Primary mitral regurgitation (MR) is the most common valvular disease in western countries. The MR mechanism is often related to a mitral valve prolapse (MVP) defined as a single or bi-leaflet prolapse of at least 2 mm beyond the long-axis mitral annular plane. In recent years, several studies have identified a subtype of MVP patients at higher risk of ventricular arrhythmias (VA) and sudden cardiac death (SCD). The presence of regional myocardial replacement fibrosis (RMRF) has been shown as a risk marker of arrhythmic events (VA and SCD) in patients with MVP. RMRF can be identified using cardiac magnetic resonance (CMR) imaging with late gadolinium enhancement (LGE+). In these patients, fibrosis was found in the basal inferolateral myocardium and at the level of papillary muscles (PMs). This fibrosis is developed beyond the volume overload related to the MVP. It is probably linked to the mechanical stretch acting upon the valve and the neighboring left ventricle (LV) myocardium. RMRF is associated with a high degree of MR, with specific features of mitral valve apparatus (bi-leaflet prolapse with marked leaflet redundancy, mitral annulus abnormalities (i.e. Mitral-Annular Disjunction)), and more dilated LV. It is also independently associated with the occurrence of cardiovascular events. Mitral valve repair (MVr) is the gold standard treatment for primary Mitral Regurgitation. Very little data concerning the impact of preoperative RMRF on mitral valve surgery outcomes is available, and the impact of myocardial fibrosis on the postoperative left ventricle remodeling has not been studied so far. No previous study compares preoperative and postoperative fibrosis evolution. Thus, no data exists regarding the postoperative evolution of this fibrosis and its relationship with ventricular arrhythmic risk after valve surgery. Small observational studies have suggested that mitral valve surgery did not reduce the risk of ventricular arrhythmias in patients with bileaflet MVP. Finally, the mechanisms involved in the development of regional myocardial replacement fibrosis within the left ventricle myocardium during the natural history of MVP cannot be understood with current standard medical imaging tools. Numerical simulation technologies provide an innovative and in-vivo approach to assess the physical and pathological mechanisms causing this fibrosis. They can also be used to assess the changes in mitral valve and myocardium dynamics after surgical mitral valve repair procedures. A large consortium, involving physicians and scientists, has been created to address these questions to fulfil our objectives over a 4 year period (SIMR project).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
5
Patients will undergo 2 MRI exams: 1 MRI before surgical intervention (maximum 21 days before) and 1 MRI three months after surgery (+/- 14 days), with intravenous administration of gadolinium.
Hôpital Pneumologique et Cardiovasculaire Louis Pradel - Hospices Civils de Lyon - Groupement Hospitalier Est
Bron, France
Evolution of regional myocardial replacement fibrosis after surgery
Evolution of fibrosis mass within the left ventricle myocardium (assessed as Regional late gadolinium enhancement) on cardiac magnetic resonance (CMR) imaging at 3 months after surgery.
Time frame: at 3 months after surgery
Left ventricular volumes
Left ventricular volumes assessed by Cardiac Magnetic Resonance Imaging (MRI)
Time frame: day 0
Left ventricular volumes
Left ventricular volumes assessed by Cardiac Magnetic Resonance Imaging (MRI)
Time frame: at 3 months after surgery
left ventricular ejection fraction
Left ventricular function quantification is assessed by left ventricular ejection fraction in %. by Cardiac Magnetic Resonance Imaging (MRI)
Time frame: day 0
left ventricular ejection fraction
Left ventricular function quantification is assessed by left ventricular ejection fraction in %. by Cardiac Magnetic Resonance Imaging (MRI
Time frame: at 3 months after surgery
Extracellular volume
Extracellular volume is assessed by Cardiac Magnetic Resonance Imaging (MRI)
Time frame: day 0
Extracellular volume
Extracellular volume is assessed by Cardiac Magnetic Resonance Imaging (MRI)
Time frame: 3 months after surgery
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by Cardiac Magnetic Resonance Imaging (MRI)
Time frame: day 0
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by Cardiac Magnetic Resonance Imaging (MRI)
Time frame: at 3 months after surgery
Number of adverse events (AEs)
Post-operative safety is assessed by occurrence of adverse events (AEs) and serious adverse events (SAEs) at each of the follow-up times
Time frame: up to 12 months
Number of serious adverse events (SAEs)
Post-operative safety is assessed by occurrence of adverse events (AEs) and serious adverse events (SAEs) at each of the follow-up times
Time frame: up to 12 months
New York Heart Association (NYHA) score
Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
Time frame: at day 0
New York Heart Association (NYHA) score
Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
Time frame: at discharge from hospital (day 15)
New York Heart Association (NYHA) score
Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
Time frame: at 1 month after surgery
New York Heart Association (NYHA) score
Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
Time frame: at 3 months after surgery
New York Heart Association (NYHA) score
Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
Time frame: at 12 months after surgery
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Time frame: at day 0
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Time frame: at discharge from hospital (day 15)
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Time frame: at 1 month after surgery
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Time frame: at 3 months after surgery
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Time frame: at 12 months after surgery
end-diastolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time frame: at day 0
end-systolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time frame: at day 0
Left ventricular volume
assessed by transthoracic echocardiographic exam
Time frame: at day 0
end-diastolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time frame: at discharge from hospital (day 15)
end-systolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time frame: at discharge from hospital (day 15)
Left ventricular volume
assessed by transthoracic echocardiographic exam
Time frame: at discharge from hospital (day 15)
Left ventricular volume
assessed by transthoracic echocardiographic exam
Time frame: at 1 month after surgery
end-diastolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time frame: at 1 month after surgery
end-systolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time frame: at 1 month after surgery
Left ventricular volume
assessed by transthoracic echocardiographic exam
Time frame: at 12 months after surgery
end-diastolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time frame: at 12 months after surgery
end-systolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time frame: at 12 months after surgery
Left atrium volume
Left atrium volume are assessed by transthoracic echocardiographic exam
Time frame: at day 0
Left atrium volume
Left atrium volume are assessed by transthoracic echocardiographic exam
Time frame: at discharge from hospital (day 15)
Left atrium volume
Left atrium volume are assessed by transthoracic echocardiographic exam
Time frame: at 1 month after surgery
Left atrium volume
Left atrium volume are assessed by transthoracic echocardiographic exam
Time frame: at 12 months after surgery
area
area assessed by transthoracic echocardiographic exam
Time frame: at day 0
area
area assessed by transthoracic echocardiographic exam
Time frame: at discharge from hospital (day 15)
area
area assessed by transthoracic echocardiographic exam
Time frame: at 1 month after surgery
area
area assessed by transthoracic echocardiographic exam
Time frame: at 12 months after surgery
Mitral annulus diameter
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Time frame: at day 0
Mitral annulus diameter
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Time frame: at discharge from hospital (day 15)
Mitral annulus diameter
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Time frame: at 1 month after surgery
Mitral annulus diameter
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Time frame: at 12 months after surgery
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by transthoracic echocardiographic exam
Time frame: at day 0
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by transthoracic echocardiographic exam
Time frame: at discharge from hospital (day 15)
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by transthoracic echocardiographic exam
Time frame: at 1 month after surgery
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by transthoracic echocardiographic exam
Time frame: at 12 months after surgery
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