Follow-up After Percutaneous Device Closure of Ventricular Septal Defects

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство • Amplatzer™ Ductal Occluder (ADO) • Amplatzer™ Muscular VSD Occluder • Amplatzer™ Membranous VSD Occluder
  VSD closure

Первичные конечные точки

• Procedural success rate [Срок оценки: baseline]
• Assess short-term complications [Срок оценки: baseline]
• Predictors of success and complications [Срок оценки: baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07715032 · Closure of VSD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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