title: Technical reliability and clinical safety of a remote monitoring system for antiarrhythmic cardiac devices.
abstract: OBJECTIVE
  In recent years, physicians have experienced a huge increase in workload associated with cardiac devices. Remote monitoring enables these devices to be monitored at a distance and could reduce the number of hospital visits. The aim of this study was to assess the technical reliability and clinical safety of the Home MonitoringTM remote monitoring system (Biotronik GmbH, Germany).
  
  
  METHODS
  The study included 162 patients: 115 with pacemakers, 44 with implantable cardioverter-defibrillators (ICDs) and three with ICDs incorporating cardiac resynchronization therapy (CRT). Patients were followed up for a mean of 303+/-244 days. We compared the survival time free of event alerts in patients with pacemakers and in those with ICDs. The remote monitoring system's reliability was evaluated by comparing the data it transmitted with clinical observations made immediately afterwards.
  
  
  RESULTS
  The mean percentage of days monitored was 88.2%. The incidence of event alerts was higher in pacemaker than ICD patients (45% vs. 34%; P=.01). Event alerts preceded the following hospital visit by 76+/-47 days. In the ICD group, the data sent by the monitoring system were judged as true-positives in 42% of cases, as true-negatives in 57% and as false-positives in 1%. No false-negative was observed. In the ICD group, the remote monitoring system had a sensitivity of 100% and a specificity of 97% (positive predictive value 96%, negative predictive value 100%).
  
  
  CONCLUSIONS
  Remote monitoring was a reliable and safe method for following up patients with cardiac devices. Its routine use could enable the early detection of device malfunctions or arrhythmic events.
authors.affiliation: Unidad de Arritmias, Servicio de Cardiología, Hospital Universitario La Fe, Valencia, Spain. j_osca@ono.com
authors.forename: Joaquín
authors.initials: J
authors.lastname: Osca
authors.forename: María José
authors.initials: MJ
authors.lastname: Sanchotello
authors.forename: Josep
authors.initials: J
authors.lastname: Navarro
authors.forename: Oscar
authors.initials: O
authors.lastname: Cano
authors.forename: Rafael
authors.initials: R
authors.lastname: Raso
authors.forename: José Enrique
authors.initials: JE
authors.lastname: Castro
authors.forename: José
authors.initials: J
authors.lastname: Olagüe
authors.forename: Antonio
authors.initials: A
authors.lastname: Salvador
mesh_terms: D000368:Aged; D017147:Defibrillators, Implantable; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000009:adverse effects / Q000592:standards; D010138:Pacemaker, Artificial; D015203:Reproducibility of Results