- Journal List 期刊列表
- J Arrhythm J 心律不齐
- v.39(3); 2023 Jun 第 39(3)期;2023 年 6 月
- PMC10264726IF: 2.2 Q2 NA
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The efficacy of detecting arrhythmia is higher with 7‐day continuous electrocardiographic patch monitoring than with 24‐h Holter monitoring
7 天连续心电图贴片监测比 24 小时 Holter 监测检测心律失常的效果更高
Ju Young Kim,医学博士, 1 , 2 Il-Young Oh、医学博士, 3 Hyejin Lee、医学博士,公共卫生硕士, 1 Ji Hyun Lee,医学博士, 3 Youngjin Cho,医学博士、 3 Yeongjoon Gil,博士、 2 Sungghoon Jung,博士, 2 Dae In Kim,学士、 2 Myung Geun Shin,理学士, 2 Joo Yeon Yoo、BS, 2 和 Jeong Yeon Kwak,BS 2
Ju Young Kim
1 Department of Family Medicine, Seoul National University Bundang Hospital, Seongnam Korea
2 Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam Korea
Hyejin Lee
1 Department of Family Medicine, Seoul National University Bundang Hospital, Seongnam Korea
Yeongjoon Gil
2 Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam Korea
Sunghoon Jung
2 Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam Korea
Dae In Kim
2 Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam Korea
Myung Geun Shin
2 Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam Korea
Joo Yeon Yoo
2 Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam Korea
Jeong Yeon Kwak
2 Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam Korea
作者信息 文章注释 版权和许可信息 PMC免责声明。
Il‐Young Oh, MD, PhD, Department of Internal Medicine, Seoul National University College of Medicine, 82 Gumi‐ro 173 Beon‐gil, Seongnam‐si, Gyeonggi‐do, Republic of South Korea.
Email: gro.hbuns@ho.gnuoyli
Associated Data 相关数据
- Data Availability Statement
数据可用性声明 The data that support the findings of this study are available from the corresponding author (Il‐Young Oh) upon reasonable request.
Abstract 摘要
Background 背景介绍
Detecting high‐risk arrhythmia is important in diagnosing patients with palpitations. We compared the diagnostic accuracies of 7‐day patch‐type electrocardiographic (ECG) monitoring and 24‐h Holter monitoring for detecting significant arrhythmias in patients with palpitations.
检测高危心律失常对诊断心悸患者非常重要。我们比较了 7 天贴片式心电图(ECG)监测和 24 小时 Holter 监测在检测心悸患者明显心律失常方面的诊断准确性。
Methods 方法
This was a single‐center prospective trial with 58 participants who presented with palpitations, chest pain or syncope. Outcomes were defined as the detection of any one of six arrhythmias, including supraventricular tachycardia (SVT), atrial fibrillation or atrial flutter lasting more than 30 s, pauses of more than 3 s, high‐degree atrioventricular block, ventricular tachycardia (VT) >3 beats, or polymorphic VT/ventricular fibrillation. The McNemar test for paired proportions was used to compare arrhythmia detection rates.
这是一项单中心前瞻性试验,有 58 名参与者出现心悸、胸痛或晕厥。结果定义为检测出六种心律失常中的任何一种,包括室上性心动过速(SVT)、持续时间超过 30 秒的心房颤动或心房扑动、超过 3 秒的停顿、高度房室传导阻滞、大于 3 次的室性心动过速(VT)或多形性 VT/心室颤动。在比较心律失常检出率时采用了配对比例 McNemar 检验。
Results 成果
The overall arrhythmia detection rate was higher with 7‐day ECG patch monitoring than with 24‐h Holter monitoring (34.5% vs. 19.0%, p = .008). Compared with the use of 24‐h Holter monitors, the use of 7‐day ECG patch monitors was associated with higher detection of SVT (29.3% vs. 13.8%, p = .042). No serious adverse skin reactions were reported among the ECG patch‐monitored participants.
7 天心电图贴片监护仪的总体心律失常检出率高于 24 小时 Holter 监护仪(34.5% 对 19.0%,p = .008)。与使用 24 小时 Holter 监测仪相比,使用 7 天心电图贴片监测仪可检测出更多 SVT(29.3% 对 13.8%,p = .042)。接受心电图贴片监测的参与者中未报告严重的皮肤不良反应。
Conclusions 结论
The results suggest that a 7‐day patch‐type continuous ECG monitor is more effective for the detection of supraventricular tachycardia than is a 24‐h Holter monitor. However, the clinical significance of device detected arrhythmia should be consolidated.
结果表明,7 天贴片式连续心电图监测仪比 24 小时 Holter 监测仪更能有效检测室上性心动过速。不过,应巩固设备检测到的心律失常的临床意义。
关键词:非卧床心电图监测、心律失常、Holter 监测、可穿戴电子设备。
A 7‐day patch‐type continuous electrocardiographic monitor is more effective in detecting significant arrhythmias than is a 24‐h Holter monitor.
与 24 小时 Holter 监护仪相比,7 天贴片式连续心电监护仪能更有效地检测出明显的心律失常。
1. INTRODUCTION 1.引言
Palpitations are one of the most common symptoms in patients who present to primary care clinicians and cardiologists.
1
Although the causes are usually benign, palpitations occasionally manifest as potentially life‐threatening arrhythmias. Thus, an appropriate evaluation of palpitations is required.
1虽然心悸的原因通常是良性的,但偶尔也会表现为可能危及生命的心律失常。因此,需要对心悸进行适当的评估。
Cardiac arrhythmias, including the development of new arrhythmias or significant changes in the rate of previously stable arrhythmias, are common causes of palpitations. Conventional Holter monitoring plays a significant role in the diagnosis of arrhythmias when evaluating palpitations.
