Diagnostic Accuracy of a Smartphone-Operated, Single-Lead Electrocardiography Device for Detection of Rhythm and Conduction Abnormalities in Primary Care

© 2019 Annals of Family Medicine, Inc..

PURPOSE: To validate a smartphone-operated, single-lead electrocardiography (1L-ECG) device (AliveCor KardiaMobile) with an integrated algorithm for atrial fibrillation (AF) against 12-lead ECG (12L-ECG) in a primary care population.

METHODS: We recruited consecutive patients who underwent 12L-ECG for any nonacute indication. Patients held a smartphone with connected 1L-ECG while local personnel simultaneously performed 12L-ECG. All 1L-ECG recordings were assessed by blinded cardiologists as well as by the smartphone-integrated algorithm. The study cardiologists also assessed all 12L-recordings in random order as the reference standard. We determined the diagnostic accuracy of the 1L-ECG in detecting AF or atrial flutter (AFL) as well as any rhythm abnormality and any conduction abnormality with the simultaneously performed 12L-ECG as the reference standard.

RESULTS: We included 214 patients from 10 Dutch general practices. Mean ± SD age was 64.1 ± 14.7 years, and 53.7% of the patients were male. The 12L-ECG diagnosed AF/AFL, any rhythm abnormality, and any conduction abnormality in 23, 44, and 28 patients, respectively. The 1L-ECG as assessed by cardiologists had a sensitivity and specificity for AF/AFL of 100% (95% CI, 85.2%-100%) and 100% (95% CI, 98.1%-100%). The AF detection algorithm had a sensitivity and specificity of 87.0% (95% CI, 66.4%-97.2%) and 97.9% (95% CI, 94.7%-99.4%). The 1L-ECG as assessed by cardiologists had a sensitivity and specificity for any rhythm abnormality of 90.9% (95% CI, 78.3%-97.5%) and 93.5% (95% CI, 88.7%-96.7%) and for any conduction abnormality of 46.4% (95% CI, 27.5%-66.1%) and 100% (95% CI, 98.0%-100%).

CONCLUSIONS: In a primary care population, a smartphone-operated, 1L-ECG device showed excellent diagnostic accuracy for AF/AFL and good diagnostic accuracy for other rhythm abnormalities. The 1L-ECG device was less sensitive for conduction abnormalities.

Medienart:

E-Artikel

Erscheinungsjahr:

2019

Erschienen:

2019

Enthalten in:

Zur Gesamtaufnahme - volume:17

Enthalten in:

Annals of family medicine - 17(2019), 5 vom: 03. Sept., Seite 403-411

Sprache:

Englisch

Beteiligte Personen:

Himmelreich, Jelle C L [VerfasserIn]
Karregat, Evert P M [VerfasserIn]
Lucassen, Wim A M [VerfasserIn]
van Weert, Henk C P M [VerfasserIn]
de Groot, Joris R [VerfasserIn]
Handoko, M Louis [VerfasserIn]
Nijveldt, Robin [VerfasserIn]
Harskamp, Ralf E [VerfasserIn]

Links:

Volltext

Themen:

Atrial fibrillation
Cardiac arrhythmia
Cardiac complexes, premature
Cardiac conduction system disease
Electrocardiography
Journal Article
Medical device
Research Support, Non-U.S. Gov't
Single-lead
Validation Study

Anmerkungen:

Date Completed 05.06.2020

Date Revised 05.06.2020

published: Print

Citation Status MEDLINE

doi:

10.1370/afm.2438

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM301100608