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.

Autor:	Versteeg H; Department of Cardiology, University Medical Centre Utrecht, Heidelberglaan 100, GA Utrecht, Utrecht, The Netherlands., Timmermans I; Department of Cardiology, University Medical Centre Utrecht, Heidelberglaan 100, GA Utrecht, Utrecht, The Netherlands.; Department of Medical and Clinical Psychology, CoRPS - Center of Research on Psychology in Somatic Diseases, Tilburg University, Tilburg, The Netherlands., Widdershoven J; Department of Medical and Clinical Psychology, CoRPS - Center of Research on Psychology in Somatic Diseases, Tilburg University, Tilburg, The Netherlands.; Department of Cardiology, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands., Kimman GJ; Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands., Prevot S; Department of Cardiology, Hôpital Privé Clairval, Marseille, France., Rauwolf T; Department of Cardiology and Angiology, Otto von Guericke University, Magdeburg, Germany., Scholten MF; Department of Cardiology, Medisch Spectrum Twente, Enschede, The Netherlands., Zitron E; Department of Cardiology, Universitätsklinikum Heidelberg, Heidelberg, Germany., Mabo P; Department of Cardiology, Centre Hospitalier Universitaire, Rennes, France., Denollet J; Department of Medical and Clinical Psychology, CoRPS - Center of Research on Psychology in Somatic Diseases, Tilburg University, Tilburg, The Netherlands.; Department of Cardiology, Antwerp University Hospital, Edegem, Belgium., Pedersen SS; Department of Psychology, University of Southern Denmark, Odense, Denmark.; Department of Cardiology, Odense University Hospital, Odense, Denmark., Meine M; Department of Cardiology, University Medical Centre Utrecht, Heidelberglaan 100, GA Utrecht, Utrecht, The Netherlands.
Jazyk:	angličtina
Zdroj:	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 [Europace] 2019 Sep 01; Vol. 21 (9), pp. 1360-1368.
DOI:	10.1093/europace/euz140
Abstrakt:	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.ClinicalTrials.gov Identifier: NCT01691586. (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)
Databáze:	MEDLINE
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