Effectiveness, utilisation and cost associated with implantable loop recorders versus external monitors after ischaemic or cryptogenic stroke.

OBJECTIVE: Implantable loop recorders (ILRs) are increasingly used for long-term rhythm monitoring after ischaemic and cryptogenic stroke, with the goal of detecting atrial fibrillation (AF) and subsequent initiation of oral anticoagulation to reduce risk of adverse clinical outcomes. There is a need to determine the effectiveness of different rhythm monitoring strategies in this context. METHODS: We conducted a retrospective cohort analysis of individuals with commercial and Medicare Advantage insurance in Optum Labs Data Warehouse who had incident ischaemic or cryptogenic stroke and no prior cardiovascular implantable electronic device from 1 January 2016 to 30 June 2021. Patients were stratified by rhythm monitoring strategy: ILR, long-term continuous external cardiac monitor (>48 hours to 30 days) or Holter monitor (≤48 hours). The primary outcome was risk-adjusted all-cause mortality at 12 months. Secondary outcomes included new diagnosis of AF and oral anticoagulation, bleeding, and costs. RESULTS: Among 48 901 patients with ischaemic or cryptogenic stroke, 9235 received an ILR, 29 103 long-term continuous external monitor and 10 563 Holter monitor only. Mean age was 69.9 (SD 11.9) years and 53.5% were female. During the 12-month follow-up period, patients who received ILRs compared with those who received long-term continuous external monitors had a higher odds of new diagnosis of AF and oral anticoagulant initiation (adjusted OR 2.27, 95% CI 2.09 to 2.48). Compared with patients who received long-term continuous external monitors, those who received ILRs had similar 12-month mortality (HR 1.00; 95% CI 0.89 to 1.12), with approximately $13 000 higher costs at baseline (including monitor cost) and $2500 higher costs during 12-month follow-up. CONCLUSIONS: In this large real-world study of patients with ischaemic or cryptogenic stroke, ILR placement resulted in more diagnosis of AF and initiation of oral anticoagulation, but no difference in mortality compared with long-term continuous external monitors.

Predictors of Success for Pulmonary Vein Isolation With Pulsed-field Ablation Using a Variable-loop Catheter With 3D Mapping Integration: Complete 12-month Outcomes From inspIRE.

BACKGROUND: We previously presented the safety and early efficacy of the inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed-field Ablation [PFA] System With Irreversible Electroporation [IRE]). With the study's conclusion, we report the outcomes of the full pivotal study cohort, with an additional analysis of predictors of success. METHODS: InspIRE was a prospective, multicenter, single-arm clinical trial of drug-refractory paroxysmal atrial fibrillation. Pulmonary vein isolation was performed with a variable-loop circular catheter integrated with a 3-dimensional mapping system. Follow-up with 24-hour Holter was at 3, 6, and 12 months, as well as remote rhythm monitoring: weekly from 3 to 5 months, monthly from 6 to 12 months, and for symptoms. The primary effectiveness end point (PEE) was acute pulmonary vein isolation plus freedom from any atrial arrhythmia at 12 months. Additional subanalyses report predictors of PEE success. RESULTS: The patient cohort included 186 patients: aged 59±10 years, female 30%, and CHA2DS2-VASc 1.3±1.2. The previously reported primary adverse event rate was 0%. One serious procedure-related adverse event, urinary retention, was reported. The PEE was achieved in 75.6% (95% CI, 69.5%-81.8%). The clinical success of freedom from symptomatic recurrence was 81.7% (95% CI, 76.1%-87.2%). Simulating a monitoring method used in standard real-world practice (without protocol-driven remote rhythm monitoring), this translates to a freedom from all and symptomatic recurrence of 85.8% (95% CI, 80.8%-90.9%) or 94.0% (95% CI, 90.6%-97.5%), respectively. Multivariate analyses revealed that left ventricular ejection fraction ≥60% (adjusted odds ratio, 0.30) and patients receiving ≥48 PFA applications (adjusted odds ratio, 0.28) were independent predictors of PEE success. Moreover, PEE success was 79.2% in patients who received ≥12 PFA applications per vein compared with 57.1% in patients receiving fewer PFA applications. CONCLUSIONS: The inspIRE study confirms the safety and effectiveness of pulmonary vein isolation using the novel 3-dimensional mapping integrated circular loop catheter. An optimal number of PFA applications (≥48 total or ≥12 per vein) resulted in an improved 1-year success rate of ≈80%. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04524364.