2
However, it has the drawbacks of low diagnostic yield in detecting paroxysmal arrhythmias, burdensome wires that interfere with daily activities, and the inability of some patients to activate the event recorders when symptoms occur.
3
,
4
心律失常,包括出现新的心律失常或以前稳定的心律失常的速率发生显著变化,是心悸的常见原因。在评估心悸时,常规 Holter 监测在诊断心律失常方面发挥着重要作用。 2 然而,它也有缺点,那就是在检测阵发性心律失常时诊断率较低,繁琐的电线会影响日常活动,而且有些患者在出现症状时无法激活事件记录器。 3 , 4
Recently, several newer generation electrocardiography (ECG) monitoring devices with advanced technologies have shown more advantages over the conventional 24‐h Holter monitoring devices in terms of convenience, efficient energy use, longer duration of monitoring, wireless data transfer, and no interruption of daily activities.
5
Researchers developed a deep neural network to diagnose cardiac arrhythmia, demonstrating its superior ability to classify the 12 rhythm classes compared with interpretations by individual cardiologists.
6
Detection rates of cardiac arrhythmias for extended durations with fully automated and highly accurate systems were studied, and the results suggested that they could aid cardiologists in the accurate detection of arrhythmias.
7
,
8
最近,几种采用先进技术的新一代心电图(ECG)监测设备在方便性、高效能源利用、更长的监测时间、无线数据传输和不影响日常活动等方面显示出比传统的 24 小时 Holter 监测设备更多的优势。 5 研究人员开发了一种用于诊断心律失常的深度神经网络,与单个心脏病专家的解释相比,该网络对 12 个心律类别的分类能力更强。 6 研究人员研究了全自动高精度系统对长时间心律失常的检测率,结果表明它们可以帮助心脏病专家准确检测心律失常。 7 , 8
The MEMO patch version 1 (HUINNO Co., Ltd.) is the first Korean Food and Drug Administration (KFDA)‐approved, single‐lead, lightweight, 7‐day ambulatory ECG adhesive patch monitor (Figure 1). Soon after the release of version 1, version 2 was developed, tested, and approved for 14‐days of ambulatory ECG monitoring by KFDA. The device has no wires and can be re‐attached every day with disposable 3M adhesives; therefore, it does not interfere with the patient's daily activities.
MEMO 贴片第 1 版(HUINNO Co., Ltd.)是韩国食品药品管理局(KFDA)批准的首款单导联、轻型、7 天动态心电图贴片监护仪(图 1 )。第 1 版发布后不久,第 2 版也已开发、测试完毕,并获得 KFDA 批准,可用于 14 天的非卧床心电图监测。该设备没有导线,可使用一次性 3M 粘合剂每天重新连接,因此不会影响患者的日常活动。
We compared the diagnostic accuracies of 7‐day adhesive patch monitoring (the MEMO patch version 1) and 24‐h Holter monitoring for detecting arrhythmias in patients with palpitations.
我们比较了 7 天贴片监测(MEMO 贴片 1 版)和 24 小时 Holter 监测在检测心悸患者心律失常方面的诊断准确性。
2. METHODS 2.方法
2.1. Study design and population
2.1.研究设计和研究对象
The Institutional Review Board of Seoul National University Bundang Hospital approved the protocol (approval No: E‐1901‐516‐001), and all participants provided informed consent to participate before enrollment. This was a single‐center, prospective cohort study. Between March 2021 and August 2021, 70 patients who visited the family medicine clinic for symptoms of palpitations, chest pain, or syncope or were referred to the cardiology department for ambulatory ECG monitoring were screened for eligibility. Patients were enrolled if they were >19 years old, capable of providing voluntary informed consent, and able to adhere to the study protocol during the 7 days of keeping a MEMO patch for ECG monitoring. Patients were excluded if they had undergone or were scheduled to undergo direct current cardioversion or catheter or surgical ablation procedures during the monitoring period due to underlying arrhythmias, or if they had known allergic reactions to adhesive patches. Of the 70 participants screened, 60 were enrolled in this study.
首尔国立大学盆唐医院机构审查委员会批准了本研究方案(批准号:E-1901-516-001),所有参与者在入组前均已获得知情同意。这是一项单中心、前瞻性队列研究。2021 年 3 月至 2021 年 8 月期间,70 名因心悸、胸痛或晕厥症状就诊于家庭医学门诊或转诊至心脏科接受流动心电图监测的患者接受了资格筛查。如果患者年龄大于 19 岁,能够自愿提供知情同意书,并能在 7 天内坚持使用 MEMO 贴片进行心电图监测,则被纳入研究计划。如果患者因潜在心律失常而在监测期间接受或计划接受直流电心脏逆转术或导管或手术消融术,或已知对贴片有过敏反应,则排除在外。在筛选出的 70 名参与者中,有 60 人参加了这项研究。
2.2. Study protocol and outcomes
2.2.研究方案和结果
A three channel Holter monitor (EVO; SPACELABS Healthcare Co.) was used for the first 24 h and the MEMO patch was concomitantly fitted over the left pectoral area of each participant's chest by clinical staffs as shown in Figure 1. The participants were given a symptom diary to record the suspected symptoms of arrhythmias and the time of symptom onset and finish. The participants were also instructed to wear the MEMO patch monitor for up to 7 days. On day 7, the participants returned the MEMO patch monitor via a prepaid mail package to the laboratory. After 1 week of monitoring, the participants visited the outpatient clinic for the results of the Holter and MEMO patch monitors and completed a survey regarding overall ease of use and satisfaction.
