Wearable Dynamic Electrocardiogram Monitor Based Screening For 2024
Wearable Dynamic Electrocardiogram Monitor Based Screening For 2024
Clinical eHealth
journal homepage: ww.keaipublishing.com/CEH
a r t i c l e i n f o a b s t r a c t
Article history: Background: Atrial fibrillation (AF) is a major public health problem with high rates of morbidity, disabil-
Received 20 January 2024 ity and mortality, especially in the elderly population. This study explored the diagnosis and treatment
Revised 28 February 2024 status of AF in adults aged 65 years in the community through wearable dynamic electrocardiogram
Accepted 4 March 2024
(ECG) monitoring.
Available online 7 March 2024
Methods: We conducted a cross-sectional study in 4 random communities within the Qingpu district of
Shanghai, China. Between January 1, 2020 and June 30, 2022, the ECGs of 3852 adults aged 65 years or
Keywords:
older were examined through wearable dynamic ECG monitoring. Data from 3839 participants were ulti-
Atrial fibrillation
Electrocardiogram
mately analyzed. Multivariate logistic regression was used to determine the independent predictors of
Anticoagulant therapy AF.
Ischemic stroke Results: Wearable dynamic ECG monitoring detected AF in 360 elderly people, 78 of whom were diag-
Elderly population nosed with AF for the first time. Multivariate logistic regression analysis revealed that snoring, renal dys-
function, coronary heart disease and high CHA2DS2-VASc score were independent risk factors for AF.
Among patients with unknown AF, 68 (87.20 %) met the criteria for anticoagulant therapy based on
the CHA2DS2-VASc score. Only 4 (5.88 %) patients were taking anticoagulants. Of the patients with a clear
history of AF, 249 (84.98 %) needed an anticoagulant strategy, but only 18 (7.23 %) took oral anticoagu-
lants.
Conclusion: Many elderly people have silent AF, and wearable dynamic ECG monitoring can be used to
screen for AF effectively.
Ó 2024 The Authors. Publishing services by Elsevier B.V. on behalf of KeAi Communications Co. Ltd. This is
an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
https://doi.org/10.1016/j.ceh.2024.03.001
2588-9141/Ó 2024 The Authors. Publishing services by Elsevier B.V. on behalf of KeAi Communications Co. Ltd.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
L. Wei, E. Su, J. Xie et al. Clinical eHealth 7 (2024) 41–50
non-AF patients of the same age.13 AF is sometimes asymptomatic, Then, we input the syntax to Stata, namely, power oneproportion
and elderly people often have multiple comorbidities and are at 0.018 0.027, power (0.80). The result was n = 1946. The number
high risk for ischemic stroke and other arterial thromboembolic of enrolled patients was approximately twice the minimum
events. Therefore, screening the above population for silent AF requirement. The inclusion criteria were as follows: 1) registered
has become a focus. residents of the community; 2) aged 65 years or older; 3) cooper-
Electrocardiography (ECG) is the gold standard for diagnosing ated with wearing the dynamic ECG monitoring equipment; and 4)
AF.16,17 Therefore, the purpose of this study was to use wearable completed a structured questionnaire on health information. The
dynamic ECG monitoring to screen community-dwelling people exclusion criterion was skin allergy to the wearable dynamic ECG
aged 65 years and older and living in the community, clarify the monitor components.
diagnosis and treatment status of AF in the elderly population. Written informed consent was obtained from all participants.
The research protocol was approved by the Medical Ethics Com-
mittee of Qingpu Branch of Zhongshan Hospital Affiliated to Fudan
2. Material and methods University (No.2019-25).
Fig. 1. ECG signals detected by the wearable dynamic ECG monitor. (A) Normal ECG; (B) AF ECG. Abbreviations: ECG, electrocardiogram; AF, atrial fibrillation.
42
L. Wei, E. Su, J. Xie et al. Clinical eHealth 7 (2024) 41–50
calculated CHA2DS2-VASc scores [congestive heart failure (1 (Fig. 1). Each ECG report had a consistent diagnosis by at least
point), hypertension (1 point), age 75 years (2 points), diabetes two doctors. All participants wore dynamic ECG monitors continu-
(1 point), stroke/transient ischemic attack (2 points), vascular dis- ously for at least 24 h.
ease (1 point), age 65–74 years (1 point), female Sex (1 point)]20–23
and HAS-BLED scores [uncontrolled hypertension (1 point), abnor- 2.4. Outcomes
mal renal/liver function (1 point or 2 points), stroke (1 point),
bleeding history or predisposition (1 point), labile international The outcome events that we recorded were ischemic stroke,
normalized ratio (1 point), age >65 years (1 point), and concomi- heart failure and peripheral artery embolism. The occurrence of
tant drug/alcohol use (1 point or 2 points)]24,25 to assess the risk these events was adjudicated by specialists. Ischemic stroke and
of ischemic stroke and bleeding among elderly people with AF. peripheral artery embolism were demonstrated by imaging.
Congestive heart failure was defined based on evidence for signs,
2.3. Wearable dynamic ECG monitor screening for AF symptoms, elevated natriuretic peptide levels, and
echocardiography.
