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.

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.

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.

Cost-Effectiveness of Extended Electrocardiogram Monitoring for Atrial Fibrillation After Stroke: A Systematic Review.

BACKGROUND AND PURPOSE: Management of cryptogenic stroke involves the identification of modifiable risk factors, such as atrial fibrillation (AF). Extended rhythm monitoring increases AF detection rates but at an increased device cost compared with conventional Holter monitoring. The objective of the study was to identify and synthesize the existing literature on the cost-effectiveness of prolonged rhythm monitoring devices for AF detection in cryptogenic stroke. METHODS: We conducted a systematic review of available economic evaluations of prolonged ECG monitoring for AF detection following cryptogenic stroke compared with standard care. RESULTS: Of the 530 unique citations, 8 studies assessed the cost-utility of prolonged ECG monitoring compared with standard care following cryptogenic stroke. The prolonged ECG monitoring strategies included 7-day ambulatory monitoring, 30-day external loop recorders or intermittent ECG monitoring, and implantable loop recorders. The majority of cost-utility analyses reported incremental cost-effectiveness ratios below $50 000 per QALY gained; and two studies reported a cost-savings. CONCLUSIONS: There is limited economic literature on the cost-effectiveness of extended ECG monitoring devices for detection of atrial fibrillation in cryptogenic stroke. In patients with cryptogenic stroke, extended ECG monitoring for AF detection may be economically attractive when traditional willingness-to-pay thresholds are adopted. However, there was substantial variation in the reported ICERs. The direct comparison of cost-effectiveness across technologies is limited by heterogeneity in modeling assumptions.

Routine Continuous Electrocardiographic Monitoring Following Percutaneous Coronary Interventions.

BACKGROUND: The clinical utility of routine electrocardiographic monitoring following percutaneous coronary interventions (PCI) is not well studied. METHODS: We prospectively evaluated the incidence, cost, and the clinical implications of actionable arrhythmia alarms on telemetry monitoring following PCI. One thousand three hundred fifty-eight PCI procedures (989 [72.8%] for acute coronary syndrome and 369 [27.2%] for stable angina) on patients admitted to nonintensive care unit were identified and divided into 2 groups; group 1, patients with actionable alarms (AA) and group 2, patients with non-AA. AA included (1) ≥3 s electrical pause or asystole; (2) high-grade Mobitz type II atrioventricular block or complete heart block; (3) ventricular fibrillation; (4) ventricular tachycardia (>15 beats); (5) atrial fibrillation with rapid ventricular response; (6) supraventricular tachycardia (>15 beats). Primary outcomes were 30-day all-cause mortality. Cost-savings analysis was performed. RESULTS: Incidence of AA was 2.2% (37/1672). Time from end of procedure to AA was 5.5 (0.5, 24.5) hours. Patients with AA were older, presented with acute congestive heart failure or non-ST-segment-elevation myocardial infarction, and had multivessel or left main disease. The 30-day all-cause mortality was significantly higher in patients with AA (6.5% versus 0.3% in non-AA [P<0.001]). Applying the standardized costing approach and tailored monitoring per the American Heart Association guidelines lead to potential cost savings of $622 480.95 for the entire population. CONCLUSIONS: AA following PCI were infrequent but were associated with increase in 30-day mortality. Following American Heart Association guidelines for monitoring after PCI can lead to substantial cost saving.

A randomized trial evaluating the accuracy of AF detection by four external ambulatory ECG monitors compared to permanent pacemaker AF detection.

