NELLIX® ENDOPROTHESIS IN THE TREATMENT OF AAA — REPORT OF OUR UNSUCCESSFULL EXPERIENCE

Detalhes bibliográficos
Autor(a) principal: Ribeiro, Tiago
Data de Publicação: 2021
Outros Autores: Ferreira, Rita Soares, Alves, Gonçalo, Catarino, Joana, Vieira, Isabel, Correia, Ricardo, Bento, Rita, Garcia, Rita, Pais, Fábio, Cardoso, Joana, Gonçalves, Frederico Bastos, Ferreira, Maria Emília
Tipo de documento: Artigo
Idioma: por
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: https://doi.org/10.48750/acv.317
Resumo: Introduction: Nellix® endoprosthesis (Endologix Inc., Irvine, CA) is composed by two ballon-expandable stents surrounded by endobags, which are filled with a polymer, thus obliterating the aneurysmal sac – Endovascular Aneurysm Sealing (EVAS). Initially, due to its properties, was introduced with extended IFU, allowing the use in more complex abdominal aortic aneurysms. However, during the initial experience with this endoprosthesis, a high number of poor outcomes have been described, leading to the progressive restriction of IFU. Currently, it has been discontinued and is only available in selected centers for clinical research purposes. Our study aim to report the institutional results of the use of the Nellix® endoprosthesis in the treatment of AAA. Material and Methods: A retrospective study was designed, including patients with AAA treated with Nellix® endoprosthesis treated at a universitary tertiary care facility. Elective and urgent patients we're included, and patients we're identified through the institutional files. Thoraco-abdominal aneurysm we're excluded. Data about baseline characteristics, surgery, hospitalization course and follow-up post discharge was obtained by consulting personal clinical files. Primary endpoints are technical and clinical success at 30 days, as complications and secondary interventions at mid and long-term. Results: Between 2015 and 2017, this endoprosthesis was used in 12 patients, 9 male and 3 female, with a mean age of 71 (±8) years. The most common comorbidities associated we're hypertension (n=12), current or former tobacco use (n=7), coronary heart disease (n=7), peripheral artery disease (n=6) and chronic kidney disease (n=6) In all patients, the treatment indication was primary degenerative aneurysm, with one exception, which was the presence of type 1a EL after EVAR. Ten patients underwent elective and 2 urgent surgery due to symptomatic aneurysm. Three we're aortoiliac aneurysms and the remaining aortic aneurysms (n=9) with three having involvement of at least one renal artery. Nine patients underwent conventional EVAS; the remaining EVAS with chimney (ChEVAS) for the renal artery(ies) or superior mesenteric artery (n=3). The average preoperative diameter was 57(±6.5) mm. One patient was simultaneously submitted to endovascular repair of a popliteal artery aneurysm with covered stent. By 30 days, death occurred in 2 patients, all submitted to ChEVAS. The most common post-operative complications we're respiratory failure (n=3), AKI with dialysis (n=3), being that in two patients there was intentional covering of the renal arteries (patients with pre-dialysis CKD). In this time frame, we verified one reintervention: catheter-directed thrombolysis for acute limb ischemia due to popliteal covered stent thrombosis. After 30 days, 4 deaths occured (2 year survival 60%, SE 0.154). The most common complications were type 1a EL(n=3), type 1b EL(n=1) and aortic stent thrombosis (n=1). Two patients have already been reintervened: one submitted to femoro-femoral crossover bypass and the other to surgical endoprosthesis explantation and in situ reconstruction aortobifemoral bypass. The last was deceased in the early postoperative period. Two patients are waiting reintervention for type Ia EL and aneurysmal sac growth. The average sac diameter in last follow-up or before secondary intervention was 59(±10.6) mm. Mean follow-up time is 2,3(±1,6) years.  Conclusions: In our institution, the use of Nellix® endoprosthesis is associated with a high rate of perioperative morbidity and mid to long-term aneurysm-related complications, being type Ia EL the most common. Although the free use of the endoprosthesis is currently discontinued, patients who have previously undergone EVAS lack a specific and more intensive surveillance plan for the timely detection and correction of complications.
