The Effect of Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children

Study Overview
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Brief Summary
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The main problem in mitral valve repair surgery in children is the high number of postoperative residual lesions (49% of the total cases). Residual lesions after mitral valve repair are associated with morbidity and complications in the form of hemolysis and could affect the postoperative reverse remodeling process. Surgery techniques for mitral valve repair in children have fewer choices than adult patients because of the smaller and thinner valve structure. Besides, the weakness of the mitral valve repair technique that often occurs in large left ventricles with severe mitral regurgitation, after repairing with ring annuloplasty, there is usually a mild residual regurgitation due to posterior mitral leaflet that tends to become restrictive due to being attracted by the left ventricular wall that remains big. No technique has been found to overcome the problem of mitral regurgitation residuals that occur postoperatively. Therefore, by analyzing postoperative mitral valve structural abnormalities with conventional techniques, an additional posterior mitral valve elevation technique was designed to increase the area of coaptation between two leaves of the mitral valve so that the incidence of postoperative regurgitation lesions can be reduced.

Detailed Description
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The main problem in mitral valve repair surgery in children is the high number of postoperative residual lesions (49% of the total cases). Residual lesions after mitral valve repair are associated with morbidity and complications in the form of hemolysis and could affect the postoperative reverse remodeling process. Surgery techniques for mitral valve repair in children have fewer choices than adult patients because of the smaller and thinner valve structure. Besides, the weakness of the mitral valve repair technique that often occurs in large left ventricles with severe mitral regurgitation, after repairing with ring annuloplasty, there is usually a mild residual regurgitation due to posterior mitral leaflet that tends to become restrictive due to being attracted by the left ventricular wall that remains big. No technique has been found to overcome the problem of mitral regurgitation residuals that occur postoperatively. Therefore, by analyzing postoperative mitral valve structural abnormalities with conventional techniques, an additional posterior mitral valve elevation technique was designed. The posterior annulus elevation technique is a technique that is carried by lifting the posterior mitral annulus towards the cranial so that the posterior mitral leaflet can meet perfectly with the anterior mitral leaflet indicated by a larger coaptation area. This technique can be applied after repair with conventional techniques done optimally to reduce the possibility of postoperative residual lesions. The hypothesis in this study is that pediatric patients with mitral regurgitation who undergo mitral valve repair surgery with posterior annulus elevation techniques can reduce residual mitral regurgitation, improve clinical and metabolic outcomes of postoperative heart failure, and reduce the risk of postoperative hemolysis.

Official Title
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The Effect of Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children

Conditions
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Mitral Valve Insufficiency

Intervention / Treatment
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* Procedure: Posterior Mitral Annulus Elevation Technique
* Procedure: Conventional Mitral Valve Repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with mitral regurgitation heart disease. Patients with an age range of 1 day - 18 years Patients with mitral regurgitation heart disease with atrial septal defects Mitral valve repair surgery performed by single surgeon (Budi Rahmat, MD) Exclusion Criteria: Patients refuse to participate in the study. Having additional cardiac abnormalities other than atrial septal defects that change the surgery plan. Reoperation mitral valve surgery. History of abnormalities in the central nervous system / preoperative stroke. Patients with severe pulmonary hypertension Patients with small left ventricles (LV smallish) History of pulmonary resuscitation (CPR) before surgery. Dropout Criteria The patient fails to complete the entire examination procedure. Mitral regurgitation patients who are decided to do mitral valve replacement intra-operatively. Using extracorporeal life support (ECMO) device after surgery. History of intra-operative CPR.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Posterior Annulus Elevation Technique Group<br>In patients who were determined in the treatment group, after the conventional procedure for mitral valve repair was completed, a posterior mitral valve elevation technique will be performed. | Procedure: Posterior Mitral Annulus Elevation Technique<br>* Posterior mitral annulus elevation technique is performed using a large pledget and non-absorbable braided suture starting from the subvalvular section of the posterior mitral valve sutured to the ring annuloplasty (if in the process of repairing the mitral valve, ring implantation is performed; if without the use of ring annuloplasty, the suture is placed in the left atrial wall / supravalvular of PML), so that the posterior annulus is slightly attracted upward toward the cranial and the PML moves toward the center.<br>|
| Placebo Comparator: Without Posterior Annulus Elevation Technique Group<br>No additional procedure will be done after conventional mitral valve repair | Procedure: Conventional Mitral Valve Repair<br>* Conventional mitral valve repair in the pediatric patient using annuloplasty, leaflet resection and plication, sliding-plasty of chordae technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual mitral valve regurgitation | Residual mitral valve regurgitation is measured using transesophageal echocardiography and transthoracic echocardiography | 5 days after surgery | 
| Mitral valve coaptation area | Mitral valve coaptation area is measured using transesophageal echocardiography and transthoracic echocardiography | Intraoperative | 
| Change of Haptoglobin at 3 months after surgery | Serum haptoglobin level that indicated the presence of intravascular hemolysis is measured after the surgery | Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery | 
| Change of Lactate dehydrogenase at 3 months after surgery | Lactate dehydrogenase level that indicated the presence of intravascular hemolysis is measured after the surgery | Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery | 
| Change of NT-proBNP at 3 months after surgery | NTproBNP is a marker of acute heart failure and indicates the process of heart remodeling. | Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posterior Annulus Elevation Technique, Pediatric Mitral Valve Insufficiency