PURPOSE: Several external cardiac monitors (ECMs) have recently been developed. These have never been compared to 'gold standard' monitoring with concurrently implanted DDDRP pacemakers. The accuracy of AF detection of Zio XT Monitor (ZM), NUUBO Vest (NV) and Carnation Ambulatory Monitor (CAM) compared with Novacor 'R' Test 4 (RT) in patients (pts) with DDDRP PPM advanced Holters as the comparator, was evaluated. METHODS: Twenty-one pts. with AF and a DDDRP PPM, each acting as their own control subject, wore every ECM for 2 weeks in randomized order. PPM downloads were performed at application and removal. Device ECGs were compared for AF burden and individual AF episodes with PPM Holters. Pt acceptability, wear time, costs and time expenditure were evaluated. RESULTS: RT AF burden was less accurate than the ZM, NV or CAM (p < 0.05). Probability of inaccurate AF diagnosis was higher for RT than ZM or CAM OR 12.31 and 5.85, respectively (p = 0.025 and p = 0.042). ZM wear time was longer than the RT: 307 h vs. 224 h; p = 0.02. Acceptability was greater for CAM than RT (1.86 ± 2.63 compared with 0.57 ± 1.17 for CAM; p = 0.024). All ECMs were more expensive than RT (p < 0.00001). CONCLUSIONS: All new ECMs were more expensive than the RT system; however, the ZM, NV and CAM are all more accurate than current standard practice RT device in AF burden assessment. The RT is more likely to give inaccurate diagnoses than ZM or CAM. This may have clinical implications.

Use of insertable cardiac monitors for the detection of atrial fibrillation in patients with cryptogenic stroke in the United States is cost-effective.

Objectives: Atrial fibrillation (AF) is the most common arrhythmia and a major marker of ischemic stroke risk. Early detection is crucial and, once diagnosed, anticoagulation therapy can be initiated to reduce stroke risk. The aim of this study was to assess the cost-effectiveness of employing an insertable cardiac monitor (ICM), BIOMONITOR, for the detection of AF compared to standard of care (SoC) ECG and Holter monitoring in patients with cryptogenic stroke, that is, stroke of unknown origin and where paroxysmal, silent AF is suspected. Materials and methods: A Markov model was developed which consisted of five main health states reflecting the potential lifetime evolution of the AF disease: post cryptogenic stroke (index event), subsequent mild, moderate and severe stroke, and death. Sub-states were included to track a patient's AF diagnostic status and the use of antiplatelet or anticoagulant therapy. AF detection was assumed to result in a treatment switch from aspirin to anticoagulants, except among those with a history of major bleeding. Detection yield and accuracy, clinical actions and treatment effects were derived from the literature and validated by an expert clinician. All relevant costs from a US Medicare perspective were included. Results and conclusions: An ICM-based strategy was associated with a reduction of 37 secondary ischemic strokes per 1000 patients monitored compared with SoC. Total per-patient costs with an ICM were higher (US$90,052 vs. US$85,157) although stroke-related costs were reduced. The use of an ICM was associated with a base-case incremental cost-effectiveness ratio of US$18,487 per life year gained compared with SoC and US$25,098 per quality-adjusted life year gained, below established willingness-to-pay thresholds. The conclusions were found to be robust over a range of input values. From a US Medicare perspective the use of a BIOMONITOR ICM represents a cost-effective diagnostic strategy for patients with cryptogenic stroke and suspected AF.

Economic evaluation of prolonged and enhanced ECG Holter monitoring in acute ischemic stroke patients.

Objective: Atrial fibrillation (AF) is a major cause for recurrent stroke, has severe impact on a patient's health and imposes a high economic burden for society. Current guidelines recommend 24 h ECG monitoring (standard-of-care, SoC) to detect AF after stroke to reduce the risk of future events. However, paroxysmal AF (PAF) is difficult to detect within this period as it occurs infrequently and unpredictably. In a randomized controlled trial (Find-AFRANDOMISED), prolonged and enhanced Holter ECG monitoring (EPM) revealed a significantly higher detection rate of AF compared to SoC, although its cost-effectiveness has not yet been investigated. Methods: Based on the data of FIND-AFRANDOMISED, an economic evaluation was conducted. One group received EPM for 10 days after the event, and at 3 and 6 months; the other group received SoC. Healthcare resource use and quality of life (QoL) data were measured at baseline, and after 6 and 12 months. Incremental costs and quality-adjusted life years (QALYs) between both groups were compared. Non-parametric bootstrapping and one-way-sensitivity analyses were performed. Results: A total of 281 patients with healthcare resource use and QoL data for all measurement points were considered in the economic evaluation (complete case analysis, CCA). The CCA yielded nonsignificant 315€ lower mean costs and 0.0013 less QALYs for patients receiving EPM with no statistically significant differences in any cost categories. Sensitivity analyses revealed robust results. Bootstrapping the results indicated moderate probability of cost-effectiveness. Conclusions: EPM yielded reduced not significantly different costs without affecting QoL and may be a useful strategy to detect PAF in acute ischemic stroke patients in time.

