Hemodynamic Changes After Wire Frame Occluders vs. Metal Mesh Devices for Atrial Septal Defect

Background: Transcatheter atrial septal defect (ASD) closure is the first treatment option for secundum ASD, but parameters for optimal device selection have not been established. We compared outcomes between occluders with a wire frame and metal mesh devices.Methods and Results: This study included...

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Published inCirculation Journal Vol. 89; no. 7; pp. 930 - 938
Main Authors Akagi, Teiji, Takaya, Yoichi, Nakayama, Rie, Nakashima, Mitsutaka, Nakamura, Kazufumi, Yuasa, Shinsuke, Nakagawa, Koji, Ejiri, Kentaro, Miki, Takashi
Format Journal Article
LanguageEnglish
Published Japan The Japanese Circulation Society 25.06.2025
一般社団法人 日本循環器学会
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ISSN1346-9843
1347-4820
1347-4820
DOI10.1253/circj.CJ-24-0966

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Abstract Background: Transcatheter atrial septal defect (ASD) closure is the first treatment option for secundum ASD, but parameters for optimal device selection have not been established. We compared outcomes between occluders with a wire frame and metal mesh devices.Methods and Results: This study included secundum ASD patients implanted with a wire frame occluder (GORE®CARDIOFORM ASD occluder [GCA]; W.L. Gore & Associates) or metal mesh devices (Amplatzer septal occluder device [Abbott] and Occlutech Figulla Flex II device [Occlutech]). The presence of residual shunt and B-type natriuretic peptide (BNP) levels after implantation were compared. Of the 970 patients with either GCA (n=48) or a metal mesh device (n=922; control), 42 patients from each group were analyzed after propensity score matching. The prevalence of residual shunt was significantly lower in the GCA group 1 day and 1 month after implantation (P<0.001 and P=0.017, respectively), whereas there was no significant difference between the 2 groups 6 months later (P=0.088). BNP levels at 1 month were significantly higher in the GCA group (ratio of change 1.36; 95% confidence interval [CI] 1.01–1.83), but did not differ significantly between the 2 groups at 6 months (ratio of change 1.04; 95% CI 0.65–1.65).Conclusions: Patients implanted with a wire frame occluder had a lower prevalence of residual shunt and a greater increase in BNP levels in the early period after implantation.
AbstractList Background: Transcatheter atrial septal defect (ASD) closure is the first treatment option for secundum ASD, but parameters for optimal device selection have not been established. We compared outcomes between occluders with a wire frame and metal mesh devices.Methods and Results: This study included secundum ASD patients implanted with a wire frame occluder (GORE®CARDIOFORM ASD occluder [GCA]; W.L. Gore & Associates) or metal mesh devices (Amplatzer septal occluder device [Abbott] and Occlutech Figulla Flex II device [Occlutech]). The presence of residual shunt and B-type natriuretic peptide (BNP) levels after implantation were compared. Of the 970 patients with either GCA (n=48) or a metal mesh device (n=922; control), 42 patients from each group were analyzed after propensity score matching. The prevalence of residual shunt was significantly lower in the GCA group 1 day and 1 month after implantation (P<0.001 and P=0.017, respectively), whereas there was no significant difference between the 2 groups 6 months later (P=0.088). BNP levels at 1 month were significantly higher in the GCA group (ratio of change 1.36; 95% confidence interval [CI] 1.01–1.83), but did not differ significantly between the 2 groups at 6 months (ratio of change 1.04; 95% CI 0.65–1.65).Conclusions: Patients implanted with a wire frame occluder had a lower prevalence of residual shunt and a greater increase in BNP levels in the early period after implantation.
Transcatheter atrial septal defect (ASD) closure is the first treatment option for secundum ASD, but parameters for optimal device selection have not been established. We compared outcomes between occluders with a wire frame and metal mesh devices. This study included secundum ASD patients implanted with a wire frame occluder (GORE CARDIOFORM ASD occluder [GCA]; W.L. Gore & Associates) or metal mesh devices (Amplatzer septal occluder device [Abbott] and Occlutech Figulla Flex II device [Occlutech]). The presence of residual shunt and B-type natriuretic peptide (BNP) levels after implantation were compared. Of the 970 patients with either GCA (n=48) or a metal mesh device (n=922; control), 42 patients from each group were analyzed after propensity score matching. The prevalence of residual shunt was significantly lower in the GCA group 1 day and 1 month after implantation (P<0.001 and P=0.017, respectively), whereas there was no significant difference between the 2 groups 6 months later (P=0.088). BNP levels at 1 month were significantly higher in the GCA group (ratio of change 1.36; 95% confidence interval [CI] 1.01-1.83), but did not differ significantly between the 2 groups at 6 months (ratio of change 1.04; 95% CI 0.65-1.65). Patients implanted with a wire frame occluder had a lower prevalence of residual shunt and a greater increase in BNP levels in the early period after implantation.