A 3-lead wearable dynamic ECG monitor (Registration Number:
Shanghai Machinery Approval 20222070199; SID Medical Co., 2.5. Statistical analysis
Ltd.), which allows continuous monitoring of ECG data for up to
72 h and can continue recording after charging, was used for Continuous variables are presented as the mean ± standard
screening AF. The ECG data collected by the eccentric electrode deviation, while categorical variables are described as percentages.
were amplified, filtered and stored through the ECG acquisition Continuous variables and categorical variables were compared
module. Doctors specializing in ECG from the Qingpu Branch of using Student’s t test and the v2 test, respectively. Multivariate
Zhongshan Hospital Affiliated to Fudan University downloaded logistic regression analysis was carried out to identify independent
the ECG data from the monitors for analysis and diagnosis predictors of AF, and the risk and strength of association are
43
L. Wei, E. Su, J. Xie et al. Clinical eHealth 7 (2024) 41–50
icance. The data were analyzed using SPSS software (version 20.0). Rhythm type AF (n = 371) (%) Non-AF
(n = 3468) (%)
Atrial premature beat, n (%) 132 (35.58) 1603 (46.22)
3. Results Atrial tachycardia, n (%) 35 (9.43) 426 (12.28)
Supraventricular tachycardia, n (%) 1 (0.27) 2 (0.06)
Ventricular premature beat, n (%) 81 (21.83) 495 (14.27)
3.1. Characteristics of the study population
Ventricular tachycardia, n (%) 0 (0) 2 (0.06)
Second-degree type II 0 (0) 1 (0.03)
From January 1, 2020, to June 30, 2022, 3877 community- sinoatrial block, n (%)
dwelling people aged 65 years or older were invited to participate
Data are expressed as the number (%) of subjects. Abbreviations: AF: atrial
in screening for AF, and 25 people were unsuccessful in participat- fibrillation.
ing in the project because they refused to sign the informed con-
sent form. A total of 3852 participants were enrolled in this No significant differences were found in sex, smoking or alcohol
study (Fig. 2). However, thirteen elderly people were excluded consumption history, or history of abnormal liver function, dia-
because their skin was sensitive to the wearable dynamic ECG betes mellitus, hyperlipidemia or hyperthyroidism between these
monitor. Therefore, 3839 were included in the final analysis. A two groups (all p > 0.05) (Table 1). Hypertension was the most
total of 360 elderly people were diagnosed with AF by wearable common complication in both groups (73.58 % and 65.74 %, respec-
dynamic ECG monitoring, 78 of whom were newly diagnosed with tively). ACEIs/ARBs were the most common medication prescribed
AF, and 282 had AF identified using 12-lead resting ECG or 24-h in both the AF group and the non-AF group (29.38 % and 34.17 %,
ambulatory ECG in their personal history. A total of 3479 residents respectively).
were not found to have an AF rhythm under screening, 11 of whom In addition to AF, wearable dynamic ECG monitoring also
had a history of AF. detected many other types of arrhythmias, including atrial prema-
We divided the 3839 eligible participants into AF and non-AF ture beats, atrial tachycardia, supraventricular tachycardia and
groups for further analysis (Table 1). There were 371 patients in ventricular premature beats, in the above groups (Table 2). In par-
the AF group and 3468 people in the non-AF group. The AF group ticular, 2 patients with ventricular tachycardia and 1 with second-
was older than the non-AF group (76.25 ± 7.39 vs. 74.14 ± 7.94 ye degree type II sinoatrial block were first identified in the non-AF
ars, p < 0.001). The AF group had significantly greater incidences of group.
snoring (30.46 % vs. 21.57 %, p < 0.001), renal dysfunction (2.96 %
vs. 0.75 %, p < 0.001), hypertension (73.58 % vs. 65.74 %,
p = 0.002), coronary artery disease (40.7 % vs. 13.67 %, p < 0.001), 3.2. Risk factors for AF diagnosis
heart failure (1.62 % vs. 0.4 %, p = 0.002) and ischemic stroke
(18.87 % vs. 13.24 %, p = 0.003) than the non-AF group. Participants Univariate analysis demonstrated that AF was associated with
diagnosed with AF also had a higher CHA2DS2-VASc score than age, snoring, renal dysfunction, hypertension, coronary artery dis-
those without evidence of AF (3.33 ± 1.30 vs. 2.87 ± 1.35, ease, heart failure and the CHA2DS2-VASc score (all p < 0.01)
p < 0.001). In terms of cardiovascular drug therapy, anticoagulant (Table 3).
drugs, antiplatelet drugs and antiarrhythmic therapy were pre- Multivariate analysis revealed that a habit of snoring (OR:
scribed more often in the AF group than in the non-AF group (all 1.533, 95 % CI [1.197–1.964], p = 0.001), renal dysfunction (OR:
p < 0.001). 2.521, 95 % CI [1.165–5.456], p = 0.019), coronary artery disease
(OR: 3.753, 95 % CI [2.964–4.751], p < 0.001) and a high
CHA2DS2-VASc score (OR: 1.168, 95 % CI [1.407–1.703],
Table 1 p = 0.005) were independent predictors of AF (Table 4).