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spelling NELLIX® ENDOPROTHESIS IN THE TREATMENT OF AAA — REPORT OF OUR UNSUCCESSFULL EXPERIENCEENDOPRÓTESE NELLIX® NO TRATAMENTO DE AAA NUMA INSTITUIÇÃO TERCIÁRIA — RELATO DO INSUCESSOAbdominal Aortic AneurysmEndovascular Aneurysm Sealing (EVAS)ComplicationsAneurisma da Aorta AbdominalEndovascular Aneurysm Sealing (EVAS)ComplicaçõesIntroduction: Nellix® endoprosthesis (Endologix Inc., Irvine, CA) is composed by two ballon-expandable stents surrounded by endobags, which are filled with a polymer, thus obliterating the aneurysmal sac – Endovascular Aneurysm Sealing (EVAS). Initially, due to its properties, was introduced with extended IFU, allowing the use in more complex abdominal aortic aneurysms. However, during the initial experience with this endoprosthesis, a high number of poor outcomes have been described, leading to the progressive restriction of IFU. Currently, it has been discontinued and is only available in selected centers for clinical research purposes. Our study aim to report the institutional results of the use of the Nellix® endoprosthesis in the treatment of AAA. Material and Methods: A retrospective study was designed, including patients with AAA treated with Nellix® endoprosthesis treated at a universitary tertiary care facility. Elective and urgent patients we're included, and patients we're identified through the institutional files. Thoraco-abdominal aneurysm we're excluded. Data about baseline characteristics, surgery, hospitalization course and follow-up post discharge was obtained by consulting personal clinical files. Primary endpoints are technical and clinical success at 30 days, as complications and secondary interventions at mid and long-term. Results: Between 2015 and 2017, this endoprosthesis was used in 12 patients, 9 male and 3 female, with a mean age of 71 (±8) years. The most common comorbidities associated we're hypertension (n=12), current or former tobacco use (n=7), coronary heart disease (n=7), peripheral artery disease (n=6) and chronic kidney disease (n=6) In all patients, the treatment indication was primary degenerative aneurysm, with one exception, which was the presence of type 1a EL after EVAR. Ten patients underwent elective and 2 urgent surgery due to symptomatic aneurysm. Three we're aortoiliac aneurysms and the remaining aortic aneurysms (n=9) with three having involvement of at least one renal artery. Nine patients underwent conventional EVAS; the remaining EVAS with chimney (ChEVAS) for the renal artery(ies) or superior mesenteric artery (n=3). The average preoperative diameter was 57(±6.5) mm. One patient was simultaneously submitted to endovascular repair of a popliteal artery aneurysm with covered stent. By 30 days, death occurred in 2 patients, all submitted to ChEVAS. The most common post-operative complications we're respiratory failure (n=3), AKI with dialysis (n=3), being that in two patients there was intentional covering of the renal arteries (patients with pre-dialysis CKD). In this time frame, we verified one reintervention: catheter-directed thrombolysis for acute limb ischemia due to popliteal covered stent thrombosis. After 30 days, 4 deaths occured (2 year survival 60%, SE 0.154). The most common complications were type 1a EL(n=3), type 1b EL(n=1) and aortic stent thrombosis (n=1). Two patients have already been reintervened: one submitted to femoro-femoral crossover bypass and the other to surgical endoprosthesis explantation and in situ reconstruction aortobifemoral bypass. The last was deceased in the early postoperative period. Two patients are waiting reintervention for type Ia EL and aneurysmal sac growth. The average sac diameter in last follow-up or before secondary intervention was 59(±10.6) mm. Mean follow-up time is 2,3(±1,6) years.  