title: The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) randomized controlled trial: phase 1 results on dynamics of early intervention with remote monitoring.
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 (25(th)-75(th) percentile, 1-4) days vs 29 (25(th)-75(th) 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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00885677; http://clinicaltrials.gov/show/NCT00885677 (Archived by WebCite at http://www.webcitation.org/6IkcCJ7NF).
authors: Institute of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, S Orsola-Malpighi University Hospital, Bologna, Italy. giuseppe.boriani@unibo.it
authors: Giuseppe
authors: G
authors: Boriani
authors: Antoine
authors: A
authors: Da Costa
authors: Renato Pietro
authors: RP
authors: Ricci
authors: Aurelio
authors: A
authors: Quesada
authors: Stefano
authors: S
authors: Favale
authors: Saverio
authors: S
authors: Iacopino
authors: Francesco
authors: F
authors: Romeo
authors: Arnaldo
authors: A
authors: Risi
authors: Lorenza
authors: L
authors: Mangoni di S Stefano
authors: Xavier
authors: X
authors: Navarro
authors: Mauro
authors: M
authors: Biffi
authors: Massimo
authors: M
authors: Santini
authors: Haran
authors: H
authors: Burri
mesh_terms: D004581:Electronics; D006801:Humans; D008991:Monitoring, Physiologic / Q000379:methods*; D017216:Telemedicine / Q000379:methods*
keywords: alerts; cardiac resynchronization therapy; heart failure; remote monitoring; telemedicine
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