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.

Keywords: Implantable cardiac defibrillator; Pacemaker; Remote interrogation; Remote monitoring; Telemedicine.

Figure 1

A flowchart of patients between enrolment and end of follow-up. CRT, cardiac resynchronization therapy; HM + IO, home monitoring plus in-office evaluations; HMo, home monitoring only; ICD, implantable cardiac defibrillator; PM, pacemaker.

Figure 2

Cumulative major adverse cardiac event survival in the overall population. HM + IO, home monitoring plus in-office evaluations; HMo, home monitoring only.

Figure 3

Cumulative major adverse cardiac event survival in the pacemaker (A) and implantable cardiac defibrillator (B) population. HM + IO, home monitoring plus in-office evaluations; HMo, home monitoring only.

Take home figure

Figure 4

Efficiency in the overall population. (A) Difference between groups in the rate of in-person evaluations per patient for the whole follow-up. (B) Difference between groups in the mean time spent by physicians and nurses per patient and follow-up.

Figure 5

Efficiency in the pacemaker (A, B) and implantable cardiac defibrillator (C, D) population. (A and C) Difference between groups in the rate of in-person evaluations per patient for the whole follow-up. (B and D) Difference between groups per patient and follow-up measuring the mean time (min) spent by staff members on each patient in any of the follow-up activities.

Figure 6

Staff workload. Minutes per 100 patients and month spent by the whole staff (C) and separately by each member: nurses (A) and physicians (B).