Midterm Outcomes With the Nellix Endograft Alone or With Chimneys

Introduction: Endovascular aneurysm sealing (EVAS) appeared to be an innovative alternative to conventional endovascular abdominal aortic aneurysm repair. However, high rates of midterm failure of EVAS led to withdrawal of the device from the market. The study aim was to report midterm outcomes of p...

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Main Authors: Salomé Kuntz, Céline Deslarzes, Alexandre Than Vinh Nguyen, Alban Longchamp, Rosalinda D'Amico, Justine Longchamp, Anne Lejay, Nabil Chakfé, Sébastien Déglise
Format: Article
Language:English
Published: Elsevier 2024-01-01
Series:EJVES Vascular Forum
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Online Access:http://www.sciencedirect.com/science/article/pii/S2666688X24000923
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author Salomé Kuntz
Céline Deslarzes
Alexandre Than Vinh Nguyen
Alban Longchamp
Rosalinda D'Amico
Justine Longchamp
Anne Lejay
Nabil Chakfé
Sébastien Déglise
author_facet Salomé Kuntz
Céline Deslarzes
Alexandre Than Vinh Nguyen
Alban Longchamp
Rosalinda D'Amico
Justine Longchamp
Anne Lejay
Nabil Chakfé
Sébastien Déglise
author_sort Salomé Kuntz
collection DOAJ
description Introduction: Endovascular aneurysm sealing (EVAS) appeared to be an innovative alternative to conventional endovascular abdominal aortic aneurysm repair. However, high rates of midterm failure of EVAS led to withdrawal of the device from the market. The study aim was to report midterm outcomes of patients treated with EVAS alone or associated with chimneys (Ch-EVAS) and the management of their complications. Methods: In this single centre study, all consecutive Nellix implants between 2013 and 2016 were included. The primary endpoint was device failure: (1) a triad of caudal migration of the Nellix stents >5 mm, separation of the endobags (>5 mm), and sac enlargement (>5 mm), with or without visible endoleak, (2) secondary aneurysm rupture, (3) surgical explant of the graft, or (4) any intervention for a type I endoleak. Overall mortality, aneurysm related mortality, and re-intervention rates were analysed. Results: Fifty patients (male n = 43, female n = 7) were included. Median follow-up was 3.05 years (interquartile range [IQR] 0.52, 4.63) and follow up index was 0.51 (IQR 0.10, 0.88). Device failures occurred in 17 patients (34%). Overall and aneurysm related mortality rates during the follow up period were 30% and 13%. Fourteen (28%) patients required re-interventions. Five EVAS patients (17%) presented with complications. Type Ia endoleaks were managed by device explantation for three patients, and endovascular aneurysm repair in Nellix for two patients. Type Ib endoleaks were managed with an iliac branched device and limb extension. Nine Ch-EVAS patients (42.9%) presented with complications. Type Ia endoleaks were was managed by Nellix stent prolongation and renal extension, two multibranched thoraco-abdominal devices, and two device explantations. Type Ib endoleaks were managed by limb extension and stent complications by stent angioplasty and iliorenal bypass. Conclusion: The midterm outcome of EVAS is poor. All patients who underwent EVAS implantation must be informed and should undergo frequent surveillance. Open repair and device explantation should be considered as the primary treatment.
