diagnostic monitors in the early assessment of syncope and collapse. Prog Cardiovasc Dis Jan;55(4): 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 Aug;14(8): Kristjánsdóttir I, Reimarsdóttir G, Arnar DO. The usefullness of implantable loop recorders for evaluation of unexplained syncope and palpitations. Laeknabladid Sep;98(9): Merlos P, Rumiz E, Ruiz-Granell R, Martínez Á, et al. Outcome of patients with syncope beyond the implantable loop recorder. Europace Jan;15(1): 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) Nov;61(5): References Update April Furukawa T, Maggi R, Bertolone C, et al. Effectiveness of remote monitoring in the management of syncope and palpitations. Europace Mar;13(3): Epub 2011 Jan Jung W, Zvereva V, Rillig A, et al. How to use implantable loop recorders in clinical trials and hybrid therapy. J Interv Card Electrophysiol Dec;32(3): Epub 2011 Oct 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 Jun;8(6): Epub 2011 Feb 2. References Update April 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 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 Feb;13(2): Epub 2010 Nov 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 Jan 1;236(1): Thomsen PE, Jons C, Raatikainen MJ, et al. Cardiac Arrhythmias and Risk Stratification After Acute Myocardial Infarction (CARISMA) Study Group. Long- Implantable Cardiac Event Monitor May 15 19

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