Transcatheter atrial septal defect (ASD) closure is the first treatment option for secundum ASD, but parameters for optimal device selection have not been established. We compared outcomes between occluders with a wire frame and metal mesh devices.BACKGROUNDTranscatheter atrial septal defect (ASD) closure is the first treatment option for secundum ASD, but parameters for optimal device selection have not been established. We compared outcomes between occluders with a wire frame and metal mesh devices.This study included secundum ASD patients implanted with a wire frame occluder (GORE®CARDIOFORM ASD occluder [GCA]; W.L. Gore & Associates) or metal mesh devices (Amplatzer septal occluder device [Abbott] and Occlutech Figulla Flex II device [Occlutech]). The presence of residual shunt and B-type natriuretic peptide (BNP) levels after implantation were compared. Of the 970 patients with either GCA (n=48) or a metal mesh device (n=922; control), 42 patients from each group were analyzed after propensity score matching. The prevalence of residual shunt was significantly lower in the GCA group 1 day and 1 month after implantation (P<0.001 and P=0.017, respectively), whereas there was no significant difference between the 2 groups 6 months later (P=0.088). BNP levels at 1 month were significantly higher in the GCA group (ratio of change 1.36; 95% confidence interval [CI] 1.01-1.83), but did not differ significantly between the 2 groups at 6 months (ratio of change 1.04; 95% CI 0.65-1.65).METHODS AND RESULTSThis study included secundum ASD patients implanted with a wire frame occluder (GORE®CARDIOFORM ASD occluder [GCA]; W.L. Gore & Associates) or metal mesh devices (Amplatzer septal occluder device [Abbott] and Occlutech Figulla Flex II device [Occlutech]). The presence of residual shunt and B-type natriuretic peptide (BNP) levels after implantation were compared. Of the 970 patients with either GCA (n=48) or a metal mesh device (n=922; control), 42 patients from each group were analyzed after propensity score matching. The prevalence of residual shunt was significantly lower in the GCA group 1 day and 1 month after implantation (P<0.001 and P=0.017, respectively), whereas there was no significant difference between the 2 groups 6 months later (P=0.088). BNP levels at 1 month were significantly higher in the GCA group (ratio of change 1.36; 95% confidence interval [CI] 1.01-1.83), but did not differ significantly between the 2 groups at 6 months (ratio of change 1.04; 95% CI 0.65-1.65).Patients implanted with a wire frame occluder had a lower prevalence of residual shunt and a greater increase in BNP levels in the early period after implantation.CONCLUSIONSPatients implanted with a wire frame occluder had a lower prevalence of residual shunt and a greater increase in BNP levels in the early period after implantation.
ArticleNumber CJ-24-0966
Author Nakamura, Kazufumi
Miki, Takashi
Ejiri, Kentaro
Yuasa, Shinsuke
Nakagawa, Koji
Nakayama, Rie
Akagi, Teiji
Nakashima, Mitsutaka
Takaya, Yoichi
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  organization: Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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  organization: Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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  organization: Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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Occlutech Figulla Flex II
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References_xml – reference: 16. Gillespie MJ, Javois AJ, Moore P, Forbes T, Paolillo JA. Use of the GORE® CARDIOFORM Septal Occluder for percutaneous closure of secundum atrial septal defects: Results of the multicenter U.S. IDE trial. Catheter Cardiovasc Interv 2020; 95: 1296–1304.
– reference: 20. Qureshi AM, Sommer RJ, Morgan G, Paolillo JA, Gray RG, Love B, et al. Long-term results of the atrial septal defect occluder assured trial for combined pivotal/continued access cohorts. JACC Cardiovasc Interv 2024; 17: 2274–2283.
– reference: 19. Kubicki R, Fingerhut K, Uhl M, Hummel J, Höhn R, Reineker K, et al. Wire-frame integrity of patch-like Gore devices following atrial septal defect closure. Catheter Cardiovasc Interv 2019; 93: E238–E243.
– reference: 11. Takaya Y, Akagi T, Nakagawa K, Nakayama R, Miki T, Toh N, et al. Feasibility of transcatheter closure for absent aortic rim in patients with atrial septal defect. Catheter Cardiovasc Interv 2021; 97: 859–864.
