Initial Experience with the Nit-Occlud ASD-R: Short-Term Results.

Abstract

We aim to assess the safety, feasibility and efficacy of the new Nit-Occlud ASD-R (NOASD-R) device. From 2014 to 2015, transcatheter closure of atrial septal defect (ASD) using the NOASD-R was performed in 30 consecutive patients. The standard deployment technique as the left upper pulmonary vein approach was used in 25 patients. Right upper pulmonary vein approach was required in five. The median age was 6years (range 3.5-60years), and median weight was 21.5kg (14-79kg). Implantation was successful in all patients. The median size of devices was 16mm (12.0-26.0mm). The mean device size/2D defect diameter ratio was 1.26±0.09 (1.12-1.40). The mean device size/color flow diameter ratio was 1.07±0.06 (range 1.0-1.22). Releasing problem was encountered in three patients. A device-related erosion on the day after the closure was observed in one patient. No further device-related complication (erosion, embolization or dislodgement of the device) was encountered in a median follow-up period of 10months (range 2-14months). Complete occlusion has occurred in all at follow-up. NOASD-R is a feasible and effective device for use in the transcatheter occlusion of moderate to large secundum ASDs in selected patients. The occurrence of the erosion on the right atrial roof may be due to the high localization of the device and the larger size of the right disk.