The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation
- Conditions
- Mitral Regurgitation
- Interventions
- Procedure: The papillary muscle approximation
- Registration Number
- NCT03038204
- Lead Sponsor
- The Federal Centre of Cardiovascular Surgery, Russia
- Brief Summary
Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these procedures is the papillary muscles approximation. However, the safety and the positive impact of this method are still in doubt.
- Detailed Description
Ischemic mitral regurgitation develops in 10-50% of patients after myocardial infarction. Among several surgical procedures, mitral ring annuloplasty has been the method of choice for a considerable period. However, mitral regurgitation recurrence after surgery has a reported occurrence that ranges from 5% to 58%. Careful consideration of the mechanisms underlying recurrence of mitral regurgitation after annuloplasty might explain the unsatisfactory outcomes. The pathophysiology of IMR is complex and results from the imbalance between closing and tethering forces acting on the mitral valve. Enlargement of the left ventricular chamber, and displacement of papillary muscles in apical and lateral direction increase the tethering forces. Left ventricular and papillary muscle dyssynchrony, reduced myocardial contractility decrease closing forces, which lead to impaired leaflet coaptation and appearance of mitral regurgitation. Thus, treatment of mitral insufficiency requires an integrated approach affecting all units of the pathogenesis of MR recurrence.
Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these procedures is the papillary muscles approximation. However, the safety and the positive impact of this method are still in doubt. This study is conducted to identify the positive qualities and safety of this technique.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Ischemic cardiomyopathy,
- Ischemic mitral regurgitation.
- Degenerative mitral valve disease,
- Unstable angina,
- Recent myocardial infarction (< 6 months),
- Papillary muscles rupture,
- Severe right ventricular dysfunction,
- Multiple organ failures,
- Concomitant left ventricular reconstruction,
- Aortic valve procedures.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PMA+MVA+CABG The papillary muscle approximation patients with ischemic cardiomyopathy and mitral regurgitation who underwent coronary artery bypass grafting, mitral annuloplasty, and papillary muscles approximation.
- Primary Outcome Measures
Name Time Method Mitral regurgitation severity (1,2 or 3) 1 year Mitral regurgitation severity is the main indicator of the effectiveness of mitral valve plasty. Evaluation of mitral regurgitation was performed in accordance with the recommendations of the American Society of Echocardiography (ASE). Recurrence of mitral regurgitation 2 and more was considered as significant.
- Secondary Outcome Measures
Name Time Method Systolic interpapillary muscle distance (mm), diastolic interpapillary muscle distance (mm), coaptation depth (mm), coaptation length (mm) 1 year Assessment of the impact of the surgery on the mitral valve configuration.
End-diastolic volume (ml), end-systolic volume (ml), stroke volume (ml) 1 year Assessment of left ventricular dimensions.
Ejection fraction (%) 1 year Assessment of myocardial contractility.
Tenting area (mm^2) 1 year Assessment of the impact of the surgery on the configuration of the mitral valve.