Initial Experience and Potential Advantages of AFX2 Bifurcated Endograft System: Comparative Case Series

Jo, Eun-Ah; Ahn, Sungyoon; Min, Seung-Kee; Mo, Hyejin; Jae, Hwan Jun; Hur, Saebeom

doi:10.5758/vsi.2019.35.4.209

Cited by 11 publications

(8 citation statements)

References 19 publications

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“…The AFX family of endografts has a unibody design, which allows some unique applications in patients with a narrow distal aorta [7,21] and in patients in whom preservation of the native aortic bifurcation is required for future treatment of peripheral vascular disease [22].…”

Section: Discussionmentioning

confidence: 99%

“…The published literature on the performance of the AFX2 endograft is limited [5][6][7][8][9], but a recent publication by Chang et al (2021) [10] which reported a single integrated healthcare system experience of AFX and AFX2, suggested that the AFX2 endograft was associated with a high rate of adverse clinical events during follow up. The present study was designed to evaluate the outcomes derived by the AFX2 endograft in a series of patients from multiple centers in the USA.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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“…There are many restrictions placed by the manufacturer on the use of IBE with the Excluder main body [ 13 , 14 ], and appropriate preoperative planning in endovascular repair may yield satisfactory results. AFX2 (Endologix, Irvine, CA, USA) is a unique bifurcated unibody endograft that fits the small terminal aorta and provides a proper landing zone for the common iliac artery (CIA) [ 18 , 19 ]. We report two cases of successful endovascular repair of iliac arterial aneurysms aiming to prevent pelvic ischemia.…”

Section: Introductionmentioning

confidence: 99%

Successful endovascular repair of iliac artery aneurysms with unsuitable anatomy by combining unibody bifurcated endograft and iliac branch systems to preserve hypogastric artery blood flow: a report of two cases

Akagi

Murase

2022

J Cardiothorac Surg

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Background To overcome the anatomical limitation of a narrow aorta and short length from the renal artery to the terminal aorta, unibody endograft AFX2 and iliac branch endoprosthesis (IBE) can be combined. Case presentation Case 1: The first patient was an 89-year-old woman who had a right saccular common iliac artery (CIA) aneurysm (38 mm); the abdominal aorta was not aneurysmal (diameter, 19 mm). The right CIA’s origin was 10 mm in diameter. A bifurcated AFX2 was placed in an ordinary manner. Then, IBE was inserted in the right leg of the AFX2. Case 2: The second patient was an 87-year-old man diagnosed with an abdominal aortic aneurysm (55 mm), right dissecting CIA aneurysm (20 mm), and right hypogastric artery aneurysm (22 mm) extending to the bifurcation of the superior and inferior gluteal arteries. The length between the renal artery and terminal aorta was 107 mm. The beginning of the right CIA was segmentally stenotic (13 mm). A bifurcated AFX2 was placed in the infrarenal aorta; IBE was advanced to the origin of the right limb of the AFX2. To control the type 1b endoleak, the right superior gluteal artery was embolized with coils and internal iliac components were deployed toward the inferior gluteal artery. Satisfactory results were obtained in both cases. Conclusion The AFX2 main body and IBE could be combined to preserve hypogastric blood flow and overcome anatomical limitations.

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“…The AFX endovascular aortic aneurysm system (AFX stent graft; Endologix, Irvine, CA) is a unique bifurcated endograft with an Active Seal technology (Supplementary Figure 1). 6–8 The Active Seal technology uses a graft material that is externally mounted and attached only at the proximal and distal ends of the stent, which allows the conformable expanded polytetrafluoroethylene (ePTFE) material to expand independently of the stent by the blood pressure (Figure 1). It can accommodate various aortic wall shapes at the proximal and distal sealing zones 7,8 and extend the proximal sealing zone.…”

Section: Introductionmentioning

confidence: 99%

Early Clinical Outcomes of the Active Seal Technology of the AFX Endovascular Aortic Aneurysm System With the VELA Cuff for Patients With a Conical Proximal Neck

et al. 2022

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Purpose: To evaluate the efficacy of the Active Seal technology employed in the AFX endovascular aortic aneurysm system (AFX), during endovascular aneurysm repair (EVAR) in patients with abdominal aortic aneurysms (AAAs) having a conical proximal neck. Materials and Methods: A retrospective analysis of the EVAR for AAA with a conical proximal neck using the AFX was performed at 17 Japanese hospitals between January 2016 and August 2020. The conical proximal neck was defined as a cone-shaped proximal neck, with more than 10% diameter increase within a 15 mm length at the proximal landing zone. All anatomical analyses were performed in the core laboratory, and cases with parallel walls within the proximal neck adequate for the landing zone were excluded from the study. Results: This study included 53 patients, but only 39 patients (mean age, 76.6 ± 6.7 years; 87.0% males; mean aneurysm diameter, 52.0 ± 8.0 mm) were analyzed after being characterized as having a pure conical neck by the core laboratory. The mean proximal neck diameters at the lower renal artery and proximal edge of the aneurysm were 20.0 ± 2.9 mm and 27.5 ± 4.9 mm, respectively. The mean proximal neck length was 21.5 ± 6.0 mm. Instructions for use violations other than the conical neck were observed in 15 patients (38.5%). The VELA cuff was used in all cases; however, additional proximal cuff was required in 9 more cases (23.1%). The Active Seal technology was able to significantly extend the proximal sealing zone from 21.5 ± 6.0 to 26.0 ± 12.2 mm ( p = .047). Thirty-six patients completed the 12-month follow-up (one patient was lost to follow-up, and 2 patients died from causes unrelated to the aneurysm), and there were no type-1a and 3 endoleaks with only one reintervention (2.6%) related to type 1b endoleak in the 12-month period. Furthermore, there was no significant enlargement of the proximal neck diameter at 12 months (at 1 month: 20.6 ± 3.4 mm and at 12 months: 21.3 ± 3.8 mm; p = .420). Conclusion: The Active Seal technology of the AFX significantly extended the proximal seal zone and no type-1a endoleak and proximal neck dilation was observed in patients with conical proximal neck at 12 months.

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Initial Experience and Potential Advantages of AFX2 Bifurcated Endograft System: Comparative Case Series

Cited by 11 publications

References 19 publications

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

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

Successful endovascular repair of iliac artery aneurysms with unsuitable anatomy by combining unibody bifurcated endograft and iliac branch systems to preserve hypogastric artery blood flow: a report of two cases

Early Clinical Outcomes of the Active Seal Technology of the AFX Endovascular Aortic Aneurysm System With the VELA Cuff for Patients With a Conical Proximal Neck

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