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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Procedural success rate
Zeitfenster: baseline
|
To evaluate the procedural success rate and immediate safety of percutaneous device closure of VSDs in paediatric patients.
|
baseline
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Assess short-term complications
Zeitfenster: 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
|
baseline
|
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Predictors of success and complications
Zeitfenster: baseline
|
To evaluate clinical, echocardiographic outcomes and compare predictors of success and complications between the two tertiary centres
|
baseline
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- Closure of VSD
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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