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.

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 / Boriani, Giuseppe; Da Costa, Antoine; Quesada, Aurelio; Ricci, Renato Pietro; Favale, Stefano; Boscolo, Gabriele; Clementy, Nicolas; Amori, Valentina; Lorenza, Mangoni di S. Stefano; Burri, Haran. - In: EUROPEAN JOURNAL OF HEART FAILURE. - ISSN 1388-9842. - 19:3(2017), pp. 416-425. [10.1002/ejhf.626]

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

BORIANI, Giuseppe;
2017

Abstract

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.
2017
28-ago-2016
19
3
416
425
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 / Boriani, Giuseppe; Da Costa, Antoine; Quesada, Aurelio; Ricci, Renato Pietro; Favale, Stefano; Boscolo, Gabriele; Clementy, Nicolas; Amori, Valentina; Lorenza, Mangoni di S. Stefano; Burri, Haran. - In: EUROPEAN JOURNAL OF HEART FAILURE. - ISSN 1388-9842. - 19:3(2017), pp. 416-425. [10.1002/ejhf.626]
Boriani, Giuseppe; Da Costa, Antoine; Quesada, Aurelio; Ricci, Renato Pietro; Favale, Stefano; Boscolo, Gabriele; Clementy, Nicolas; Amori, Valentina; Lorenza, Mangoni di S. Stefano; Burri, Haran
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/1139526
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