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.
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
Study Type
OBSERVATIONAL
Enrollment
600
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
Mitral valve replacement is performed using mechanical or biological prosthesis while preserving the subvalvular apparatus to avoid dilation of the left ventricle over time.
Mitral valve repair consists of a restrictive mitral annuloplasty (RMA) using a prosthetic ring
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.
Francesco Nappi
Saint-Denis, France
Centre Cardiologique Du Nord
Saint-Denis, France
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
Time frame: 5 years
Overall Mortality
The secondary endpoint of the study is the evaluation of overall mortality
Time frame: 5 years
Cardiac Death
The secondary endpoint of the study is the evaluation of cardiac death
Time frame: 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.
Time frame: 5 years
Echocardiographic Parameter Changes (LVEF)
Changes from baseline parameters including left ventricular ejection fraction
Time frame: 5 years
Echocardiographic Parameter Changes (recurrence)
Recurrent moderate-to-severe mitral regurgitation after intervention
Time frame: 5 years
Echocardiographic Parameter Changes (LVEDD)
Changes from baseline Left Ventricular End Diastolic Diameter
Time frame: 5 years
Echocardiographic Parameter Changes (Mitral Valve tenting area and height)
Changes from baseline tenting area and height
Time frame: 5 years
Echocardiographic Parameter Changes (Pulmonary artery systolic pressure)
Changes from baseline pulmonary artery systolic pressure
Time frame: 5 years
Echocardiographic Parameter Changes (anteroposterior mitral valve annular diameter)
Changes from baseline anteroposterior mitral valve annular diameter
Time frame: 5 years
Echocardiographic Parameter Changes ( interpapillary distance)
Changes from baseline distance between papillary muscles
Time frame: 5 years
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