A randomized trial of long-term remote monitoring of pacemaker recipients (The COMPAS trial)

International audienceAIMS: 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. METHODS AND 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. CONCLUSION: 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

Single-chamber versus dual-chamber pacing for high-grade atrioventricular block

background In the treatment of atrioventricular block, dual-chamber cardiac pacing is thought to confer a clinical benefit as compared with single-chamber ventricular pacing, but the supporting evidence is mainly from retrospective studies. Uncertainty persists regarding the true benefits of dual-chamber pacing, particularly in the elderly, in whom it is used less often than in younger patients. methods In a multicenter, randomized, parallel-group trial, 2021 patients 70 years of age or older who were undergoing their first pacemaker implant for high-grade atrioventricular block were randomly assigned to receive a single-chamber ventricular pacemaker (1009 patients) or a dual-chamber pacemaker (1012 patients). In the singlechamber group, patients were randomly assigned to receive either fixed-rate pacing (504 patients) or rate-adaptive pacing (505 patients). The primary outcome was death from all causes. Secondary outcomes included atrial fibrillation, heart failure, and a composite of stroke, transient ischemic attack, or other thromboembolism. results The median follow-up period was 4.6 years for mortality and 3 years for other cardiovascular events. The mean annual mortality rate was 7.2 percent in the single-chamber group and 7.4 percent in the dual-chamber group (hazard ratio, 0.96; 95 percent confidence interval, 0.83 to 1.11). We found no significant differences between the group with single-chamber pacing and that with dual-chamber pacing in the rates of atrial fibrillation, heart failure, or a composite of stroke, transient ischemic attack, or other thromboembolism. conclusions In elderly patients with high-grade atrioventricular block, the pacing mode does not influence the rate of death from all causes during the first five years or the incidence of cardiovascular events during the first three years after implantation of a pacemaker