Abstract
Background: Atrial fibrillation (AF) is the most common type of cardiac arrhythmia and is associated with increases in the risk of stroke and congestive heart failure. Lead-I electrocardiogram (ECG) devices are handheld instruments that can be used to detect AF at a single-time point in people who present with relevant signs or symptoms.
Objectives: To assess the diagnostic test accuracy, clinical impact and cost effectiveness of single-time point lead-I ECG devices for the detection of AF in people presenting to primary care with signs or symptoms of AF and who have an irregular pulse compared with manual pulse palpation (MPP) followed by a 12-lead ECG in primary or secondary care.
Methods: The systematic review methods followed published guidance. Two reviewers screened the search results (April 2018), extracted data and assessed the quality of the included studies. Summary estimates of diagnostic accuracy were calculated using bivariate models. An economic model consisting of a decision tree and two cohort Markov models was developed to evaluate the cost effectiveness of lead-I ECG devices.
Results: No studies were identified that evaluated the use of lead-I ECG devices for patients with signs or symptoms of AF. Therefore, the diagnostic accuracy and clinical impact results presented 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%). One study reported limited clinical outcome data. Acceptability of lead-I ECG devices was reported in four studies, with generally positive views.
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.
Conclusions: The use of single-time point lead-I ECG devices 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 in primary or secondary care, given the assumptions used in the base case model. The benefits accumulated during the time interval between the lead-I ECG and confirmatory 12-lead ECG tests are sufficiently large for lead-I ECG devices to be cost effective in this specific population.
Limitations: No published data evaluating the diagnostic accuracy, clinical impact or cost effectiveness of lead-I ECG devices for the population of interest are available.
Future work: Studies assessing how the use of lead-I ECG devices in this population affects the number of people diagnosed with AF when compared with current practice would be useful.
Study registration: The protocol for this review is registered on PROSPERO as CRD42018090375.
Funding: This Diagnostics Assessment Report was commissioned by the NIHR HTA Programme on behalf of the National Institute for Health and Care Excellence as project number 16/30/05.
Objectives: To assess the diagnostic test accuracy, clinical impact and cost effectiveness of single-time point lead-I ECG devices for the detection of AF in people presenting to primary care with signs or symptoms of AF and who have an irregular pulse compared with manual pulse palpation (MPP) followed by a 12-lead ECG in primary or secondary care.
Methods: The systematic review methods followed published guidance. Two reviewers screened the search results (April 2018), extracted data and assessed the quality of the included studies. Summary estimates of diagnostic accuracy were calculated using bivariate models. An economic model consisting of a decision tree and two cohort Markov models was developed to evaluate the cost effectiveness of lead-I ECG devices.
Results: No studies were identified that evaluated the use of lead-I ECG devices for patients with signs or symptoms of AF. Therefore, the diagnostic accuracy and clinical impact results presented 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%). One study reported limited clinical outcome data. Acceptability of lead-I ECG devices was reported in four studies, with generally positive views.
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.
Conclusions: The use of single-time point lead-I ECG devices 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 in primary or secondary care, given the assumptions used in the base case model. The benefits accumulated during the time interval between the lead-I ECG and confirmatory 12-lead ECG tests are sufficiently large for lead-I ECG devices to be cost effective in this specific population.
Limitations: No published data evaluating the diagnostic accuracy, clinical impact or cost effectiveness of lead-I ECG devices for the population of interest are available.
Future work: Studies assessing how the use of lead-I ECG devices in this population affects the number of people diagnosed with AF when compared with current practice would be useful.
Study registration: The protocol for this review is registered on PROSPERO as CRD42018090375.
Funding: This Diagnostics Assessment Report was commissioned by the NIHR HTA Programme on behalf of the National Institute for Health and Care Excellence as project number 16/30/05.
| Original language | English |
|---|---|
| Journal | Health Technology Assessment |
| Publication status | Accepted/In press - 30 Jan 2019 |
