title: Rationale and design of the MONITOR-ICD study: a randomized comparison of economic and clinical effects of automatic remote MONITORing versus control in patients with Implantable Cardioverter Defibrillators.
abstract: OBJECTIVE
  Implantable cardioverter defibrillator (ICD) remote follow-up and ICD remote monitoring (RM) are established means of ICD follow-up. The reduction of the number of in-office visits and the time to decision is proven, but the true clinical benefit is still unknown. Cost and cost-effectiveness of RM remain leading issues for its dissemination. The MONITOR-ICD study has been designed to assess costs, cost-effectiveness, and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized controlled trial.
  
  
  RESULTS
  Patients indicated for single- or dual-chamber ICD are eligible for the study and are implanted an RM-capable Biotronik ICD (Lumax VR-T or Lumax DR-T; Biotronik SE & Co KG, Berlin, Germany). Implantable cardioverter defibrillator programming and alert-based clinical responses in the RM group are highly standardized by protocol. As of December 2011, recruitment has been completed, and 416 patients have been enrolled. Subjects are followed-up for a minimum of 12months and a maximum of 24months, ending in January 2013. Disease-specific costs from a societal perspective have been defined as primary end point and will be compared between RM and standard-care groups. Secondary end points include ICD shocks (including appropriate and inappropriate shocks), cardiovascular hospitalizations and cardiovascular mortality, and additional health economic end points.
  
  
  CONCLUSIONS
  The MONITOR-ICD study will be an important randomized RM study to report data on a primary economic end point in 2014. Its results on ICD shocks will add to the currently available evidence on clinical benefit of RM.
authors.affiliation: Department of Cardiology and Pneumology, University of Göttingen, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Zabel
authors.affiliation: Institute for Social Medicine, Epidemiology and Health Economics, Charitè University Medical Center, Berlin, Germany; Saw Swee Hock School of Public Health, National University of Singapore, Singapore. Electronic address: falk.mueller-riemenschneider@charite.de.
authors.forename: Falk
authors.initials: F
authors.lastname: Müller-Riemenschneider
authors.affiliation: Division of Cardiology, Zentralklinik, Bad Berka, Germany.
authors.forename: J Christoph
authors.initials: JC
authors.lastname: Geller
authors.affiliation: Heart Center, Coburg, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Brachmann
authors.affiliation: Heart Center, Konstanz, Germany.
authors.forename: Volker
authors.initials: V
authors.lastname: Kühlkamp
authors.affiliation: Klinikum Reinkenheide, Bremerhaven, Germany.
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Dissmann
authors.affiliation: Institute for Social Medicine, Epidemiology and Health Economics, Charitè University Medical Center, Berlin, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Reinhold
authors.affiliation: Institute for Social Medicine, Epidemiology and Health Economics, Charitè University Medical Center, Berlin, Germany.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Roll
authors.affiliation: Department of Cardiology and Pneumology, University of Göttingen, Germany.
authors.forename: Lars
authors.initials: L
authors.lastname: Lüthje
authors.affiliation: Medizinische Klinik II, University of Lübeck, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Bode
authors.affiliation: Division of Clinical and Experimental Electrophysiology - Department of Cardiology and Angiology, University of Münster, Germany.
authors.forename: Lars
authors.initials: L
authors.lastname: Eckardt
authors.affiliation: Institute for Social Medicine, Epidemiology and Health Economics, Charitè University Medical Center, Berlin, Germany.
authors.forename: Stefan N
authors.initials: SN
authors.lastname: Willich
mesh_terms: D000368:Aged; D003362:Cost-Benefit Analysis; D017147:Defibrillators, Implantable / Q000191:economics*; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000191:economics / Q000628:therapy*; D006760:Hospitalization / Q000191:economics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life