Abstract
Anew implantable cardiac monitor (BioMonitor, Biotronik) with acontinuous remote monitoring option was prospectively implanted in patients with suspected arrhythmias or for therapy control after atrial fibrillation (AF) ablation. Athree-lead ECG detection was intended to make the implantation more independent of the implantation site and the electrical heart axis. Because noise is afrequent problem in implantable cardiac monitors, an active noise detection algorithm was implemented. The aim of the trial was to evaluate the clinical performance of the device. The device performance was evaluated in aprospective nonrandomized multicenter study with afollow-up of 12months. Study endpoints were device-related serious adverse events at 3months, appropriate QRS detection in direct comparison with synchronized Holter ECG recordings, sensitivity and positive predictive value of arrhythmia detection in comparison with Holter ECG and independent of it, and noise burden during the entire follow-up period. The implantation was successful in all 152 patients. Two device-related serious adverse events (pocket infections) occurred by 3months. The mean QRS amplitude of 0.3± 0.2mV at implantation remained stable over 12months. QRS sensing performance indicated little over- and undersensing in most patients. More than 80 % of the patients had more than 22h of noise-free monitoring per day. BioMonitor effectively detects patients with bradycardia, tachycardia, AF, or asystole. Active noise detection seems to reduce the transmission of meaningless data without diminishing the positive predictive value of the device.
Published Version
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