title: New implantable cardiac monitor with three-lead ECG and active noise detection.
abstract: BACKGROUND
  A new implantable cardiac monitor (BioMonitor, Biotronik) with a continuous remote monitoring option was prospectively implanted in patients with suspected arrhythmias or for therapy control after atrial fibrillation (AF) ablation. A three-lead ECG detection was intended to make the implantation more independent of the implantation site and the electrical heart axis. Because noise is a frequent problem in implantable cardiac monitors, an active noise detection algorithm was implemented. The aim of the trial was to evaluate the clinical performance of the device.
  
  
  METHODS
  The device performance was evaluated in a prospective nonrandomized multicenter study with a follow-up of 12 months. Study endpoints were device-related serious adverse events at 3 months, appropriate QRS detection in direct comparison with synchronized Holter ECG recordings, sensitivity and positive predictive value of arrhythmia detection in comparison with Holter ECG and independent of it, and noise burden during the entire follow-up period.
  
  
  RESULTS
  The implantation was successful in all 152 patients. Two device-related serious adverse events (pocket infections) occurred by 3 months. The mean QRS amplitude of 0.3 ± 0.2 mV at implantation remained stable over 12 months. QRS sensing performance indicated little over- and undersensing in most patients. More than 80 % of the patients had more than 22 h of noise-free monitoring per day.
  
  
  CONCLUSIONS
  BioMonitor effectively detects patients with bradycardia, tachycardia, AF, or asystole. Active noise detection seems to reduce the transmission of meaningless data without diminishing the positive predictive value of the device.
authors: Department of Electrophysiology, KMG Hospital Güstrow, Friedrich-Trendelenburg-Allee 1, 18273, Güstrow, Germany. Lauschke.mail@freenet.de.
authors: J
authors: J
authors: Lauschke
authors: Department of Cardiology, University Hospital, Greifswald, Germany.
authors: M
authors: M
authors: Busch
authors: Department of Cardiology, Charité University Hospital, Berlin, Germany.
authors: W
authors: W
authors: Haverkamp
authors: Faculty of Health and Social Sciences, University of South Bohemia, České Budejovice, Czech Republic.
authors: A
authors: A
authors: Bulava
authors: Department of Electrophysiology, KMG Hospital Güstrow, Friedrich-Trendelenburg-Allee 1, 18273, Güstrow, Germany.
authors: R
authors: R
authors: Schneider
authors: Evangelical Hospital Hubertus, Berlin, Germany.
authors: D
authors: D
authors: Andresen
authors: Department of Heart Failure and Devices, Albertinen Hospital, Hamburg, Germany.
authors: H
authors: H
authors: Nägele
authors: Evangelical Hospital, Bielefeld, Germany.
authors: C
authors: C
authors: Israel
authors: Heart Centre Leipzig, University Hospital, Leipzig, Germany.
authors: G
authors: G
authors: Hindricks
authors: Department of Electrophysiology, KMG Hospital Güstrow, Friedrich-Trendelenburg-Allee 1, 18273, Güstrow, Germany.
authors: D
authors: D
authors: Bänsch
mesh_terms: D000328:Adult; D000465:Algorithms; D001145:Arrhythmias, Cardiac / Q000175:diagnosis* / Q000601:surgery; D001281:Atrial Fibrillation / Q000175:diagnosis* / Q000601:surgery; D017115:Catheter Ablation; D004562:Electrocardiography / Q000295:instrumentation*; D015716:Electrocardiography, Ambulatory / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000175:diagnosis*; D011446:Prospective Studies; D019736:Prostheses and Implants / Q000592:standards; D058998:Remote Sensing Technology / Q000295:instrumentation*
keywords: Artifacts; Atrial fibrillation; Cardiac arrhythmia; Electrocardiography; Predictive value