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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±0.39mV 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 (sECG), 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. [ABSTRACT FROM AUTHOR]

Background: Implantable Cardiac Monitors (ICMs) are used for long-term monitoring of arrhythmias. BIOMONITOR III is a novel ICM with a miniaturized profile, long sensing vector due to a flexible antenna, simplified implantation with a dedicated insertion tool for pocket formation and ICM placement in a single step, and daily automatic Home Monitoring (HM) function., Methods: In 47 patients undergoing BIOMONITOR III insertion for any ICM indication, 16 investigators at 10 Australian sites assessed handling characteristics of the insertion tool, R-wave amplitudes, noise burden, P-wave visibility, and HM transmission success. Patients were followed for 1 month., Results: All 47 attempted insertions were successful. Median time from skin incision to removal of the insertion tool after ICM insertion was 39 s (IQR 19-65) and to wound closure and cleaning was 4.7 min (IQR 3.5-7.8). All aspects of the insertion tool were rated as "good" or "excellent" in ≥97.9% and "fair" in ≤2.1% of patients, except for "force needed for tunnelling" (91.5% good/excellent, 8.5% fair). Based on HM data, R-waves in the first month were stable at 0.70 ± 0.37 mV. Median noise burden (disabling automatic rhythm evaluation) was 0.19% (IQR 0.00-0.93), equivalent to 2.7 min (IQR 0.0-13.4) per day. In HM-transmitted ECG strips with regular sinus rhythm, P-waves were visible in 89 ± 24% of heart cycles. Patient-individual automatic Home Monitoring transmission success was 98.0% ± 5.5%., Conclusions: The novel ICM performed well in all aspects studied, including fast insertion, reliable R-wave sensing, good P-wave visibility, and highly successful HM transmissions., Competing Interests: Declaration of competing interest JM, RW, UM, PG, RP, TL, AC, PI and SP have received honoraria and/or non-financial support from Biotronik in the context of this study. JS is a full-time employee of Biotronik. PG, DHL and UW has received honoraria from Biotronik outside the context of this study., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)