Baseline characteristics of the study population.
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L. Wei, E. Su, J. Xie et al. Clinical eHealth 7 (2024) 41–50
Fig. 3. Stroke risk assessment of patients with AF. CHA2DS2-VASc score of (A) patients diagnosed with AF for the first time and (B) patients with a history of AF. Abbreviation:
AF, atrial fibrillation.
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L. Wei, E. Su, J. Xie et al. Clinical eHealth 7 (2024) 41–50
Fig. 4. Antithrombotic therapy of AF patients with CHA2DS2-VASc scores 2 (men) or 3 (women). The percentages of patients treated with anticoagulant therapy,
antiplatelet therapy, and no antithrombotic therapy among (A) patients diagnosed with AF for the first time and (B) patients with a history of AF. Abbreviation: AF, atrial
fibrillation.
anticoagulants. Given the side effects such as bleeding and renal ischemic stroke. However, only 1 (4.48 %) patient received antico-
dysfunction associated with anticoagulants, 15.67 % of female agulant therapy. Among the participants with a history of AF, 6
patients and 11.34 % of male patients refused to take anticoagulant (2.05 %), 59 (20.14 %) and 2 (0.68 %) had complications of heart fail-
drugs. ure, ischemic stroke and peripheral artery embolism, respectively.
Fifty (84.75 %) patients complicated with ischemic stroke and 2
(100 %) with peripheral artery embolism were not treated with
3.4. Clinical complications in AF patients
anticoagulant drugs.
Table 5 indicates that the proportions of ischemic stroke were
4.65 %, 85 %, 100 % and 100 % in female AF patients with 4. Discussion
CHA2DS2-VASc scores of 4, 5, 6 and 7, respectively. The percent-
ages of the above events were 75 %, 100 % and 100 % in male AF According to a meta-analysis of 66 cohort studies, AF increased
patients with CHA2DS2-VASc scores of 4, 5 and 6, respectively. the risk of all-cause mortality by 46 %, ischemic heart disease by
These results suggested that the incidence of thromboembolic 61 %, chronic kidney disease by 64 %, sudden cardiac death by
events increases with the CHA2DS2-VASc score, with a signifi- 88 %, and major cardiovascular events by 96 %.26 The epidemiology
cantly greater percentage of female AF patients having a of AF has changed over the past 15 years, as patients have aged and
CHA2DS2-VASc score 5 and male AF patients having a are more affected by cardiovascular and noncardiovascular comor-
CHA2DS2-VASc score 4. bidities.27 Approximately 10 % of patients hospitalized for ischemic
We further investigated antithrombotic therapy strategies for stroke are first diagnosed with AF during their stay.28 Approxi-
AF patients with outcome events, including heart failure, ischemic mately 1.4 % of patients aged 65 years or older had unknown AF
stroke and peripheral artery embolism (Table 6). Among the partic- detected on a single time-point ECG or pulse test.28 In this study,
ipants who were found to have new-onset AF, 11 (14.10 %) had 9.66 % of individuals had an ECG indicating AF rhythm or a clear
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L. Wei, E. Su, J. Xie et al. Clinical eHealth 7 (2024) 41–50
Fig. 5. Distribution of reasons for not receiving anticoagulant treatment in patients with a history of AF. The percentages of not treating with anticoagulant therapy in (A)
female patients with CHA2DS2-VASc scores 3 and in (B) male patients with CHA2DS2-VASc scores 2. Abbreviation: AF, atrial fibrillation.
Table 5
Association of thromboembolic events with CHA2DS2-VASc score in AF patients.
Female Male
CHA2DS2-VASc score (n = 233) Ischemic stroke Peripheral artery embolism CHA2DS2-VASc score (n = 138) Ischemic stroke Peripheral artery embolism
1 (0) 0 (0) 0 (0) 1 (n = 17) 0 (0) 0 (0)
2 (n = 37) 0 (0) 0 (0) 2 (n = 47) 0 (0) 0 (0)
3 (n = 66) 0 (0) 1 (1.52 %) 3 (n = 47) 0 (0) 0 (0)
4 (n = 86) 4 (4.65 %) 0 (0) 4 (n = 8) 6 (75 %) 0 (0)
5 (n = 20) 17 (85 %) 0 (0) 5 (n = 17) 17 (100 %) 0 (0)
6 (n = 22) 22 (100 %) 0 (0) 6 (n = 2) 2 (100 %) 0 (0)
7 (n = 2) 2 (100 %) 1 (50 %) 7 (0) 0 (0) 0 (0)
Data are expressed as the number (%) of subjects. Abbreviation: AF: atrial fibrillation.
history of AF, and 2.03 % of individuals were diagnosed with AF for the community. Therefore, screening for unknown AF and
the first time. The number of patients with newly detected AF strengthening the management of community-dwelling older
accounted for 21.02 % of the total elderly population with AF in adults with AF are essential. A meta-analysis of 44 prospective
47
L. Wei, E. Su, J. Xie et al. Clinical eHealth 7 (2024) 41–50
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