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Cost Effectiveness of Implantable Cardiac Monitor-Guided Intermittent Anticoagulation for Atrial Fibrillation: An Analysis of the REACT.COM Pilot Study.

ABSTRACT: INTRODUCTION:Anticoagulation guidelines for patients with atrial fibrillation (AF) disregard AF burden. A strategy of targeted anticoagulation with novel oral anticoagulants (NOACs) based on continuous rhythm assessment with an implantable cardiac monitor (ICM) has recently been explored. We evaluated the potential cost-effectiveness of this strategy versus projected outcomes with continuous anticoagulation. METHODS AND RESULTS:We developed a Markov model using data from the Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring (REACT.COM) pilot study (N = 59) and prior NOAC trials to calculate the costs and quality-adjusted life years (QALYs) associated with ICM-guided intermittent anticoagulation for AF versus standard care during a 3-year time horizon. Health state utilities were estimated from the pilot study population using the SF-12. Costs were based on current Medicare reimbursement. Over 14 ± 4 months of follow-up, 18 of 59 patients had 35 AF episodes. The ICM-guided strategy resulted in a 94% reduction in anticoagulant use relative to continuous treatment. There were no strokes, 3 (5.1%) TIAs, 2 major bleeding events (on aspirin) and 3 minor bleeding events with the ICM-guided strategy. The projected total 3-year costs were $12,535 for the ICM-guided strategy versus $13,340 for continuous anticoagulation. Projected QALYs were 2.45 for both groups. CONCLUSION:Based on a pilot study, a strategy of ICM-guided anticoagulation with NOACs may be cost-saving relative to expected outcomes with continuous anticoagulation, with similar quality-adjusted survival. This strategy could be attractive from a health economic perspective if shown to be safe and effective in a rigorous clinical trial.

SUBMITTER: Steinhaus DA

PROVIDER: S-EPMC5334450 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Cost Effectiveness of Implantable Cardiac Monitor-Guided Intermittent Anticoagulation for Atrial Fibrillation: An Analysis of the REACT.COM Pilot Study.

Steinhaus Daniel A DA Zimetbaum Peter J PJ Passman Rod S RS Leong-Sit Peter P Reynolds Matthew R MR

Journal of cardiovascular electrophysiology 20161004 11

<h4>Introduction</h4>Anticoagulation guidelines for patients with atrial fibrillation (AF) disregard AF burden. A strategy of targeted anticoagulation with novel oral anticoagulants (NOACs) based on continuous rhythm assessment with an implantable cardiac monitor (ICM) has recently been explored. We evaluated the potential cost-effectiveness of this strategy versus projected outcomes with continuous anticoagulation.<h4>Methods and results</h4>We developed a Markov model using data from the Rhyth ...[more]

PMID: 27571718

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Project description:BackgroundLimited information is available on paroxysmal atrial fibrillation (PAF) in the horse. Indeed, undiagnosed PAF could result in poor performance. Due to the intermittent occurrence, PAF is difficult to diagnose. However, implanting a small ECG device (implantable loop recorder, ILR) subcutaneously, allows the continuous and automatic detection of PAF.ObjectivesThe aim was to investigate the potential of ILRs as a tool for diagnosing PAF in horses with poor performance.Study designProspective field study.MethodsTwelve racing Standardbred trotters with intermittent reduced performance (mean age: six years) were enrolled prospectively. The ILR was implanted subcutaneously at the fifth or sixth left intercostal space and data from the ILR was collected during the study period in which the horses were followed for a median duration of 7.5 month (range 6-28).ResultsThe ILR was able to detect PAF in four out of twelve racehorses. The ILR also detected sustained atrial fibrillation (AF) in one horse during the study. The ILRs rely on RR detection and R waves were correctly identified in 96%. One hundred episodes were categorised as AF by the ILRs and subsequently visual ECG inspection categorised 12 as sinus rhythm (SR), 28 as sinus arrhythmia (SA), 14 as other arrhythmias and 46 as AF episodes. The Root Mean Square of the Successive Differences (RMSSD) values were significantly increased for AF compared to SR and SA.Main limitationsFew horses included and duration of study period varied among the horses. Further it was not possible to assess the sensitivity of the device in the current study and the ILRs proved to have a high rate of false positive misclassifications.ConclusionsThis study indicates that ILRs can be used for detection of PAF episodes and could be a useful ECG tool for horses presenting with poor performance. This methodology provides a platform to facilitate the long-term assessment of AF development and quantification of AF burden in horses. Further studies including both healthy and poor performing horses are needed in order to learn more about PAF prevalence in racehorses.

