Early detection and treatment of atrial arrhythmias with home monitoring may decrease atrial fibrillation burden in pacemaker recipients: The randomized, multicenter SETAM trial - 10/11/15
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Résumé |
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 24h spent at an atrial rate>200bpm) 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±3.3months. 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%/24h 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 4hours per day (18% of 24h) 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.
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Vol 64 - N° 5
P. 420-421 - novembre 2015 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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