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

Research output: Contribution to journalJournal articleResearchpeer-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.ClinicalTrials.gov Identifier: NCT01691586.

Original languageEnglish
JournalEuropace
Volume21
Issue number9
Pages (from-to)1360-1368
ISSN1099-5129
DOIs
Publication statusPublished - Sep 2019

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Implantable Defibrillators
Physiologic Monitoring
Linear Models
Medical Records
Clinical Trials

Keywords

  • Health status
  • Heart failure
  • Implantable cardioverter-defibrillator
  • Patient-reported outcomes
  • REMOTE-CIED
  • Remote monitoring

Cite this

Versteeg, Henneke ; Timmermans, Ivy ; Widdershoven, Jos ; Kimman, Geert-Jan ; Prevot, Sébastien ; Rauwolf, Thomas ; Scholten, Marcoen F ; Zitron, Edgar ; Mabo, Philippe ; Denollet, Johan ; Pedersen, Susanne S ; Meine, Mathias. / 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. In: Europace. 2019 ; Vol. 21, No. 9. pp. 1360-1368.
@article{73a87ba52cdc4215b42d547859c0044d,
title = "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",
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{\circledR} 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.",
keywords = "Health status, Heart failure, Implantable cardioverter-defibrillator, Patient-reported outcomes, REMOTE-CIED, Remote monitoring",
author = "Henneke Versteeg and Ivy Timmermans and Jos Widdershoven and Geert-Jan Kimman and S{\'e}bastien Prevot and Thomas Rauwolf and Scholten, {Marcoen F} and Edgar Zitron and Philippe Mabo and Johan Denollet and Pedersen, {Susanne S} and Mathias Meine",
year = "2019",
month = "9",
doi = "10.1093/europace/euz140",
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Versteeg, H, Timmermans, I, Widdershoven, J, Kimman, G-J, Prevot, S, Rauwolf, T, Scholten, MF, Zitron, E, Mabo, P, Denollet, J, Pedersen, SS & Meine, M 2019, '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', Europace, vol. 21, no. 9, pp. 1360-1368. https://doi.org/10.1093/europace/euz140

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

In: Europace, Vol. 21, No. 9, 09.2019, p. 1360-1368.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator

T2 - primary results of the REMOTE-CIED randomized trial

AU - Versteeg, Henneke

AU - Timmermans, Ivy

AU - Widdershoven, Jos

AU - Kimman, Geert-Jan

AU - Prevot, Sébastien

AU - Rauwolf, Thomas

AU - Scholten, Marcoen F

AU - Zitron, Edgar

AU - Mabo, Philippe

AU - Denollet, Johan

AU - Pedersen, Susanne S

AU - Meine, Mathias

PY - 2019/9

Y1 - 2019/9

N2 - 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.

AB - 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.

KW - Health status

KW - Heart failure

KW - Implantable cardioverter-defibrillator

KW - Patient-reported outcomes

KW - REMOTE-CIED

KW - Remote monitoring

U2 - 10.1093/europace/euz140

DO - 10.1093/europace/euz140

M3 - Journal article

C2 - 31168604

VL - 21

SP - 1360

EP - 1368

JO - Europace

JF - Europace

SN - 1099-5129

IS - 9

ER -