Midterm outcomes of AFX2 endografts used in combination with

aortic cuffs
Katsuyuki Hoshina, PhD, Masamitsu Suhara, PhD, Kazuhiro Miyahara, PhD, Yasuaki Mochizuki, PhD,
Ryosuke Taniguchi, PhD, and Toshio Takayama, PhD, the Japan AFX registry, Tokyo, Japan

ABSTRACT
Objective: Type III endoleaks after endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) with the
Endologix unibody endograft remain a major concern, despite fabric, system, and instructional updates. The purpose of
this study was to examine real-world outcomes of repairing AAAs using the current version of the AFX2 main body in
combination with an aortic cuff, specifically focusing on type III endoleaks and morphological changes of the endograft.
Methods: We recruited facilities in Japan that used AFX2 combined with an aortic cuff for at least five cases between April
2017 and March 2018. A total of 175 cases in 24 facilities were analyzed. Patients’ background information, including
anatomic factors, operative findings, device component variations, and midterm outcomes at 3 years after the EVAR were
collected. The data on computed tomography scans from cases registered as types I and III endoleaks and migration
from each institute were sent to our department for verification.
Results: The mean patient age was 74.6 6 8.1 years, and 48 cases (27%) were saccular aneurysms. The mean fusiform and
saccular AAA diameters were 50.5 6 5.8 mm and 43.5 6 8.9 mm, respectively. No in-hospital deaths occurred. Data at
3 years, including computed tomography images, of 128 cases were analyzed. Overall survival, freedom from aneurysm-
related mortality, and freedom from reintervention rates at 3 years were 85.8%, 99.3%, and 87.3%, respectively. There were
three, one, and three cases of types I, IIIa, and IIIb endoleaks without sac dilatations, respectively. Among five migration
cases, one case of aortic cuff migration presented as a type Ia endoleak, and four cases demonstrated sideways
displacement, one of which presented as a type IIIa endoleak. The sac regression and enlargement rates at 3 years were
41.4% and 20.5% in the fusiform group and 44.2% and 16.7% in the saccular group, respectively. The proximal neck
diameter slightly increased from 20.8 6 2.7 mm before the EVAR to 22.2 6 4.6 mm after the repair.
Conclusions: Midterm outcomes of the AFX2 used in combination with an aortic cuff were acceptable, considering the
rates of types I and III endoleaks. However, there were cases of sideways displacement that could cause future type IIIa
endoleaks. When the AFX2 is used in combination with an aortic cuff, close surveillance for endograft deformations and
subsequent adverse events, including type III endoleaks, is needed. (J Vasc Surg 2023;77:424-31.)
Keywords: Abdominal aortic aneurysm; Type III endoleak; Unibody endograft; Aortic cuff migration; Sideways
displacement

More than 30 years have passed since Parodi et al first re-
ported the successful use of a stent graft in 1991 to treat an
abdominal aortic aneurysm (AAA).1 Although the excel-
lent low mortality of endovascular aneurysm repair
(EVAR) for AAA in the short term was initially promising,2,3
From the Department of Vascular Surgery, Graduate School of Medicine, The
University of Tokyo.
Author conflict of interest: Katsuyuki Hoshina received funding from Japan Life-
line Co.
Additional material for this article may be found online at www.jvascsurg.org.
Correspondence: Katsuyuki Hoshina, PhD, Department of Surgery, Graduate
School of Medicine, the University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo
113-8655, Japan (e-mail: traruba@gmail.com).
The editors and reviewers of this article have no relevant financial relationships to
disclose per the JVS policy that requires reviewers to decline review of any
manuscript for which they may have a conflict of interest.
