Closure of patent ductus arteriosus in children small infants and premature babies with Amplatzer duct occluder II additional sizes multicenter study

Abstract

Objectives: To evaluate safety and efficacy of closure of patent ductus arteriosus (PDA) with Amplatzer duct occluder II Additional Sizes (ADO II AS) and to report early and midterm results of the device in children and very young symptomatic infants. Methods: Retrospective analysis of angiographic data of 60 children from four pediatric cardiology centers. Results: The median patient age and weight were 6.5 (0.5–168) months and 6.8 (1.19–57) kg, respectively. In the study, 26 children had a body weight of 6 kg. Of these 26 children, 9 had a body weight of 3 kg. The median narrowest diameter of PDA was 2 (1.2–4) mm. Ductal anatomy was Type A in 29, Type B in 2, Type C in 11, Type D in 1, and Type E in 16 patients, and a residual PDA after surgery in 1 patient. Closure with ADO II AS was achieved in 58 (96.6%) of 60 attempted cases. In two infants, the device was not released because of significant residual shunt. ADO II was used in one, and the other was sent to surgery. Complete closure was observed in all ADO II AS deployed children by the next day on echocardiography. Median follow-up was 12 (1–18) months. Neither death nor any major complications occurred. Conclusions: Our study shows that closure of medium and small sized PDA by using ADO II AS device is effective and safe in children. The use of the device will expand the field of application of PDA closure in small infants.