key: cord-0763230-m0mqb55i
authors: Magnocavallo, Michele; Vetta, Giampaolo; Bernardini, Alessia; Piro, Agostino; Mei, Maria Chiara; Di Iorio, Martina; Mariani, Marco Valerio; Della Rocca, Domenico G.; Severino, Paolo; Quaglione, Raffaele; Giunta, Giuseppe; Chimenti, Cristina; Miraldi, Fabio; Vizza, Carmine Dario; Fedele, Francesco; Lavalle, Carlo
title: Impact of COVID-19 Pandemic on Cardiac Electronic Device Management and Role of Remote Monitoring
date: 2021-10-30
journal: Card Electrophysiol Clin
DOI: 10.1016/j.ccep.2021.10.010
sha: e5a84161a8c6a4e16ef27745d1ac24390ff192a3
doc_id: 763230
cord_uid: m0mqb55i

During the Coronavirus Disease 2019 (COVID-19) worldwide pandemic, patients with cardiac implantable electronic device (CIED) refused scheduled follow-up visits due to the risk of infection. In this scenario, different telemedicine strategies have been implemented to ensure continuity of care to CIED patients. Patients can be monitored through dedicated apps, telephone calls, or virtual visits providing easy access to valuable information, such as arrhythmic events, acute decompensation manifestations and device-related issues, without the need of in-person visits. This review provides a comprehensive description of the many possible applications of telemedicine for CIED patients during COVID-19 period.

In December 31st 2019, a cluster of pneumonia cases of unknown origin was reported in the city of Wuhan; Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) was then discovered as the causative agent of the respiratory disease named Coronavirus Disease 2019 (COVID-19) [1] . The epidemic spread rapidly through China and subsequently to the rest of the world, leading the World Health Organization to declare the pandemic state in March 11th 2020.

COVID-19 has caused a global impact on public health services that led to the reorganization of hospital settings, including in-office visits for patients with cardiac implantable electronic device (CIED). Remote monitoring (RM) of CIED patients represents an appropriate strategy to minimize any potential risk of virus exposure for patients and healthcare providers, without compromising the quality of care [2] [3] [4] [5] . RM offers access to the same information as an in-office visit and may contribute to the early detection of atrial and ventricular arrhythmias [6, 7] , prevent heart failure (HF) decompensation, and manage device-related issues [8] [9] [10] [11] [12] . RM has also confirmed its usefulness in decreasing the hospitalization rate and improving clinical outcomes [13] . Moreover, since the onset of the COVID-19 pandemic, physicians have suspended non-urgent scheduled visits and made a rapidly transition to virtual visits (VV) [14] [15] [16] . Thanks to the technological improvement, patients utilizing wearable sensors for the measurement of hemodynamic parameters (blood pression and saturation, heart rate) and adopting virtual health platforms may be monitored directly from home without any risk of infection.

In this review, we provide an overview of the many possible applications of RM, its limitations and challenges in patients with CIED during COVID-19 pandemic.

RM of CIED patients has become increasingly popular in clinical practice, especially during COVID19 pandemic [17] . Indeed, in the new guidelines of the European Society of Cardiology (ESC) on cardiac pacing, RM is recommended to reduce the number of in-office follow-up in J o u r n a l P r e -p r o o f patients with pacemaker (PMK) who have difficulties to attend in-person visits. RM may also be useful in case of a device component that has been recalled or is on advisory, to enable early detection of actionable events in patients at high risk [18] . RM provide the same information of an in-person visit ensuring an early identification of cardiac arrhythmias, such as ventricular tachycardias or atrial fibrillation, device therapy and device-related issues like lead malfunction and early battery discharge [19] [20] [21] [22] . Additional benefits were also demonstrated among HF patients in terms of preventing unfavourable cardiovascular events and reducing hospital readmissions [12, 23] .

