key: cord-1009149-kkkdd15n
authors: Piro, Agostino; Magnocavallo, Michele; Della Rocca, Domenico Giovanni; Neccia, Matteo; Manzi, Giovanna; Mariani, Marco Valerio; Straito, Martina; Bernardini, Alessia; Severino, Paolo; Iannucci, Gino; Giunta, Giuseppe; Chimenti, Cristina; Natale, Andrea; Fedele, Francesco; Lavalle, Carlo
title: Management of cardiac implantable electronic device follow‐up in COVID‐19 pandemic: Lessons learned during Italian lockdown
date: 2020-09-30
journal: J Cardiovasc Electrophysiol
DOI: 10.1111/jce.14755
sha: 1c1daa13fb88175a505064b3398cef5f3e3e3d46
doc_id: 1009149
cord_uid: kkkdd15n

INTRODUCTION: Remote monitoring (RM) has significantly transformed the standard of care for patients with cardiac electronic implantable devices. It provides easy access to valuable information, such as arrhythmic events, acute decompensation manifestations and device‐related issues, without the need of in‐person visits. METHODS: Starting March 1st, 332 patients were introduced to an RM program during the Italian lockdown to limit the risk of in‐hospital exposure to severe acute respiratory syndrome‐coronavirus‐2. Patients were categorized into two groups based on the modality of RM delivery (home [n = 229] vs. office [n = 103] delivered). The study aimed at assessing the efficacy of the new follow‐up protocol, assessed as mean RM activation time (AT), and the need for technical support. In addition, patients' acceptance and anxiety status were quantified via the Home Monitoring Acceptance and Satisfaction Questionnaire and the Generalized Anxiety Disorder 7‐item scale. RESULTS: AT time was less than 48 h in 93% of patients and 7% of them required further technical support. Despite a higher number of trans‐telephonic technical support in the home‐delivered RM group, mean AT was similar between groups (1.33 ± 0.83 days in home‐delivered vs 1.28 ± 0.81 days in office‐delivered patients; p = .60). A total of 28 (2.5%) urgent/emergent in‐person examinations were required. A high degree of patient satisfaction was reached in both groups whereas anxiety status was higher in the office‐delivered group. CONCLUSIONS: The adoption of RM resulted in high patient satisfaction, regardless of the modality of modem delivery; nonetheless, in‐office modem delivery was associated with a higher prevalence of anxiety symptoms.

The adoption of RM resulted in high patient satisfaction, regardless of the modality of modem delivery; nonetheless, in-office modem delivery was associated with a higher prevalence of anxiety symptoms. for early detection of atrial and ventricular arrhythmias, as well as monitoring of system performance (e.g., lead failure and battery depletion [1] [2] [3] [4] . Additional benefits were also demonstrated among heart failure (HF) patients in terms of preventing unfavorable cardiovascular events and reducing hospital readmissions. [5] [6] [7] [8] [9] The outbreak of the novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) forced a prompt reorganization of healthcare service delivery, mostly for nonurgent or nonemergent patients, including in-office follow-up appointments for patients with a CIED.

In line with the recently issued Heart Rhythm Society indications, 10 our Cardiac Electrophysiology and Stimulation Center (CESC) revised the preexisting workflow for CIED patients. The cornerstone of the novel management protocol was the improvement of RM coverage to prevent any potential risk of exposure for patients and healthcare providers, without jeopardizing the quality of care. The purpose of the present study was to report the efficacy and patient satisfaction with the new CIED management protocol adopted during the coronavirus disease-2019 (COVID-19)-related Italian lockdown.

This single-center study was prospectively conducted at the Department of Cardiovascular and Respiratory Diseases, Umberto I Hospital, Sapienza University of Rome, Rome, Italy. Our study cohort included 3762 non-COVID-19 CIED patients who had been routinely followed by our CESC.

Baseline, clinical and device characteristics, and follow-up data were prospectively collected in an Institutional Review Board approved database. Patients were asked to sign an informed consent for data collection and study participation.

