At-home ECG monitoring with a real-time outpatient cardiac telemetry system during the COVID-19 pandemic

Context: During the COVID-19 pandemic, essential in-person electrocardiogram (ECG) recordings became un-feasible, while patients continued to suffer from cardiac conditions. To circumvent these challenges, the cardiology clinic (Long Island Heart Rhythm Center [LIHRC]) at the New York Institute of Technology College of Osteopathic Medicine (NYITCOM) transitioned to a remote real-time outpatient cardiac telemetry (ROCT) service. Objectives: The goal of this study is to test the hypothesis that at-home ROCT, provided by the LIHRC, is an effective method of providing ECG monitoring to symptomatic patients during the COVID-19 pandemic. Methods: Seventeen patients at the LIHRC that required ECGsbetweenMarch11andAugust1,2020,wereincludedin this study. The patients ’ medical records were de-identified and reviewed for age, gender, ROCT indications, findings, patient comfort, and ease of use. A retrospective analysis of observational de-identified data obtained from the LIHRC was approved and permitted by the NYITCOM Institutional Review Board (BHS-1465). These FDA-cleared medical devices (DMS-300, DM Software, Stateline, NV) were ship-ped to the patients ’ homes and were self-applied through adhesive chest patches. The devices communicated with a cloud-based system that produced reports including a continuous 6-lead ECG and many other cardiovascular parameters. Additionally, a patient-activated symptom recorder was available to correlate symptoms to ECG findings. Results: Seventeen patients

During the coronavirus disease 2019 (COVID-19) pandemic, an emergency declaration expanded telehealth utilization, making essential in-person electrocardiogram (ECG) recordings more difficult to perform.Both patients and providers at the Long Island Heart Rhythm Center (LIHRC), a cardiac electrophysiology clinic at New York Institute of Technology College of Osteopathic Medicine (NYITCOM), became reluctant to utilize in-person office visits for ECG recordings.This was due to both the high risk of infection during the peak of the COVID-19 pandemic and stay-athome orders mandated by the US.Government.These unique circumstances also warranted the use of ambulatory ECG devices for various applications during the COVID-19 pandemic.
One small study (n=47) conducted at a neurology clinic showed successful implementation of a mail-delivered single-lead ECG system for long-term monitoring during the pandemic [1].A separate study effectively utilized mail-delivered ECG monitors for long-term monitoring in patients after a COVID-19 diagnosis [2].A mail-delivered ECG monitor that connects to mobile smartphones was also successfully implemented in a remote clinical trial of hydroxychloroquine treatment for COVID-19 [3].In addition, a 2021 HRS/EHRA/APHRS/LAHRS/ACC/AHA practice update suggested direct-to-consumer ECG monitors as a solution to the issue of socially distanced cardiac evaluation [4].Thus, to perform an ECG for cardiopulmonary evaluation and avoid COVID-19 exposure, the LIHRC transitioned to a remote real-time outpatient cardiac telemetry (ROCT) system for both patients and providers.This study aims to test the hypothesis that at-home ROCT, provided by the LIHRC, is an effective method of providing ECG monitoring to patients during the COVID-19 pandemic.An effective method is defined as one that fulfills all the following criteria: can be mail-delivered and remotely transmit ECG data to the clinician and can correlate patient symptoms to the ECG rhythm strip to detect arrhythmias.