Diagnostic Yield and Economic Assessment of a Diagnostic Protocol With Systematic Use of an External Loop Recorder for Patients With Palpitations.

INTRODUCTION AND OBJECTIVES: To assess the diagnostic yield and cost-effectiveness of a diagnostic protocol based on the systematic use of latest-generation external loop recorders (ELRs) compared with the classic diagnostic strategy for patients with recurrent unexplained palpitations. METHODS: Two cohorts of consecutive patients referred for diagnosis of unexplained palpitations to the outpatient clinic of the arrhythmia unit were compared: a prospective cohort after the implementation of a new diagnostic protocol based on the systematic use of ELRs, and another, retrospective, cohort before the implementation of the protocol. The cost of diagnosis was calculated based on the number of complementary examinations, visits to outpatient clinics, or emergency department visits required to reach a diagnosis, and its costs according the prices published for the local health system. RESULTS: One hundred and forty-nine patients were included (91 in the ELR group, 58 in the control group). The diagnostic yield was higher in the ELR group (79 [86.8%] definitive diagnoses in the ELR group vs 12 [20.7%] in the control group, P < .001). The cost per diagnosis was €375.13 in the ELR group and €5184.75 in the control group (P < .001). The cost-effectiveness study revealed that the systematic use of ELR resulted in a cost reduction of €11.30 for each percentage point of increase in diagnosis yield. CONCLUSIONS: In patients with recurrent unexplained palpitations, evaluation by means of a study protocol that considers the systematic use of a latest-generation ELR increases diagnostic yield while reducing the cost per diagnosis.

Screening for Atrial Fibrillation Using Economical and Accurate Technology (From the SAFETY Study).

The prevalence of atrial fibrillation (AF) is estimated at more than 3% in the adult population and there has been increased interest in screening for AF. In the SAFETY trial we chose to evaluate if inexpensive, wearable, consumer electrocardiography (ECG) sensing devices (Polar-H7 [PH7] and Firstbeat Bodyguard 2 [BG2]), could be used to detect AF accurately. We undertook a case-control study of 418 participants aged >65 (82 with AF and/or flutter at the study visit and 336 without) attending 3 general practice surgeries in Hampshire, UK for a single screening visit. The PH7 and BG2 devices were tested alongside 2 established AF detection devices (AliveCor and WatchBP) in random order and the diagnosis of AF was confirmed by 12-Lead ECG interpreted by a panel of cardiologists. The sensitivity (95% confidence interval [CI] range), specificity (95% CI range), and overall accuracy (95% CI range) of the 4 devices were: AliveCor: 87.8% (78.7% to 94.0%), 98.8% (97.0% to 99.7%), 96.7% (94.4% to 98.2%); WatchBP: 96.3% (89.7% to 99.2%), 93.5% (90.3% to 95.9%), 94.0% (91.3% to 96.1%): PH7: 96.3% (89.7% to 99.2%), 98.2% (96.2% to 99.3%), 97.9% (96.0% to 99.0%). BG2: 96.3% (89.7% to 99.2%), 98.5% (96.6% to 99.5%), 98.1% (96.3% to 99.2%). The PH7 and BG2 devices were highly reliable (the devices acquired sufficient data and obtained a diagnostic result in all but 1 participant on the first attempt). In conclusion, inexpensive, consumer heart rate monitoring devices (PH7 and BG2) can be used to detect AF accurately with sensitivity and specificity >95%. The consumer devices performed as well or better than WatchBP and AliveCor and have the capability to store or transmit ECG data which could be used to confirm AF.

Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study.

