Clinical trial NCT04518709: The Effect of Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children
Official title: The Effect of Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mitral Valve Insufficiency
Keywords: Posterior Annulus Elevation Technique
Pediatric Mitral Valve Insufficiency
Lead sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 58
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Residual mitral valve regurgitation
timeFrame: 5 days after surgery
measure: Mitral valve coaptation area
timeFrame: Intraoperative
measure: Change of Haptoglobin at 3 months after surgery
timeFrame: Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery
measure: Change of Lactate dehydrogenase at 3 months after surgery
timeFrame: Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery
measure: Change of NT-proBNP at 3 months after surgery
timeFrame: Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: