Transcatheter Closure of Atrial Septal Defect with Carag Bioresorbable Septal Occluder™: First-in-Child Experience with 12-MonthFollow-Up

Background. Nowadays, transcatheter device closure of an atrial septal defect (ASD) is a standard approach in children. Potential early and long-term side effects or complications related to the metal framework of the devices are a known issue. A bioresorbable device such as the Carag Bioresorbable...

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Main Authors: Alessia Callegari, Daniel Quandt, Johannes Nordmeyer, Stephan Schubert, Peter Kramer, Walter Knirsch, Oliver Kretschmar
Format: Article
Language:English
Published: Hindawi-Wiley 2022-01-01
Series:Journal of Interventional Cardiology
Online Access:http://dx.doi.org/10.1155/2022/3476398
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author Alessia Callegari
Daniel Quandt
Johannes Nordmeyer
Stephan Schubert
Peter Kramer
Walter Knirsch
Oliver Kretschmar
author_facet Alessia Callegari
Daniel Quandt
Johannes Nordmeyer
Stephan Schubert
Peter Kramer
Walter Knirsch
Oliver Kretschmar
author_sort Alessia Callegari
collection DOAJ
description Background. Nowadays, transcatheter device closure of an atrial septal defect (ASD) is a standard approach in children. Potential early and long-term side effects or complications related to the metal framework of the devices are a known issue. A bioresorbable device such as the Carag Bioresorbable Septal Occluder™ (CBSO) could resolve such complications. Material and Results. The Carag Bioresorbable Septal Occluder™ (CBSO; Carag AG, Baar, Switzerland) is a self-centering double disk, repositionable, and retractable device with a bioresorbable framework (polylactic-co-glycolic acid), which is almost completely resorbed by 18–24 months postimplantation. This manuscript reports the four first-in-child ASD device closures using a CBSO. The patients’ age was median (IQ1-IQ3), 4.5 years (4–7.25). Weight was 21.3 kg (17.6–32.7). We demonstrated procedural feasibility and safety. Effective defect closure with the device was 100%. Echocardiographic measurements of the thickness of the interatrial septum did not show any relevant increase over a 12-monthfollow-up period. There were no residual defects found after the procedure or later during the resorption process. The patients showed no evidence of any local or systemic inflammatory reaction. Conclusions. The CBSO device system could offer a new treatment option for transcatheter ASD device closure in the pediatric and adult fields. In our first-in-child experience, it was effectively and safely implanted. During the first 12 months of follow-up, no complications occurred.
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spelling doaj.art-b77c2faaaece498991fc16f94507657f2023-01-09T01:30:18ZengHindawi-WileyJournal of Interventional Cardiology1540-81832022-01-01202210.1155/2022/3476398Transcatheter Closure of Atrial Septal Defect with Carag Bioresorbable Septal Occluder™: First-in-Child Experience with 12-MonthFollow-UpAlessia Callegari0Daniel Quandt1Johannes Nordmeyer2Stephan Schubert3Peter Kramer4Walter Knirsch5Oliver Kretschmar6Division of Pediatric Cardiology, Pediatric Heart Center, and Children’s Research CenterDivision of Pediatric Cardiology, Pediatric Heart Center, and Children’s Research CenterDepartment for Congenital Heart Disease/Pediatric CardiologyDepartment for Congenital Heart Disease/Pediatric CardiologyDepartment for Congenital Heart Disease/Pediatric CardiologyDivision of Pediatric Cardiology, Pediatric Heart Center, and Children’s Research CenterDivision of Pediatric Cardiology, Pediatric Heart Center, and Children’s Research CenterBackground. Nowadays, transcatheter device closure of an atrial septal defect (ASD) is a standard approach in children. Potential early and long-term side effects or complications related to the metal framework of the devices are a known issue. A bioresorbable device such as the Carag Bioresorbable Septal Occluder™ (CBSO) could resolve such complications. Material and Results. The Carag Bioresorbable Septal Occluder™ (CBSO; Carag AG, Baar, Switzerland) is a self-centering double disk, repositionable, and retractable device with a bioresorbable framework (polylactic-co-glycolic acid), which is almost completely resorbed by 18–24 months postimplantation. This manuscript reports the four first-in-child ASD device closures using a CBSO. The patients’ age was median (IQ1-IQ3), 4.5 years (4–7.25). Weight was 21.3 kg (17.6–32.7). We demonstrated procedural feasibility and safety. Effective defect closure with the device was 100%. Echocardiographic measurements of the thickness of the interatrial septum did not show any relevant increase over a 12-monthfollow-up period. There were no residual defects found after the procedure or later during the resorption process. The patients showed no evidence of any local or systemic inflammatory reaction. Conclusions. The CBSO device system could offer a new treatment option for transcatheter ASD device closure in the pediatric and adult fields. In our first-in-child experience, it was effectively and safely implanted. During the first 12 months of follow-up, no complications occurred.http://dx.doi.org/10.1155/2022/3476398
spellingShingle Alessia Callegari
Daniel Quandt
Johannes Nordmeyer
Stephan Schubert
Peter Kramer
Walter Knirsch
Oliver Kretschmar
Transcatheter Closure of Atrial Septal Defect with Carag Bioresorbable Septal Occluder™: First-in-Child Experience with 12-MonthFollow-Up
Journal of Interventional Cardiology
title Transcatheter Closure of Atrial Septal Defect with Carag Bioresorbable Septal Occluder™: First-in-Child Experience with 12-MonthFollow-Up
title_full Transcatheter Closure of Atrial Septal Defect with Carag Bioresorbable Septal Occluder™: First-in-Child Experience with 12-MonthFollow-Up
title_fullStr Transcatheter Closure of Atrial Septal Defect with Carag Bioresorbable Septal Occluder™: First-in-Child Experience with 12-MonthFollow-Up
title_full_unstemmed Transcatheter Closure of Atrial Septal Defect with Carag Bioresorbable Septal Occluder™: First-in-Child Experience with 12-MonthFollow-Up
title_short Transcatheter Closure of Atrial Septal Defect with Carag Bioresorbable Septal Occluder™: First-in-Child Experience with 12-MonthFollow-Up
title_sort transcatheter closure of atrial septal defect with carag bioresorbable septal occluder™ first in child experience with 12 monthfollow up
url http://dx.doi.org/10.1155/2022/3476398
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