BACKGROUND: Asymptomatic atrial fibrillation (AF) is increasingly common in the aging population and implicated in many ischemic strokes. Earlier identification of AF with appropriate anticoagulation may decrease stroke morbidity and mortality. METHODS: We conducted a randomized controlled trial of AF screening using an AliveCor Kardia monitor attached to a WiFi-enabled iPod to obtain ECGs (iECGs) in ambulatory patients. Patients ≥65 years of age with a CHADS-VASc score ≥2 free from AF were randomized to the iECG arm or routine care (RC). iECG participants acquired iECGs twice weekly over 12 months (plus additional iECGs if symptomatic) onto a secure study server with overread by an automated AF detection algorithm and by a cardiac physiologist and/or consultant cardiologist. Time to diagnosis of AF was the primary outcome measure. The overall cost of the devices, ECG interpretation, and patient management were captured and used to generate the cost per AF diagnosis in iECG patients. Clinical events and patient attitudes/experience were also evaluated. RESULTS: We studied 1001 patients (500 iECG, 501 RC) who were 72.6±5.4 years of age; 534 were female. Mean CHADS-VASc score was 3.0 (heart failure, 1.4%; hypertension, 54%; diabetes mellitus, 30%; prior stroke/transient ischemic attack, 6.5%; arterial disease, 15.9%; all CHADS-VASc risk factors were evenly distributed between groups). Nineteen patients in the iECG group were diagnosed with AF over the 12-month study period versus 5 in the RC arm (hazard ratio, 3.9; 95% confidence interval=1.4-10.4; P=0.007) at a cost per AF diagnosis of $10 780 (£8255). There was a similar number of stroke/transient ischemic attack/systemic embolic events (6 versus 10, iECG versus RC; hazard ratio=0.61; 95% confidence interval=0.22-1.69; P=0.34). The majority of iECG patients were satisfied with the device, finding it easy to use without restricting activities or causing anxiety. CONCLUSIONS: Screening with twice-weekly single-lead iECG with remote interpretation in ambulatory patients ≥65 years of age at increased risk of stroke is significantly more likely to identify incident AF than RC over a 12-month period. This approach is also highly acceptable to this group of patients, supporting further evaluation in an appropriately powered, event-driven clinical trial. CLINICAL TRIAL REGISTRATION: URL: https://www.isrctn.com. Unique identifier: ISRCTN10709813.

Atrial fibrillation detected by continuous electrocardiographic monitoring using implantable loop recorder to prevent stroke in individuals at risk (the LOOP study): Rationale and design of a large randomized controlled trial.

Atrial fibrillation (AF) increases the rate of stroke 5-fold, and AF-related strokes have a poorer prognosis compared with non-AF-related strokes. Atrial fibrillation and stroke constitute an intensifying challenge, and health care organizations are calling for awareness on the topic. Previous studies have demonstrated that AF is often asymptomatic and consequently undiagnosed. The implantable loop recorder (ILR) allows for continuous, long-term electrocardiographic monitoring with daily transmission of arrhythmia information, potentially leading to improvement in AF detection and stroke prevention. METHODS: The LOOP study is an investigator-initiated, randomized controlled trial with 6,000 participants randomized 3:1 to a control group or to receive an ILR with continuous electrocardiographic monitoring. Participants are identified from Danish registries and are eligible for inclusion if 70years or older and previously diagnosed as having at least one of the following conditions: hypertension, diabetes mellitus, heart failure, or previous stroke. Exclusion criteria include history of AF and current oral anticoagulation treatment. When an AF episode lasting ≥6minutes is detected, oral anticoagulation will be initiated according to guidelines. Expected follow-up is 4years. The primary end point is time to stroke or systemic embolism, whereas secondary end points include time to AF diagnosis and death. CONCLUSION: The LOOP study will evaluate health benefits and cost-effectiveness of ILR as a screening tool for AF to prevent stroke in patients at risk. Secondary objectives include identification of risk factors for the development of AF and characterization of arrhythmias in the population. The trial holds the potential to influence the future of stroke prevention.

Long-Term Continuous Ambulatory ECG Monitors and External Cardiac Loop Recorders for Cardiac Arrhythmia: A Health Technology Assessment.