Impact of an expanded reimbursement policy on utilization of implantable loop recorders in patients with cryptogenic stroke in Korea.

BACKGROUND/AIMS: The reimbursement policy for cryptogenic stroke (CS) was expanded in November 2018 from recurrent strokes to the first stroke episode. No reports have demonstrated whether this policy change has affected trends in implantable loop recorder (ILR) utilization. METHODS: We identified patients who received an ILR implant using the Korea Health Insurance Review and Assessment Service database between July 2016 and October 2021. Patients meeting all the following criteria were considered to have CS indication: 1) prior stroke history, 2) no previous history of atrial fibrillation or flutter (AF/AFL), and 3) no maintenance of oral anticoagulant for ≥4 weeks within a year before ILR implant. AF/AFL diagnosed within 3 years after ILR implant or before ILR removal was considered ILR-driven. RESULTS: Among 3,056 patients, 1,001 (32.8%) had CS indications. The total ILR implant number gradually increased for both CS and non-CS indications and the number of CS indication significantly increased after implementing the expanded reimbursement policy. The detection rate for AF/AFL was 26.3% in CS patients over 3 years, which was significantly higher in patients implanted with an ILR within 2 months after stroke than those implanted later. CONCLUSION: The expanded coverage policy for CS had a significant impact on the number of ILR implantation for CS indication. The diagnostic yield of ILR for AF/AFL detection seems better when ILR is implanted within 2 months than later. Further investigation is needed to demonstrate other clinical benefits and the optimal ILR implantation timing.

Detection of paroxysmal atrial fibrillation preceding persistent atrial fibrillation in a horse using an implantable loop recorder with remote monitoring.

Implantable loop recorders (ILRs) are increasingly used in equine cardiology to detect arrhythmias in the context of collapse, poor performance or monitoring for recurrence of atrial fibrillation (AF). However to date, the ILR has never been reported to be used with a remote monitoring functionality in horses, therefore the arrhythmia is only discovered when a clinician interrogates the ILR using dedicated equipment, which might delay diagnosis and intervention. This case report describes the use of an ILR with remote monitoring functionality in a horse with recurrent AF. The remote monitoring consisted of a transmission device located in the stable allowing daily transmission of arrhythmia recordings and functioning messages to an online server, available for the clinician to evaluate without specialised equipment. The ILR detected an episode of paroxysmal AF approximately three months after implantation. Seven months after implantation, initiation of persistent AF was seen on an episode misclassified by the ILR as bradycardia, and the horse was retired. This report shows the feasibility and benefits of remote monitoring for ILRs in horses, but also the shortcomings of current algorithms to interpret the equine electrocardiogram.

The Beneficial Role of Telemedicine for Arrhythmic Risk Stratification in Asymptomatic Brugada Syndrome: An Exemplary Case Report.

Telemedicine and remote monitoring devices, including implantable loop recorders (ILR), are increasingly adopted in the cardiologic setting. These are valuable tools in the arrhythmic stratification of patients at risk of sudden cardiac death, providing a tailored therapeutic management to prevent lethal arrhythmias. We report a case of an asymptomatic 18-year-old boy with a family history of syncope and cardiac arrest, who had a diagnosis of Brugada syndrome with an inducible type 1 pattern and carrier of a missense mutation of the SCN5A gene. In light of the risk factors, although not recommended by current guidelines, we decided to proceed with the implantation of an ILR with remote monitoring service. A few months later, an episode of asymptomatic sustained polymorphic ventricular tachycardia was promptly observed by the remote monitoring, leading to a timely implantation of a subcutaneous cardiac implantable defibrillator.

"But for the blind spot": Accuracy and diagnostic performance of smart watch cardiac features in pediatric patients.