Conclusions: In our institution, the use of Nellix® endoprosthesis is associated with a high rate of perioperative morbidity and mid to long-term aneurysm-related complications, being type Ia EL the most common. Although the free use of the endoprosthesis is currently discontinued, patients who have previously undergone EVAS lack a specific and more intensive surveillance plan for the timely detection and correction of complications.Introdução: A endoprótese Nellix® (Endologix Inc., Irvine CA) é composta por dois stents expansíveis por balão envolvidos por endobags preenchidos por um polímero, obliterando assim o saco aneurismático – Endovascular Aneurysm Sealing (EVAS). Inicialmente, pelas suas propriedades, foi introduzida com instruções para uso (IFU) alargadas, possibilitando a utilização em Aneurismas da Aorta Abdominal (AAA) de anatomia mais complexa. Porém, durante a experiência com esta endoprótese, foi descrito um elevado número de complicações, levando à restrição progressiva das IFU. Atualmente, o seu uso livre foi descontinuado e apenas está disponível em centros selecionados e para efeitos investigacionais. O objetivo deste estudo é reportar os resultados institucionais da utilização da endoprótese Nellix® no contexto de AAA. Material e Métodos: Realizou-se um estudo retrospectivo referente a doentes tratados a AAA utilizando a endoprótese Nellix® numa instituição terciária universitária. Foram incluídos todos os casos eletivos e urgentes, identificados através da consulta de registos clínicos da instituição. Foram excluídos casos de aneurisma toraco-abdominal. Os dados referentes às características de base, procedimento realizado, curso do internamento e seguimento pós hospitalar foram obtidos por consulta dos processos clínicos. Foram analisados como endpoints o sucesso técnico e clínico aos 30 dias, assim como complicações e intervenções secundárias a médio e longo prazo. Resultados: Entre 2015 e 2017, a esta endoprótese foi utilizada em 12 doentes, 9 homens e 3 mulheres, com média de 71(±8) anos. As comorbilidades mais frequentemente associadas foram HTA (n=12), tabagismo (n=7), cardiopatia isquémica (n=7), DAOP (n=6) e DRC (n=6). Em todos os doentes a indicação foi aneurisma primário degenerativo, com uma excepção, cuja indicação foi a presença de endoleak (EL) tipo 1a pós-EVAR prévio. Dez doentes foram submetidos a cirurgia eletiva e dois a cirurgia urgente, ambos por aneurisma sintomático. Três eram aneurismas aortoilíacos e os restantes aórticos (n=9), sendo que 3 tinham envolvimento de pelo menos uma artéria renal. Nove doentes foram submetidos a EVAS sem procedimentos complementares; os restantes a EVAS com chimney (ChEVAS) para as renais e/ou artéria mesentérica superior (n=3). O diâmetro médio pré-operatório era de 57mm (±6.5mm). Num doente tratou-se concomitantemente um aneurisma popliteu através do implante de stent coberto. Aos 30 dias verificou-se o óbito em 2 doentes submetidos a ChEVAS. As complicações mais frequentes foram Insuficiência Respiratória (n=3) e LRA com necessidade de diálise (n=3), sendo que em dois houve oclusão intencional das artérias renais (doentes com DRC terminal em pré-diálise). Neste período, houve uma reintervenção, por isquémia aguda de membro por trombose aguda de stent popliteu, tratada com sucesso com trombólise dirigida por catéter.Após os 30 dias, verificou-se o óbito em 4 doentes (sobrevivência aos 2 anos de 60%, SE=.154). As complicações verificadas foram EL tipo 1a (n=3), EL 1b (n=1) e trombose de stent aórtico (n=1). Dois doentes foram submetidos a intervenção secundária: um submetido a pontagem femoro-femoral cruzada por trombose de stent e outro a explantação protésica e reconstrução in-situ através de pontagem aorto-bifemoral. No último, verificou-se o óbito no pós-operatório precoce. Dois doentes aguardam intervenção secundária por EL tipo 1a e crescimento do saco. O diâmetro médio do saco aneurismático no último exame ou pré-intervenção secundária era 59mm (±10.6mm). O tempo médio de follow-up é de 2.3(±1.6) anos. Conclusões: Na nossa instituição, a utilização da endoprótese Nellix® está associada a elevada taxa de complicações perioperatórias e a médio prazo, com elevada taxa de complicações relacionadas com o aneurisma, sendo o EL tipo 1a a mais frequente. Apesar de atualmente o uso livre da endoprótese estar descontinuado, os doentes que foram submetidos previamente a EVAS carecem de um plano de vigilância específico e mais intensivo, para deteção e correção atempada de complicações.Sociedade Portuguesa de Angiologia e Cirurgia Vascular2021-09-10T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttps://doi.org/10.48750/acv.317oai:ojs.acvjournal.com:article/317Angiologia e Cirurgia Vascular; Vol. 17 No. 2 (2021): June; 88-96Angiologia e Cirurgia Vascular; Vol. 17 N.