BACKGROUND: Ambulatory electrocardiography (ECG) monitors are often used to detect cardiac arrhythmia. For patients with symptoms, an external cardiac loop recorder will often be recommended. The improved recording capacity of newer Holter monitors and similar devices, collectively known as longterm continuous ambulatory ECG monitors, suggests that they will perform just as well as, or better than, external loop recorders. This health technology assessment aimed to evaluate the effectiveness, cost-effectiveness, and budget impact of longterm continuous ECG monitors compared with external loop recorders in detecting symptoms of cardiac arrhythmia. METHODS: Based on our systematic search for studies published up to January 15, 2016, we did not identify any studies directly comparing the clinical effectiveness of longterm continuous ECG monitors and external loop recorders. Therefore, we conducted an indirect comparison, using a 24-hour Holter monitor as a common comparator. We used a meta-regression model to control for bias due to variation in device-wearing time and baseline syncope rate across studies. We conducted a similar systematic search for cost-utility and cost-effectiveness studies comparing the two types of devices; none were found. Finally, we used historical claims data (2006-2014) to estimate the future 5-year budget impact in Ontario, Canada, of continued public funding for both types of longterm ambulatory ECG monitors. RESULTS: Our clinical literature search yielded 7,815 non-duplicate citations, of which 12 cohort studies were eligible for indirect comparison. Seven studies assessed the effectiveness of longterm continuous monitors and five assessed external loop recorders. Both types of devices were more effective than a 24-hour Holter monitor, and we found no substantial difference between them in their ability to detect symptoms (risk difference 0.01; 95% confidence interval -0.18, 0.20). Using GRADE for network meta-analysis, we evaluated the quality of the evidence as low. Our budget impact analysis showed that use of the longterm continuous monitors has grown steadily in Ontario since they became publicly funded in 2006, particularly since 2011 when monitors that can record for 14 days or longer became funded, and the use of external cardiac loop recorders has correspondingly declined. The analysis suggests that, with these trends, continued public funding of both types of longterm ambulatory ECG testing will result in additional costs ranging from $130,000 to $370,000 per year over the next 5 years. CONCLUSIONS: Although both longterm continuous ambulatory ECG monitors and external cardiac loop recorders were more effective than a 24-hour Holter monitor in detecting symptoms of cardiac arrhythmia, we found no evidence to suggest that these two devices differ in effectiveness. Assuming that the use of longterm continuous monitors will continue to increase in the next 5 years, the public health care system in Ontario can expect to see added costs of $130,000 to $370,000 per year.

Screening for Atrial Fibrillation using Economical and accurate TechnologY (SAFETY)-a pilot study.

INTRODUCTION: Atrial fibrillation (AF) is a cause of stroke and a marker of atherosclerosis and of all patients with stroke, around 17% have AF. The screening and treatment of AF could prevent about 12% of all strokes. Several relatively low-cost devices with good accuracy now exist which can detect AF including WatchBP and AliveCor. However, they can only measure the ECG or pulse over short time periods. Inexpensive devices such as heart rate monitors, which are widely available, can measure heart rate for prolonged periods and may have potential in screening for AF. This study aims to determine the accuracy of AliveCor and WatchBP along with a bespoke algorithm using a heart rate monitor belt (Polar H7) and a wearable RR interval recorder (Firstbeat Bodyguard 2) for detecting AF during a single screening visit in primary care patients. METHODS/ANALYSIS: A multicentre case-control diagnostic study comparing the four different devices for the detection of AF with a reference standard consisting of a 12-lead ECG in GP surgeries across Hampshire, UK. We aim to recruit 92 participants with AF and 329 without AF aged 65 years and over. We will ask participants to rate comfort and overall impression for each device. We will collect qualitative data from participants capturing their experience of using wearable devices in order to evaluate acceptability. We will collect data from GPs to determine their views on AF screening. ETHICS AND DISSEMINATION: This protocol was approved by the London-City & East Research Ethics Committee in June 2016. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and the Atrial Fibrillation Association, UK. TRIAL REGISTRATION NUMBER: ISRCTN17495003, Pre-results.

The Impact of First Procedure Success Rate on the Economics of Atrial Fibrillation Ablation.

