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

• Main Authors: Boriani, Giuseppe (Author), Da Costa, Antoine (Author), Ricci, Renato Pietro (Author), Quesada, Aurelio (Author), Favale, Stefano (Author), Iacopino, Saverio (Author), Romeo, Francesco (Author), Risi, Arnaldo (Author), Mangoni di S Stefano, Lorenza (Author), Navarro, Xavier (Author), Biffi, Mauro (Author), Santini, Massimo (Author), Burri, Haran (Author)
• Format: Book
• Published: JMIR Publications, 2013-08-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 1438-8871; 10.2196/jmir.2608
• Keywords: Computer applications to medicine. Medical informatics; R858-859.7; Public aspects of medicine; RA1-1270
• Source: Journal of Medical Internet Research, Vol 15, Iss 8, p e167 (2013)

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<.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). ConclusionsRM 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 RegistrationClinicaltrials.gov NCT00885677; http://clinicaltrials.gov/show/NCT00885677 (Archived by WebCite at http://www.webcitation.org/6IkcCJ7NF).