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.

Autor: Boriani G; University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy.; University of Bologna, S. Orsola-Malpighi University Hospital, Bologna, Italy., Da Costa A; University Hospital, St. Etienne, France., Quesada A; University General Hospital, Valencia, Spain., Ricci RP; San Filippo Neri Hospital, Rome, Italy., Favale S; University Hospital, Bari, Italy., Boscolo G; Chioggia ULSS 14, Chioggia, Italy., Clementy N; Tours University Hospital, Tours, France., Amori V; Medtronic EMEA Regional Clinical Center, Rome, Italy., Mangoni di S Stefano L; Medtronic EMEA Regional Clinical Center, Rome, Italy., Burri H; University Hospital of Geneva, Geneva, Switzerland.
Jazyk: angličtina
Zdroj: European journal of heart failure [Eur J Heart Fail] 2017 Mar; Vol. 19 (3), pp. 416-425. Date of Electronic Publication: 2016 Aug 28.
DOI: 10.1002/ejhf.626
Abstrakt: Aims: 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.
Methods and Results: 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.
Conclusions: 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.
Trial Registration: NCT00885677.
(© 2016 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
Databáze: MEDLINE
Externí odkaz: