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 in | Circulation Journal Vol. 89; no. 7; pp. 930 - 938 |
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Main Authors | , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Japan
The Japanese Circulation Society
25.06.2025
一般社団法人 日本循環器学会 |
Subjects | |
Online Access | Get full text |
ISSN | 1346-9843 1347-4820 1347-4820 |
DOI | 10.1253/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. |
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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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Cites_doi | 10.1002/ejhf.1494 10.1002/ccd.28103 10.1016/j.jacc.2023.05.042 10.1002/ccd.28728 10.1002/ccd.25175 10.1002/ccd.20211 10.1016/j.jcin.2024.07.013 10.4244/EIJV12SXA3 10.1016/j.jccase.2024.04.001 10.1016/j.jccase.2013.12.004 10.1007/s00380-020-01739-1 10.1002/sim.3697 10.1002/ccd.30556 10.1002/ccd.29457 10.1016/j.jacasi.2024.09.006 10.1002/ccd.29977 10.1253/circj.CJ-24-0313 10.15829/1560-4071-2021-4702 10.1002/ccd.28814 10.1136/heart.89.2.199 10.1016/j.echo.2018.06.004 10.1136/bmjopen-2018-026590 10.1016/j.ahj.2005.02.051 10.1253/circj.CJ-22-0109 10.1016/j.echo.2017.01.007 10.1016/j.echo.2016.01.011 10.1253/circj.CJ-24-0630 10.1161/CIRCULATIONAHA.106.627224 |
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Keywords | GORE® CARDIOFORM ASD occluder Amplatzer septal occluder Transcatheter atrial septal defect closure Occlutech Figulla Flex II |
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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. 26. Nakashima M, Akagi T, Takaya Y, Miki T, Nakayama R, Nakagawa K, et al. Crescent-shaped atrial septal defect: A new clinical entity of an acquired defect for transcatheter closure. JACC Asia 2024; 4: 1013–1016. 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. 14. Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, et al. Recommendations for noninvasive evaluation of native valvular regurgitation: A report from the American Society of Echocardiography developed in collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr 2017; 30: 303–371. 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. 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. 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. 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. 28. 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Guidelines for performing a comprehensive transthoracic echocardiographic examination in adults: Recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr 2019; 32: 1–64. 4. Fischer G, Stieh J, Uebing A, Hoffmann U, Morf G, Kramer HH. Experience with transcatheter closure of secundum atrial septal defects using the Amplatzer septal occluder: A single centre study in 236 consecutive patients. Heart 2003; 89: 199–204. 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. 7. Amin Z. Echocardiographic predictors of cardiac erosion after Amplatzer septal occluder placement. Catheter Cardiovas Interv 2014; 83: 84–92. 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. 27. Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat Med 2009; 28: 3083–3107. 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. 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. 22 23 24 25 26 27 28 10 11 12 13 14 15 16 17 18 19 1 2 3 4 5 6 7 8 9 20 21 |
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. – reference: 27. Austin PC. 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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 |
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