title: Quarterly vs. yearly clinical follow-up of remotely monitored recipients of prophylactic implantable cardioverter-defibrillators: results of the REFORM trial.
abstract: OBJECTIVE
  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.
  
  
  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'.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT00401466 (http://www.clinicaltrials.gov/ct2/show/NCT00401466).
authors.affiliation: Internal Medicine and Cardiology Division, University of Leipzig Heart Center, Strümpellstrasse 39, Leipzig D-04289, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Hindricks
authors.forename: Christian
authors.initials: C
authors.lastname: Elsner
authors.forename: Christopher
authors.initials: C
authors.lastname: Piorkowski
authors.forename: Milos
authors.initials: M
authors.lastname: Taborsky
authors.forename: Jan Christoph
authors.initials: JC
authors.lastname: Geller
authors.forename: Burghard
authors.initials: B
authors.lastname: Schumacher
authors.forename: Jan
authors.initials: J
authors.lastname: Bytesnik
authors.forename: Hans
authors.initials: H
authors.lastname: Kottkamp
mesh_terms: D001145:Arrhythmias, Cardiac / Q000517:prevention & control*; D017147:Defibrillators, Implantable; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000150:complications; D006699:Home Care Services; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000379:methods; D009203:Myocardial Infarction / Q000150:complications; D009819:Office Visits / Q000706:statistics & numerical data; D011788:Quality of Life; D019114:Remote Consultation / Q000379:methods; D013997:Time Factors
keywords: Implantable defibrillator; Office visits; Patient schedule; Quality of life; Remote sensing technology; Telemedicine