BACKGROUND: Implantable loop recorders (ILR) are valuable tools for the investigation of patients with suspected arrhythmias. The BioMonitor 2-AF is a novel insertable ILR with enhanced atrial fibrillation (AF) detection algorithm and remote monitoring capability. OBJECTIVE: The objective of this first-in-human study with the BioMonitor 2-AF was to analyze course of P-wave sensing performance and R-wave amplitude, prevalence of false and correctly sensed and classified episodes, and effectiveness of remote monitoring. METHODS: All 19 patients who underwent ILR insertion were included in the BIOTRONIK Home Monitoring® system (BIOTRONIK GmbH, Berlin, Germany). Daily changes in P-wave and R-wave sensing were analyzed over 6 weeks. A breathing test (in- and expiration) was performed in two different body positions at baseline and during a 6-week in-house follow-up to investigate alterations of P-wave and R-wave sensing. RESULTS: R-wave amplitude and the high P-wave visibility (94.4%) remained unchanged during the follow-up period. In most patients both an increase and decrease of R-wave amplitude, and in some cases a complete R-wave vector change (31.6%), was documented during the "breathing test." Change of body position did not alter R-wave sensing amplitude mostly. "Breathing test" and change of body position had no effect on P-wave sensing performance. In 15.8% of the patients, misclassification of episodes as AF or high ventricular rates due to P-wave oversensing occurred. No ILR-related complication occurred. Automatic transmission via BIOTRONIK Home Monitoring® was successful 100% of the time. CONCLUSION: This study demonstrates that the BioMonitor 2-AF is a safe and effective tool for continuous cardiac monitoring.
BACKGROUND: Implantable loop recorders (ILR) are valuable tools for the investigation of patients with suspected arrhythmias. The BioMonitor 2-AF is a novel insertable ILR with enhanced atrial fibrillation (AF) detection algorithm and remote monitoring capability. OBJECTIVE: The objective of this first-in-human study with the BioMonitor 2-AF was to analyze course of P-wave sensing performance and R-wave amplitude, prevalence of false and correctly sensed and classified episodes, and effectiveness of remote monitoring. METHODS: All 19 patients who underwent ILR insertion were included in the BIOTRONIK Home Monitoring® system (BIOTRONIK GmbH, Berlin, Germany). Daily changes in P-wave and R-wave sensing were analyzed over 6 weeks. A breathing test (in- and expiration) was performed in two different body positions at baseline and during a 6-week in-house follow-up to investigate alterations of P-wave and R-wave sensing. RESULTS: R-wave amplitude and the high P-wave visibility (94.4%) remained unchanged during the follow-up period. In most patients both an increase and decrease of R-wave amplitude, and in some cases a complete R-wave vector change (31.6%), was documented during the "breathing test." Change of body position did not alter R-wave sensing amplitude mostly. "Breathing test" and change of body position had no effect on P-wave sensing performance. In 15.8% of the patients, misclassification of episodes as AF or high ventricular rates due to P-wave oversensing occurred. No ILR-related complication occurred. Automatic transmission via BIOTRONIK Home Monitoring® was successful 100% of the time. CONCLUSION: This study demonstrates that the BioMonitor 2-AF is a safe and effective tool for continuous cardiac monitoring.
Authors: Femke Wouters; Henri Gruwez; Julie Vranken; Dimitri Vanhaen; Bo Daelman; Ludovic Ernon; Dieter Mesotten; Pieter Vandervoort; David Verhaert Journal: Front Cardiovasc Med Date: 2022-04-13
Authors: Matthew Swale; Sinny Delacroix; Glenn Young; Vincent Paul; Luke McSpadden; Kyungmoo Ryu; David Di Fiore; Maria Santos; Isabel Tan; Andre Conradie; MyNgan Duong; Nisha Schwarz; Stephen Worthley; Stephen Pavia Journal: Cardiovasc Digit Health J Date: 2021-12-30
Authors: Thomas Deneke; Pilar Cabanas; Daniel Hofer; Thomas Gaspar; Bertrand Pierre; Giovanni Bisignani; Rajeev Kumar Pathak; Victor Manuel Sanfins; Eimo Martens; Jacques Mansourati; Antonio Berruezo-Sanchez; Marcus Wiemer; Andreas Hain; Thomas Pezawas; Beate Wenzel; Dennis Lau Journal: Heart Rhythm O2 Date: 2022-01-30