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

National Cardiovascular Center Harapan Kita Hospital Indonesia

Status: Unknown

Conditions: Mitral Valve Insufficiency

Treatments: Procedure: Conventional Mitral Valve Repair; Procedure: Posterior Mitral Annulus Elevation Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT04518709

NationalCCHK

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with mitral regurgitation heart disease.
2. Patients with an age range of 1 day - 18 years
3. Patients with mitral regurgitation heart disease with atrial septal defects
4. Mitral valve repair surgery performed by single surgeon (Budi Rahmat, MD)

Exclusion criteria

1. Patients refuse to participate in the study.
2. Having additional cardiac abnormalities other than atrial septal defects that change the surgery plan.
3. Reoperation mitral valve surgery.
4. History of abnormalities in the central nervous system / preoperative stroke.
5. Patients with severe pulmonary hypertension
6. Patients with small left ventricles (LV smallish)
7. History of pulmonary resuscitation (CPR) before surgery.

Dropout Criteria

1. The patient fails to complete the entire examination procedure.
2. Mitral regurgitation patients who are decided to do mitral valve replacement intra-operatively.
3. Using extracorporeal life support (ECMO) device after surgery.
4. History of intra-operative CPR.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups, including a placebo group

Posterior Annulus Elevation Technique Group

Experimental group

Description:

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.

Treatment:

Procedure: Posterior Mitral Annulus Elevation Technique

Without Posterior Annulus Elevation Technique Group

Placebo Comparator group

Description:

No additional procedure will be done after conventional mitral valve repair

Treatment:

Procedure: Conventional Mitral Valve Repair