Lead-I ECG for detecting atrial fibrillation in patients with an irregular pulse using single time point testing: a systematic review and economic evaluation

Background Atrial fibrillation (AF) is the most common type of cardiac arrhythmia and is associated with an increased 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. Objective To assess the diagnostic test accuracy, clinical impact and cost-effectiveness of using single time point lead-I ECG devices for the detection of AF in people presenting to primary care with relevant signs or symptoms, and who have an irregular pulse compared with using manual pulse palpation (MPP) followed by a 12-lead ECG in primary or secondary care. Data sources MEDLINE, MEDLINE Epub Ahead of Print and MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, PubMed, Cochrane Databases of Systematic Reviews, Cochrane Central Database of Controlled Trials, Database of Abstracts of Reviews of Effects and the Health Technology Assessment Database. Methods The systematic review methods followed published guidance. Two reviewers screened the search results (database inception to 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 generated ICERs per QALY gained below the £20,000–30,000 threshold. Kardia Mobile (AliveCor Ltd, Mountain View, CA, USA) is the most cost-effective option in a full incremental analysis. 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. Conclusions Single time point lead-I ECG devices for the detection of AF in people with signs or symptoms of AF and an irregular pulse appear 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. 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 This study is registered as PROSPERO CRD42018090375. Funding The National Institute for Health Research Health Technology Assessment programme.

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P6538Validity of two weeks daily self pulse-palpation for opportunistic screening for atrial fibrillation among patients 65 years and older

European Heart Journal ◽

10.1093/eurheartj/ehz746.1128 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

F Ghazal ◽

F Al-Khalili ◽

M Rosenqvist

Keyword(s):

Atrial Fibrillation ◽

Positive Predictive Value ◽

Negative Predictive Value ◽

Predictive Value ◽

Single Time ◽

Measurement Occasion ◽

Pulse Palpation ◽

Single Time Point ◽

Irregular Pulse ◽

Time Point

Abstract Background Pulse-palpation is recommended (ESC IA) for single time-point screening for atrial fibrillation (AF). AF may, however, be paroxysmal which can make AF detection difficult to detect on single time-point measurement. Intermittent ECG recording is a sensitive method to detect AF. However, the role of pulse-palpation for AF detection has not been validated against simultaneous ECG recordings. Purpose To study the validity of AF detection using self pulse-palpation simultaneously with hand-hold ECG recording 3 times daily for two weeks for AF. Method Patients 65 years and older visiting four primary health care centers, four any reason, were invited to AF screening from July 2017 to December 2018. Hand-held intermittent ECG recordings, 30 seconds three times a day, was offered to participants without AF for a period of 2 weeks. Patients were instructed how to take their own pulse, simultaneously with intermittent ECG measurement and in written to note whether it was irregular or not. Results A total of 1010 patients (mean age 73 years, 61% women) participated in the study, 27 new cases of AF (mostly paroxysmal) were detected. Totally 53 782 simultaneous ECG-recordings and pulse-measurements were registered. AF was verified in 311 ECG-recordings but the pulse was palpated as irregular only in 77 of these recordings (25% sensitivity per measurement-occasion). Of those 27 detected AF cases, 15 cases felt their pulse as irregular at least at once occasion (56% sensitivity per individuals). 187 individuals without AF felt their pulse as irregular in at least one occasion. The specificity per measurement-occasion and per individuals were 98% and 81% respectively. Diagnostic odds ratio was 5.3. AF 27 patients No AF 983 patients Irregular pulse 202 individuals 15 187 Regular pulse 808 individuals 12 796 Sensitivity 56% Specificity 81% Positive Predictive Value 7% Negative Predictive Value 99% AF 311 measurements No AF 53471 measurements Irregular pulse 1046 measurements 77 969 Regular pulse 52,736 measurements 234 52,502 Sensitivity 25% Specificity 98% Positive Predictive Value 7% Negative Predictive Value 99% Conclusion AF screening using own pulse-palpation 3 times daily for two weeks is feasible but has a low sensitivity for AF detection. Acknowledgement/Funding This study was supported by the Swedish Heart and Lung Foundation, Pfizer, Boehringer-Ingelheim and Bayer

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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

PLoS ONE ◽

10.1371/journal.pone.0226671 ◽

2019 ◽

Vol 14 (12) ◽

pp. e0226671 ◽

Cited By ~ 3

Author(s):

Rui Duarte ◽

Angela Stainthorpe ◽

James Mahon ◽

Janette Greenhalgh ◽

Marty Richardson ◽

...

