使用植入式环形记录仪对射血分数降低的心力衰竭患者进行连续心律失常监测的评估：LINQ2-HF试验原理与方案

Evaluation of continuous arrhythmia monitoring using an implantable loop recorder in heart failure patients with a reduced ejection fraction: The LINQ2-HF trial rationale and protocol.

作者信息

Tateishi Ryo, Miyazaki Shinsuke, Yamao Kazuya, Negishi Miho, Honda Masaki, Omori Mari, Kanno Yoshinori, Kawamura Iwanari, Matsuda Yuji, Yamakami Yosuke, Goto Kentaro, Hirasawa Kensuke, Nishimura Takuro, Ochida Mie, Sugiyama Tomoyo, Tao Susumu, Umemoto Tomoyuki, Takigawa Masateru, Yonetsu Taishi, Maejima Yasuhiro, Hirakawa Akihiro, Sasano Tetsuo

机构信息

Department of Cardiovascular Medicine, Institute of Science Tokyo, Tokyo, Japan.

Department of Clinical Biostatistics, Institute of Science Tokyo, Tokyo, Japan.

出版信息

PLoS One. 2025 Aug 28;20(8):e0321604. doi: 10.1371/journal.pone.0321604. eCollection 2025.

DOI:10.1371/journal.pone.0321604

PMID:40875644

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12393711/

Abstract

INTRODUCTION

Heart failure with a reduced ejection fraction (HFrEF) is a common and serious condition often associated with atrial fibrillation (AF) and ventricular arrhythmias, leading to poor outcomes such as rehospitalizations and death. Detecting asymptomatic arrhythmias remains challenging, as traditional monitoring methods like 12-lead electrocardiograms (ECGs) or Holter ECGs are insufficient for continuous surveillance. This study aims to evaluate the utility of continuous arrhythmia monitoring using an implantable loop recorder (ILR) to detect asymptomatic arrhythmias in HFrEF patients, particularly for AF and ventricular tachycardia (VT).

METHODS AND ANALYSIS

This is a single-center, non-randomized exploratory study. Thirty-five patients with HFrEF (LVEF ≤ 40%) and no history of AF will receive ILR implants. Primary endpoints include the detection of new-onset AF lasting at least 6 minutes and sustained or non-sustained VT. Secondary endpoints include the identification of bradycardia, pauses, and other arrhythmias, along with cardiovascular outcomes such as death and hospitalization. Additionally, secondary endpoints will include arrhythmia treatments, including anticoagulation therapy, catheter ablation, and implant of therapy devices. Data will be collected via remote monitoring through the Medtronic CareLink system, with event rates estimated using Kaplan-Meier methods. Data collection will span three years, with analyses conducted in the first and third years.

CONCLUSION

The LINQ2-HF trial is designed to detect new-onset AF and VT in HFrEF patients using ILR, with the aim of informing future strategies for arrhythmia management in this population.

NAME OF THE REGISTRY

Japan Registry of Clinical Trials (jRCT).

TRIAL REGISTRY NUMBER

jRCTs032240593.

REGISTRATION DATA

https://jrct.niph.go.jp/en-latest-detail/jRCTs032240593.

摘要

引言

射血分数降低的心力衰竭（HFrEF）是一种常见且严重的病症，常与心房颤动（AF）和室性心律失常相关，会导致再次住院和死亡等不良后果。检测无症状心律失常仍然具有挑战性，因为传统的监测方法如12导联心电图（ECG）或动态心电图对于持续监测而言并不充分。本研究旨在评估使用植入式环路记录器（ILR）进行连续心律失常监测以检测HFrEF患者无症状心律失常的效用，特别是针对AF和室性心动过速（VT）。

方法与分析

这是一项单中心、非随机的探索性研究。35例HFrEF（左心室射血分数≤40%）且无AF病史的患者将接受ILR植入。主要终点包括检测持续至少6分钟的新发AF以及持续性或非持续性VT。次要终点包括识别心动过缓、停搏和其他心律失常，以及心血管结局如死亡和住院。此外，次要终点将包括心律失常治疗，如抗凝治疗、导管消融和治疗设备植入。数据将通过美敦力CareLink系统进行远程监测收集，事件发生率采用Kaplan-Meier方法估算。数据收集将持续三年，在第一年和第三年进行分析。