Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects

• Major adverse events [ Time Frame: till study end ] [ Designated as safety issue: Yes ]
  Major adverse events included but were not limited to death during or after the procedure because of complications of the procedure,cAVB requiring pacemaker implantation, thromboembolism, and new-onset valvular regurgitation requiring surgical repair.
  
  

• Minor adverse events [ Time Frame: Till study end ] [ Designated as safety issue: Yes ]
  Minor adverse events included but were not limited to groin hematoma, blood loss requiring transfusion, device embolization with transcatheter removal, any cardiac arrhythmia that required medication, new or increased valvular regurgitation less than two grades, hemolysis requiring medication, fever >38.5°C, rash, and loss of peripheral pulse. These minor adverse events required medical intervention but were not life threatening; they had no long-term sequelae and did not require long-term therapy.
  
  

Perimembranous Ventricular septal defect (VSD) is the most common congenital cardiac malformation and constitutes over 20% of all congenital cardiac disease. Though conventional surgery for VSD is a widely accepted procedure with minimal operative mortality, it carries a small but definite risk of morbidity and mortality associated with cardiopulmonary bypass and surgical closure. The newly appeared transcatheter device closure technique provides an alternative to surgical closure. However, the mid-to-long term effects of this technique using occluders is not clear. The aim of this study was to evaluate the safety and effectiveness of transcatheter closure of perimembranous ventricular septal defects using septal occluders.