一项国际注册观察性研究的研究方案，该研究旨在评估经导管二尖瓣手术与标准外科二尖瓣手术治疗继发性二尖瓣反流的临床结局：TEERMISO研究

Study protocol for an international registry observational study evaluating clinical outcomes of transcatheter versus standard surgical mitral valve operation for secondary mitral regurgitation: the TEERMISO study.

作者信息

Nappi Francesco, Singh Sanjeet Singh Avtaar, Salsano Antonio, Spadaccio Cristiano, Shingu Yasushige, Wakasa Satoru, Fiore Antonio

机构信息

Department of Cardiac Surgery, Centre Cardiologique du Nord, Saint-Denis, France

Department of Cardiothoracic Surgery, Royal Infirmary of Edinburgh, Edinburgh, UK.

出版信息

BMJ Open. 2025 Jan 8;15(1):e086888. doi: 10.1136/bmjopen-2024-086888.

DOI:10.1136/bmjopen-2024-086888

PMID:39779262

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11749030/

Abstract

BACKGROUND

Secondary mitral regurgitation (SMR) is a condition affecting the left ventricle (LV) rather than the mitral valve (MV). If the MV remains structurally unchanged, enlargement of the LV or impairment of the papillary muscles can occur. Several mechanical interventions are available to dictate the resolution of MR. However, there is a lack of robust data to compare MV replacement, MV repair (including subvalvular repair) and transcatheter mitral valve procedures (TMVp). This study aims to compare the effectiveness and clinical outcomes of TMVp using the edge-to-edge mitral valve repair technique and standard surgical mitral valve procedures in patients with SMR.

METHODS AND ANALYSIS

Five cardiac surgery centres from four European countries and Japan have collaborated to create a multicentre observational registry (TEERMISO). The registry will enrol consecutive patients who underwent mechanical intervention for SMR between January 2007 and December 2023. The investigators assessed the difference between replacement and repair for both the standard surgical approach and the transcatheter procedure. The main clinical outcome will be the degree of LV remodelling as assessed by the Left Ventricular End-Diastolic Volume Index at 10 years. The study will measure several secondary endpoints, including all-cause mortality as the primary endpoint, followed by functional status, hospitalisation, neurocognition, physiological measures (echocardiographic assessment), adverse events and reoperation.

ETHICS AND DISSEMINATION

Ethics approval was obtained in Montpellier University Hospital on 24 May 2022 (Institutional Review Board Approval Number: IRB-MTP_2022_05_202201143). The results of the main study and each sub-analysis will be submitted for publication in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER

NCT05090540.

摘要

背景

继发性二尖瓣反流（SMR）是一种影响左心室（LV）而非二尖瓣（MV）的病症。如果二尖瓣结构保持不变，则可能发生左心室扩大或乳头肌功能受损。有几种机械干预措施可用于控制二尖瓣反流的解决。然而，缺乏有力的数据来比较二尖瓣置换术、二尖瓣修复术（包括瓣下修复）和经导管二尖瓣手术（TMVp）。本研究旨在比较采用缘对缘二尖瓣修复技术的经导管二尖瓣手术与标准外科二尖瓣手术治疗SMR患者的有效性和临床结局。

方法与分析

来自四个欧洲国家和日本的五个心脏外科中心合作创建了一个多中心观察性注册研究（TEERMISO）。该注册研究将纳入2007年1月至2023年12月期间因SMR接受机械干预的连续患者。研究人员评估了标准外科手术方法和经导管手术在置换和修复之间的差异。主要临床结局将是10年时通过左心室舒张末期容积指数评估的左心室重塑程度。该研究将测量几个次要终点，包括以全因死亡率作为主要终点，其次是功能状态、住院情况、神经认知、生理指标（超声心动图评估）、不良事件和再次手术。