Midterm outcomes of 455 patients receiving the AFX2 endovascular graft for the treatment of abdominal aortic aneurysm: A retrospective multi-center analysis.

Raymond Vetsch,Matt Thompson,Harvey E Garrett,Christopher L Stout,Alan R Wladis,Joseph V Lombardi,Athanasios Saratzis

doi:10.1371/journal.pone.0261623

Abstract

Since being introduced into clinical practice the AFX family of endografts has undergone labelling updates, design and manufacturing changes to address a Type III failure mode. The published literature on the performance of the current endograft–AFX2 –is limited to small series with limited follow up. The present study reports the largest series of patients implanted with AFX2 for the treatment of abdominal aortic aneurysms. The study was a retrospective, 5 center study of patients receiving an AFX2 endograft from January 2016 until Dec 2020. Electronic case report forms were provided to four of the centers, with one additional site providing relevant outcomes in an independent dataset. Relevant outcomes were reported via Kaplan-Meier analysis and included all-cause mortality, aneurysm-related mortality, post EVAR aortic rupture, open conversion, device related reinterventions and endoleaks. Among a cohort of 460 patients, 405 underwent elective repair of an AAA, 50 were treated for a ruptured AAA, and 5 were aorto-iliac occlusive disease cases. For the elective cohort (mean age 73.7y, 77% male, mean AAA diameter 5.4cm), the peri-operative mortality was 1.7%. Freedom from aneurysm-related mortality was 98.2% at 1,2,3 and 4 years post-operatively, there were no post-operative aortic ruptures, and 2 patients required open conversion. Freedom from Type Ia endoleaks was 99.4% at 1, 2, 3 and 4 years. Freedom from Type IIIa and Type IIIb endoleaks were 100% and 100% (year 1), 100% and 99.6% (year 2), 99.4% and 99.6% (year 3), 99.4% and 99.6% (year 4) respectively. Freedom from all device-related reintervention (including Type II endoleaks) at 4 y was 86.8%. The AFX2 endograft appears to perform to a satisfactory standard in terms of patient centric outcomes in mid-term follow up. The Type Ia and Type III endoleaks rates at 4y appear to be within acceptable limits. Further follow up studies are warranted.

Highlights

Endovascular aneurysm repair (EVAR) is the dominant modality of abdominal aortic aneurysm (AAA) repair in the USA [1]
The present study reports the largest series of patients receiving the AFX2 endograft for the treatment of AAA
The AFX family of endografts was introduced into commercial practice in 2011 and succeeded the Powerlink system which had a reasonable body of clinical data and a low rate of Type III endoleaks [17,18,19]

Summary

Introduction

Endovascular aneurysm repair (EVAR) is the dominant modality of abdominal aortic aneurysm (AAA) repair in the USA [1]. A successful EVAR procedure is partially predicated on achieving proximal fixation and aortic seal to effectively exclude the aneurysm from the circulation. The majority of endografts used for EVAR have a design that includes an active mechanism for supra-renal or infra-renal fixation in the proximal aorta [2]. In contrast to these proximally fixated grafts, the AFX2 endograft (Endologix, Irvine, CA, USA), uses anatomical fixation on the aortic bifurcation with a modular proximal cuff for aortic seal. The proximally fixated endografts have an exoskeleton with firmly adherent graft material

Methods

Results

Discussion

Conclusion