Donato Melissano,Maria Rosaria Gualtieri,Assunta Greco,Antonella Muscella,Antonio Marzo,Claudio Perrone
Creation of pacemaker remote monitoring networks between hospital and pharmacies during Covid-19 outbreak
Pacemaker,Remote monitoring,Covid-19,Pharmacy,Network,Follow-up
Introduction Remote Monitoring (RM) of Cardiac Implantable Electronic Devices (CIEDs) is proven to be safe and efficient. It has been adopted in our center since years. At the time of the recent Covid-19 outbreak, we introduced and tested a collaborative organizational model, through a new RM device (Totem), creating a network with the surrounding territory and limiting CIED patients’ presence in hospital. Methods We involved 4 neighbor pharmacies where Totem devices were installed; we called and informed 64 patients with Totem compatible pacemaker (PM) about the possibility to perform their PM follow-up (FU) in-pharmacy; 58 gave their consent and their data were inserted into our RM database. Results During an 18-month FU period, a total of 70 RM transmissions have been received: one alert of high atrial burden triggering a pharmacological optimization, one alert of high ventricular impedance leading to a new ventricular lead implantation and four alerts of elective replacement indicator. Fulfilled questionnaires revealed complete patient satisfaction. Conclusions A collaborative network between our hospital and the surrounding territory to perform RM FUs of CIEDs during Covid-19 pandemic was feasible, leading to patient compliance and satisfaction and revealing important technical and clinical alerts.
Creation of pacemaker remote monitoring networks between hospital and pharmacies during Covid-19 outbreak

Remote Monitoring (RM) of Cardiac Implantable Electronic Devices (CIEDs) is proven to be safe and efficient. It has been adopted in our center since years. At the time of the recent Covid-19 outbreak, we introduced and tested a collaborative organizational model, through a new RM device (Totem), creating a network with the surrounding territory and limiting CIED patients’ presence in hospital.

We involved 4 neighbor pharmacies where Totem devices were installed; we called and informed 64 patients with Totem compatible pacemaker (PM) about the possibility to perform their PM follow-up (FU) in-pharmacy; 58 gave their consent and their data were inserted into our RM database.

During an 18-month FU period, a total of 70 RM transmissions have been received: one alert of high atrial burden triggering a pharmacological optimization, one alert of high ventricular impedance leading to a new ventricular lead implantation and four alerts of elective replacement indicator. Fulfilled questionnaires revealed complete patient satisfaction.

A collaborative network between our hospital and the surrounding territory to perform RM FUs of CIEDs during Covid-19 pandemic was feasible, leading to patient compliance and satisfaction and revealing important technical and clinical alerts.

The recent COVID-19 pandemic reduced every kind of social interactions, making in-person, in-hospital visits and follow-ups difficult to be performed and underlining the need to explore new care models. Patients had to face a cultural change: social restrictions and distance, together with issues in routine check-ups, replaced by remote visits. Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) is both an opportunity, with the possibility to daily check CIED correct functionality and clinical diagnostic, and a challenge, with the need to introduce precise organizational models in the cardiology department. RM can potentially replace in-hospital FUs, safely and efficiently, preventing issues such as inappropriate shocks due to lead failure in Implantable Cardioverter Defibrillators (ICDs) or thromboembolic events due to atrial fibrillation onset. Nowadays, RM is recognized as class IA indication by the recent European Society of Cardiology (ESC) Guidelines to reduce number of FUs in patients who have difficulties to attend in-office visits. This aspect was already well clear before Covid-19 pandemic, but RM adoption has been generally low, especially in small centers lacking of dedicated personnel or of a precise RM organizational model. In a pandemic scenario, where social distance was compulsory and all in-person visits were suspended or postponed, there was the need to introduce and potentiate RM in order to guarantee a high standard of care level to CIEDs patients. The surrounding territorial points of care (pharmacies, general practitioners) may play a key role in patients' first screening and may be considered in RM FUs if properly trained and supplied with dedicated RM devices. In such a way, patients’ presence in hospitals could be limited or completely avoided. With these premises, we tried to explore a novel organizational model, providing pharmacies with a dedicated RM device and so able to support patients in performing RM FUs, in an effort to create a network among pharmacies and hospital, strengthen RM and guarantee CIEDs FUs during pandemic.

RM of CIEDs has been available in our center since 2004, with more than 500 patients, implanted with devices from all the current manufacturers, remotely followed-up. However, most patients (>90%) in our RM databases are implanted with a cardioverter defibrillator (ICD) or cardiac resynchronization defibrillator or pacemaker (CRT-D or CRT-P). Patients implanted with a Pacemaker (PM) received an RM device only in particular cases (recalls, Atrial Fibrillation monitoring). For this reason, at the time of COVID-19 outbreak, most PM patients were found without an RM device, making their routine in-hospital FUs a challenge.