OBJECTIVES: The purpose of this study was to compare health care costs associated with repeat ablation of atrial fibrillation (AF) with health care costs associated with a successful first procedure. BACKGROUND: Catheter ablation has become established as a rhythm control strategy for symptomatic paroxysmal and persistent AF. The economic impact of ablation is not completely understood, and it may be affected by repeat procedures performed for recurrent AF. METHODS: The source of data was the MarketScan (Truven Health, Ann Arbor, Michigan) administrative claims dataset from April 2008 to March 2013, including U.S. patients with private and Medicare supplemental insurance. Patients who underwent an outpatient atrial ablation procedure and a diagnosis of AF were identified. Total health care cost was calculated for 1 year before and after the ablation. Patients were categorized as having undergone a repeat ablation if an additional ablation was performed in the following year. RESULTS: Of 12,027 patients included in the study, repeat ablation was performed in 2,066 (17.2%) within 1 year. Patients with repeat ablation had higher rates of emergency department visits (43.4% vs. 32.2%; < 0.001) and subsequent hospitalization (35.6% vs. 21.5%; p < 0.001), after excluding hospitalizations for the repeat procedure. Total medical cost was higher for patients with repeat ablation ($52,821 vs. $13,412; p < 0.001), and it remained 46% higher even after excluding the cost associated with additional ablations ($19,621 vs. $13,412; p < 0.001). CONCLUSIONS: Health care costs are significantly higher for patients with a repeat ablation for AF than for patients with only a single ablation procedure, even though both groups have similar baseline characteristics. The increased costs persist even after excluding the cost of the repeat ablation itself. These results emphasize the economic benefit of procedural success in AF ablation.

Potential Cost-Effectiveness of Ambulatory Cardiac Rhythm Monitoring After Cryptogenic Stroke.

BACKGROUND AND PURPOSE: Prolonged ambulatory ECG monitoring after cryptogenic stroke improves detection of covert atrial fibrillation, but its long-term cost-effectiveness is uncertain. METHODS: We estimated the cost-effectiveness of noninvasive ECG monitoring in patients aged ≥55 years after a recent cryptogenic stroke and negative 24-hour ECG. A Markov model used observed rates of atrial fibrillation detection and anticoagulation from a randomized controlled trial (EMBRACE) and the published literature to predict lifetime costs and effectiveness (ischemic strokes, hemorrhages, life-years, and quality-adjusted life-years [QALYs]) for 30-day ECG (primary analysis) and 7-day or 14-day ECG (secondary analysis), when compared with a repeat 24-hour ECG. RESULTS: Prolonged ECG monitoring (7, 14, or 30 days) was predicted to prevent more ischemic strokes, decrease mortality, and improve QALYs. If anticoagulation reduced stroke risk by 50%, 30-day ECG (at a cost of USD $447) would be highly cost-effective ($2000 per QALY gained) for patients with a 4.5% annual ischemic stroke recurrence risk. Cost-effectiveness was sensitive to stroke recurrence risk and anticoagulant effectiveness, which remain uncertain, especially at higher costs of monitoring. Shorter duration (7 or 14 days) monitoring was cost saving and more effective than an additional 24-hour ECG; its cost-effectiveness was less sensitive to changes in ischemic stroke risk and treatment effect. CONCLUSIONS: After a cryptogenic stroke, 30-day ECG monitoring is likely cost-effective for preventing recurrent strokes; 14-day monitoring is an attractive value alternative, especially for lower risk patients. These results strengthen emerging recommendations for prolonged ECG monitoring in secondary stroke prevention. Cost-effectiveness in practice will depend on careful patient selection.

Cost comparison of two implantable cardiac monitors in two different settings: Reveal XT in a catheterization laboratory vs. Reveal LINQ in a procedure room.

AIMS: Implantable cardiac monitors (ICMs) are used for long-term heart rhythm monitoring, e.g. to diagnose unexplained syncope or for detection of suspected atrial and ventricular arrhythmias. The newest ICM, Reveal LINQ™ (Medtronic Inc.), is miniaturized and inserted with a specific insertion tool kit. The procedure is therefore minimally invasive and can be moved from catheterization laboratory (cath lab) to a less resource intensive setting. This study aims to assess the change in procedure costs when performed outside the cath lab. METHODS AND RESULTS: A bottom-up costing methodology was used. Data were collected from interviews with physicians, cath lab managers, and financial controllers. Hospitals in the Netherlands, France, and the UK were included in this study. The cost comparison of a Reveal XT implantation in a cath lab setting vs. a Reveal LINQ insertion outside a cath lab resulted in an estimated reduction of €662 for the UK, €682 for the Netherlands, and €781 for France. These cost savings were primarily realized through fewer staff, less equipment, and overhead costs. The net effect on savings depends on the price differential between these two technologies. The patient care pathway can be improved due to the possibility to move the procedure out of the cath lab. CONCLUSION: Inserting the miniaturized version of the ICM is simpler and faster, and the procedure can take place outside the cath lab in a less resource intensive environment. Hospitals save resources when the higher price of the Reveal LINQ does not outweigh these savings.

