Pediatric Cardiology, VSD
Conditions
Brief summary
Ventricular septal defects (VSDs) are the most common congenital heart defects, accounting for 30-40% of congenital cardiac anomalies. They result from an abnormal opening in the interventricular septum, leading to left-to-right shunting. Clinical presentation depends on defect size and pulmonary vascular resistance, ranging from asymptomatic small defects to heart failure symptoms in infancy, with older children developing exercise intolerance or pulmonary hypertension. Although surgical closure has long been the standard treatment, percutaneous transcatheter device closure has emerged as a less invasive alternative for selected VSD types, particularly muscular and suitable perimembranous defects. This approach offers comparable efficacy with reduced morbidity and shorter hospital stays. This bicentric study aims to evaluate procedural success, complications, and short-term outcomes of percutaneous VSD closure in paediatric patients from Upper Egypt, providing essential data to guide clinical practice and quality improvement in tertiary cardiac centres.
Detailed description
Ventricular septal defects (VSDs) are the most common congenital heart defects, accounting for 30-40% of congenital cardiac anomalies. They result from an abnormal opening in the interventricular septum, leading to left-to-right shunting. Clinical presentation depends on defect size and pulmonary vascular resistance, ranging from asymptomatic small defects to heart failure symptoms in infancy, with older children developing exercise intolerance or pulmonary hypertension. Diagnosis is primarily established by transthoracic echocardiography, which accurately defines defect anatomy, shunt severity, ventricular function, and pulmonary artery pressures. Management is individualized according to hemodynamic significance, with small asymptomatic defects managed conservatively and significant defects requiring intervention following initial medical therapy. Although surgical closure has long been the standard treatment, percutaneous transcatheter device closure has emerged as a less invasive alternative for selected VSD types, particularly muscular and suitable perimembranous defects. This approach offers comparable efficacy with reduced morbidity and shorter hospital stays. Recent studies report high procedural success rates (95-98%) using evolving device technologies, including Amplatzer™ and newer asymmetric occluders. However, outcome data from developing regions remain limited, highlighting the need for population-specific evidence. This bicentric study aims to evaluate procedural success, complications, and short-term outcomes of percutaneous VSD closure in paediatric patients from Upper Egypt, providing essential data to guide clinical practice and quality improvement in tertiary cardiac centres.
Interventions
VSD closure
Sponsors
Study design
Eligibility
Inclusion criteria
1. Age: 6 months to 18 years 2. Confirmed diagnosis of VSD (perimembranous, muscular) by transthoracic echocardiography (TTE) 3. Hemodynamically significant VSD with: (Imtiaz et al., 2023) * Pulmonary blood flow (Qp) to Systemic blood flow (Qs) ≥1.5:1, OR * Evidence of left ventricular volume overload, OR * Pulmonary arterial hypertension (PAH) with reversible pulmonary vascular resistance 4. Suitable anatomy for device closure as assessed by TTE and/or transesophageal echocardiography (TEE) 5. Adequate rim (≥2mm) from VSD edges to cardiac valves and conduction system (for perimembranous VSDs) 6. Written informed consent from parents/legal guardians 7. Assent from children ≥ 12 years (as appropriate
Exclusion criteria
1. Active endocarditis or systemic infection 2. Fixed, irreversible pulmonary arterial hypertension (pulmonary vascular resistance \>8 Wood units/m² or ratio of pulmonary vascular resistance (Rp) to systemic vascular resistance (Rs) \>0.5) 3. Multiple VSDs not amenable to device closure 4. VSD associated with complex congenital heart disease requiring surgical intervention 5. Contraindication to antiplatelet therapy 6. Known allergy to device materials (nickel-titanium alloy) 7. Patient or family unwilling to comply with follow-up protocol 8. Life expectancy \<1 year due to non-cardiac conditions 9. Body weight \<5 kg (relative contraindication, case-by-case assessment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success rate | baseline | To evaluate the procedural success rate and immediate safety of percutaneous device closure of VSDs in paediatric patients. |
| Assess short-term complications | baseline | To assess short-term complications, including residual shunts, rhythm disturbances (especially AV block), and device-related adverse events during follow-up up to 6 months |
| Predictors of success and complications | baseline | To evaluate clinical, echocardiographic outcomes and compare predictors of success and complications between the two tertiary centres |