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Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study
Abstract
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.
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“Although such systems can support various types of biophysical measurements of physiological health (8–13), additional advances are needed to meet the challenging requirements of the NICU, where comprehensive, continuous sensing with wireless functionality, clinical-grade measurement fidelity, and mechanical form factors that eliminate risk of harm to exceptionally fragile neonatal skin are essent”
From Binodal, wireless epidermal electronic systems with in-sensor analytics for neonatal intensive care (2019) · cites this paper as [12]
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“The recent REHEARSE-AF study (19) showed that remote ECG monitoring with Kardia in ambulatory patients is more likely to identify atrial fibrillation than routine care.”
From Artificial Intelligence in Medicine: Today and Tomorrow (2020) · cites this paper as [19]
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“Whilst AliveCor has now undergone assessment against conventional care for AF detection [25], it has yet to be assessed against standard care for the broader investigation of palpitations and arrhythmia assessment.”
From Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study (2019) · cites this paper as [25]
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“A recent trial comparing AliveCor’s technology with routine care (n = 1001) resulted in a nearly fourfold increase in atrial fibrillation diagnosis [15].”
From Wearables and the Medical Revolution (2018) · cites this paper as [15]
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Cites
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2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
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Power and sample size calculations
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Hindricks, G., Potpara, T., Dagres, N., Arbelo, E., Bax, J. J., Blomström‐Lundqvist, C., Boriani, G., Castella, M., Dan, G.-A., Dilaveris, P., et al. (2020) · European Heart Journal · doi:10.1093/eurheartj/ehaa612 · Cited by 10,550
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Binodal, wireless epidermal electronic systems with in-sensor analytics for neonatal intensive care
Chung, H. U., Kim, B. H., Lee, J. Y., Lee, J., Xie, Z., Ibler, E. M., Lee, K., Banks, A., Jeong, J. Y., Kim, J., et al. (2019) · Science · doi:10.1126/science.aau0780 · Cited by 807
Metadata
- Authors
- Halcox, J. P. J., Wareham, K., Cardew, A., Gilmore, M., Barry, J. P., Phillips, C., & Gravenor, M. B.
- Affiliations
- Morriston Hospital (GB)
- From Swansea University Medical School, UK (J.P.J.H., K.W., M.B.G.); Swansea University College of Health and Human Sciences, UK (C.P., A.C.); Princess of Wales Hospital, Cardiology, Bridgend, UK (M.G.); and Regional Cardiac Centre, Morriston Hospital, Swansea, UK (J.P.B.).
- Venue
- Circulation
- Published
- 2017-11-07
- Volume
- 136
- Issue
- 19
- Pages
- 1784-1794
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- OpenAlex
- W2752766789
- Cited by
- 580
- References
- 44
- Citations by year
- 2026: 31 · 2025: 53 · 2024: 60 · 2023: 67 · 2022: 67 · 2021: 96 · 2020: 76 · 2019: 72 · 2018: 52 · 2017: 6
- FWCI
- 43.28
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Circulation (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › ECG Monitoring and Analysis
- Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
- Keywords
- atrial fibrillation, stroke prevention, systemic embolism, patient satisfaction, older adults, anticoagulation, ischemic stroke risk stratification
- MeSH terms
- Action Potentials, Aged, Algorithms, Atrial Fibrillation, Cost-Benefit Analysis, Equipment Design, Female, Heart Conduction System, Heart Rate, Humans, Male, Predictive Value of Tests, Prognosis, Prospective Studies, Signal Processing, Computer-Assisted, Telemetry, Time Factors, Wales, Reproducibility of Results, Electrocardiography, Ambulatory, Health Care Costs, Telemedicine, Computers, Handheld, Asymptomatic Diseases, Remote Sensing Technology, Mobile Applications
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