0741-5214
Copyright Ó 2022 The Authors. Published by Elsevier Inc. on behalf of the So-
ciety for Vascular Surgery. This is an open access article under the CC BY li-
cense (http://creativecommons.org/licenses/by/4.0/).
https://doi.org/10.1016/j.jvs.2022.09.006
the early benefits of EVAR compared with those of open
surgical repairs disappeared in the midterm and long
term.4 Considering the increased long-term mortality
and higher reintervention rates owing to endoleaks or
sac enlargements, EVAR is a less-durable treatment that
has room for improvement.5 With the accumulation of
EVAR experience, operators have learned the characteris-
tics of various devices, and they now select devices ac-
cording to the AAA anatomy for better long-term
outcomes. Among various endografts, the AFX Endovas-
cular AAA System (Endologix, Inc.; Irvine, CA) is a
unibody-type device with unique features such as the
ActiveSeal mechanism, which extends the sealing zone
in the AAA sac.6,7 The AFX was considered ideal for a
saccular AAA, narrow aortic bifurcations, hostile (eg,
reverse tapered or bulging) necks, and cases with a short
length from the lower renal artery to the aortic bifurca-
tion.7 However, this unibody endograft has shown high
rates of type III endoleaks,8-10 and the US Food and
Drug Administration issued a class I voluntary recall of

424
Journal of Vascular Surgery
Volume 77, Number 2
AFX systems in 2018. Nevertheless, there has been no clear
evidence of flaws in studies using large cohorts and less
bias. A recent study revealed excellent outcomes after us-
ing 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. After the US
Food and Drug Administration-issued briefing regarding
the high risk of type III endoleaks with the AFX2, as well
as with the previous version of AFX with Strata,12 real-
world data regarding the risk of type III endoleaks after
using AFX were needed. In this study, we focused on
type III endoleaks as an adverse outcome after EVAR
and collected and analyzed the data of patients treated
with AFX2 in combination with an aortic cuff.
METHODS
The Japan AFX registry. After the launch of AFX2 in
February 2017 in Japan, more than 3 years of EVAR out-
comes data have accumulated. We recruited facilities
in Japan for inclusion in the registry that had used
AFX2 in combination with an aortic cuff for at least five
cases between April 2017 and March 2018. During this
period, there were 1807 EVAR cases using AFX2, and
aortic cuffs were used with main body in 1125 cases.
Our recruited 175 cases were 15.5%. The share of AFX
among all EVAR devices was 14%.
Cases with operative indications for iliac artery aneu-
rysms, infection, and rupture were excluded. In addition,
we excluded facilities that did not agree to the contract
or an ethical review. As a result, 24 facilities participated
in the Japan AFX registry. Anonymized data from 175
cases were sent from each facility to the Department of
Vascular Surgery at the University of Tokyo for analysis.
The data of 175 cases registered initially were followed
up at 6 months and at 1, 2, and 3 years.
The Japan AFX registry was conducted according to the
principles of the Declaration of Helsinki, the International
Conference on Harmonization, and the Good Clinical
Practice guidelines. Informed consent was obtained
from all patients in each institute, and the protocol was
approved comprehensively by the Institutional Review
Board of the University of Tokyo Hospital (approval num-
ber: 2019268NI).
Outcomes. Outcomes, including the rates of overall
survival, freedom from aneurysm-related mortality, and
freedom from reintervention, were analyzed. The preop-
erative patient demographics included age; sex; smoking
habits; the presence of hypertension, diabetes mellites,
coronary artery disease, cerebrovascular disease, and
respiratory disorders under treatment; and the use of
antiplatelets and anticoagulants. Saccular and fusiform
morphologies were assessed by the operators. Other
anatomic parameters included the AAA diameter, prox-
imal neck diameter, length of the proximal neck, and
terminal aorta diameter. Severe suprarenal (>45
) and
Hoshina et al 425
ARTICLE HIGHLIGHTS
d
Type of Research: Retrospective, single-arm study
from the multicenter Japan AFX registry
d
Key Findings: Abdominal aortic aneurysms of 175 pa-
tients repaired with AFX2 endografts in combination
with aortic cuffs resulted in low rates of types IIIa and
IIIb endoleaks (n ¼ 4 [3.1%]); however, sideways
displacement sometimes occurred in the midterm
(n ¼ 4 [3.1%]), which could cause future type IIIa
endoleaks.
d
Take Home Message: Migration could occur, which
might cause future type IIIa endoleaks. AFX2 endog-
rafts, especially in combination with aortic cuffs,
should be used with the longest possible compo-
nents and receive close surveillance to prevent
device-related adverse events.
infrarenal (>60
) neck angulations and a reverse tapered
neck were regarded as hostile anatomies.
