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\begin{document}

\title{Reorganizing the device clinic: remote monitoring of cardiac implantable
electronic devices during the COVID-19 pandemic}



\author[1]{Elisa Ebrille}%
\author[1]{Claudia Amellone}%
\author[1]{Maria Teresa Lucciola}%
\author[1]{Marco Suppo}%
\author[1]{Giuseppe Antonacci}%
\author[1]{Franco Gotta}%
\author[1]{Marco Birolo}%
\author[1]{Fabrizio Orlando}%
\author[1]{Elisa Favro}%
\author[1]{Massimo Giammaria}%
\affil[1]{Maria Vittoria Hospital}%


\vspace{-1em}



  
  \date{May 30, 2024}


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\selectlanguage{english}
\begin{abstract}
COVID-19 pandemic has caused a necessary reorganization of the elective
outpatient device clinic. Remote monitoring (RM) of cardiac implantable
electronic devices (CIEDs) has been validated as a safe and effective
tool to follow patients, limiting the need for in-person visits. We
provided a snapshot of the current clinical practice in a tertiary
electrophysiology center in Italy, suggesting a potential model of care
for patients with CIEDs. Before the COVID-19 pandemic, patients with
implantable cardioverter defibrillators/cardiac resynchronization
therapy (ICD/CRTs) were evaluated in the device clinic twice a year and
patients with pacemakers (PMs) once a year; loop recorder (ILR) patients
were followed remotely only. In the COVID-19 period RM was implemented
for all compatible CIEDs. Patients with RM were not seen in clinic
anymore and were followed with RM. In the COVID-19 period, 100\% of
newly implanted devices received RM (82 ILR, 194 PMs, 80 ICDs/CRTs),
compared to 68\% in the same months of 2019 (106/106 ILR, 83/203 PMs,
78/82 ICD/CRTs), p\textless{}0.01. Moreover, 502 previously implanted
patients with RM compatible devices were contacted and received RM. By
the end of February 2021, 1676 patients were remotely monitored at our
Institution, with a potential saving of outpatient visits of 1683
visits/year, against an average of 8514 RM transmissions/year needing
evaluation. RM of CIEDs is essential to reduce in-person visits during
the COVID-19 pandemic. The potential for elective outpatient
appointments reduction has to be counterbalanced by the sustainability
of a large number of transmissions and data to analyze.%
\end{abstract}%



\sloppy


\textbf{Title Page}

\textbf{Title:} Reorganizing the device clinic: remote monitoring of
cardiac implantable electronic devices during the COVID-19 pandemic

\textbf{Authors:} Elisa EBRILLE MD\textsuperscript{1}, Claudia AMELLONE
MD\textsuperscript{1}, Maria Teresa LUCCIOLA MD\textsuperscript{1},
Marco SUPPO\textsuperscript{1}, Giuseppe ANTONACCI\textsuperscript{1},
Franco GOTTA\textsuperscript{1}, Marco BIROLO\textsuperscript{1},
Fabrizio ORLANDO MD\textsuperscript{1}, Elisa FAVRO
MD\textsuperscript{1}, Massimo GIAMMARIA MD\textsuperscript{1}

\textbf{Affiliations:} \textsuperscript{1}Cardiology Division, Maria
Vittoria Hospital, Turin, Italy

All Authors take responsibility for all aspects of the reliability and
freedom from bias of the data presented and their discussed
interpretation.

\textbf{Corresponding Author:}

Elisa Ebrille

Cardiology Division, Maria Vittoria Hospital

Via Luigi Cibrario 72, Turin, Italy, 10144

Tel (+39)0114393246

Fax (+39)0114393465

Email: elisa.ebrille@gmail.com

\textbf{Funding:} None

\textbf{Conflict of Interest:} None

\textbf{Unstructured Abstract}

COVID-19 pandemic has caused a necessary reorganization of the elective
outpatient device clinic.

Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs)
has been validated as a safe and effective tool to follow patients,
limiting the need for in-person visits.

We provided a snapshot of the current clinical practice in a tertiary
electrophysiology center in Italy, suggesting a potential model of care
for patients with CIEDs.

Before the COVID-19 pandemic, patients with implantable cardioverter
defibrillators/cardiac resynchronization therapy (ICD/CRTs) were
evaluated in the device clinic twice a year and patients with pacemakers
(PMs) once a year; loop recorder (ILR) patients were followed remotely
only. In the COVID-19 period RM was implemented for all compatible
CIEDs. Patients with RM were not seen in clinic anymore and were
followed with RM.

In the COVID-19 period, 100\% of newly implanted devices received RM (82
ILR, 194 PMs, 80 ICDs/CRTs), compared to 68\% in the same months of 2019
(106/106 ILR, 83/203 PMs, 78/82 ICD/CRTs), p\textless{}0.01. Moreover,
502 previously implanted patients with RM compatible devices were
contacted and received RM. By the end of February 2021, 1676 patients
were remotely monitored at our Institution, with a potential saving of
outpatient visits of 1683 visits/year, against an average of 8514 RM
transmissions/year needing evaluation.

RM of CIEDs is essential to reduce in-person visits during the COVID-19
pandemic. The potential for elective outpatient appointments reduction
has to be counterbalanced by the sustainability of a large number of
transmissions and data to analyze.

