@Article{info:doi/10.2196/jmir.2608,
author="Boriani, Giuseppe
and Da Costa, Antoine
and Ricci, Renato Pietro
and Quesada, Aurelio
and Favale, Stefano
and Iacopino, Saverio
and Romeo, Francesco
and Risi, Arnaldo
and Mangoni di S Stefano, Lorenza
and Navarro, Xavier
and Biffi, Mauro
and Santini, Massimo
and Burri, Haran",
title="The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) Randomized Controlled Trial: Phase 1 Results on Dynamics of Early Intervention With Remote Monitoring",
journal="J Med Internet Res",
year="2013",
month="Aug",
day="21",
volume="15",
number="8",
pages="e167",
keywords="cardiac resynchronization therapy; heart failure; alerts; remote monitoring; telemedicine",
abstract="Background: Remote monitoring (RM) in patients with advanced heart failure and cardiac resynchronization therapy defibrillators (CRT-D) may reduce delays in clinical decisions by transmitting automatic alerts. However, this strategy has never been tested specifically in this patient population, with alerts for lung fluid overload, and in a European setting. Objective: The main objective of Phase 1 (presented here) is to evaluate if RM strategy is able to reduce time from device-detected events to clinical decisions. Methods: In this multicenter randomized controlled trial, patients with moderate to severe heart failure implanted with CRT-D devices were randomized to a Remote group (with remote follow-up and wireless automatic alerts) or to a Control group (with standard follow-up without alerts). The primary endpoint of Phase 1 was the delay between an alert event and clinical decisions related to the event in the first 154 enrolled patients followed for 1 year. Results: The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group: 2 (25th-75th percentile, 1-4) days vs 29 (25th-75th percentile, 3-51) days respectively, P=.004. In-hospital visits were reduced in the Remote group (2.0 visits/patient/year vs 3.2 visits/patient/year in the Control group, 37.5{\%} relative reduction, P<.001). Automatic alerts were successfully transmitted in 93{\%} of events occurring outside the hospital in the Remote group. The annual rate of all-cause hospitalizations per patient did not differ between the two groups (P=.65). Conclusions: RM in CRT-D patients with advanced heart failure allows physicians to promptly react to clinically relevant automatic alerts and significantly reduces the burden of in-hospital visits. Trial Registration: Clinicaltrials.gov NCT00885677; http://clinicaltrials.gov/show/NCT00885677 (Archived by WebCite at http://www.webcitation.org/6IkcCJ7NF). ",
issn="14388871",
doi="10.2196/jmir.2608",
url="http://www.jmir.org/2013/8/e167/",
url="https://doi.org/10.2196/jmir.2608",
url="http://www.ncbi.nlm.nih.gov/pubmed/23965236"
}