Initial Clinical Experience with New Technology: ePatch^TM Extended Holter Monitoring

Introduction and objectives: Conventional methods of Holter (H) monitoring, data analysis and reporting can be inefficient, leading to high costs and long response times. Traditional H devices can be cumbersome to wear, and uncomfortable testing can reduce patient compliance and satisfaction, impacting diagnostic performance. This new device ePatch^TM is a simple application of patch and activation without the need to charge the battery and without connecting cables (Figure 1). Up to 14 days of continuous Electrocardiogram (ECG) recording. It can be worn in the shower and during exercise. Single channel, up to 14 days. Two channels, up to 7 days. Our objective is to evaluate the quality and diagnostic efficacy of ePatch^TM in different clinical settings.

Methods: Prospective study of patients with ePatch^TM placed in our centre requested for the study of undocumented palpitations, syncope or cryptogenic stroke. Clinical variables, diagnostic accuracy and time to diagnostic event are analysed.

Results: The first 154 patients were included, of whom (51.3%) were women, with a mean age of 66.6 years (range 18 to 89). The most frequent indication was palpitations (37%) followed by cryptogenic stroke (34.4%), followed by syncope (28.5%). All patients had correct compliance and tolerance and the monitored ECG was of good quality. A conclusive diagnosis: (sustained symptomatic tachyarrhythmia, atrioventricular block with bradyarrhythmia, significant pauses or atrial fibrillation) was obtained in 15 patients (9.7% of the total). 14-, 7-, and 5-day recorders were used. The median event time since ePatch^TM logging began was 2.6 days (range 1 to 5 days). Only the duration of H (OR 10.6), and left atrial dilation (OR 5) were significant predictors of arrhythmic event in the multivariate analysis.

Conclusion: ePatch^TM is a new H device that offers a simple, complete and effective ECG monitoring system. This new technology is safe and has numerous advantages: spending less time on device logistics and handling, preparing patients efficiently, eliminating the need for additional consumables, and constantly replacing the battery. The ECG monitor can be used for up to 14 days. It is designed to address the challenges of traditional H monitoring.

Holter (H) monitor is used to detect potential cardiac arrhythmias such as Atrial Fibrillation (AF). However, conventional Electrocardiogram (ECG) monitoring, data analysis and reporting methods can be labour-intensive and inefficient, leading to high upfront costs and long turnaround times. At the same time, traditional H can be cumbersome to wear, while inconvenient processes may reduce patient compliance and satisfaction – which impacts diagnostic yield [1,2].

Ambulatory monitoring devices for cardiac disorders are showing great promise for the early detection of life-threatening conditions and critical events through long-term continuous monitoring during routine daily lives of individuals. They also show a significant potential of reducing health care costs by preventing unnecessary hospitalizations as well as enabling better self-management and intervention approaches. Remote and ambulatory monitoring is becoming increasingly popular among health care practitioners and patients for the long term continuous monitoring and diagnosis of cardiac diseases [1]. Hardware and software advancements have led to the development of novel devices, which are both practical and affordable, and enable monitoring of vulnerable populations from the comfort of their homes, while at the same time providing critical alerts for events requiring prompt medical attention or hospitalization [3].

Some devices have demonstrated new ways of monitoring, from adhesive patches to mobile telemetry and both have shown good feasibility as monitoring tools [4,5]. Wearable technology is a new concept for noninvasive monitoring of vital signs based on adapted sensors to the body surface.

Traditional H monitors can only be worn for a certain amount of time (normally 24-48 hours), unlike wearable devices which can be worn daily. The H may also need to be worn multiple times to catch an arrhythmia, causing the bill to add up that much more. The monitors can also be uncomfortable, with many patients complaining about skin irritation due to the adhesive on the electrodes. The monitor and wires can also be cumbersome, possibly getting in the way of daily activities.

Textile Wearable Holter (TWH) for prolonged cardiac monitoring from acute phase of stroke was used in clinical studies [6].

There are other new devices like ePatch^TM Philips Extended H (Philips Medical Systems BV

High Tech Campus 52, Eindhoven, The Netherlands). It consists of a wireless adhesive patch inside which the recorder is inserted and allows the wearer to make a mark (on the ECG record knocking the device twice in a row) if feels a clinical event, facilitating its analysis. With no battery charging needed and no cable attachments (Figure 1). It can record the ECG continuously for up to 14 days. It can be worn in the shower, during exercise and while you sleep. Single-channel, up to 14 days. Two-channel, up to 5 days. Philips ePatch^TM is designed to address the challenges of traditional H monitoring: minimize clinical and administrative burden and improve the patient experience and compliance. The advantages are: create reports with less artifacts than H monitoring, support patient comfort and compliance with an easy-to-use device that can be worn during active life. Wearable ECG monitor can be used for up to 14 days–with no cable attachments, enable efficient workflows and timely diagnoses, easily access ready-to-use ePatch^TM monitors which can be stored on shelf at your clinic, spend less time on logistics and device handling, prepare your patients efficiently and eliminate the need for additional consumables and constant battery replacement.