The types of endoleaks and migration were determined
by the operators. The data on computed tomography
(CT) scans from each institute from cases registered as
type I or III endoleaks and migration were sent to our
department for verification. The number of cases with
less than 5 mm of AAA sac enlargement or shrinkage
were counted.
Statistical analyses. Categorical and continuous vari-
ables were presented as number and percentage and as
mean 6 standard deviation, respectively. The Kaplan-
Meier method with log-rank testing was used to analyze
the overall survival, freedom from aneurysm-related
mortality, freedom from reintervention rates, and the cu-
mulative probability of sac enlargement and regression.
All statistical analyses were performed with JMP Pro 15.1.0
(SAS Institute Inc., Cary, NC) software. The threshold for
statistical significance was a P value of less than .05.
RESULTS
Patient backgrounds. The baseline background char-
acteristics of the study cohort are shown in Table I. The
mean patient age was 74.6 6 8.1 years, and 154 patients
(88%) were men. There were 48 cases (27%) with saccular
aneurysms. The mean fusiform and saccular AAA di-
ameters were 50.5 6 5.8 mm and 43.5 6 8.9 mm,
respectively. Most cases (n ¼ 158 [89%]) had an athero-
sclerotic etiology, followed by dissection, inflammation,
and vasculitis in 13 (7.4%), 4 (2.3%), and 1 (0.6%) cases,
respectively. The mean proximal neck diameter, prox-
imal neck length, and terminal aorta diameter were
20.8 6 2.7 mm, 37.9 6 15.2 mm, and 20.7 6 7.6 mm,
respectively. A small number of cases had severe neck
angulations; nine cases had a suprarenal angle of more
than 45
and 12 had an infrarenal angle of more than 60
.
426 Hoshina et al Journal of Vascular Surgery
February 2023

Table I. Baseline demographic characteristics of the study access stenoses (n ¼ 7) and sac dilatation with type II
population (n ¼ 175) endoleak (n ¼ 10). Among the three open conversions
Mean 6 standard with sac dilatation in noninfectious cases, intraoperative
deviation or No. (%) findings in one case revealed fabric holes that were
Demographic parameters suspected to cause the sac dilatation. There were no
Age, years 74.6 6 8.1 endoleaks, fabric tears, stent fractures, or migrations in
Male 154 (88) the other two cases; therefore, endotension (ie, without
Smoking 124 (70) other endoleaks or device-related issues) was considered
Hypertension 136 (78)
to cause the sac dilatation. Freedom from reintervention
rates at 1, 2, and 3 years were 96.4%, 92.4%, and 87.3%,
Diabetes mellites 26 (14)
respectively (Fig 1, C).
Coronary artery disease 61 (35)
Cerebrovascular disease 31 (17) Endoleaks. There were three cases (2.3%) with type I
Respiratory disorder 43 (31) endoleaks without sac dilatation. In the first case, a
Serum creatinine level, mg/dL 1.10 6 0.90 type Ia endoleak occurred 2 years after EVAR as a
Antiplatelet drug 70 (40) consequence of the downward migration of the aortic
Anticoagulant drug 17 (9)
cuff without suprarenal stent. The length of the main
body was 80 mm and of the aortic cuff was 95 mm.