如图1 所示,在前 24 小时使用三通道 Holter 监护仪(EVO;SPACELABS Healthcare Co.参与者会收到一份症状日记,记录疑似心律失常的症状以及症状出现和结束的时间。参与者还被要求佩戴 MEMO 贴片监测仪长达 7 天。第 7 天,参与者通过预付邮资的邮包将 MEMO 贴片监测仪交还给实验室。监测 1 周后,参与者前往门诊部了解 Holter 和 MEMO 贴片监测仪的监测结果,并填写一份关于总体易用性和满意度的调查表。
The MEMO patch can store ECG data for up to 14 days in its internal storage. The stored ECG data can be extracted by connecting the device to a dedicated cradle with software for data download. The extracted ECG data are automatically uploaded to a cloud‐based system through the software, and the initial analysis by the artificial neural network, constructed and trained by HUINNO, is automatically triggered. The network used in this study for the seven‐class ECG classification was based on the 152‐layer convolutional neural network architecture with skip connections, which is called a residual network, and squeeze and excitation blocks.
9
The ECG recording was initially analyzed using deep learning‐based automated algorithms,
9
however, technicians manually double checked and reviewed the artificial intelligence (AI) diagnosis and if needed, revised the diagnosis after it was confirmed by cardiologists. The correction rate of the AI driven diagnosis, except for the ECG noise, included a total of three diagnoses (3/51, 5.9%), specifically, two for second‐degree (Mobitz type I) atrioventricular block (AVB) and one for intermittent 2:1 AVB.
MEMO 贴片的内部存储器可存储长达 14 天的心电图数据。将设备连接到带数据下载软件的专用机座上,即可提取存储的心电图数据。提取的心电图数据通过软件自动上传到云端系统,并自动触发由 HUINNO 构建和训练的人工神经网络进行初步分析。本研究中用于七级心电图分类的网络基于 152 层卷积神经网络架构,具有跳越连接,即所谓的残差网络,以及挤压和激励块。 9 最初使用基于深度学习的自动算法分析心电图记录, 9 不过,技术人员会人工反复检查和复核人工智能(AI)诊断,必要时经心脏病专家确认后修改诊断。除心电图噪音外,人工智能驱动诊断的修正率共包括三个诊断(3/51,5.9%),具体而言,两个为二度(Mobitz I 型)房室传导阻滞(AVB),一个为间歇性 2:1 AVB。
The network was trained by cardiologist‐reviewed 18 000 lead II ECG data recordings acquired from the Seoul National University Bundang Hospital.
该网络由心脏科医生通过审查从首尔国立大学盆唐医院获得的 18000 份第二导联心电图数据记录进行训练。
The Holter and MEMO data were subjected to a technical review for report generation and quality assurance. This report was then uploaded to a secure website for independent review by two investigators (J.H.L. and Y.C.). If there were any discrepancies in the interpretation of the ECG signals, then the sets of signals were sent to a senior cardiologist who decided on the final classification (I.‐Y.O.).
Holter 和 MEMO 数据经过技术审查,以生成报告并保证质量。然后将报告上传到一个安全网站,由两名研究人员(J.H.L. 和 Y.C.)进行独立审查。如果对心电图信号的解释存在任何差异,则将信号集发送给一位资深心脏病专家,由其决定最终分类(I.-Y.O.)。
Outcomes were defined as the detection of any one of the six arrhythmias: (1) supraventricular tachycardia (>3 beats, not including atrial fibrillation or flutter), (2) atrial fibrillation or atrial flutter lasting more than 30 s, (3) pause of more than 3 s, (4) AVB (second‐degree AVB Mobitz type II or third‐degree AVB), (5) ventricular tachycardia >3 beats, or (6) polymorphic ventricular tachycardia or ventricular fibrillation.
结果定义为检测到六种心律失常中的任何一种:(1) 室上性心动过速(>3 次,不包括心房颤动或扑动);(2) 持续时间超过 30 秒的心房颤动或心房扑动;(3) 停顿超过 3 秒、(4)房室传导阻滞(二度房室传导阻滞 Mobitz II 型或三度房室传导阻滞);(5)室性心动过速(>3 次);或(6)多形性室性心动过速或心室颤动。
2.3. Statistics 2.3.统计资料
The MEMO Patch and the Holter device were used simultaneously on the same patients during the first 24 h. This study compared the detection rates of arrhythmia events between the MEMO patch and Holter device over the total monitoring time of each device. Continuous variables are presented as means and standard deviations, and categorical variables are shown as numbers with percentages. The McNemar test for paired proportions was used to compare the detection rate for arrhythmias between the Holter and MEMO patch monitors.
