The Ceraflex and Figulla atrial septal occluders: early and intermediate-term safety and efficacy study

Leong, Ming Chern; Borhanuddin, Boekren K.; Ramli, Mohd Nor Hisham; Tan, Jason Weng Yew; Alwi, Mazeni

doi:10.1017/s1047951121004728

Cited by 2 publications

(1 citation statement)

References 18 publications

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“…This is a German prospective multi-center trial evaluating the efficacy and safety of the LifeTech CeraFlex TM ASD occluder for transcatheter closure in patients with secundum ASD. Unique strengths of this trial compared to published studies (12,13,16) are a prospective multicenter study design and sample size of more than 100 patients that underwent ASD closure with the LifeTech CeraFlex TM ASD occluder. The results of this intention to treat analysis demonstrate efficient and safe ASDO and extend these positive results to the first visit 6 months after ASDO.…”

Section: Discussionmentioning

confidence: 99%

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

Fritz¹,

Engelhardt²,

Grohmann³

et al. 2022

Cardiovasc Diagn Ther

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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.

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Section: Discussionmentioning

confidence: 99%

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

Fritz¹,

Engelhardt²,

Grohmann³

et al. 2022

Cardiovasc Diagn Ther

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An Up-to-Date Narrative Review on Congenital Heart Disease Percutaneous Treatment in Children Using Contemporary Devices

et al. 2022

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Background: Congenital heart pathology has a significant burden regarding morbidity and mortality in the pediatric population. Several transcatheter interventions and devices have been designed as an alternative to surgical repair. Percutaneous interventions have been proven to yield good results in most cases but with less stress and trauma than that attributed to surgical treatment, especially in frail pediatric patients. We aimed to review the literature and to investigate the feasibility and efficacy of transcatheter interventions and implantable devices for congenital heart disease management in children. Methods: We performed a search in Scopus and MEDLINE databases using prespecified keywords to retrieve clinical studies published between 2000 and 2021. Results: This article provides an up-to-date review regarding the applicability of interventional techniques in simple inter-atrial or inter-ventricular defects, and in challenging congenital defects, such as hypoplastic left heart syndrome, tetralogy of Fallot, or coronary artery fistula. Furthermore, we reviewed recent indications for defibrillator and cardiac resynchronization therapy, and new and promising devices currently being tested. Conclusion: Transcatheter treatment represents a feasible and efficient alternative to surgical repair of congenital heart defects. Novel devices could extend the indications and possibilities of percutaneous interventions in pediatric patients with congenital heart diseases.

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The Ceraflex and Figulla atrial septal occluders: early and intermediate-term safety and efficacy study

Cited by 2 publications

References 18 publications

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

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

An Up-to-Date Narrative Review on Congenital Heart Disease Percutaneous Treatment in Children Using Contemporary Devices

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