We performed a study to evaluate the quality and diagnostic efficacy of ePatch^TM in different clinical settings.

Prospective study of patients with ePatch^TM placed in our centre requested for study of undocumented palpitations, syncope or cryptogenic stroke. The test was ordered by cardiologists or neurologists. Clinical variables, diagnostic accuracy, and time to diagnostic event are analysed. The study was ordered by cardiologist or neurologist of our institution.

All patients had ePatch^TM applied in the sternum zone of the chest after skin preparation. This new device (ePatch^TM-Philips Extended H) consists of a wireless adhesive patch inside which the recorder is inserted. No battery charging is needed. It can be worn in the shower, and during exercise.

The ePatch^TM was placed (with 5 or 14 day H recorders) then the patient returns the device when the duration has completed. The specialized nurse downloads the record on the web platform CardiologsTM (arrhythmia diagnostic software cloud-based) and performs an initial review searching for artefacts. Then the cardiologist made the finale report through the same web platform.

When the patients feels any symptoms, such as palpitations, dizziness, or near-syncope, they are instructed to tap her finger 2 times in a row on the ePatch^TM and that is when an event is marked in the recording

We analysed tolerance, clinical and echocardiographic characteristics of the sample, rate of positive events, average event time since record started and predictive factors of arrhythmic event.

Quantitative data were reported as mean ± standard deviation, and qualitative data were expressed as proportions (percentages). The comparison of means between two groups was conducted using the Student's t-test, while the comparison of proportions utilized chi-square tests.

Binary logistic regression was employed to identify factors associated with the outcome of interest. Variables that demonstrated a p < 0.1 in the preliminary analyses were considered for inclusion in the logistic regression model. They were directly introduced into the model to assess their independent effects. The criterion for statistical significance was set at a p < 0.05. All analyses were conducted using SPSS software, version 26.

We enrolled the first 154 patients, of whom 51.3% were women, with a mean age of 66.6 years (range 18 to 89). The most common indication was undocumented palpitations (37%), followed by cryptogenic stroke (34.41%), and followed by syncope (28.5%). All the patients had correct compliance, tolerance and the ECG monitored was of good quality.

The baseline characteristics of the population can be seen in table 1.

Nine patients wore the device for 14 days of recording and 145 patients for 5 or 7 days.

A conclusive diagnosis: (symptomatic sustained tachyarrhythmia, atrial-ventricular block with bradyarrhythmia, significant pauses or AF) was obtained in 15 patients (9.7% of the total).

The significant arrhythmias found were: 10 patients (66.6%), with AF, 3 patients (20%) with supraventricular tachycardia, and 2 patients (13.3%) with ventricular tachycardia.

The average event time since ePatch registration started was 2.6 days (range 1 to 5 days).

More arrhythmic events were recorded in the patients wearing the 14 days device than in those of 5 or 7 days (Table 2).

Among the variables studied, a statistically significant difference in arrhythmic events was observed in: H duration (p = 0.04), left atrial enlargement (p = 0.007), and diabetes mellitus (p = 0.08) (Table 3).

Only the duration of H (OR 10.6), and left atrial dilation (OR 5) were significant predictors of arrhythmic event in the multivariate analysis (Table 4).

All of the patents tolerated well the ePatch^TM. In only one patient the patch came off the first day due to excessive sweating and it was repositioned. None of the patients complained of significant skin reaction, only mild skin reactions. All ECG records were of good quality, including single channel reports. And as we have said in the methods, it is not necessary to change the battery. The cost of the 5-7 day recorder is cheaper than carrying out a traditional record (in our centre we use 48-hour recorders that the patient must replace until the 5-7 days are completed). Likewise, the time for nursing is higher to explain the patient and to analyse the record which has more artifacts than the ePatch^TM.

The ePatch^TM is a new extended H device offering a simple, complete and efficient ECG monitoring system. This new technology is safe and has numerous advantages against tradicional H: spend less time on logistics and device handling, prepare your patients efficiently, and eliminate the need for additional consumables (cables, electrodes) and constant battery replacement. It can be used for up to 14 days and the record is of good quality. It’s designed to address the challenges of traditional H monitoring.

The ePatch^TM is a continuous ambulatory ECG adhesive monitoring patch that is comfortable to wear, and the recording is of good quality with few artefacts.

