DISCUSSION
Hereby, we describe our institutional experience on the feasibility and
patient satisfaction with a novel CIED follow-up protocol during the
COVID-19 Italian lockdown. Our main findings were the following:
- A reorganization of follow-up workflow with transition from IPE to RM
was easily achieved in short period of time in a large population of
CIED patients, without jeopardizing the quality of care of our
service;
- Approximately 93% of the patients newly introduced to RM performed
their first manual transmission within 48 hours. Despite a trend
toward a higher number of trans-telephonic technical support contacts
in Group hdRM , RM Activation Time was similar among
patients who received the modem at home and those whose monitor was
delivered during an IPE.
- No significant differences in number and type of transmissions were
reported between these groups. Twenty-eight (2.5%) urgent/emergent
IPE were easily and safely planned in RM population when a
trans-telephonic examination was not enough.
- High degree of patient’s satisfaction was reached in both groups while
a higher anxiety status was registered when transmitter was delivered
during an in-office visit.
Since January 2020, the steep increasing number of COVID-19 cases
worldwide has had a huge impact on public health, conditioning medical
activity and making standard, urgent, and emergent clinical management
of patients more complex. As such, a rapid reorganization of healthcare
service delivery was deemed necessary, including the in-office follow-up
for patients with a CIED. As recommended by the Heart Rhythm Society
COVID-19 Task Force (11), early efforts were made to secure an efficient
and safe elective patient care (e.g., social distancing, mobility
restrictions, use of personal protective equipment). In order to reduce
virus exposure, the cornerstone of the novel management protocol was the
improvement of RM coverage. As RM allows for transmission of data to
dedicated platforms accessible to physicians, it represented an
extremely valuable tool during the Italian COVID-19 lockdown. RM gives
access to the same information of IPEs, which may contribute to the
early detection of a wide range of arrhythmic manifestations, acute
decompensation and device-related issues (6). As reported in several
studies (9,14), RM not only plays a central role in preventing
hospitalizations, improving survival and quality of life of patients
with CIEDs, but is also a cost-effective alternative to IPEs (15). In
our experience RM allowed for an effective and safe delivery of
healthcare services. A large number of our patients was rapidly
introduced to RM, with high patient acceptance. Additionally, the
continuous technical assistance offered by our medical staff led to a
high degree of patients’ compliance to the RM system; about 93% of our
patients performed the first manual transmission within 48 hours from RM
delivery with no difference observed between Group hdRM andGroup odRM . Despite a longer RM Activation Time observed in
people older than 75 years and/or who live alone, all patients
successfully completed RM activation. These observations suggest that a
RM-based follow-up protocol is feasible also in elderly patients and in
those without significant in-home support (16). These subpopulations are
also at higher-risk of COVID-19-related complications and mortality, due
to a higher prevalence of comorbidities. However, RM allowed for a safe
and uninterrupted patient care, avoiding the risk of in-hospital virus
transmission.
Recent study (17), has shown a significant reduction in admissions for
acute coronary syndromes during the Italian lockdown. Despite chest pain
and other ischemia-related symptoms, many patients avoided hospital
admission due to the increased risk of virus exposure. In this context,
RM promoted a continuous patient assistance and monitoring and resulted
in being a valuable tool to identify and timely treat arrhythmic/heart
failure events, thereby avoiding potentially life-threatening
consequences. In our population, no significant differences in number
and type of transmissions were reported between Group hdRM andGroup odRM . Furthermore, an urgent/emergent IPE was planned in 28
(2.5%) patients due to arrhythmic events and 19 (1.7%) were admitted
to the hospital.
From the psychological standpoint, the COVID-19 outbreak and the Italian
lockdown were emotionally challenging and had a serious impact on the
mental health of the entire population. In this context, we decided to
administer 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
(12). Additionally, despite the ongoing pandemic and national lockdown,
patients referred a sense of security and expressed interest in
continuing with RM. Yet, GAD-7 results confirmed that SARS-CoV2 has
increased patients’ level of anxiety and psychological pressure, as
confirmed in patients of Group odRM who reported a higher rate of
anxiety associated with in-office delivery of the RM system.