Long-Term Results After Standard Endovascular Aneurysm Repair With the Endurant and Excluder Stent Grafts

Detalhes bibliográficos
Autor(a) principal: Oliveira-Pinto, J
Data de Publicação: 2020
Outros Autores: Oliveira, N, Bastos Gonçalves, F, Hoeks, S, Rijn, MJ, Raa, S, Mansilha, A, Verhagen, H
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10400.17/3880
Resumo: Objective: Many endografts are currently available for standard endovascular repair of infrarenal abdominal aortic aneurysms. Comparison of long-term outcomes between devices might aid in this decision process, but comparative data are scarce. The purpose of this study was to report long-term clinical outcomes of two commercially available endoprosthesis, the Endurant (Medtronic Vascular, Inc, Minneapolis, Minn) and the Excluder (W. L. Gore & Associates, Flagstaff, Ariz) stent grafts. Methods: Patients undergoing standard endovascular repair from July 2004 to December 2011 in a single institution with the Endurant or the Low-Porosity Excluder endografts were eligible. Only patients treated for intact degenerative abdominal infrarenal aneurysms were included. All measurements were performed on center-lumen line reconstructions obtained on dedicated software. The primary end point was primary clinical success, defined as clinical success without the need for an additional or secondary surgical or endovascular procedure. Neck-related events (a composite of type IA endoleak, neck-related secondary intervention, or migration of >5 mm), neck morphology changes, renal function, and overall survival were secondary end points. Results: The study included 277 patients (156 Endurants; 121 Excluders). The median follow-up was 5.8 years (range, 0.1-12.4 years) and did not differ between groups (P = .18). Patients treated with the Endurant stent graft had wider (neck diameter of >28 mm, 27.3% vs 1.7% [P < .001]; neck diameter of 27 mm, [interquartile range (IQR), 24-29 mm] for Endurant and 24 mm [IQR, 22-25 mm] for Excluder; P < .001) and more angulated necks (β-angle of >60°, 26.7% vs 12.5%; P = .004). Oversizing was greater in the Endurant group (16% [IQR, 12%-22%] vs 13% [IQR, 8%-17%], respectively; P < .001). Patients were treated outside device instructions for use regarding proximal neck: 16.7% in the Endurant and 17.3% in the Excluder group (P = .720). The 7-year primary clinical success was 54.7% for the Endurant and 58.1% for the Excluder groups (P = .53). Freedom from neck-related events at 7 years was 76.7% for the Endurant and 78.8% for Excluder group (P = .94). The Endurant stent graft (hazard ratio [HR], 2.7; 95% confidence interval [CI], 1.3-5.8; P = .009) was an independent predictor of significant renal function decline. Neck dilatation was greater in Endurant-implanted patients (13% [95% CI, 2%-22%] vs 4% [95% CI, 0%-10%]; P < .001). Overall survival at 7 years was 61.4% in the Endurant and 50.3% (n = 50; standard error, 0.047) in the Excluder group (P = .39). Conclusions: This study reveals that durable and sustainable results can be obtained with either of these late generation devices. This finding suggests that careful planning and a tailored device selection taking into account the patient's anatomy are more relevant determinants than the graft model itself to obtain clinical success. The Endurant endoprosthesis seems to be associated with a higher rate of neck dilatation and faster decrease in the estimated glomerular filtration rate, but further studies with longer follow-up are necessary to determine the clinical relevance of these findings.
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spelling Long-Term Results After Standard Endovascular Aneurysm Repair With the Endurant and Excluder Stent GraftsHSM CIR VASCAgedFemaleMaleAortic Aneurysm, Abdominal / diagnostic imagingHumansAortic Aneurysm, Abdominal / mortalityAortic Aneurysm, Abdominal / surgery*Blood Vessel Prosthesis Implantation / adverse effectsBlood Vessel Prosthesis Implantation / instrumentation*Blood Vessel Prosthesis Implantation / mortalityBlood Vessel Prosthesis*Databases, FactualEndovascular Procedures / adverse effectsEndovascular Procedures / instrumentation*Endovascular Procedures / mortalityPostoperative Complications / etiologyProsthesis DesignRetrospective StudiesRisk FactorsStents*Time FactorsTreatment OutcomeObjective: Many endografts are currently available for standard endovascular repair of infrarenal abdominal aortic aneurysms. Comparison of long-term outcomes between devices might aid in this decision process, but comparative data are scarce. The purpose of this study was to report long-term clinical outcomes of two commercially available endoprosthesis, the Endurant (Medtronic Vascular, Inc, Minneapolis, Minn) and the Excluder (W. L. Gore & Associates, Flagstaff, Ariz) stent grafts. Methods: Patients undergoing standard endovascular repair from July 2004 to December 2011 in a single institution with the Endurant or the Low-Porosity Excluder endografts were eligible. Only patients