title: A randomized trial of long-term remote monitoring of pacemaker recipients (the COMPAS trial).
abstract: OBJECTIVE
  Professional practice guidelines recommend that pacemaker recipients be followed regularly. However, the majority of scheduled ambulatory visits is unproductive and imposes a heavy burden on the health-care system.
  
  
  RESULTS
  The COMPAS randomized, multicentre, non-inferiority trial examined the safety of long-term remote monitoring of pacemakers. Between December 2005 and January 2008, 538 patients were randomly assigned to remote monitoring follow-up (active group) vs. standard care (control group). The primary objective was to confirm that the proportion of patients who experienced at least one major adverse event (MAE), including all-cause death and hospitalizations for device-related or cardiovascular adverse events, was not >7% higher in the active than in the control group. MAE-free survivals and quality of life were compared in both groups. The characteristics of the study groups were similar. Over a follow-up of 18.3 months, 17.3% of patients in the active and 19.1% in the control group experienced at least one MAE (P < 0.01 for non-inferiority). Hospitalizations for atrial arrhythmias (6 vs. 18) and strokes (2 vs. 8) were fewer (P < 0.05), and the number of interim ambulatory visits was 56% lower (P < 0.001) in the active than the control group. Changes in pacemaker programming or drug regimens were made in 62% of visits in the active vs. 29% in the control group (P < 0.001). Quality of life remained unchanged in both groups.
  
  
  CONCLUSIONS
  Remote monitoring was a safe alternative to conventional care and significantly lowered the number of ambulatory visits during long-term follow-up of permanently paced patients. ClinicalTrials.gov identifier: NCT00989326.
authors: Centre Hospitalier Universitaire Pontchaillou, 2 Rue Henri Le Guilloux, Rennes 35000, France. philippe.mabo@chu-rennes.fr
authors: Philippe
authors: P
authors: Mabo
authors: Frédéric
authors: F
authors: Victor
authors: Patrick
authors: P
authors: Bazin
authors: Saïd
authors: S
authors: Ahres
authors: Dominique
authors: D
authors: Babuty
authors: Antoine
authors: A
authors: Da Costa
authors: Didier
authors: D
authors: Binet
authors: Jean-Claude
authors: JC
authors: Daubert
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001145:Arrhythmias, Cardiac / Q000628:therapy*; D002304:Cardiac Pacing, Artificial / Q000401:mortality*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D010138:Pacemaker, Artificial; D011182:Postoperative Care / Q000379:methods / Q000401:mortality; D019114:Remote Consultation / Q000379:methods*; D016896:Treatment Outcome