J. Med. Internet Res. - The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) randomized controlled trial: phase 1 results on dynamics of early intervention with remote monitoring.

Tópicos

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Resumo

CKGROUND: 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).

Resumo Limpo

ckground remot monitor rm patient advanc heart failur cardiac resynchron therapi defibril crtd may reduc delay clinic decis transmit automat alert howev strategi never test specif patient popul alert lung fluid overload european settingobject main object phase present evalu rm strategi abl reduc time devicedetect event clinic decisionsmethod multicent random control trial patient moder sever heart failur implant crtd devic random remot group remot followup wireless automat alert control group standard followup without alert primari endpoint phase delay alert event clinic decis relat event first enrol patient follow yearresult median delay devicedetect event clinic decis consider shorter remot group compar control group thth percentil day vs thth percentil day respect p inhospit visit reduc remot group visitspatientyear vs visitspatientyear control group relat reduct p automat alert success transmit event occur outsid hospit remot group annual rate allcaus hospit per patient differ two group pconclus rm crtd patient advanc heart failur allow physician prompt react clinic relev automat alert signific reduc burden inhospit visitstri registr clinicaltrialsgov nct httpclinicaltrialsgovshownct archiv webcit httpwwwwebcitationorgikccjnf

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