Fritz Celina, Engelhardt Andrea, Grohmann Jochen, Dähnert Ingo, Hummel Johanna, Tanase Daniel, Ewert Peter, Eicken Andreas
Department of Congenital Heart Disease and Pediatric Cardiology, German Heart Center Munich, Technical University of Munich, Munich, Germany.
Department of Congenital Heart Disease and Pediatric Cardiology, University Heart Center Freiburg-Bad Krozingen, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Cardiovasc Diagn Ther. 2022 Aug;12(4):475-484. doi: 10.21037/cdt-21-798.
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 ASD occluder for interventional closure of secundum ASD with a 6-month follow-up (FU).
Procedure specific data was collected on patients considered for ASD closure with the CeraFlex 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.
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 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 Three patients had withdrawn their study-participation and one patient had moderate residual shunt, but not related to the occluder.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.
Catheter interventional closure of secundum ASDs with the CeraFlex ASD occluder was feasible, safe and effective in this study.
在过去几十年中，继发孔房间隔缺损（ASD）封堵的治疗策略和封堵器改良取得了显著进展。此前已证实ASD封堵装置的获批情况、疗效和安全性。本研究调查了LifeTech CeraFlex ASD封堵器介入封堵继发孔ASD并进行6个月随访（FU）的临床疗效和安全性。
收集了2016年4月至2019年12月期间在德国三个中心考虑使用CeraFlex封堵器进行ASD封堵的患者的特定手术数据。在装置封堵后、出院时及随访6个月时评估疗效和安全性。
103例患者中有102例（99%）达到主要终点（成功封堵ASD且无严重并发症）。2例患者发生装置栓塞（1例早期栓塞和1例晚期栓塞）。在对1例栓塞装置进行早期圈套器取出后，该ASD通过手术封堵，另1例晚期装置栓塞患者使用更大的CeraFlex封堵器封堵缺损。98例患者中有94例达到次要终点（6个月后的临床疗效），因为有4例患者出现新发心律失常。3例患者退出了研究，1例患者有中度残余分流，但与封堵器无关。31例患者出现不完全性右束支传导阻滞（iRBBB）。在最后一次随访时，只有17例患者仍有iRBBB，表明右心室有效容量负荷减轻。
在本研究中，使用CeraFlex ASD封堵器经导管介入封堵继发孔ASD是可行、安全且有效的。