Anatomic parameters
The second case was a type Ib endoleak that appeared
Saccular aneurysm 48 (27)
3 years after EVAR (main body, 80 mm; aortic cuff,
Maximum diameter (fusiform) 50.5 6 5.8 (mm)
95 mm). In the third case, a type Ib endoleak initially
Maximum diameter (saccular) 43.5 6 8.9 (mm) occurred at 1 year owing to the severe calcification of
Etiology the landing zone in the iliac artery; thereafter, a type
Atherosclerosis 156 (89) Ia endoleak occurred 3 years after EVAR as a conse-
Dissection 13 (7.4) quence of the downward migration of the aortic cuff
Inflammation 4 (2.3) with suprarenal stent (main body, 90 mm; aortic cuff,
Vasculitis 1 (0.6) 95 mm). There was one case of a type IIIa endoleak as
Others 1 (0.6) a consequence of endograft deformation (main body,
Proximal neck diameter, mm 20.8 6 2.7 90 mm; aortic cuff, 75 mm) and three cases of type
Proximal neck length, mm 37.9 6 15.2
IIIb endoleaks without sac dilatation (main body,
70 mm, 70 mm, and 80 mm; aortic cuff, 95 mm,
Terminal aorta diameter, mm 20.7 6 7.6
95 mm, and 75 mm).
Suprarenal angle >45
9 (0.5)
Infrarenal angle >60
12 (0.7) Migration (sideways displacement). There were five
Reversed tapered neck 31 (17) cases of aortic cuff and main body migrations. One
case was the downward migration of the aortic cuff
without top stent resulting in type Ia endoleak at 2 years
Operative data. Most cases (n ¼ 166 [95%]) underwent (main body, 80 mm; aortic cuff, 95 mm). A unique phe-
EVAR under general anesthesia. The mean operative nomenon of this device is that the main body can grad-
duration was 126.4 6 76.8 minutes, and the mean esti- ually billow like a ship’s sail and contract downward,
mate intraoperative blood loss was 148.7 6 320.9 mL. resulting in migration and causing an uncoupling from
There were no in-hospital deaths (Table II). The data of the aortic cuffs. Four cases showed this type of migration,
the device component size variations used in this study named sideways displacement, at 3 years after EVAR9,13
are shown in the Supplementary Table (online only). (Fig 2). One case of sideways displacement presented
as a type IIIa endoleak (main body, 90 mm; aortic cuff,
Three-year outcomes. Data from 128 cases at 3 years af- 75 mm); however, newly emerged endoleaks were not
ter EVAR were obtained (Table III). There were 23 deaths found in the other three cases (main body, 70 mm,
during 3 years, including 1 case each of AAA rupture 90 mm, and 80 mm; aortic cuff, 55 mm, 95 mm, and
without detailed data including type I or III endoleaks, 95 mm).
nonocclusive mesenteric ischemia, and thoracic aortic
aneurysm rupture; 7 cases of malignancy; and 4 cases of Changes in AAA sac and neck diameters. The AAA sac
pneumonia. The overall survival rates at 1, 2, and 3 years diameters were decreased in the fusiform and saccular
were 96.5%, 92.2%, and 85.8%, respectively (Fig 1, A). The groups between the pre- and post-EVAR periods, from
freedom from aneurysm-related mortality rate at 3 years 50.5 6 5.8 mm to 45.4 6 9.0 mm and from 43.5 6 8.9 mm
was 99.3% (Fig 1, B). There were 19 cases of reintervention: to 37.9 6 9.5 mm, respectively. The cumulative proba-
4 open conversions for sac infections (n ¼ 1) and di- bility of sac regression rates at 1, 2, and 3 years were
latations (n ¼ 3) and 15 endovascular treatments for 26.9%, 37.7%, and 41.4% in the fusiform group and 24.6%,
Journal of Vascular Surgery Hoshina et al 427
Volume 77, Number 2

Table II. Operative data (n ¼ 175) DISCUSSION

Mean 6 standard This study exclusively evaluated patients undergoing
deviation or No. (%) EVAR using the main body and an aortic cuff from the
General anesthesia 166 (95) AFX2 Stent Graft System for AAA. We assumed that two
Local anesthesia 7 (4.0) unique features of the AFX2 might be associated with
