Midterm outcomes for 605 patients receiving Endologix AFX or

AFX2 Endovascular AAA Systems in an integrated healthcare

system
Robert W. Chang, MD,a,b Kara A. Rothenberg, MD,c Jessica E. Harris, MS, RD,d Rebecca C. Gologorsky, MD,c
Jeffrey H. Hsu, MD, FACS,e Thomas F. Rehring, MD,f Homayon Hajarizadeh, MD,g Nicolas A. Nelken, MD,h
Elizabeth W. Paxton, PhD, MA,d and Heather A. Prentice, PhD, MPH,d South San Francisco, Oakland, and
San Diego, Calif; Denver, Colo; Clackamas, Ore; and Honolulu, Hi

ABSTRACT
Background: Endologix issued important safety updates for the AFX Endovascular AAA System in 2016 and 2018 owing
to the risk of type III endoleaks. Outcomes with these devices are limited to small case series with short-term follow-up.
We describe the midterm outcomes for a large cohort of patients who received an Endologix AFX or AFX2 device.
Study design: Data from an integrated healthcare system’s implant registry, which prospectively monitors all patients
after endovascular aortic repair, was used for this descriptive study. Patients undergoing endovascular aortic repair with
three AFX System variations (Strata [AFX-S], Duraply [AFX-D], and AFX2 with Duraply [AFX2]) were identified (2011-2017).
Crude cumulative event probabilities for endoleak (types I and III), major reintervention, conversion to open, rupture, and
mortality (aneurysm related and all cause) were estimated.
Results: Among 605 patients, 375 received AFX-S, 197 received AFX-D, and 33 received AFX2. Median follow-up for the
cohort was 3.9 (interquartile range, 2.5-5.1) years. The crude 2-year incidence of overall endoleak, any subsequent rein-
tervention or conversion, and mortality was 8.8% (95% confidence interval [CI], 6.3-12.3), 12.0% (95% CI, 9.1-15.9), and 8.8%
(95% CI, 6.3-12.2) for AFX-S. Respective estimates for AFX-D were 7.9% (95% CI, 4.8-13.0), 10.6% (95% CI, 6.9-16.1), and 9.7%
(95% CI, 6.3-14.7); for AFX2, they were 14.1% (95% CI, 4.7-38.2), 16.2% (95% CI, 6.4-37.7), and 21.2% (95% CI, 10.7-39.4).
Conclusions: The midterm outcomes of a large U.S. patient cohort with an Endologix AFX or AFX2 System demonstrate a
concerning rate of adverse postoperative events. Patients with these devices should receive close clinical surveillance to
prevent device-related adverse events. (J Vasc Surg 2021;73:856-66.)
Keywords: Aneurysm; Endovascular aortic repair; Endologix; Endoleak; Reintervention; Mortality

Since the first reported endovascular aneurysm repair
(EVAR) in 1990,1 iterative stent graft improvements
continue to broaden their use and applicability for
abdominal aortic aneurysm (AAA) repair. Successful
EVAR relies on device integrity for fixation and seal to
prevent aneurysm pressurization and expansion. A
complication exclusive to EVAR is type III endoleak, esti-
mated to occur in 3.0% to 4.5% of patients.2,3 In type IIIA
endoleaks, graft component separation or lack of apposi-
tion allows pressurization of the aneurysm sac. Type IIIB
endoleaks occur secondary to stent graft fabric
disruption. Although rare, type III endoleaks can occur
anytime during follow-up, with one study finding late
main body component uncoupling and type IIIA endo-
leaks at a mean follow-up of 32 months (2.7 years),4
and another reporting a median time from EVAR to
endoleak of 5.6 years.5 Endoleaks are also associated
with serious subsequent complications, including a
higher risk of rupture and death.6
The Endologix, Inc, AFX Endovascular AAA Systems
(Irvine, Calif) were first introduced into the U.S. market
in 2011. Initial findings on the AFX device were

From the Department of Vascular Surgery, The Permanente Medical Group,
South San Franciscoa; the Division of Research, Kaiser Permanente Northern
California,b and the Department of Surgery, University of California San Fran-
cisco - East Bay, Oaklandc; the Surgical Outcomes and Analysis, Kaiser Perma-
nente, San Diegod; the Department of Vascular Surgery, Southern California
Permanente Medical Group, Fontanae; the Department of Vascular Surgery,
Colorado Permanente Medical Group, Denverf; the Department of Vascular
Surgery, Northwest Permanente Physicians and Surgeons, Clackamasg; and
the Department of Vascular Surgery, Hawaii Permanente Medical Group,
Honolulu.h
Supported in part by The Permanente Medical Group Delivery Science and
Physician Researcher Programs. This work was performed at Surgical Out-
comes and Analysis, Kaiser Permanente, San Diego, California.
Author conflict of interest: none.
Presented at the American College of Surgeons Clinical Congress 2019, San
Francisco, Calif, October 2019.
Correspondence: Robert W. Chang, MD, Department of Vascular Surgery, The
Permanente Medical Group, 1200 El Camino Real, 3rd Floor MOB, South
San Francisco, CA, 94080 (e-mail: Robert.W.Chang@kp.org).
