The Nellix endovascular aneurysm sealing system: current perspectives

Xin Y Choo,1 Shahab Hajibandeh,1 Shahin Hajibandeh,1 George A Antoniou1,2 1Department of Vascular and Endovascular Surgery, The Royal Oldham Hospital, Pennine Acute Hospitals NHS Trust, Manchester, UK; 2Division of Cardiovascular Sciences, School of Medical Sciences, University of Manchester, Manche...

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Autores principales:	Choo XY, Hajibandeh S, Antoniou GA
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2019
Materias:	endovascular aneurysm sealing Nellix aortic aneurysm Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/1b91aa5fc5224616bcafce0dcf7dd34c
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spelling	oai:doaj.org-article:1b91aa5fc5224616bcafce0dcf7dd34c2021-12-02T02:34:41ZThe Nellix endovascular aneurysm sealing system: current perspectives1179-1470https://doaj.org/article/1b91aa5fc5224616bcafce0dcf7dd34c2019-02-01T00:00:00Zhttps://www.dovepress.com/the-nellix-endovascular-aneurysm-sealing-system-current-perspectives-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Xin Y Choo,1 Shahab Hajibandeh,1 Shahin Hajibandeh,1 George A Antoniou1,2 1Department of Vascular and Endovascular Surgery, The Royal Oldham Hospital, Pennine Acute Hospitals NHS Trust, Manchester, UK; 2Division of Cardiovascular Sciences, School of Medical Sciences, University of Manchester, Manchester, UK Background: The Nellix endovascular aneurysm sealing (EVAS) system is a novel approach for the treatment of abdominal aortic aneurysm (AAA). We aimed to evaluate the efficacy of EVAS in the management of patients with AAA. Materials and methods: We searched PubMed/MEDLINE, CINAHL, and bibliographic reference lists to identify studies reporting clinical outcomes in patients with asymptomatic, non-ruptured AAA treated with EVAS with the Nellix device. We pooled dichotomous outcome data using random-effects models. Results: We identified 14 single-arm observational studies, reporting a total of 1,510 patients. The pooled estimate of technical success was 99% (95% CI =98–100; heterogeneity: P=0.869, I2=0%). Adjunctive procedures were carried out in 39% (95% CI =19–63; heterogeneity: P<0.0001, I2=88%). Two cases of aneurysm rupture were reported within 30 days of treatment (0.7%, 95% CI =0.3–1.6; heterogeneity: P=0.923, I2=0%) and another five cases of rupture occurred during follow-up (0.8%, 95% CI =0.4–1.6; heterogeneity: P=0.958, I2=0%). The pooled estimates of early (within 30 days) and late (during follow-up) type I endoleak were 2.8 % (95% CI =1.8–4.2; heterogeneity: P=0.254, I2=18%) and 1.9% (95% CI =1.3–2.8; heterogeneity: P=0.887, I2=0%), respectively. Sac enlargement was noted in 3.1% (95% CI =1.8–5.4; heterogeneity: P=0.419, I2=0%) and device migration in 2.1% (95% CI =0.8–5.3; heterogeneity: P=0.004, I2=65%). The early and late reintervention rates were 2.7% (95% CI =1.7–4.2; heterogeneity: P=0.183, I2=27%) and 3.5% (95% CI =2.3–5.5; heterogeneity: P=0.061, I2=42%), respectively. The pooled estimate of 30-day mortality was 1.5% (95% CI =0.9–2.6; heterogeneity: P=0.559, I2=0%) and the pooled estimate of aneurysm-related death during follow-up was 1.0% (95% CI =0.6–1.9; heterogeneity: P=0.872, I2=0%). Conclusion: Reported outcomes of EVAS are acceptable. Type I endoleak, sac enlargement, device migration, and aneurysm rupture are recognized complications. High-level research is required to investigate potential advantages of EVAS over conventional treatments. Keywords: endovascular aneurysm sealing, Nellix, aortic aneurysm, EVAS, AAA, endovascular aneurysm repair, EVARChoo XYHajibandeh SHajibandeh SAntoniou GADove Medical Pressarticleendovascular aneurysm sealingNellixaortic aneurysmMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 12, Pp 65-79 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	endovascular aneurysm sealing Nellix aortic aneurysm Medical technology R855-855.5