– reference: 22. Mueller C, McDonald K, de Boer RA, Maisel A, Cleland JGF, Kozhuharov N, et al. Heart Failure Association of the European Society of Cardiology practical guidance on the use of natriuretic peptide concentrations. Eur J Heart Fail 2019; 21: 715–731.
– reference: 5. Amin Z, Hijazi ZM, Bass JL, Cheatham JP, Hellenbrand WE, Kleinman CS. Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: Review of registry of complications and recommendations to minimize future risk. Catheter Cardiovasc Interv 2004; 63: 496–502.
– reference: 3. Butera G, Carminati M, Chessa M, Youssef R, Drago M, Giamberti A, et al. Percutaneous versus surgical closure of secundum atrial septal defect: Comparison of early results and complications. Am Heart J 2006; 151: 228–234.
– reference: 9. Sommer RJ, Love BA, Paolillo JA, Gray RG, Goldstein BH, Morgan GJ, et al. ASSURED clinical study: New GORE® CARDIOFORM ASD occluder for transcatheter closure of atrial septal defect. Catheter Cardiovasc Interv 2020; 95: 1285–1295.
– reference: 15. Santoro G, Cuman M, Pizzuto A, Haxhiademi D, Lunardini A, Franchi E, et al. GORE® Cardioform ASD Occluder experience in transcatheter closure of “complex” atrial septal defects. Catheter Cardiovasc Interv 2022; 99: E22–E30.
– reference: 18. Ejiri K, Miyoshi T, Nakamura K, Sakuragi S, Munemasa M, Namba S, et al. Effect of luseogliflozin on heart failure with preserved ejection fraction in patients with diabetes mellitus. J Am Heart Assoc 2020; 9: e015103.
– reference: 23. Nakashima M, Tanakaya M, Miyoshi T, Saito T, Katayama Y, Sakuragi S, et al. The Fibrosis-4 index predicts cardiovascular prognosis in patients with severe isolated tricuspid regurgitation. Circ J 2022; 86: 1777–1784.
– reference: 6. Tadros VX, Asgar AW. Atrial septal defect closure with left ventricular dysfunction. EuroIntervention 2016; 12(Suppl X): X13–X17.
– reference: 2. Baumgartner H, De Backer J, Babu-Narayan SV, Budts W, Chessa M, Diller GP, et al. 2020 ESC guidelines for the management of adult congenital heart disease. Eur Heart J 2021; 42: 563–645.
– reference: 28. Nakashima M, Akagi T, Miki T, Nakayama R, Takaya Y, Nakagawa K, et al. Fenestrated GORE® CARDIOFORM ASD occluder for transcatheter atrial septal defect closure in a geriatric patient. J Cardiol Cases 2024; 30: 31–34.
– reference: 21. Cicek V, Orhan LA, Saylik F, Sharma V, Tur Y, Erdem A, et al. Predicting short-term mortality in patients with acute pulmonary embolism with deep learning. Circ J 2025; 89: 602–611.
– reference: 24. Nakagawa K, Akagi T, Takaya Y, Miki T, Kijima Y, Nakayama R, et al. Temporary balloon occlusion test can overestimate the risk of acute pulmonary edema after transcatheter atrial septal defect closure. Catheter Cardiovasc Interv 2023, doi:10.1002/ccd.30556.
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Snippet Background: Transcatheter atrial septal defect (ASD) closure is the first treatment option for secundum ASD, but parameters for optimal device selection have...
Transcatheter atrial septal defect (ASD) closure is the first treatment option for secundum ASD, but parameters for optimal device selection have not been...
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SubjectTerms Adult
Aged
Amplatzer septal occluder
Female
GORE® CARDIOFORM ASD occluder
Heart Septal Defects, Atrial - blood
Heart Septal Defects, Atrial - physiopathology
Heart Septal Defects, Atrial - surgery
Hemodynamics
Humans
Male
Middle Aged
Natriuretic Peptide, Brain - blood
Occlutech Figulla Flex II
Retrospective Studies
Septal Occluder Device
Transcatheter atrial septal defect closure
Title Hemodynamic Changes After Wire Frame Occluders vs. Metal Mesh Devices for Atrial Septal Defect
URI https://www.jstage.jst.go.jp/article/circj/89/7/89_CJ-24-0966/_article/-char/en
https://cir.nii.ac.jp/crid/1390866591962914688
https://www.ncbi.nlm.nih.gov/pubmed/40139815
https://www.proquest.com/docview/3182474510
Volume 89
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