Although guidelines recommended the use of RM for the follow-up of patients with CIED, the coverage of RM was limited due to the organizational problems of healthcare systems and reimbursement issues [18, 20] . The COVID-19 pandemic forced all healthcare providers to minimize interpersonal contacts to limit the spread of the virus, which led to a total reshaping of outpatient cardiology management and accelerated the deployment and widespread use of RM [24] . BlueSync [24] . As demonstrated in a recent multicentre study, the communicator LATITUDE was home delivered to 1324 patients from 49 different Italian centres and successful activation through telephone training was achieved in 92% of cases [27] . Moreover, De Larochellière and colleagues confirmed that switching from a follow up model with in-person visits to a RM model did not impair the management of ICD patients, and significantly reduced the number of in-person visits [28] . In Figure 1 , we summarized a protocol for setting up and managing RM during the COVID-19 pandemic. When the device is suitable for RM, home delivery of the transmitter is an appropriate strategy for minimizing any potential risk of virus exposure for patients and healthcare providers.

Overall, the available evidence confirmed that RM is an easy-to-use and effective tool for the management of CIED patients even during the pandemic and demonstrated that the home delivery and activation of communicators without an in-patient visit is a potential opportunity to further extend RM in the future.

The ESC and HRS consensus documents stated that in-person visits should be replaced by telemedicine consultations in order to prevent the virus spread among cardiovascular patients [3, 24] . Indeed, the worldwide survey by Han and colleagues about the use of eHealth technologies during the COVID-19 pandemic showed a significant increase in the use of teleconsultations in the management of cardiological patients (5.9% vs 58.6%; p < 0.001) for all types of consultations compared to the pre-pandemic period [25].

Supplementing teleconsultation in CIED patients could be a key tool in the management of these patients during COVID-19 pandemic, especially for those affected by HF. ICD and CRT have the capability of monitoring HF by measuring thoracic impedance (Optivol, Medtronic; CorVue, Abbott) [29] or by integration of several indices (HeartLogic, Boston Scientific) [30] . Nevertheless, guidance statements issued by experts in electrophysiology and HF recommend that every effort should be made to convert in office visits to telehealth and VV. Specifically, the VVs used for J o u r n a l P r e -p r o o f decades to reach remote communities [31] , but less commonly employed in advanced health care systems, have now emerged as the cornerstone of ambulatory care in all subspecialties [32] . The potential benefits of VV for HF patients are providing access to care and medical advice, which would be otherwise difficult to obtain and reducing in-person exposure to SARS-CoV-2. Cardiac rhythm professionals are advantaged by having wireless technology available to transmit monitored information to keep them connected [33] . Moreover, VVs have the advantage of detecting and alerting caregivers about relevant parameter changes, allowing earlier hospitalisation of the patient, even in a pre-symptomatic phase [34] . A flowchart for VV was summarized in Figure 2 ; VV was recommended in patients with atrial arrhythmias, alert for HF decompensation and non-sustained ventricular tachycardia.

Overall, new technologies and digital platforms to aid in remote care should be developed and further research on the role of telehealth, continuous data collecting, advanced automotive features, and RM is needed to guide best practices.

As in any healthcare interaction, patient involvement plays an important role, and in the case of RM, active participation is fundamental. Patients must adhere to transmission timetables and keep in contact with the physician to guarantee a successful healthcare system based on RM. Therefore, from a positive reciprocal interaction between patient and caregiver usually derives a high acceptability and satisfaction. From the point of view of the patient, especially during COVID-19 period, RM should be ease of use [35] [36] [37] , even when manual transmission of the data is requested, and guarantee a positive relationship with their health-care provider at enrolment and during all the monitored period [36, [38] [39] [40] . The Home Monitoring Acceptance and Satisfaction Questionnaire is administered to evaluate the acceptability and satisfaction of RM (HoMASQ) and showed that ICD patients had a higher level of acceptance and satisfaction than patients with PMK [35, 39] .

Moreover, RM demonstrated to be easy to use and well accepted even for older people and patients J o u r n a l P r e -p r o o f with a low level of scholarity [41] . Otherwise, the most frequent causes of non-compliance seem to be:  age-related: age under 40 years old was associated with lower compliance.

 Healthcare systems-related: high volume clinics were associated with better compliance.

 Device relate: wireless devices are characterised by a better compliance compared to those requiring use of a wand [42] .

The institution of a RM patient agreement supported by the Heart Rhythm Society enhances the compliance because patients can freely share information and experiences [17] .

