Justin A Mariani1, Rukshen Weerasooriya2, Olivier van den Brink3, Uwais Mohamed4, Paul A Gould5, Rajeev K Pathak6, Tina Lin7, Andre Conradie8, Peter Illes9, Stephen Pavia10, Kushwin Rajamani11, Sam Lovibond12, Ian Matthews13, David DiFiore14, Deepak Arumugam15, Jürgen Schrader16, Dennis H Lau17. 1. The Alfred Hospital, 55 Commercial Rd, Melbourne, VIC 3004, Australia; Central Clinical School, Monash University, 99 Commercial Rd, Melbourne, VIC 3004, Australia. Electronic address: j.mariani@alfred.org.au. 2. University of Western Australia, Department of Medicine, Crawley, WA 6000, Australia. Electronic address: rukshen@afablationclinic.com.au. 3. The Alfred Hospital, 55 Commercial Rd, Melbourne, VIC 3004, Australia; Central Clinical School, Monash University, 99 Commercial Rd, Melbourne, VIC 3004, Australia. Electronic address: olivier.vandenbrink@isp.net.au. 4. St Vincent's Hospital, 41 Victoria Parade, Fitzroy, VIC 3065, Australia. Electronic address: Uwais.mohamed@svha.org.au. 5. The University of Queensland, and Department of Cardiology, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102, Australia. Electronic address: paul.gould2@health.qld.gov.au. 6. Australian National University and The Canberra Hospital, Yamba Dr, Canberra, ACT 2605, Australia. Electronic address: rajeev.pathak@act.gov.au. 7. GenesisCare Victoria, 5/126 Wellington Pde, East Melbourne, VIC 3002, Australia. Electronic address: tina.lin@genesiscare.com. 8. GenesisCare, Friendly Society Private Hospital, 19-23 Bingera Street, Bundaberg, QLD 4670, Australia. Electronic address: andre.conradie@genesiscare.com. 9. Sydney Adventist Hospital, 185 Fox Valley Road, Wahroonga, NSW 2076, Australia. 10. GenesisCare, The Wesley Hospital, 30 Chasely St, Auchenflower, QLD 4066, Australia. Electronic address: stephen.pavia@genesiscare.com. 11. University of Western Australia, Department of Medicine, Crawley, WA 6000, Australia. 12. The Alfred Hospital, 55 Commercial Rd, Melbourne, VIC 3004, Australia; Central Clinical School, Monash University, 99 Commercial Rd, Melbourne, VIC 3004, Australia. 13. St Vincent's Hospital, 41 Victoria Parade, Fitzroy, VIC 3065, Australia. Electronic address: ian.matthews@svha.org.au. 14. GenesisCare, Friendly Society Private Hospital, 19-23 Bingera Street, Bundaberg, QLD 4670, Australia. Electronic address: david.difiore@genesiscare.com. 15. GenesisCare, The Wesley Hospital, 30 Chasely St, Auchenflower, QLD 4066, Australia. Electronic address: deepak.arumugam@genesiscare.com. 16. Biotronik SE & Co. KG, Woermannkehre 1, 12359 Berlin, Germany. Electronic address: juergen.schrader@biotronik.com. 17. Centre for Heart Rhythm Disorders, The University of Adelaide and Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000, Australia. Electronic address: dennis.h.lau@adelaide.edu.au.
Abstract
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.
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.
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