BioMonitor 2 Pilot Study: Early experience with implantation of the Biotronik BioMonitor 2 implantable cardiac monitor

BioMonitor 2 Study Investigators

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

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 +/- 0.39 mV 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 (5ECG), 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.

Original languageEnglish
Pages (from-to)1462-1466
Number of pages5
JournalHeart Lung and Circulation
Volume27
Issue number12
DOIs
Publication statusPublished - Dec 2018

Cite this

@article{41f3e6ed540349c892449940b5b087f6,
title = "BioMonitor 2 Pilot Study: Early experience with implantation of the Biotronik BioMonitor 2 implantable cardiac monitor",
abstract = "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 +/- 0.39 mV 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 (5ECG), 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.",
keywords = "Remote monitoring, Syncope, Arrhythmia, ATRIAL-FIBRILLATION, LOOP RECORDERS, SYNCOPE, TRIAL",
author = "{BioMonitor 2 Study Investigators} and Sze-Yuan Ooi and Ben Ng and Suresh Singarayar and Kevin Hellestrand and Peter Illes and Uwais Mohamed and Shakeeb Razak and Rukshen Weerasooriya",
year = "2018",
month = "12",
doi = "10.1016/j.hlc.2017.09.005",
language = "English",
volume = "27",
pages = "1462--1466",
journal = "Heart, Lung & Circulation",
issn = "1444-2892",
publisher = "Academic Press",
number = "12",

}

BioMonitor 2 Pilot Study : Early experience with implantation of the Biotronik BioMonitor 2 implantable cardiac monitor. / BioMonitor 2 Study Investigators.

In: Heart Lung and Circulation, Vol. 27, No. 12, 12.2018, p. 1462-1466.

Research output: Contribution to journalArticle

TY - JOUR

T1 - BioMonitor 2 Pilot Study

T2 - Early experience with implantation of the Biotronik BioMonitor 2 implantable cardiac monitor

AU - BioMonitor 2 Study Investigators

AU - Ooi, Sze-Yuan

AU - Ng, Ben

AU - Singarayar, Suresh

AU - Hellestrand, Kevin

AU - Illes, Peter

AU - Mohamed, Uwais

AU - Razak, Shakeeb

AU - Weerasooriya, Rukshen

PY - 2018/12

Y1 - 2018/12

N2 - 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 +/- 0.39 mV 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 (5ECG), 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.

AB - 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 +/- 0.39 mV 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 (5ECG), 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.

KW - Remote monitoring

KW - Syncope

KW - Arrhythmia

KW - ATRIAL-FIBRILLATION

KW - LOOP RECORDERS

KW - SYNCOPE

KW - TRIAL

U2 - 10.1016/j.hlc.2017.09.005

DO - 10.1016/j.hlc.2017.09.005

M3 - Article

VL - 27

SP - 1462

EP - 1466

JO - Heart, Lung & Circulation

JF - Heart, Lung & Circulation

SN - 1444-2892

IS - 12

ER -