Quarterly vs. yearly clinical follow-up of remotely monitored recipients of prophylactic implantable cardioverter-defibrillators: results of the REFORM trial

Eur Heart J. 2014 Jan;35(2):98-105. doi: 10.1093/eurheartj/eht207. Epub 2013 Jul 18.


Aims: The rapidly increasing number of patients with implantable cardioverter-defibrillators (ICD) places a large burden on follow-up providers. This study investigated the possibility of longer in-office follow-up intervals in primary prevention ICD patients under remote monitoring with automatic daily data transmissions from the implant memory.

Methods and results: Conducted in 155 ICD recipients with MADIT II indications, the study compared the burden of scheduled and unscheduled ICD follow-up visits, quality of life (SF-36), and clinical outcomes in patients randomized to either 3- or 12-month follow-up intervals in the period between 3 and 27 months after implantation. Remote monitoring (Biotronik Home Monitoring) was used equally in all patients. In contrast to previous clinical studies, no calendar-based remote data checks were performed between scheduled in-office visits. Compared with the 3-month follow-up interval, the 12-month interval resulted in a minor increase in the number of unscheduled follow-ups (0.64 vs. 0.27 per patient-year; P = 0.03) and in a major reduction in the total number of in-office ICD follow-ups (1.60 vs. 3.85 per patient-year; P < 0.001). No significant difference was found in mortality, hospitalization rate, or hospitalization length during the 2-year observation period, but more patients were lost to follow-up in the 12-month group (10 vs. 3; P = 0.04). The SF-36 scores favoured the 12-month intervals in the domains 'social functioning' and 'mental health'.

Conclusion: In prophylactic ICD recipients under automatic daily remote monitoring, the extension of the 3-month in-office follow-up interval to 12 months appeared to safely reduce the ICD follow-up burden during 27 months after implantation.

Clinicaltrialsgov identifier: NCT00401466 (http://www.clinicaltrials.gov/ct2/show/NCT00401466).

Keywords: Implantable defibrillator; Office visits; Patient schedule; Quality of life; Remote sensing technology; Telemedicine.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Arrhythmias, Cardiac / prevention & control*
  • Defibrillators, Implantable*
  • Female
  • Follow-Up Studies
  • Heart Failure / complications
  • Home Care Services
  • Hospitalization / statistics & numerical data
  • Humans
  • Male
  • Middle Aged
  • Monitoring, Ambulatory / methods
  • Myocardial Infarction / complications
  • Office Visits / statistics & numerical data
  • Quality of Life
  • Remote Consultation / methods
  • Time Factors

Associated data

  • ClinicalTrials.gov/NCT00401466