Denollet, Johan

Kimman, Geert-Jan

Mabo, Philippe

Meine, Mathias

Pedersen, Susanne S.

Prevot, Sebastien

Rauwolf, Thomas

Scholten, Marcoen F.

Timmermans, Ivy

Versteeg, Henneke

Widdershoven, Jos

Zitron, Edgar

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 (R) 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

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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

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

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Institutional Repository Universiteit Antwerpen