The monitoring resynchronization dEvices and CARdiac patiEnts (MORE-CARE) randomized controlled trial: Phase 1 results on dynamics of early intervention with remote monitoring

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.