Hernandez-Hernandez Jesus, Cruz-Galban Alba, Duran-Bobin Olga, Garcia-Seara Javier, Gonzalez-Ferrero Teba, Morinigo Jose, González-Juanatey Carlos, Sanchez-Garcia Manuel, Fernandez-Palacios Gonzalo, Seijas-Amigo Jose, Elices Juliana, Portales-Fernandez Javier, Martin-Herrero Francisco, García-Campos Ana, Perez-Rivera Jose A, Martin-Garcia Ana, Alonso-Fernandez-Gatta Marta, Macías Alfonso, Perez-Espejo Paloma, Garcia-Fernandez Javier, Sanchez Pedro L, Jimenez-Candil Javier
Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain.
Cardiology, IBSAL-Hospital Universitario de Salamanca, Salamanca, Spain.
BMJ Open. 2025 May 2;15(5):e094764. doi: 10.1136/bmjopen-2024-094764.
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.
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.
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.
NCT04765943.
基于植入式心脏复律除颤器（ICD）的更新后的心肌梗死后心脏性猝死（SCD）一级预防策略是必要的。基于左心室收缩功能和功能分级的当前建议可能过时了，因为它们源自年代久远的研究，未纳入当前缺血性心脏病综合治疗的潜在益处或现代设备程控。在心肌梗死后左心室功能障碍患者中，现代植入式心脏监测设备（ICM）提供了一个独特的机会，可实时确定非持续性室性心动过速的负荷及其与随后发生的持续性或有症状事件的关系。
约200例急性心肌梗死后左心室射血分数（LVEF）等于或低于40%的患者将被纳入研究。他们将植入一台Confirm RX，这是一种可通过智能手机进行实时远程连接的ICM。在6个月时，重新评估LVEF和功能状态，并通过MRI进行心脏形态功能特征分析。此时，根据当前欧洲指南，有适应症的患者将接受ICD；其他患者将继续使用ICM监测至少2年。预计患者在索引事件后将随访4年。预计将分析超过20000次远程传输数据。该研究将聚焦于ICM检测到的非持续性室性心动过速（定义为每分钟160次心跳时至少8个R-R间期）与随后发生的有症状心律失常事件之间的关系。将使用机器学习和深度学习技术进行高级统计分析，以确定临床变量，即那些源自监测和影像学检查且与中期预后相关的变量。
该研究于2020年4月30日获得萨拉曼卡大学医院伦理委员会批准（方案编号PI 2019 03 246）。每位患者将由医生以口头和书面形式告知研究情况，并在获得书面同意后纳入研究。该研究将首次提供关于心肌梗死后心室功能障碍患者心律失常负荷及其中期预后意义的实时信息。计划在科学期刊上发表多篇论文。
NCT04765943。
