Lead-I ECG for detecting atrial fibrillation in patients attending primary care with an irregular pulse using single-time point testing: A systematic review and economic evaluation
Open accessAbstract
BACKGROUND: Atrial fibrillation (AF) is the most common type of cardiac arrhythmia and is associated with increased risk of stroke and congestive heart failure. Lead-I electrocardiogram (ECG) devices are handheld instruments that can detect AF at a single-time point. PURPOSE: To assess the diagnostic test accuracy, clinical impact and cost effectiveness of single-time point lead-I ECG devices compared with manual pulse palpation (MPP) followed by a 12-lead ECG for the detection of AF in symptomatic primary care patients with an irregular pulse. METHODS: Electronic databases (MEDLINE, MEDLINE Epub Ahead of Print and MEDLINE In-Process, EMBASE, PubMed and Cochrane Databases of Systematic Reviews, Cochrane Central Database of Controlled Trials, Database of Abstracts of Reviews of Effects, Health Technology Assessment Database) were searched to March 2018. Two reviewers screened the search results, extracted data and assessed study quality. Summary estimates of diagnostic accuracy were calculated using bivariate models. Cost-effectiveness was evaluated using an economic model consisting of a decision tree and two cohort Markov models. RESULTS: Diagnostic accuracy The diagnostic accuracy (13 publications reporting on nine studies) and clinical impact (24 publications reporting on 19 studies) results are derived from an asymptomatic population (used as a proxy for people with signs or symptoms of AF). The summary sensitivity of lead-I ECG devices was 93.9% (95% confidence interval [CI]: 86.2% to 97.4%) and summary specificity was 96.5% (95% CI: 90.4% to 98.8%). Cost effectiveness The de novo economic model yielded incremental cost effectiveness ratios (ICERs) per quality adjusted life year (QALY) gained. The results of the pairwise analysis show that all lead-I ECG devices generate ICERs per QALY gained below the £20,000-£30,000 threshold. Kardia Mobile is the most cost effective option in a full incremental analysis. Lead-I ECG tests may identify more AF cases than the standard diagnostic pathway. This comes at a higher cost but with greater patient benefit in terms of mortality and quality of life. LIMITATIONS: No published data evaluating the diagnostic accuracy, clinical impact or cost effectiveness of lead-I ECG devices for the target population are available. CONCLUSIONS: The use of single-time point lead-I ECG devices in primary care for the detection of AF in people with signs or symptoms of AF and an irregular pulse appears to be a cost effective use of NHS resources compared with MPP followed by a 12-lead ECG, given the assumptions used in the base case model. REGISTRATION: The protocol for this review is registered on PROSPERO as CRD42018090375.
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Lead I represents the standard lead obtained from wearable devices.
“Lead I was chosen as it represents the standard lead obtained from wearable devices11.”
From Detection of left ventricular systolic dysfunction from single-lead electrocardiography adapted for portable and wearable devices (2023) · cites this paper as [11]
The Introduction (page unavailable) describes lead-I ECG devices as handheld instruments that simulate Lead I of a 12-lead ECG. A search for wearable devices found no passage saying that Lead I is the standard lead obtained from them. (LLM, conf=0.72)
Experimental — accuracy not yet measured
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The Use of Wearable ECG Devices in the Clinical Setting: A Review
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- Authors
- Duarte, R., Stainthorpe, A., Mahon, J., Greenhalgh, J., Richardson, M., Nevitt, S., Kotas, E., Boland, A., Thom, H., Marshall, T., Hall, M., & Takwoingi, Y.
- Affiliations
- University of Liverpool (GB)
- University of Bristol (GB)
- University of Birmingham (GB)
- Liverpool Heart and Chest Hospital (GB)
- University Hospitals Birmingham NHS Foundation Trust (GB)
- Corresponding author
- Duarte, Rui
- ORCID
- Venue
- PLOS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2019-12-23
- Volume
- 14
- Issue
- 12
- Pages
- e0226671
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC6927656
- OpenAlex
- W2996595048
- Cited by
- 28
- References
- 8
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 7 · 2023: 5 · 2022: 3 · 2021: 4 · 2020: 3
- FWCI
- 0.45
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS ONE (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, cc-by)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Figshare (submittedVersion, cc-by)
- Explore Bristol Research (submittedVersion, cc-by)
- Funders
- Health Technology Assessment Programme (16/30/05)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › ECG Monitoring and Analysis
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
- Keywords
- atrial fibrillation, irregular pulse, pulse palpation, 12-lead ECG, diagnostic accuracy, cost-effectiveness, primary care, quality-adjusted life years, arrhythmia detection, stroke risk, mortality, quality of life, decision tree, Markov model, economic evaluation, sensitivity and specificity
- MeSH terms
- Aged, Aged, 80 and over, Atrial Fibrillation, Cost-Benefit Analysis, Electrocardiography, Female, Humans, Male, Markov Chains, Middle Aged, Primary Health Care, Pulse
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