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.

Trial registration: Clinicaltrials.gov NCT00885677; http://clinicaltrials.gov/show/NCT00885677 (Archived by WebCite at http://www.webcitation.org/6IkcCJ7NF).

Keywords: alerts; cardiac resynchronization therapy; heart failure; remote monitoring; telemedicine.

Figure 1

Remote monitoring system platform and interactions between health care professionals and patient.

Figure 2

Scheduling of follow-up in the Remote group (with RM and in-office follow-up) and in the Control group (with in-office follow-up only).

Figure 3

Phase 1 follow-up experience flow-chart.

Figure 4

Time from device events to clinical decisions for the phase 1 primary end-points (19 in Control group and 37 in Remote group); box-and-whisker plots show the quartiles with the medians labeled, and the whiskers extended to the lower and the upper adjacent value; plus symbols show the outside values.

Figure 5

Distribution of specific clinical actions related to device-detected events in the Remote group (n=43) and in the Control group (n=26) respectively.

Figure 6

Annual rates per randomization group of scheduled visits (in-office visits performed as per protocol requirement), unscheduled planned (in-office visits not required by the protocol, not patient initiated), and unplanned visits (in-office visits not required by the protocol, patient initiated) and emergency room admissions (for each randomization group and for each type of visit, the total number of occurrences is displayed beside the corresponding bar).