Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occluders

Abstract Background Complete endothelialization is often not achieved within 6 months after implantation of an atrial septal defect (ASD) occluder, which may lead to microthrombus or thrombosis. This study aimed to assess the endothelialization and morphology of a novel puncturable ASD occluder (ReA...

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Main Authors: Yanxing Fang, Kai Hou, Dawei Lin, Daxin Zhou, Wenzhi Pan, Junbo Ge
Format: Article
Language:English
Published: BMC 2024-12-01
Series:BMC Cardiovascular Disorders
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Online Access:https://doi.org/10.1186/s12872-024-04438-1
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author Yanxing Fang
Kai Hou
Dawei Lin
Daxin Zhou
Wenzhi Pan
Junbo Ge
author_facet Yanxing Fang
Kai Hou
Dawei Lin
Daxin Zhou
Wenzhi Pan
Junbo Ge
author_sort Yanxing Fang
collection DOAJ
description Abstract Background Complete endothelialization is often not achieved within 6 months after implantation of an atrial septal defect (ASD) occluder, which may lead to microthrombus or thrombosis. This study aimed to assess the endothelialization and morphology of a novel puncturable ASD occluder (ReAces) compared with traditional occluders 1 year post-implantation using computed tomography angiography (CTA). Methods Fifteen patients from each group in a randomized controlled trial comparing ReAces with traditional occluders were included at the 1-year follow-up at Zhongshan Hospital, Fudan University. Baseline characteristics and procedural data were recorded. CTA was performed to assess the device morphology and degree of endothelialization. Independent samples t-test and Fisher's exact test were primarily used to compare the above data. Results Each patient received a single device and had no residual shunts. There were no differences in defect size (15.3 ± 4.0 mm vs. 15.3 ± 4.7 mm, p = 1.00) or occluder size (21.2 ± 4.4 mm vs. 21.5 ± 5.3 mm, p = 0.882) between the two groups. At the 1-year follow-up CTA, the central region thickness (4.2 mm ± 0.9 mm vs. 7.8 mm ± 2.4 mm, p < 0.0001), left atrial device-occupied volume (1863.3 mm2 ± 404.4 mm2 vs. 4764.4 mm2 ± 2321.2 mm2, p < 0.001), and device compression rates (10.1 ± 4.8% vs. 17.5 ± 5.6%, p = 0.001) were significantly lower in the experimental group. All occluders in the experimental group achieved complete endothelialization, whereas in the control group, 7 patients did not (100% vs. 53.3%, p = 0.006). Conclusions Compared with traditional occluders, ReAces presented a significantly greater complete endothelialization rate, lower central region thickness, lower left atrial device-occupied volume, and lower device compression rates at 1 year post-implantation by CTA. Trial registration Trial registry: ClinicalTrials.gov. Unique identifying number: NCT05371366. Date of registration: 04/05/2022. Graphical Abstract
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spelling doaj-art-54dcac080eba4e299d240a801f29f4812025-08-20T02:53:54ZengBMCBMC Cardiovascular Disorders1471-22612024-12-0124111110.1186/s12872-024-04438-1Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occludersYanxing Fang0Kai Hou1Dawei Lin2Daxin Zhou3Wenzhi Pan4Junbo Ge5Department of Cardiology, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, Shanghai Institute of Cardiovascular DiseasesDepartment of Radiology, Zhongshan Hospital, Fudan UniversityDepartment of Cardiology, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, Shanghai Institute of Cardiovascular DiseasesDepartment of Cardiology, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, Shanghai Institute of Cardiovascular DiseasesDepartment of Cardiology, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, Shanghai Institute of Cardiovascular DiseasesDepartment of Cardiology, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, Shanghai Institute of Cardiovascular DiseasesAbstract Background Complete endothelialization is often not achieved within 6 months after implantation of an atrial septal defect (ASD) occluder, which may lead to microthrombus or thrombosis. This study aimed to assess the endothelialization and morphology of a novel puncturable ASD occluder (ReAces) compared with traditional occluders 1 year post-implantation using computed tomography angiography (CTA). Methods Fifteen patients from each group in a randomized controlled trial comparing ReAces with traditional occluders were included at the 1-year follow-up at Zhongshan Hospital, Fudan University. Baseline characteristics and procedural data were recorded. CTA was performed to assess the device morphology and degree of endothelialization. Independent samples t-test and Fisher's exact test were primarily used to compare the above data. Results Each patient received a single device and had no residual shunts. There were no differences in defect size (15.3 ± 4.0 mm vs. 15.3 ± 4.7 mm, p = 1.00) or occluder size (21.2 ± 4.4 mm vs. 21.5 ± 5.3 mm, p = 0.882) between the two groups. At the 1-year follow-up CTA, the central region thickness (4.2 mm ± 0.9 mm vs. 7.8 mm ± 2.4 mm, p < 0.0001), left atrial device-occupied volume (1863.3 mm2 ± 404.4 mm2 vs. 4764.4 mm2 ± 2321.2 mm2, p < 0.001), and device compression rates (10.1 ± 4.8% vs. 17.5 ± 5.6%, p = 0.001) were significantly lower in the experimental group. All occluders in the experimental group achieved complete endothelialization, whereas in the control group, 7 patients did not (100% vs. 53.3%, p = 0.006). Conclusions Compared with traditional occluders, ReAces presented a significantly greater complete endothelialization rate, lower central region thickness, lower left atrial device-occupied volume, and lower device compression rates at 1 year post-implantation by CTA. Trial registration Trial registry: ClinicalTrials.gov. Unique identifying number: NCT05371366. Date of registration: 04/05/2022. Graphical Abstracthttps://doi.org/10.1186/s12872-024-04438-1Atrial septal defectOccluderCTAEndothelializationMorphology
spellingShingle Yanxing Fang
Kai Hou
Dawei Lin
Daxin Zhou
Wenzhi Pan
Junbo Ge
Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occluders
BMC Cardiovascular Disorders
Atrial septal defect
Occluder
CTA
Endothelialization
Morphology
title Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occluders
title_full Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occluders
title_fullStr Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occluders
title_full_unstemmed Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occluders
title_short Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occluders
title_sort device endothelialization and morphology assessments at 1 year using computed tomography angiography comparison of traditional with novel puncturable atrial septal defect occluders
topic Atrial septal defect
Occluder
CTA
Endothelialization
Morphology
url https://doi.org/10.1186/s12872-024-04438-1
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