Editor's Choice - Endurant Stent Graft in Patients with Challenging Neck Anatomy "One Step Outside Instructions for Use": Early and Midterm Results from the EAGLE Registry.
Details
Serval ID
serval:BIB_C42A82B149D7
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Editor's Choice - Endurant Stent Graft in Patients with Challenging Neck Anatomy "One Step Outside Instructions for Use": Early and Midterm Results from the EAGLE Registry.
Journal
European journal of vascular and endovascular surgery
Working group(s)
EAGLE registry collaborators
Contributor(s)
Schoder M., Maleux G., Böckler D., Torsello G.B., Georgiadis G.S., Matsagkas M., Speziale F., Teijink JAW, Sondakh A.O., Vahl A.C., de Vries J.P., van Herwaarden J.A., Reichmann B.L., Lardenoye J.H., Krasznai A.G., Akkersdijk G.P., van der Laan L., Ünlü Ҫ., Jiang H.L., Buscher H.C., Schmidli J., Zimmermann A., Saucy F.
ISSN
1532-2165 (Electronic)
ISSN-L
1078-5884
Publication state
Published
Issued date
12/2022
Peer-reviewed
Oui
Volume
64
Number
6
Pages
611-619
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Publication Status: ppublish
Abstract
The aim of the Endurant for Challenging Anatomy: Global Experience (EAGLE) registry is to evaluate prospectively the technical and clinical success rate of a stentgraft used in patients with challenging neck anatomy outside the instructions for use (IFU) but within objective anatomical limits.
This was a prospective, international, multicentre, observational study. From 1 February 2012 to 1 September 2017, patients with an abdominal aortic aneurysm with a challenging infrarenal neck that were deemed suitable for endovascular aneurysm repair were included prospectively at 23 European centres. Patients were distributed by anatomy into three groups: short neck (SN; infrarenal neck 5 - 10 mm in combination with suprarenal angulation [α] ≤ 45° and infrarenal angulation [β] ≤ 60°); medium neck (MN; infrarenal neck 10 - 15 mm with α ≤ 60° and β 60° - 75° or α 45°- 60° and β ≤ 75°; and long angulated neck (LN; infrarenal neck ≥ 15 mm with α ≤ 75° and β 75°- 90° or α 60°- 75° and β ≤ 90°. All computed tomography scans were reviewed by an independent core laboratory. Primary outcomes were technical and clinical success. Secondary endpoints were peri-operative major adverse events, all cause mortality, aneurysm related mortality, endoleaks, migration, and secondary intervention.
One hundred and fifty patients (81.3% male) were included (SN = 55, MN = 16, LN = 79). The median follow up was 36 ± 12.6 months. In the overall cohort, the technical success rate was 93.3%. Estimated freedom from aneurysm related death was 97.3% at three years. Freedom from secondary interventions was 84.7% at three years. Estimated clinical success was 96.0%, 90.8%, and 83.2% at 30 days, one year, and three years, respectively. Estimated freedom from all cause mortality, late type IA endoleak, and migration at three years was 75.1%, 93.7%, and 99.3%, respectively.
The early and midterm results of the EAGLE registry show that endovascular repair with the Endurant stentgraft in selected patients with challenging infrarenal neck anatomy yields results in line with large "real world" registries. Long term results are awaited for more definitive conclusions.
This was a prospective, international, multicentre, observational study. From 1 February 2012 to 1 September 2017, patients with an abdominal aortic aneurysm with a challenging infrarenal neck that were deemed suitable for endovascular aneurysm repair were included prospectively at 23 European centres. Patients were distributed by anatomy into three groups: short neck (SN; infrarenal neck 5 - 10 mm in combination with suprarenal angulation [α] ≤ 45° and infrarenal angulation [β] ≤ 60°); medium neck (MN; infrarenal neck 10 - 15 mm with α ≤ 60° and β 60° - 75° or α 45°- 60° and β ≤ 75°; and long angulated neck (LN; infrarenal neck ≥ 15 mm with α ≤ 75° and β 75°- 90° or α 60°- 75° and β ≤ 90°. All computed tomography scans were reviewed by an independent core laboratory. Primary outcomes were technical and clinical success. Secondary endpoints were peri-operative major adverse events, all cause mortality, aneurysm related mortality, endoleaks, migration, and secondary intervention.
One hundred and fifty patients (81.3% male) were included (SN = 55, MN = 16, LN = 79). The median follow up was 36 ± 12.6 months. In the overall cohort, the technical success rate was 93.3%. Estimated freedom from aneurysm related death was 97.3% at three years. Freedom from secondary interventions was 84.7% at three years. Estimated clinical success was 96.0%, 90.8%, and 83.2% at 30 days, one year, and three years, respectively. Estimated freedom from all cause mortality, late type IA endoleak, and migration at three years was 75.1%, 93.7%, and 99.3%, respectively.
The early and midterm results of the EAGLE registry show that endovascular repair with the Endurant stentgraft in selected patients with challenging infrarenal neck anatomy yields results in line with large "real world" registries. Long term results are awaited for more definitive conclusions.
Keywords
abdominal aortic aneurysm, challenging anatomy, endovascular procedures, infrarenal neck, instructions for use, Abdominal aortic aneurysm, Challenging anatomy, Endovascular procedures, Infrarenal neck, Instructions for use
Pubmed
Web of science
Create date
30/08/2022 9:01
Last modification date
06/07/2024 6:05
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