º 2 (2021): Junho; 88-962183-00961646-706Xreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAPporhttp://acvjournal.com/index.php/acv/article/view/317https://doi.org/10.48750/acv.317http://acvjournal.com/index.php/acv/article/view/317/243Copyright (c) 2021 Angiologia e Cirurgia Vascularinfo:eu-repo/semantics/openAccessRibeiro, TiagoFerreira, Rita SoaresAlves, GonçaloCatarino, JoanaVieira, IsabelCorreia, RicardoBento, RitaGarcia, RitaPais, FábioCardoso, JoanaGonçalves, Frederico BastosFerreira, Maria Emília2022-05-23T15:10:10Zoai:ojs.acvjournal.com:article/317Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T14:57:40.907765Repositório 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 NELLIX® ENDOPROTHESIS IN THE TREATMENT OF AAA — REPORT OF OUR UNSUCCESSFULL EXPERIENCE
ENDOPRÓTESE NELLIX® NO TRATAMENTO DE AAA NUMA INSTITUIÇÃO TERCIÁRIA — RELATO DO INSUCESSO
title NELLIX® ENDOPROTHESIS IN THE TREATMENT OF AAA — REPORT OF OUR UNSUCCESSFULL EXPERIENCE
spellingShingle NELLIX® ENDOPROTHESIS IN THE TREATMENT OF AAA — REPORT OF OUR UNSUCCESSFULL EXPERIENCE
Ribeiro, Tiago
Abdominal Aortic Aneurysm
Endovascular Aneurysm Sealing (EVAS)
Complications
Aneurisma da Aorta Abdominal
Endovascular Aneurysm Sealing (EVAS)
Complicações
title_short NELLIX® ENDOPROTHESIS IN THE TREATMENT OF AAA — REPORT OF OUR UNSUCCESSFULL EXPERIENCE
title_full NELLIX® ENDOPROTHESIS IN THE TREATMENT OF AAA — REPORT OF OUR UNSUCCESSFULL EXPERIENCE
title_fullStr NELLIX® ENDOPROTHESIS IN THE TREATMENT OF AAA — REPORT OF OUR UNSUCCESSFULL EXPERIENCE
title_full_unstemmed NELLIX® ENDOPROTHESIS IN THE TREATMENT OF AAA — REPORT OF OUR UNSUCCESSFULL EXPERIENCE
title_sort NELLIX® ENDOPROTHESIS IN THE TREATMENT OF AAA — REPORT OF OUR UNSUCCESSFULL EXPERIENCE
author Ribeiro, Tiago
author_facet Ribeiro, Tiago
Ferreira, Rita Soares
Alves, Gonçalo
Catarino, Joana
Vieira, Isabel
Correia, Ricardo
Bento, Rita
Garcia, Rita
Pais, Fábio
Cardoso, Joana
Gonçalves, Frederico Bastos
Ferreira, Maria Emília
author_role author
author2 Ferreira, Rita Soares
Alves, Gonçalo
Catarino, Joana
Vieira, Isabel
Correia, Ricardo
Bento, Rita
Garcia, Rita
Pais, Fábio
Cardoso, Joana
Gonçalves, Frederico Bastos
Ferreira, Maria Emília
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Ribeiro, Tiago
Ferreira, Rita Soares
Alves, Gonçalo
Catarino, Joana
Vieira, Isabel
Correia, Ricardo
Bento, Rita
Garcia, Rita
Pais, Fábio
Cardoso, Joana
Gonçalves, Frederico Bastos
Ferreira, Maria Emília
dc.subject.por.fl_str_mv Abdominal Aortic Aneurysm
Endovascular Aneurysm Sealing (EVAS)
Complications
Aneurisma da Aorta Abdominal
Endovascular Aneurysm Sealing (EVAS)
Complicações
topic Abdominal Aortic Aneurysm
Endovascular Aneurysm Sealing (EVAS)
Complications
Aneurisma da Aorta Abdominal
Endovascular Aneurysm Sealing (EVAS)
Complicações
description Introduction: Nellix® endoprosthesis (Endologix Inc., Irvine, CA) is composed by two ballon-expandable stents surrounded by endobags, which are filled with a polymer, thus obliterating the aneurysmal sac – Endovascular Aneurysm Sealing (EVAS). Initially, due to its properties, was introduced with extended IFU, allowing the use in more complex abdominal aortic aneurysms. However, during the initial experience with this endoprosthesis, a high number of poor outcomes have been described, leading to the progressive restriction of IFU. Currently, it has been discontinued and is only available in selected centers for clinical research purposes. Our study aim to report the institutional results of the use of the Nellix® endoprosthesis in the treatment of AAA. Material and Methods: A retrospective study was designed, including patients with AAA treated with Nellix® endoprosthesis treated at a universitary tertiary care facility. Elective and urgent patients we're included, and patients