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Cardiovascular events in perimembranous ventricular septal defect with left ventricular volume overload: a French
Lisa Guirgis1, Estibaliz Valdeolmillos2, Guy Vaksmann3
1Department of Pediatric and Adult Congenital Heart Diseases, Marie Lannelongue Hospital, Groupe Hospitalier Paris Saint-Joseph, centre de reference cardiopathies congénitales complexes M3C, université Paris-Sud, Le Plessis-Robinson, France.
Insights
The FRANCISCO study investigates long-term outcomes for children over 1 year old with perimembranous ventricular septal defects (pmVSD) and left ventricle overload. It compares treatment strategies to guide optimal management for this patient group.
Area of Science:
- Pediatric Cardiology
- Congenital Heart Disease
- Cardiovascular Research
Background:
- Management of pediatric perimembranous ventricular septal defect (pmVSD) with left ventricle (LV) volume overload and no pulmonary arterial hypertension (PAH) is controversial.
- Current therapeutic approaches include watchful waiting, surgical closure, and percutaneous closure.
- Long-term outcomes based on pmVSD anatomical characteristics and treatment strategy require further investigation.
Purpose of the Study:
- To investigate the long-term outcomes of pediatric patients with isolated pmVSD and LV volume overload.
- To compare outcomes based on different treatment strategies: watchful waiting, surgical closure, and percutaneous closure.
- To provide guidance for optimal treatment decisions in this specific population.
Main Methods:
- The FRANCISCO registry is a prospective, nationwide, multi-center observational cohort study.
- Enrolled patients are children over 1 year old with isolated pmVSD and LV volume overload, excluding prevalent complications.
- Data collected include clinical, echocardiographic, and functional parameters at baseline and at 1, 5, and 10 years. A core lab analyzes echocardiographic data for anatomical pmVSD features.
- The primary outcome is the 5-year incidence of cardiovascular events, with plans to enroll 200 patients.
Main Results:
- The study is ongoing and will provide long-term incidence data.
- Associations between anatomical pmVSD features, treatment strategy, and complication incidence will be assessed.
Conclusions:
- The FRANCISCO study will offer crucial long-term data on complications in pediatric pmVSD patients with LV volume overload.
- Results are anticipated to enhance evidence-based guidance for treatment decisions in this population.
Abstract:
The long-term prospective multi-centre nationwide (French) observational study FRANCISCO will provide new information on perimembranous ventricular septal defect with left ventricular overload but no pulmonary hypertension in children older than 1 year. Outcomes will be compared according to treatment strategy (watchful waiting, surgical closure, or percutaneous closure) and anatomic features of the defect. The results are expected to provide additional guidance about the optimal treatment of this specific population, which is unclear at present.
Background:
The management of paediatric isolated perimembranous ventricular septal defect (pmVSD) with left ventricle (LV) volume overload but no pulmonary arterial hypertension (PAH) remains controversial. Three therapeutic approaches are considered: watchful waiting, surgical closure, and percutaneous closure. We aim to investigate the long-term outcomes of these patients according to anatomic pmVSD characteristics and treatment strategy.
Methods:
The Filiale de Cardiologie Pediatrique et Congénitale (FCPC) designed the FRANCISCO registry, a long-term prospective nationwide multi-centre observational cohort study sponsored by the French Society of Cardiology, which enrolled, over 2 years (2018–2020), patients older than 1 year who had isolated pmVSD with LV volume overload. Prevalent complications related to pmVSD at baseline were exclusion criteria. Clinical, echocardiographic, and functional data will be collected at inclusion then after 1, 5, and 10 years. A core lab will analyse all baseline echocardiographic data to depict anatomical pmVSD features. The primary outcome is the 5-year incidence of cardiovascular events (infective endocarditis, sub-aortic stenosis, aortic regurgitation, right ventricular outflow tract stenosis, tricuspid regurgitation, PAH, arrhythmia, stroke, haemolysis, heart failure, or death from a cardiovascular event). We plan to enrol 200 patients, given the 10% estimated 5-year incidence of cardiovascular events with a 95% confidence interval of ±5%. Associations linking anatomical pmVSD features and treatment strategy to the incidence of complications will be assessed.
Conclusions:
The FRANSCICO study will provide the long-term incidence of complications in patients older than 1 year with pmVSD and LV volume overload. The results are expected to improve guidance for treatment decisions.
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