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Randomized Controlled Trial
. 2012 May;33(9):1105-11.
doi: 10.1093/eurheartj/ehr419. Epub 2011 Nov 29.

A Randomized Trial of Long-Term Remote Monitoring of Pacemaker Recipients (The COMPAS Trial)

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Free PMC article
Randomized Controlled Trial

A Randomized Trial of Long-Term Remote Monitoring of Pacemaker Recipients (The COMPAS Trial)

Philippe Mabo et al. Eur Heart J. .
Free PMC article

Abstract

Aims: 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.

Figures

Figure 1
Figure 1
(A) Cumulative survival free from MAE in each study group estimated by Kaplan–Meier analysis. (B) Outcomes of the test of non-inferiority among various patient subgroups.
Figure 2
Figure 2
Number of follow-ups per patient. The blue and orange curves indicate the number of follow-ups per patient in the control and the active groups, respectively. The shaded areas represent the 95% CI. At 18 months, the number of follow-ups was 36% lower in the active than in the control group. The slopes (▵) of the dotted line indicate the mean number of visits per year.

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