Insertion procedure assessment, sensing and detection performance of a novel miniaturized implantable cardiac monitor with a long sensing vector

Abstract

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): unrestricted grant by Biotronik Background The Biotronik BioMonitor III (BM III) is a novel implantable cardiac monitor (ICM) with a miniaturized profile, long sensing vector and simplified implantation technique. Objective We assessed insertion procedure, reliability of sensing quality and detection performance of the BM III. Methods The ICM was implanted in the left parasternal region between the suprasternal notch and the nipple, preferentially at a 45° angle to the sternum. R-wave amplitude was recorded immediately post implantation and at day 1. Follow-up was after 3 months or an event. All episodes, R-wave amplitude and noise burden were documented. The anatomical ICM position was determined at day 1 and after 3 months. A patient questionnaire on pain after implantation, prolonged paresthesia, restriction of daily activity, handling of the HomeMonitoring system and overall satisfaction was conducted after 3 months. Results In 30 patients (age 67 years, 40% male) a BM III was successfully inserted, without complications. Indications were: unexplained syncope (80%), suspected AF (3%) and cryptogenic stroke (17%). Median implantation time was 6 min. Mean R-wave amplitude was 0.73 mV at insertion, 0.77 mV at day 1 (p=0.59) and 0.81 mV after 107 days (p=0.39). At day 1 and at follow-up visit, an anatomically stable device position was demonstrated. Vertical distance from fossa jugularis to the lowest part of the ICM was 14.5 cm at implantation and 14.5 cm at follow-up (p=0.94). The horizontal cranial sternal-to-device distance was 4.4 cm and 4.3 cm at follow-up (p=0.87). The horizontal caudal sternal-to-device distance was 6.0 cm and 5.7 cm at follow-up (p=0.7). Median time to first event was 12 days. In 13 (43%) patients, true episodes were detected. False arrhythmia alerts were detected in 12 (40%) patients, in 7/12 false AF alerts due to recurrent premature atrial contractions (PAC) were recorded. Total number of false detections was low. Patient-satisfaction rate was high, with very few limitations in daily activity. Conclusion Insertion of the novel Biotronik BioMonitor III ICM is fast, uncomplicated and keeps an anatomically stable position of the device over time. Initial sensing values are good and remain stable over time. False arrhythmia alert, mainly due to PACs, occurred in 40% of patients, with a low total number of false detections.