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

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 mail-delivered, to transmit ECG data remotely (these devices are cleared 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.

Figure 1:

Flow chart of the methods and inclusion/exclusion criteria.

Results

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 patient-centered 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].

Conclusions

Overall, all patients were able to effectively transmit ECG data, including symptom correlation, remotely; however, one patient experienced issues with the specific mail-delivered 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.