gms | German Medical Science

10th Munich Vascular Conference

01.-03.12.2021, online

Endograft type is a risk factor for limb graft occlusion in patients treated with EVAR

Meeting Abstract

  • author Marko Bogdanovic - Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
  • author presenting/speaker Mårten Huss - Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
  • author Otto Stackelberg - Department of Clinical Science and Education, Karolinska Institutet at Södersjukhuset, Stockholm, Sweden
  • author David Lindström - Department of Surgical Sciences, Section of Vascular Surgery, Uppsala University, Uppsala, Sweden
  • author Samuel Ersryd - Centre for Research and Development, Uppsala University/County Council of Gävleborg, Gävle, Sweden
  • author Manne Andersson - Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden
  • author Håkan Roos - Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
  • author Antti Siika - Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
  • author Magnus Jonsson - Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
  • corresponding author Joy Roy - Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden

10th Munich Vascular Conference. sine loco [digital], 01.-03.12.2021. Düsseldorf: German Medical Science GMS Publishing House; 2021. Doc10

doi: 10.3205/21mac10, urn:nbn:de:0183-21mac103

Published: December 22, 2021

© 2021 Bogdanovic et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

Text

Background: Limb graft occlusion (LGO) is a serious complication after endovascular aneurysm repair (EVAR). In recent years, the vascular community has seen a rapid development of endograft devices enabling treatment of increasingly complex aortic anatomy yet little is published on how endograft type affects the risk of certain complications such as LGO. This retrospective study aimed to explore the incidence and risk factors associated with LGO after EVAR using the Cook Zenith Alpha, Gore Excluder and Medtronic Endurant devices.

Methods: We included all patients treated with standard EVAR, between January 2012 and December 2018, at five Swedish vascular surgery centres. LGO was defined as a total limb occlusion regardless of symptoms, or a treated significant stenosis. A nested case control (NCC) design with incidence density sampling of 1:3 was used for analysis of potential per-operative and morphological risk factors for LGO. Computed tomography angiography (CTA) imaging preoperatively and at occlusion/ postoperatively were analysed with 3Mensio Vascular for all patients included in the NCC. Conditional logistic regression was used to estimate multivariable odds ratios (OR) with 95% confidence intervals (CI). Further sub-analysis comparing outcome and morphological differences between cases and controls within the endograft device type with the highest occlusion rate was conducted.

Results: Of the 924 patients included (Zenith Alpha (n=315, ZISL limbs), Excluder (n=152, PLC/PXC limbs), and Endurant (n=457, ETLW/ ETEW limbs), 84% were male. The mean age was 76 years (7.5 SD), and median AAA diameter was 59 mm (IQR 55, 67). During median follow up of 37 months (IQR 21, 62), 55 occlusions were recorded (5.9%); of which 39 were seen with the Zenith Alpha device (12.4%), one with Excluder (0.7%), and 15 with Endurant (3.3%). In the NCC analysis, external iliac artery (EIA) landing (OR 5.91, 95% CI 1.30-26.7), EIA diameter <10 mm (OR 4.99, 95% CI 1.46-16.9) and the Zenith Alpha device (OR 5.31, 95% CI 1.97-14.3) were independent risk factors for LGO. Further detailed analysis of the cause of occlusions in patients with the Zenith Alpha device is ongoing.

Conclusion: This study concludes that endograft device type is an independent risk factor for LGO after EVAR. Specifically, the Zenith Alpha demonstrated an increased risk of LGO compared with the Endurant and Excluder devices. In addition, landing zone in the EIA and a narrow EIA and are also risk factors for LGO. Our study highlights the need for industry – independent investigations on outcomes after introduction of new medical devices.