spellingShingle	endovascular aneurysm sealing Nellix aortic aneurysm Medical technology R855-855.5 Choo XY Hajibandeh S Hajibandeh S Antoniou GA The Nellix endovascular aneurysm sealing system: current perspectives
description	Xin Y Choo,1 Shahab Hajibandeh,1 Shahin Hajibandeh,1 George A Antoniou1,2 1Department of Vascular and Endovascular Surgery, The Royal Oldham Hospital, Pennine Acute Hospitals NHS Trust, Manchester, UK; 2Division of Cardiovascular Sciences, School of Medical Sciences, University of Manchester, Manchester, UK Background: The Nellix endovascular aneurysm sealing (EVAS) system is a novel approach for the treatment of abdominal aortic aneurysm (AAA). We aimed to evaluate the efficacy of EVAS in the management of patients with AAA. Materials and methods: We searched PubMed/MEDLINE, CINAHL, and bibliographic reference lists to identify studies reporting clinical outcomes in patients with asymptomatic, non-ruptured AAA treated with EVAS with the Nellix device. We pooled dichotomous outcome data using random-effects models. Results: We identified 14 single-arm observational studies, reporting a total of 1,510 patients. The pooled estimate of technical success was 99% (95% CI =98–100; heterogeneity: P=0.869, I2=0%). Adjunctive procedures were carried out in 39% (95% CI =19–63; heterogeneity: P<0.0001, I2=88%). Two cases of aneurysm rupture were reported within 30 days of treatment (0.7%, 95% CI =0.3–1.6; heterogeneity: P=0.923, I2=0%) and another five cases of rupture occurred during follow-up (0.8%, 95% CI =0.4–1.6; heterogeneity: P=0.958, I2=0%). The pooled estimates of early (within 30 days) and late (during follow-up) type I endoleak were 2.8 % (95% CI =1.8–4.2; heterogeneity: P=0.254, I2=18%) and 1.9% (95% CI =1.3–2.8; heterogeneity: P=0.887, I2=0%), respectively. Sac enlargement was noted in 3.1% (95% CI =1.8–5.4; heterogeneity: P=0.419, I2=0%) and device migration in 2.1% (95% CI =0.8–5.3; heterogeneity: P=0.004, I2=65%). The early and late reintervention rates were 2.7% (95% CI =1.7–4.2; heterogeneity: P=0.183, I2=27%) and 3.5% (95% CI =2.3–5.5; heterogeneity: P=0.061, I2=42%), respectively. The pooled estimate of 30-day mortality was 1.5% (95% CI =0.9–2.6; heterogeneity: P=0.559, I2=0%) and the pooled estimate of aneurysm-related death during follow-up was 1.0% (95% CI =0.6–1.9; heterogeneity: P=0.872, I2=0%). Conclusion: Reported outcomes of EVAS are acceptable. Type I endoleak, sac enlargement, device migration, and aneurysm rupture are recognized complications. High-level research is required to investigate potential advantages of EVAS over conventional treatments. Keywords: endovascular aneurysm sealing, Nellix, aortic aneurysm, EVAS, AAA, endovascular aneurysm repair, EVAR
format	article
author	Choo XY Hajibandeh S Hajibandeh S Antoniou GA
author_facet	Choo XY Hajibandeh S Hajibandeh S Antoniou GA
author_sort	Choo XY
title	The Nellix endovascular aneurysm sealing system: current perspectives
title_short	The Nellix endovascular aneurysm sealing system: current perspectives
title_full	The Nellix endovascular aneurysm sealing system: current perspectives
title_fullStr	The Nellix endovascular aneurysm sealing system: current perspectives
title_full_unstemmed	The Nellix endovascular aneurysm sealing system: current perspectives
title_sort	nellix endovascular aneurysm sealing system: current perspectives
publisher	Dove Medical Press
publishDate	2019
url	https://doaj.org/article/1b91aa5fc5224616bcafce0dcf7dd34c
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The Nellix endovascular aneurysm sealing system: current perspectives

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