Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial
Versteeg, Henneke; Timmermans, Ivy; Widdershoven, Jos; Kimman, Geert Jan; Prevot, Sébastien; Rauwolf, Thomas; Scholten, Marcoen F.; Zitron, Edgar; Mabo, Philippe; Denollet, Johan; Pedersen, Susanne S.; Meine, Mathias
(2019) Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, volume 21, issue 9, pp. 1360 - 1368
(Article)
Abstract
AIMS: The European REMOTE-CIED study is the first randomized trial primarily designed to evaluate the effect of remote patient monitoring (RPM) on patient-reported outcomes in the first 2 years after implantation of an implantable cardioverter-defibrillator (ICD). METHODS AND RESULTS: The sample consisted of 595 European heart failure patients implanted with
... read more
an ICD compatible with the Boston Scientific LATITUDE® RPM system. Patients were randomized to RPM plus a yearly in-clinic ICD check-up vs. 3-6-month in-clinic check-ups alone. At five points during the 2-year follow-up, patients completed questionnaires including the Kansas City Cardiomyopathy Questionnaire and Florida Patient Acceptance Survey (FPAS) to assess their heart failure-specific health status and ICD acceptance, respectively. Information on clinical status was obtained from patients' medical records. Linear regression models were used to compare scores between groups over time. Intention-to-treat and per-protocol analyses showed no significant group differences in patients' health status and ICD acceptance (subscale) scores (all Ps > 0.05). Exploratory subgroup analyses indicated a temporary improvement in device acceptance (FPAS total score) at 6-month follow-up for secondary prophylactic in-clinic patients only (P < 0.001). No other significant subgroup differences were observed. CONCLUSION: Large clinical trials have indicated that RPM can safely and effectively replace most in-clinic check-ups of ICD patients. The REMOTE-CIED trial results show that patient-reported health status and ICD acceptance do not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation.ClinicalTrials.gov Identifier: NCT01691586.
show less
Download/Full Text
The full text of this publication is not available.
Keywords: Health status, Heart failure, Implantable cardioverter-defibrillator, Patient-reported outcomes, Remote monitoring, REMOTE-CIED, Cardiology and Cardiovascular Medicine, Physiology (medical)
ISSN: 1099-5129
Publisher: Oxford University Press
Note: Publisher Copyright: © 2019 Published on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.
(Peer reviewed)