title: Remote monitoring improves outcome after ICD implantation: the clinical efficacy in the management of heart failure (EFFECT) study.
abstract: OBJECTIVE
  Internet-based remote interrogation systems have been shown to reduce emergency department and in-office visits in patients with implantable cardioverter defibrillators (ICDs), resulting in increased efficiency for healthcare providers. Nonetheless, studies sized to demonstrate the impact of remote monitoring on patients' outcome have been lacking.
  
  
  RESULTS
  The EFFECT study was a multicentre clinical trial aimed at measuring and comparing the outcome of ICD patients conventionally followed-up by means of in-clinic visits (Standard arm) or by remote monitoring (Remote arm) in the clinical practice of 25 Italian centres. From 2011 to 2013, 987 consecutive patients were enrolled and followed up for at least 12 months. The primary endpoint was the rate of death and cardiovascular hospitalizations. Remote monitoring was adopted by 499 patients. Patients in the Standard and Remote arms did not differ significantly in terms of baseline clinical characteristics, except for a more frequent use of ICD with cardiac resynchronization therapy (CRT-D) in the Remote arm (48 vs. 36%, P < 0.001). One-year rates of the primary combined endpoint were 0.27 events/year for patients in the Standard arm and were 0.15 events/year for those in the Remote arm (incident rate ratio, 0.55; 95% CI, 0.41-0.73; P < 0.001). The endpoint rates in the Standard and Remote arms were 0.27 and 0.08 events/year, respectively, among CRT-D recipients (P < 0.001), and 0.28 vs. 0.21 among ICD patients (P = 0.094). The rates of in-office visits were 1.9 per year in the Standard arm and 1.7 per year in the Remote arm.
  
  
  CONCLUSIONS
  Compared with the standard follow-up through in-office visits, remote monitoring is associated with reduced death and cardiovascular hospitalizations in patients with ICD in clinical practice.
  
  
  BACKGROUND
  URL: http://clinicaltrials.gov/ Identifier: NCT01723865.
authors.affiliation: Laboratorio di Elettrofisiologia, Clinica San Michele, Via Montella, 16, Maddaloni (CE) 81024, Italy antoniodesimone2@alice.it.
authors.forename: Antonio
authors.initials: A
authors.lastname: De Simone
authors.affiliation: Policlinico Universitario, Padua, Italy.
authors.forename: Loira
authors.initials: L
authors.lastname: Leoni
authors.affiliation: Università Politecnica delle Marche, Ancona, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Luzi
authors.affiliation: Ospedale di Ciriè - ASL TO 4, Ciriè (TO), Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Amellone
authors.affiliation: Clinica Mediterranea, Naples, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Stabile
authors.affiliation: Laboratorio di Elettrofisiologia, Clinica San Michele, Via Montella, 16, Maddaloni (CE) 81024, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: La Rocca
authors.affiliation: Università Politecnica delle Marche, Ancona, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Capucci
authors.affiliation: Ospedale Monaldi, Naples, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: D'onofrio
authors.affiliation: Ospedale Monaldi SUN, Naples, Italy.
authors.forename: Ernesto
authors.initials: E
authors.lastname: Ammendola
authors.affiliation: Boston Scientific Italia, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Accardi
authors.affiliation: Boston Scientific Italia, Milan, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Valsecchi
authors.affiliation: Policlinico Universitario, Padua, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Buja
mesh_terms: D000368:Aged; D016757:Death, Sudden, Cardiac / Q000453:epidemiology* / Q000517:prevention & control*; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality* / Q000517:prevention & control*; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D012307:Risk Factors; D015996:Survival Rate; D017216:Telemedicine / Q000706:statistics & numerical data*; D016896:Treatment Outcome
keywords: Cardiac resynchronization therapy; Heart failure; Implantable cardioverter-defibrillator; Remote monitoring; Telemedicine