type III endoleaks. First, the AFX2 endograft positions on
Epidural anesthesia 1 (0.6)
the aortic bifurcation provide anatomic fixation, thus
Operative duration, minutes 126.4 6 76.8
maintaining the native bifurcation. The area of the graft
Intraoperative bleeding, mL 148.7 6 320.9
fabric in contact with the native aorta or artery is greater
Simultaneous arterial embolization
than that of other devices, which might cause higher rates
IMA 10 (5.8) of type IIIb endoleaks (ie, fabric tears). Second, the fabric is
Lumbar arteries 7 (4.0) externally mounted and attached only to the proximal
Hypogastric artery (ipsilateral) 18 (10) and distal ends of the stent, which enables this device
Hypogastric arteries (bilateral) 3 (1.7) to anatomically fit the AAA morphology by the ActiveSeal
In-hospital death 0 (0) mechanism. This flexible and expandable structure also
IMA, Inferior mesenteric artery. means that the endograft body lacks rigidity, which might
easily cause deformations. In addition, there is no metallic
Table III. Three-year outcomes (n ¼ 128) hook on the proximal edge. Owing to these factors, the
No. (%) No. (%) AFX2 is more prone to migration, sideways displacement,
and subsequent type IIIa endoleaks, as compared with
Mortality 23 (17)
other devices.9,13 Although only four cases of type III endo-
AAA rupture 1 (0.7)
leaks were found in this study, the four cases of sideways
NOMI 1 (0.7)
displacement may present type IIIa endoleaks in the
TAA rupture 1 (0.7) future. We opine that the 3-year follow-up period should
Malignancy 7 (5.4) be sufficiently short to assess the number of type III endo-
Pneumonia 4 (3.1) leaks occurrences considering the cases of sideways
Others 7 (5.4) displacement.10 One of the messages in this study is to
Reintervention 19 (14.8) alert the future risk of morphological adverse events,
Open surgery for AAA sac dilatation 3 (2.3) including type III endoleaks.
Infection of AAA sac 1 (0.7) Therefore, the overlap length should be as long as
EVT for AAA sac dilatation 10 (7.8) possible when the aortic cuff is used in combination
EVT for access stenosis 5 (3.9)
with the AFX main body. From the data of the device
component size variations used in this study, most
Endoleak Reintervention
main body and extension components were long
Type I 3 (2.3) 3 (2.3)
(90 cm and 95 cm, respectively). We assume that the
Type II 16 (12.5) 3 (2.3)
experienced operators in this registry selected longer
Type III 4 (3.1) 3 (2.3) components instinctively.
Type V 1 (0.7) 1 (0.7) Another anatomic risk of migration is a large AAA diam-
Migration 5 (3.9) 3 (2.3) eter of more than 60 or 65 mm.9,14 Two hypotheses have
(Sideways displacement) 4 (3.1) been reported: the deformation of the sideways
AAA, Abdominal aortic aneurysm; EVT, endovascular therapy; NOMI, displacement can occur within a sufficient AAA sac vol-
nonocclusive mesenteric ischemia; TAA, thoracic aortic aneurysm. ume and the billowing fabric of the aortic cuff provides
35.4%, and 44.2% in the saccular group, respectively a reverse windsock effect that increases distraction
(Fig 3, A). The cumulative probability of sac enlargement forces between the main body and the aortic cuff. In
rates at 1, 2, and 3 years were 3.3%, 8.4%, and 20.5% in the our study, a type IIIa endoleak occurred in a case with
fusiform group and 4.9%, 8.3%, and 16.7% in the saccular a relatively large terminal aorta (28 mm in diameter).
group, respectively (Fig 3, B). We assumed that the sufficient space around the termi-
The proximal neck diameter slightly increased between nal aorta allowed the main body to billow downward,
the pre- and post-EVAR periods, from 20.8 6 2.7 mm to which caused the uncoupling of the endograft compo-
22.2 6 4.6 mm. nents. The scenario of the risk of a large AAA may be
the reason that the AFX is suitable for a saccular AAA.
