Open Access

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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Date: 5 June 2019
Journal: EP Europace Journal , Volume 21 , Issue 9 , Pages 1360 - 1368
Authors: H. Versteeg , I. Timmermans , J. Widdershoven , G. Kimman , S. Prevot , T. Rauwolf , M. Scholten , E. Zitron , P. Mabo , J. Denollet , S. Pedersen , M. Meine

ESC Journals

AbstractAims

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.

ClinicalTrials.gov Identifier: NCT01691586.

About the contributors

Henneke Versteeg

Role: Author

Ivy Timmermans

Role: Author

Jos Widdershoven

Role: Author