BACKGROUND: The Apple Watch™ (AW) offers heart rate (HR) tracking by photoplethysmography (PPG) and single-lead electrocardiographic (ECG) recordings. The accuracy of AW-HR and diagnostic performance of AW-ECGs among children during both sinus rhythm and arrhythmias have not been explored. OBJECTIVE: The purposes of this study were to assess the accuracy of AW-HR measurements compared to gold standard modalities in children during sinus rhythm and arrhythmias and to identify non-sinus rhythms using AW-ECGs. METHODS: Subjects ≤18 years wore an AW during (1) telemetry admission, (2) electrophysiological study (EPS), or (3) exercise stress test (EST). AW-HRs were compared to gold standard modality values. Recorded AW-ECGs were reviewed by 3 blinded pediatric electrophysiologists. RESULTS: Eighty subjects (median age 13 years; interquartile range 1.0-16.0 years; 50% female) wore AW (telemetry 41% [n = 33]; EPS 34% [n = 27]; EST 25% [n = 20]). A total of 1090 AW-HR measurements were compared to time-synchronized gold standard modality HR values. Intraclass correlation coefficient (ICC) was high 0.99 (0.98-0.99) for AW-HR during sinus rhythm compared to gold standard modalities. ICC was poor comparing AW-HR to gold standard modality HR in tachyarrhythmias (ICC 0.24-0.27) due to systematic undercounting of AW-HR values. A total of 126 AW-ECGs were reviewed. Identification of non-sinus rhythm by AW-ECG showed sensitivity of 89%-96% and specificity of 78%-87%. CONCLUSIONS: We found high levels of agreement for AW-HR values with gold standard modalities during sinus rhythm and poor agreement during tachyarrhythmias, likely due to hemodynamic effects of tachyarrhythmias on PPG-based measurements. AW-ECGs had good sensitivity and moderate specificity in identification of non-sinus rhythm in children.

Early atrial fibrillation recurrence post catheter ablation: Analysis from insertable cardiac monitor in the era of optimized radiofrequency ablation.

BACKGROUND: Early recurrence of atrial tachyarrhythmia (ERAT) is associated with ablation-induced proarrhythmogenic inflammation; however, existing studies used intermittent monitoring or nonoptimized radiofrequency (RF) applications (noncontiguous or without ablation index target value). OBJECTIVE: The purpose of this study was to investigate the relationship between ERAT and late recurrence based on insertable cardiac monitor (ICM) data. METHODS: We compiled data from Close-To-Cure and Close Maze studies, which enrolled patients who underwent RF ablation for paroxysmal or persistent atrial fibrillation (AF). All patients were implanted with an ICM 2-3 months before ablation. RESULTS: We studied 165 patients (104 with paroxysmal AF, 61 with persistent AF). Over the 1-year follow-up period, 41 of the patients experienced late recurrence. The risk of late recurrence was higher in patients experiencing ERAT (hazard ratio [HR] 6.2; 95% confidence interval [CI] 3.0-13.0), with negative and positive predictive values of 90.5% and 45.7%, respectively. Median burden of AF during the blanking period was significantly higher in patients with late recurrence (7.9% [0.0%-99.6%]) compared to those without recurrence (0.0% [0.0%-6.0]; P <.001). For each 1% increase in AF burden during the blanking period, late recurrence increased by 4.6% (HR 1.046; 95% CI 1.035-1.059). The best tradeoff for predicting AF from ERAT occurrence was AF burden of 0.6% and last ERAT at 64 days. CONCLUSION: In patients ablated for paroxysmal and persistent AF with a durable RF lesion set and implanted with a continuous monitoring device, postablation early AF recurrence and burden significantly predict late recurrence. The post-AF ablation blanking period should be reduced to 2 months.

Identifying high risk patients post myocardial infarction with reduced left ventricular function using loop recorders INSPIRE-ELR clinical study.

