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:
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.