Safety and efficiency of a common and simplified protocol for pacemaker and defibrillator surveillance based on remote monitoring only: a long-term randomized trial (RM-ALONE)

Abstract

Aims This trial aimed to evaluate the safety and efficiency of a common and simplified protocol for the surveillance of cardiac implantable electronic devices based on remote monitoring (RM) in patients with pacemakers (PMs) and implantable cardiac defibrillators (ICDs) for at least 24 months. Methods and results The RM-ALONE is a multicentre prospective trial that randomly assigned 445 patients in two groups, both followed by RM: the home monitoring-only (HMo) based on RM + remote interrogations (RIs) every 6 months and the HM + IO that adds in-office evaluations every 6 months to RM. Four hundred and forty-five patients were enrolled in the study, 294 PMs and 151 ICDs recipients. In the HMo group, 20% of patients experienced ≥1 major adverse cardiac event (MACE) vs. 19.5% in HM + IO group ( P = 0.006 for non-inferiority). The proportion of patients with a PM/ICD who experienced ≥1 MACE was 15.2/29.3% in HMo group and 16.1/26.3% in HM + IO group (hazard ratio 0.95/1.15, 95% confidence interval 0.53–1.70/0.62–2.10). There were 789 in-office evaluations (136 in the HMo and 653 in the HM + IO; P < 0.001). There was a 79.2% reduction of in-office evaluations with no significant differences in unscheduled visits between groups: 122 (54.5%) in HMo and 101 (45.3%) in HM + IO; P = 0.15. The time a physician/nurse spent per patient/follow-up was significantly reduced in the HMo group: 4/5 min (0–30)/(1–30) vs. 10/10 min (0–40)/(1–40) in HM + IO ( P < 0.0001). Conclusion The RM-ALONE protocol common for ICD and PM surveillance, consisting of RM + RI every 6 months has proven safe and efficient in reducing hospital visits and staff workload.

Cost–utility analysis of telemonitoring versus conventional hospital-based follow-up of patients with pacemakers. The NORDLAND randomized clinical trial

“…These results are consistent with the results of bivariate analysis that found no relevant differences in any outcome-including QALYs-or in costs (except for hospitalization), but contrast with those found in studies on costs and cost-effectiveness in other types of CIEDs (such as implantable cardioverter defibrillators or cardiac resynchronization therapies) in which there were significant differences-albeit not always relevant-found in utilization and costs favoring the telemonitoring group with equal or higher effectiveness [48][49][50][51][52][53][54][55][56], whereby suggesting that telemonitoring is a cost-effective (or dominant) alternative compared to conventional follow-up in hospital, as well as with the results of economic PM studies comparing both types of follow-up, suggesting lower utilization and costs, as well as cost-effective indices favoring remote monitoring alternatives [57].…”

Effectiveness and Safety in Remote Monitoring of Patients with Pacemakers Five Years after an Implant: The Poniente Study

“…Another study in line with these findings is the RM-ALONE [4], a multicentre prospective trial assigned 445 patients to evaluate the efficiency and safety of RM in patients with PMs and implantable cardiac defibrillators (ICDs) during 24 months. The study reported that RM reduced 79.2% the number of face-to-face visits, decreasing the workload of the personnel.…”

“…The study reported that RM reduced 79.2% the number of face-to-face visits, decreasing the workload of the personnel. Continuous 'remote' contact with patients sending clinical reports avoided unnecessary visits, often resulting from patient anxiety [4].…”

“…Regular follow-ups play a crucial role in the quick detection of technical and clinical faults that may appear during the functioning of the PM. However, it significantly increases the workload of the staff of institutions that manage these devices as evident from the fact that the most frequent task performed by cardiac electrophysiologists is to regularly check the implanted PMs [3,4]. Moreover, these patients often visit emergency hospitalisation and rehospitalisation with long periods of hospitalisation, resulting in reduced QoL [5].…”

“…In general, different trials have shown multiple advantages of RM; moreover, RM is not inferior to conventional follow-up in terms of safety in PMs [20]. Furthermore, RM decreases the time to make a clinical decision, thereby preventing several worsening conditions, allowing rapid detection of arrhythmias, reducing inappropriate shocks and sparing ICD batteries or device malfunctioning [4,21].…”