Endosuture aneurysm repair in patients treated with

Endurant II/IIs in conjunction with Heli-FX EndoAnchor

implants for short-neck abdominal aortic aneurysm
Frank R. Arko III, MD,a Gregory A. Stanley, MD,a Benjamin J. Pearce, MD,b John P. Henretta, MD,c
Mark W. Fugate, MD,d Manish Mehta, MD, MPH,e Giovanni Torsello, MD, PhD,f
Jean M. Panneton, MD, FRCSC, FACS,g and H. Edward Garrett Jr, MD,h Birmingham, Ala; Charlotte and Asheville,
NC; Chattanooga and Memphis, Tenn; Queensbury, NY; Münster, Germany; and Norfolk, Va

ABSTRACT
Objective: Endovascular repair of abdominal aortic aneurysm (AAA) remains a challenging clinical scenario when there is
a short or nonexistent segment of healthy infrarenal aorta. This study sought to determine the safety and effectiveness of
endosuture aneurysm repair (ESAR) using the Endurant II/IIs endograft (Medtronic Vascular, Santa Rosa, Calif) in
conjunction with Heli-FX EndoAnchors (Medtronic Vascular) in the treatment of short-neck AAA.
Methods: In this subgroup analysis, 70 patients were identified from the Aneurysm Treatment Using the Heli-FX
EndoAnchor System Global Registry (ANCHOR) who had an infrarenal neck length <10 mm down to 4 mm based on
core laboratory measurements. Primary outcomes included technical success of the index procedure, rate of type IA
endoleak at 1 month and 12 months, and rate of secondary procedures at 12 months.
Results: In this short-neck cohort (n ¼ 70), the average neck length and diameter were 6.9 6 1.6 mm and 25.7 6 4.0 mm,
respectively. Investigators reported an overall procedural success rate of 97.1% and a technical success rate of 88.6%. The
duration of the implant procedure, EndoAnchor implantation, and total fluoroscopy time was 148.0 6 80.0 minutes, 17.1 6
11.5 minutes, and 35.3 6 22.0 minutes, respectively, and an average of 5.5 6 2.1 EndoAnchors were implanted per patient.
Through the 30-day follow-up, type IA endoleaks were reported in four patients, of which three resolved spontaneously by
the 12-month follow-up. There was an additional type IA endoleak through the 12-month follow-up that has not resulted
in AAA enlargement or required a secondary procedure. The Kaplan-Meier estimate for freedom from secondary
endovascular procedures and all-cause mortality is 95.4% and 92.7% through 365 days, respectively. No patient in the
short-neck cohort experienced main body stent migration, increase in maximum aneurysm diameter, or aneurysm
rupture or required conversion to open surgical repair through 12 months.
Conclusions: In this analysis of the short-neck cohort from ANCHOR, the Endurant II/IIs endograft in conjunction with
Heli-FX EndoAnchor implants (ESAR) appears to be a safe and effective treatment option with a high technical success
rate and low incidence of type IA endoleaks and secondary interventions. Despite the complex and hostile anatomies,
the ESAR method required short procedure and fluoroscopy times. These short-term outcomes suggest that ESAR could
be complementary to therapies currently available for treatment of hostile AAA anatomy and a viable off-the-shelf
endovascular treatment option for patients with short-neck AAAs, although long-term follow-up is critically
important. (J Vasc Surg 2019;70:732-40.)
Keywords: Endosuture aneurysm repair; EndoAnchor; EVAR; fEVAR; chEVAR

The presence of a short or nonexistent segment of
healthy infrarenal aorta can create a challenging clinical
scenario for an endovascular repair of abdominal aortic
aneurysm (AAA). Open surgical repair with suprarenal
or supraceliac clamping is a viable treatment option
but is often avoided because of prohibitively high risks
associated with the patient’s medical comorbidities.
Standard endovascular aneurysm repair (EVAR) has
limited applicability in patients with an infrarenal neck
length <10 mm as off-label implantation in challenging