AIMS: Sudden cardiac death (SCD) continues to be a devastating complication amongst survivors of myocardial infarction (MI). Mortality is high in the initial months after MI. The aims of the INSPIRE-ELR study were to assess the proportion of patients with significant arrhythmias early after MI and the association with mortality during 12 months of follow-up. METHODS: The study included 249 patients within 14 days after MI with left ventricular ejection fraction (LVEF) ≤35% at discharge in 11 hospitals in India. Patients received a wearable external loop recorder (ELR) 5 ± 3 days after MI to monitor arrhythmias for 7 days. RESULTS: Patients were predominantly male (86%) with a mean age of 56 ± 12 years. In 82%, reperfusion had been done and all received standard of care cardiovascular medications at discharge. LVEF was 32.2 ± 3.9%, measured 5.1 ± 3.0 days after MI. Of the 233 patients who completed monitoring (7.1 ± 1.5 days), 81 (35%) experienced significant arrhythmias, including Ventricular Tachycardia/Fibrillation (VT/VF): 10 (4.3%); frequent Premature Ventricular Contractions (PVCs): 65 (28%); Atrial Fibrillation (AF): 8 (3.4%); chronic atrial flutter: 4 (1.7%); 2nd or 3rd degree Atrioventricular (AV) block: 4 (1.7%); and symptomatic bradycardia: 8 (3.4%). In total, 26 patients died. Mortality was higher in patients with clinically significant arrhythmia (at 12 months: 23.6% vs 4.8% with 19 vs 7 deaths, hazard ratio (HR) = 5.5, 95% confidence interval (CI) 2.3 to 13.0, p < 0.0001). Excluding 7 deaths during ELR monitoring, HR = 4.5, p < 0.001. CONCLUSION: ELR applied in patients with acute MI and LV dysfunction at the time of discharge identifies patients with high mortality risk.

Role of subcutaneous implantable loop recorder for the diagnosis of arrhythmias in Brugada syndrome: A United Kingdom single-center experience.

BACKGROUND: Experience with implantable loop recorders (ILRs) in Brugada syndrome (BrS) is limited. OBJECTIVE: The purpose of this study was to evaluate the indications and yield of ILR monitoring in a single-center BrS registry. METHODS: Demographic, clinical and follow-up data of BrS patients with ILR were collected. RESULTS: Of 415 BrS patients recruited consecutively, 50 (12%) received an ILR (58% male). Mean age at ILR implantation was 44 ± 15 years. Thirty-one (62%) had experienced syncopal or presyncopal episodes, and 23 (46%) had palpitations. During median follow-up of 28 months (range 1-68), actionable events were detected in 11 subjects (22%); 7 had recurrences of syncope/presyncope, with 4 showing defects in sinus node function or atrioventricular conduction. New supraventricular tachyarrhythmias were recorded in 6 subjects; a run of fast nonsustained ventricular tachycardia was detected in 1 patient. Patients implanted with an ILR were less likely to show a spontaneous type 1 pattern or depolarization electrocardiographic (ECG) abnormalities compared to those receiving a primary prevention implantable-cardioverter defibrillator. Age at implantation, gender, Shanghai score, and ECG parameters did not differ between subjects with and those without actionable events. ILR-related complications occurred in 3 cases (6%). CONCLUSION: In a large cohort of BrS patients, continuous ILR monitoring yielded a diagnosis of tachy- or bradyarrhythmic episodes in 22% of cases. Recurrences of syncope were associated with bradyarrhythmic events. Use of ILR can be helpful in guiding the management of low-/intermediate-risk BrS patients and ascertaining the cause of unexplained syncope.

Meta-Analysis of Randomized Clinical Trials Comparing the Impact of Implantable Loop Recorder Versus Usual Care After Ischemic Stroke for Detection of Atrial Fibrillation and Stroke Risk.

Implantable loop recorder (ILR) is recommended to detect subclinical atrial fibrillation (AF) after cryptogenic stroke; however, the clinical outcomes of this practice is unclear. We conducted a systematic review and meta-analysis of randomized controlled trials to evaluate 12-month AF detection, change in oral anticoagulation (OAC), and recurrent stroke in ILR versus usual care after ischemic stroke. We searched Medline, Embase, Web of Science, Cochrane Library for randomized controlled trials comparing ILR with usual care after any ischemic stroke. Primary outcomes were cumulative AF detection and recurrent stroke (ischemic or hemorrhagic) or transient ischemic attack over 12 months. Secondary outcome was OAC initiation. Meta-analysis was performed with Mantel-Haenszel pooled odds ratios (ORs) and random effects models. Of 200 identified articles, 3 trials were included (1,233 participants). Cryptogenic stroke and underlying AF included cryptogenic stroke only, stroke of known cause and underlying-AF included small or large vessel stroke only, and post embolic rhythm detection with implantable vs external monitoring included all ischemic strokes. The 12-month AF detection was 13% in the ILR group and 2.4% in controls. ILR was more likely to detect AF compared with usual care (OR 5.8, 95% confidence interval 3.2 to 10.2). Stroke or transient ischemic attack occurred in 7% with ILR and 9% with usual care (OR 0.8, 95% confidence interval 0.5 to 1.2). In patients with detected AF, 97% and 100% were started on OAC in cryptogenic stroke and underlying AF and post embolic rhythm detection with implantable vs external monitoring, respectively, compared with 68% in stroke of known cause and underlying-AF. In conclusion, ILR was superior to usual care in AF detection, but the relative low incidence of AF and the nondifferential risk of stroke between the ILR and usual care arms may suggest that most patients do not benefit from ILR implantation. Further studies are warranted to understand if patient selection can be improved to increase the diagnostic yield of ILR.