Small-area low-power heart condition monitoring system using dual-mode SAR-ADC for low-cost wearable healthcare systems.

BACKGROUND: Heart rate monitoring is useful to detect many cardiovascular diseases. It can be implemented in a small device with low power consumption, and it can exploit low-cost piezoelectric pressure sensors to measure heart rate. However, it is also desirable to transmit heartbeat waveform for emergency treatment, which significantly increases transmission power. OBJECTIVE: In this paper, a low-cost wireless heart condition monitoring SoC is proposed. It can monitor and transmit both heart rate and heartbeat waveform, but the hardware is extremely simplified to achieve in a small package. METHODS: By slight modification of successive-approximation analog-digital converter, it can count heart rate and read out heartbeat waveform with the same hardware. In the normal mode, only an 8-bit heart rate is transmitted for power reduction. If the heart rate is out of a given range, it goes to the emergency mode and a 10-bit heartbeat waveform is transmitted for fast treatment. RESULTS: The fabricated chip size is 1.1 mm2 in 0.11 µ m CMOS technology, including the radio-frequency transmitter. The measured power consumption is 161.8 µ W in normal mode and 507.3 µ W in emergency mode, respectively. CONCLUSION: The proposed SoC achieves low-cost, small area, and low-power. It is useful as part of a disposable healthcare system.

A cost-effectiveness analysis of screening for silent atrial fibrillation after ischaemic stroke.

AIMS: The purpose of this study was to estimate the cost-effectiveness of two screening methods for detection of silent AF, intermittent electrocardiogram (ECG) recordings using a handheld recording device, at regular time intervals for 30 days, and short-term 24 h continuous Holter ECG, in comparison with a no-screening alternative in 75-year-old patients with a recent ischaemic stroke. METHODS AND RESULTS: The long-term (20-year) costs and effects of all alternatives were estimated with a decision analytic model combining the result of a clinical study and epidemiological data from Sweden. The structure of a cost-effectiveness analysis was used in this study. The short-term decision tree model analysed the screening procedure until the onset of anticoagulant treatment. The second part of the decision model followed a Markov design, simulating the patients' health states for 20 years. Continuous 24 h ECG recording was inferior to intermittent ECG in terms of cost-effectiveness, due to both lower sensitivity and higher costs. The base-case analysis compared intermittent ECG screening with no screening of patients with recent stroke. The implementation of the screening programme on 1000 patients resulted over a 20-year period in 11 avoided strokes and the gain of 29 life-years, or 23 quality-adjusted life years, and cost savings of €55 400. CONCLUSION: Screening of silent AF by intermittent ECG recordings in patients with a recent ischaemic stroke is a cost-effective use of health care resources saving costs and lives and improving the quality of life.

The effect of late adoption of Canadian innovations: a case for implantable cardiac monitors.

Syncope is a sudden and generally momentary loss of consciousness, which can have serious adverse events. The outcomes of the syncope episode can vary from a fall to fatal accidents. Syncope has a major negative effect on the patient's health-related quality of life. The economic burden of syncope on healthcare systems is considerable. There are no clear diagnostic pathways for identifying the cause of syncope; patients can be admitted to hospital and undergo expensive and often repeated and inconclusive diagnostic tests. Implantable cardiac monitors have been available for more than a decade to help early diagnosis of syncope in unexplained cases. However, despite being a Canadian invention, the use of the implantable cardiac monitors has been suboptimal in the Canadian healthcare system. This study provides an overview of syncope, its management, and presents the estimated potential cost savings per diagnosis of systematic use of implantable cardiac monitors in Ontario.