From the Department of Vascular and Endovascular Surgery, Carolinas
Medical Center, Charlottea; the Department of Vascular/Endovascular
Surgery, University of Alabama at Birmingham, Birminghamb; the Depart-
ment of Vascular Surgery, Mission Hospital, Ashevillec; the Department of
Surgery, Chattanooga Heart Institute Memorial Hospital, Chattanoogad;
the Department of Vascular Surgery, Vascular Health Partners, Queens-
burye; the Department of Vascular Surgery, St. Franziskus-Hospital,
Münsterf; the Department of Vascular Surgery, Eastern Virginia Medical
School, Norfolkg; and the Department of Surgery, University of Tennessee,
Memphis.h
Author conflict of interest: F.R.A. is a consultant for Medtronic and is on the
speakers bureau. G.A.S. is a consultant for Medtronic. J.M.P. is a consultant
for Medtronic and is on the speakers bureau.
Presented in part at podium at the Charing Cross International Symposium,
London, United Kingdom, April 15-18, 2018.
Correspondence: Frank R. Arko III, MD, Chief of Vascular and Endovascular
Surgery, Sanger Heart and Vascular Institute, Carolinas Health Care System,
1001 Blythe Blvd, Charlotte, NC 28203 (e-mail: farkomd@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 2019 The Authors. Published by Elsevier Inc. on behalf of the
Society for Vascular Surgery. This is an open access article under the CC
BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
https://doi.org/10.1016/j.jvs.2018.11.033

732
Journal of Vascular Surgery
Volume 70, Number 3
short-neck anatomy results in increased rates of type IA
endoleak, endograft migration, and late aneurysm
rupture.1-3 Advanced endovascular repairs, such as fenes-
trated EVAR (fEVAR) and chimney stents used in combi-
nation with standard EVAR (chEVAR), currently provide
the only feasible endovascular options for short-neck
aneurysms.4,5
Whereas fEVAR and chEVAR techniques have been
widely used and reported in the literature, the proced-
ures are technically demanding with associated
increases in operative times, volume of contrast material
used, and radiation exposure over standard EVAR.1,6,7
Furthermore, manipulation and stenting of the renal
arteries have been correlated with permanent renal
dysfunction and urgent secondary procedures to treat
stent stenosis or thrombosis.8-10 The optimal endovascu-
lar solution would harbor the benefits of standard EVAR
without the technical difficulty and risks associated with
concomitant renal artery intervention.
The primary challenge to achieving an adequate prox-
imal seal within a <10-mm neck length may be overcome
with reinforcement of the proximal graft using the Heli-FX
EndoAnchor System (Medtronic Vascular, Santa Rosa,
Calif). Clinical data have demonstrated the ability of
EndoAnchor implants to improve fixation and seal
between the native aorta and an aortic stent graft in
both short- and standard-neck anatomies when used
with a variety of abdominal stent grafts, including the
Endurant II/IIs Stent Graft System (Medtronic Vascular).11
With the clear need for an off-the-shelf solution for patients
with short infrarenal necks, this study sought to determine
the safety and effectiveness of endosuture aneurysm
repair (ESAR) to treat AAA with an infrarenal neck length
of <10 mm down to 4 mm using the Endurant II/IIs endog-
raft in conjunction with Heli-FX EndoAnchor implants.
METHODS
This study is a subgroup analysis of the Aneurysm Treat-
ment Using the Heli-FX EndoAnchor System Global
Registry (ANCHOR), an international, multicenter, post-