Other complications. There was one case of AAA Hence, we initially expected the average diameter of
rupture at 3 years with an unknown detailed etiology. There AFX cases to be smaller. The fusiform AAA diameter
were no cases of limb occlusion, vascular injury, thrombo- was relatively small at 5.05 cm; however, it was compa-
embolism, paraplegia, or renal function deterioration. rable with the AAA average diameter in 38,003 EVAR
428 Hoshina et al Journal of Vascular Surgery
February 2023

Fig 1. (A) Overall survival, (B) freedom from aneurysm-related mortality, and (C) freedom from reintervention
rates.

Fig 2. Sideways displacement. A severely angulated abdominal aortic aneurysm (AAA) was treated with the AFX2
and an aortic cuff. The straightened endograft after endovascular aneurysm repair (EVAR) gradually angulated
over time. At 3 years, the uncoupling of the main body and aortic cuff resulted in sideways displacement.

patients of the nationwide registry in Japan (5.1 cm).15
Regarding the fusiform aneurysms, this study revealed
that the operators followed the surgical indication of
AAA diameter, as well as other devices.
One of the upgrades from the AFX to the AFX2 was the
addition of a new rim cover that eliminated the exposure
of the main body grafts and prevented the graft from
rubbing directly against the native aorta and causing
fabric damage. Despite this upgrade, type IIIb endoleaks
with AFX2 have been reported,8 including three cases in
this study. Another mechanism is that the thin and soft
expanded polytetrafluoroethylene fabric at the terminal
joint of the AFX main body that has been sutured with
polypropylene threads might be easily torn by the forces
applied when bilateral limbs are deployed.16 The AFX
fabric was changed from Strata to the spiral,
Journal of Vascular Surgery
Volume 77, Number 2
Fig 3. Cumulative probabilities of (A) sac regression and
(B) sac enlargement.
multilayered Duraply, which has reduced the occurrence
of type IIIb endoleaks; however, because type IIIb endo-
leaks still occur, the durability of the fabric may need to
be strengthened further.
The in-hospital mortality rate was zero, and the overall
survival, freedom from aneurysm-related mortality, and
freedom from reintervention rates were acceptable
compared with previous large population studies.15
Fortunately, there were no specific procedure-related
adverse events, including limb occlusion, vascular injury,
or thromboembolism, in this study. Therefore, the
midterm outcomes of using AFX2 were acceptable.
Changes in the sac diameter after EVAR are important
to predict the prognosis. We expected a high sac regres-
sion rate after using AFX2 owing to the exclusion of
aortic branches with the ActiveSeal mechanism, and
the incidence of type II endoleaks was relatively low
(12.5%), compared with the data from a nationwide
study in Japan (21%).15 The sac regression rate was
more than 40% at 3 years, which is comparable with
previous reports, namely, 39.7% at 1 year (any type of de-
vice), 53.7% at 3 years (Endurant; Medtronic, Santa Rosa,
CA), and 53% during the follow-up period (median,
45 months) (any type of device).17-19 In Japan, where
the preemptive embolization of the inferior mesenteric
artery or lumbar arteries is sometimes performed for
EVAR, the sac regression rates vary from 24% (Endurant)
to 31.7% (Gore Excluder; W. L. Gore & Associates, Inc,
Flagstaff, AZ) and 40.7% (Endurant).20,21 Sac expansion
Hoshina et al 429
was one of the adverse outcomes after EVAR that might
require future reinterventions. The nationwide EVAR
registry data in Japan revealed that 23.3% of EVAR pa-
tients demonstrated a sac expansion of more than
5 mm at 5 years.16 The expansion rates of 20.5% in the
fusiform group and of 16.7% in the saccular group at
3 years were similar to the nationwide data. From these
results, the contribution of the ActiveSeal in the AAA sac
was less than expected.
