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Research Letters

Six-lead device superior to single-lead


smartwatch ECG in atrial fibrillation detection
Josca Scholten, BSc a,b , Ward P.J. Jansen, MD a , Thomas Horsthuis, MD, PhD a , Anuska D. Mahes, BSc a ,
Michiel M. Winter, MD, PhD b , Aeilko H. Zwinderman, PhD c , Jan T. Keijer, MD, PhD a , Madelon Minneboo, MD,
PhD a,b , Joris R. de Groot, MD, PhD b , and Jouke P. Bokma, MD, PhD a,b North Holland, The Netherlands

This was a head-to-head comparative study on different electrocardiogram (ECG)-based smartwatches and devices for atrial
fibrillation detection. We prospectively included 220 patients scheduled for electrical cardioversion and recorded ECGs with
3 different devices (Withings Move ECG, Apple Watch 5, Kardia Mobile 6-leads) as well as the standard 12-lead ECG (gold
standard), both before and after cardioversion.
All atrial fibrillation detection algorithms had high accuracy (sensitivity and specificity: 91–99%) but were hampered by unin-
terpretable recordings (20–24%). In cardiologists’ interpretation, the 6-lead device was superior (sensitivity 99%, specificity
97%) to both single-lead smartwatches (P < .05) for atrial fibrillation detection. (Am Heart J 2022;253:53–58.)

Atrial fibrillation (AF) is the most common tach- admitted for electrical cardioversion (ECV) for AF or
yarrhythmia with a cumulative lifetime risk of approxi- atrial flutter (AFL) were included between February 2020
mately 37%.1 Because AF is asymptomatic in a subset of and March 2021 (Fig. 1 for inclusion and exclusion cri-
patients, stroke can be the first clinical manifestation of teria). This study was reviewed by the medical ethical
“silent” AF.2 Screening for “silent” AF may prevent stroke board of Amsterdam University Medical Center and con-
but accurate AF diagnosis by the screening test is of forms to the declaration of Helsinki. No extramural fund-
paramount importance to appropriately start preventive ing was used to support this work. The authors are solely
anticoagulant treatment. Worldwide use of commercially responsible for the design and conduct of this study, all
available devices for electrocardiogram (ECG) based AF study analyses, the drafting and editing of the paper and
detection is increasing despite lack of comparative data its final contents.
between single-lead smartwatches and novel six-lead de- Standard 12-lead ECGs in supine position were
vices.3-5 Therefore, head-to-head comparisons between recorded followed by consecutive, supervised thirty sec-
devices reliability are needed to inform AF screening in ond ECGs by different devices, both before and after the
high-risk patients but also to improve interpretation of ECV. First, the Withings Move ECG (Withings, Issy les
device ECGs presented directly by individuals. We per- Moulineaux, France) and the Apple Watch series 5 (Ap-
formed a proof-of-concept, head-to-head comparison be- ple Inc, Los Altos) were used to acquire a single-lead
tween smartphone ECG smartwatches/devices for AF de- I ECG, according to manufacturer’s instructions. Sub-
tection. sequently, patients were randomly allocated (based on
study inclusion number) to acquire a single-lead II ECG
with either Withings or Apple in a 1:1 ratio. For this pur-
Materials and methods
pose, the Withings or Apple Watch was placed on the left
This was a prospective, nonrandomized, adjudicator-
knee and hold with the right hand. Finally, Kardia Mo-
blinded study in a non-academic, regional hospital (Ter-
bile 6L (AliveCor, Mountain View) was placed on the left
gooi Hospital, Blaricum, The Netherlands). Adult patients
knee with both thumbs on the device to simultaneously
record a six-lead ECG (leads I, II, III, aVR, aVL, aVF). Dur-
From the a Department of Cardiology, Tergooi Hospital, Blaricum, North Holland, the
ing all measurements, patients were verbally instructed
Netherlands, b Location Academic Medical Center, Department of Cardiology, Amster-
dam University Medical Center, Meibergdreef 9, Amsterdam, North Holland 1105 AZ, how to hold the devices by the study investigator, who
the Netherlands, c Location Academic Medical Center, Department of Clinical Epidemiol- stored the recordings on a mobile device (Apple iPhone
ogy, Biostatistics and Bioinformatics, Amsterdam University Medical Center, Amsterdam,
North Holland, the Netherlands 7 Plus).
Submitted March 7, 2022; accepted June 29, 2022 A single cardiologist, not blinded for other clinical data,
Corresponding author at: Location Academic Medical Center, Department of Cardiology, analyzed all standard 12-lead ECG recordings for rhythm
Amsterdam University Medical Center, Meibergdreef 9, Amsterdam, North Holland 1105
AZ, the Netherlands. (AF, AFL, or normal), which was considered the gold stan-
E-mail address: j.p.bokma@amsterdamumc.nl. dard. Presumed atrial tachycardia was classified as AFL.
0002-8703
In addition, all thirty second ECGs were anonymized and
© 2022 Elsevier Inc. All rights reserved.
https://doi.org/10.1016/j.ahj.2022.06.010 interpreted by 2 cardiologists independently, blinded to
American Heart Journal
54 Scholten et al
November 2022

