Home delivery of the communicator for remote monitoring of cardiac implantable devices: A multicenter experience during the covid‐19 lockdown

Abstract Background During the COVID‐19 pandemic in‐person visits for patients with cardiac implantable electronic devices should be replaced by remote monitoring (RM), in order to prevent viral transmission. A direct home‐delivery service of the RM communicator has been implemented at 49 Italian arrhythmia centers. Methods According to individual patient preference or the organizational decision of the center, patients were assigned to the home‐delivery group or the standard in‐clinic delivery group. In the former case, patients received telephone training on the activation process and use of the communicator. In June 2020, the centers were asked to reply to an ad hoc questionnaire to describe and evaluate their experience in the previous 3 months. Results RM was activated in 1324 patients: 821 (62%) received the communicator at home and the communicator was activated remotely. Activation required one additional call in 49% of cases, and the median time needed to complete the activation process was 15 min [25th‐75th percentile: 10–20]. 753 (92%) patients were able to complete the correct activation of the system. At the time when the questionnaire was completed, 743 (90%) communicators were regularly transmitting data. The service was generally deemed useful (96% of respondents) in facilitating the activation of RM during the COVID‐19 pandemic and possibly beyond. Conclusions Home delivery of the communicator proved to be a successful approach to system activation, and received positive feedback from clinicians. The increased use of a RM protocol will reduce risks for both providers and patients, while maintaining high‐quality care.

reply to an ad hoc questionnaire to describe and evaluate their experience in the previous 3 months.
Results: RM was activated in 1324 patients: 821 (62%) received the communicator at home and the communicator was activated remotely. Activation required one additional call in 49% of cases, and the median time needed to complete the activation process was 15 min [25th-75th percentile: [10][11][12][13][14][15][16][17][18][19][20]. 753 (92%) patients were able to complete the correct activation of the system. At the time when the questionnaire was completed, 743 (90%) communicators were regularly transmitting data. The service was generally deemed useful (96% of respondents) in facilitating the activation of RM during the COVID-19 pandemic and possibly beyond.
Conclusions: Home delivery of the communicator proved to be a successful approach to system activation, and received positive feedback from clinicians. The increased use of a RM protocol will reduce risks for both providers and patients, while maintaining high-quality care.

K E Y W O R D S
cardiac implantable electronic device, covid-19, follow-up, remote monitoring

INTRODUCTION
In December 2019, an outbreak of pneumonia caused by a novel coronavirus occurred in Wuhan, China. 1 The virus was identified as severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), which causes Coronavirus disease 2019 (COVID- 19), and triggered a worldwide health emergency. [2][3][4][5] On March 8th, Italy became the second most severely affected country in the world, and specific restrictions on social contacts were imposed by the Italian government. 6 In accordance with the European Society of Cardiology (ESC) guidelines for the diagnosis and management of cardiovascular disease during the COVID-19 pandemic, 7 patients with ambulatory stable heart failure had to refrain from hospital visits, and cardiology centers were strongly encouraged to conduct follow-up and provide patients with medical advice by means of telemedicine, in order to prevent viral transmission to patients and healthcare providers. [8][9][10] These recommendations specifically applied to patients with cardiac implantable electronic devices (CIEDs). 11,12 For these patients, inperson office visits could be replaced by remote contact, by using the device information obtained through remote monitoring (RM). 13,14 Since the beginning of the lockdown phase in Italy, Boston Scientific has communicated to all Italian centers implanting CIEDs its willingness to implement a direct home-delivery service of the LATITUDE communicator, in order to allow RM of all patients not yet monitored, without requiring access to the hospital. The initiative included delivery of the communicator, the informed consent process, and organization of remote training for patients and the staff of the center, if needed.
Here, we report the results of a questionnaire designed to evaluate the experience of the centers that adhered to the "LATITUDE at home" campaign.

METHODS
Starting on March 20, the centers adhering to the initiative identi-

Statistical analysis
In the present report, continuous data are expressed as medians and interquartile ranges. Categorical data are expressed as percentages.
Differences in proportions were compared by means of Chi-square analysis or Fisher's exact test, as appropriate. A p-value < .05 was considered significant for all tests. All statistical analyses were performed by means of R: a language and environment for statistical computing (R Foundation for Statistical Computing, Vienna, Austria).

Participating centers
During the lockdown period, RM by means of before the lockdown period, in 24 centers the number was less than 50, and eight centers were not using the LATITUDE system for RM prior to the lockdown period. At the centers, remote data were routinely reviewed by the physician, or by a nurse and a physician in accordance with a 'Primary Nursing' model (Table 1). In addition to scheduled remote interrogations, RM was frequently used to detect device performance issues and arrhythmias or to monitor the patient's clinical status, by enabling dedicated alerts (Table 1).