Among 3762 patients with a CIED, 425 (11.4%) patients had a single chamber implantable cardioverter-defibrillator (ICD), 528 (14.0%) a dual-chamber ICD, 95 (2.5%) a subcutaneous ICD, 283 (7.7%) a cardiac resynchronization therapy (CRT) device, 231 (6.1%) a singlechamber pacemaker (PMK), 1472 (39.1%) a dual-chamber PMK, and 728 (19.3%) an implantable loop recorder (ILR). Of them, 662 (17.6%) patients were already in RM before the COVID-19 outbreak.

A description of the CESC workflow is depicted in Figure 1 .

Patients with an IPE scheduled between March and April 2020 were categorized into two groups: patients with a RM system before the lockdown (Group wRM) and without a RM system (Group w/oRM).

Group wRM: Scheduled IPEs for these patients were canceled upon exclusion of any patient-and device-related issues assessed via a trans-telephonic contact and a device transmission performed within a week from the scheduled IPE appointment. For those reporting symptoms of HF or whose latest transmission documented a problem with system performance were followed up over the phone or, if necessary, scheduled for an IPE.

Group w/oRM: Patients without an RM system before the lockdown were further classified upon assessment of device features and compatibility for RM, individual clinical risk, and patient's agreement.

Patients implanted with a CIED without RM capabilities or not willing to receive an RM system were classified by reviewing the available medical charts and over a trans-telephonic screening contact. Two groups were identified:

-"Low-Risk" group: a) CIED with a battery longevity ≥12 months estimated during an IPE performed within the 6 months before study initiation b) No device alerts detected during the last IPE performed within the 6 months before study initiation c) No history of complex arrhythmias d) No referred symptoms of acute decompensation and syncope. For "Low-Risk" patients the IPE was directly postponed within 6-9 months (long-term IPE) from the original in-hospital visit. Yet, a direct phone line with a team of specialized nurses was provided and patients were asked to report any new symptoms, emergency room visits, or hospital admissions.

The remaining patients deemed being at "High-Risk" were scheduled for an IPE to be performed the same day or within 1 month from their original in-hospital examination.

Patients implanted with a CIED with RM capabilities and willing to receive the system were further categorized into two groups on the basis of the modality the RM system was assigned. Office delivered RM (Group officeRM): A short-term IPE (the same day or within a month from the original in-hospital visit) was scheduled. A dedicated questionnaire to screen for COVID-19 symptoms and rule out any at-risk exposure was administered to all patients before IPE was performed. In a suspected case of COVID-19 infection, a serological test was requested. A specific pathway was created for IPEs to guarantee patients' and workers' safety. IPEs were performed in two different office rooms; one caregiver per patient was allowed to enter the room and only if properly wearing personal protective equipment. A maximum of eight patients per room were scheduled every day and, between one visit and the next, a period of approximately 45 min was respected to sanitize the room. A single specialized nurse delivered the RM system and performed patient training and education. Every 2 weeks, or in case an at-risk exposure was suspected, a COVID-19 test, either viral or serological, was performed for all nurses and physicians. After discharge, the patient was asked to perform a manual transmission from home.

Each nurse reported to a referring physician responsible for informed consent submission and clinical management. Yet, a direct phone line with a team of specialized nurses was provided and patients were asked to report any technical issues with the system, as well as new symptoms, emergency room visits, or hospital admissions. Compliance to drug therapy was monitored by phone contacts conducted either periodically (monthly or bimonthly based on patient's risk profile and medical history) or in case of event recurrences. Pharmacological therapy titration and clinical event management were discussed among the clinical staff and, when necessary, an IPE or a hospital admission was programmed according to the clinical status of the patient. All patients admitted to the F I G U R E 1 CIED management protocol adopted during COVID-19 Italian lockdown. CIED, cardiac implantable electronic device; COVID-19, coronavirus disease-2019; Group homeRM, RM home delivered; Group officeRM, RM in office delivered; IPE, inperson evaluation; RM, remote monitoring emergency room underwent a serological test for COVID-19. If the serological test was negative, the patient was hospitalized in a "COVID-19-Free" Cardiology Unit. Otherwise, patients who tested positive were admitted to a dedicated Department.