Figure 1

Flow chart of study inclusion. Flow chart of patients screened for inclusion, reasons for dropout and measurements performed. Total 12-L
ECGs performed: n = 415. In 17 cases (4.1%) Kardia 6L was not recorded. In 3 cases (0.7%) Withings was not recorded. In all cases
(n = 415) Apple ECG was recorded. A maximum of 3 attempts to record per device was allowed. Abbreviations: AF, atrial fibrillation; ECV,
electrical cardioversion; SR, sinus rhythm.

other clinical data. The thirty second ECGs were classi- rate of uninterpretable ECGs (1:1 comparisons). Sensitiv-
fied by the cardiologists as supraventricular tachycardia ity and specificity of devices for AF detection compared
(SVT) or sinus rhythm (SR). The SVT interpretations were to the gold standard were determined for the automatic
further divided into AF or AFL, similar to the 12-lead ECG. algorithms and for the 2 cardiologists’ interpretations (av-
If there was uncertainty about the classification (SR vs eraged), excluding AFL and uninterpretable ECGs (for au-
SVT), this was noted. tomatic algorithm). Wilcoxon signed rank test was used
to compare accuracy of AF detection by the cardiologists
Statistical methods between all devices (1 point attributed if classified in-
McNemar’s test for paired dichotomous outcome vari- correctly, 0 points if classified correctly. Score 0 to 2 for
ables was used to test differences between devices in the all devices). Similarly, the proportions of reported uncer-
American Heart Journal
Scholten et al 55
Volume 253

Table I. Sensitivity and specificity for AF detection of ECG device algorithms and cardiologists’ interpretations.

Devices Device algorithms Cardiologists’ Cardiologists’ interpretationAll


interpretationSubgroup patients with SR/AF
“uninterpretable” by algorithm
Uninterpretable Sensitivity Specificity Sensitivity Specificity Sensitivity Specificity
(95% CI) (95% CI) (95% CI) (95% CI) (95% CI) (95% CI) (95% CI)

Withings 19.8% 97.5% 94.9% 85.3% 88.7% 95.4% 94.9%


lead I (16.0 %-23.6%) (95.1%- (91.4%- (74.5%- (79.3%- (93.2%- (92.7%-
99.9%) 98.4%) 96.1%) 98.1%) 98.6%) 97.1%)
Apple 20.0% 94.4% 98.2% 93.2% 95.9% 96.2% 94.4%
lead I (16.2%-23.8%) (90.6%- (96.2%- (85.8%- (88.0%- (94.2%- (91.1%-
98.2%) 100%) 100%) 100%) 98.2%) 97.7%)
32.0%∗ 95.9% 98.7% 89.7% 77.3% 95.7% 94.7%
Smartwatch (27.5%-36.5%) (92.4%- (96.9%- (83.9%- (67.2%- (92.8%- (91.5%-
lead II 99.4%) 100%) 95.5%) 87.4%) 98.6%) 97.9%)
Kardia 23.6% 99.4% 91.4% 92.6% 93.6% 98.9%∗ 96.7%∗
6 leads (19.5%-27.7%) (98.2%- (86.7%- (83.9%- (85.2%- (97.8%- (94.1%-
100%) 96.1%) 100%) 100%) 100%) 99.3%)
ECGs before and after ECV were pooled, ECGs with AFL were excluded. For the device algorithms, uninterpretable/unrecorded ECGs by devices were excluded. Number
of ECGs: N = 316 for Withings, N = 308 for Apple Watch, N = 272 for lead II, and N = 297 for Kardia Mobile 6L.
For cardiologists’ interpretations, ECGs not classified by cardiologists were excluded. Total number of ECG interpretations N = 487 for ECGs “uninterpretable” by the
algorithm. Cardiologists’ device ECG interpretations: N = 2,913 for all patients with SR/AF section.
AF, atrial fibrillation; AFL, atrial flutter; CI, confidence interval; ECG, electrocardiogram.

indicates P-value < .05 compared to the other devices in correct classifications.