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 2020 by the Society for Vascular Surgery. Published by Elsevier Inc.
https://doi.org/10.1016/j.jvs.2020.06.048

856
Journal of Vascular Surgery
Volume 73, Number 3
well-received, with low rates of device- and procedure-
related complications.4,7 The incidence of type IIIA endo-
leaks for both studies was just over 2%, comparable with
prior literature for other Endologix devices,8,9 as well as
across all types of EVAR devices.2,3,10,11 Although these
real-world results were encouraging, the study by
Welborn et al7 included only 108 patients with a limited
mean follow-up of 11 months. Skibba et al4 followed 701
Endologix patients with longer follow-up; however, this
cohort included both AFX and Powerlink devices. How-
ever, from 2013 to 2015, the U.S. Food and Drug Adminis-
tration’s Medical Device Reporting system received
voluntary reports of both type IIIA and IIIB endoleaks.
Endologix, Inc, also received internal reports of endo-
leaks, which led to the development of newer genera-
tions of the AFX device, including longer bifurcated
grafts to increase component overlapping, a change of
the graft material from Strata (AFX-S) to Duraply (AFX-
D) to address the fabric durability concerns,12 and up-
dates to the instructions for use (IFU) guidelines. In
2015, the AFX2 system was introduced, which was
intended to “reduce the potential for damage to the
graft during loading into the delivery system.13 Despite
the modifications, reports of type III endoleaks
continued, including 1 study reporting a greater likeli-
hood of type III endoleaks for aneurysms more than
6.5 cm when using Endologix devices compared with a
reference group of patients with Gore, Cook, and Med-
tronic devices.14 In July 2018, the U.S. Food and Drug
Administration issued a class I recall status for the com-
pany’s revisions to the IFU for all Endologix AFX Systems
owing to evidence of a continued risk for type III
endoleak.15
The currently available literature on Endologix Endovas-
cular AAA Systems is limited to these smaller series with
short-term follow-up.4,7,14 In addition, literature on the
outcomes for newer Endologix AFX2 devices is lacking.
An understanding of performance is needed for both cli-
nicians and patients who received these devices. We
sought to report the crude midterm postoperative out-
comes, including endoleak, surgical reintervention,
rupture, and mortality rates, for a cohort of patients
who received an Endologix AFX or AFX2 Endovascular
AAA System in an integrated U.S. healthcare system,
stratified by device type.
METHODS
Study design and setting. Kaiser Permanente is an in-
tegrated health system that covers more than 12.2
million members throughout eight geographic regions
(Colorado, Georgia, Hawaii, Mid-Atlantic, Northern Cali-
fornia, Pacific Northwest, Southern California, and
Washington state) in the United States. Data from the
Kaiser Permanente endovascular stent graft registry were
used to conduct a descriptive study. Members of this
healthcare system have previously been found to be
Chang et al 857
ARTICLE HIGHLIGHTS
d
Type of Research: Multicenter, retrospective analysis
of prospectively collected registry data from an inte-
grated healthcare system’s implant registry
d
Key Findings: Of 605 patients who underwent endo-
vascular aortic aneurysm repair (EVAR), 375 received
an Endologix AFX-Strata (AFX-S), 197 received the
AFX-Duraply (AFX-D), and 33 received the AFX2. The
crude 2-year incidence of overall endoleak, any sub-
sequent intervention or conversion, and mortality
for the AFX-S were 8.8% (95% confidence interval
[CI], 6.3-12.3), 12.0% (95% CI, 9.1-15.9), and 8.8% (95%
CI, 6.3-12.2); for AFX-D, 7.9% 95% CI, (4.8-13.0), 10.6%
(95% CI, 6.9-16.1), 9.7% (95% CI, 6.3-14.7); and for
AFX2, 14.1% (95% CI, 4.7-38.2), 16.2% (95% CI, 6.4-
37.7), and 21.2% (95% CI, 10.7-39.4).
d
Take Home Message: Despite the changes in the
AFX systems, our findings suggest a continued
intrinsic issue requiring close monitoring in patients
with AFX devices to ensure device integrity and pa-
tient safety.
demographically and socioeconomically representative
of the geographic region served.16,17 This study was
approved by the Institutional Review Board of Kaiser
Permanente.
Study sample. All patients aged 18 years and older who
underwent endovascular repair for aneurysm with an
Endologix AFX or AFX2 Endovascular AAA System from
January 1, 2011, through December 31, 2017, comprised
the study sample. Systems comprising the study sample
included: the AFX System with AFX-S, the AFX System
with Duraply (AFX-D), and the AFX2 Bifurcated Endograft
System manufactured with Duraply (AFX2).
Data source. A detailed summary of data collection
procedures and participation rates for our endovascular
stent graft registry was previously published.18,19 In brief,
started in 2010, this prospective surveillance tool for all
EVAR performed within six regions (Colorado, Hawaii,
Mid-Atlantic, Northern California, Northwestern, and
Southern California) of the integrated healthcare system
collects a predefined set of patient, procedure, implant,
surgeon, and hospital information with 100% capture of
all endografts implanted in the healthcare system.
Treatment, including endograft selection, is at the
discretion of the operating surgeon. At the time of the
EVAR, the operating surgeon completes a templated
electronic operative note in the integrated electronic
health record (EHR) asking relevant procedural details.
