Protocol for Pacemaker and Defibrillator Surveillance Based on Remote Monitoring Only - RM-ALONE

Jun 27, 2019
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Biotronik
Date Published:
06/14/2019
Date Updated:
06/27/2019
Original Posted Date:
05/31/2019
References

Contribution To Literature:

The RM-ALONE trial showed that remote monitoring with remote interrogation every 6 months was noninferior to remote monitoring + in-office visits in terms of safety, and superior in terms of resource savings, among patients who were implanted with a Biotronik PPM/ICD equipped for remote monitoring.

Description:

The goal of the trial was to assess the safety and efficacy of remote monitoring compared with in-person office visits for permanent pacemakers (PPMs) and implantable cardioverter-defibrillators (ICDs).  

Study Design

After a 12-week post-implant face-to-face visit to reprogram the cardiovascular implantable electronic device (CIED) and check the wound, patients were randomly assigned in a 1:1 fashion to the home monitoring-only group (n = 220) or to the home monitoring + in-office visits group (n = 225). Remote monitoring was performed by remote interrogation every 6 months.

  • Total number of enrollees: 445
  • Duration of follow-up: 24 months
  • Mean patient age: 68.9 years
  • Percentage female: 35%

Inclusion criteria:

  • ≥18 years
  • Had an implanted CIED equipped with Home Monitoring
  • Had medical/psychic status controlled
  • Had stable Global System for Mobile communications (GSM) network coverage

Exclusion criteria:

  • Replaced implant
  • Upgraded to cardiac resynchronization therapy (CRT)

Other salient features:

  • Persistent/permanent atrial fibrillation: 14.6%
  • Among PPM patients, underlying atrioventricular block: 62%, 80% double-chambered
  • ICD: 33.9%, single-chamber: 72%

Principal Findings:

The primary outcome, ≥1 major adverse cardiac event, for home monitoring-only vs. home monitoring + in-office visit, was 19.8% vs. 19.5%, p for noninferiority = 0.006, p for superiority = 0.84.

  • Death: 6.8% vs. 6.7% (p > 0.05)
  • Stroke: 2.2% vs. 1.8% (p = 0.64)

Secondary outcomes,for home monitoring-only vs. home monitoring + in-office visit:

  • Hospitalizations due to CIED or cardiovascular reasons: 53 vs. 55 (p = 0.71)
  • Among ICD patients, receipt of appropriate therapies: 34.6% vs. 27.6% (p = 0.35)
  • Unscheduled visits: 0.55 vs. 0.44/patient (p = 0.16)
  • Scheduled visits: 0.06 vs. 2.45/patient (p < 0.001)
  • Mean time spent by physicians per patient: by physician, 5.9 vs. 10.2 minutes (p < 0.0001); by registered nurse/technician, 6.3 vs. 11.1 minutes (p < 0.0001)

Interpretation:

The results of this trial indicate that remote monitoring with remote interrogation every 6 months was noninferior in terms of safety to remote monitoring + in-office visits among patients who were implanted with a Biotronik PPM/ICD equipped for remote monitoring. Resource utilization was significantly lower with the remote monitoring-only strategy. Importantly, patients who were PPM dependent were not excluded in the current trial. These are important findings since in-person monitoring of CIEDs is one of the biggest workloads for electrophysiologists.

Studies indicate that of all patients undergoing routine follow-up visits, only about 10% result in a clinically actionable episode, such as programming changes. Remote monitoring has gained increased attention in the past few years, with a promise to streamline care for patients receiving ICD implantation. One note of caution: despite not requiring routine clinic follow-up, there was a nonadherence rate of about 12% in the remote monitoring arm. These and other issues such as telecommunication failures will need to be addressed before remote monitoring can be routinely advocated for patients undergoing ICD implantation. Further studies assessing the generalizability in other populations and with other devices are also needed.

References:

García-Fernández FJ, Asensi JO, Romero R, et al. 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). Eur Heart J 2019;40:1837-46.

Editorial Comment: Hindricks G, Dagres N. Remote monitoring, healthcare costs, and workload for healthcare professionals. Eur Heart J 2019;40:1847-9.

Clinical Topics: Arrhythmias and Clinical EP, Cardiovascular Care Team, Prevention, Implantable Devices, EP Basic Science, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Arrhythmias, Cardiac, Atrial Fibrillation, Atrioventricular Block, Defibrillators, Defibrillators, Implantable, Remote Consultation, Monitoring, Physiologic, Office Visits, Pacemaker, Artificial, Secondary Prevention, Stroke, Telecommunications


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