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spelling doaj-art-d957b2ce93f0422f83876a267e77ecf02025-08-20T01:56:24ZengElsevierEJVES Vascular Forum2666-688X2024-01-016281410.1016/j.ejvsvf.2024.06.001Midterm Outcomes With the Nellix Endograft Alone or With ChimneysSalomé Kuntz0Céline Deslarzes1Alexandre Than Vinh Nguyen2Alban Longchamp3Rosalinda D'Amico4Justine Longchamp5Anne Lejay6Nabil Chakfé7Sébastien Déglise8Department of Vascular Surgery and Kidney Transplantation, University of Strasbourg, France; Gepromed, Strasbourg, France; Department of Vascular Surgery, Lausanne University Hospital, Lausanne, Switzerland; Corresponding author. Department of Vascular Surgery and Kidney Transplantation, Strasbourg University Hospital, Nouvel Hôpital Civil, 1 Place de l'hôpital, 67091 Strasbourg Cedex, France.Department of Vascular Surgery, Lausanne University Hospital, Lausanne, SwitzerlandDepartment of Vascular Surgery, Lausanne University Hospital, Lausanne, SwitzerlandDepartment of Vascular Surgery, Lausanne University Hospital, Lausanne, SwitzerlandDepartment of Vascular Surgery, Lausanne University Hospital, Lausanne, SwitzerlandDepartment of Vascular Surgery, Lausanne University Hospital, Lausanne, SwitzerlandDepartment of Vascular Surgery and Kidney Transplantation, University of Strasbourg, France; Gepromed, Strasbourg, FranceDepartment of Vascular Surgery and Kidney Transplantation, University of Strasbourg, France; Gepromed, Strasbourg, FranceDepartment of Vascular Surgery, Lausanne University Hospital, Lausanne, SwitzerlandIntroduction: Endovascular aneurysm sealing (EVAS) appeared to be an innovative alternative to conventional endovascular abdominal aortic aneurysm repair. However, high rates of midterm failure of EVAS led to withdrawal of the device from the market. The study aim was to report midterm outcomes of patients treated with EVAS alone or associated with chimneys (Ch-EVAS) and the management of their complications. Methods: In this single centre study, all consecutive Nellix implants between 2013 and 2016 were included. The primary endpoint was device failure: (1) a triad of caudal migration of the Nellix stents >5 mm, separation of the endobags (>5 mm), and sac enlargement (>5 mm), with or without visible endoleak, (2) secondary aneurysm rupture, (3) surgical explant of the graft, or (4) any intervention for a type I endoleak. Overall mortality, aneurysm related mortality, and re-intervention rates were analysed. Results: Fifty patients (male n = 43, female n = 7) were included. Median follow-up was 3.05 years (interquartile range [IQR] 0.52, 4.63) and follow up index was 0.51 (IQR 0.10, 0.88). Device failures occurred in 17 patients (34%). Overall and aneurysm related mortality rates during the follow up period were 30% and 13%. Fourteen (28%) patients required re-interventions. Five EVAS patients (17%) presented with complications. Type Ia endoleaks were managed by device explantation for three patients, and endovascular aneurysm repair in Nellix for two patients. Type Ib endoleaks were managed with an iliac branched device and limb extension. Nine Ch-EVAS patients (42.9%) presented with complications. Type Ia endoleaks were was managed by Nellix stent prolongation and renal extension, two multibranched thoraco-abdominal devices, and two device explantations. Type Ib endoleaks were managed by limb extension and stent complications by stent angioplasty and iliorenal bypass. Conclusion: The midterm outcome of EVAS is poor. All patients who underwent EVAS implantation must be informed and should undergo frequent surveillance. Open repair and device explantation should be considered as the primary treatment.http://www.sciencedirect.com/science/article/pii/S2666688X24000923Abdominal aortic aneurysmEndoleakEndovascular Aneurysm SealingEVASNellix
spellingShingle Salomé Kuntz
Céline Deslarzes
Alexandre Than Vinh Nguyen
Alban Longchamp
Rosalinda D'Amico
Justine Longchamp
Anne Lejay
Nabil Chakfé
Sébastien Déglise
Midterm Outcomes With the Nellix Endograft Alone or With Chimneys
EJVES Vascular Forum
Abdominal aortic aneurysm
Endoleak
Endovascular Aneurysm Sealing
EVAS
Nellix
title Midterm Outcomes With the Nellix Endograft Alone or With Chimneys
title_full Midterm Outcomes With the Nellix Endograft Alone or With Chimneys
title_fullStr Midterm Outcomes With the Nellix Endograft Alone or With Chimneys
title_full_unstemmed Midterm Outcomes With the Nellix Endograft Alone or With Chimneys
title_short Midterm Outcomes With the Nellix Endograft Alone or With Chimneys
title_sort midterm outcomes with the nellix endograft alone or with chimneys
topic Abdominal aortic aneurysm
Endoleak
Endovascular Aneurysm Sealing
EVAS
Nellix
url http://www.sciencedirect.com/science/article/pii/S2666688X24000923
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