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

Mitral Valve Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04518709
• Other study ID #: NationalCCHK
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: August 17, 2022

Study information

• Verified date: August 2020
• Source: National Cardiovascular Center Harapan Kita Hospital Indonesia
• Contact: Budi Rahmat, MD
• Phone: +628128800076
• Email: budirahmat[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: August 17, 2022
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cardiovascular Center Harapan Kita Hospital Indonesia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual mitral valve regurgitation	Residual mitral valve regurgitation is measured using transesophageal echocardiography and transthoracic echocardiography	5 days after surgery
Primary	Mitral valve coaptation area	Mitral valve coaptation area is measured using transesophageal echocardiography and transthoracic echocardiography	Intraoperative
Primary	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
Primary	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
Primary	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