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

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.

Study Overview

• Status: Unknown
• Conditions: Mitral Valve Insufficiency
• Intervention / Treatment: Procedure: Posterior Mitral Annulus Elevation Technique; Procedure: Conventional Mitral Valve Repair

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 Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Placebo Comparator: Without Posterior Annulus Elevation Technique Group; No additional procedure will be done after conventional mitral valve repair	Procedure: Conventional Mitral Valve Repair; Conventional mitral valve repair in the pediatric patient using annuloplasty, leaflet resection and plication, sliding-plasty of chordae technique

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia

Study record dates

Study Major Dates

• Study Start (Anticipated): August 17, 2020
• Primary Completion (Anticipated): August 17, 2022
• Study Completion (Anticipated): August 17, 2022

Study Registration Dates

• First Submitted: August 2, 2020
• First Submitted That Met QC Criteria: August 16, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 16, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Posterior Annulus Elevation Technique; Pediatric Mitral Valve Insufficiency
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: NationalCCHK (Other Identifier: National Cardiac Center Harapan Kita)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No