This note was developed by registry staff and in
consensus with vascular surgeons in the healthcare sys-
tem. Implant information is collected into the EHR via
858 Chang et al
barcode scans; this information is then extracted to the
registry and then mapped to a comprehensive device
directory. This information was supplemented with data
from the EHR, administrative claims data, membership
data, and social security records. From 2010 to 2017, 4743
EVAR procedures comprised the registry, 605 (12.8%)
using an Endologix AFX device. Once in the registry, each
patient is monitored for outcomes; all patients are fol-
lowed until either death or healthcare plan membership
termination. Outcomes are longitudinally monitored by
the registry using operative forms completed by the
surgeon and via a passive electronic screening algorithm
of procedural and diagnostic codes in EHR. Identified
outcomes are then manually validated by trained clinical
content experts to ensure registry accuracy. For the pre-
sent study, the end date for monitoring longitudinal
outcomes was December 31, 2018. This prospective data
collection of predefined information and validation of
identified outcomes for all procedures ensures a high
level of data integrity and capture of all outcomes
tracked, increasing internal validity.
Outcomes of interest. Midterm outcomes evaluated
included endoleak, major reintervention, aneurysm
rupture, and mortality. Endoleak included type I, type III,
and type unknown. Endoleak was defined per standard
reporting guidelines.20 Imaging study reports (angiogram,
computed tomography scan, computed tomography
angiography scan, and ultrasound examination), clinical
notes, and operative dictations were reviewed and used to
determine the presence of endoleak. For this study, iso-
lated type II leaks and their associated interventions (eg,
branch embolization or sac injection) were not assessed
because isolated type II leaks tend of have a benign
course21 and the incidence of reintervention would be
much more varied and dependent on individual practice
patterns. An unknown endoleak was documented when a
nontype II endoleak was observed, but the specific etiology
could not be determined. Major reintervention was defined
as an additional procedure after the primary EVAR that
involved placement of a new endograft component to
repair the primary implant. Conversion to open repair
involved an open (nonendovascular) approach. Indications
for the surgical reintervention are reported to the registry
using electronic intraoperative forms by the operating
surgeon; validation was performed by trained research as-
sociates through manual chart review. Death assessment
included all-cause and aneurysm-related mortality. All-
cause mortality information was obtained from the Social
Security Administration, ensuring complete capture of
mortality information regardless of healthcare plan mem-
bership at the time of death. Aneurysm-related mortality
was defined as any death owing to aortic rupture during or
after endograft placement, any death within 30 days of the
index procedure or any associated reintervention, or any
other related condition.20
Journal of Vascular Surgery
March 2021
Statistical analysis. Patient characteristics and demo-
graphics were described using frequencies, proportions,
means, standard deviation, medians, and interquartile
range (IQR). Kaplan-Meier curves are presented with
number of patients still at risk and cumulative number of
patients who experienced the outcome of interest ac-
cording to each year of postoperative follow-up to show
the incidence of outcomes after the index procedure. To
calculate the crude incidence of outcomes, the cumula-
tive incidence probabilities were calculated as one minus
the Kaplan-Meier estimator. Proportions and 95% confi-
dence intervals (CIs) are presented. Because newer gen-
erations of the device were in use for less time and patients
in the study sample had variable follow-up, the cumula-
tive incidence probability is more informative; it includes
follow-up in the calculation of the estimate.22 Follow-up
time for endoleak, reintervention, and rupture was
defined as the time from the index procedure to the date
of the outcome, date of death, date of lost to follow-up, or
study end date (December 31, 2018), whichever came first.
Follow-up time for mortality outcomes was defined as the
time from the index procedure to the date of death, date
of lost to follow-up, or study end date, whichever came
first. Loss to follow-up was defined as terminating
healthcare plan membership. All results are presented by
device type. Analyses were performed using R software
version 3.6.0 (The R Foundation, Vienna, Austria).
RESULTS
The final cohort comprised 605 patients: 375 received
AFX-S, 197 received AFX-D, and 33 received AFX2. EVAR
procedures included in the study sample were performed
by 60 surgeons at 23 healthcare centers. The mean age
and body mass index for the cohort was 73.5 6 8.4 years
and 28.2 6 5.1 kg/m2, respectively. Most patients were
male (83.5%), of white race (78.6%), and either former
(66.7%) or current smokers (20.9%). The most common co-
morbidity was hypertension (73.1%), followed by periph-
eral vascular disorders (70.7%), diabetes (34.2%), and
chronic pulmonary disease (30.7%). Most procedures
were for asymptomatic indications (95.2%). The abdom-
inal aorta only was the most common repair location
(68.6%) and adjunct procedures were infrequent (16.8%)
with an expandable stent being the most frequent
(7.9%). At the time of the EVAR, 24.3% of patients had an
AAA of 6 cm or larger. Characteristics of the study sample
by device type received are presented in Table I.
The median postoperative follow-up for the entire cohort
was 3.9 years (IQR, 2.5-5.1 years), with a maximum follow-up
of 7.3 years. There were 45 patients (7.4%) lost to follow-up
through healthcare membership termination at a median
follow-up time of 1.6 years (IQR, 0.6-2.6 years).
