Transcatheter closure of perimembranous and intracristal ventricular septal defects with the shsma occluder

OBJECTIVES: The objective of this study was to evaluate the safety and efficacy of transcatheter closure of perimembranous ventricular septal defect (pmVSD) and intracristal VSD (icVSD) using the Shanghai Shape Memory Alloy (SHSMA) pmVSD occluder. BACKGROUND: There is still limited experience with transcatheter closure of pmVSD and icVSD. METHODS: Between January 2003 and September 2010, 348 patients with pmVSD and 47 patients with icVSD underwent transcatheter closure using a SHSMA pmVSD occluder. RESULTS: The total successful closure rate in pmVSD and icVSD subjects was 97.4 and 78.7%, respectively. During the perioperative period, no death, major bleeding or hemolysis occurred in both groups. In pmVSD group, one case of occluder dislodgement, one case of pericardial tamponade, and two cases of thromboembolism occurred. None in icVSD group had these complications. During a median of 3.2 years of follow-up, there was no evidence of significant residual shunt and device-related valve regurgitation. None in icVSD group and 10 patients (2.9%) in pmVSD group had a persistent arrhythmia. Overall, only one patient (0.3%) with pmVSD acquired complete atrioventricular block requiring implantation of a permanent pacemaker. The rim from the tricuspid valve to the defect < 4 mm was the only predictor of arrhythmic complications after procedure (OR = 4.24; P = 0.021). CONCLUSIONS: Transcatheter closure of pmVSD in selected patients using the SHSMA occluder is effective and safe. Transcatheter closure of icVSD in experienced hands using this device is also feasible and safe.