Congenital Heart Disease
Conditions
Keywords
Ventricular septal defect, Congenital heart disease, Outcome
Brief summary
Ventricular septal defects (VSD) are the most common cardiac congenital heart defect (about 1/3 of patients with congenital heart disease). VSD management is related to hemodynamics and anatomical localization and the occurrence of complications. Small perimembranous VSD without pulmonary hypertension and without significant left to right shunting are tolerated, whereas large VSD with pulmonary hypertension require early surgical management in the first months of life. The management uncertainties concern the medium-sized perimembranous VSD causing a significant left-right shunt but without pulmonary hypertension, which are of variable treatment (surgical correction, percutaneous treatment, medical or abstention). There are no recommendations or consensus on the preferred indication of a therapeutic attitude. The Pediatric and Congenital Cardiology Subsidiary, within the French Society of Cardiology, set up an observatory of perimembranous VSD with significant shunting, without pulmonary hypertension the objectives of this study are: * To study the incidence of cardiovascular events in perimembranous VSD and search for predictive anatomical markers of events. * To study the evolution of echocardiographic and functional data of patients having percutaneous or surgical closure compared to patient managed medically. This observatory will provide a better understanding of the therapeutic algorithm in the management of VSD with pulmonary overload without pulmonary hypertension.
Interventions
None listed
Sponsors
French Cardiology Society
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient at least 1 year old * Having a perimembranous VSD with pulmonary overload defined by a left-right shunt and a z-score of the left ventricular end-diastolic diameter\> = 2. * Consent for inclusion in the study was signed by the parents or legal guardian for minors, by the patient for the adults.
Exclusion criteria
* Congenital heart disease associated with membranous VSD * Stenosis of the left ventricular outflow tract (average gradient ≥20 mmHg) * Aortic insufficiency * sub-pulmonary stenosis (mean gradient ≥20 mmHg) * Tricuspid insufficiency ≥ 2/4 * History of cardiac surgery or cardiac interventional catheterization * Shunt right-left through the VSD * Pulmonary Arterial Hypertension defined on the data of a catheterization by PAPM\> = 25 mmHg and pulmonary vascular resistance\> = 3 UW.m² * Active infectious endocarditis * Cardiac insufficiency according to the ESC 2016 criteria, other than a symptomatology of pulmonary hyper flow during the first year of life. Heart failure is defined by the presence of clinical signs of heart failure associated with a structural or cardiac functional abnormality resulting in a decrease in cardiac output and / or an increase in filling pressures. * History of persistent or chronic atrial arrhythmia (atrial flutter, atrial tachycardia or chronic atrial fibrillation or requiring electrical cardioversion, drug therapy or endocavitary ablation) * History of sustained ventricular arrhythmia (duration\> = 30 seconds) * Complete BAV * Refusal of the patient or guardian to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Cardiovascular Events at 5 Years of Perimembranous VSD with pulmonary overload | 5 years of follow-up | The main criterion cardiovascular event is a composite criterion. At least 1 of the following criteria is required for the primary criterion to be met: * endocarditis, * aortic stenosis (mean gradient\> 20 mmHg) * aortic insufficiency * left ventricular outflow tract stenosis (mean gradient\> 20 mmHg) * tricuspid insufficiency ≥2 * surgery or cardiac interventional catheterization for an abnormality in relation to the VSD (other than simple closing) * persistent supraventricular arrhythmias, sustained ventricular arrhythmia, * stroke * Complete atrioventricular block (AVB) * Pulmonary Arterial Hypertension (PAH) * heart failure * cardiovascular deaths, * severe haemolysis (= requiring transfusion or interventional catheterization or surgical). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anatomical predictive elements of events at 5 years of follow-up. | 5 years of follow-up | The event criterion meets the same definition as the primary judgment criterion. The association between anatomical elements (size of the VSD, presence of aneurysm, diameter and depth of the aneurysm, septo-aortic angulation) and cardiovascular events will be studied. |
| Evolution of the left ventricular end diastolic diameter z-score one year after VSD closure | 1 year of follow-up | Evolution of the left ventricular end diastolic diameter z-score one year after VSD closure |
| Incidence of cardiovascular events of high-flow VSDs according to the different therapeutic options at 5 years of follow-up | 5 years of follow-up | Incidence of cardiovascular events of high-flow VSDs according to the different therapeutic options (medical - percutaneous closure - surgical closure) at 5 years of follow-up. The event criterion meets the same definition as the primary judgment criterion. |
| Incidence of cardiovascular events of high-flow VSDs according to the different therapeutic options at 10 years of follow-up. | 10 years of follow-up | Incidence of cardiovascular events of high-flow VSDs according to the different therapeutic options (medical - percutaneous closure - surgical closure) at 10 years of follow-up. The event criterion meets the same definition as the primary judgment criterion. |
Countries
France
Outcome results
None listed