Differences in Inpatient Insertable Cardiac Monitor Placement after Ischemic Stroke.

BACKGROUND AND PURPOSE: Cryptogenic stroke accounts for 30% of ischemic stroke and in such patients, cardiac monitoring leads to increased detection of AF, increased utilization of anticoagulation, and decreased risk of recurrent stroke. We aim to identify differences in inpatient utilization of implantable cardiac monitors (ICMs) in patients with ischemic stroke. METHODS: This is an analysis of the National Inpatient Sample. We included all ischemic stroke hospitalizations nation-wide between Jan 1st 2016 and Dec 31st 2018. We excluded patients with history of atrial fibrillation or atrial flutter. We compared survey weighted baseline demographics and characteristics between patients who received an inpatient ICM versus those who didn't using logistic regression models. RESULTS: We identified a weighted total 1,069,395 patients who met the inclusion criteria; 2.2% received an inpatient ICM. In multivariable analyses, factors associated with decreased odds of inpatient ICM placement including Black race (OR 0.76 95% CI 0.68 - 0.84, p < 0.001), residence in a micropolitan area (OR 0.79 95% CI 0.67 - 0.94, p = 0.008), hospital region [Midwest (OR 0.74 95% CI 0.61 - 0.90, p = 0.002), South (OR 0.68 95% CI 0.57 - 0.81, p < 0.001), and West (OR 0.37 95% CI 0.29 - 0.45, p < 0.001)], hospital bed size [small (OR 0.38 95% CI 0.39-0.46, p < 0.001) and medium hospital bed size (OR 0.73 95% CI 0.63 - 0.84, p < 0.001)], insurance status [Medicaid (OR 0.86 95% CI 0.76 - 0.98, p = 0.02) and self-pay (OR 0.51 95% CI 0.41 - 0.62, p < 0.001)], and non-teaching hospital (OR 0.52 95% CI 0.47 - 0.60, p < 0.001). CONCLUSIONS: There are important differences in inpatient ICM placement in patients with ischemic stroke highlighting disparities in inpatient care for patients hospitalized with ischemic stroke. More studies are needed to validate our findings.

Changing patterns of use of implantable cardiac monitors from 2011 to 2018 for a large commercially-insured U.S. population.

ABSTRACT: Implantable cardiac monitors (ICMs) provide long-term electrocardiographic monitoring for a number of indications. However, frequencies of use by indication and temporal changes have not been characterized on a national scale. We sought to characterize overall use and changes between 2011 and 2018. We used generalized linear models to characterize the incidence rate per 1,000,000 patient-quarters at risk and an autoregressive integrated moving average model to account for autocorrelation in this time series data. We studied commercially-insured patients and their insured dependents in the IBM MarketScan Commercial Database who had an ICM placed. We described the characteristics of individuals who received ICMs and the frequency of placements into 3 guideline concordance groups. We estimated the mean change per quarter in ICM placements (mean quarterly change in incidence rate per 1,000,000 patient-quarters at risk) for quarter (Q)1 2011 through Q1 2014, Q1 2014 to Q2 2014, and Q2 2014 through Q4 2018 for each guideline concordance group. The most common indications for categorizable ICM placement were syncope (24%), atrial fibrillation (11%), and stroke (11%). For each of the 3 guideline concordance groups except guideline unaddressed inpatient ICM placements, there was a significant increase in use either during the Q1 2014 to Q2 2014 or the Q2 2014 through Q4 2018 periods. A significant portion of ICM placements were for indications that lack strong evidence, such as established atrial fibrillation. The incidence of ICM placement for most of the indications and settings increased after miniaturization and technical improvements.