market registry intended to assess the use and long-
term efficacy of the Heli-FX EndoAnchor System in
real-world clinical practice.11 ANCHOR patients were
enrolled into either the primary or revision arms of the
registry. The primary arm consisted of patients who
received EndoAnchor implants either prophylactically
or for treatment of type IA endoleaks during the index
EVAR procedure. Patients enrolled into the revision arm
received EndoAnchor implants as a secondary proced-
ure to address late type IA endoleak or graft migration.
This study evaluated patients enrolled in the ANCHOR
primary arm with infrarenal neck lengths of <10 mm
down to 4 mm based on core laboratory measurements.
These patients were enrolled in a 3-year time frame
between 2012 and 2015 by physicians skilled in EVAR
techniques and were classified as the short-neck cohort.
Arko et al 733
ARTICLE HIGHLIGHTS
d
Type of Research: Retrospective subgroup analysis
of prospectively collected Aneurysm Treatment
Using the Heli-FX EndoAnchor System Global Regis-
try (ANCHOR) data
d
Key Findings: In 70 patients with infrarenal neck
length <10 mm and >4 mm, EndoAnchor implanta-
tion was performed with technical and procedural
success (88.6% and 97.1%, respectively). Type IA
endoleak was identified in 6.8% and 1.9% of patients
at 30 days and 12 months. Kaplan-Meier survival esti-
mate for all-cause mortality at 30 days and 1 year was
94.3% and 92.7%.
d
Take Home Message: Whereas long-term follow-up
is still needed to assess the durability of this repair
strategy, endosuture aneurysm repair may be
considered a viable off-the-shelf, complementary
endovascular treatment option for patients with
short-neck AAAs.
As per ANCHOR protocols, investigational sites were
required to follow local legal and regulatory requirements
for Ethics Committee and Institutional Review Board
approvals, and a signed informed consent was required
from each study participant before enrollment. Per the
protocol, sites were instructed to collect data and images
from standard of care follow-up visits. The patient treat-
ment, timing, and method of image collection were also
completed per institution standard of care. All pertinent
imaging studies were sent by the investigational sites to
Syntactx (New York, NY), the imaging core laboratory
used for independent analysis and verification in ANCHOR.
Study design. Clinical outcome measures from AN-
CHOR were used to evaluate the safety and effectiveness
of Endurant or Endurant II/IIs plus Heli-FX EndoAnchor
System in the short-neck cohort. Primary outcomes
include technical success of the index procedure, rate of
type IA endoleak at 1 month and 12 months, and rate of
secondary procedures at 12 months.
Technical success required two components: successful
access and delivery of the Endurant stent graft main
body to the intended aortic landing zone; and successful
and accurate deployment of each EndoAnchor attemp-
ted to be implanted. According to the Heli-FX instruc-
tions for use (IFU), the recommended minimum
number of EndoAnchor implants is based on vessel
angulation and native vessel diameter. For a bifurcated
endograft with #60-degree angulation, four EndoAn-
chors are the minimum recommended for a proximal
neck diameter #29 mm, and six EndoAnchors are rec-
ommended for proximal necks between 30 and
32 mm. Per the protocol, procedural success was an
investigator-reported subjective assessment.
734 Arko et al Journal of Vascular Surgery
September 2019

