Clinical analysis of transcatheter closure of perimembranous ventricular septal defects with occluders made in China.

BACKGROUND Results of perimembranous ventricular septal defects (pmVSD) transcatheter closure have been reported in the literature mostly using a Amplatzer VSD device. However, the data of percutaneous closure of pmVSD with VSD occluder (VSD-O) made in China are still limited. We sought to analyze safety, efficacy, and follow-up results of percutaneous closure of pmVSD with VSD-O made in China. METHODS Between February 2005 and June 2009, 78 patients underwent percutaneous closure of pmVSD at our institution. A VSD device made in China was used for all subjects. The safety and the efficacy of the VSD-O were investigated. RESULTS The average age at closure was 11 years (range 2.5 to 44 years). The attempt to place device was successful in 74 patients (94.9%). The average device size used was 8 mm (range 5 to 16 mm). No deaths occurred. Total occlusion rate was 62.8% at completion of the procedure, rising up to 87.2% at discharge and 99.0% during follow-up. A total of eight early complications occurred (10.3%), but in all subjects these were transient. The average follow-up period was 40.5 months. The most significant complication was complete atrioventricular block (cAVB) in the early phase (five subjects, 6.4%) and during the follow-up (1 subject, 1.3%), which saw no need for pacemaker implantation in six subjects. Cox proportional hazards regression analysis showed that the age was only the variable significantly associated with the occurrence of this complication during the procedure (P = 0.025; relative risk 0.22). The subjects who experienced this complication were less than five years old. CONCLUSIONS Percutaneous pmVSD closure used VSD-O made in China is associated with excellent success and closure rates, no mortality, and low morbidity. Longer follow-up data and improvements in device characteristics are needed to reduce the risk of cAVB.