title: Remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic: results from a randomized pilot clinical trial.
abstract: BACKGROUND
  Remote monitoring is increasingly becoming the new standard of care for implantable cardioverter defibrillator (ICD) follow-up. We sought to determine whether remote monitoring of ICDs improves patient outcomes compared with quarterly device interrogations in clinic.
  
  
  RESULTS
  In this single-center pilot clinical trial, adult patients with an ICD were randomly assigned to remote monitoring versus quarterly device interrogations in clinic. The primary endpoint was a composite of cardiovascular hospitalization, emergency room visit for a cardiac cause, and unscheduled visit to the electrophysiology clinic for a device-related issue at 1 year. We also examined health-related quality of life, costs, and patient satisfaction with their ICD care. Of 151 patients enrolled in this trial, 76 were randomized to remote monitoring and 75 to quarterly device interrogations in clinic. There was no significant difference in the primary endpoint (32% in the remote monitoring arm vs 34% in the control arm; P = 0.8), mortality, or cost between the 2 arms. Quality of life and patient satisfaction were significantly better in the control arm than in the remote monitoring arm at 6 months (83 [25th, 75th percentiles 70, 90] vs 75 [50, 85]; P = 0.002 and 88 [75, 100] vs 75 [75, 88]; P = 0.03, respectively), but not at 12 months.
  
  
  CONCLUSIONS
  We showed no significant reduction in cardiac-related resource utilization with remote monitoring of ICDs. However, given the small number of patients in our study, the real clinical and health economics impact of remote monitoring needs to be verified by a large, multicenter, randomized clinical trial.
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina 27710, USA. alkha001@mc.duke.edu
authors.forename: Sana M
authors.initials: SM
authors.lastname: Al-Khatib
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Piccini
authors.forename: David
authors.initials: D
authors.lastname: Knight
authors.forename: Margaret
authors.initials: M
authors.lastname: Stewart
authors.forename: Nancy
authors.initials: N
authors.lastname: Clapp-Channing
authors.forename: Gillian D
authors.initials: GD
authors.lastname: Sanders
mesh_terms: D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use; D001145:Arrhythmias, Cardiac / Q000188:drug therapy / Q000628:therapy; D003363:Cost Control; D003362:Cost-Benefit Analysis; D017147:Defibrillators, Implantable / Q000191:economics; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000191:economics / Q000379:methods*; D009819:Office Visits; D017060:Patient Satisfaction; D010865:Pilot Projects; D011788:Quality of Life; D013689:Telephone; D016896:Treatment Outcome
chemical_list: D000889:Anti-Arrhythmia Agents