treated for intact degenerative abdominal infrarenal aneurysms were included. All measurements were performed on center-lumen line reconstructions obtained on dedicated software. The primary end point was primary clinical success, defined as clinical success without the need for an additional or secondary surgical or endovascular procedure. Neck-related events (a composite of type IA endoleak, neck-related secondary intervention, or migration of >5 mm), neck morphology changes, renal function, and overall survival were secondary end points. Results: The study included 277 patients (156 Endurants; 121 Excluders). The median follow-up was 5.8 years (range, 0.1-12.4 years) and did not differ between groups (P = .18). Patients treated with the Endurant stent graft had wider (neck diameter of >28 mm, 27.3% vs 1.7% [P < .001]; neck diameter of 27 mm, [interquartile range (IQR), 24-29 mm] for Endurant and 24 mm [IQR, 22-25 mm] for Excluder; P < .001) and more angulated necks (β-angle of >60°, 26.7% vs 12.5%; P = .004). Oversizing was greater in the Endurant group (16% [IQR, 12%-22%] vs 13% [IQR, 8%-17%], respectively; P < .001). Patients were treated outside device instructions for use regarding proximal neck: 16.7% in the Endurant and 17.3% in the Excluder group (P = .720). The 7-year primary clinical success was 54.7% for the Endurant and 58.1% for the Excluder groups (P = .53). Freedom from neck-related events at 7 years was 76.7% for the Endurant and 78.8% for Excluder group (P = .94). The Endurant stent graft (hazard ratio [HR], 2.7; 95% confidence interval [CI], 1.3-5.8; P = .009) was an independent predictor of significant renal function decline. Neck dilatation was greater in Endurant-implanted patients (13% [95% CI, 2%-22%] vs 4% [95% CI, 0%-10%]; P < .001). Overall survival at 7 years was 61.4% in the Endurant and 50.3% (n = 50; standard error, 0.047) in the Excluder group (P = .39). Conclusions: This study reveals that durable and sustainable results can be obtained with either of these late generation devices. This finding suggests that careful planning and a tailored device selection taking into account the patient's anatomy are more relevant determinants than the graft model itself to obtain clinical success. The Endurant endoprosthesis seems to be associated with a higher rate of neck dilatation and faster decrease in the estimated glomerular filtration rate, but further studies with longer follow-up are necessary to determine the clinical relevance of these findings.ElsevierRepositório do Centro Hospitalar Universitário de Lisboa Central, EPEOliveira-Pinto, JOliveira, NBastos Gonçalves, FHoeks, SRijn, MJRaa, SMansilha, AVerhagen, H2021-10-13T14:49:37Z20202020-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.17/3880engJ Vasc Surg. 2020 Jan;71(1):64-74.10.1016/j.jvs.2019.03.039.info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-03-10T09:44:31Zoai:repositorio.chlc.min-saude.pt:10400.17/3880Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T17:21:11.792241Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Long-Term Results After Standard Endovascular Aneurysm Repair With the Endurant and Excluder Stent Grafts
title Long-Term Results After Standard Endovascular Aneurysm Repair With the Endurant and Excluder Stent Grafts
spellingShingle Long-Term Results After Standard Endovascular Aneurysm Repair With the Endurant and Excluder Stent Grafts
Oliveira-Pinto, J
HSM CIR VASC
Aged
Female
Male
Aortic Aneurysm, Abdominal / diagnostic imaging
Humans
Aortic Aneurysm, Abdominal / mortality
Aortic Aneurysm, Abdominal / surgery*
Blood Vessel Prosthesis Implantation / adverse effects
Blood Vessel Prosthesis Implantation / instrumentation*
Blood Vessel Prosthesis Implantation / mortality
Blood Vessel Prosthesis*
Databases, Factual
Endovascular Procedures / adverse effects
Endovascular Procedures / instrumentation*
Endovascular Procedures / mortality
Postoperative Complications / etiology
Prosthesis Design
Retrospective Studies
Risk Factors
Stents*
Time Factors
Treatment Outcome
title_short Long-Term Results After Standard Endovascular Aneurysm Repair With the Endurant and Excluder Stent Grafts
title_full Long-Term Results After Standard Endovascular Aneurysm Repair With the Endurant and Excluder Stent Grafts
title_fullStr Long-Term Results After Standard Endovascular Aneurysm Repair With the Endurant and Excluder Stent Grafts
title_full_unstemmed Long-Term Results After Standard Endovascular Aneurysm Repair With the Endurant and Excluder Stent Grafts
title_sort Long-Term Results After Standard Endovascular Aneurysm Repair With the Endurant and Excluder Stent Grafts
author Oliveira-Pinto, J
author_facet Oliveira-Pinto, J
Oliveira, N
Bastos Gonçalves, F
Hoeks, S
Rijn, MJ
Raa, S
Mansilha, A
Verhagen, H
author_role author
author2 Oliveira, N
Bastos Gonçalves, F
Hoeks, S
Rijn, MJ
Raa, S
Mansilha, A
Verhagen, H
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Repositório do Centro Hospitalar Universitário de Lisboa Central, EPE