Postoperative endoleak. Fig 1 presents Kaplan-Meier
curves for postoperative endoleaks during post-
operative follow-up. At 2 years of follow-up, the crude
Journal of Vascular Surgery Chang et al 859
Volume 73, Number 3

Table I. Characteristics of 605 patients who received an Endologix AFX Endovascular AAA System for primary endovascular
aortic repair, by system (2011-2017)
Characteristic AFX-S AFX-D AFX2
Total No. 375 197 33
Patient characteristics
Age, years 73.0 6 8.2 74.1 6 8.9 75.2 6 6.9
BMI, kg/m2 28.4 6 5.1 27.9 6 5.0 27.3 6 4.1
Male sex 320 (85.3) 158 (80.2) 27 (81.8)
Race/ethnicity
Asian 20 (5.4) 13 (6.9) 0 (0.0)
Black 15 (4.0) 16 (8.5) 0 (0.0)
Hispanic 37 (10.0) 17 (9.0) 3 (12.0)
Native American 2 (0.5) 2 (1.1) 0 (0.0)
White 297 (80.1) 141 (74.6) 22 (88.0)
Smoking status
Never 38 (10.3) 28 (14.9) 3 (12.0)
Passive 1 (0.3) 2 (1.1) 0 (0.0)
Quit 250 (67.6) 121 (64.4) 18 (72.0)
Smoker 81 (21.9) 37 (19.7) 4 (16.0)
Diabetes 128 (34.1) 68 (34.5) 11 (33.3)
Elixhauser comorbiditiesa
Alcohol abuse 25 (7.4) 7 (3.9) 1 (4.0)
Chronic pulmonary disease 112 (32.9) 63 (35.2) 11 (44.0)
Coagulopathy 24 (7.1) 18 (10.1) 0 (0.0)
Congestive heart failure 27 (7.9) 13 (7.3) 1 (4.0)
Deficiency anemia 52 (15.3) 32 (17.9) 5 (20.0)
Depression 28 (8.2) 11 (6.2) 3 (12.0)
Fluid and electrolyte disorders 32 (9.4) 18 (10.1) 5 (20.0)
Hypertension 276 (81.2) 145 (81.0) 21 (84.0)
Hypothyroidism 32 (9.4) 22 (12.3) 4 (16.0)
Liver disease 18 (5.3) 9 (5.0) 4 (16.0)
Lymphoma 3 (0.9) 2 (1.1) 0 (0.0)
Obesity 95 (27.9) 48 (26.8) 3 (12.0)
Other neurologic disorders 12 (3.5) 11 (6.2) 2 (8.0)
Peripheral vascular disorders 255 (75.0) 150 (83.8) 23 (92.0)
Psychoses 22 (6.5) 16 (8.9) 2 (8.0)
Renal failure 101 (29.7) 58 (32.4) 6 (24.0)
Solid tumor without metastasis 20 (5.9) 12 (6.7) 2 (8.0)
Valvular disease 13 (3.8) 9 (5.0) 1 (4.0)
Weight loss 14 (4.1) 6 (3.4) 3 (12.0)
Procedure characteristics
Indicationa
Asymptomatic 349 (95.4) 178 (94.7) 22 (95.6)
Rupture 4 (1.1) 1 (0.5) 0 (0.0)
Symptomatic 13 (3.6) 9 (4.8) 1 (4.4)
Repair location
Abdominal 251 (66.9) 139 (70.6) 25 (75.8)
Abdominal and iliac 103 (27.5) 46 (23.5) 6 (18.2)
Iliac 21 (5.6) 12 (6.1) 2 (6.1)
(Continued on next page)
860 Chang et al Journal of Vascular Surgery
March 2021

Table I. Continued.
Characteristic AFX-S AFX-D AFX2
AAA size at procedure, cm
<5.00 64 (17.5) 24 (16.7) 2 (11.8)
5.00-5.59 114 (31.2) 46 (31.9) 5 (29.4)
5.60-5.99 71 (19.5) 35 (24.3) 5 (29.4)
$6.00 96 (26.3) 28 (19.4) 4 (23.5)
No AAA 20 (5.5) 11 (7.6) 1 (5.9)
a
Adjunct procedure 64 (17.3) 30 (15.9) 4 (16.0)
Common femoral artery patch 0 (0.0) 2 (1.1) 1 (4.0)
Endarterectomy 0 (0.0) 1 (0.5) 0 (0.0)
Balloon expandable stent 30 (8.1) 16 (8.5) 0 (0.0)
Fem-fem bypass 3 (0.8) 0 (0.0) 2 (8.0)
Interposition graft 3 (0.8) 1 (0.5) 0 (0.0)
Other 8 (2.2) 7 (3.7) 1 (4.0)
Renal artery stent 7 (1.9) 2 (1.9) 0 (0.0)
Snorkel 24 (6.5) 8 (4.2) 0 (0.0)
Postoperative follow-up
Follow-up time, years 4.8 (3.2-5.6) 3.3 (2.5-3.8) 2.0 (1.3-2.5)
Lost to follow-up 27 (7.2) 14 (7.1) 4 (12.1)
Time at lost to follow-up 1.9 (1.3-3.3) 0.6 (0.3-2.1) 0.8 (0.5-1.7)
AAA, Abdominal aortic aneurysm; AFX-D, AFX-Duraply; AFX-S, AFX Strata; BMI, body mass index.
Values are mean 6 standard deviation, number (%), or median (interquartile range).
