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

Part of: Interventional Cardiology

Published online by Cambridge University Press:  24 March 2022

Ming Chern Leong Open the ORCID record for Ming Chern Leong [Opens in a new window] ,
Boekhren Karyostyko Open the ORCID record for Boekhren Karyostyko [Opens in a new window] ,
Mohd Nor Hisham Ramli ,
Jason Weng Yew Tan Open the ORCID record for Jason Weng Yew Tan [Opens in a new window]  and
Mazeni Alwi
Ming Chern Leong*
Affiliation:
Paediatric & Congenital Heart Centre, Institut Jantung Negara (National Heart Institute), Kuala Lumpur, Malaysia
Boekhren Karyostyko
Affiliation:
Paediatric & Congenital Heart Centre, Institut Jantung Negara (National Heart Institute), Kuala Lumpur, Malaysia
Mohd Nor Hisham Ramli
Affiliation:
Paediatric & Congenital Heart Centre, Institut Jantung Negara (National Heart Institute), Kuala Lumpur, Malaysia
Jason Weng Yew Tan
Affiliation:
Paediatric & Congenital Heart Centre, Institut Jantung Negara (National Heart Institute), Kuala Lumpur, Malaysia
Mazeni Alwi
Affiliation:
Paediatric & Congenital Heart Centre, Institut Jantung Negara (National Heart Institute), Kuala Lumpur, Malaysia
*
Author for correspondence: M. C. Leong, Paediatric & Congenital Heart Centre, Institut Jantung Negara (National Heart Institute of Malaysia), 145, Jalan Tun Razak, 50400Kuala Lumpur, Malaysia. Tel: +603-26178470; Fax: +603 - 2694 6478. E-mail: mcleong@ijn.com.my
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Abstract

Background:

Ceraflex septal occluder and the Figulla atrial septal defect occluder have the advantage of a pivoting mechanism and softer device architecture. This study sought to examine the safety and efficacy of these occluders compared to the Amplatzer septal occluder.

Methods:

This was a retrospective study. Between January, 2013 and April, 2020, patients with at least 6 months of follow-up were included. Early and late-onset outcomes were examined.

Results:

Four hundred seven patients (range: 0.17–70.72 years; 53.1% >18 years; male: 29.2%) underwent atrial septal defect occlusion using Amplatzer septal occluder (n = 313), Ceraflex septal occluder (n = 36) and FSO (n = 58). A longer procedure time was observed in the Amplatzer septal occluder group. Early-onset complication rates in Amplatzer septal occluder, Ceraflex septal occluder and Figulla atrial septal defect occluder were 3.83%, 5.56% and 0%. Ten (2.46%) patients developed delayed complications (2.56%, 0% and 1.72% in the Amplatzer septal occluder, Ceraflex septal occluder and Figulla atrial septal defect occluder groups). Device erosion rate was not different between groups. The occlusion rates were comparable among all the devices.

Conclusion:

There is no significant difference in safety and efficacies between the novel atrial septal defect occluding devices compared to Amplatzer septal occluder.

Keywords

Atrial septal defectatrial septal occluderpivoting mechanismsafety and efficacy
Type
Original Article
Information
Cardiology in the Young , Volume 32 , Issue 10 , October 2022 , pp. 1621 - 1627
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Copyright
© The Author(s), 2022. Published by Cambridge University Press

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