The Outcome of Percutaneous Balloon Pulmonary Valvuloplasty in Pediatrics

Not yet recruiting

• Conditions: Balloon Pulmonary Valvuloplasty in Pulmonary Valvular Stenosis

• Registration Number: NCT05748431
• Lead Sponsor: Assiut University

Brief Summary

evaluation the outcome of percutaneous balloon pulmonary valvuloplasty in children with valvular pulmonary stenosis at the Pediatric Cardiology Unit.

Detailed Description

Pulmonary valve stenosis (PS) is a heart valve disorder in which outflow of blood from the right ventricle of the heart is obstructed at the level of the pulmonic valve. Although most commonly diagnosed and treated in the pediatric population, individuals with more severe forms of PS are surviving into adulthood and require ongoing assessment and cardiovascular care. The prevalence of valvular pulmonary stenosis has been reported at 0.6 to 0.8 cases per 1000 live births. When associated with other congenital heart disorder, it occurs in approximately 50% of all born with some kind of congenital heart disease . Pulmonary stenosis can be due to isolated valvular (90%), subvalvular, or peripheral (supravalvular) obstruction, or it may be found in association with congenital heart disorders of some other kind .

Critical pulmonary stenosis (PS) is a life-threatening congenital heart disease which requires immediate treatment . Unlike older children with isolated PS, neonates with critical PS presents with severe cyanosis and the suprasystemic right ventricle (RV) pressure may result in RV dilatation and failure with severe tricuspid regurgitation (TR). Since the discovery of balloon pulmonary valvuloplasty (BPV), it has replaced surgical approach for relieving PS . Femoral vein is the most common venous access for BPV; however, crossing the pulmonary valve using this approach can be difficult, especially in the presence of severe TR and right chambers dilatation . This problem can be overcome by using transjugular approach, yet many operators are reluctant to use this method because of potential complications and lack of data reporting transjugular approach. Balloon pulmonary valvuloplasty (BPV) is a safe and effective treatment for isolated pulmonary valve stenosis . The optimal age or body size for elective BPV depends on an individual's pulmonary valve diameter, transpulmonary pressure gradient, and femoral vessel size. Selecting a balloon with an appropriate profile also affects outcomes. An ideal balloon catheter for BPV in younger, smaller patients would have a low profile with a short, round shoulder to lessen the risk of valvular or vascular injury . Balloon pulmonary valvuloplasty provides long-term relief of stenosis of the pulmonary valve in the majority of patients with moderate to severe pulmonary valve stenosis.

Study Timeline

• Study First Submitted: 2022-08-23
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-27
• Last Update Submitted: 2023-02-27
• Study First Posted: 2023-02-28
• Last Update Posted: 2023-02-28
• Study Start: 2023-03
• Primary Completion: 2023-03
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Children with valvular pulmonary stenosis confirmed by Echocardiography, and managed with percutaneous balloon pulmonary valvuloplasty

Exclusion Criteria

• Cases with pulmonary stenosis not candidate for balloon valvuloplasty Cases with pulmonary stenosis associated with other congenital heart diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the outcome of percutaneous ballon pulmonary valvuloplasty in children with pulmonary valvular stenosis at the pediatric cardiology unit	3 years	Evaluation depend on Echocariography measurement of pressure gradient pre and post valvuloplasty for about 100 cases of children up to 6 years in the pediatric cardiology y