Missing data: BMI, n ¼ 20 (3.3%); race, n ¼ 20 (3.3%); smoking status, n ¼ 22 (3.6%); Elixhauser comorbidities, n ¼ 61 (10.1%); indication, n ¼ 20 (3.3%); AAA
size, n ¼ 79 (13.1%); adjunct procedure, n ¼ 20 (3.3%).
a
Comorbidities present in 20 or more patients in the study sample reported.

incidence of type I endoleak was 4.9% (95% CI, 3.1-7.7) for
AFX-S and 1.7% (95% CI, 0.6-5.1) for AFX-D (Table II).
Respective estimates for type III endoleaks were 4.0%
(95% CI, 2.4-6.7) for AFX-S and 5.1% (95% CI, 2.7-9.7) for
AFX-D; for endoleaks of an unknown type, they were
0.8% (95% CI, 0.3-2.5) for AFX-S and 1.2% (95% CI, 0.3-4.7)
for AFX-D. The incidence of type III endoleaks was 14.1%
(95% CI, 4.7-38.2) for the AFX2 group; no type I endoleaks
or endoleaks of an unknown type were observed during
postoperative follow-up.
Reintervention. Fig 2 presents Kaplan-Meier curves for
any subsequent procedure (major reintervention or
conversion) during postoperative follow-up. Looking at
major reintervention, at 2 years of follow-up, the crude
incidence by device type was 12.3% (95% CI, 9.3-16.2) for
AFX-S, 9.5% (95% CI, 6.0-14.8) for AFX-D, and 16.2% (95%
CI, 6.4-37.7) for AFX2 (Table III). The most common reason
reported for major reintervention was a type III endoleak
for both the AFX-S (37.7%) and the AFX-D (31.0%) groups
(Table IV). The next most frequently reported reasons
were type I endoleak (20.8%) and increase in sac size
(without documented endoleak, 17.9%) for AFX-S and
occlusion (24.1%) and type I endoleak (17.2%) for AFX-D.
The incidence of conversion to open repair was 0.3%
(95% CI, 0.0%-2.0%) for AFX-S and 1.2% (95% CI, 0.3%-
4.6%) for AFX-D at 2 years of postoperative follow-up.
The most frequent reason reported for open repair was
a type III endoleak for the AFX-S group and type II endo-
leak for the AFX-D group. No conversions to open repair
were observed during follow-up for patients who
received the AFX2.
Rupture. At 2 years of follow-up, the crude incidence of
rupture by device type was 0.6% (95% CI, 0.2%-2.4%) for
AFX-S, 0.6% (95% CI, 0.1%-4.0%) for AFX-D, and 7.3% (95%
CI, 1.8%-26.5%) for AFX2. The time from the index EVAR
to rupture ranged from 97 days to 5.2 years for patients
who received AFX-S, 1.0 and 3.2 years for those with
AFX-D, and 1 day and 1.4 years for AFX2.
In total, there were 12 patients who had a rupture during
postoperative follow-up (8 AFX-S, 2 AFX-D, and 2 AFX2).
Three patients had an adjunctive procedure during the in-
dex EVAR. Endoleaks were observed in nine patients and
all but one patient underwent a subsequent surgical rein-
tervention. Eight patients died within 30 days of the
rupture date. Table V presents a description of the patients
who experienced a rupture by device type.
Mortality. Survival during postoperative follow-up is
presented in Fig 3. At 2 years of follow-up, the crude
incidence of all-cause mortality by device type was 8.8%
Journal of Vascular Surgery
Volume 73, Number 3
Fig 1. Postoperative endoleak-free probability (solid line)
and 95% confidence interval (CI) (shaded area) by Endo-
logix AFX Endovascular AAA System device type. A, Type I
endoleak. B, Type III endoleak. The table below each curve
presents the number of patients still at risk (cumulative
number of patients who experienced the outcome of in-
terest) at each year of postoperative follow-up.
(95% CI, 6.3%-12.2%) for AFX-S, 9.7% (95% CI, 6.3%-14.7%)
for AFX-D, and 21.2% (95% CI, 10.7%-39.4%) for AFX2
(Table VI). For aneurysm-related mortality specifically, the
incidence was 1.6% (95% CI, 0.7%-3.6%) for AFX-S, 2.6%
(95% CI, 1.1%-6.0%) for AFX-D, and 6.1% (95% CI, 1.6%-
22.1%) for AFX2 at 2-years postoperative follow-up.
DISCUSSION
We describe midterm postoperative outcomes with
the Endologix AFX and AFX2 Systems for a cohort of
Chang et al 861
patients treated in a large U.S. integrated healthcare
system. To our knowledge, this is the first study to
report outcomes using the AFX2 device, as well as
the largest cohort with the longest follow-up to date
for the earlier generation of implants. In this study,
we present real-world data from a prospective registry,
finding an incidence of endoleaks that is higher than
currently reported for all AFX devices, including the
newer AFX-D and AFX2 devices. More than 50% of rein-
terventions were performed for type III endoleaks. In
addition, we observed rupture and mortality rates
that were higher than current reports.