Methods
Seventeen patients at the LIHRC that required ECGs between March 11 and August 1, 2020, were included in this study.This study was deemed to have exempt status, and informed consent was waived by the NYITCOM Institutional Review Board (BHS-1465 -Diagnostic and Therapeutic Outcomes from the Long Island Heart Rhythm Center).No funding was required for this medical record review, and no compensation was provided.
The subject inclusion criteria for this study are as follows: (1) presented to the LIHRC telehealth clinic virtually during the first surge of the COVID-19 pandemic between March 11 and August 1, 2020, and was recommended ECG monitoring via the FDA-cleared ROCT system; and (2) consented to using this system in lieu of coming to the LIHRC clinic in person for an ECG and agreed to follow up with the clinic virtually.The exclusion criteria are as follows: (1) under 18 years of age; and 2) inability to understand written instructions.Following telehealth presentation to the LIHRC, the included patients requiring ECGs were mailed the ROCT system.The FDA-cleared ROCT system (DMS-300, DM Software, Stateline, NV) consisted of small waterproof white plastic devices with three electrodes that were self-applied to patients' chests through adhesive patches.The DMS-300 system was chosen based on its ability to be shipped to and from the patient's homes, DM Software's customer service helpdesk, and an established relationship between the LIHRC and the company.The devices were shipped to and from the patients' homes directly from the DM Software company.Through a wireless internet connection, 24-h real-time data were sent to a computer at the clinic's base and stored using cloud-based Smartsheet ® software (Smartsheet, Bellevue, WA).The system then produced clinical reports that included a continuous 6-lead ECG with patient symptom correlation; heart rate average, maximum, minimum, and variability; ST-segment analysis with depression and elevation times; ventricular ectopy including total, runs, pairs, bigeminy, and trigeminy; bradycardia including significant pauses greater than 2.5 seconds, maximum pause, and bundle branch blocks; QT/QTc intervals; supraventricular ectopy including total, runs, pairs, bigeminy, trigeminy, and atrial fibrillation/flutter (Table 1).Additionally, patients were instructed to activate the device's symptom recorder to correlate symptomatic episodes to the ECG recordings.
The patients' electronic medical records were de-identified and reviewed for age, gender, indications, ROCT findings (abnormalities in the six-lead ECG), and ease of use.A flow chart of the methods is shown in Figure 1.Patient comfort and ease of use of the devices were important aspects evaluated in consideration of the mind and spirit in the osteopathic approach and the psycho-behavioral components of osteopathic care.The data were counted, and the mean and standard deviation for age were calculated.The hypothesis and effectivity of the devices were assessed by determining their ability to be maildelivered, to transmit ECG data remotely (these devices are cleared

Arrhythmia detection
Seventeen patients (15 women) from the LIHRC were included in the analysis with an average monitoring duration of 27 h (range, 24-72 h).No patients were excluded from the study.The patients' ages ranged from 21 to 85 years old with a mean of 37 years old and a standard deviation of 19 years.ROCT indications included palpitations (n=9), presyncope (n=8), chest pain (n=5), syncope (n=3), shortness of breath (n=2), cough (n=1), and a family history of arrythmias (n=1) (Table 2).One patient also received ROCT due to short PR intervals observed on a prepandemic ECG.One patient who received the ROCT was unable to transmit ECG data for unclear reasons and sent back the device for download of stored data; the device was lost in the mail and never received.In the interim, they obtained a similar remote monitoring device (non-DMS) through their local cardiologist, which identified asymptomatic nonsustained ventricular tachycardia, PVCs, and marked bradycardia.This data were sent to our clinic, and the patient was referred for an electrophysiology study and subsequently received a pacemaker implant.Two patients experienced palpitations while wearing the ROCT device: one had supraventricular tachycardia at 150 beats per minute; and the other had unifocal frequent premature ventricular contractions (PVCs), eventually undergoing a successful left-sided PVC ablation treatment.Most patients experienced no symptomatic episodes during ROCT (n=15).Eight of those patients had no abnormal findings on ECG.Positive ECG findings in the other seven asymptomatic patients included PVCs (n=3), wandering atrial pacemaker (n=2), sinus tachycardia (n=1), premature atrial contractions (PACs) (n=1), ectopic atrial rhythms (n=1), and sinus arrhythmia (n=1) (Table 3).

Patient and provider ease of use
The LIHRC staff experienced some device and connectivity issues.The staff occasionally had difficulty with downloading the reports from the devices from the clinic's home-based computer; however, these were resolved through contact with the DM Software service helpdesk.Most patients reported no issues; however, one patient had difficulty with setting up the device initially.Virtual assistance by the device's technical team helped resolve the problem.Two patients experienced intermittent discomfort with the device's adhesive electrodes; however, this did not affect the quality of the data obtained.
This study demonstrated that at-home ROCT, provided by LIHRC, was effective in providing mail-delivered ECG monitoring with symptom-ECG correlation to patients during the COVID-19 pandemic in 16/17 patients (94.1%).Considering that the ECG data obtained from a separate provider's mail-delivered ROCT device, 17/17 patients (100%) were able to transmit ECG data effectively with symptoms correlated to the ECG rhythm strip.The data retrieved provided incremental information as compared to not recording any elective ECG information at a time when it was difficult for in-person ECG recordings, except in emergencies.This study thus demonstrates the effectiveness of the ROCT system, but most importantly, the utility of remote ECG monitoring as a method of documenting arrhythmias and correlating symptoms during the COVID-19 pandemic.

