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

Henneke Versteeg*, Ivy Timmermans, Jos Widdershoven, Geert-jan Kimman, Sébastien Prevot, Thomas Rauwolf, Marcoen F Scholten, Edgar Zitron, Philippe Mabo, Johan Denollet, Susanne S Pedersen, Mathias Meine

*Corresponding author for this work

Research output: Contribution to journalArticleScientificpeer-review

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 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.
Original languageEnglish
Pages (from-to)1360-1368
JournalEuropace
Volume21
Issue number9
DOIs
Publication statusPublished - 2019

Keywords

  • CARE
  • ELECTRONIC DEVICES
  • HEALTH-STATUS
  • Health status
  • Heart failure
  • Implantable cardioverter-defibrillator
  • METAANALYSIS
  • PERSPECTIVE
  • Patient-reported outcomes
  • REMOTE-CIED
  • Remote monitoring
  • STATEMENT

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