本研究比较了 MEMO 贴片和 Holter 设备在总监测时间内对心律失常事件的检出率。连续变量以均值和标准差表示,分类变量以数字和百分比表示。在比较 Holter 和 MEMO 贴片监护仪的心律失常检出率时使用了配对比例 McNemar 检验。
2.3.1. Estimation of sample size calculation
A previous study showed that the adhesive patch monitor detected 36 more arrhythmia events than did the Holter monitor, while the Holter monitor detected one event undetected by the adhesive patch monitor. 10 Another study found that 202 atrial fibrillation or flutter episodes were detected in six patients with 14‐day ECG patches, while only one atrial fibrillation episode was detected in a patient with a 24‐h Holter monitor. 11 Since our study aimed to compare 7‐day ECG patch monitors with 24‐h Holter monitors, we assumed that the odds ratio of detecting arrhythmias could be six times higher with the MEMO patch than with the 24‐h Holter monitor. A sample size of at least 57 after attrition achieved 90% power for a two‐tailed McNemar test with a type 1 error of 0.05 (G*Power software version 3.1.9.4). 12
2.3.1.样本量计算估算
先前的一项研究表明,贴片式心电监护仪比 Holter 监护仪多检测出 36 个心律失常事件,而 Holter 监护仪检测出的一个事件贴片式心电监护仪却未检测到。10 另一项研究发现,在六名使用 14 天心电图贴片的患者中检测到 202 次心房颤动或扑动发作,而在一名使用 24 小时 Holter 监护仪的患者中仅检测到一次心房颤动发作。11 由于我们的研究旨在比较 7 天心电图贴片监护仪和 24 小时 Holter 监护仪,因此我们假设 MEMO 贴片检测到心律失常的几率可能是 24 小时 Holter 监护仪的六倍。自然减员后的样本量至少为 57 个,双尾 McNemar 检验的功率达到 90%,类型 1 误差为 0.05(G*Power 软件版本 3.1.9.4)。123. RESULTS 3.结果
Of the 70 participants screened, 60 were enrolled; 2 enrolled patients were lost to follow‐up. A total of 58 participants with data available from both the Holter and MEMO patch groups were included in the final analysis. The baseline characteristics of the patients are presented in Table 1. The mean age was 50.5 years and 57% (33/58) were women. Hypertension (15/58, 26%) and dyslipidemia (14/58, 24%) were common underlying medical conditions.
在筛选出的 70 名参与者中,有 60 人被录取;有 2 名被录取的患者失去了随访机会。共有 58 名同时拥有 Holter 和 MEMO 贴片组数据的患者被纳入最终分析。患者的基线特征见表1 。患者平均年龄为 50.5 岁,57%(33/58)为女性。高血压(15/58,26%)和血脂异常(14/58,24%)是常见的基础疾病。
TABLE 1 表 1
Characteristics 特点 | |
---|---|
Age (year), mean (SD) 年龄(岁),平均值(标清) | 50.03 (15.07) |
Female, n (%) 女性,n (%) | 33 (56.9) |
Body mass index, kg/m2, mean (SD) 体重指数,千克/米2,平均值(标清) | 23.85 (3.72) |
Comorbidities, n (%) 合并症,n (%) | |
Hypertension 高血压 | 15 (25.9) |
Dyslipidemia 血脂异常 | 14 (24.1) |
Diabetes mellitus 糖尿病 | 4 (6.9) |
Aortic dissection 主动脉夹层 | 1 (1.7) |
Transient ischemic attack 短暂性脑缺血发作 | 1 (1.7) |
Concurrent medication, n (%) 同时用药,n (%) | |
Antihypertensive medication 抗高血压药物 | 26 (44.8) |
Lipid‐lowering medication 降血脂药物 | 17 (29.3) |
Psycholeptic treatment 心理治疗 | 5 (8.6) |
Anti‐diabetic medication 抗糖尿病药物 | 4 (6.9) |
Sex hormone treatments 性激素治疗 | 4 (6.9) |
Antithrombotic agents 抗血栓形成剂 | 3 (5.2) |
Anti‐inflammatory agents 抗炎剂 | 3 (5.2) |
Abbreviation: SD, standard deviation.
缩写:缩写:SD,标准偏差。
3.1. Detection rate for significant arrhythmias
3.1.重大心律失常的检出率
The detection rates of significant arrhythmias, defined as the outcomes, are summarized in Table 2. The cumulative detection rates of MEMO patches on days 1 and 7 were 19.0% (11/58) and 34.5% (20/58), respectively, and that of Holter monitors on day 1 was 19.0%. Of the 44 participants without arrhythmias in 24‐h Holter monitoring, nine had significant arrhythmias in 7‐day MEMO patch monitoring (Figure 2).
表 2 总结了重大心律失常的检出率(定义为结果)。MEMO 贴片在第 1 天和第 7 天的累计检出率分别为 19.0%(11/58)和 34.5%(20/58),Holter 监测仪在第 1 天的累计检出率为 19.0%。在 24 小时 Holter 监测中无心律失常的 44 名参与者中,有 9 人在 7 天的 MEMO 贴片监测中出现了明显的心律失常(图 2 )。
TABLE 2 表 2
MEMO patch monitor 补丁监视器 | 24‐h Holter monitor 24 小时动态心电图监测仪 |
p‐value p-value | |
---|---|---|---|
Number of participants diagnosed with significant arrhythmias 诊断出严重心律失常的参与者人数 | 20/58 (34.5%) | 11/58 (19.0%) | .008 |
Number of detected arrhythmias 检测到的心律失常次数 | 25 | 11 | .005 |
Supraventricular tachycardia 室上性心动过速 | 17 | 8 | .042 |
Atrial fibrillation/atrial flutter 心房颤动/心房扑动 | 6 | 2 | .143 |
Sinus pause (≥3 s) 窦性停搏(≥3 秒) | 1 | 1 | 1.000 |
Second (Mobitz type II)/third‐degree AVB 二度(莫比茨 II 型)/三度 AVB | 0 | 0 | ‐ |
Ventricular tachycardia (≥3 events) 室性心动过速(≥3 次) | 1 | 0 | .315 |
Polymorphic ventricular tachycardia/ventricular fibrillation 多形性室性心动过速/室颤 | 0 | 0 | ‐ |
Abbreviation: AVB, atrioventricular block.
