Why the study?
The BIOTRONIK BIOMONITOR III is a novel injectable cardiac monitor with a miniaturized profile, long sensing vector, and simplified implantation technique that required clinical evaluation.
Does the BIOTRONIK BIOMONITOR III injectable cardiac monitor provide stable sensing characteristics and high patient satisfaction?
Does the BIOTRONIK BIOMONITOR III injectable cardiac monitor provide stable sensing characteristics and high patient satisfaction?
The BIOMONITOR III injectable cardiac monitor demonstrates stable sensing characteristics, fast implantation times, and high patient satisfaction at 3 months.
Background: Injectable cardiac monitors (ICMs) are leadless subcutaneous devices for long-term monitoring of arrhythmias. The BIOTRONIK BIOMONITOR III is a novel ICM with a miniaturized profile, long sensing vector, and simplified implantation technique. Methods: R-wave amplitude was recorded immediately after implantation, the day after implantation, and after 3 months. Follow-up was scheduled after 3 months or after an event. All data from the ICM were retrieved. The anatomical position of the ICM was determined post-implantation and after 3 months. A patient questionnaire was conducted after 3 months. Results: In 36 patients (mean age 67 ± 13 years; 40% male) an ICM was inserted. Six patients were not included in the final analysis. The median time from skin cut to wound closure was 6 [IQR 5–7] minutes. Mean R-wave amplitude increased over time (0.73 ± 32 mV vs. 0.78 ± 0.38 mV vs. 0.81 ± 0.39 mV; p = ns). Three months after implantation, the ICM was in an anatomically stable position. In 14 (47%) patients, true episodes were detected. False arrhythmia alerts were detected in 13 (43%) patients. The total number of false detections was low, and the patient satisfaction rate was high. Conclusion: Implantation of the novel BIOMONITOR III is fast and uncomplicated; its sensing characteristics are excellent and improve over time, and patient satisfaction is high.
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Reinsch et al. (2022) studied this question.
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