we're identified through the institutional files. Thoraco-abdominal aneurysm we're excluded. Data about baseline characteristics, surgery, hospitalization course and follow-up post discharge was obtained by consulting personal clinical files. Primary endpoints are technical and clinical success at 30 days, as complications and secondary interventions at mid and long-term. Results: Between 2015 and 2017, this endoprosthesis was used in 12 patients, 9 male and 3 female, with a mean age of 71 (±8) years. The most common comorbidities associated we're hypertension (n=12), current or former tobacco use (n=7), coronary heart disease (n=7), peripheral artery disease (n=6) and chronic kidney disease (n=6) In all patients, the treatment indication was primary degenerative aneurysm, with one exception, which was the presence of type 1a EL after EVAR. Ten patients underwent elective and 2 urgent surgery due to symptomatic aneurysm. Three we're aortoiliac aneurysms and the remaining aortic aneurysms (n=9) with three having involvement of at least one renal artery. Nine patients underwent conventional EVAS; the remaining EVAS with chimney (ChEVAS) for the renal artery(ies) or superior mesenteric artery (n=3). The average preoperative diameter was 57(±6.5) mm. One patient was simultaneously submitted to endovascular repair of a popliteal artery aneurysm with covered stent. By 30 days, death occurred in 2 patients, all submitted to ChEVAS. The most common post-operative complications we're respiratory failure (n=3), AKI with dialysis (n=3), being that in two patients there was intentional covering of the renal arteries (patients with pre-dialysis CKD). In this time frame, we verified one reintervention: catheter-directed thrombolysis for acute limb ischemia due to popliteal covered stent thrombosis. After 30 days, 4 deaths occured (2 year survival 60%, SE 0.154). The most common complications were type 1a EL(n=3), type 1b EL(n=1) and aortic stent thrombosis (n=1). Two patients have already been reintervened: one submitted to femoro-femoral crossover bypass and the other to surgical endoprosthesis explantation and in situ reconstruction aortobifemoral bypass. The last was deceased in the early postoperative period. Two patients are waiting reintervention for type Ia EL and aneurysmal sac growth. The average sac diameter in last follow-up or before secondary intervention was 59(±10.6) mm. Mean follow-up time is 2,3(±1,6) years.  Conclusions: In our institution, the use of Nellix® endoprosthesis is associated with a high rate of perioperative morbidity and mid to long-term aneurysm-related complications, being type Ia EL the most common. Although the free use of the endoprosthesis is currently discontinued, patients who have previously undergone EVAS lack a specific and more intensive surveillance plan for the timely detection and correction of complications.
publishDate 2021
dc.date.none.fl_str_mv 2021-09-10T00:00:00Z
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dc.identifier.uri.fl_str_mv https://doi.org/10.48750/acv.317
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dc.relation.none.fl_str_mv http://acvjournal.com/index.php/acv/article/view/317
https://doi.org/10.48750/acv.317
http://acvjournal.com/index.php/acv/article/view/317/243
dc.rights.driver.fl_str_mv Copyright (c) 2021 Angiologia e Cirurgia Vascular
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2021 Angiologia e Cirurgia Vascular
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Sociedade Portuguesa de Angiologia e Cirurgia Vascular
publisher.none.fl_str_mv Sociedade Portuguesa de Angiologia e Cirurgia Vascular
dc.source.none.fl_str_mv Angiologia e Cirurgia Vascular; Vol. 17 No. 2 (2021): June; 88-96
Angiologia e Cirurgia Vascular; Vol. 17 N.º 2 (2021): Junho; 88-96
2183-0096
1646-706X
reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
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instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
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reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
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