Early detection and treatment of atrial arrhythmias with home monitoring may decrease atrial fibrillation burden in pacemaker recipients: The randomized, multicenter SETAM trial

Background Home monitoring (HM) technology in pacemakers provides relevant daily notifications on atrial high-rate for detection of atrial arrhythmias. The SETAM trial has already shown as a main endpoint that HM reduced the time to manage atrial arrhythmias as compared to conventional follow-ups in pacemaker recipients. Purpose As secondary objective, the SETAM trial examined the impact of HM on atrial fibrillation burden per day (percentage of time at a high-defined atrial rate) and clinical events. Methods Recipients of dual chamber pacemaker were eligible for enrolment if they were in sinus rhythm, untreated with antiarrhythmics and antithrombotics and if they had a ≥ 2 CHA2DS2-VASc score for thromboembolic risk. The patients were randomly assigned to an active group followed by HM (HM-ON), or a control group without home monitoring surveillance (HM-OFF). The proportion of patients who experienced at least one serious adverse event (SAE) and the mean atrial fibrillation burden (percentage of time per 24 h spent at an atrial rate > 200 bpm) were compared between the groups. Results A total of 595 patients (mean age = 79 ± 8 y.o, 63% male, mean CHA2DS2-VASc score = 3.7 ± 1.2) were followed during 12.8 ± 3.3 months. The most prevalent concomitant disorders were hypertension (81% patients), diabetes (29%) and vascular disease (24%). Atrial arrhythmias were detected in 83 of 291 patients (28%) in the HM-ON group versus 66 of 304 patients (22%) in the HM-OFF group ( P  = ns). A treatment was prescribed to 49 of the 83 patients (59%) in the HM-ON group vs 43 of the 66 patients (65%) in the HM-OFF group ( P  = ns). Anticoagulation was introduced in 80% of patients and antiarrhythmic drugs in 55% of patients with similar rates in both study groups. Among the 92 treated patients, the 12-month atrial fibrillation burden was ≤ 10%/24 h in 33 patients (89%) in the HM-ON group, vs 21 patients (68%) in the HM-OFF group ( P  = 0.03). This significant difference was observed over time: the mean atrial fibrillation burden was reduced by 4 hours per day (18% of 24 h) over the last 4 months of follow-up in the HM-ON group (6 ± 19% per day versus 24 ± 41% per day in the HM-OFF, P  = 0.04). No significant difference was observed between the groups in terms of SAE. Conclusion The SETAM study provided evidence that early detection and treatment of atrial arrhythmias with home monitoring reduced atrial fibrillation burden in pacemaker recipients.