\textbf{Key Words:} COVID-19, Remote monitoring, Cardiac implantable
electronic devices, Device clinic, Cardiac pacing

\textbf{Abbreviations}

CIEDs: Cardiac implantable electronic devices

COVID-19: Coronavirus Disease 19

CRT: Cardiac resynchronization therapy

EP: Electrophysiology

ICD: Implantable cardioverter defibrillator

ILR: Implantable loop recorder

PM: Pacemaker

RM: Remote monitoring



\textbf{Brief Communication}

\textbf{Introduction}

Coronavirus Disease 19 (COVID-19) has caused a necessary reorganization
of the elective outpatient device clinic, highly impacted by the
pandemic because of the usual need for multiple follow-up appointments.

Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs)
has already been validated as a safe and effective tool to follow
patients, limiting the need for in-person visits\textsuperscript{1}.

Aim of our study was to provide a snapshot of the current clinical
practice in a tertiary electrophysiology (EP) center in Italy and
suggesting a potential model of care for patients with CIEDs in an era
of limited access to hospital facilities.

\textbf{Methods and Results}

Before the COVID-19 pandemic, only patients implanted with a loop
recorder (ILR) and patients implanted with an implantable cardioverter
defibrillator (ICD) or a cardiac resynchronization therapy (CRT) device
were given the possibility to have default RM. Conversely, only a
minority of patients implanted with a pacemaker (PM) were on RM.
Historically, patients with ICDs and CRTs were evaluated in our device
clinic twice a year and patients with PMs once a year, whether or not
they had a RM system at home. Conversely, ILR patients were followed
exclusively with RM without routine in-person visits.

During the COVID-19 pandemic (March 2020-February 2021) the strategy of
our center was to implement RM for all compatible CIEDs, in order to
reduce in-person visits. Patients already in possession of a RM system
were not seen in the device clinic anymore and were followed exclusively
from home. During the study period, 100\% of newly implanted devices
received RM at the time of the implantation procedure: 82 ILR, 194 PMs,
80 ICDs/CRTs. This was a significant increase compared to the same
months of 2019, when only 68\% of patients received RM at the time of
device implantation (106/106 ILR, 83/203 PMs, 78/82 ICD/CRTs;
p\textless{}0.01). In addition, 502 patients implanted before March 2020
with RM compatible devices and not in possession of a RM system were
contacted to receive the transmitter. A specific pathway was created to
limit patient-to-patient interaction. A dedicated EP nurse contacted the
patients by phone to perform an interview to screen for signs and
symptoms of possible COVID-19 infection. If negative, the patient was
scheduled to present to the device clinic to sign the RM consent form.
Appointment slots were 30 minutes apart to avoid patients' interaction.
Upon arrival in clinic, body temperature was measured, and a health
screening form was filled and registered. The device was checked by an
electrophysiologist only if the patient was due for his usual follow-up
appointment (12 months since the prior follow-up for PMs, 6 months for
ICDs/CRTs). For selected device types having the RM function programmed
as ON by default, the RM monitoring transmitter was just handed over to
the patient or mailed at home the following day and the patient was able
to activate the system and initiate a transmission on his own or with
the help of the technical support over the phone. For a minority of
patients, the device-RM transmitter coupling was performed in-office.
Scheduled transmissions were then organized every 3 months. In case of
symptom onset (tachycardia, dizziness, syncope, chest pain, etc.), the
patients were instructed to send an urgent manual transmission and
contact the device clinic. None of the patients with RM was routinely
seen in clinic anymore, not even at the time of the alleged 6-month or
12-month appointment. By the end of February 2021, a total of 1676
patients have been remotely monitored at our Institution. This greatly
reduced semiannual and annual in-person visits (potential saving of 1683
visits/year), which translates into a significant reduction in patients'
potential exposure to COVID-19.

\textbf{Discussion}

From the safety point of view, similar survival rates and safety
outcomes have been demonstrated when RM was compared to in-person
follow-up appointments in randomized clinical trials and
metanalysis\textsuperscript{2-5}. Moreover, it is well known that RM
allows a prompt and quicker detection of arrhythmias and device
malfunctions\textsuperscript{5}. During the study period, we observed
213 clinical events that triggered an urgent manual transmission and/or
required physician's intervention (table 1), successfully resolved over
the following 24 h. None of the 1676 patients presented to the emergency
room with a problem that went unnoticed by the RM system. However, the
safe profile of RM had to be balanced against the high number of
transmissions that our dedicated team received and that required daily
evaluation (8514 RM transmissions/year).

\textbf{Conclusion}

In conclusion, RM of CIEDs, greatly increased in the past year, has
become an essential tool to reduce in-person visits during the COVID-19
pandemic, and has shown to be safe and effective. The potential for
elective outpatient appointments reduction has to be counterbalanced by
the sustainability of a large number of transmissions and data to
analyze.

\textbf{References}

\begin{enumerate}
\tightlist
\item
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\end{enumerate}



\textbf{Table 1: Clinical events detected on RM}\selectlanguage{english}
\begin{longtable}[]{@{}ll@{}}
\toprule
Clinical Event & n (\%)\tabularnewline
\midrule
\endhead
De novo atrial fibrillation / atrial fibrillation with rapid ventricular
rate & 91 (5.4\%)\tabularnewline
Ventricular tachycardia & 39 (2.3\%)\tabularnewline
Antitachycardia pacing and/or shocks & 24 (1.4\%)\tabularnewline
Inappropriate shocks & 6 (0.3\%)\tabularnewline
Low battery voltage or elective replacement indication & 19
(1.1\%)\tabularnewline
Device / Lead anomalies & 13 (0.8\%)\tabularnewline
Significant pause / conduction system disease requiring PM implantation
& 21 (1.2\%)\tabularnewline
\bottomrule
\end{longtable}

\selectlanguage{english}
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\end{document}

