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

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.

Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices

“…This same study reported type III endoleak rates of 14.1% for AFX2 at 2 years post intervention, although these results were based on a cohort of only 33 patients. These results are in contrast to findings reported in a multicenter retrospective analysis sponsored by Endologix, which reported 2-year rates of type III endoleaks of 0.4% in a cohort of 405 patients. Our findings, based on 602 patients receiving AFX2 devices, fall in between, with a rate of type III endoleaks of 4.5% at 2 years.…”

Surgery for late type Ia/IIIb endoleak from a fabric tear and stent fracture of AFX2 stent graft

“… 15 , 16 Following these investigations, multiple product design, manufacturing, and labeling updates were implemented, which led to significant improvement in the outcomes by a reduction in the incidence of aneurysm-related complications and a lower incidence of type III endoleaks using the DuraPly AFX stent compared with the Strata stent. 17 , 18…”

“…Several studies have investigated the outcomes associated with the first generation of AFX (Strata) and have shown a high rate of Type IIIa/IIIb endoleak at three years 15,16 . Following these investigations, multiple product design, manufacturing, and labeling updates were implemented which led to a significant improvement of outcomes in terms of a reduction of aneurysm related complications, and of a lower incidence of type III endoleak with Duraply compared to Strata 17,18 .…”

Midterm outcomes of AFX2 endografts used in combination with aortic cuffs

“…A recent study revealed excellent outcomes after using AFX with a low rate of type-III endoleaks. 11 In Japan, the latest version of the unibody stent graft (AFX2) was launched in February 2017.…”