Atrial fibrillation detection in outpatient electrocardiogram monitoring: An algorithmic crowdsourcing approach.

BACKGROUND: Atrial fibrillation (AFib) is the most common cardiac arrhythmia associated with stroke, blood clots, heart failure, coronary artery disease, and/or death. Multiple methods have been proposed for AFib detection, with varying performances, but no single approach appears to be optimal. We hypothesized that each state-of-the-art algorithm is appropriate for different subsets of patients and provides some independent information. Therefore, a set of suitably chosen algorithms, combined in a weighted voting framework, will provide a superior performance to any single algorithm. METHODS: We investigate and modify 38 state-of-the-art AFib classification algorithms for a single-lead ambulatory electrocardiogram (ECG) monitoring device. All algorithms are ranked using a random forest classifier and an expert-labeled training dataset of 2,532 recordings. The seven top-ranked algorithms are combined by using an optimized weighting approach. RESULTS: The proposed fusion algorithm, when validated on a separate test dataset consisting of 4,644 recordings, resulted in an area under the receiver operating characteristic (ROC) curve of 0.99. The sensitivity, specificity, positive-predictive-value (PPV), negative-predictive-value (NPV), and F1-score of the proposed algorithm were 0.93, 0.97, 0.87, 0.99, and 0.90, respectively, which were all superior to any single algorithm or any previously published. CONCLUSION: This study demonstrates how a set of well-chosen independent algorithms and a voting mechanism to fuse the outputs of the algorithms, outperforms any single state-of-the-art algorithm for AFib detection. The proposed framework is a case study for the general notion of crowdsourcing between open-source algorithms in healthcare applications. The extension of this framework to similar applications may significantly save time, effort, and resources, by combining readily existing algorithms. It is also a step toward the democratization of artificial intelligence and its application in healthcare.

The predictive role of early recurrences of atrial arrhythmias after pulmonary vein cryoballoon ablation. Is blanking period an outdated concept? Insights from 12-month continuous cardiac monitoring.

BACKGROUND: Early recurrences of atrial arrhythmias (ERAA) after atrial fibrillation (AF) catheter ablation do not predict procedural failure. A well-demarcated homogeneous lesion delivered by cryoballoon is less arrhythmogenic, and the recommended three-months blanking period may not refer to cryoballoon ablation (CBA). OBJECTIVE: We aimed to evaluate the predictive role of ERAA after second-generation CBA using an implantable loop recorder. METHODS: This prospective observational study enrolled 100 patients (58 males, median age 58) with paroxysmal/persistent AF undergoing pulmonary vein (PV) CBA using second-generation cryoballoon with simultaneous ECG loop recorder implantation. The duration of follow-up was 12 months, with scheduled visits at 3, 6 and 12 months. RESULTS: 99 patients from 100 completed the 12-month follow-up period. ERAA occurred in 31.3 % of patients. 83.9 % of patients with ERAA also developed late recurrences. The 12-month freedom from AF in patients with ERAA was significantly lower than in those without ERAA (p < 0.0001). Non-paroxysmal AF and longer arrhythmia history were associated with increased risk of both early (HR 3.27; 95 % CI 1.32-8.08; p = 0.010 and HR 1.0147; 95 % CI 1.008-1.086; p = 0.015, respectively) and late recurrences (HR 3.89; 95 % CI 1.67-9.04; p = 0.002 and HR 1.0142; 95 % CI 1.007-1.078; p = 0.019, respectively) of AF. ERAA were another predictor for procedural failure (HR 15.2; 95 % CI (6.42-35.99; p = 0.019). CONCLUSIONS: ERAA occurred in the third of the patients after PV second-generation CBA and are strongly associated with procedural failure. Longer duration of AF history and persistent AF are independent predictors of AF's early and late recurrence.

Outcomes of Implantable Loop Monitoring in Patients <21 Years of Age.

