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

Not Applicable

• Conditions: Mitral Valve Insufficiency
• Interventions: Procedure: Conventional Mitral Valve Repair; Procedure: Posterior Mitral Annulus Elevation Technique

• Registration Number: NCT04518709
• Lead Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-02
• Study First Submitted QC: 2020-08-16
• Last Update Submitted: 2020-08-16
• Study Start: 2020-08-17
• Study First Posted: 2020-08-19
• Last Update Posted: 2020-08-19
• Primary Completion: 2022-08-17
• Study Completion: 2022-08-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without Posterior Annulus Elevation Technique Group	Conventional Mitral Valve Repair	No additional procedure will be done after conventional mitral valve repair
Posterior Annulus Elevation Technique Group	Posterior Mitral Annulus Elevation Technique	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.

Primary Outcome Measures

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