RM-ALONE

RM-ALONE

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

GARCIA FJ ET AL., EUROPEAN HEART JOURNAL 2019

Study Design

  • Prospective, randomized, multicenter clinical trial
  • 445 pacemaker (PM) and ICD patients randomized 1:1 at 16 Spanish institutions
  • Patient surveillance by Home Monitoring + remote device interrogations every 6 months (RM-ALONE protocol) vs. Home Monitoring + in-office evaluations every 6 months
  • 24 months follow-up period
  • To demonstrate the possibility to safely and efficiently dispense with face-to-face follow-up visits by the RM-ALONE protocol for both pacemaker – and ICD-bearing patients

Key Result 1

The RM-ALONE protocol demonstrated non-inferiority in terms of safety in comparison to continuous remote monitoring associated with on-site visits every 6 months for the overall population of PM- and ICD patients.

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Key Result 2

Patient surveillance exclusively based on Home Monitoring (RM-ALONE Protocol) reduces number of follow-up visits and clinical workload

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Clinical Relevance

  • RM-ALONE is the first randomized trial surveilling PM and ICD patients with a simplified uniform follow-up pattern and using remote monitoring only as a gold standard in both groups.
  • Before RM-ALONE, the main concern about extending the time between in-office follow-ups was that safety may be compromised. The RM-ALONE results indicate that surveillance of a real-world PM- and ICD- patient population exclusively based on remote monitoring is safe.
  • CIED follow-up is the most frequent activity reported by cardiac electrophysiologists. By following the RM-ALONE follow-up protocol, the clinical workload resulting from follow-up activities can be significantly reduced for pacemaker and ICD patients.

Study Objective
  • To demonstrate the possibility to safely and efficiently dispense with face-to-face follow-up visits by the RM-ALONE protocol for both pacemaker – and ICD-bearing patients
Primary Endpoint
  • Proportion of patients with ≥1 major adverse cardiac event (MACE) over 24 months of follow-up
Major Secondary Endpoints
  • Decrease in the number of in-office follow-ups in the HMo group, and to compare the workload of healthcare professionals in following up patients of the HMo and HM + IO groups
Clinical Sites
  • 16 Spanish institutions
Sample Size
  • 445 patients enrolled
Main Inclusion Criteria
  • Patients ≥ 18 years
  • implanted CIED equipped with Home Monitoring®
  • medical/psychic status controlled
  • provided written informed consent
  • stable Global System for Mobile communications (GSM) network coverage
Main Exclusion Criteria
  • replaced implant or upgraded to cardiac resynchronization therapy (CRT)
Follow-Up
  • 24 months follow-up
Study Duration
  • Between May 2010 and December 2013
Principal Investigators
  • Francisco Javier García-Fernández (Hospital Universitario de Burgos, Spain)