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Clinical evaluation of a small implantable cardiac monitor with a long sensing vector
Author(s) -
Piorkowski Christopher,
Busch Mathias,
Nölker Georg,
Schmitt Jörn,
Roithinger Franz Xaver,
Young Glenn,
Táborský Miloš,
Herrmann Gundula,
Schmitz Dietmar
Publication year - 2019
Publication title -
pacing and clinical electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.686
H-Index - 101
eISSN - 1540-8159
pISSN - 0147-8389
DOI - 10.1111/pace.13728
Subject(s) - medicine , atrial fibrillation , cardiology , adverse effect , prospective cohort study , ventricular fibrillation
We conducted this study to show the safety and efficacy of a new implantable cardiac monitor (ICM), the BioMonitor 2 (Biotronik SE & Co. KG; Berlin, Germany), and to describe the arrhythmia detection performance. Methods The BioMonitor 2 has an extended sensing vector and is implanted close to the heart. It can transmit up to six subcutaneous electrocardiogram strips by Home Monitoring each day. We enrolled 92 patients with a standard device indication for an ICM in a single‐arm, multicenter prospective trial. Patients were followed for 3 months, and 48‐h Holter recordings were used to evaluate the arrhythmia detection performance. Results One patient withdrew consent and in one patient, the implantation failed. Two study device‐related serious adverse events were reported, satisfying the primary safety hypothesis. Implantations took 7.4 ± 4.4 min from skin cut to suture. At 1 week, the R‐wave amplitude was 0.75 ± 0.53 mV. In the 82 patients with completed Holter recordings, all patients with arrhythmias were correctly identified. False positive detections of arrhythmia were mostly irregular rhythms wrongly detected as atrial fibrillation (episode‐based positive predictive value 72.5%). Daily Home Monitoring transmission was 94.9% successful. Conclusion Safety and efficacy of the new device has been demonstrated. The detected R‐wave amplitudes are large, leading to a low level of inappropriate detections due to over‐ or undersensing.