Update on the Amplatzer duct occluder: a 10-year experience in Asia.

Few data exist regarding the efficacy and safety of the Amplatzer ductal occluder (ADO) type 1 device in the Asian region. This retrospective study, conducted between August 2001 and April 2011, attempted device placement for 231 patients (165 females and 66 males) with a median age of 7.4 years (range, 3 months to 64 years) and an average weight of 19.4 kg (range, 4.1-81.0 kg). Among the patients in this study, 66 (28.6%) had pulmonary hypertension, ten (4.3%) had trisomy 21, and eight (3.5%) had other congenital cardiac anomalies. The mean narrowest patent ductus arteriosus (PDA) diameter was 4.2 mm (range, 1.3-10 mm), and the ampulla size was 9.6 mm (range, 4-20 mm). Successful implantation was achieved for 229 patients (99.1%). Complete angiographic occlusion was achieved for 201 patients (87.8%) at the end the procedure. Follow-up data were available for 129 patients (66%). At the follow-up assessment, complete echocardiographic occlusion was seen in 128 patients (99.2%) after 1 month and in 100% of the patients after 6 months. The significant morbidities involved one device embolization and one dislodgment, for which surgical retrieval was performed. No mortalities occurred during the study period, and no late clinical adverse events occurred during the follow-up period. Occlusion of the PDA using ADO is safe, effective, and applicable for a wide range of PDA sizes including large PDAs in small symptomatic infants and in adults. Good outcomes can be attributed to experience of the operators, proper patient selection, and appropriate device size selection.