Strategy of early detection and active management of supra-ventricular arrhythmia with remote monitoring: The SETAM trial

Purpose Atrial fibrillation is the most commonly encountered sustained cardiac arrhythmia in medical practice and it is often associated with conduction disorders. Biotronik home monitoring (HM) technology provides relevant notifications for detection of supra-ventricular arrhythmias (SVA). The SETAM randomized, multicenter trial assessed the impact of HM on detection and treatment of SVA. Method Patients implanted with a dual chamber pacemaker were enrolled in the study at hospital discharge if they had a sinusal rhythm at enrollment, no anti-arrhythmic, anticoagulant or dual-anti-platelet therapy, and if they had a CHA2DS2-VASc score for stroke risk of 2 or more. The patients were randomly assigned to an active group, followed by HM, or a control group without HM surveillance. The time from enrollment to the management of SVA was compared between the two groups. Results A total of 595 patients (mean age = 79 ± 8 yo, 63% male, mean CHA2DS2-VASc score = 3.7 ± 1.2) were followed during 12.8 ± 3.3 months. There was no difference in the baseline clinical characteristics between the two groups. The most prevalent concomitant co-morbidities were hypertension (82% patients), diabetes (29%) and vascular disease (24%). Implantation indications were atrio-ventricular blocks in 77% of patients, sinus node disease in 20% and conduction disorders or others in 3%. The global SVA incidence was 25% (29% in the active group vs 22% in the control group, P  = ns). A therapy (drugs or ablation) was instituted for 47/291 patients (16%) in the active group versus 44/304 patients (14%) in the control group ( P  = ns). The treatment strategy was the same between the groups; anticoagulation was initiated in the majority of patients (75%), anti-arrhythmic drugs in 49% of patients. The median time from enrollment to the first therapy for SVA was 109 [44; 211] days in the active group versus 210 [66; 370] days in the control group, representing a median gain of 101-days in SVA management (48% reduction, P  = 0.01). In the active group, 93% of the notifications transmitted by HM were appropriate for SVA detection. The remaining 7% were inappropriate for SVA (over-sensing, noise or non-sustained VT). Among the 91 patients receiving a therapy, 58% were free of SVA at 12 months in the active group vs 22% in the control group ( P  = 0.003). Conclusion The SETAM study provided evidence that HM allows earlier detection and treatment of SVA in patients implanted with pacemakers.