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

Autoři: Rui Duarte aff001;  Angela Stainthorpe aff001;  James Mahon aff003;  Janette Greenhalgh aff001;  Marty Richardson aff001;  Sarah Nevitt aff001;  Eleanor Kotas aff001;  Angela Boland aff001;  Howard Thom aff005;  Tom Marshall aff006;  Mark Hall aff007;  Yemisi Takwoingi aff006
Působiště autorů: Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, United Kingdom aff001;  Health Economics and Outcomes Research Ltd, Cardiff, United Kingdom aff002;  Coldingham Analytical Services, Berwickshire, United Kingdom aff003;  York Health Economics Consortium, University of York, York, United Kingdom aff004;  Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom aff005;  Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom aff006;  Liverpool Heart and Chest Hospital, Liverpool, United Kingdom aff007;  NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, United Kingdom aff008
Vyšlo v časopise: PLoS ONE 14(12)
Kategorie: Research Article
doi: 10.1371/journal.pone.0226671



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.


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.


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.


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.


No published data evaluating the diagnostic accuracy, clinical impact or cost effectiveness of lead-I ECG devices for the target population are available.


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.


The protocol for this review is registered on PROSPERO as CRD42018090375.

Klíčová slova:

Atrial fibrillation – Cost-effectiveness analysis – Database searching – Diagnostic medicine – Electrocardiography – Medical devices and equipment – Primary care


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