Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Aug;12(4):475-484.
doi: 10.21037/cdt-21-798.

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

Celina Fritz  1 , Andrea Engelhardt  1 , Jochen Grohmann  2 , Ingo Dähnert  3 , Johanna Hummel  2 , Daniel Tanase  1 , Peter Ewert  1 , Andreas Eicken  1
Affiliations

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

Celina Fritz et al. Cardiovasc Diagn Ther. 2022 Aug.

Abstract

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 CeraFlexTM 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 CeraFlexTM 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 CeraFlexTM 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 Three patients had withdrawn their study-participation and one patient had moderate residual shunt, but not related to the occluder.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 CeraFlexTM ASD occluder was feasible, safe and effective in this study.

Keywords: CeraFlexTM; Interventional closure; secundum atrial septal defect (secundum ASD); septal occluder.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://cdt.amegroups.com/article/view/10.21037/cdt-21-798/coif). The series “Current Management Aspects in Adult Congenital Heart Disease (ACHD): Part V” was commissioned by the editorial office without any funding or sponsorship. A Engelhardt and DT report grants from Medtronic and LifeTech. ID reports that he was paid by the German Heart Center a reimbursement. A Eicken reports that he has acted as proctor for LifeTech ASD-Occlusion. The authors have no other conflicts of interest to declare.

Figures

Figure 1
Figure 1
LifeTech CeraFlexTM ASD occluder. ASD, atrial septal defect.
Figure 2
Figure 2
Course of study.
See this image and copyright information in PMC

References

    1. Fuster V, Brandenburg RO, McGoon DC, et al. Clinical approach and management of congenital heart disease in the adolescent and adult. Cardiovasc Clin 1980;10:161-97. - PubMed
    1. Warnes CA, Williams RG, Bashore TM, et al. ACC/AHA 2008 guidelines for the management of adults with congenital heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Develop Guidelines on the Management of Adults With Congenital Heart Disease). Developed in Collaboration With the American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2008;52:e143-263. 10.1016/j.jacc.2008.10.001 - DOI - PubMed
    1. Alexi-Meskishvili VV, Konstantinov IE. Surgery for atrial septal defect: from the first experiments to clinical practice. Ann Thorac Surg 2003;76:322-7. 10.1016/S0003-4975(03)00508-3 - DOI - PubMed
    1. Hörer J, Eicken A, Müller S, et al. Risk factors for prolonged intensive care treatment following atrial septal defect closure in adults. Int J Cardiol 2008;125:57-61. 10.1016/j.ijcard.2007.02.022 - DOI - PubMed
    1. King TD, Thompson SL, Steiner C, et al. Secundum atrial septal defect. Nonoperative closure during cardiac catheterization. JAMA 1976;235:2506-9. 10.1001/jama.1976.03260490024013 - DOI - PubMed