缩写:缩写:AVB,房室传导阻滞。
Among the 58 participants, six atrial fibrillation/atrial flutter episodes were detected by MEMO patch monitoring, and only two were detected by Holter monitoring.
在 58 名参与者中,MEMO 贴片监测发现了六次心房颤动/心房扑动发作,而 Holter 监测只发现了两次。
The detection rate for total significant arrhythmias was higher with MEMO patches (34.5% vs. 19.0%, p = .008), as shown in Table 2.
如表 2 所示,MEMO 贴片的总显著心律失常检出率更高(34.5% 对 19.0%,p = .008)。
3.2. Detection of all arrhythmias
3.2.检测所有心律失常
A total of 51 arrhythmias were detected by MEMO patch monitoring and 22 arrhythmias were detected by Holter monitoring, as shown in Table 3. Supraventricular tachycardia was the most commonly detected arrhythmia (29.3% by the MEMO patch and 13.8% by the Holter monitor, p = .042).
如表 3 所示,MEMO 贴片监测共检测到 51 种心律失常,Holter 监测检测到 22 种心律失常。室上性心动过速是最常检测到的心律失常(MEMO 贴片检测到 29.3%,Holter 监护仪检测到 13.8%,p = .042)。
TABLE 3 表 3
MEMO patch monitor 补丁监视器 | 24‐h Holter monitor 24 小时动态心电图监测仪 |
p‐value p-value | |
---|---|---|---|
Number of participants diagnosed with arrhythmias 诊断出心律失常的参与者人数 | 29/58 (50.0%) | 17/58 (29.3%) | .001 |
Number of detected arrhythmias 检测到的心律失常次数 | 51 | 22 | <.001 |
Supraventricular tachycardia 室上性心动过速 | 17 | 8 | .042 |
Atrial fibrillation/atrial flutter 心房颤动/心房扑动 | 6 | 2 | .143 |
Atrial premature beats 房性早搏 | 4 | 4 | 1.000 |
Ventricular premature beats 室性早搏 | 5 | 5 | 1.000 |
Tachycardia‐bradycardia syndrome 心动过速-心动过缓综合征 | 1 | 0 | .315 |
Sinus pause (≥3 s) 窦性停搏(≥3 秒) | 1 | 1 | 1.000 |
Second‐degree (Mobitz type I) AVB 二度(莫比茨 I 型)反车辆地雷 | 4 | 2 | .402 |
Second‐degree (Mobitz type II) AVB 二度(莫比茨 II 型)房室传导阻滞 | 0 | 0 | ‐ |
Intermittent 2:1 AVB 间歇式 2:1 AVB | 1 | 0 | .315 |
Third‐degree AVB 三度 AVB | 0 | 0 | ‐ |
Wolff–Parkinson–White syndrome 沃尔夫-帕金森-怀特综合征 | 1 | 0 | .315 |
Sick sinus syndrome 病态窦综合征 | 1 | 0 | .315 |
Short run of accelerated idioventricular rhythm 特发性心律加速的短程运行 | 1 | 0 | .315 |
Ventricular tachycardia (≥3 events) 室性心动过速(≥3 次) | 1 | 0 | .315 |
Polymorphic ventricular tachycardia/ventricular fibrillation 多形性室性心动过速/室颤 | 0 | 0 | ‐ |
Abbreviation: AVB, atrioventricular block.
缩写:缩写:AVB,房室传导阻滞。
Notably, tachycardia‐bradycardia syndrome, Wolff–Parkinson–White syndrome, sick sinus syndrome, short run of accelerated idioventricular rhythm, and ventricular tachycardia were only detected using the MEMO patch. Several examples of arrhythmias detected by the MEMO patch are presented in Figure 3.
值得注意的是,只有使用 MEMO 补丁才能检测到心动过速-心动过缓综合征、沃尔夫-帕金森-怀特综合征、病窦综合征、短程加速性特发性心律和室性心动过速。图 3 显示了 MEMO 贴片检测到的心律失常的几个例子。
3.3. Adverse skin reactions
3.3.皮肤不良反应
There were 99 reported adverse skin reactions among 9% (5/58) of the participants. Approximately 86% (85/99) of symptoms were self‐limited itching sensations with mild redness, which were categorized as mild reactions; 82% (81/99) of all cases occurred 24 h after adhesive patches were attached to the participants' skins. No severe reactions were observed in this study.
9% 的参与者(5/58)报告了 99 例皮肤不良反应。约 86%(85/99)的症状为自限性瘙痒,伴有轻微发红,被归类为轻度反应;82%(81/99)的病例发生在皮肤贴上胶贴 24 小时后。本研究未发现严重反应。
4. DISCUSSION 4.讨论
Our study demonstrated that 7 days of monitoring with a wearable ECG patch was superior to 24 h of monitoring with a Holter monitor for detecting clinically significant supraventricular tachycardia among patients with palpitations, chest pain, or syncope. However, 7 days of monitoring failed to detect other clinically significant arrhythmias including atrial fibrillation more effectively than a Holter monitor in our study participants.
我们的研究表明,在检测心悸、胸痛或晕厥患者中具有临床意义的室上性心动过速方面,使用可穿戴心电图贴片进行 7 天监测优于使用 Holter 监测仪进行 24 小时监测。但是,在我们的研究对象中,7 天的监测未能比 Holter 监测器更有效地检测出其他具有临床意义的心律失常,包括心房颤动。
Both MEMO patch monitoring and Holter monitoring showed similar arrhythmia detection rates over 24 h. Compared to 24‐h Holter monitoring, the detection rate increased 1.24‐fold during the extended 6 days of MEMO patch monitoring.
