title: A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices.
abstract: OBJECTIVE
  Only limited comparative data exist on the benefits of fluid monitoring (FM) combined with remote monitoring (RM) regarding morbidity and mortality of heart failure (HF) patients. This prospective single-centre randomized pilot study aimed to estimate the influence of RM in combination with FM on HF hospitalizations as well as ventricular tachyarrhythmias and mortality.
  
  
  RESULTS
  Patients with standard indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy and defibrillator were implanted with devices capable of RM and FM, and were followed for 15 months. Subjects were randomly allocated to RM including OptiVol and predefined management of alerts (remote group), or standard in-office visits every 3 months (control group). A total of 176 patients (77% male; 66 ± 12 years; left ventricular ejection fraction (LVEF) 32 ± 11%; ischemic cardiomyopathy 50%; CRT device 50%; primary prevention 85%) were analysed. Cox proportional hazard analysis on the time to first HF-related hospitalization showed a hazard ratio of 1.23 [0.62-2.44] (P = 0.551) favouring the control group. In the remote group, 13 patients (15%) experienced ICD shocks vs. 10 patients (11%) in the control group (P = 0.512). The average time to first ICD shock was 212 ± 173 days in the remote arm and 212 ± 143 days in the control arm (P = 0.994). The Kaplan-Meier estimate of mortality after 1 year was 8.6% (eight deaths) in the remote group vs. 4.6% in the control group (six deaths; P = 0.502).
  
  
  CONCLUSIONS
  In a single-centre randomized pilot study of RM in combination with FM, no significant influence on HF-related hospitalizations, ICD shocks, or mortality was found.
authors.affiliation: Division of Cardiology and Pneumology, Heart Center, University of Göttingen, Robert-Koch-Str. 40, Göttingen 37075, Germany larsluethje@med.uni-goettingen.de.
authors.forename: Lars
authors.initials: L
authors.lastname: Lüthje
authors.affiliation: Division of Cardiology and Pneumology, Heart Center, University of Göttingen, Robert-Koch-Str. 40, Göttingen 37075, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Vollmann
authors.affiliation: Division of Cardiology and Pneumology, Heart Center, University of Göttingen, Robert-Koch-Str. 40, Göttingen 37075, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Seegers
authors.affiliation: Division of Cardiology and Pneumology, Heart Center, University of Göttingen, Robert-Koch-Str. 40, Göttingen 37075, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Sohns
authors.affiliation: Division of Cardiology and Pneumology, Heart Center, University of Göttingen, Robert-Koch-Str. 40, Göttingen 37075, Germany.
authors.forename: Gerd
authors.initials: G
authors.lastname: Hasenfuß
authors.affiliation: Division of Cardiology and Pneumology, Heart Center, University of Göttingen, Robert-Koch-Str. 40, Göttingen 37075, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Zabel
mesh_terms: D000368:Aged; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D005260:Female; D005858:Germany / Q000453:epidemiology; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality* / Q000517:prevention & control*; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D010138:Pacemaker, Artificial / Q000706:statistics & numerical data*; D015995:Prevalence; D012307:Risk Factors; D015996:Survival Rate; D017216:Telemedicine / Q000706:statistics & numerical data*; D016896:Treatment Outcome
keywords: Cardiac decompensation; Fluid monitoring; Heart failure; OptiVol fluid index; Remote monitoring; Telemedicine