To evaluate the patients' acceptance and satisfaction with the RM program, two nurses administered (within a month since the first transmission) the Home Monitoring Acceptance and Satisfaction Questionnaire (HoMASQ) to all new patients who received the RM system. 11 HoMASQ includes 12 items aimed at investigating five different aspects: 1-relationship with their healthcare provider, 2-ease of use of home monitoring technology, 3-related psychological aspects, 4-implications on general health and 5-overall satisfaction. Each item is rated on a 5-point scale (from 0 [strongly unfavorable] to 4 [strongly favorable]); each answer was considered favorable with a score ≥2.

scale was administered by the same nurses to all new patients in RM. GAD-7 was administered to assess the level of safety or anxiety associated with RM and the psychological discomfort related to the home-delivery and office-delivery services. The questionnaire consists of seven items: 1-feeling nervous, anxious, or on edge; 2-being able to stop or control worrying; 3-worrying too much about different things; 4-trouble relaxing; 5-being restless; 6-becoming easily annoyed or irritable; 7-feeling afraid as if something awful might happen. 12 Response options are "not at all" (scores as 0), "several days" (scores as 1), "more than half the days" (scores as 2), and "nearly every day" (scores as 3). The total score ranges from 0 to 21, with scores of 5, 10, and 15 representing the cut-off points for mild, moderate, and severe anxiety, respectively.

The aim of the study was to evaluate the efficacy and patient satisfaction with the new CESC protocol adopted during COVID-19 lockdown.

The primary endpoints were: (1) "RM Activation Time (AT)" in Group homeRM versus Group officeRM, defined as the time to first independent manual transmission since modem was received;

(2) Need for technical support in Group homeRM versus Group officeRM, defined as the number of phone calls or IPEs the patient required due to technical problems activating the RM system. 

Continuous data were described as mean ± SD, while the median (interquartile range) was used for abnormal data. Categorical data were described with a number (percentage). All tests were twosided, and a p value of less than .05 was considered statistically significant. The statistical analysis was performed using SPSS version 25.0 for Windows (IBM Software, Inc).

The study population included 3762 CIED patients systematically followed-up at our Institution, 662 (17.6%) of whom were in RM before the COVID-19 outbreak. Among the 3762 patients, 1114

had an IPE scheduled between March and April 2020 and were included in the study cohort. Baseline characteristics are summarized in Table 1 .

Among 1114 CIED patients, 265 (23.8%) were already in RM (Group wRM). RM eligibility was checked for the remaining 849 (76.2%) patients not in RM (Group w/oRM). A total of 517 (60.9%) patients were ineligible for RM owing to connectivity or device-compatibility issues. Therefore, individual risk assessment was performed: a long-term IPE was scheduled for 423 (81.8%) "Low-Risk" patients, whereas 94 (18.2%) patients were deemed being at "High-Risk" and scheduled for a short-term IPE.

The remaining 332 patients implanted with a CIED with RM capabilities ( Table 2) 

A comparison of number and type of clinically relevant RM transmissions among newly-enrolled RM patients and those with a previous RM system is depicted in Table 3 . Table 5 . the HoMASQ to evaluate RM acceptance and the GAD-7 questionnaire to assess the level of anxiety associated with the new RM-based follow-up and the modality of delivery of the modem.

A high patient satisfaction rate was documented from the HoMASQ; specifically, patients reported an easy understanding of the device activation process, as well as high satisfaction with the use of the transmitter. 11 In addition, despite the ongoing pandemic and national lockdown, patients referred to a sense of security and expressed interest in continuing with RM. Yet, GAD-7 results confirmed that SARS-CoV-2 has increased patients' level of anxiety and psychological pressure, as demonstrated in Group officeRM patients who reported a higher rate of anxiety associated with in-office delivery of the RM system. 

Andrea Natale http://orcid.org/0000-0002-5487-0728

Carlo Lavalle https://orcid.org/0000-0002-9480-1209

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