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

NCT ID: NCT04518709

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-17
• Study Completion Date: 2022-08-17

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.

Conditions

Mitral Valve Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Posterior Annulus Elevation Technique Group

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.

Group Type: EXPERIMENTAL

Posterior Mitral Annulus Elevation Technique

Intervention Type: PROCEDURE

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.

Without Posterior Annulus Elevation Technique Group

No additional procedure will be done after conventional mitral valve repair

Group Type: PLACEBO_COMPARATOR

Conventional Mitral Valve Repair

Intervention Type: PROCEDURE

Conventional mitral valve repair in the pediatric patient using annuloplasty, leaflet resection and plication, sliding-plasty of chordae technique

Interventions

Posterior Mitral Annulus Elevation Technique

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.

Intervention Type: PROCEDURE

Conventional Mitral Valve Repair

Conventional mitral valve repair in the pediatric patient using annuloplasty, leaflet resection and plication, sliding-plasty of chordae technique

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cardiovascular Center Harapan Kita Hospital Indonesia

OTHER

Sponsor Role: lead

Responsible Party

Budi Rahmat

Chief of Pediatric & Congenital Heart Surgery Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Budi Rahmat, MD

Role: CONTACT

budirahmat@gmail.com

+628128800076

Other Identifiers

NationalCCHK

Identifier Type: -

Identifier Source: org_study_id