While several studies have reviewed remote monitoring in implantable cardioverter defibrillators (ICDs), few have looked at remote monitoring in pacemakers. A new study in the European Heart Journal shows that Biotronik’s Home Monitoring system is as safe as standard follow-up in patients with pacemakers.
The COMPAS (Comparative follow-up schedule with home monitoring) study assessed 494 patients with pacemakers (248 assigned to remote monitoring and 246 assigned to standard follow-up). The main aim of the non-inferiority study was, according to Philippe Mabo, Centre Hospitalier Universitaire, Pontchaillou, and his co-authors, to confirm that: “The proportion of patients who experienced at least one major adverse event including (i) death (ii) hospitalisation for complications related to the pacing system and (iii) hospitalisation for an adverse cardiovascular event was not higher in the remote follow-up than in the standard care group.” Secondary objectives included comparing the incidence of major adverse events in both groups, measuring the decrease in the number of in-office follow-ups conferred by remote monitoring, and retrospectively analysing the delay in the management of adverse events in both study groups.
After 18 months, Mabo et al reported, the non-inferiority of the remote monitoring was confirmed. They wrote: “By the end of the trial, 90 patients (18.2%) had experienced a major adverse event, including 43 patients (17.3%) in the active group and 47 (19.1%) in the control group (HR 0.90; 95% CI:0.59–1.41; p=0.63).” They added that the “non-inferiority” of remote monitoring was also confirmed among selected subgroups, including patients aged over 80 years and patients with a left ventricular ejection fraction of ≤50%. Also, no significant differences were observed between the remote monitoring group and the standard follow-up group regarding the number of hospitalisations for major adverse cardiovascular events (11.7% vs. 11.8%, respectively; p=0.66).
As was predicted, the total number of follow-ups in the active group was considerably lower than in the control group-by the end of the study, as imposed by design of the study, the number of follow-ups was reduced by nearly 60% in the remote monitoring group. Mabo et al reported: “Over 70% of the routine ambulatory visits in the control group were non-contributory whereas the much less frequent and unscheduled follow-ups prompted by remote monitoring in the active group were usually medically appropriate.” However, despite the remote monitoring group having fewer appointments than the control group, an a posterior analysis of all daily transmissions of remote monitoring showed that medical interventions in the control group was considerably delayed compared with the remote monitoring group (a delay of 139 days vs. 17 days, respectively, representing a mean gain of 117 days for the remote monitoring group; p=0.001).
Mabo et al stated that COMPAS does not show that remote monitoring is a substitute for an emergency system as it prompted only a few hospitalisations, but added that it eliminated unnecessary follow-ups and allowed the early detection of events. They wrote: “It is noteworthy that over 40% of the overall population transmitted no warning message… Moreover, over 50% of patients in the active group needed no interim follow-ups. The observations made in this trial might soon set a new standard of care for the follow-up of pacemaker recipients.”