Project description:ImportanceUndiagnosed atrial fibrillation (AF) is an important cause of stroke. Screening for AF using wrist-worn wearable devices may prevent strokes, but their cost-effectiveness is unknown.ObjectiveTo evaluate the cost-effectiveness of contemporary AF screening strategies, particularly wrist-worn wearable devices.Design setting and participantsThis economic evaluation used a microsimulation decision-analytic model and was conducted from September 8, 2020, to May 23, 2022, comprising 30 million simulated individuals with an age, sex, and comorbidity profile matching the US population aged 65 years or older.InterventionsEight AF screening strategies, with 6 using wrist-worn wearable devices (watch or band photoplethysmography, with or without watch or band electrocardiography) and 2 using traditional modalities (ie, pulse palpation and 12-lead electrocardiogram) vs no screening.Main outcomes and measuresThe primary outcome was the incremental cost-effectiveness ratio, defined as US dollars per quality-adjusted life-year (QALY). Secondary measures included rates of stroke and major bleeding.ResultsIn the base case analysis of this model, the mean (SD) age was 72.5 (7.5) years, and 50% of the individuals were women. All 6 screening strategies using wrist-worn wearable devices were estimated to be more effective than no screening (range of QALYs gained vs no screening, 226-957 per 100 000 individuals) and were associated with greater relative benefit than screening using traditional modalities (range of QALYs gained vs no screening, -116 to 93 per 100 000 individuals). Compared with no screening, screening using wrist-worn wearable devices was associated with a reduction in stroke incidence by 20 to 23 per 100 000 person-years but an increase in major bleeding by 20 to 44 per 100 000 person-years. The overall preferred strategy was wearable photoplethysmography, followed conditionally by wearable electrocardiography with patch monitor confirmation, which had an incremental cost-effectiveness ratio of $57 894 per QALY, meeting the acceptability threshold of $100 000 per QALY. The cost-effectiveness of screening was consistent across multiple scenarios, including strata of sex, screening at earlier ages (eg, ≥50 years), and with variation in the association of anticoagulation with risk of stroke in the setting of screening-detected AF.Conclusions and relevanceThis economic evaluation of AF screening using a microsimulation decision-analytic model suggests that screening using wearable devices is cost-effective compared with either no screening or AF screening using traditional methods.

Project description:BACKGROUND:Atrial fibrillation (AF) represents the most common sustained cardiac arrhythmia. A service evaluation was carried out at an anticoagulation clinic in Newcastle upon-Tyne to explore the efficacy of introducing self-testing of anticoagulation status for AF patients on warfarin. The analysis presented aims to assess the potential cost savings and clinical outcomes associated with introducing self-testing at a clinic in the Northeast of England, and to determine the cost-effectiveness of a redesigned treatment pathway including genetic testing and self-testing components. METHODS:Questionnaires were administered to individuals participating in the service evaluation to understand the patient costs associated with clinical monitoring (139 patients), and quality-of-life before and after the introduction of self-testing (varying numbers). Additionally, data on time in therapeutic range (TTR) were captured at multiple time points to identify any change in outcome. Finally, an economic model was developed to assess the cost-effectiveness of introducing a redesigned treatment pathway, including genetic testing and self-testing, for AF patients. RESULTS:The average cost per patient of attending the anticoagulation clinic was £16.24 per visit (including carer costs). Costs were higher amongst patients tested at the hospital clinic than those tested at the community clinic. Improvements in quality-of-life across all psychological topics, and improved TTR, were seen following the introduction of self-testing. Results of the cost-effectiveness analysis showed that the redesigned treatment pathway was less costly and more effective than current practice. CONCLUSIONS:Allowing AF patients on warfarin to self-test, rather than attend clinic to have their anticoagulation status assessed, has the potential to reduce patient costs. Additionally, self-testing may result in improved quality-of-life and TTR. Introducing genetic testing to guide patient treatment based on sensitivity to warfarin, and applying this in combination with self-testing, may also result in improved patient outcomes and reduced costs to the health service in the long-term.

Dataset Information

Cost Effectiveness of Implantable Cardiac Monitor-Guided Intermittent Anticoagulation for Atrial Fibrillation: An Analysis of the REACT.COM Pilot Study.

Publications

Cost Effectiveness of Implantable Cardiac Monitor-Guided Intermittent Anticoagulation for Atrial Fibrillation: An Analysis of the REACT.COM Pilot Study.

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