One of the main advantages over the traditional long-duration H lies in the fact that we increasingly have older patients, who live alone and the instructions, positioning of cables and battery charging become more difficult to explain and achieve. Another advantage is that women can wear a bra compared to traditional H in which they cannot wear it to avoid the artefacts of registration.

Ambulatory ECG monitoring beyond 7 days often provides only an additional 3.9% of patients with a diagnosis [7]. Consistent with our findings, there is substantial evidence to suggest that extending the ECG monitoring period beyond 24 hours increases the diagnostic yield of arrhythmias. To date, however, this could only be achieved using bulky, activity-limiting technology requiring multiple chest leads [8]. Although previous studies have demonstrated the incremental diagnostic yield of prolonging the monitoring period, in this study the extended monitoring was achieved with a more lightweight, unobtrusive, adhesive, patch device [9-11]. Pagola, et al. [12] with a textile wearable H during 28 days observed that the rate of undiagnosed AF detection was 21.9% (only five patients were needed to screen to detected one case of AF).

Other factors may influence the rate of AF detection. First, previous studies supported the advantages of monitoring from the acute stroke phase [13,14]. Second, the risk of stroke increases with the age of the patient and CHA2DS2VASc score [15,16]. And third, the cerebral infarction profile (cortical infarction) is similar to infarction due to AF.

According to the document “Recommendations for cardiac monitoring in patients with cryptogenic stroke” [17] published by the Spanish Society of Cardiology and the Spanish Society of Neurology it is recommended prolonged monitoring of heart rate for those patients considered high risk and in whom cardioembolic stroke due to silent AF is suspected: CHA2DS2-VASC > 5., multiple non-lacunar cerebral infarcts in different vascular territories ,left atrial enlargement (> 45 mm), other atrial rhythm disturbances and presence of spontaneous echocontrast or slow flow in the appendage.

They suggest for the selection of the type of cardiac monitoring is based on the following criteria:

– Time to monitoring since the stroke: >2 months: implantable monitor and < 2months: external monitor.

Based on the results of the Crystal AF and Embrace studies (According to Crystal AF Median detection of atrial fibrillation in patients with cryptogenic stroke was 84 days) [1].

– Probability of early detection of arrhythmias: low: implantable monitor and high: External monitor

(LA dilation, premature beats, etc.)

– Collaboration by the patient (age, social support, and functional situation): low: implantable monitor and high: External monitor

In any case, the selection of the monitoring method will be individualized according to of the patient's characteristics. (Patient over 80 years old, with partial dependence).

With the patch we can monitored patients very old and with dependence instead of traditional H monitoring.

Other studies with adhesive patch electrocardiographic monitoring different from our device have been published. Barret, et al. [18], concluded that the adhesive patch monitor (Zio Patch) detected more events than the H monitor. A total of 146 patients referred for evaluation of cardiac arrhythmia underwent simultaneous ambulatory ECG recording with a conventional 24-hour H monitor and a 14- day adhesive patch monitor. The adhesive patch monitor detected 96 arrhythmia events compared with 61 arrhythmia events by the H monitor (p < .001). The study of Chua SK, et al. [19] compared a 14-day ECG monitor patch-a single-use, noninvasive, waterproof, continuous monitoring patch (EZYPRO) —with a 24-hour H monitor in 32 consecutive patients with suspected arrhythmia concluded that The 14-day ECG patch was well tolerated and allowed for longer continuous monitoring than the 24-hour H monitor, thus resulting in improved clinical accuracy in the detection of paroxysmal arrhythmias. Karunadas CP, et al. [20], compared the arrhythmia detection by WebCardio a new system which records ECG in two leads for 72 h and conventional H. Arrhythmia was picked up in more number of patients by the WebCardio compared to H. The study of Kwon S, et al. [21] is a prospective cohort study of the comparison between the 24-hour H Test and 72-hour single-lead electrocardiogram monitoring with an adhesive patch-type device (MobiCARE MC-100) for atrial fibrillation detection in 200 patients. Compared with 24-hour H monitoring, 72-hour monitoring with the APD increased the detection rate of paroxysmal AF by 2.2-fold (44/20). Asymptomatic or subclinical AF is increasingly common in aging populations and has been identified as a risk factor for ischemic stroke. The early identification of AF and appropriate anticoagulation therapy may therefore decrease stroke morbidity and mortality.

It is a study related to one single centre. We have few patients with 14-day patch monitor in our study (single-channel). The reference standard is the 3-lead, 24-hour H monitor, and the value of a single-lead, 14-day adhesive patch monitor needs to be assessed in comparison with this standard, but in our patients the tracings were of good quality.

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