Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation

Study Overview
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Brief Summary
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The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER). The key question of this study is to establish the difference in left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-systolic dimension(LVESD), all-cause and cause-specific (cardiac vs noncardiac) mortality in patients who received the TEER vs the standard surgical procedure for SMR.

Detailed Description
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The target population enrolled in the registry includes patients with moderate to severe secondary mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology who have had TEER or standard surgical procedure of their mitral valves with or without CABG. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, mitral regurgitation, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV. Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement and recipients of mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair. Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement, and those who received mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair

Official Title
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Transcatheter Edge to Edge Mitral Valve Repair Versus Standard Surgical Mitral Valve Operation for Secondadry Mitral Regurgitation

Conditions
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Severe Mitral Valve Regurgitation (Disorder)

Intervention / Treatment
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* Device: Trancatheter Edge to Edge Repair
* Procedure: Mitral Valve Replacement
* Procedure: Restrictive Mitral Annuloplastie
* Procedure: Restrictive Mitral Annuloplastie/Subvalvular Repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Ischemic NoIschemic cardiomyopathy EROA> 0,2 cm2 or Regurgitant Volume > 30 ml (ESC guidelines). EROA ≥ 0.4 cm2 with tethering (ACC/AHA) MR Grade 3/4 Eligible for TEE, surgical repair and replacement of mitral valve Coronary artery disease with or without the need for coronary revascularization Average value LVEDD 62 mm LVEF 42% Exclusion Criteria: Pediatric Any echocardiographic evidence of structural (chordal or leaflet) mitral-valve disease ruptured papillary

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

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 |
| --- | --- |
| Transcatheter Edge to Edge Repair<br>TEER procedure is performed by apposing the edges of the anterior and posterior leaflet (edge-to-edge) of MV. If the use of one MitraClip device does not result in sufficient reduction in mitral regurgitation, a second MitraClip device may be used to reduce MR optimizing the procedure. | Device: Trancatheter Edge to Edge Repair<br>* TEER is performed by apposing the edges of the anterior and posterior leaflet (edge-to-edge) of prolapsed MV. The patient may be under conscious sedation or general anesthesia, depending on hospital standard practice. The procedure is performed through femoral venous access and the inter-atrial septum is crossed using standard techniques. Trans-septal puncture allows MitraClip Steerable Guide Catheter (Guide) to advance so that the guide is positioned over the mitral valve. The MitraClip delivery catheter is advanced to the MitraClip device and emerges from the tip of the guide into the left atrium. The MitraClip device can now be opened and advanced through the MV in the LV. Once in the LV, it is pulled back to grasp the leaflets. Two-dimensional and/or 3-dimensional echocardiography and color Doppler are useful for evaluating the anatomical features of the mitral valve and directing the procedure until the double orifice is formed alongside evaluating residual mitral regurgitation<br>* Other names: Mitraclip procedure;|
| Mitral Valve Replacement<br>Mitral-valve replacement includes complete preservation of the subvalvular apparatus to avoid dilation of the left ventricle over time. The technique of preservation, type of prosthetic valve implanted, and technique of suture placement has been chosen according to the preference of the surgeons. In SMR due to ischemic cardiomyopathy, CABG operation(Revascularization) is required | Procedure: Mitral Valve Replacement<br>* Mitral valve replacement is performed using mechanical or biological prosthesis while preserving the subvalvular apparatus to avoid dilation of the left ventricle over time.<br>|
| Restrictive Mitral Annuloplasty<br>RMA may be performed with the use of complete rigid or semi-rigid annuloplasty ring which has been downsized for the annulus diameter. Since patients who received RMA have coronary artery lesions, a CABG operation is useful to ensure favorable remodeling of the left ventricle. | Procedure: Restrictive Mitral Annuloplastie<br>* Mitral valve repair consists of a restrictive mitral annuloplasty (RMA) using a prosthetic ring<br>* Other names: Undersizing Mitral Annuloplastie;|
| Restrictive Mitral Annuloplastie Plus Subvalvular Repair<br>RMA may be associated with the use of a subvalvular repair (SVR). The SVR permits the approximation or the relocation of papillary muscles which is displaced by post infarction scar formation. In patients who received SVR due to ischemic cardiomyopathy CABG operation is required | Procedure: Restrictive Mitral Annuloplastie/Subvalvular Repair<br>* RMA may be associated with the use of a subvalvular repair (SR). The SR permits the approximation or the relocation of papillary muscles which is displaced by post infarction scar formation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Reverse Remodelling | The primary end point of the study is the degree of left ventricular reverse remodeling, as assessed by means of the left ventricular end systolic dimension on the basis of transthoracic echocardiography | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Mortality | The secondary endpoint of the study is the evaluation of overall mortality | 5 years | 
| Cardiac Death | The secondary endpoint of the study is the evaluation of cardiac death | 5 years | 
| Major Adverse Cardiac or Cerebrovascular Events (MACCE) | Composite of major adverse cardiac or cerebrovascular events (rate of death, stroke, subsequent mitral valve surgery, hospitalization for heart failure, or an increase in New York Heart Association class higher than one), serious adverse events, recurrent mitral regurgitation, quality of life, and rehospitalization. | 5 years | 
| Echocardiographic Parameter Changes (LVEF) | Changes from baseline parameters including left ventricular ejection fraction | 5 years | 
| Echocardiographic Parameter Changes (recurrence) | Recurrent moderate-to-severe mitral regurgitation after intervention | 5 years | 
| Echocardiographic Parameter Changes (LVEDD) | Changes from baseline Left Ventricular End Diastolic Diameter | 5 years | 
| Echocardiographic Parameter Changes (Mitral Valve tenting area and height) | Changes from baseline tenting area and height | 5 years | 
| Echocardiographic Parameter Changes (Pulmonary artery systolic pressure) | Changes from baseline pulmonary artery systolic pressure | 5 years | 
| Echocardiographic Parameter Changes (anteroposterior mitral valve annular diameter) | Changes from baseline anteroposterior mitral valve annular diameter | 5 years | 
| Echocardiographic Parameter Changes ( interpapillary distance) | Changes from baseline distance between papillary muscles | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SMR; TEER; MVRpl; MVR; RMA; Subvalvular Repair