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.
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Descrição detalhada
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.
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Age: 6 months to 18 years
- Confirmed diagnosis of VSD (perimembranous, muscular) by transthoracic echocardiography (TTE)
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
- Suitable anatomy for device closure as assessed by TTE and/or transesophageal echocardiography (TEE)
- Adequate rim (≥2mm) from VSD edges to cardiac valves and conduction system (for perimembranous VSDs)
- Written informed consent from parents/legal guardians
- Assent from children ≥ 12 years (as appropriate
Exclusion Criteria:
- Active endocarditis or systemic infection
- 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)
- Multiple VSDs not amenable to device closure
- VSD associated with complex congenital heart disease requiring surgical intervention
- Contraindication to antiplatelet therapy
- Known allergy to device materials (nickel-titanium alloy)
- Patient or family unwilling to comply with follow-up protocol
- Life expectancy <1 year due to non-cardiac conditions
- Body weight <5 kg (relative contraindication, case-by-case assessment)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Procedural success rate
Prazo: baseline
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To evaluate the procedural success rate and immediate safety of percutaneous device closure of VSDs in paediatric patients.
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baseline
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Assess short-term complications
Prazo: baseline
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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
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baseline
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Predictors of success and complications
Prazo: baseline
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To evaluate clinical, echocardiographic outcomes and compare predictors of success and complications between the two tertiary centres
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baseline
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Colaboradores e Investigadores
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Início do estudo
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Conclusão Primária
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Conclusão do estudo
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Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
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Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
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Termos relacionados a este estudo
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Outros números de identificação do estudo
- Closure of VSD
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