Discussion
This remote ROCT system provided a unique solution for the challenges faced during the pandemic.Similar ambulatory ECG monitoring systems have been employed in the past for a variety of purposes.In 2017, the International Society for Holter and Noninvasive Electro-cardiology, alongside the Heart Rhythm Society, delivered a consensus statement on ambulatory ECG and external cardiac monitoring/telemetry, which outlined their recommendations on the appropriate indications for ambulatory ECGs [6].These indications include quantification of arrhythmia burden, uncertain frequency of symptomatic events, unexplained syncope or palpitations, and many others.Thus, there is a variety of options available to perform an ECG on an outpatient basis, as outlined in Table 4.Most of these devices also have the potential for use in the setting of telehealth, due to the ability to be shipped to and from patients, to be self-applied, and to have their data stored via the internet or downloaded from the returned device.The exception is the implantable cardiac monitor, which requires surgical implantation before use and is utilized for longer monitoring times [7].
In comparison to the traditional Holter monitor, ROCT allowed immediate access to real-time telemetry data for a longer period (greater than 48 h) and symptom-ECG correlation without having to wait for a monitoring report.This methodology can also be utilized to deliver patientcentered care to those with limited mobility or in rural areas.This is particularly important for the physician to provide holistic patient-centered care that considers factors such as limited access to transportation and mobility and is consistent with the tenets of osteopathy.In addition, newer ECG-capable devices are being developed and tested, including leadless adhesive modules and wearable technology, such as smartwatches, which may further increase the efficiency of tele-ECG evaluations [8].

Limitations
This study is limited by its retrospective and observational nature and its small sample size.Further studies are therefore necessary to determine the true utility of ROCT ECG monitoring in a larger patient population and to determine its accuracy when compared to 12-lead ECGs.

Conclusions
Overall, all patients were able to effectively transmit ECG data, including symptom correlation, remotely; however, one patient experienced issues with the specific maildelivered LIHRC system and required a backup remote ECG system obtained from another provider.With the unique challenges of the COVID-19 pandemic, physicians can use this innovative ROCT service as part of the osteopathic approach to prevent infection and diagnose cardiac diseases.Most patients and staff were able to utilize the system without issues.Therefore, this system may also be utilized to deliver osteopathic patient-centered care to those with limited mobility and healthcare access when coupled with a telemedicine visit.Further studies are necessary to determine the effectiveness of at-home ROCT ECG monitoring compared to the traditional in-person ECG.
Research funding: None reported.
Author contributions: Nolberto Jaramillo Jr. provided substantial contributions to acquisition, analysis, and interpretation of data, as well as writing of the article.Denis Malkov provided substantial contributions to data interpretation and editing of the article.Todd J. Cohen provided substantial contributions to the conception and design as well as gave final approval for the version of the article to be published.Jacqueline Nikakis and Uddampreet S. Arora both contributed substantially to editing of the article.All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Competing interests: None reported.
Ethical Approval: This study is under exempt status under the NYITCOM IRB as it is a retrospective analysis using deidentified patient data sets.Number: BHS 1465.Informed Consent: Informed Consent was waived for this study.

Figure 1 :
Figure 1: Flow chart of the methods and inclusion/exclusion criteria.

Table  :
[5]diovascular health parameters collected through ROCT.by the FDA to transmit accurate ECG data and are regularly monitored remotely/examined by technicians from the manufacturer[5]), and to correlate patient symptoms to ECG recordings.

Table  :
ROCT indications for  patients at the LIHRC during the COVID- pandemic.

Table  :
ROCT ECG findings for  patients at the LIHRC during the COVID- pandemic.
a Denotes the findings of one patient who received a remote ECG monitor through a different provider.Patients may have had more than one finding on the ECG report.

Table  :
Monitoring duration, features, and data retrieval methods for various outpatient ECG monitoring systems[].Note that auto trigger devices detect arrhythmias and record the events before and after.