tainty by the cardiologists about the classifications (SR 5% high heart rate, 2% low heart rate)(P < .001 com-
or SVT) were determined (1 point attributed if uncer- pared to Withings lead I, P < .001 compared to Apple
tain, 0 points if no uncertainty. Score 0-2 for all devices) lead I, and P = .003 compared to Kardia). Excluding un-
and compared using Wilcoxon signed rank test. Finally, interpretable ECGs, sensitivity and specificity of the AF
we examined the reliability of cardiologists to differen- detection algorithms were 91% to 99%, similar for all de-
tiate between SR, AF, and AFL. We combined both car- vices (Table 1) (P > .05 for all head-to-head comparisons
diologists interpretations (2 points attributed if SR/SVT in accuracy).
classified incorrect, 1 point attributed if SVT (AF/AFL)
sub classification incorrect, 0 points if classified correct)
to compare the different devices using Wilcoxon signed Cardiologists’ interpretation
rank test. Statistical analyses were performed using SPSS The cardiologists’ interpretation of Withings leads I
25.0 (IBM). and Apple lead I had sensitivity and specificity of 94–96%
(Table 1). The accuracy of Kardia 6L was significantly
better (sensitivity 99% and specificity 97%; correct classi-
Results fications 97.9% (95% confidence interval: 96.8–99.0%)),
A total of 220 patients were included (age 70 ± 10 P = .013 vs Withings, P = .024 vs Apple (Table 1). Re-
years, female 35%) from a total of 234 screened patients sults for the cardiologists’ interpretation of the subset
(online supplementary table). In total, 415 12-lead ECGs with an “uninterpretable” ECG by the algorithm are listed
were recorded (45% SR, 45% AF, 10% AFL). Repeat ECGs in Table 1. The average proportions of cardiologists’ un-
were missing in 25 patients (no ECV performed n = 19, certainty were 8.5% for Withings, 9.9% for Apple, 10.5%
withdrawal/lack-of-time n = 6). for lead II, and 4.4% for Kardia (Kardia 6L P ≤ .001 com-
pared to all).
AF algorithms
Withings lead I, Apple lead I, and Kardia 6L had com- Atrial flutter detection
parable proportions of uninterpretable ECGs: 20% (12% The differentiation between SR, AF, and AFL is shown
inconclusive, 4% high heart rate, 2% low heart rate, 1% in Table 2 (A–D). Averaged over the 2 cardiologists, their
unclassified), 20% (11% inconclusive, 6% high heart rate, classification showed a correct diagnosis of AFL in 28%
3% low heart rate), and 24% (15% inconclusive, 3% high for Withings lead I and 33% for Apple lead I. The correct
heart rate, 1% low heart rate, 4% unclassified) respec- classification was numerically higher when based on lead
tively (P > .05 for all comparisons in percentage unin- II: 54% (P = .076 compared to Withings and P = .246
terpretable) (Table 1). The single-lead II had a higher pro- compared to Apple). Kardia 6L was most accurate in dif-
portion of uninterpretable ECGs: 32% (25% inconclusive, ferentiating between SR, AF, and AFL, with a correct di-
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56 Scholten et al
November 2022

Table II. (A-D) Cardiologists’ differentiation of SR, AF, and AFL

The total number of observations is listed for both cardiologists (on each ECG) and the corresponding gold standard 12L ECG (2
per patient: both before and after ECV). Percentage values are averaged over the 2 cardiologists’ classifications on each device
compared to the 12-lead ECG. Patients were randomly allocated to acquire a single-lead II ECG with either Withings or Apple
in a 1:1 ratio. Both cardiologists were asked to interpret all device ECGs once.
A. Withings lead I, total number of ECG interpretations: N = 823,
B. Apple lead I, total number of ECG interpretations: N = 819,
C. Total lead II, total number of ECG interpretations: N = 822,
D. Kardia 6 leads, total number of ECG interpretations: N = 796.
AF, atrial fibrillation; AFL, atrial flutter; ECG, electrocardiogram; SR, sinus rhythm.