As part of the primary outcomes, investigator-
submitted computed tomography angiography images
for the 30-day and 12-month follow-ups were assessed
by the core laboratory for type IA endoleak determina-
tion. Although not part of the primary outcomes, endo-
leaks present at the end of the implant procedure are
also described here, noting that these data were investi-
gator reported, not core laboratory determined. Second-
ary procedures were defined as any subsequent surgical
or endovascular procedure related to the access vessels
or the targeted vascular segment treated during the
index EVAR procedure.
Secondary outcomes were grouped into three cate-
gories: index procedure-related events, device-related
events, and safety- and effectiveness-related measures.
Index procedure-related measures included fluoroscopy
time, procedure success, procedure time, and accessory
device use. Device-related events included endograft or
EndoAnchor adverse events through 12 months and
maintenance of adequate EndoAnchor implantation
into the aortic wall through 30 days and 12 months.
Safety and effectiveness outcomes measured aneurysm
expansion >5 mm at 12 months compared with the
1-month computed tomography image, aneurysm-
related mortality and aneurysm rupture through
30 days and 12 months, major adverse events (MAEs)
through 30 days, endograft migration at 12 months, sec-
ondary procedures through 30 days, renal insufficiency
and failure through 30 days, conversion to open surgical
repair through 30 days, and type III endoleaks through
30 days and 12 months. Additional outcome measures
included all-cause mortality, acute procedural outcomes,
hospital-related outcomes, and adverse events through
12 months.
Statistical analysis. This is a single-arm study designed
to evaluate the safety and effectiveness of ESAR
using Endurant II/IIs with Heli-FX in the short-neck
cohort, a retrospectively identified group of patients
from ANCHOR. The primary and secondary clinical out-
comes were prospectively defined. No formal hypothesis
test was planned, and all clinical outcomes were
analyzed descriptively. All data presented are based on
enrolled patients with available data with no exclusions
of data.
Statistical analyses for this study were performed using
SAS for Windows version 9.4 (SAS Institute, Cary, NC).
Categorical data are presented as percentage (number
of patients in category/number of patients with available
values). Continuous data are presented as mean 6 stan-
dard deviation (number of patients with available values).
Primary outcomes including type IA endoleak and tech-
nical success were estimated as binomial rate. The
survival from aneurysm-related mortality and freedom
from secondary procedures through 1 year were
described by the Kaplan-Meier survival curve.
Table I. Baseline patient demographics and risk factors of
short-neck cohort
Baseline patient characteristics Short-neck cohort
Age, years 71.3 6 8.1 (70)
Male sex 72.9 (51/70)
Body mass index, kg/m2 28.4 6 5.3 (70)
Risk factors
Tobacco use (past or current) 80.0 (56/70)
Hypertension 84.3 (59/70)
Hyperlipidemia or 74.3 (52/70)
hypercholesterolemia
Diabetes 22.9 (16/70)
Cardiac disease 62.9 (44/70)
Pulmonary disease 48.6 (34/70)
Renal insufficiency 11.4 (8/70)
Cerebrovascular or neurologic 18.6 (13/70)
disease
Lower extremity peripheral artery 18.6 (13/70)
disease
ASA class
1 2.9 (2/70)
2 4.3 (3/70)
3 67.1 (47/70)
4 25.7 (18/70)
ASA, American Society of Anesthesiologists.
Categorical variables are presented as % (number of patients in the
category/number of patients with available values). Continuous vari-
ables are presented as mean 6 standard deviation (number of patients
with available values).
RESULTS
At 12 months, there was a 92% (61/66) compliance with
clinical follow-ups and an 88% (58/66) compliance with
imaging follow-ups. Patients’ data and imaging were
collected per institution standard of care, and 65%
(43/66) and 48% (32/66) of patients had computed
tomography or duplex ultrasound images, respectively.
Baseline characteristics. Between May 2012 and
December 2015, there were 70 patients enrolled in the
ANCHOR primary arm who met the inclusion criteria
for the short-neck cohort. Baseline demographics and
medical comorbidities of the short-neck cohort are
summarized in Table I. There was a greater representa-
tion of women (27.1%) compared with usual EVAR trials,
most patients were American Society of Anesthesiolo-
gists class 3 (67.1%) or 4 (25.7%), and preoperative renal
insufficiency was present in 11.4% of patients. Baseline
aneurysm characteristics as assessed by the core labo-
ratory (Table II) showed that the average maximum
aneurysm diameter was 57.7 6 12.7 mm and the average
neck diameter was 25.7 6 4.0 mm. The average neck
length was 6.9 6 1.6 mm, with 34% (24/70) having neck
lengths <6 mm. The average neck thrombus and neck
calcium thickness was 0.9 6 1.1 mm and 1.3 6 1.2 mm,
Journal of Vascular Surgery Arko et al 735
Volume 70, Number 3

