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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:
This observatory will provide a better understanding of the therapeutic algorithm in the management of VSD with pulmonary overload without pulmonary hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perimembranous VSD with high pulmonary flow rate | It is an observational study, no intervention or examination will be realized for the sole purpose of the study. Patient management will be at the discretion of referral cardiologists according to the practices of the centers. As part of the usual follow-up of these patients, the participating centers collect the clinical and echocardiography data from inclusion and the following year, as well as data from a functional assessment at baseline and at one year. and the collection of cardiovascular events at 5 years and 10 years of follow-up. Data from a possible percutaneous or surgical closure procedure will be collected. The indication of VSD closure will be left to the discretion of participating centers. There will be no recommendation for percutaneous or surgical closure of VSD for the sole purpose of this observatory. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Cardiovascular Events at 5 Years of Perimembranous VSD with pulmonary overload | 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:
| 5 years of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Anatomical predictive elements of events at 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. | 5 years of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients who agreed to participate in the study, met the inclusion criteria, and treated in a French medical and surgical center with pediatric and congenital cardiology activity
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Chirurgical Marie Lannelongue | Le Plessis-Robinson | France | ||||
| Hopital Europeen Georges Pompidou |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21349577 | Background | Penny DJ, Vick GW 3rd. Ventricular septal defect. Lancet. 2011 Mar 26;377(9771):1103-12. doi: 10.1016/S0140-6736(10)61339-6. Epub 2011 Feb 23. | |
| 26844920 | Background | Karonis T, Scognamiglio G, Babu-Narayan SV, Montanaro C, Uebing A, Diller GP, Alonso-Gonzalez R, Swan L, Dimopoulos K, Gatzoulis MA, Li W. Clinical course and potential complications of small ventricular septal defects in adulthood: Late development of left ventricular dysfunction justifies lifelong care. Int J Cardiol. 2016 Apr 1;208:102-6. doi: 10.1016/j.ijcard.2016.01.208. Epub 2016 Jan 23. |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D006345 | Heart Septal Defects, Ventricular |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| Evolution of the left ventricular end diastolic diameter z-score one year after VSD closure | Evolution of the left ventricular end diastolic diameter z-score one year after VSD closure | 1 year of follow-up |
| Incidence of cardiovascular events of "high-flow" VSDs according to the different therapeutic options at 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. | 5 years of follow-up |
| Incidence of cardiovascular events of "high-flow" VSDs according to the different therapeutic options at 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. | 10 years of follow-up |
| Paris |
| France |
| Gh Sud Hopital Haut Leveque | Pessac | France |
| Chu Toulouse - Hopital Des Enfants | Toulouse | France |
| 26683488 | Background | Videbaek J, Laursen HB, Olsen M, Hofsten DE, Johnsen SP. Long-Term Nationwide Follow-Up Study of Simple Congenital Heart Disease Diagnosed in Otherwise Healthy Children. Circulation. 2016 Feb 2;133(5):474-83. doi: 10.1161/CIRCULATIONAHA.115.017226. Epub 2015 Dec 18. |
| 24413836 | Background | Odemis E, Saygi M, Guzeltas A, Tanidir IC, Ergul Y, Ozyilmaz I, Bakir I. Transcatheter closure of perimembranous ventricular septal defects using Nit-Occlud((R)) Le VSD coil: early and mid-term results. Pediatr Cardiol. 2014 Jun;35(5):817-23. doi: 10.1007/s00246-013-0860-8. Epub 2014 Jan 12. |
| 21648053 | Background | Chungsomprasong P, Durongpisitkul K, Vijarnsorn C, Soongswang J, Le TP. The results of transcatheter closure of VSD using Amplatzer(R) device and Nit Occlud(R) Le coil. Catheter Cardiovasc Interv. 2011 Dec 1;78(7):1032-40. doi: 10.1002/ccd.23084. Epub 2011 Jun 6. |
| 34551835 | Result | Guirgis L, Valdeolmillos E, Vaksmann G, Karsenty C, Houeijeh A, Hery E, Amedro P, Pangaud N, Benbrik N, Vastel C, Legendre A, Jalal Z, Hadeed K, Ladouceur M, Iserin L, Laux D, Iriart X, Warin Fresse K, Leobon B, Harchaoui S, Lambert V, Bonefoy R, Basquin A, Chalard A, Douchin S, Bouzguenda I, Denis C, Lucron H, Bosser G, Barre E, Urbina-Hiel B, Helms P, Ansquer H, Hauet Q, Leborgne AS, Cohen L, Lupoglazoff JM, Guirgis M, Gronier C, Maragnes P, Moceri P, Mauran P, Bertail C, Lefort B, Godart F, Baruteau AE, Ovaert C, Bonnet D, Combes N, Khraiche D, Houyel L, Thambo JB, Mostefa-Kara M, Hascoet S; FRANCISCO investigators. Cardiovascular events in perimembranous ventricular septal defect with left ventricular volume overload: a French prospective cohort study (FRANCISCO). Cardiol Young. 2021 Oct;31(10):1557-1562. doi: 10.1017/S1047951121002717. Epub 2021 Sep 23. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006343 | Heart Septal Defects |