Rhythm-symptom correlation in pediatric patients with syncope/palpitations or at risk cohorts can be difficult, but important given potential associations with treatable or malignant arrhythmia. We sought to evaluate the use, efficacy and outcomes of implantable loop recorders (ILR) in pediatrics. We conducted a retrospective study of pediatric patients (<21 years) with implanted ILR. Patient/historical characteristics and ILR indication were obtained. Outcomes including symptom documentation, arrhythmia detection and ILR based changes in medical care were identified. Comparison of outcomes were performed based on implant indication. Additional sub-analyses were performed in syncope-indication patients comparing those with and without changes in clinical management. A total of 116 patients with ILR implant were identified (79 syncope/37 other). Symptoms were documented 58% of patients (syncope 68% vs nonsyncope 35%; p = 0.002). A total of 37% of patients had a documented clinically significant arrhythmia and 25% of patients had a resultant change in clinical management independent of implant indication. Arrhythmia type was dependent on implant indication with nonsyncope patients having more ventricular arrhythmias. Pacemaker/defibrillator implantation and mediation management were the majority of the clinical changes. In conclusion, IRL utilization in selected pediatric populations is associated with high efficacy and supports clinical management. ILR efficacy is similar regardless of indication although patients with nonsyncope indications had a higher frequency of ventricular arrhythmias as opposed to asystole and heart block in syncope indications. The majority of arrhythmic findings occurred in the first 12 months, and new technology that would allow for less invasive monitoring for 6 to 12 months may be of value.

Implantable loop recorder detection of atrial fibrillation to prevent stroke (The LOOP Study): a randomised controlled trial.

BACKGROUND: It is unknown whether screening for atrial fibrillation and subsequent treatment with anticoagulants if atrial fibrillation is detected can prevent stroke. Continuous electrocardiographic monitoring using an implantable loop recorder (ILR) can facilitate detection of asymptomatic atrial fibrillation episodes. We aimed to investigate whether atrial fibrillation screening and use of anticoagulants can prevent stroke in individuals at high risk. METHODS: We did a randomised controlled trial in four centres in Denmark. We included individuals without atrial fibrillation, aged 70-90 years, with at least one additional stroke risk factor (ie, hypertension, diabetes, previous stroke, or heart failure). Participants were randomly assigned in a 1:3 ratio to ILR monitoring or usual care (control) via an online system in permuted blocks with block sizes of four or eight participants stratified according to centre. In the ILR group, anticoagulation was recommended if atrial fibrillation episodes lasted 6 min or longer. The primary outcome was time to first stroke or systemic arterial embolism. This study is registered with ClinicalTrials.gov, NCT02036450. FINDINGS: From Jan 31, 2014, to May 17, 2016, 6205 individuals were screened for inclusion, of whom 6004 were included and randomly assigned: 1501 (25·0%) to ILR monitoring and 4503 (75·0%) to usual care. Mean age was 74·7 years (SD 4·1), 2837 (47·3%) were women, and 5444 (90·7%) had hypertension. No participants were lost to follow-up. During a median follow-up of 64·5 months (IQR 59·3-69·8), atrial fibrillation was diagnosed in 1027 participants: 477 (31·8%) of 1501 in the ILR group versus 550 (12·2%) of 4503 in the control group (hazard ratio [HR] 3·17 [95% CI 2·81-3·59]; p<0·0001). Oral anticoagulation was initiated in 1036 participants: 445 (29·7%) in the ILR group versus 591 (13·1%) in the control group (HR 2·72 [95% CI 2·41-3·08]; p<0·0001), and the primary outcome occurred in 318 participants (315 stroke, three systemic arterial embolism): 67 (4·5%) in the ILR group versus 251 (5·6%) in the control group (HR 0·80 [95% CI 0·61-1·05]; p=0·11). Major bleeding occurred in 221 participants: 65 (4·3%) in the ILR group versus 156 (3·5%) in the control group (HR 1·26 [95% CI 0·95-1·69]; p=0·11). INTERPRETATION: In individuals with stroke risk factors, ILR screening resulted in a three-times increase in atrial fibrillation detection and anticoagulation initiation but no significant reduction in the risk of stroke or systemic arterial embolism. These findings might imply that not all atrial fibrillation is worth screening for, and not all screen-detected atrial fibrillation merits anticoagulation. FUNDING: Innovation Fund Denmark, The Research Foundation for the Capital Region of Denmark, The Danish Heart Foundation, Aalborg University Talent Management Program, Arvid Nilssons Fond, Skibsreder Per Henriksen, R og Hustrus Fond, The AFFECT-EU Consortium (EU Horizon 2020), Læge Sophus Carl Emil Friis og hustru Olga Doris Friis' Legat, and Medtronic.