08 Aug 2019
Prospective concurrent head-to head comparison of three different types of nitinol occluder device for transcatheter closure of secundum ASD
EuroIntervention Journal
Previous comparisons between AMPLATZER septal occluders and other designs were retrospective, non-randomised, non-concurrent and involved fewer patients... A prospective concurrent head-to-head comparison of AMPLATZER (ASO), Cera (CSO) and Figulla (FSO) septal occluders was planned to study the patient outcomes.
The three occluders were serially allocated in a cycle of three to consecutively included patients. Demographic, procedural details and complications were analysed. After calculating a sample size of 122 patients in each group, additional patients were recruited to ensure at least 80% follow-up. Four hundred and fifty (450) consecutive patients equally divided among the three designs were comparable in all parameters. There were no major complications and procedural success was 99.6%. The defects and device sizes were similar in all groups; the delivery system was significantly smaller with the ASO. The FSO needed special deployment techniques less often and formed a cobra deformity more often, though this was not statistically significant. Patient outcome was similar among the groups at a follow-up of 12-47 months
Authors
S. Bhattacharjya, L. Sadasivan Pillai, V. Doraiswamy, R. Mysore Satyanarayana, R. Chandrasekaran, S. Pavithran1, K. Sivakumar