The investigators' hypothesis is that CMR tissue characterization and myocardial function analysis acquired by CMR feature tracking technique predict reverse remodeling in patients with severe secondary mitral regurgitation (MR) undergoing transcatheter mitral edge-to-edge repair.
Diametrically opposed results of the COAPT- and the MITRA-FR trial have demonstrated the need for additional evidence in the field of transcatheter mitral edge-to-edge repair. Reverse left ventricular remodeling after treatment of severe secondary mitral regurgitation can indicate treatment response and is associated with positive outcomes. However, so far it is reverse remodeling, respectively treatment response is difficult to predict, which complicates patient selection for mitral edge-to-edge repair. Previous studies have shown, that focal (late gadolinium enhancement (LGE)) but not diffuse myocardial fibrosis (T1 mapping and extracellular volume fraction (ECV)) burden quantification using CMR predicts reverse left ventricular remodeling following cardiac resynchronization therapy in patients with heart failure with reduced ejection fraction (HFrEF). On the other hand, myocardial T1 mapping was predictive for beneficial left ventricular remodeling after long-term heart failure therapy. Furthermore, in patients with HFrEF, LGE is associated with clinical outcome and an incremental predictive value to left ventricular dimensions and function. However, as only 1/3 of HFrEF patients show LGE, subtle fibrosis might be missed. Recently the investigators have shown that different novel fibrosis detection techniques (naive T1 mapping, mean ECV and λGd being the delta of pre- and post T1 mapping and ECV calculation) all demonstrated strong association with outcome in patients with heart failure. The investigators' hypothesis is that these markers (CMR tissue characterization and myocardial function analysis acquired by a CMR feature tracking) might also be helpful in predicting reverse remodeling after transcatheter mitral edge-to-edge repair. This project might help to understand the pathophysiology of the disease in patients with secondary mitral regurgitation, improve risk stratification in this clinical setting, and optimize selection of patients who benefit from transcatheter mitral edge-to-edge repair.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
CMR image acquisition with previously mentioned analysis
Included patients will undergo Transcatheter mitral edge-to-edge repair.
Department of Cardiology, University Hospital Bern, Inselspital, Bern
Bern, Switzerland
RECRUITINGRate of patients with reverse remodeling after 12 months
Defined as ≥10% reduction in left ventricular end-diastolic volume in patients with successful MR reduction to grade 2+ or less 12 months after mitral edge-to-edge repair assessed by echocardiography.
Time frame: 12 months after mitral edge-to-edge repair
Rate of patients with procedural and device success
Procedural and device success as defined according to the criteria of the Mitral Valve Academic Research Consortium
Time frame: 24 months after mitral edge-to-edge repair
Rate of patients with reverse remodeling after 6 and 24 months
Reverse remodeling at 6 and 24 months, defined according to previously mentioned criteria.
Time frame: 6 and 24 months after mitral edge-to-edge repair
Change of left ventricular sphericity index
Echocardiographic assessment of LV sphericity index measured using the LV short/long axis dimension ratio in the end-diastolic four-chamber apical view.
Time frame: 6, 12 and 24 months after mitral edge-to-edge repair
Change in NT-proBNP levels
Change in NT-proBNP levels as an indirect sign of changes in left ventricular filling pressure, fibrosis and reverse remodeling will be measured in clinically indicated follow-ups at different time points after the intervention.
Time frame: 6, 12 and 24 months after mitral edge-to-edge repair
All cause death
Occurence of death from any cause
Time frame: 6, 12 and 24 months after mitral edge-to-edge repair
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DIAGNOSTIC
Masking
NONE
Enrollment
300
Cardiovascular death
Occurence of death from cardiovascular reason
Time frame: 6, 12 and 24 months after mitral edge-to-edge repair
Rate of patients with heart-failure related hospitalization
Hospitalizations for heart failure within the observation time will be systematically recorded.
Time frame: 6, 12 and 24 months after mitral edge-to-edge repair
Change in NYHA class
Change in NYHA class ≥ +/- 1 compared to baseline NYHA-class before mitral edge-to-edge repair.
Time frame: 6, 12 and 24 months after mitral edge-to-edge repair
Change in myocardial strain
Clinically indicated follow-up imaging (CMR) will be analyzed by CMR feature tracking
Time frame: Within 24 months after mitral edge-to-edge repair
Change in left ventricular ejection fraction
Echocardiographic assessment of left ventricular ejection fraction measured according to biplane Simpson disk summation method.
Time frame: 6, 12 and 24 months after mitral edge-to-edge repair