BioMonitor 2 Pilot Study: Early Experience With Implantation of the Biotronik BioMonitor 2 Implantable Cardiac Monitor - 25/01/19

Doi : 10.1016/j.hlc.2017.09.005

Sze-Yuan Ooi, MBBS, MD, FRACP ^a,^b,^⁎ , Ben Ng, MBBS, FRACP ^a,^b, Suresh Singarayar, MBBS, PhD, FRACP ^a,^b, Kevin Hellestrand, MBBS, PhD, FRACP ^c, Peter Illes, MBBS, FRACP ^c, Uwais Mohamed, MBBS, FRACP ^d, Shakeeb Razak, MBBS, FRACP ^e, Rukshen Weerasooriya, MBBS, FRACP ^f,^g
for the BioMonitor 2 Study Investigators
^a Prince of Wales Hospital and Eastern Heart Clinic, Sydney, NSW, Australia
^b University of New South Wales, Sydney, NSW, Australia
^c Sydney Adventist Hospital, Sydney, NSW, Australia
^d Northern Hospital, Melbourne, Vic, Australia
^e Joondalup Health Campus, Perth, WA, Australia
^f Hollywood Private Hospital, Perth, WA, Australia
^g University of Western Australia, Perth, WA, Australia

^⁎Corresponding author at: Department of Cardiology, Level 3, Clinical Sciences Building, Prince of Wales Hospital, Randwick, NSW 2032, Australia. Tel.: +61 2 9382 0770, Fax: +61 2 9382 0799.Department of CardiologyLevel 3, Clinical Sciences Building, Prince of Wales HospitalRandwickNSW2032Australia

Résumé

Background

The BioMonitor 2 Pilot Study assessed the implantation procedure, the sensing amplitude and the remote monitoring transmission success rate of the second generation implantable cardiac monitor, the BioMonitor 2 (Biotronik, Berlin, Germany).

Methods

This was a prospective, multi-centre, single-arm, non-randomised study involving seven operators in five sites across Australia. Data were collected at implantation, during clinic visits at 1 week and 1 month post-implantation, and through wireless remote monitoring.

Results

Thirty patients with indications for long-term cardiac monitoring underwent successful insertion of a study device. The median implantation time was 9 minutes (interquartile range (IQR) 5–14 mins). The mean R-wave amplitude at 1 week was 0.75±0.39mV and remained stable over the follow-up period. Within 1 day, 97% of the patients connected to the remote monitoring network and daily messages were transmitted on 93.8% of all study days. Seventy-six per cent of patients transmitted at least one subcutaneous ECG (sECG), with a median number of sECGs per patient of seven (IQR 3–37) within 28 days.

Conclusions

The results of the BioMonitor 2 Pilot study confirm the excellent sensing amplitudes afforded by this new device and the utility of the implantation tools and technique. Patient compliance with and the transmission success rate of the home monitoring system were excellent.

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Keywords : Remote monitoring, Syncope, Arrhythmia

Plan

Investigational Device

Implantation Procedure

Insertion Procedure Results

Home Monitoring Transmission

Transmission of Arrhythmia Episodes

☆	Clinical trial registration: Australian New Zealand Clinical Trials Registry ID: ACTRN12614001266651.

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Vol 27 - N° 12

P. 1462-1466 - décembre 2018 Retour au numéro

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BioMonitor 2 Pilot Study: Early Experience With Implantation of the Biotronik BioMonitor 2 Implantable Cardiac Monitor - 25/01/19

Résumé

Background

Methods

Results

Conclusions

Plan

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