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 The RM-ALONE is a multicentre prospective trial that randomly assigned 445 patients in two groups, both fol- and results lowed by RM: the home monitoring-only (HMo) based on RM þ remote interrogations (RIs) every 6 months and the HM þ 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 þ 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 þ 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 þ 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 þ 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 þ IO (P < 0.0001). Conclusion The RM-ALONE protocol common for ICD and PM surveillance, consisting of RM þ RI every 6 months has proven safe and efficient in reducing hospital visits and staff workload.