Proximal neck dilatation was sometimes found in the
follow-up of EVAR, and the radial force of the stent graft
could be one of the causes, as well as age-related athero-
sclerotic aortic dilatation. In this study, the diameter had
increased by 1.4 6 1.9 mm (þ6.7%) at 3 years, which was
comparable with or less than the values from a previous
study (2.0 mm [9.5%]) analyzing 460 EVAR cases using
either Endurant (52%) or Excluder (39%) devices.22 In a
previous study of EVAR cases using Palmaz stents suppor-
tively for proximal neck exclusions, the downward
displacement of the Palmaz stent was found in 23 of 28
cases in the midterm.23 Whether the relatively loose prox-
imal fixation would be completely beneficial for the prox-
imal neck fixation is unclear. The soft and thin fabric of the
AFX without a proximal hook could cause type I endo-
leaks or a downward migration in the short term; in
contrast, less pressure on the neck might prevent long-
term native aortic neck dilatations. Therefore, it is impor-
tant to completely understand the special characteristics
of this device and use it according to the AAA anatomy.
We found that a relatively higher rate of cases (12%) un-
derwent hypogastric artery embolization. The international
multicenter study which analyzed anatomic data of 296
AAA patients revealed that Caucasian patients had longer
common iliac arteries (right, 65.0 mm vs 33.1 mm [P < .001]
and left, 65.0 mm vs 35.2 mm [P < .001]) compared with
Asian patients.24 In addition, this report revealed narrower
access (smaller diameter of iliac arteries) in Asian patients
compared with Caucasian patients, which could cause ac-
cess difficulties. The high rate of embolization might attri-
bute to the operators’ preference to a more flexible leg
device such as Gore Excluder legs.
This study has some limitations. First, this was a retrospec-
tive, single-arm study. Second, the relatively experienced
operators and high-volume institutes recruited in this reg-
istry might produce results that do not represent real-
world data.15 The operators had experienced previous ver-
sions of the unibody stent graft (Powerlink and the AFX
with Duraply) and readily recognized the procedural steps,
tricks, pitfalls, and troubleshooting required for AFX2. They
recognized that AFX is preferable for saccular AAA with
narrow terminal aorta based on their experience and pre-
vious studies. It may cause a selection bias. Third, we spe-
cifically double-checked the CT images of types I and III
endoleaks and migration; however, the review method
might be regarded as arbitrary and could be biased.
Fourth, we did not set the length of the overlap between
430 Hoshina et al
the main body and aortic cuff. We initially planned to mea-
sure the overlapped distance to evaluate the risk of type
IIIa or migration. However, we found that the overlapped
lesions of cases without migration or type I or III endoleaks
were not clearly detected in the postoperative CT image.
Because migration was assessed and registered by each
operator, we assume that real migration cases potentially
existed beyond the registered cases.
CONCLUSIONS
Midterm outcomes of using the AFX2 in combination
with an aortic cuff were acceptable, considering the rates
of types I and III endoleaks. However, there were four
cases of sideways displacements that could cause future
IIIa endoleaks. When the AFX2 is used in combination
with an aortic cuff, patients should undergo close surveil-
lance for endograft deformations and subsequent
adverse events, including type III endoleaks.
The authors thank the Japan AFX registry members for
providing data.
