97-01: BioMonitor 2 Pilot Study: First experience with the Biotronik BioMonitor 2 implantable cardiac monitor

Purpose of the study: The BioMonitor 2 Pilot Study was a first‐in‐human study investigating the second generation implantable cardiac monitor, the BioMonitor 2 (Biotronik, Berlin, Germany), with remote monitoring capacity. Method used: This was a prospective, multi‐center, non‐randomized study involving 5 sites across Australia. Data was collected at insertion and during clinic visits at 1 week and 1 month post‐insertion, and from the Biotronik Home Monitoring Service Center. We evaluated the operators' assessments of the insertion tool set handling, R‐wave amplitudes and noise burden, defined as the percentage of time in which high rate detection rendered the device effectively unable to monitor the patient's rhythm, in addition to transmission performance, defined as the ratio of days with messages to study‐days post insertion. Summary of results: A total of 30 patients were successfully implanted with a study device, without intraoperative complications. Patients had a mean age of 63 + 14 years and 73% were male. The indications for the device included syncope in 13 (42%), atrial arrhythmia in 13 (42%), palpitations in 3 (10%) and cryptogenic stroke in 1 (3%). The median time from skin cut to final positioning was 2.5 minutes (interquartile range [IQR] 1‐4), and from skin cut to last suture was 9 minutes (IQR 5‐14). The tunneling tool was assessed as "acceptable" or "good" by the operator in 97% of the cases, and in 100% of the cases for the insertion tool. The median R‐wave amplitude was 0.7 mV (IQR 0.6‐1.1) at insertion and remained stable during follow‐up. The mean noise burden was 1.3 + 2.3 % (median 0.0, IQR 0.0‐2.0 %) at one week and 2.3 + 3.1 % (median 1.0, IQR 0.0‐3.0 %) at one month. All patients transmitted messages, 22 of them (73%) by the day after insertion. The overall transmission performance was 93.8% (913 messages on 973 days). At an individual patient level, the median performance was 100% (interquartile range 93.4‐100%). Conclusion: The results of the BioMonitor 2 Pilot Study confirm the utility of the insertion tools and technique and the excellent sensing amplitudes afforded by this new device. Adherence to remote monitoring and transmission performance were shown to be excellent.