Abstract 15063: Remote Monitoring for Follow-up of patients implanted with pacemaker: The First prospective randomized trial (COMPAS Trial)
Introduction: The COMPAS prospective, randomized, multicentric clinical study evaluates the safety and the efficacy of long term pacemaker (PM) follow-up (FU) with remote monitoring (RM).
Methods: Between February 2006 and January 2008, 538 patients (65% male, mean age 76±9 y.o.) were randomly assigned to RM FU (Active group (AG)) or to standard of care (Control group (CG)). All patients were followed up during 18 months. RM was also switched on in the CG in order to allow a retrospective comparison between the two groups, but the data were not available to physician. The primary endpoint of this non-inferiority study was to demonstrate that there was no difference on the composite endpoint comprising deaths, re-hospitalizations for PM dysfunctions and cardiovascular events between the two groups.
Results: AG (n=269) and CG (n=269) were similar in age, gender, LVEF (59±13 vs 56±12 %), PM indications, history of atrial arrhythmia (9.8% vs 10.6% pts), symptoms and heart disease. During an average FU of 18.3 months, 17.3% of patients in the AG and 19.1% in the CG experienced at least one event of the composite endpoint (deaths: 7.3% vs 5.3% PM dysfunctions: 0.4% vs 2.8% cardiovascular events: 11.7% vs 13.0% respectively in AG vs CG) (p<0.01 for non-inferiority). In the AG, the number of interim in-office PM visits was reduced by 55% and was more frequently considered as useful (62%) in the AG vs 29% in the CG. No significant difference was observed concerning the quality of life SF-36 between both groups (68±22 vs 71±19 at 18 months). Moreover RM follow-up facilitated the early detection of clinical events. Atrial arrhythmias (6 vs 18) and strokes (2 vs 8) were significantly reduced in the AG (p<0.05).
Conclusions: COMPAS demonstrated that remote monitoring is a safe alternative to conventional care in PM patients, allowing a reduced number of in office FU together with improved patient care.
- © 2010 by American Heart Association, Inc.