Although the estimated risk of type III endoleak after
EVAR is 3.0% to 4.5% during long-term follow-up,2,3
the overall incidence of type III endoleak at 2 years
of follow-up in this study was already 4.0% (AFX-S),
5.1% (AFX-D), and 14.1% (AFX2), which may increase
as we continue surveillance for these patients through
longer follow-up. More recently presented data on
Endologix AFX Systems also suggest that the device
updates and IFU changes may have had little impact
on mitigating the incidence of endoleaks and postop-
erative outcomes. An unpublished study by Chang
et al (unpublished data, presented at the 2018 Society
for Clinical Vascular Surgery 46th Annual Symposium),
found type III endoleaks continued to be discovered
despite using the AFX Systems on smaller aneurysms,
within up-to-date IFU specifications, and apparent
adequate component overlap. A recently presented
study by Wanken et al23 failed to observe a difference
between the Strata vs non-Strata fabric, suggesting
that the fabric change did not decrease the need
for close follow-up and possible reintervention.
Perhaps even more concerning, Barleben et al24 sug-
gested that type III endoleak rates may be underre-
ported, finding it to be as high as 24.3% through
targeted follow-up.
With regard to major reinterventions, the 2-year
rates for Endologix devices in our study ranged
from 9.5% to 16.2%, which is similar to a recent
Vascular Quality Initiative study reporting a reinterven-
tion rate of 16%, although this was at 3 years postop-
eratively.25 However, these results are difficult to
interpret owing to the subjectivity of defining reinter-
ventions. Data from the manufacturer reported in
2018 suggest lower than reported adverse events in
contrast with this study; however, the manufacturer’s
data source is voluntarily submitted and not a
comprehensive representation of device performance
overall.26
The Endologix-sponsored LEOPARD (Looking at EVAR
Outcomes by Primary Analysis of Randomized Data)
Trial27 recently presented unpublished findings at
3 years of follow-up. LEOPARD is a novel randomized
trial comparing the AFX-D and AFX2 systems together
(n ¼ 235) with a reference group comprising a
862 Chang et al Journal of Vascular Surgery
March 2021

Table II. Crude incidence and cumulative endoleak probability following primary endovascular aortic repair with an
Endologix AFX Endovascular AAA System
Endoleak type AFX-S (n ¼ 375) AFX-D (n ¼ 197) AFX2 (n ¼ 33)
Overall endoleak
Overall 97 (25.9) 28 (14.2) 3 (9.1)
2-year cumulative probability 8.8 (6.3-12.3) 7.9 (4.8-13.0) 14.1 (4.7-38.2)
Type I
Overall 33a (8.8) 8b (4.1) 0 (0.0)
2-year cumulative probability 4.9 (3.1-7.7) 1.7 (0.6-5.1) e
Type III
Overall 62a (16.5) 19b (9.6) 3 (9.1)
2-year cumulative probability 4.0 (2.4-6.7) 5.1 (2.7-9.7) 14.1 (4.7-38.2)
Unknown type
Overall 7 (1.9) 3 (1.5) 0 (0.0)
2-year cumulative probability 0.8 (0.3-2.5) 1.2 (0.3-4.7) e
AAA, Abdominal aortic aneurysm; AFX-D, AFX-Duraply; AFX-S, AFX Strata.
Values are percent (95% confidence interval) or number (%).
a
Five patients had both a type I and type III endoleak prior to any reintervention.
b
Two patients had both a type I and type III endoleak prior to any reintervention.

combination of three commercially available EVAR de-

vices (Medtronic Endurant [Medtronic, Dublin, Ireland],
n ¼ 91; Gore Excluder [W. L. Gore & Associates, Flagstaff,
Ariz], n ¼ 72; and Cook Zenith (Cook Group, Blooming-
ton, Ind], n ¼ 57). In the LEOPARD AFX group, they re-
ported freedom from type I endoleak, conversion,
rupture, and all-cause mortality at 2 years of follow-
up to be 97.3%, 100.0%, 100.0%, and 90.0%, respec-
tively. Corresponding estimates in the present study if
the AFX-D and AFX2 groups were combined were
comparable at 98.5%, 99.0%, 98.6%, and 88.2%, respec-
tively. However, the 2-year survival from type III endo-
leaks (93.9%) and reintervention (89.8%) were lower
for patients who received these devices in our cohort
compared with that reported by the LEOPARD trial
at 99.6% and 94.7%, respectively, although the defini-
tions for reintervention likely vary. The scope of the pre-
sent study limits our ability to compare these results,
Fig 2. Postoperative surgical reintervention-free probabil-
but we observed similar incidence during postopera- ity (solid line) and 95% confidence interval (CI) (shaded
tive follow-up for a number of outcomes using real- area) by Endologix AFX Endovascular AAA System device
world data. Of concern, though, when stratifying by de- type. The table below presents the number of patients still
vice type, 2-year freedom from type III endoleaks and at risk (cumulative number of patients who experienced
the outcome of interest) at each year of postoperative
all-cause mortality for the AFX-D system was compara-
follow-up.
