Rationale and design of the SafeHeart study: Development and testing of a mHealth tool for the prediction of arrhythmic events and implantable cardioverter-defibrillator therapy

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Standard

Rationale and design of the SafeHeart study: Development and testing of a mHealth tool for the prediction of arrhythmic events and implantable cardioverter-defibrillator therapy. / Frodi, Diana M.; Kolk, Maarten Z.h.; Langford, Joss; Andersen, Tariq O.; Knops, Reinoud E.; Tan, Hanno L.; Svendsen, Jesper H.; Tjong, Fleur V.y.; Diederichsen, Søren Z.

I: Cardiovascular Digital Health Journal, Bind 2, Nr. 6, 2021, s. S11-S20.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Harvard

Frodi, DM, Kolk, MZH, Langford, J, Andersen, TO, Knops, RE, Tan, HL, Svendsen, JH, Tjong, FVY & Diederichsen, SZ 2021, 'Rationale and design of the SafeHeart study: Development and testing of a mHealth tool for the prediction of arrhythmic events and implantable cardioverter-defibrillator therapy', Cardiovascular Digital Health Journal, bind 2, nr. 6, s. S11-S20. https://doi.org/10.1016/j.cvdhj.2021.10.002

APA

Frodi, D. M., Kolk, M. Z. H., Langford, J., Andersen, T. O., Knops, R. E., Tan, H. L., Svendsen, J. H., Tjong, F. V. Y., & Diederichsen, S. Z. (2021). Rationale and design of the SafeHeart study: Development and testing of a mHealth tool for the prediction of arrhythmic events and implantable cardioverter-defibrillator therapy. Cardiovascular Digital Health Journal, 2(6), S11-S20. https://doi.org/10.1016/j.cvdhj.2021.10.002

Vancouver

Frodi DM, Kolk MZH, Langford J, Andersen TO, Knops RE, Tan HL o.a. Rationale and design of the SafeHeart study: Development and testing of a mHealth tool for the prediction of arrhythmic events and implantable cardioverter-defibrillator therapy. Cardiovascular Digital Health Journal. 2021;2(6):S11-S20. https://doi.org/10.1016/j.cvdhj.2021.10.002

Author

Frodi, Diana M. ; Kolk, Maarten Z.h. ; Langford, Joss ; Andersen, Tariq O. ; Knops, Reinoud E. ; Tan, Hanno L. ; Svendsen, Jesper H. ; Tjong, Fleur V.y. ; Diederichsen, Søren Z. / Rationale and design of the SafeHeart study: Development and testing of a mHealth tool for the prediction of arrhythmic events and implantable cardioverter-defibrillator therapy. I: Cardiovascular Digital Health Journal. 2021 ; Bind 2, Nr. 6. s. S11-S20.

Bibtex

@article{06d6917d47a94e30910a542f0f00d649,
title = "Rationale and design of the SafeHeart study: Development and testing of a mHealth tool for the prediction of arrhythmic events and implantable cardioverter-defibrillator therapy",
abstract = "BackgroundPatients with an implantable cardioverter-defibrillator (ICD) are at a high risk of malignant ventricular arrhythmias. The use of remote ICD monitoring, wearable devices, and patient-reported outcomes generate large volumes of potential valuable data. Artificial intelligence–based methods can be used to develop personalized prediction models and improve early-warning systems.ObjectiveThe purpose of this study was to develop an integrated web-based personalized prediction engine for ICD therapy.MethodsThis international, multicenter, prospective, observational study consists of 2 phases: (1) a development study and (2) a feasibility study. We plan to enroll 400 participants with an ICD (with or without cardiac resynchronization therapy) on remote monitoring: 300 participants in the development study and 100 in the feasibility study. During 12-month follow-up, electronic health record data, remote monitoring data, accelerometry-assessed physical behavior data, and patient-reported data are collected. By using machine- and deep-learning approaches, a prediction engine is developed to assess the risk probability of ICD therapy (shock and antitachycardia pacing). The feasibility of the prediction engine as a clinical tool, the SafeHeart Platform, is assessed during the feasibility study.ResultsDevelopment study recruitment commenced in 2021. The feasibility study starts in 2022.ConclusionSafeHeart is the first study to prospectively collect a multimodal data set to construct a personalized prediction engine for ICD therapy. Moreover, SafeHeart explores the integration and added value of detailed objective accelerometer data in the prediction of clinical events. The translation of the SafeHeart Platform to clinical practice is examined during the feasibility study.",
author = "Frodi, {Diana M.} and Kolk, {Maarten Z.h.} and Joss Langford and Andersen, {Tariq O.} and Knops, {Reinoud E.} and Tan, {Hanno L.} and Svendsen, {Jesper H.} and Tjong, {Fleur V.y.} and Diederichsen, {S{\o}ren Z.}",
year = "2021",
doi = "10.1016/j.cvdhj.2021.10.002",
language = "English",
volume = "2",
pages = "S11--S20",
journal = "Cardiovascular Digital Health Journal",
issn = "2666-6936",
publisher = "Elsevier",
number = "6",