Home delivery of the communicator
As depicted in Figure 2, of the 1324 patients who agreed to receive the in centers that remotely monitored less than 50 patients (p = .005).
In the case of home delivery of communicators, the signature of the patient's informed consent document was obtained by e-mail in 63% of cases and at the hospital in 16% of cases; consent was obtained by telephone in 16% of cases and by other methods in the remaining 5% of cases. Figure 3 shows the use of the home-delivery service, broken down by type of patient and device, at the centers that responded to the survey. The majority of centers preferred to assign a homedelivered communicator to specific subgroups of patients, that is., patients with more complex devices-implantable defibrillators (ICD) or

Activation rate and follow-up transmission
Of the 821 patients who received the communicator at home and who were remotely trained to use the system, 753 (92%) were able to perform a manual transmission in order to complete the correct activation of the system (Figure 2

DISCUSSION
This multicenter study examined the utility and feasibility of home delivery of communicators for RM. Its main findings are: -Reorganization of RM enrollment during the lockdown period was easily achieved in a large population of CIED patients; services of comparable quality were provided, and no additional personnel was required in 78% of the centers.
-Although a higher activation rate was observed when the communicator was delivered during an in-clinic visit (95% vs. 92%, p = .001), the majority (92%) of patients who received the communicator at home were able to correctly finalize activation of the system. Moreover, thanks to the trans-telephonic technical support, 90% of communicators were regularly transmitting data at the time of questionnaire completion. ) to support patients in installing and verifying system operation (67% of the answers).

F I G U R E 3
-The home-delivery service was especially adopted for patients with ICD or CRT, those with difficulties in accessing the hospital (59%) and those whose scheduled office visit was canceled because of the lockdown (44%).
-Clinician feedback on the home-delivery service was very satisfying: the service was deemed to be an efficient and useful means of man-aging patients during the lockdown period. In addition, 92% of clinicians were interested in continuing the use of this service.
The spread of the COVID-19 epidemic required a rapid response with regard to in-hospital activity. 1,2 The primary modes of disease prevention recommended by the Center for Disease Control have involved limiting exposure and social distancing. To comply with these measures, the healthcare system has had to postpone elective procedures and non-essential follow-up visits, implement virtual interactions and adopt new work procedures in order to provide excellent care. [10][11][12][13][14] This rapid reorganization has also affected CIED patients, for whom RM has proved able to replace in-person visits. [15][16][17][18][19][20] As reported in the Heart Rhythm Society COVID-19 Task Force and ESC COVID-19 guidelines, in order to maintain a high degree of safety and limit faceto-face interactions, an extensive use of telehealth technologies has been necessary. 11 The safety and efficacy of RM was established a decade ago by the landmark TRUST trial, in which RM with automatic daily surveillance of ICD was able to detect actionable events more rapidly than conventional in-office visits. 15 As also reported in several studies, not only does RM play a central role in preventing hospitalizations and improving survival and quality of life in patients with CIEDs, it is also a costeffective alternative to in-person evaluations. [16][17][18][19][20][21][22][23][24][25] Overall, in the con- The results of our survey reveal general approval of RM and of the usefulness of the new service of home delivery; indeed, very few patients refused the system (n = 28, 2%). As expected, centers preferred to assign a home-delivered communicator to specific subgroups of patients (i e., ICD, CRT-D, patients with difficulties in accessing the hospital or those with visits scheduled shortly, in order to protect these compliance or preference. 13 The observation that the percentage of correct activations was higher in centers with previous greater RM activity, suggests that the experience of the center may play a role in patient training. These considerations show that the procedure needs to be better planned in order to be applied in all centers in a nonemergency setting. This is relevant, as patient training has an important role in the perception and acceptance of RM 34 and in the continuity of monitoring, which is also known to be linked to patient outcome. 35 As emerged from the questionnaire, the home-delivery service received positive feedback from clinicians, 96% of whom considered it useful in order to manage patients during the COVID-19 pandemic, while 92% stated that they like to continue it beyond the lockdown.
Only 4% of clinicians claimed that RM was not a useful means of patient management and 6% thought that home delivery was not efficient for RM activation. These negative views could probably be improved through more consolidated organization or by providing better assistance by medical and technical staff.

Limitations
Our findings are affected by potential limitations. The project was limited to a single RM platform, thus our results may not be applicable to other systems. Moreover, the participation in the initiative and in the present survey was voluntary, and this may have introduced biases. In addition, we cannot exclude possible differences in the implementation of the initiative among centers, with an impact on the degree of success. However, the overall success of the initiative is reassuring.

CONCLUSION
The increased use of a RM protocol will reduce risks for both providers and patients, while maintaining high-quality care. Home delivery of the communicator proved to be a successful approach to system activation, which is a major determinant of effective RM, and both clinicians and patients agreed on the usefulness of this model. Similarly, remotely training the patient to use the system seemed feasible.

CONFLICTS OF INTEREST
Monica Campari and Sergio Valsecchi are employees of Boston Scientific. The other authors report no conflicts.

DATA AVAILABILITY STATEMENT
The data that support the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author upon reasonable request.