Background The BioMonitor 2 Pilot Study assessed the implantation procedure, the sensing amplitude and the remote monitoring transmission success rate of the second generation implantable cardiac monitor, the BioMonitor 2 (Biotronik, Berlin, Germany).
Methods This was a prospective, multi-centre, single-arm, non-randomised study involving seven operators in five sites across Australia. Data were collected at implantation, during clinic visits at 1 week and 1 month post-implantation, and through wireless remote monitoring.
Results Thirty patients with indications for long-term cardiac monitoring underwent successful insertion of a study device. The median implantation time was 9 minutes (interquartile range (IQR) 5-14 mins). The mean R-wave amplitude at 1 week was 0.75 +/- 0.39 mV and remained stable over the follow-up period. Within 1 day, 97% of the patients connected to the remote monitoring network and daily messages were transmitted on 93.8% of all study days. Seventy-six per cent of patients transmitted at least one subcutaneous ECG (5ECG), with a median number of sECGs per patient of seven (IQR 3-37) within 28 days.
Conclusions The results of the BioMonitor 2 Pilot study confirm the excellent sensing amplitudes afforded by this new device and the utility of the implantation tools and technique. Patient compliance with and the transmission success rate of the home monitoring system were excellent.