ble with findings from the LEOPARD trial, and they
were much lower for the AFX2 system (85.9% and
78.8%, respectively). Because our AFX2 group only
included 33 patients with a median follow-up of 2 years, not available to elucidate factors possibly leading to
there is uncertainty around our crude estimates, and rupture, the ability for devices to prevent rupture is
these findings need confirmation in other cohorts of paramount and argues for indefinite implant surveil-
patients who received the AFX2. lance. In June 2017, a system-wide decision was
The number of ruptures after EVAR, particularly with made among the inter-regional chiefs of vascular sur-
the newer generation devices, is notable. Although gery to stop using the Endologix AFX devices unless
the present study is descriptive in nature, and data el- there was a strong clinical justification. The registry
ements of interest (anatomy, operative technique) were has also identified all patients who have had a device
Journal of Vascular Surgery
Volume 73, Number 3
Table III. Crude incidence and cumulative subsequent procedure probability after primary endovascular aortic repair with
an Endologix AFX Endovascular AAA System
Surgical reintervention type AFX-S (n ¼ 375)
a
Any subsequent procedure
Overall 115 (30.7)
2-year cumulative probability 12.0 (9.1-15.9)
Major reinterventionb
Overall 106 (28.3)
2-year cumulative probability 12.3 (9.3-16.2)
Conversion to open repair
Overall 12 (3.2)
2-year cumulative probability 0.3 (0.0-2.0)
AAA, Abdominal aortic aneurysm; AFX-D, AFX-Duraply; AFX-S, AFX Strata.
Values are percent (95% confidence interval) or number (%).
a
Any subsequent procedure was defined as major reintervention (including reoperation and revision) and conversion to open repair.
b
Major reintervention was as an additional procedure after the primary endovascular aortic aneurysm repair that involved placement of a new
endograft component to repair the primary implant.
implanted and provided surgeons and healthcare cen-
ters this information so that appropriate aggressive
postmarket surveillance and lower treatment thresh-
olds could be put in place for individual patients who
received these endografts. Accordingly, this study dem-
onstrates the value of prospective long-term registry
along with safety net guidelines. Surveillance within a
closed system allows real-time adjustment to moni-
toring and patient communication. In addition, given
the constant iteration of technology and of emerging
awareness of implant deficiencies, prospective registries
allow for contemporaneous examination of outcomes
of interest, especially in devices with need for long-
term follow-up.
This study has several limitations. Most important, this
study is descriptive in nature and we report only the
crude incidence of outcomes without a comparison
group; therefore, inferences cannot be made. Future
study evaluating whether there is a difference in out-
comes using an appropriate comparator device with
adjustment for potential confounders is needed. Sec-
ond, as noted, only 33 patients comprised the AFX2
group. The small size of the AFX2 cohort was due, in
part to an informal practice decision within our inte-
grated healthcare system to cease device use. Further-
more, follow-up for this group was shorter owing to the
device only being available more recently. This small
subset was included in the study sample to compre-
hensively report our experience with this endograft sys-
tem, and all patients in the study sample will continue
to be monitored longitudinally for long-term outcomes.
Third, we are limited to data captured by the registry,
and therefore do not have information on surgeon de-
cision making or additional detail for the adjunct pro-
cedures performed; nor do we have information on
IFU or imaging confirmation through a core imaging
Chang et al 863
AFX-D (n ¼ 197) AFX2 (n ¼ 33)
31 (15.7) 4 (12.1)
10.6 (6.9-16.1) 16.2 (6.4-37.7)
29 (14.7) 4 (12.1)
9.5 (6.0-14.8) 16.2 (6.4-37.7)
2 (1.0) 0 (0.0)
1.2 (0.3-4.6) 0.0 (0.0-0.0)
laboratory. However, all outcomes, including endoleak
and rupture, were validated through manual chart re-
view. Fourth, we were unable to accurately subcatego-
rize type I or III leaks, which could have implications
regarding graft design and failure mode. In addition,
because a type II endoleak may seem to be similar
on computed tomography scans to a type III endoleak
owing to fabric tears, there is a potential for some
misclassification of endoleak type. True adjudication
of these events would require explantation and exam-
ination of all devices, which is outside the scope of our
registry. Therefore, we chose not to define these leaks
to prevent inaccurate reporting. This diagnostic defi-
ciency with respect to endoleak is apparent in the
number of reinterventions for increased sac size in
the absence of endoleak. Last, our outcomes are
limited to those that occurred within our integrated
health system. It is possible for patients to present
with complications to other institutions or suffer
adverse events after leaving the health plan. However,
loss to follow-up was low (7.4%) and we have complete
capture of mortality information. Owing to the nature
of the healthcare plan, patients have little incentive
to seek care outside of the healthcare system and pa-
tients who are admitted elsewhere are typically repatri-
ated unless not feasible.
