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© 2025 Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Introduction

Updated primary prevention strategies are needed for post-infarction sudden cardiac death (SCD) based on implantable cardioverter-defibrillator (ICD). Current recommendations, based on left ventricular systolic function and functional class, may be obsolete because they are derived from ancient studies that do not incorporate the potential benefit of either current comprehensive treatment of ischaemic heart disease or modern device programming. Among patients with post-infarction left ventricular dysfunction, modern implantable cardiac monitoring devices (ICM) allow a unique opportunity to determine in real-time the burden of non-sustained ventricular tachycardias and their relationship to the subsequent occurrence of sustained or symptomatic events.

Methods and analysis

Approximately 200 patients with left ventricular ejection fraction (LVEF) equal to or less than 40% after acute myocardial infarction will be included in the study. They will be implanted with a Confirm RX, an ICM with real-time remote connection via a smartphone. At 6 months, LVEF and functional status will be re-evaluated and cardiac morpho-functional characterisation will be performed by MRI. At this time, and following current European guidelines, patients with an indication will receive an ICD; the others will continue to be monitored using an ICM for a minimum of 2 years. Patients are expected to be followed up for 4 years after the index event. More than 20 000 remote transmissions are expected to be analysed. The study will focus on the relationship between the detection of non-sustained ventricular tachycardias by ICMs (defined as at least 8 R-R intervals at 160 beats per minute) and the subsequent occurrence of symptomatic arrhythmic events. An advanced statistical analysis will be performed using machine and deep learning techniques to determine the clinical variables, those that are derived from monitoring and imaging tests and related to mid-term prognosis.

Ethics and dissemination

The study was approved by the Ethical Committee of the University Hospital of Salamanca (protocol number PI 2019 03 246) on 30 April 2020. Each patient will be informed about the study in both oral and written form by a physician and will be included in the study after written consent is obtained.

For the first time, a study will provide real-time information on the arrhythmic burden of patients with post-infarction ventricular dysfunction and its prognostic implications in the medium term. Several publications in scientific journals are planned.

Trial registration number

NCT04765943.

Details

Title
Prospective study of continuous rhythm monitoring in patients with early post-infarction systolic dysfunction: clinical impact of arrhythmias detected by an implantable cardiac monitoring device with real-time transmission—the TeVeO study protocol
Author
Hernandez-Hernandez, Jesus 1 ; Cruz-Galban, Alba 2 ; Duran-Bobin, Olga 3 ; Garcia-Seara, Javier 4 ; Gonzalez-Ferrero, Teba 5 ; Morinigo, Jose 6 ; González-Juanatey, Carlos 5 ; Sanchez-Garcia, Manuel 2 ; Fernandez-Palacios, Gonzalo 7 ; Seijas-Amigo, Jose 8 ; Elices, Juliana 5 ; Portales-Fernandez, Javier 9 ; Martin-Herrero, Francisco 6 ; García-Campos, Ana 4 ; Perez-Rivera, Jose A 7 ; Martin-Garcia, Ana 10 ; Alonso-Fernandez-Gatta, Marta 11 ; Macías, Alfonso 12 ; Perez-Espejo, Paloma 9 ; Garcia-Fernandez, Javier 7 ; Sanchez, Pedro L 13 ; Jimenez-Candil, Javier 14   VIAFID ORCID Logo 

 Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain 
 Cardiology, IBSAL-Hospital Universitario de Salamanca, Salamanca, Spain 
 Cardiology, Hospital Universitario de Lugo, Lugo, Spain; Hospital General Universitario Nuestra Señora del Prado, Talavera de la Reina, Spain 
 Hospital Clínico Universitario de Santiago de Compostela Servicio de Cardiología, Santiago De Compostela, Spain; Instituto de Investigación Biomédica de Santiago de Compostela, Spain (IDIS-SERGAS), Santiago de Compostela, Spain 
 Cardiology, Hospital Universitario de Lugo, Lugo, Spain 
 Cardiology, IBSAL-Hospital Universitario de Salamanca, Salamanca, Spain; Medicine, Universidad de Salamanca, Salamanca, Spain 
 Hospital Universitario de Burgos, Burgos, Castilla y León, Spain 
 Hospital Clínico Universitario de Santiago de Compostela Servicio de Cardiología, Santiago De Compostela, Spain 
 Hospital Universitario de Caceres, Caceres, Spain 
10  Medicine, Universidad de Salamanca, Salamanca, Spain; Cardiology, Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain; CIBERCV, Madrid, Comunidad de Madrid, Spain 
11  Cardiology, IBSAL-Hospital Universitario de Salamanca, Salamanca, Spain; CIBERCV, Madrid, Comunidad de Madrid, Spain 
12  Hospital General Universitario Nuestra Señora del Prado, Talavera de la Reina, Spain 
13  Cardiology, IBSAL-Hospital Universitario de Salamanca, Salamanca, Spain; Medicine, Universidad de Salamanca, Salamanca, Spain; CIBERCV, Madrid, Comunidad de Madrid, Spain 
14  Medicine, Universidad de Salamanca, Salamanca, Spain; CIBERCV, Madrid, Comunidad de Madrid, Spain; Cardiology, Hospital Universitario de Salamanca, Salamanca, CL, Spain 
First page
e094764
Section
Cardiovascular medicine
Publication year
2025
Publication date
2025
Publisher
BMJ Publishing Group LTD
e-ISSN
20446055
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3201682914
Copyright
© 2025 Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.