Mitral Regurgitation
Conditions
Keywords
Papillary muscles approximation
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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Ejection fraction (%) | 1 year | Assessment of myocardial contractility. |
| 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. |
| Tenting area (mm^2) | 1 year | Assessment of the impact of the surgery on the configuration of the mitral valve. |
| End-diastolic volume (ml), end-systolic volume (ml), stroke volume (ml) | 1 year | Assessment of left ventricular dimensions. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body mass index (kg/m^2) | 1 year | Description and comparison of groups of patients. |
| Body surface area (m^2) | 1 year | Description and comparison of groups of patients. |
| NYHA (I, II, III or IV) | 1 year | Description and comparison of groups of patients. |
| EuroSCORE | 1 year | Description and comparison of groups of patients. |
| Six minute walk test (m) | 1 year | Description and comparison of groups of patients. |
| Hypertension (absence, stage 1, 2 or 3) | 1 year | Description and comparison of groups of patients. Impact of the factor on the long-term survival. |
| Diabetes mellitus (absence, insulin-dependent or noninsulin-dependent) | 1 year | Description and comparison of groups of patients. Impact of the factor on the long-term survival. |
| Obesity (absence, class 1, 2 or 3) | 1 year | Description and comparison of groups of patients. Impact of the factor on the long-term survival. |
| Multifocal atherosclerosis (presence or absence) | 1 year | Description and comparison of groups of patients. Impact of the factor on the long-term survival. |
| COPD (absence, GOLD 1, 2, 3 or 4) | 1 year | Description and comparison of groups of patients. Impact of the factor on the long-term survival. |
| Age (years) | 1 year | Description and comparison of groups of patients |