MEMO 贴片监测和 Holter 监测在 24 小时内的心律失常检出率相似。与 24 小时 Holter 监测相比,MEMO 贴片监测在延长的 6 天内检出率增加了 1.24 倍。
The detection rate with 14‐day Zio patch monitoring (iRhythm Technologies, Inc.) was higher than that with 24‐h Holter monitoring (96 vs. 61 events, p < .001).
10
Another study conducted by Chua et al. showed that 14 days of patch‐type ECG monitoring detected more arrhythmia events than did 24‐h Holter monitoring (66% vs. 9%, p < .001).
11
Another study also confirmed that 14‐day ECG patch monitoring showed higher arrhythmia detection rates (up to 60% [94/158]) than did 24‐h Holter monitoring (up to 19%).
13
The diagnostic yield of arrhythmias usually increases proportionally with the monitoring duration. However, several studies showed that approximately 90% of total arrhythmias can be detected if ECG monitoring periods are between 7 and 10 days.
11
,
13
In our study, 7‐days of ECG patch monitoring among generally low risk patients with symptoms could yield a low detection rate of significant arrhythmias other than supraventricular tachycardia. Thus, a longer monitoring duration of 14 days may be needed to detect significant arrhythmias including subclinical atrial fibrillation/flutter.
14 天 Zio 贴片监测(iRhythm Technologies, Inc.)的检出率高于 24 小时 Holter 监测(96 对 61 个事件,p < .001)。 10 Chua 等人进行的另一项研究显示,14 天的贴片式心电图监测比 24 小时 Holter 监测发现更多的心律失常事件(66% 对 9%,p < .001> )。9%, p < .001)。 11 另一项研究也证实,14 天心电图贴片监测的心律失常检出率(高达 60% [94/158])高于 24 小时 Holter 监测(高达 19%)。 13 心律失常的诊断率通常随监测时间的延长而成正比增加。然而,多项研究表明,如果心电图监测时间在 7 到 10 天之间,大约 90% 的心律失常可以被检测出来。 11 , 13 在我们的研究中,对有症状的一般低风险患者进行为期 7 天的心电图贴片监测,除室上性心动过速外,对明显心律失常的检出率较低。因此,要检测出包括亚临床心房颤动/扑动在内的明显心律失常,可能需要更长的 14 天监测时间。
Holter monitors are the device of choice for cardiac monitoring to detect arrhythmias. However, because of their size, inconvenience, and relatively short monitoring period, their usefulness in long‐term ambulatory monitoring is limited. Recently, many wearable devices have been introduced for monitoring patients remotely, which are small, comfortable, and compact. Several modalities of ECG monitoring exist, including monitoring type (continuous versus event monitoring), presence of event trigger function, presence of real‐time monitoring, or duration of monitoring.
14
Compared with Holter monitors, patch‐type monitors consist of a single lead, are easier to use, and have higher adherence; however, they might suffer from low signal quality with different body types.
15
Patch‐type ECGs usually do not have functions such as event‐based recording or real‐time data monitoring. In patients with intermittent palpations, patch‐type ECG monitoring may be appropriate for symptom rhythm correlations.
Holter 监护仪是检测心律失常的首选心脏监护设备。然而,由于其体积庞大、使用不便且监测时间相对较短,其在长期非卧床监测中的作用有限。最近,许多用于远程监测患者的可穿戴设备问世,它们体积小、佩戴舒适、结构紧凑。心电图监测有多种模式,包括监测类型(连续监测与事件监测)、是否有事件触发功能、是否有实时监测或监测持续时间。 14 与 Holter 监护仪相比,贴片式监护仪由单导联组成,使用更方便,依从性更高;但在不同体型下可能会出现信号质量低的问题。 15 贴片式心电图通常不具备事件记录或实时数据监测等功能。对于间歇性触诊的患者,贴片式心电图监测可能适用于症状节律相关性。
Among patients treated for atrial fibrillation, 72‐h single‐lead ECG monitoring was superior to 24‐h Holter monitoring; an additional 13.6% of patients with negative results in Holter monitoring were diagnosed with paroxysmal atrial fibrillation using 72‐h single‐lead ECG monitoring.
16
Undiagnosed paroxysmal atrial fibrillation can lead to recurrent stroke or embolic events.
17
,
18
In addition, a higher atrial burden is a significant risk factor for clinical atrial fibrillation and future stroke.
19
In this regard, continuous monitoring using patch‐type ECG can be useful, especially for patients with a history of strokes or transient ischemic attacks.
20
Ambulatory patch‐type ECG monitoring may also be useful in emergency department patients with unexplained syncope.
21
在接受心房颤动治疗的患者中,72 小时单导联心电图监测优于 24 小时 Holter 监测;在 Holter 监测结果为阴性的患者中,另有 13.6% 的患者通过 72 小时单导联心电图监测确诊为阵发性心房颤动。 16 未确诊的阵发性心房颤动可导致复发性中风或栓塞事件。 17 , 18 此外,较高的心房负担是临床心房颤动和未来中风的重要风险因素。 19 在这方面,使用贴片式心电图进行连续监测非常有用,尤其是对有脑卒中或短暂性脑缺血发作病史的患者。 20 非卧床贴片式心电图监测对急诊科不明原因晕厥患者也很有用。
Smartphone‐based arrhythmia detection using a combined approach with single‐lead ECG and photoplethysmography is a promising tool for the early detection of atrial fibrillation.
22
Due to their general availability, smartphone‐based algorithms enable patients to easily record symptomatic arrhythmias; however, short subclinical episodes may not be detected. A recent meta‐analysis showed that smartphones using only photoplethysmography‐based algorithms seemed to be biased, low‐quality monitoring devices with unrealistically high sensitivity and specificity.
