Follow-up After Percutaneous Device Closure of Ventricular Septal Defects

Outcomes and Short-term Follow-up After Percutaneous Device Closure of Ventricular Septal Defects: A Study From Two Tertiary Pediatric Cardiac Care Centers in Upper Egypt

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Cardiology; VSD
• Intervention / Treatment: Device: • Amplatzer™ Ductal Occluder (ADO) • Amplatzer™ Muscular VSD Occluder • Amplatzer™ Membranous VSD Occluder

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.

• Study Type: Observational
• Enrollment (Estimated): 85

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Paediatric patients (age ≤18 years) undergoing percutaneous device closure of VSDs at the participating centres

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success rate	To evaluate the procedural success rate and immediate safety of percutaneous device closure of VSDs in paediatric patients.	baseline
Assess short-term complications	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	baseline
Predictors of success and complications	To evaluate clinical, echocardiographic outcomes and compare predictors of success and complications between the two tertiary centres	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Closure of VSD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No