Henneke Versteeg1, Ivy Timmermans1,2, Jos Widdershoven2,3, Geert-Jan Kimman4, Sébastien Prevot5, Thomas Rauwolf6, Marcoen F Scholten7, Edgar Zitron8, Philippe Mabo9, Johan Denollet2,10, Susanne S Pedersen11,12, Mathias Meine1. 1. Department of Cardiology, University Medical Centre Utrecht, Heidelberglaan 100, GA Utrecht, Utrecht, The Netherlands. 2. Department of Medical and Clinical Psychology, CoRPS - Center of Research on Psychology in Somatic Diseases, Tilburg University, Tilburg, The Netherlands. 3. Department of Cardiology, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands. 4. Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands. 5. Department of Cardiology, Hôpital Privé Clairval, Marseille, France. 6. Department of Cardiology and Angiology, Otto von Guericke University, Magdeburg, Germany. 7. Department of Cardiology, Medisch Spectrum Twente, Enschede, The Netherlands. 8. Department of Cardiology, Universitätsklinikum Heidelberg, Heidelberg, Germany. 9. Department of Cardiology, Centre Hospitalier Universitaire, Rennes, France. 10. Department of Cardiology, Antwerp University Hospital, Edegem, Belgium. 11. Department of Psychology, University of Southern Denmark, Odense, Denmark. 12. Department of Cardiology, Odense University Hospital, Odense, Denmark.
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.ClinicalTrials.gov Identifier: NCT01691586. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
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 failurepatients 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 ICDpatients. 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.
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