23
基于智能手机的心律失常检测采用单导联心电图和照相血流动力学相结合的方法,是早期检测心房颤动的一种很有前途的工具。最近的一项荟萃分析表明,仅使用基于光电血压计算法的智能手机似乎是有偏差的、低质量的监测设备,具有不切实际的高灵敏度和特异性。
Other types of portable devices include the external loop recorder, which has a recording time of up to 4 weeks, and requires activation by patients during the onset of symptoms. In contrast, patch‐type ECG monitors have no external leads or wires, usually have a recording time of up to 14 days, and continuously monitor the patients' signals; thus, they are more useful in conditions such as syncope.
24
Implantable loop recorders have the longest recording time of up to 3 years, activated by both an automatic algorithm and patient input; however, invasive procedures, high costs, and limited availability constrain their widespread use among patients.
24
Various devices with different diagnostic yields, cost‐effectiveness, and patient preference and convenience should be considered when choosing diagnostic methods for symptomatic patients or screening high‐risk patients.
其他类型的便携式设备包括外部循环记录器,其记录时间长达 4 周,需要患者在症状出现时启动。相比之下,贴片式心电监护仪没有外部导线或电线,记录时间通常长达 14 天,可持续监测患者的信号,因此在晕厥等情况下更有用。 24 植入式循环记录器的记录时间最长可达 3 年,由自动算法和患者输入激活;然而,侵入性程序、高昂的费用和有限的供应限制了其在患者中的广泛使用。 24 为无症状患者或高危患者筛查选择诊断方法时,应考虑各种具有不同诊断效果、成本效益以及患者偏好和便利性的设备。
In our study, we also found that meaningful arrhythmias, including sick sinus syndrome and Wolff–Parkinson–White syndrome, were only detected in MEMO patch monitoring. Tachycardia bradycardia syndrome and sick sinus syndrome can be categorized as sinus node dysfunction, which can cause many symptoms, including syncope, presyncope, and lightheadedness, and patients with these conditions may need permanent pacemakers and concomitant treatment for atrial fibrillation.
25
Wolff–Parkinson–White syndrome causes palpitations or syncope, and if accompanied by atrial fibrillation, it may cause ventricular fibrillation and sudden death, although that is rare.
26
在我们的研究中,我们还发现只有在 MEMO 贴片监测中才能检测到有意义的心律失常,包括病窦综合征和沃尔夫-帕金森-怀特综合征。心动过速过缓综合征和病窦综合征可归类为窦房结功能障碍,可引起晕厥、晕厥前和头昏眼花等多种症状,患有这些疾病的患者可能需要永久性心脏起搏器并同时治疗心房颤动。 25 沃尔夫-帕金森-怀特综合征会引起心悸或晕厥,如果伴有心房颤动,可能会导致心室颤动和猝死,但这种情况很少见。
This study has several limitations. The participants were recruited from one hospital, which limits the generalizability of the study findings. Moreover, there might have been false‐positive or false‐negative episodes with the MEMO patch monitoring that could not be accounted for because of the lack of validated comparable tools. However, considering the same detection rates on the first day of concomitant Holter and MEMO patch monitoring, it can be inferred that the detection rates of both devices were similar. Further studies are required to confirm the effectiveness of 7‐day continuous ECG patch monitoring in detecting meaningful arrhythmias in specific populations.
这项研究有几个局限性。参与者是从一家医院招募的,这限制了研究结果的普遍性。此外,由于缺乏经过验证的可比工具,MEMO 贴片监测可能会出现假阳性或假阴性的情况,而这些情况无法被考虑在内。不过,考虑到 Holter 和 MEMO 贴片同时监测的首日检出率相同,可以推断两种设备的检出率相似。要确认 7 天连续心电图贴片监测在特定人群中检测有意义的心律失常的有效性,还需要进一步的研究。
5. CONCLUSION 5.结论
In this single‐center prospective trial, 7‐day patch‐type continuous ECG monitoring was more effective in detecting supraventricular tachycardia than was 24‐h Holter monitoring. However, detecting other types of significant arrhythmias with ECG patch monitoring might require a longer duration of more than 7 days. Further studies on the efficacy of detecting specific arrhythmias in certain populations are required. In addition, studying the comparative effectiveness will help choose the most appropriate options for patients in terms of monitoring periods, costs, convenience, and limitations among various types of ECG devices.
在这项单中心前瞻性试验中,7 天贴片式连续心电图监测在检测室上性心动过速方面比 24 小时 Holter 监测更有效。不过,通过心电图贴片监测检测其他类型的重大心律失常可能需要更长的时间,超过 7 天。还需要进一步研究在特定人群中检测特定心律失常的效果。此外,研究比较效果将有助于从监测时间、成本、便利性和各种心电图设备的局限性等方面为患者选择最合适的方案。
AUTHOR CONTRIBUTIONS 作者贡献
Ju Young Kim conceived, designed, and performed the study. Ji Hyun Lee, Youngjin Cho, and Hyejin Lee designed and performed the study and reviewed the literature. Yeongjoon Gil and Sunghoon Jung performed the artificial intelligence analytic program and were involved in the interpretation of the results. Dae In Kim, Joo Yeon Yoo, and Jeong Yeon Kwak performed the clinical study and collected clinical data. Dae In Kim, Myung Geun Shin, and Jeong Yeon Kwak performed statistical analyses. Il‐young Oh took part in the study design and was responsible for the final draft. All authors have contributed to the manuscript and approved the submitted version.