Keyword(s):

Atrial Fibrillation ◽

Systematic Review ◽

Primary Care ◽

Economic Evaluation ◽

Single Time ◽

Single Time Point ◽

Irregular Pulse ◽

Time Point

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Single time-point AF screening does not appear to be cost effective in older patients in Germany

PharmacoEconomics & Outcomes News ◽

10.1007/s40274-021-08002-4 ◽

2021 ◽

Vol 886 (1) ◽

pp. 24-24

Keyword(s):

Older Patients ◽

Cost Effective ◽

Single Time ◽

Single Time Point ◽

Time Point

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A programme of studies including assessment of diagnostic accuracy of school hearing screening tests and a cost-effectiveness model of school entry hearing screening programmes

Health Technology Assessment ◽

10.3310/hta20360 ◽

2016 ◽

Vol 20 (36) ◽

pp. 1-178 ◽

Cited By ~ 15

Author(s):

Heather Fortnum ◽

Obioha C Ukoumunne ◽

Chris Hyde ◽

Rod S Taylor ◽

Mara Ozolins ◽

...

Keyword(s):

Cost Effectiveness ◽

Diagnostic Accuracy ◽

Hearing Impairment ◽

Cost Effective ◽

Health Technology ◽

Hearing Screening ◽

School Entry ◽

Screening Tests ◽

The Uk ◽

The Cost

BackgroundIdentification of permanent hearing impairment at the earliest possible age is crucial to maximise the development of speech and language. Universal newborn hearing screening identifies the majority of the 1 in 1000 children born with a hearing impairment, but later onset can occur at any time and there is no optimum time for further screening. A universal but non-standardised school entry screening (SES) programme is in place in many parts of the UK but its value is questioned.ObjectivesTo evaluate the diagnostic accuracy of hearing screening tests and the cost-effectiveness of the SES programme in the UK.DesignSystematic review, case–control diagnostic accuracy study, comparison of routinely collected data for services with and without a SES programme, parental questionnaires, observation of practical implementation and cost-effectiveness modelling.SettingSecond- and third-tier audiology services; community.ParticipantsChildren aged 4–6 years and their parents.Main outcome measuresDiagnostic accuracy of two hearing screening devices, referral rate and source, yield, age at referral and cost per quality-adjusted life-year.ResultsThe review of diagnostic accuracy studies concluded that research to date demonstrates marked variability in the design, methodological quality and results. The pure-tone screen (PTS) (Amplivox, Eynsham, UK) and HearCheck (HC) screener (Siemens, Frimley, UK) devices had high sensitivity (PTS ≥ 89%, HC ≥ 83%) and specificity (PTS ≥ 78%, HC ≥ 83%) for identifying hearing impairment. The rate of referral for hearing problems was 36% lower with SES (Nottingham) relative to no SES (Cambridge) [rate ratio 0.64, 95% confidence interval (CI) 0.59 to 0.69;p < 0.001]. The yield of confirmed cases did not differ between areas with and without SES (rate ratio 0.82, 95% CI 0.63 to 1.06;p = 0.12). The mean age of referral did not differ between areas with and without SES for all referrals but children with confirmed hearing impairment were older at referral in the site with SES (mean age difference 0.47 years, 95% CI 0.24 to 0.70 years;p < 0.001). Parental responses revealed that the consequences to the family of the referral process are minor. A SES programme is unlikely to be cost-effective and, using base-case assumptions, is dominated by a no screening strategy. A SES programme could be cost-effective if there are fewer referrals associated with SES programmes or if referrals occur more quickly with SES programmes.ConclusionsA SES programme using the PTS or HC screener is unlikely to be effective in increasing the identified number of cases with hearing impairment and lowering the average age at identification and is therefore unlikely to represent good value for money. This finding is, however, critically dependent on the results of the observational study comparing Nottingham and Cambridge, which has limitations. The following are suggested: systematic reviews of the accuracy of devices used to measure hearing at school entry; characterisation and measurement of the cost-effectiveness of different approaches to the ad-hoc referral system; examination of programme specificity as opposed to test specificity; further observational comparative studies of different programmes; and opportunistic trials of withdrawal of SES programmes.Trial registrationCurrent Controlled Trials ISRCTN61668996.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 36. See the NIHR Journals Library website for further project information.