}

RIS

TY - JOUR

T1 - Rationale and design of the SafeHeart study: Development and testing of a mHealth tool for the prediction of arrhythmic events and implantable cardioverter-defibrillator therapy

AU - Frodi, Diana M.

AU - Kolk, Maarten Z.h.

AU - Langford, Joss

AU - Andersen, Tariq O.

AU - Knops, Reinoud E.

AU - Tan, Hanno L.

AU - Svendsen, Jesper H.

AU - Tjong, Fleur V.y.

AU - Diederichsen, Søren Z.

PY - 2021

Y1 - 2021

N2 - BackgroundPatients with an implantable cardioverter-defibrillator (ICD) are at a high risk of malignant ventricular arrhythmias. The use of remote ICD monitoring, wearable devices, and patient-reported outcomes generate large volumes of potential valuable data. Artificial intelligence–based methods can be used to develop personalized prediction models and improve early-warning systems.ObjectiveThe purpose of this study was to develop an integrated web-based personalized prediction engine for ICD therapy.MethodsThis international, multicenter, prospective, observational study consists of 2 phases: (1) a development study and (2) a feasibility study. We plan to enroll 400 participants with an ICD (with or without cardiac resynchronization therapy) on remote monitoring: 300 participants in the development study and 100 in the feasibility study. During 12-month follow-up, electronic health record data, remote monitoring data, accelerometry-assessed physical behavior data, and patient-reported data are collected. By using machine- and deep-learning approaches, a prediction engine is developed to assess the risk probability of ICD therapy (shock and antitachycardia pacing). The feasibility of the prediction engine as a clinical tool, the SafeHeart Platform, is assessed during the feasibility study.ResultsDevelopment study recruitment commenced in 2021. The feasibility study starts in 2022.ConclusionSafeHeart is the first study to prospectively collect a multimodal data set to construct a personalized prediction engine for ICD therapy. Moreover, SafeHeart explores the integration and added value of detailed objective accelerometer data in the prediction of clinical events. The translation of the SafeHeart Platform to clinical practice is examined during the feasibility study.

AB - BackgroundPatients with an implantable cardioverter-defibrillator (ICD) are at a high risk of malignant ventricular arrhythmias. The use of remote ICD monitoring, wearable devices, and patient-reported outcomes generate large volumes of potential valuable data. Artificial intelligence–based methods can be used to develop personalized prediction models and improve early-warning systems.ObjectiveThe purpose of this study was to develop an integrated web-based personalized prediction engine for ICD therapy.MethodsThis international, multicenter, prospective, observational study consists of 2 phases: (1) a development study and (2) a feasibility study. We plan to enroll 400 participants with an ICD (with or without cardiac resynchronization therapy) on remote monitoring: 300 participants in the development study and 100 in the feasibility study. During 12-month follow-up, electronic health record data, remote monitoring data, accelerometry-assessed physical behavior data, and patient-reported data are collected. By using machine- and deep-learning approaches, a prediction engine is developed to assess the risk probability of ICD therapy (shock and antitachycardia pacing). The feasibility of the prediction engine as a clinical tool, the SafeHeart Platform, is assessed during the feasibility study.ResultsDevelopment study recruitment commenced in 2021. The feasibility study starts in 2022.ConclusionSafeHeart is the first study to prospectively collect a multimodal data set to construct a personalized prediction engine for ICD therapy. Moreover, SafeHeart explores the integration and added value of detailed objective accelerometer data in the prediction of clinical events. The translation of the SafeHeart Platform to clinical practice is examined during the feasibility study.

U2 - 10.1016/j.cvdhj.2021.10.002

DO - 10.1016/j.cvdhj.2021.10.002

M3 - Journal article

C2 - 35265921

VL - 2

SP - S11-S20

JO - Cardiovascular Digital Health Journal

JF - Cardiovascular Digital Health Journal

SN - 2666-6936

IS - 6

ER -

ID: 301363049