agnosis of AFL in 63% of all cases (P < .001 compared to p-wave detection to help differentiate between SR and
Withings and Apple). AF.6 In addition, cardiologists were less uncertain about
their interpretation when analyzing Kardia 6L compared
to the single-lead ECGs, which is relevant in situations
Discussion when no simultaneous 12-lead ECG is available. Differ-
This is the first study to compare multiple commer- ences in hardware and recording electrodes could have
cially available devices with different methods of ECG- also played a role in the better accuracy of Kardia 6L com-
acquisition for AF detection. Sensitivity and specificity of pared to the single-lead smartwatches.
the algorithms by all devices were high (91–99%) com- It is conceivable AF detection algorithms can fur-
pared to the gold standard 12-lead ECG. However, we ther improve, especially when information from multi-
excluded uninterpretable results, which led to overesti- ple leads is integrated (not the case for the Kardia algo-
mation of algorithm accuracy in practice. The propor- rithm during our study). In clinical practice or popula-
tion of uninterpretable ECGs by devices (20–24%) were tion screening programs, health care provider interpreta-
in line with most previous studies, although a recent tion may be needed only to confirm newly detected AF
study reported fewer uninterpretable ECGs by the Ap- or evaluate uninterpretable ECGs by the algorithm. Kar-
ple watch.3-5 This difference might be explained by more dia 6L may be preferred due to the combined high sen-
“high heart rate” classifications in our older study popu- sitivity of the algorithm and accurate cardiologists’ inter-
lation admitted for ECV.5 pretation. Considering the rate of uninterpretable device
Our results of the cardiologists’ interpretation revealed ECGs, mass utilization by the general population may
that the six-lead Kardia ECG was superior to both single- lead to increased health care utilization.7 This study in-
lead smartwatches to detect AF, and accurate in ECGs forms high-risk population screening programs, in which
that were uninterpretable by the algorithm. We hypothe- appropriate use may facilitate early AF detection and pre-
size that the improved AF detection can be explained by vent stroke. Previous studies found that mobile devices
information provided by the multiple leads that improves could detect 1–3% of new AF in an elderly high-risk pop-
American Heart Journal
Scholten et al 57
Volume 253

ulation and are cost efficient for this purpose.8 , 9 Long- ologists, the Kardia 6-lead ECG was superior (sensitivity
term intermittent rhythm monitoring in an at-risk popu- 99%, specificity 97%) to single-lead ECGs.
lation has higher yield than one single screening ECG.10
Another benefit of the six-lead Kardia ECG was the im-
proved differentiation between AFL and AF compared Author contributions
to the single-lead ECGs. The trend towards better AFL Jouke P. Bokma: conceived of the study. Jouke
recognition on lead II suggests that recording an addi- P. Bokma, Ward P.J. Jansen, Aeilko H. Zwin-
tional lead II ECG (instead of lead I) by the patient could derman, Joris R. de Groot: designed the research.
be informative when there is doubt about the rhythm Josca Scholten, Anuska D. Mahes, Madelon Min-
using a single-lead device. Currently, there is little evi- neboo, Jouke P. Bokma, Ward P.J. Jansen, Thomas
dence on accuracy of single-lead devices beyond AF de- Horsthuis: conducted the research and contributed to
tection.11 Our findings suggest Kardia 6L has clinical ben- data collection. Jan T. Keijer, Aeilko H. Zwinderman,
efit compared to the single-lead devices, but only when Michiel M. Winter, Joris R. de Groot: contributed to
reviewed by cardiologists. In comparison to single-lead the interpretation of the data. Josca Scholten, Jouke P.
ECGs, a six-lead device can more accurately diagnose AF Bokma: analyzed the data under supervision of Aeilko
and may lead to less health care utilization when uncer- H. Zwinderman. Josca Scholten, Jouke P. Bokma:
tainty remains after cardiologists’ interpretation. Many wrote the paper. Jouke P. Bokma: is the guarantor of
cardiologists are reluctant to initiate therapies such as an- this research. All authors read and approved the final
ticoagulant treatment based on a single-lead ECG sugges- manuscript.
tive of new AF.12 Overall, our findings suggest that mobile
ECGs are sufficient to establish an AF diagnosis when the Funding
rhythm is interpretable to the cardiologist without uncer-
J.P. Bokma was supported by a research grant of Am-
tainty.
sterdam Cardiovascular Sciences. All devices were pur-
chased by the Cardiology department of Tergooi Hospi-
Limitations tal.
This was a single-center study including AF patients
scheduled for ECV in a regional hospital with a uniform Declaration of Competing Interest
protocol and high inclusion rate. In this controlled en-
None.
vironment, devices were compared that can be used
at-home with low AF prevalence in a population with
high AF prevalence, which may influence accuracy, al- Supplementary materials
though likely similar in all devices. We did not evaluate Supplementary material associated with this article can
devices used by patients themselves at-home, although be found, in the online version, at doi:10.1016/j.ahj.
instructions were limited and patients needed to acquire 2022.06.010.
the ECGs themselves, this could have affected quality.
False classifications may be more prevalent in patients
with symptomatic premature atrial contractions or other References
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November 2022

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