Table II. Aneurysm characteristics at baseline for short- Table III. Index procedure and EndoAnchor-related
neck cohort measures for the short-neck cohort
Baseline aneurysm characteristics Short-neck cohort Index procedure and Short-neck
EndoAnchor-related measures cohort
Aneurysm symptoms
Asymptomatic 82.9 (58/70) Type of access
Symptomatic 17.1 (12/70) Open 62.9 (44/70)

Aneurysm status Percutaneous 37.1 (26/70)

Ruptured 2.9 (2/70) Duration of implant procedure, 148.0 6 80.0 (70)
minutes
Unruptured 97.1 (68/70)
Time to implant EndoAnchors, 17.1 6 11.5 (68)
Core laboratory-reported aneurysm minutes
characteristics
Volume of contrast material, mL 126.1 6 80.8 (26)
Aortic diameter just below renals, mm 25.7 6 4.0 (70)
Total fluoroscopy time, minutes 35.3 6 22.0 (44)
Measured proximal neck length, mm 6.9 6 1.6 (70)
Duration of ICU stay, days 0.8 6 1.6 (69)
Neck tortuosity index 1.0 6 0.1 (69)
Duration of hospital stay, days 3.7 6 4.3 (70)
Suprarenal angulation, degrees 14.1 6 8.3 (70)
Proximal size of Endurant stent graft
Infrarenal angulation, degrees 20.6 6 14.4 (69)
23 mm 7.1 (5/70)
Maximum aortic diameter, mm 57.7 6 12.7 (69)
25 mm 8.6 (6/70)
Neck thrombus average thickness, mm 0.9 6 1.1 (64)
28 mm 25.7 (18/70)
Neck calcium average thickness, mm 1.3 6 1.2 (70)
32 mm 24.3 (17/70)
Right iliac minimum diameter, mm 6.9 6 1.8 (60)
36 mm 34.3 (24/70)
Left iliac minimum diameter, mm 7.0 6 1.9 (58)
Reason for EndoAnchor placement
Categorical variables are presented as % (number of patients in the
category/number of patients with available values). Continuous vari- Treatment of type IA endoleak 20.0 (14/70)
ables are presented as mean 6 standard deviation (number of patients Concern for late failure 55.7 (39/70)
with available values).
Prevention of neck dilation 22.9 (16/70)
Concern for type IA endoleak 1.4 (1/70)
respectively. Seventeen percent of patients presented No. of EndoAnchor implants used 5.5 6 2.1 (70)
symptomatically; two patients were treated for ruptured Overall procedural success 97.1 (68/70)
aneurysms, with the remaining patients treated elec- (investigator assessed)
tively for unruptured aneurysms. Endograft components misdeployed
proximal to intended landing zone
Index procedure and EndoAnchor-related measures. Stent graft main bodya 0.0 (0/70)
Details of the index procedure are summarized in Left iliac extension 0.0 (0/70)
Table III. Most patients had open arterial exposure and
Right iliac extension 0.0 (0/70)
received larger Endurant stent grafts (28, 32, and 36 mm)
Aortic cuff 1.4 (1/70)
at the proximal end. On average, the duration of the
Endoleak present at end of procedure
overall procedure was 148.0 6 80.0 minutes, of which
17.1 6 11.5 minutes were devoted to the introduction and Type IA 12.9 (9/70)
deployment of EndoAnchor implants. An average of Type IB 1.4 (1/70)
5.5 6 2.1 EndoAnchor implants were used for the Type II 20.0 (14/70)
following reasons, as noted by the treating physician at Type III 0.0 (0/70)
time of implantation: concern for late failure, prevention Type IV 7.1 (5/70)
of neck dilation, and treatment of type IA endoleaks. By ICU, Intensive care unit; IFU, instructions for use.
the authors’ assessment, other ancillary procedures Categorical variables are presented as % (number of patients in the
category/number of patients with available values). Continuous vari-
performed at the time of device implantation to ables are presented as mean 6 standard deviation (number of patients
address potential neck-related complications included with available values).
a
Misdeployment of the main body component proximal to the
ballooning (n ¼ 7), cuff placement (n ¼ 3), and use of intended landing zone is a component of technical success.
coils (n ¼ 1).
Based on investigator-reported data, there were type
IA endoleaks in 12.9% (9/70) of patients at the end of
the index procedure. These were considered minor endograft to the intended landing zone. In the other
enough to not warrant intervention, and all resolved case, the EndoAnchors were implanted to treat a
without secondary procedures by the 30-day visits. type IA endoleak seen during the index procedure,
The overall procedural success rate was 97.1%, with but the type IA endoleak persisted at the end of the
one failure being unable to deliver the main body procedure.
736 Arko et al Journal of Vascular Surgery
September 2019

Table IV. Primary outcomes in the short-neck cohort

Primary outcomes Short-neck cohort
Technical success rate at index procedurea 88.6 (62/70)
Delivery to target site
Access to the targeted aortic site was achieved by the EndoAnchor system 100.0 (70/70)
Successful delivery of the main body to the intended landing zone 94.3 (66/70)
Deployment of device
Successful deployment of the endovascular stent graft at the intended implantation siteb 100.0 (70/70)
c
Successful and accurate deployment of EndoAnchor implants was achieved 92.9 (65/70)
Absence of unintentional coverage of the renal arteries 97.1 (68/70)
Type IA endoleak at 1 monthd 6.8 (4/59)
Type IA endoleak at 1 yeard 1.9 (1/53)
Secondary procedures through 1 year 4.7 (3/64)
Conversion to open surgical repair through 12 months 0.0 (0/64)
Other secondary open surgical procedures through 12 months 1.6 (1/64)
Variables are presented as % (number of patients in the category/number of patients with available values).
a
Technical success was defined as successful delivery and deployment of the stent graft, without unintentional coverage of the renal arteries, and
successful implantation of the EndoAnchor implants at the target aortic site.
b
Absence of misdeployment of the main body proximal to the intended landing zone.
c
Each EndoAnchor adequately penetrated the aortic wall (investigator’s assessment), and in the investigator’s opinion, implantation of the
EndoAnchor was successful.
d
Core laboratory reported.