The collaborators and facilities involved in the Japan AFX
registry are as follows: Toshihiro Onohara (Department of
Vascular Surgery, National Hospital Organization Kyushu
Medical Center, Fukuoka, Japan), Masaki Hamamoto
(Department of Cardiovascular Surgery, JA Hiroshima
General Hospital, Hiroshima, Japan), Satoru Makita (Divi-
sion of Cardiovascular Surgery, Yokosuka Kyosai Hospital,
Kanagawa, Japan), Daiki Uchida (Department of Vascular
Surgery, Asahikawa Medical University, Hokkaido, Japan),
Takaki Sugimoto (Department of Cardiovascular Surgery,
Awaji Medical Center, Hyogo, Japan), Kazushige Kanki
(Department of Thoracic and Cardiovascular Surgery, Sap-
poro Medical University School of Medicine, Shinsapporo
Hospital of Cardiology, Hokkaido, Japan), Daijirou Aka-
matsu (Department of Surgery, Division of Vascular Sur-
gery, Tohoku University Graduate School of Medicine,
Miyagi Japan), Yoshio Arai (Department of Cardiovascular
Surgery, Kokura Memorial Hospital, Fukuoka, Japan), Taka-
shi Ohtani (Department of Cardiovascular Surgery, The
Japanese Red Cross, Tokushima Hospital, Tokushima
Japan), Yasuhara Kiyomitsu (Department of Cardiovascu-
lar Surgery, Isesaki Municipal Hospital, Gunma, Japan),
Ryota Watanabe (Department of Cardiology, Gifu Prefec-
tural General Medical Center, Gifu, Japan), Hiroshi Nishi-
maki (Department of Cardiovascular Surgery, St.
Marianna University School of Medicine, Kanagawa,
Japan), Yoshihiko Kurimoto (Department of Cardiovascu-
lar Surgery, Teine Keijinkai Hospital, Hokkaido, Japan),
Taro Kanamori (Cardiovascular Surgery, Kawaguchi Car-
diovascular and Respiratory Hospital, Saitama, Japan),
Kenichi Hashizume (Department of Cardiovascular Sur-
gery, Saiseikai Utsunomiya Hospital, Tochigi, Japan),
Makoto Sumi (Department of Vascular Surgery, Saitama
Prefectural Cardiovascular and Respiratory Center, Sai-
tama, Japan), Nobuya Zempo (Department of Vascular
Surgery, Kansai Medical University, Osaka, Japan), Toshio
Journal of Vascular Surgery
February 2023
Baba (Department of Vascular Surgery, Bellland General
Hospital, Osaka, Japan), Hideki Ueda (Department of Car-
diovascular Surgery, Chiba University, Chiba, Japan),
Yusuke Date (Department of Cardiovascular Surgery, Sai-
tama Sekishinkai Hospital, Saitama, Japan), Yuki Tada
(Department of Cardiovascular Surgery, Steel Memorial
Muroran Hospital, Hokkaido, Japan), Toshiaki Mishima
(Department of Cardiovascular Surgery, Kitasato Univer-
sity School of Medicine, Kanagawa, Japan), Takuki Wada
(Department of Cardiovascular Surgery, Shizuoka General
Hospital, Shizuoka, Japan), and Hiroyuki Ito (Department
of Cardiovascular Surgery, Saiseikai Fukuoka General Hos-
pital, Fukuoka, Japan).
AUTHOR CONTRIBUTIONS
Conception and design: KH, MS
Analysis and interpretation: KH, MS
Data collection: KH, MS, KM, YM, RT, TT
Writing the article: KH, MS
Critical revision of the article: KH, KM, YM, RT, TT
Final approval of the article: KH, MS, KM, YM, RT, TT
Statistical analysis: MS
Obtained funding: KH
Overall responsibility: KH
KH and MS contributed equally to this article and share
co-first authorship.
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431.e1 Hoshina et al Journal of Vascular Surgery
February 2023

Supplementary Table (online only). Size variation of the endograft components

Main body mm Case (%) mm Case (%)
Length of the main body 60 5 (2) Proximal diameter 22 52 (29)
70 29 (16) 25 96 (54)
80 45 (25) 28 27 (15)
90 64 (36) Distal diameter 16 117 (67)
100 31 (17) 20 57 (32)
Length of the leg 30 93 (53)
40 81 (46)
Extension
Length (infrarenal) 55 4 (2) Diameter (infrarenal) 25 40 (23)
75 20 (11) 28 33 (19)
80 1(1) 34 1 (1)
95 49 (28)
100 0 (0)
Length (suprarenal) 75 26 (15) Diameter (suprarenal) 25 39 (22)
80 2 (1) 28 57 (33)
95 70 (40) 34 5 (3)
100 3 (1)