During COVID-19 pandemic, also the delivery of the communicator for RM could reduce the risk of contagion and influence patient's acceptability. Piro and colleagues demonstrated that homedelivery of the communicator and intensive trans-telephonic support for its activation resulted in an easy understanding of the device activation process, as well as high satisfaction with the use of the transmitter [2] . In addition, despite the ongoing pandemic and national lockdown, patients referred a sense of security and expressed interest in continuing with RM; also, in-office modem delivery and activation was associated with a higher prevalence of anxiety symptoms due to COVID-19 pandemic, compared to home modem delivery [2, 27] .

In conclusion several studies showed a high level of patient satisfaction and compliance, making it possible to extend this form of management to a growing volume of patients, especially in times of pandemic.

CIED patients are usually affected by multiple comorbidities: neurological syndromes, chronic kidney disease, chronic obstructive pulmonary disease, diabetes mellitus and other endocrinological disorders. New technologies and the adaptation of existing telemedicine tools represent an alternative option for an integrated monitoring [3, 32] . For example, diabetes patients need recurrent medical consultations to optimize drug therapy and blood sugar levels, and telemedicine can be a J o u r n a l P r e -p r o o f valuable alternative, especially during a pandemic when contacts need to be limited [43] . To confirm the effectiveness of RM for diabetes management, a recent meta-analysis demonstrated a reduction in glycated haemoglobin in the RM group compared to controls [44] . Moreover, continuous glucose monitoring is effective in the management of high-risk patients with type 1 diabetes mellitus without any diabetic ketoacidosis [45] .

Telemedicine also spread into the field of neurology and a tele-stroke unit was established to allow remote assessment of patients with suspected stroke to minimise unnecessary in-person visits [46] .

The latest evidence demonstrated that in-hospital management of end-stage renal disease patients increased the risk of infection up to 4 times compared to telemedicine-based home management and was more expensive. Similarly, RM appeared effective in the rehabilitation and management of chronic obstructive pulmonary disease patients, leading to a reduction in hospitalizations and emergency department visits [47] .

All this evidence shows how the pandemic escalated the adoption of telemedicine and all aspects of digital health, and this new reality is now likely to define medicine in the future not only in cardiology but also in other branches of medicine.

In addition to primary analyses focusing on cardiovascular outcomes (hospitalizations, cardiovascular death, overall death), another important aspect to consider for the adoption of digital health solutions is their impact on healthcare expenditure [48, 49] . Due to the outbreak of the SARS-CoV-2, a prompt reorganization of healthcare services was necessary with a related new economic-financial business plan.

The TARIFF study demonstrated that the overall mean annual cost per patient for in-office followup was significantly higher than a RM-based one (-53.87% in the RM group). The main reason for cost reduction is due to the cost of cardiovascular hospitalizations (€ 886.67 ± €1979.13 vs €432.34 ± €2488.10; p =0.0030) [50] . The same findings were reported in the EVOLVO study, a multicentre J o u r n a l P r e -p r o o f clinical trial aiming at measuring the benefits of RM for HF patients with ICDs. The results of this study showed that RM was cost-effective with an average saving of €888.10 per patient [48] .

Notably, cost-effectiveness between countries varied considerably depending on whether there was specific reimbursement for RM services. In fact, there was heterogeneity among countries, with RM generating less profits for providers in the absence of specific reimbursements and similar or increased profits in cases such reimbursements existed [51] . Indeed, according to a recent European survey, the absence of reimbursement in many countries is generally considered the major barrier to the implementation of RM in standard practice [20] .

RM was cost-effective for health care systems due to lower follow-up costs and hospitalisation reductions; the future challenge will be a more uniform deployment of appropriate reimbursement systems.

The COVID-19 pandemic imposed challenges to the traditional rules of access and delivery of health care worldwide [52] . It accelerated the adoption of telemedicine and digital health, confirming a new era in the management of CIED patients. Patient outcomes could be improved with device-based intensive monitoring compared to traditional in-clinic follow-up at regular intervals [53] . The pandemic experience promoted the search for alternative solutions for an effective patient follow-up, such as validation of digital technologies, data management strategies, 

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