title: A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial.
abstract: OBJECTIVE
  The ECOST trial examined prospectively the long-term safety and effectiveness of home monitoring (HM) of implantable cardioverter defibrillators (ICD).
  
  
  RESULTS
  The trial's primary objective was to randomly compare the proportions of patients experiencing ≥ 1 major adverse event (MAE), including deaths from all causes, and cardiovascular, procedure-related, and device-related MAE associated with HM (active group) vs. ambulatory follow-ups (control group) in a sample of 433 patients. The 221 patients assigned to the active group were seen once a year, unless HM reported an ICD dysfunction or a clinical event requiring an ambulatory visit, while the 212 patients in the control group underwent ambulatory visits every 6 months. The characteristics of the study groups were similar. Over a follow-up of 24.2 months, 38.5% of patients in the active and 41.5% in the control group experienced ≥ 1 MAE (P < 0.05 for non-inferiority). The overall number of shocks delivered was significantly lower in the active (n = 193) than in the control (n = 657) group (P < 0.05) and the proportion of patients who received inappropriate shocks was 52% lower in the active (n = 11) than in the control (n = 22) group (P < 0.05). At the end of the follow-up, the battery longevity was longer in the active group because of a lower number of capacitor charges (499 vs. 2081).
  
  
  CONCLUSIONS
  Our observations indicate that long-term HM of ICD is at least as safe as standard ambulatory follow-ups with respect to a broad spectrum of MAE. It also lowered significantly the number of appropriate and inappropriate shocks delivered, and spared the device battery. Clinical trials registration NCT00989417.
authors.affiliation: Centre Hospitalier Régional et Universitaire, Lille, France. laurence.guedon@chru-lille.fr
authors.forename: Laurence
authors.initials: L
authors.lastname: Guédon-Moreau
authors.forename: Dominique
authors.initials: D
authors.lastname: Lacroix
authors.forename: Nicolas
authors.initials: N
authors.lastname: Sadoul
authors.forename: Jacques
authors.initials: J
authors.lastname: Clémenty
authors.forename: Claude
authors.initials: C
authors.lastname: Kouakam
authors.forename: Jean-Sylvain
authors.initials: JS
authors.lastname: Hermida
authors.forename: Etienne
authors.initials: E
authors.lastname: Aliot
authors.forename: Michel
authors.initials: M
authors.lastname: Boursier
authors.forename: Olivier
authors.initials: O
authors.lastname: Bizeau
authors.forename: Salem
authors.initials: S
authors.lastname: Kacet
mesh_terms: D000553:Ambulatory Care; D001145:Arrhythmias, Cardiac / Q000401:mortality / Q000628:therapy*; D002423:Cause of Death; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory; D011446:Prospective Studies; D019114:Remote Consultation; D016896:Treatment Outcome