Transcatheter Versus Surgical Closure of Ventricular Septal Defect: A Comparative Study
Heart Defects, Congenital
About this trial
This is an interventional treatment trial for Heart Defects, Congenital
Eligibility Criteria
Inclusion Criteria:
- Ventricular septal defect: All patients who have congenital VSD which require intervention and accepting the selected measure of intervention. Surgery closure for Perimembranous VSD which is not suitable for catheter closure, muscular VSD. Catheter closure for Perimembranous VSD with at least 4 mm distal from aortic valve, mid muscular, anterior muscular.
- Age: Pediatric age group with minimum age of 10 months to 18 years old.
- Gender: both males and females.
- Intervention classification: Elective.
- NYHA classification: I - III
- weight more than 8 Kg.
- left to right shunt with Qp/Qs more than 1.5.
Exclusion Criteria:
- Non-congenital VSD.
- severe pulmonary hypertension with right to left shunt.
- ischemic stroke
- hemorrhage stroke
- systemic thromboembolism
- heart failure
- rheumatic heart disease
- cardiac valvular abnormalities
- infective endocarditis
- high degree atrioventricular block
- atrial fibrillation, atrial flutter
- paroxysmal supraventricular tachycardia
- endocardial cushing syndome,
- Ebstein's anomaly
- hemodynamically significant atrial septal defect
- transposition of great vessels
- tetralogy of Fallot.
Sites / Locations
- Hamdy Singab
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Ventricular septal defect closure surgery
catheter closure of ventricular septal defect
Surgical closure would be done under general anesthesia, hypothermic cardiopulmonary bypass and cardioplegic arrest. Chest would be opened through standard median sternotomy Surgical techniques would be determined according to the nature of every defect and includes direct closure, patch closure which involves the use of autologous pericardium; however, polyethylene terephthalate (Dacron; C.R Bard, Haverhill, MA) and expanded polytetrafluoroethylene (Gore-Tex; W.L. Gore & Associates, Inc.,AZ) may be occasionally used. These patches are held with continuous or interrupted sutures. Direct closure (without a patch may be done for the very small defects.Most VSDs would be repaired through right atriotomy to avoid the the undesirable effects of the trans ventricular approach.
Under general anesthesia, patients will be fully heparinized (100IU/Kg) with follow up by activated clotting time. IntraoperativeTEE will be done for more detailed assessment of the defect size, relation to the surrounding structures especially the distance from the tricuspid and the aortic valve to guide the procedure and for proper assessment after device positioning yet before its release. Left ventricular angiogram will be done in LAO 60, cranial 30 projection to define location and size of the defect. Accordingly, proper selection of the device siz.