التفاصيل البيبلوغرافية
| العنوان: |
The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) Randomized Controlled Trial: Phase 1 Results on Dynamics of Early Intervention With Remote Monitoring. |
| المؤلفون: |
Boriani, Giuseppe, Costa, Antoine Da, Ricci, Renato Pietro, Quesada, Aurelio, Favale, Stefano, Iacopino, Saverio, Romeo, Francesco, Risi, Arnaldo, Stefano, Lorenza Mangoni di S, Navarro, Xavier, Biffi, Mauro, Santini, Massimo, Burri, Haran |
| المصدر: |
Journal of Medical Internet Research; Aug2013, Vol. 15 Issue 8, p1-1, 1p, 6 Color Photographs |
| مصطلحات موضوعية: |
RANDOMIZED controlled trials, CARDIAC patients, HEART failure, BODY fluids, CONTROL groups |
| مستخلص: |
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/NCT00885677Test (Archived by WebCite at http://www.webcitation.org/6IkcCJ7NFTest). (J Med Internet Res 2013;15(8):e167) [ABSTRACT FROM AUTHOR] |
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