CONCLUSIONS
This study describes postoperative outcomes, including
risk for endoleak and rupture, after EVAR with an Endo-
logix AFX or AFX2 System in a community-based health-
care setting. By using a prospective implant registry,
these results have the most reliable follow-up and are
most applicable to a real-world setting. To our knowl-
edge, this is the only prospective registry data currently
864 Chang et al Journal of Vascular Surgery
March 2021

Table IV. Reasons for reintervention following primary endovascular aortic repair with an Endologix AFX Endovascular AAA
System
Reasona AFX-S AFX-D AFX2
Major reintervention
Total No. 106 29 4
Component separation/unopposed trunk or limb 8 (7.6) 2 (6.9) 0 (0.0)
Dissection 2 (1.9) 0 (0.0) 0 (0.0)
Hematoma/seroma 1 (0.9) 0 (0.0) 0 (0.0)
Increase in sac size 19 (17.9) 4 (13.8) 1 (25.0)
Infection 1 (0.9) 0 (0.0) 0 (0.0)
Ischemic bowel 2 (1.9) 0 (0.0) 0 (0.0)
Kinking of limb/trunk 3 (2.8) 3 (10.3) 0 (0.0)
Migration of graft 11 (10.4) 3 (10.3) 0 (0.0)
Occlusion of CFA/CIA/limb/thrombosis 11 (10.4) 7 (24.1) 1 (25.0)
Other 6 (5.7) 0 (0.0) 0 (0.0)
Pseudoaneurysm 2 (1.9) 0 (0.0) 0 (0.0)
Rupture 4 (3.8) 1 (3.5) 1 (25.0)
Stenosis 2 (1.9) 2 (6.9) 0 (0.0)
Type I endoleak 22 (20.8) 5 (17.2) 0 (0.0)
Type II endoleak 9 (8.5) 2 (6.9) 0 (0.0)
Type III endoleak 40 (37.7) 9 (31.0) 1 (25.0)
Type unknown endoleak 3 (2.8) 0 (0.0) 1 (25.0)
Conversion to open repair
Total No. 12 2 0
Component separation/unopposed trunk or limb 2 (16.7) 0 (0.0) e
Increase in sac size 1 (8.3) 0 (0.0) e
Infection 1 (8.3) 0 (0.0) e
Rupture 4 (33.3) 1 (50.0) e
Type I endoleak 1 (8.3) 0 (0.0) e
Type II endoleak 2 (16.7) 2 (100.0) e
Type III endoleak 5 (41.7) 0 (0.0) e
AAA, Abdominal aortic aneurysm; AFX-D, AFX-Duraply; AFX-S, AFX Strata; CFA, common femoral artery; CIA, common iliac artery.
Values are number (%).
a
Patients could have more than one reason specified.

Table V. Description of 12 patients who had a rupture after primary endovascular aortic repair with an Endologix AFX
Endovascular AAA System
AFX-S (n ¼ 8) AFX-D (n ¼ 2) AFX2 (n ¼ 2)
Adjunct procedure during index 2 (25.0) 1 (50.0) 0 (0.0)
Endoleak 7 (87.5) 2 (100.0) 0 (0.0)
Type I 3 (37.5) 1 (50.0) 0 (0.0)
Type III 3 (37.5) 1 (50.0) 0 (0.0)
Unknown type 1 (12.5) 0 (0.0) 0 (0.0)
Any subsequent procedurea 8 (100.0) 2 (100.0) 1 (50.0)
Major reoperation 4 (50.0) 1 (50.0) 1 (50.0)
Conversion to open repair 4 (50.0) 1 (50.0) 0 (0.0)
All-cause mortality 7 (87.5) 2 (100.0) 1 (50.0)
Aneurysm-related mortality 5 (62.5) 2 (100.0) 1 (50.0)
AAA, Abdominal aortic aneurysm; AFX-D, AFX-Duraply; AFX-S, AFX Strata.
Values are number (%).
a
Any subsequent procedure was defined as major reintervention (including reoperation and revision) and conversion to open repair.
Journal of Vascular Surgery
Volume 73, Number 3
Fig 3. Postoperative survival probability (solid line) and
95% confidence interval (CI) (shaded area) by Endologix
AFX Endovascular AAA System device type. A, All-cause
mortality. B, Aneurysm-related mortality. The table
below each curve presents the number of patients still
at risk (cumulative number of patients who experienced
the outcome of interest) at each year of postoperative
follow-up.
available regarding Endologix AFX devices, spanning
the entire course of our healthcare system’s experience
with the AFX systems, including the real-time adjust-
ments to surveillance and patient communication.
Despite the changes in the AFX systems, our findings
suggest a continued intrinsic issue requiring close
monitoring in patients with AFX devices to ensure de-
vice integrity and patient safety. Further study is
needed to confirm the present findings and identify
the underlying mechanism, that may not be limited
to aneurysm size, fabric, or IFU.
Chang et al 865
Table VI. Crude mortality and cumulative mortality
probability following primary endovascular aortic repair
with an Endologix AFX Endovascular AAA System
AFX-S AFX-D AFX2
Mortality (n ¼ 375) (n ¼ 197) (n ¼ 33)
All-cause
Overall 118 (31.5) 39 (19.8) 7 (21.2)
2-year cumulative 8.8 (6.3-12.2) 9.7 (6.3-14.7) 21.2 (10.7-39.4)
probability
Aneurysm related
Overall 15 (4.0) 6 (3.1) 2 (6.1)
2-year cumulative 1.6 (0.7-3.6) 2.6 (1.1-6.0) 6.1 (1.6-22.1)
probability
AAA, Abdominal aortic aneurysm; AFX-D, AFX-Duraply; AFX-S, AFX
Strata.
Values are percent (95% confidence interval) or number (%).
The authors acknowledge all the Kaiser Permanente
surgeons who contribute to National Implant Registries
and the Surgical Outcomes and Analysis Department,
which coordinates Registry operations.
AUTHOR CONTRIBUTIONS
Conception and design: RC, KR, JH, JHH, TR, HH, NN, EP,
HP
Analysis and interpretation: RC, KR, JH, HP
Data collection: KR, JH, RG, HP
Writing the article: RC, KR, JH, HP
Critical revision of the article: RC, KR, JH, RG, JHH, TR, HH,
NN, EP, HP
Final approval of the article: RC, KR, JH, RG, JHH, TR, HH,
NN, EP, HP
Statistical analysis: JH, HP
Obtained funding: Not applicable
Overall responsibility: RC
RC and KR share co-first authorship.
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