0107: Strategy of early detection and active management of supraventricular arrhythmia with remote monitoring: the randomized, multicenter SETAM trial

Objective Atrial fibrillation (AF) is a common arrhythmia associated with increased risk of thromboembolic events or other complications. The French randomized, multicenter, SETAM trial assessed the impact of the home monitoring (HM) technology on detection and treatment of supra-ventricular arrhythmia (SVA). Methods Patients (pts) implanted with a dual chamber pacemaker were enrolled in the study at hospital discharge if they had a sinusal rhythm at enrollment, no antiarrhythmic, anticoagulant or dual-antiplatelet therapy, and if they had a CHA2DS2-VASc score of 2 or more. The pts were randomly assigned to an active group (Act Gp), followed by Biotronik HM, or a control group (Cont Gp) without HM surveillance. The time from implantation to the first SVA-related intervention was compared between the 2 groups (primary endpoint). Results A total of 595 pts (mean age = 79±8 y.o, 63% male, mean CHA2DS2-VASc score = 3.7±1.2) were followed during 12.8±3.3Mo. The most prevalent co-morbidities were hypertension (82% pts), diabetes (29%) and vascular disease (24%). Implantation indications were atrio-ventricular blocks in 77% of pts, sinus node disease in 20% and others in 3%.The global SVA incidence was 25% (29% in the Act Gp vs 22% in the Cont Gp, p=ns).A therapy (drugs or ablation) was instituted for 49/291 pts (17%) in the Act Gp vs 43/304 pts (14%) in the Cont Gp (p=ns). The median time from implantation to the first therapy for SVA was 114 [44; 241] days in the Act Gp vs 224 [67; 366] days in the Cont Gp, representing a median gain of 110-days in SVA management (50% reduction, p=0.01). Over these 92 pts, 54 had AF (59%) and 38 had atrial flutter or tachyarrhythmia (41%). Anticoagulation was initiated in 80% of pts and antiarrhythmic drugs in 55%. Conclusion The SETAM study demonstrated that HM allows earlier detection and treatment of SVA in pacemaker pts. The next step is to report how early detection of SVA with HM can possibly improve the patients clinical outcome.