Giuseppe Boriani1,2, Antoine Da Costa3, Aurelio Quesada4, Renato Pietro Ricci5, Stefano Favale6, Gabriele Boscolo7, Nicolas Clementy8, Valentina Amori9, Lorenza Mangoni di S Stefano9, Haran Burri10. 1. University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy. 2. University of Bologna, S. Orsola-Malpighi University Hospital, Bologna, Italy. 3. University Hospital, St. Etienne, France. 4. University General Hospital, Valencia, Spain. 5. San Filippo Neri Hospital, Rome, Italy. 6. University Hospital, Bari, Italy. 7. Chioggia ULSS 14, Chioggia, Italy. 8. Tours University Hospital, Tours, France. 9. Medtronic EMEA Regional Clinical Center, Rome, Italy. 10. University Hospital of Geneva, Geneva, Switzerland.
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.
RCT Entities:
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 failurepatients 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.
Authors: David Duncker; Roman Michalski; Johanna Müller-Leisse; Christos Zormpas; Thorben König; Christian Veltmann Journal: Herzschrittmacherther Elektrophysiol Date: 2017-08-15
Authors: Michael Gruska; Gerhard Aigner; Johann Altenberger; Dagmar Burkart-Küttner; Lukas Fiedler; Marianne Gwechenberger; Peter Lercher; Martin Martinek; Michael Nürnberg; Gerhard Pölzl; Gerold Porenta; Stefan Sauermann; Christoph Schukro; Daniel Scherr; Clemens Steinwender; Markus Stühlinger; Alexander Teubl Journal: Wien Klin Wochenschr Date: 2020-12-01 Impact factor: 1.704