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. 2022 Mar 16;11(6):1634.
doi: 10.3390/jcm11061634.

The BIOMONITOR III Injectable Cardiac Monitor: Clinical Experience with a Novel Injectable Cardiac Monitor

Nico Reinsch  1   2 , Anna Füting  1   2 , Dennis Höwel  1 , Kars Neven  1   2
Affiliations

The BIOMONITOR III Injectable Cardiac Monitor: Clinical Experience with a Novel Injectable Cardiac Monitor

Nico Reinsch et al. J Clin Med. .

Abstract

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.

Keywords: BIOMONITOR III; R-wave sensing; implantable cardiac monitor; implantable loop recorder; signal quality.

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Conflict of interest statement

N.R. has received honoraria outside the content of this study. The authors declare no conflict of interest. The corresponding author had full access to the data and had final responsibility for the decision to submit for publication. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

Figures

Figure 1
Figure 1
Insertion procedure: (a) A skin fold is formed and the cutting tool produces a defined incision. (b,c) The fast insertion tool forms the device pocket. (d) The tool is unlocked. (e,f) The tool holds the device in place while it is withdrawn from the pocket. Reprinted with permission from BIOTRONIK SE & Co., KG, Berlin, Germany.
Figure 2
Figure 2
Anatomical position of the BIOMONITOR III: (A) Recommended and (B) alternative anatomical positions of the BIOMONITOR III in the present study.
Figure 3
Figure 3
Subcutaneous ECG examples: (a) Correct classification as atrial fibrillation in a subcutaneous ECG showing atrial flutter; clear visualization of the P-wave improves diagnosis, and may guide the treatment. (b) Frequent premature ventricular contractions (PVCs); irregular R–R intervals due to ectopic beats can be misinterpreted as the start of an AF episode.
Figure 4
Figure 4
Evaluation of questionnaire answers provided by the study population.
See this image and copyright information in PMC

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