Miniaturized implantable cardiac monitor with a long sensing vector (BIOMONITOR III): Insertion procedure assessment, sensing performance, and home monitoring transmission success
| Autor: | Dennis H. Lau, Tina Lin, Sam Lovibond, Andre Conradie, Uwais Mohamed, Jürgen Schrader, Stephen Pavia, Peter Illes, Ian Matthews, Justin A. Mariani, Rajeev Kumar Pathak, Paul A. Gould, David DiFiore, Rukshen Weerasooriya, Deepak Arumugam, Olivier W V van den Brink, Kushwin Rajamani |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Skin incision business.industry Australia Arrhythmias Cardiac Single step 030204 cardiovascular system & hematology Electrocardiography 03 medical and health sciences 0302 clinical medicine Transmission (telecommunications) Electrocardiography Ambulatory Implantable loop recorder Humans Medicine Insertion procedure Sinus rhythm 030212 general & internal medicine Implantable cardiac monitor Radiology Cardiology and Cardiovascular Medicine business Pocket formation |
| Zdroj: | Journal of Electrocardiology. 60:118-125 |
| ISSN: | 0022-0736 |
| Popis: | Background Implantable Cardiac Monitors (ICMs) are used for long-term monitoring of arrhythmias. BIOMONITOR III is a novel ICM with a miniaturized profile, long sensing vector due to a flexible antenna, simplified implantation with a dedicated insertion tool for pocket formation and ICM placement in a single step, and daily automatic Home Monitoring (HM) function. Methods In 47 patients undergoing BIOMONITOR III insertion for any ICM indication, 16 investigators at 10 Australian sites assessed handling characteristics of the insertion tool, R-wave amplitudes, noise burden, P-wave visibility, and HM transmission success. Patients were followed for 1 month. Results All 47 attempted insertions were successful. Median time from skin incision to removal of the insertion tool after ICM insertion was 39 s (IQR 19–65) and to wound closure and cleaning was 4.7 min (IQR 3.5–7.8). All aspects of the insertion tool were rated as “good” or “excellent” in ≥97.9% and “fair” in ≤2.1% of patients, except for “force needed for tunnelling” (91.5% good/excellent, 8.5% fair). Based on HM data, R-waves in the first month were stable at 0.70 ± 0.37 mV. Median noise burden (disabling automatic rhythm evaluation) was 0.19% (IQR 0.00–0.93), equivalent to 2.7 min (IQR 0.0–13.4) per day. In HM-transmitted ECG strips with regular sinus rhythm, P-waves were visible in 89 ± 24% of heart cycles. Patient-individual automatic Home Monitoring transmission success was 98.0% ± 5.5%. Conclusions The novel ICM performed well in all aspects studied, including fast insertion, reliable R-wave sensing, good P-wave visibility, and highly successful HM transmissions. |
| Databáze: | OpenAIRE |
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