Recently, an RM device called Totem (developed and distributed by Microport CRM, Saluggia, Italy) has been introduced (Fig. 1). Briefly speaking, it consists of a mobile column equipped with a transmitter, through which patients implanted with a Microport PM are able to transfer, autonomously, safely and without healthcare personnel help all PM data. Totem instructions for use are written on its frontal panel, helping patients in performing RM transmission step by step. Totem acquired data are sent to the same RM database (Smartview), already active in our center, provided by Microport for all its devices, easily accessible via a website protected by a password.

With the aim to limit in-hospital patient access, and to create a network between our hospital and territory, Totem devices have been introduced into 4 neighbor pharmacies, in order to cover a territory as wide as possible around our hospital (Fig. 2). Pharmacies, among other available points of care, were chosen because they are widely known by patients, there is always dedicated personnel patients can trust and there is space enough to install Totem device and perform RM data acquisition. Patients, having instructions for use on the frontal panel and user-friendly lights, can use Totem device autonomously. However, in order to improve patients’ compliance and satisfaction, pharmacists have been trained on CIED FUs and RM in general, focusing on the technology and the organizational model on the basis of RM. Technical staff from Microport installed and instructed pharmacists about the correct Totem device use, in order to be able to guide patients if necessary.

The full remote interrogation consists of few simple steps. First of all, patients need to place Totem telemetry wand over their implanted PM. When the telemetry wand detects the device, the transmission button blinks green, meaning the patient can press it. The progression lights light up one after the other while the patient keeps the telemetry head over the PM. If the transmission button flashes red, it means that the telemetry wand is not correctly placed. Simply re-positioning the telemetry head, the progression lights turn green on again. When the progression lights bar turn off, the patient removes the Telemetry Wand and the procedure is over. During data retrieving, the PM continues to work as programmed, so there is no risk for patients (above all for those PM dependant). The complete procedure takes 5–10 min to conduct. Pharmacists sanitized Telemetry Wand according to current recommendations after each RM transmission, informed our physicians once RM was performed and gave patients another FU appointment at 6–9 months.

At the end of the procedure, patients were asked to fill a simple questionnaire (Table 1), indicating their satisfaction, comfort and Totem easiness of use.

Our internal, well-established standard RM organization consists of a dedicated nurse who revises all transmitted data and a dedicated physician who revises critical alerts (example: abnormal pacing impedance, battery depletion and so on) and calls back patients for in-hospital visits if necessary. This organization did not change after Totem introduction.

Patients implanted with a Totem compatible PM (i.e. PMs produced by Microport), not equipped with an RM device, have been called back and informed about the possibility to perform a remote Totem FU, Totem functioning and where they could find the novel RM device. They were asked to contact pharmacies to schedule an appointment, indicating the device type and implant date. In our database, we found 64 patients (Fig. 3) implanted with Totem compatible PMs and not remotely monitored yet, implanted in the last 10 years, whose in-hospital FUs were foreseen in the following months. Among them, 3 declined their participation, 2 were followed elsewhere, 1 lived far from the chosen pharmacies. 58 gave their consent to perform a Totem RM FU and their data, including clinical background and PM details, were inserted into our RM database. Patient median age was 75 years and 38 (65%) were male; 45 (78%) had a dual-chamber PM, 13 (22%) had a single-chamber PM. During an 18 months FU period (December 2020–June 2022), a total of 70 RM transmissions have been received, and, among them, 6 alerts. One patient experienced issues in data transmission, unable to complete the RM procedure. The 6 received alerts triggered precise clinical actions: one patient was called back in-hospital to optimize pharmacological therapy due to high atrial fibrillation burden, one patient was called back due to abnormal ventricular pacing impedance, with the implantation of a new ventricular lead, and four patients were called back due to elective device replacement. Questionnaires revealed full patient satisfaction, in terms of Totem device easiness of use and patient comfort.

