The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Procedure: The papillary muscle approximation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic cardiomyopathy, Ischemic mitral regurgitation. Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PMA+MVA+CABG<br>patients with ischemic cardiomyopathy and mitral regurgitation who underwent coronary artery bypass grafting, mitral annuloplasty, and papillary muscles approximation. | Procedure: The papillary muscle approximation<br>* Surgery is performed through median sternotomy, aortic and bicaval cannulation, normothermic perfusion, and antegrade cardioplegia with the use of cardioplegic solution. After coronary anastomosis, the mitral valve is exposed by a transseptal incision. The papillary muscles are approximated through the mitral valve at the level of papillary muscles heads. Nonabsorbable, braided sutures of 2-0 (Ethibond, Ethicon, Inc.) with PTFE felt pledgets are used for this purpose. Annuloplasty mitral rings of different sizes are anchored using multiple deep U-shaped stitches of Ethibond 2-0 (Ethicon, Inc., USA). After MV repair, the LV is forcefully filled with saline water to test the valve competence. After satisfactory hydraulic test walls of the heart chambers are sutured.<br>|
| MVA+CABG<br>patients with ischemic cardiomyopathy who underwent coronary artery bypass grafting and mitral valve annuloplasty. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitral regurgitation severity (1,2 or 3) | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-diastolic volume (ml), end-systolic volume (ml), stroke volume (ml) | Assessment of left ventricular dimensions. | 1 year | 
| Ejection fraction (%) | Assessment of myocardial contractility. | 1 year | 
| Systolic interpapillary muscle distance (mm), diastolic interpapillary muscle distance (mm), coaptation depth (mm), coaptation length (mm) | Assessment of the impact of the surgery on the mitral valve configuration. | 1 year | 
| Tenting area (mm^2) | Assessment of the impact of the surgery on the configuration of the mitral valve. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Papillary muscles approximation