Transcatheter closure of perimembranous ventricular septal defects (VSD) with VSD occluder: early and mid-term results.

Results of perimembranous ventricular septal defects (pmVSD) transcatheter closure have been reported in the literature, mostly with the Amplatzer VSD device (muscular or eccentric) (AGA Medical Corp., Golden Valley, MN, USA). However, the data of percutaneous closure of pmVSD with VSD occluder (VSD-O) made in China are still limited. We sought to analyze the safety, efficacy, and follow-up results of percutaneous closure of pmVSD with VSD-O made in China. Seventy-eight patients underwent percutaneous closure of pmVSD at our institution between February 2005 and June 2007. A VSD device made in china (Huayishengjie Medical Corp., Beijing, China) was used in all subjects. The mean age at closure was 11 years (range 2.5-44 years). The attempt to place the device was successful in 74 patients (94.9%). The median device size used was 8 mm (range 5-16 mm). No deaths occurred. Total occlusion rate was 62.8% at completion of the procedure, rising to 87.2% at discharge and 99% during the follow-up. A total of eight early complications occurred (10.3%), but in all subjects these were transient. The median follow-up was 32 months. The most significant complication was complete atrioventricular block (cAVB) in the early phase (five subjects, 6.4%) and during the follow-up (one subject, 1.3%), and there was no need for pacemaker implantation in six subjects. Logistic regression analysis showed that the only variable significantly associated with the occurrence of this complication was age at the time of the procedure (p = 0.025; OR 0.22). All subjects experiencing this problem were <5 years old. Percutaneous pmVSD closure used VSD-O made in China is associated with excellent success and closure rates, no mortality, and low morbidity. Nowadays, pmVSD percutaneous closure is a valuable alternative to surgery. Longer follow-up data and improvements in device characteristics are needed to reduce the risk of cAVB.