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MRI-guided pulmonary vein isolation for atrial fibrillation: what is good enough? An early health technology assessment

Open Heart ◽

10.1136/openhrt-2019-001014 ◽

2019 ◽

Vol 6 (2) ◽

pp. e001014

Author(s):

Steven Wenker ◽

Chris van Lieshout ◽

Geert Frederix ◽

Jeroen van der Heijden ◽

Peter Loh ◽

...

Keyword(s):

Atrial Fibrillation ◽

Cost Effectiveness ◽

Health Technology Assessment ◽

Pulmonary Vein ◽

Technology Assessment ◽

Clinical Effectiveness ◽

Cost Effective ◽

Health Technology ◽

Mri Guided ◽

Effectiveness Threshold

Next to anticoagulation, pulmonary vein isolation (PVI) is the most important interventional procedure in the treatment of atrial fibrillation (AF). Despite widespread clinical application of this therapy, patients often require multiple procedures to reach clinical success. In contrast to conventional imaging modalities, MRI allows direct visualisation of the ablation lesion. Therefore, the use of real-time MRI to guide cardiac electrophysiology procedures may increase clinical effectiveness. An essential aspect, from a decision-making point of view, is the effect on costs and the potential cost-effectiveness of new technologies. Generally, health technology assessment (HTA) studies are performed when innovations are close to clinical application. However, early stage HTA can inform users, researchers and funders about the ultimate clinical and economic potential of a future innovation. Ultimately, this can guide funding allocation. In this study, we performed an early HTA evaluate MRI-guided PVIs.MethodsWe performed an economic evaluation using a decision tree with a time-horizon of 1 year. We calculated the clinical effectiveness (defined as the proportion of patients that is long-term free of AF after a single procedure) required for MRI-guided PVI to be cost-effective compared with conventional treatment.ResultsDepending on the cost-effectiveness threshold (willingness to pay for one additional quality-of-life adjusted life year (QALY), interventional MRI (iMRI) guidance for PVI can be cost-effective if clinical effectiveness is 69.8% (at €80 000/QALY) and 77.1% (at €20 000/QALY), compared with 64% for fluoroscopy-guided procedures.ConclusionUsing an early HTA, we established a clinical effectiveness threshold for interventional MRI-guided PVIs that can inform a clinical implementation strategy. If crucial technologies are developed, it seems plausible that iMRI-guided PVIs will be able to reach this threshold.

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Clinical Factors Associated with Atrial Fibrillation Detection on Single-Time Point Screening Using a Hand-Held Single-Lead ECG Device

Journal of Clinical Medicine ◽

10.3390/jcm10040729 ◽

2021 ◽

Vol 10 (4) ◽

pp. 729 ◽

Cited By ~ 1

Author(s):

Giuseppe Boriani ◽

Pietro Palmisano ◽

Vincenzo Livio Malavasi ◽

Elisa Fantecchi ◽

Marco Vitolo ◽

...

Keyword(s):

Atrial Fibrillation ◽

Negative Predictive Value ◽

Predictive Value ◽

High Sensitivity ◽

Lower Sensitivity ◽

Single Time ◽

High Negative Predictive Value ◽

Low Sensitivity ◽

Single Time Point ◽

Time Point

Our aim was to assess the prevalence of unknown atrial fibrillation (AF) among adults during single-time point rhythm screening performed during meetings or social recreational activities organized by patient groups or volunteers. A total of 2814 subjects (median age 68 years) underwent AF screening by a handheld single-lead ECG device (MyDiagnostick). Overall, 56 subjects (2.0%) were diagnosed with AF, as a result of 12-lead ECG following a positive/suspected recording. Screening identified AF in 2.9% of the subjects ≥ 65 years. None of the 265 subjects aged below 50 years was found positive at AF screening. Risk stratification for unknown AF based on a CHA2DS2VASc > 0 in males and >1 in females (or CHA2DS2VA > 0) had a high sensitivity (98.2%) and a high negative predictive value (99.8%) for AF detection. A slightly lower sensitivity (96.4%) was achieved by using age ≥ 65 years as a risk stratifier. Conversely, raising the threshold at ≥75 years showed a low sensitivity. Within the subset of subjects aged ≥ 65 a CHA2DS2VASc > 1 in males and >2 in females, or a CHA2DS2VA > 1 had a high sensitivity (94.4%) and negative predictive value (99.3%), while age ≥ 75 was associated with a marked drop in sensitivity for AF detection.

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