Patient perspective on remote monitoring of cardiovascular implantable electronic devices: rationale and design of the REMOTE-CIED study.

H Versteeg,P Mabo,J O Schwab,S S Pedersen,M H Mastenbroek,W K Redekop,M Meine

doi:10.1007/s12471-014-0587-z

Abstract

BackgroundRemote patient monitoring is a safe and effective alternative for the in-clinic follow-up of patients with cardiovascular implantable electronic devices (CIEDs). However, evidence on the patient perspective on remote monitoring is scarce and inconsistent.ObjectivesThe primary objective of the REMOTE-CIED study is to evaluate the influence of remote patient monitoring versus in-clinic follow-up on patient-reported outcomes. Secondary objectives are to: 1) identify subgroups of patients who may not be satisfied with remote monitoring; and 2) investigate the cost-effectiveness of remote monitoring.MethodsThe REMOTE-CIED study is an international randomised controlled study that will include 900 consecutive heart failure patients implanted with an implantable cardioverter defibrillator (ICD) compatible with the Boston Scientific LATITUDE® Remote Patient Management system at participating centres in five European countries. Patients will be randomised to remote monitoring or in-clinic follow-up. The In-Clinic group will visit the outpatient clinic every 3–6 months, according to standard practice. The Remote Monitoring group only visits the outpatient clinic at 12 and 24 months post-implantation, other check-ups are performed remotely. Patients are asked to complete questionnaires at five time points during the 2-year follow-up.ConclusionThe REMOTE-CIED study will provide insight into the patient perspective on remote monitoring in ICD patients, which could help to support patient-centred care in the future.

Highlights

Given the growth in the number of patients receiving a cardiovascular implantable electronic device (CIED), in particular the implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy (CRT) devices, the burden on outpatient clinics to follow up these patients is increasing [1,2,3]
No prospective randomised study has examined whether there is a subset of patients who might not benefit from remote monitoring in terms of patient-reported outcomes and might be more satisfied with standard clinical follow-up visits
Patients implanted with a first-time ICD or CRT-D compatible with the LATITUDE® Patient Management system from Boston Scientific, with left ventricular ejection fraction ≤35 % and symptomatic heart failure (New York Heart Association functional class II or III) at the time of implantation, and providing written informed consent will be eligible to participate

Summary

Introduction

Given the growth in the number of patients receiving a cardiovascular implantable electronic device (CIED), in particular the implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy (CRT) devices, the burden on outpatient clinics to follow up these patients is increasing [1,2,3]. Neth Heart J (2014) 22:423–428 transmitter that interrogates the CIED at pre-specified time points and sends the acquired data (e.g. information on battery status, lead impedances) from the patient’s home to the hospital, hereby avoiding or reducing the number of unnecessary in-clinic visits. In between these scheduled remote follow-ups, the transmitter sends information to the physician on technical (e.g., device integrity) or clinical (e.g., arrhythmias) issues, which are checked regularly [4]. Remote patient monitoring is a safe and effective alternative for the in-clinic follow-up of patients with cardiovascular implantable electronic devices (CIEDs). Evidence on the patient perspective on remote monitoring is scarce and inconsistent

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