dc.contributor.author.fl_str_mv Oliveira-Pinto, J
Oliveira, N
Bastos Gonçalves, F
Hoeks, S
Rijn, MJ
Raa, S
Mansilha, A
Verhagen, H
dc.subject.por.fl_str_mv HSM CIR VASC
Aged
Female
Male
Aortic Aneurysm, Abdominal / diagnostic imaging
Humans
Aortic Aneurysm, Abdominal / mortality
Aortic Aneurysm, Abdominal / surgery*
Blood Vessel Prosthesis Implantation / adverse effects
Blood Vessel Prosthesis Implantation / instrumentation*
Blood Vessel Prosthesis Implantation / mortality
Blood Vessel Prosthesis*
Databases, Factual
Endovascular Procedures / adverse effects
Endovascular Procedures / instrumentation*
Endovascular Procedures / mortality
Postoperative Complications / etiology
Prosthesis Design
Retrospective Studies
Risk Factors
Stents*
Time Factors
Treatment Outcome
topic HSM CIR VASC
Aged
Female
Male
Aortic Aneurysm, Abdominal / diagnostic imaging
Humans
Aortic Aneurysm, Abdominal / mortality
Aortic Aneurysm, Abdominal / surgery*
Blood Vessel Prosthesis Implantation / adverse effects
Blood Vessel Prosthesis Implantation / instrumentation*
Blood Vessel Prosthesis Implantation / mortality
Blood Vessel Prosthesis*
Databases, Factual
Endovascular Procedures / adverse effects
Endovascular Procedures / instrumentation*
Endovascular Procedures / mortality
Postoperative Complications / etiology
Prosthesis Design
Retrospective Studies
Risk Factors
Stents*
Time Factors
Treatment Outcome
description Objective: Many endografts are currently available for standard endovascular repair of infrarenal abdominal aortic aneurysms. Comparison of long-term outcomes between devices might aid in this decision process, but comparative data are scarce. The purpose of this study was to report long-term clinical outcomes of two commercially available endoprosthesis, the Endurant (Medtronic Vascular, Inc, Minneapolis, Minn) and the Excluder (W. L. Gore & Associates, Flagstaff, Ariz) stent grafts. Methods: Patients undergoing standard endovascular repair from July 2004 to December 2011 in a single institution with the Endurant or the Low-Porosity Excluder endografts were eligible. Only patients treated for intact degenerative abdominal infrarenal aneurysms were included. All measurements were performed on center-lumen line reconstructions obtained on dedicated software. The primary end point was primary clinical success, defined as clinical success without the need for an additional or secondary surgical or endovascular procedure. Neck-related events (a composite of type IA endoleak, neck-related secondary intervention, or migration of >5 mm), neck morphology changes, renal function, and overall survival were secondary end points. Results: The study included 277 patients (156 Endurants; 121 Excluders). The median follow-up was 5.8 years (range, 0.1-12.4 years) and did not differ between groups (P = .18). Patients treated with the Endurant stent graft had wider (neck diameter of >28 mm, 27.3% vs 1.7% [P < .001]; neck diameter of 27 mm, [interquartile range (IQR), 24-29 mm] for Endurant and 24 mm [IQR, 22-25 mm] for Excluder; P < .001) and more angulated necks (β-angle of >60°, 26.7% vs 12.5%; P = .004). Oversizing was greater in the Endurant group (16% [IQR, 12%-22%] vs 13% [IQR, 8%-17%], respectively; P < .001). Patients were treated outside device instructions for use regarding proximal neck: 16.7% in the Endurant and 17.3% in the Excluder group (P = .720). The 7-year primary clinical success was 54.7% for the Endurant and 58.1% for the Excluder groups (P = .53). Freedom from neck-related events at 7 years was 76.7% for the Endurant and 78.8% for Excluder group (P = .94). The Endurant stent graft (hazard ratio [HR], 2.7; 95% confidence interval [CI], 1.3-5.8; P = .009) was an independent predictor of significant renal function decline. Neck dilatation was greater in Endurant-implanted patients (13% [95% CI, 2%-22%] vs 4% [95% CI, 0%-10%]; P < .001). Overall survival at 7 years was 61.4% in the Endurant and 50.3% (n = 50; standard error, 0.047) in the Excluder group (P = .39). Conclusions: This study reveals that durable and sustainable results can be obtained with either of these late generation devices. This finding suggests that careful planning and a tailored device selection taking into account the patient's anatomy are more relevant determinants than the graft model itself to obtain clinical success. The Endurant endoprosthesis seems to be associated with a higher rate of neck dilatation and faster decrease in the estimated glomerular filtration rate, but further studies with longer follow-up are necessary to determine the clinical relevance of these findings.
publishDate 2020
dc.date.none.fl_str_mv 2020
2020-01-01T00:00:00Z
2021-10-13T14:49:37Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10400.17/3880
url http://hdl.handle.net/10400.17/3880
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv J Vasc Surg. 2020 Jan;71(1):64-74.
10.1016/j.jvs.2019.03.039.
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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