Although RM brings improvement in patient management, special attention should be considered in implementing a proper organizational model inside a cardiology department. CIEDs transmit a huge data amount via RM and there is the precise need to review and filter these data before bringing them to the attention of the physician. Besides, these data should be checked in a timely manner, above all if they are related to worsening patient conditions (example: increase in arrhythmias like atrial fibrillation) or to critical technical alerts (battery depletion, out of range lead impedance). The Home Guide Registry [1] described for the first time how to manage RM and how many resources are needed introducing RM, establishing a collaboration between a nurse for ordinary screening and a physician for medical decisions. The analysis considered 1650 patients in 75 sites. The authors concluded that this kind of workflow model required less than 1 h/month every 100 patients to detect most actionable events. In our center, we use a similar organizational model, consisting of a dedicated nurse who daily checks RM transmissions and who contacts the physician for critical alerts, to call back patients if appropriate. Moreover, other studies analyzed cooperation among hospitals in RM implementation. Monic study [2] described a Hub-Spoke RM model, consisting of one monitoring center, with a dedicated telemonitoring nurse and a supporting physician, and 9 satellite clinics, managing 62 PMs and 59 ICDs patient data. Screening and communication of relevant events required a total of 30 min (nurse) and 1.1 min (physician) daily per 100 patients. Our experience with the novel Totem Device is a sort of Hub-Spoke model, involving pharmacies from the surrounding territory with the precise aim to limit patients’ presence inside hospitals during COVID-19 outbreak. This kind of network may help to spread even further RM adoption, even beyond pandemic, thanks to the use of fully automatic RM devices that do not imply any medical personnel on site. RM efficacy has been proved mostly for ICD/CRT [[3], [4], [5]] patients. Trust study revealed RM in ICD/CRT patients is as safe as in-hospital FUs being at the same time more efficient in reducing in-hospital visits by 45%. Similarly, Ecost study underlined how, through the use of RM, there is a decrease in inappropriate shocks by 52%, improving battery longevity due to low capacitor charges. In-Time study focused more on clinical aspects of ICD patients, revealing that RM may reduce patient mortality. RM applied to PM population has not been widely investigated. No randomized trials demonstrated a survival benefit for RM applied to PMs. However, a mega-cohort observational study [6], enrolling more than 269.000 patients, of whom more than 115.000 patients, revealed that RM was associated with an improved survival. Compas study [7] analyzed 538 patients randomly assigned to RM or standard care, revealing a lower number (56%) of ambulatory visits in RM group. Besides, RM was non inferior to standard care in terms of major adverse events, showing significant differences in the rates of hospitalizations for the management of atrial arrhythmias and strokes. A recent study [8] randomized consecutive PM patients to either remote (558 patients) or conventional in-office (550 patients) FU for 2 years. The authors found that replacing periodic in-office FUs with remote FUs does not increase the occurrence of events, reducing at the same time resource consumption. This is similar to our experience: through Totem device we were able to detect 4 elective battery depletions, but clinical or system events were limited to just one medical adjustment due to atrial fibrillation burden and one abnormal ventricular impedance. In a recent position paper [9], an RM organizational model has been hypothesized (so called “CIED team”) considering the creation of intrahospital networks with territorial realities, for example involving general practitioners and operators of retirement homes for elderly. Our experience could be considered an example of collaboration and cooperation between hospital and the surrounding territory, involving pharmacies where Totem devices have been installed. A recent Australian experience [10] involved the creation of a network between hospital and two rural pharmacies during early Covid-19 phase; 101 patients with Medtronic and Abbott PMs were enrolled. Pharmacies were provided with devices capable of standard inductive RM FUs. 96 patients were able to perform RM FU: 3 of them required subsequent device replacement and 3 required medication changes. Although results were similar to ours, 10 (12%) of the 81 patients who completed a satisfaction survey complained about the absence of face-to-face contact with an experienced clinician during the device check. We built a similar organizational model, based on our previous RM multi-year experience, in an effort to create a network between our hospital and the neighbor territory, involving 4 pharmacies. Differently from the Australian experience, we made use of a dedicated Totem RM device, able to interrogate only Microport PMs. Totem was equipped with clear instructions for use on the frontal panel and intuitive light signals that made the RM FU easy to be performed. Besides, the assistance of pharmacy personnel, well instructed in guiding patients if needed, probably contributed to patient final satisfaction. During COVID-19 pandemic, as most Italian hospitals, we were forced to postpone in-office CIEDs FUs, with the high risk of not being able to detect technical or clinical issues on patients with PMs. Fortunately, RM in our center has been active since years and patients already enrolled in RM database (mostly ICDs and CRTDs) had the possibility to be remotely checked. However, there was a high proportion of patients, above all those implanted with a PM, who were not remotely monitored. For some of these patients, implanted with a Microport PM, we made use of a novel Totem RM device. We decided to introduce it into pharmacies, first of all because these are places which are familiar and easy to be accessed by patients. Secondly, pharmacies already offer some services like pressure or glucose measurement with dedicated personnel. RM FUs went in the direction of adding a new service that during pandemic was vital in ensuring PM FUs. Pharmacy personnel was trained enough in order to guarantee assistance to patients during RM FU, but also after it, scheduling the next FU and underlining the fact that a dedicated physician would have been informed about. This maybe contributed to increase patient compliance and satisfaction.

The recent pandemic has been a challenge, with excessive hospital workload brought by Covid-19, but, at the same time, it strengthened the evidence that RM is vital and should be ensured for every CIED patients, also with the collaboration and networking with the surrounding territory, like pharmacies in our experience. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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