The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) Randomized Controlled Trial: Phase 1 Results on Dynamics of Early Intervention With Remote Monitoring

Autor: Giuseppe, Boriani, Antoine, Da Costa, Renato Pietro, Ricci, Aurelio, Quesada, Stefano, Favale, Saverio, Iacopino, Francesco, Romeo, Arnaldo, Risi, Lorenza, Mangoni di S Stefano, Xavier, Navarro, Mauro, Biffi, Massimo, Santini, Haran, Burri, E, Zima
Přispěvatelé: Giuseppe Boriani, Antoine Da Costa, Renato Pietro Ricci, Aurelio Quesada, Stefano Favale, Saverio Iacopino, Francesco Romeo, Arnaldo Risi, Lorenza Mangoni di S Stefano, Xavier Navarro, Mauro Biffi, Massimo Santini, Haran Burri
Rok vydání: 2013
Předmět:
Zdroj: Journal of Medical Internet Research, Vol. 15, No 8 (2013) P. e167
Journal of Medical Internet Research
Journal of Medical Internet Research, Vol 15, Iss 8, p e167 (2013)
ISSN: 1438-8871
DOI: 10.2196/jmir.2608
Popis: BackgroundRemote 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. ObjectiveThe 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. MethodsIn 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. ResultsThe 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
Databáze: OpenAIRE