A 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

Background

Secondary mitral regurgitation (SMR) is a condition affecting the left ventricle (LV) rather than the mitral valve (MV). If the mitral valve (MV) remains structurally unchanged, enlargement of the left ventricle (LV) or impairment of the papillary muscles (PM) can occur. Several mechanical interventions are available to dictate the resolution of MR. However, there is a lack of robust data to compare mitral valve replacement, mitral valve 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 (TEER) technique and standard surgical mitral valve procedures (S-SMVp) 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 (IRB) 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. ClinicalTrials.gov ID: NCT05090540 ; IRB ID: 202201143. (Supplementary material)

Strengths and limitations of this study

• This study will be conducted as a large international registry concerning interventions to correct secondary mitral regurgitation; it will provide clinicians important information about transcatheter and surgical techniques in the specific field of the secondary mitral regurgitation.

• The primary outcome will offer opportunity to better predict left ventricular remodeling after the procedures.

• The secondary outcomes of this study will offer opportunity to provide important information abut survival

• The retrospective nature of the study is a limitation to the study design.