Ju Young Kim 构思、设计并实施了这项研究。Ji Hyun Lee、Youngjin Cho 和 Hyejin Lee 设计和实施了研究,并查阅了文献。Yeongjoon Gil 和 Sunghoon Jung 执行了人工智能分析程序,并参与了结果的解释。Dae In Kim、Joo Yeon Yoo 和 Jeong Yeon Kwak 进行了临床研究并收集了临床数据。Dae In Kim、Myung Geun Shin 和 Jeong Yeon Kwak 进行了统计分析。Il-young Oh参与了研究设计,并负责最终稿的撰写。所有作者都参与了手稿的撰写,并批准了提交的版本。
FUNDING INFORMATION 资金信息
This work was mainly supported by the Korea International Cooperation Agency under the title “Prediction and management system for the patients of cardiovascular disease” between 2018 and 2021 (No. 2018‐1580). This study was also partly supported by the Korea Medical Device Development Fund from the Ministry of Science and ICT (Project number: 1711138361), Ministry of Trade Industry and Energy (Project number: RS‐2020‐KD00017), Ministry of Health & Welfare (Project number: 1711139106), and Ministry of Food and Drug Safety (Project Number: RS‐2021‐KD000011). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
本研究主要得到了韩国国际协力团 2018 年至 2021 年 "心血管疾病患者预测和管理系统"(编号:2018-1580)的支持。本研究还得到了科学和信息通信技术部(项目编号:1711138361)、通商产业和能源部(项目编号:RS-2020-KD00017)、保健福祉部(项目编号:1711139106)和食品药品安全部(项目编号:RS-2021-KD000011)的韩国医疗设备开发基金的部分支持。资助方未参与研究设计、数据收集和分析、发表决定或稿件撰写。
CONFLICT OF INTEREST STATEMENT
利益冲突声明
JuYK is employed part‐time at HUINNO Co., Ltd Seoul, Korea. YG, SJ, DK, MGS, JYY, and JK are currently employed at HUINNO Co., Ltd Seoul, Korea. The rest of the authors declare that they have no conflicts of interest.
JuYK 在韩国首尔 HUINNO 有限公司兼职。YG、SJ、DK、MGS、JYY 和 JK 目前受雇于韩国首尔 HUINNO 有限公司。其余作者声明没有利益冲突。
DECLARATIONS 声明
Approval of the research protocol: The Institutional Review Board of Seoul National University Bundang Hospital approved the protocol on February 08, 2019. Informed consent: All participants provided informed consent to participate before enrollment. Registry and the Registration No: Approval No: E‐1901‐516‐001. Animal studies: N/A.
研究方案批准:首尔国立大学盆唐医院机构审查委员会于2019年2月8日批准了该方案。知情同意:所有参与者在入组前均提供了知情同意书。注册表和注册号:批准号:E-1901-516-001。动物研究:不适用。
ETHICS APPROVAL STATEMENT
伦理批准声明
The Institutional Review Board of Seoul National University Bundang Hospital approved the protocol (approval No: E‐1901‐516‐001).
首尔大学盆唐医院机构审查委员会批准了该方案(批准号:E-1901-516-001)。
PATIENT CONSENT STATEMENT
患者同意声明
All participants provided informed consent to participate before enrollment.
所有参与者在报名前均已获得知情同意。
ACKNOWLEDGMENTS 致谢
We would like to thank the following family physicians and research coordinators that collaborated with our study: Eunbyol Cho, Sumi Lee, Siye Gil, and Hyerim Kim, of the Seoul National University Bundang Hospital. We also thank all the patients who participated in the study.
我们衷心感谢以下家庭医生和研究协调员对我们的研究给予的合作:首尔国立大学盆唐医院的 Eunbyol Cho、Sumi Lee、Siye Gil 和 Hyerim Kim。我们还要感谢所有参与研究的患者。
Notes 说明
Kim JY, Oh I‐Y, Lee H, Lee JH, Cho Y, Gil Y, et al. The efficacy of detecting arrhythmia is higher with 7‐day continuous electrocardiographic patch monitoring than with 24‐h Holter monitoring. J Arrhythmia. 2023;39:422–429. 10.1002/joa3.12865IF: 2.2 Q2 NA
[] [Google Scholar]
Kim JY、Oh I-Y、Lee H、Lee JH、Cho Y、Gil Y 等。7 天连续心电图贴片监测比 24 小时 Holter 监测检测心律失常的效率更高。J Arrhythmia。2023;39:422–429.10.1002/joa3.12865 [] [Google Scholar].
DATA AVAILABILITY STATEMENT
数据可用性声明
The data that support the findings of this study are available from the corresponding author (Il‐Young Oh) upon reasonable request.
支持本研究结果的数据可向通讯作者(Il-Young Oh)索取。
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- Abstract 摘要
- 1. INTRODUCTION 1.引言
- 2. METHODS 2.方法
- 3. RESULTS 3.结果
- 4. DISCUSSION 4.讨论
- 5. CONCLUSION 5.结论
- AUTHOR CONTRIBUTIONS 作者贡献
- FUNDING INFORMATION 资金信息
- CONFLICT OF INTEREST STATEMENT
利益冲突声明 - DECLARATIONS 声明
- ETHICS APPROVAL STATEMENT
伦理批准声明 - PATIENT CONSENT STATEMENT
患者同意声明 - ACKNOWLEDGMENTS 致谢
- Notes 说明
- DATA AVAILABILITY STATEMENT
数据可用性声明 - REFERENCES 参考文献
《心律失常杂志》的文章由日本心脏节律学会提供。