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
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Published on: December 11, 2019
Rui Duarte1, Angela Stainthorpe1,2, James Mahon3
1Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, United Kingdom.
Insights
Handheld lead-I ECG devices show high accuracy in detecting atrial fibrillation (AF) in primary care. These devices are a cost-effective alternative to traditional methods, improving patient outcomes.
Area of Science:
- Cardiology
- Medical Devices
- Health Economics
Background:
- Atrial fibrillation (AF) is a common arrhythmia linked to stroke and heart failure.
- Lead-I electrocardiogram (ECG) devices offer single-time point AF detection.
Purpose of the Study:
- To evaluate the diagnostic accuracy, clinical impact, and cost-effectiveness of lead-I ECG devices versus manual pulse palpation (MPP) and 12-lead ECG for AF detection in symptomatic primary care patients with irregular pulse.
Main Methods:
- Systematic review of electronic databases (MEDLINE, EMBASE, Cochrane) up to March 2018.
- Diagnostic accuracy assessed using bivariate models; cost-effectiveness evaluated with a de novo economic model.
Main Results:
- Lead-I ECG devices demonstrated high summary sensitivity (93.9%) and specificity (96.5%).
- Economic modeling indicated lead-I ECG devices are cost-effective, with Kardia Mobile being the most cost-effective option.
- These devices may identify more AF cases than the standard pathway, offering greater patient benefit.
Conclusions:
- Single-time point lead-I ECG devices represent a cost-effective use of NHS resources for AF detection in primary care.
- They offer a viable alternative to MPP followed by 12-lead ECG, improving patient outcomes.
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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