Prospective, multicentre validation of a simple, patient-operated electrocardiographic system for the detection of arrhythmias and electrocardiographic changes

Kaleschke, Gerrit; Hoffmann, Boris; Drewitz, Imke; Steinbeck, Gerhard; Naebauer, M; Goette, Andreas; Breithardt, Günter; Kirchhof, Paulus

doi:10.1093/europace/eup262

Cited by 72 publications

(49 citation statements)

References 23 publications

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“…There were 10 studies with a single set of inclusion criteria (cohort or one-gate studies), 19,60,[63][64][65][66][67][68][69] three studies with two sets of inclusion criteria (case-control or two-gate studies) [70][71][72] and two studies of unclear design. 73,74 One of the case-control studies grouped participants into those with known sustained AF, those with other non-AF arrhythmias and those in sinus rhythm.…”

Section: Methodsmentioning

confidence: 99%

“…Reasons for exclusion were that the study was not a DTA study; that the target condition was not AF (this included studies in which DTA data for AF could not be extracted, for example when AF and atrial flutter were combined); that the information was not per person (i.e. the unit of analysis was not the person, for example the unit of analysis was the reading or the segment of a reading); population reasons (people Four studies awaiting assessment (see Table 1 Seventeen publications 19,36,[60][61][62][63][64][65][66][67][68][69][70][71][72][73][74] (15 studies) containing 56 comparisons of an index test with the reference standard were found to meet the full set of eligibility criteria and were included in the review. One publication contained two eligible studies.…”

Section: Study Selectionmentioning

confidence: 99%

“…68 Age was an inclusion criterion in seven studies. Participants had to be ≥ 18 years in two studies, 63,66 ≥ 35 years in one study, 71 ≥ 60 years in one study, 69 ≥ 65 years in two studies 19,70 and ≥ 75 years in one study. 67 Seven of the studies excluded patients with a pacemaker and/or an implanted defibrillator (in some cases only if they were in active pacing mode).…”

Section: Population and Settingmentioning

confidence: 99%

See 2 more Smart Citations

Screening strategies for atrial fibrillation: a systematic review and cost-effectiveness analysis

Welton

McAleenan

Thom

et al. 2017

Health Technol Assess

122

116

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BackgroundAtrial fibrillation (AF) is a common cardiac arrhythmia that increases the risk of thromboembolic events. Anticoagulation therapy to prevent AF-related stroke has been shown to be cost-effective. A national screening programme for AF may prevent AF-related events, but would involve a substantial investment of NHS resources.ObjectivesTo conduct a systematic review of the diagnostic test accuracy (DTA) of screening tests for AF, update a systematic review of comparative studies evaluating screening strategies for AF, develop an economic model to compare the cost-effectiveness of different screening strategies and review observational studies of AF screening to provide inputs to the model.DesignSystematic review, meta-analysis and cost-effectiveness analysis.SettingPrimary care.ParticipantsAdults.InterventionScreening strategies, defined by screening test, age at initial and final screens, screening interval and format of screening {systematic opportunistic screening [individuals offered screening if they consult with their general practitioner (GP)] or systematic population screening (when all eligible individuals are invited to screening)}.Main outcome measuresSensitivity, specificity and diagnostic odds ratios; the odds ratio of detecting new AF cases compared with no screening; and the mean incremental net benefit compared with no screening.Review methodsTwo reviewers screened the search results, extracted data and assessed the risk of bias. A DTA meta-analysis was perfomed, and a decision tree and Markov model was used to evaluate the cost-effectiveness of the screening strategies.ResultsDiagnostic test accuracy depended on the screening test and how it was interpreted. In general, the screening tests identified in our review had high sensitivity (> 0.9). Systematic population and systematic opportunistic screening strategies were found to be similarly effective, with an estimated 170 individuals needed to be screened to detect one additional AF case compared with no screening. Systematic opportunistic screening was more likely to be cost-effective than systematic population screening, as long as the uptake of opportunistic screening observed in randomised controlled trials translates to practice. Modified blood pressure monitors, photoplethysmography or nurse pulse palpation were more likely to be cost-effective than other screening tests. A screening strategy with an initial screening age of 65 years and repeated screens every 5 years until age 80 years was likely to be cost-effective, provided that compliance with treatment does not decline with increasing age.ConclusionsA national screening programme for AF is likely to represent a cost-effective use of resources. Systematic opportunistic screening is more likely to be cost-effective than systematic population screening. Nurse pulse palpation or modified blood pressure monitors would be appropriate screening tests, with confirmation by diagnostic 12-lead electrocardiography interpreted by a trained GP, with referral to a specialist in the case of an unclear diagnosis. Implementation strategies to operationalise uptake of systematic opportunistic screening in primary care should accompany any screening recommendations.LimitationsMany inputs for the economic model relied on a single trial [the Screening for Atrial Fibrillation in the Elderly (SAFE) study] and DTA results were based on a few studies at high risk of bias/of low applicability.Future workComparative studies measuring long-term outcomes of screening strategies and DTA studies for new, emerging technologies and to replicate the results for photoplethysmography and GP interpretation of 12-lead electrocardiography in a screening population.Study registrationThis study is registered as PROSPERO CRD42014013739.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Methodsmentioning

confidence: 99%

Section: Study Selectionmentioning

confidence: 99%

Section: Population and Settingmentioning

confidence: 99%

See 1 more Smart Citation

Screening strategies for atrial fibrillation: a systematic review and cost-effectiveness analysis

Welton

McAleenan

Thom

et al. 2017

Health Technol Assess

122

116

View full text Add to dashboard Cite

show abstract

“…Powtarzana codzienna rejestracja EKG zwiększała szansę wykrycia niemego klinicznie, bezobjawowego napadowego AF w nieselekcjonowanej szwedzkiej populacji osób w wieku > 75 lat [120,135]. Kilka urządzeń obsługiwanych przez pacjenta [136,137] oraz przedłużone ciągłe monitorowanie EKG za pomocą rejestratorów z elektrodą przyklejaną do skóry [138] uzyskały walidację jako metody wykrywania napadowego AF (dodatkowa ryc. 1) [139].…”

Section: Długotrwałe Monitorowanie W Celu Wykrywania Napadowego Migotunclassified

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

Kirchhof

Benussi

Kotecha³

et al. 2016

Kardiol Pol

2,402

4,206

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“…120 Repeated daily ECG recordings increased the detection of silent, asymptomatic paroxysmal AF in an unselected Swedish population aged .75 years. 120,135 Several patient-operated devices 136,137 and extended continuous ECG monitoring using skin patch recorders 138 have been validated for the detection of paroxysmal AF (Web Figure 1). 139 The detection of asymptomatic AF by new technologies, such as smartphone cases with ECG electrodes, smart watches, and blood pressure machines with AF detection algorithms, has not yet been formally evaluated against an established arrhythmia detection method.…”

Section: Prolonged Monitoring For Paroxysmal Atrial Fibrillationmentioning

confidence: 99%

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

Kirchhof¹,

Benussi²,

Kotecha³

et al. 2016

Eur J Cardiothorac Surg

931

625

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Prospective, multicentre validation of a simple, patient-operated electrocardiographic system for the detection of arrhythmias and electrocardiographic changes

Cited by 72 publications

References 23 publications

Screening strategies for atrial fibrillation: a systematic review and cost-effectiveness analysis

Screening strategies for atrial fibrillation: a systematic review and cost-effectiveness analysis

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

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