title: Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE-CARE multicentre randomized controlled trial.
abstract: The aim of this study was to evaluate the clinical efficacy and safety of remote monitoring in patients with heart failure implanted with a biventricular defibrillator (CRT-D) with advanced diagnostics.
  
  
  
  The MORE-CARE trial is an international, prospective, multicentre, randomized controlled trial. Within 8 weeks of de novo implant of a CRT-D, patients were randomized to undergo remote checks alternating with in-office follow-ups (Remote arm) or in-office follow-ups alone (Standard arm). The primary endpoint was a composite of death and cardiovascular (CV) and device-related hospitalization. Use of healthcare resources was also evaluated. A total of 865 eligible patients (mean age 66 ± 10 years) were included in the final analysis (437 in the Remote arm and 428 in the Standard arm) and followed for a median of 24 (interquartile range = 15-26) months. No significant difference was found in the primary endpoint between the Remote and Standard arms [hazard ratio 1.02, 95% confidence interval (CI) 0.80-1.30, P = 0.89] or in the individual components of the primary endpoint (P > 0.05). For the composite endpoint of healthcare resource utilization (i.e. 2-year rates of CV hospitalizations, CV emergency department admissions, and CV in-office follow-ups), a significant 38% reduction was found in the Remote vs. Standard arm (incidence rate ratio 0.62, 95% CI 0.58-0.66, P < 0.001) mainly driven by a reduction of in-office visits.
  
  
  
  In heart failure patients implanted with a CRT-D, remote monitoring did not reduce mortality or risk of CV or device-related hospitalization. Use of healthcare resources was significantly reduced as a result of a marked reduction of in-office visits without compromising patient safety.
  
  
  
  NCT00885677.
authors: University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy.|University of Bologna, S. Orsola-Malpighi University Hospital, Bologna, Italy.
authors: Giuseppe
authors: G
authors: Boriani
authors: University Hospital, St. Etienne, France.
authors: Antoine
authors: A
authors: Da Costa
authors: University General Hospital, Valencia, Spain.
authors: Aurelio
authors: A
authors: Quesada
authors: San Filippo Neri Hospital, Rome, Italy.
authors: Renato Pietro
authors: RP
authors: Ricci
authors: University Hospital, Bari, Italy.
authors: Stefano
authors: S
authors: Favale
authors: Chioggia ULSS 14, Chioggia, Italy.
authors: Gabriele
authors: G
authors: Boscolo
authors: Tours University Hospital, Tours, France.
authors: Nicolas
authors: N
authors: Clementy
authors: Medtronic EMEA Regional Clinical Center, Rome, Italy.
authors: Valentina
authors: V
authors: Amori
authors: Medtronic EMEA Regional Clinical Center, Rome, Italy.
authors: Lorenza
authors: L
authors: Mangoni di S Stefano
authors: University Hospital of Geneva, Geneva, Switzerland.
authors: Haran
authors: H
authors: Burri
mesh_terms: D000359:Aftercare / Q000379:methods*; D000368:Aged; D058406:Cardiac Resynchronization Therapy; D058409:Cardiac Resynchronization Therapy Devices; D002318:Cardiovascular Diseases; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data*; D005260:Female; D006333:Heart Failure / Q000628:therapy*; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory; D009026:Mortality; D011446:Prospective Studies; D017216:Telemedicine / Q000379:methods*
keywords: Cardiac resynchronization therapy; Costs; Healthcare; Heart failure; Outcome; Remote monitoring