Primary outcomes. The primary outcomes are summa-
rized in Table IV, and the technical success rate was
88.6% (62/70). Technical failures were due to deploy-
ment of the main body slightly lower than the intended
target (n ¼ 4), EndoAnchor implants inadequately
penetrating the aortic wall (n ¼ 5), and unintentional
coverage of an accessory renal artery during aortic cuff
placement (n ¼ 2). As determined by the core laboratory,
the type IA endoleak rate in the first month was 6.8%
(4/59). In three of the four patients, the type IA endoleak
was identified at the 1-month follow-up visit and
resolved spontaneously by the 12-month follow-up. For
the fourth patient, a type IA endoleak was not identified
during the 1-month visit because the patient had been
treated with sac embolization, including 13 large coils
and filling of the area with Onyx (ev3, Covidien, Ply-
mouth, Minn) on post-index procedure day 9, which
resolved the event. The core laboratory reported a type
IA endoleak rate of 1.9% (1/53) at the 12-month follow-up,
and the single patient with the type IA endoleak has not
had AAA enlargement or undergone a secondary
procedure.
Three patients underwent five secondary procedures
through 1 year. The secondary procedures addressed
limb thrombosis (n ¼ 2), type IA endoleak (n ¼ 1), femoral
pseudoaneurysm repair (n ¼ 1), and femorofemoral
bypass (n ¼ 1). The Kaplan-Meier estimate for freedom
from secondary endovascular procedures is 97.0% and
95.4% at 30 and 365 days, respectively (Fig 1). No patients
in the short-neck cohort have required conversion to
open surgical repair.
Secondary outcomes. Table V summarizes secondary
outcomes including endograft and EndoAnchor perfor-
mance, safety and effectiveness measures, and MAEs. Of
note, there were no cases of main body migration,
increase in maximum aneurysm diameter, aneurysm
rupture, or EndoAnchor implant fractures through
12 months.
There were four (5.7%) deaths within 30 days of the index
procedure, which by protocol definition are considered
aneurysm-related deaths. However, the causes of death
were cardiac arrest (day 5); cardiac arrest and congestive
heart failure (day 6); cardiac and respiratory failure (day
9); and acute alcoholic hepatitis, pancreatitis, and renal
failure (day 13). None of these deaths were attributed to
the aneurysm by the site investigators. There was an addi-
tional death on day 353 due to fulminant pneumonia and
sepsis. The Kaplan-Meier survival estimate for all-cause
mortality through 30 days and 1 year was 94.3% and
92.7%, respectively (Fig 2). There were 18 MAEs reported
among 15 patients through 12-month follow-up, and
none were related to the EndoAnchor implants.
DISCUSSION
The Endurant stent graft has low rates of type IA endo-
leaks in cases within the IFU12-14 as well as in off-label
challenging neck situations.15 Similarly, the Heli-FX
EndoAnchor System was designed to enhance proximal
neck fixation and seal zone competency and to prevent
and treat type IA endoleaks.11 The combination of these
independently effective devices, aptly named ESAR, is a
logical next step to contend with the challenge
Journal of Vascular Surgery Arko et al 737
Volume 70, Number 3

