Open AccessNecklace‐embedded electrocardiogram for the detection and diagnosis of atrial fibrillation
Author(s) -
Santala Onni E.,
Lipponen Jukka A.,
Jäntti Helena,
Rissanen Tuomas T.,
Halonen Jari,
Kolk Indrek,
PohjantähtiMaaroos Hanna,
Tarvainen Mika P.,
Väliaho EemuSamuli,
Hartikainen Juha,
Martikainen Tero
Publication year - 2021
Publication title -
clinical cardiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.263
H-Index - 72
eISSN - 1932-8737
pISSN - 0160-9289
DOI - 10.1002/clc.23580
Subject(s) - medicine , atrial fibrillation , necklace , cardiology , asymptomatic , sinus rhythm , gold standard (test) , electrocardiography , normal sinus rhythm , premature atrial contraction , mathematics , combinatorics
Abstract Background Atrial fibrillation (AF) is the major cause of stroke since approximately 25% of all strokes are of cardioembolic‐origin. The detection and diagnosis of AF are often challenging due to the asymptomatic and intermittent nature of AF. Hypothesis A wearable electrocardiogram (ECG)‐device could increase the likelihood of AF detection. The aim of this study was to evaluate the feasibility and reliability of a novel, consumer‐grade, single‐lead ECG recording device (Necklace‐ECG) for screening, identifying and diagnosing of AF both by a cardiologist and automated AF‐detection algorithms. Methods A thirty‐second ECG was recorded with the Necklace‐ECG device from two positions; between the palms (palm) and between the palm and the chest (chest). Simultaneously registered 3‐lead ECGs (Holter) served as a golden standard for the final rhythm diagnosis. Two cardiologists interpreted independently in a blinded fashion the Necklace‐ECG recordings from 145 patients (66 AF and 79 sinus rhythm, SR). In addition, the Necklace‐ECG recordings were analyzed with an automatic AF detection algorithm. Results Two cardiologists diagnosed the correct rhythm of the interpretable Necklace‐ECG with a mean sensitivity of 97.2% and 99.1% (palm and chest, respectively) and specificity of 100% and 98.5%. The automatic arrhythmia algorithm detected the correct rhythm with a sensitivity of 94.7% and 98.3% (palm and chest) and specificity of 100% of the interpretable measurements. Conclusions The novel Necklace‐ECG device is able to detect AF with high sensitivity and specificity as evaluated both by cardiologists and an automated AF‐detection algorithm. Thus, the wearable Necklace‐ECG is a new, promising method for AF screening. Clinical trial registration: Study was registered in the ClinicalTrials.gov database (NCT03753139).