A multi-center trial on efficacy and safety of the LifeTech CeraFlex(TM) ASD occluder for transcatheter closure in patients with secundum atrial septal defects

BACKGROUND: The last decades have brought remarkable improvements in treatment strategy and occluder modification of secundum atrial septal defect (ASD) closure. Approval, efficacy and safety of ASD closure devices have previously been demonstrated. This study investigated the clinical efficacy and safety of the LifeTech CeraFlex(TM) ASD occluder for interventional closure of secundum ASD with a 6-month follow-up (FU). METHODS: Procedure specific data was collected on patients considered for ASD closure with the CeraFlex(TM) occluder between April 2016 and December 2019 in three German centers. Efficacy and safety were assessed after device closure, at discharge, and at 6-month FU. RESULTS: The primary endpoint (successful ASD closure without severe complications) was reached by 102/103 patients (99%). Device embolization occurred in two patients (one early and one late embolization). After early snare-retrieval of an embolized device, this ASD was closed surgically and in the other patient with late device embolization the defect was closed with a larger CeraFlex(TM) occluder. The secondary endpoint (clincal efficacy after 6 months) was reached by 94/98 patients since new onset of arrhythmia occurred in four patients. Three patients had withdrawn their study-participation and one patient had moderate residual shunt, but not related to the occluder. Incomplete right bundle branch block (iRBBB) was seen in 31 patients. At last FU only 17 patients had remaining iRBBB documenting effective volume unloading of the right ventricle. CONCLUSIONS: Catheter interventional closure of secundum ASDs with the CeraFlex(TM) ASD occluder was feasible, safe and effective in this study.