Table V. Secondary outcomes for the short-neck cohort

Short-neck
Secondary outcomes cohort
Aneurysm diameter change at 12 months
Increase 0.0 (0/54)
Stable 57.4 (31/54)
Decrease 42.6 (23/54)
Endograft patency
Limb occlusiona through 30 days 3.4 (2/58)
Limb occlusiona through 12 months 5.9 (3/51)
Endograft stenosis through 30 days 1.8 (1/57)
Endograft stenosis through 12 months 2.0 (1/51)
Maintained adequate penetration by
EndoAnchor
Fig 1. Kaplan-Meier estimates for freedom from secondary
endovascular procedures for the short-neck cohort. At 30 days 98.0 (50/51)
At 12 months 94.6 (35/37)
Safety and effectiveness measures
of obtaining an adequate proximal seal within an infrare- Aneurysm-related mortality 5.7 (4/70)
nal neck <10 mm down to 4 mm. Furthermore, this through 30 daysb
technique offers a simple endovascular solution Aneurysm-related mortality 5.9 (4/68)
with the potential to minimize risks associated with through 12 monthsb
fEVAR or chEVAR, namely, secondary procedures and Aneurysm rupture through 30 days 0.0 (0/70)
renal compromise. Direct comparisons with other treat- Aneurysm rupture through 12 months 0.0 (0/64)
ment modalities should not be made because of differ- Migration at 12 monthsc 0.0 (0/41)
ences in patients’ baseline characteristics, aneurysm Total No. of MAEs through 12 months 18
morphology, and reporting measures that are likely to Patients with one or more MAEs through 21.4 (15/70)
exist between these studies. For example, all patients in 12 months
this series had short-neck infrarenal aneurysms, whereas All-cause mortality 7.1 (5/70)
fEVAR studies often include aneurysms of greater extent Bowel ischemia 1.4 (1/70)
and more complexity. However, an examination of the
Myocardial infarction 2.9 (2/70)
published results of fEVAR and chEVAR provides some
Paraplegia 0.0 (0/70)
context for the outcomes of ESAR in the short-neck
Procedural blood lossd 7.1 (5/70)
cohort presented herein.
Renal failure 0.0 (0/70)e
As a primary outcome measure, technical success in
the short-neck cohort was 88.6% (62/70). Notably, tech- Respiratory failure 4.3 (3/70)
nical success in this study required both delivery and Stroke 1.4 (1/70)
implantation of the stent graft main body and every MAEs, Major adverse events.
Variables are presented as % (number of patients in the category/
EndoAnchor implant. Inadequate aortic wall penetration number of patients with available values).
of a single EndoAnchor accounted for five of the eight a
Device occlusion defined as occlusion of a graft lumen.
b
Aneurysm-related mortality is defined as death within 30 days of the
technical failures. This may be a reflection of the 32.8% index procedure, death within 30 days of any secondary procedure to
of patients included in this cohort who were reported address the aneurysm, or death from rupture.
c
to have diffuse neck calcium involving a mean of 25% Based on core laboratory-related data. Migration is defined as
>10-mm movement of aortic endograft from its position at the
of the aortic wall circumference, measuring up to 1-month postimplantation measurement.
d
2.4 mm thick. Importantly, investigator-reported proce- Procedural blood loss/hemorrhage reported as a serious adverse
event at time of index procedure or secondary procedure is reported
dural success in this cohort was 97.1% (68/70) and is in here as an MAE.
e
line with previously published studies for fEVAR and chE- One patient died on day 13 after the index procedure, and
investigator-determined cause of death included acute renal failure.
VAR, which exceed 96%.6,16,17 There is now a current This was captured as a multisystem organ failure.
recommendation of placing four EndoAnchors for necks
#29 mm, whereas it is recommended to place six for
necks >29 mm. Per this protocol, procedural success could be reflective of the greater representation of
was an investigator-reported subjective assessment. women (27.1%) in the short-neck cohort. Previous litera-
Further evaluation of the IFU may need to be performed ture reported that women have smaller anatomic and
to determine the appropriate number of EndoAnchors. aneurysm measurements and should receive interven-
It is also noted that a fair number of small tion earlier than the current sex-neutral 5.5-cm-diameter
aneurysms, <4.5 cm, were treated in this cohort. This threshold for repair.18,19
738 Arko et al
Fig 2. Kaplan-Meier estimates for freedom from all-cause
mortality for the short-neck cohort.
Although the investigator-reported type IA endoleaks
present at the end of a case are concerning, these endo-
leaks were small enough to not warrant intervention and
required monitoring only. Based on core laboratory
assessment, the type IA endoleak rate of 6.8% at 1 month
after ESAR is on par with alternative endovascular repair
options in this complex anatomy.20 Contemporary
studies of fEVAR have reported type IA endoleak rates
between 0% and 3.6%, but they have been as high as
7.1% in early reports.5,21 Similarly, type IA endoleak after
chEVAR ranges from 0% to 7.7% in several studies.17,22
At 12 months, core laboratory-determined type IA endo-
leaks were identified in 1.9% (1/53) of patients. Although
not a direct comparison, these results are in line with
both fEVAR (<2% type IA endoleaks at 1 year)23 and
chEVAR (0%-6.3% type IA endoleaks in studies including
>15 patients),17,22 demonstrating the additive benefit of
adjunctive EndoAnchor placement to augment proximal
sealing within an otherwise hostile neck. Notably, no
aneurysm sac growth, aneurysm rupture, or stent graft
migration was observed at 12 months after ESAR.
Secondary endovascular procedures were required in
4.7% (3/64) of short-neck cohort patients through
12 months: two patients with limb thrombosis issues and
one patient with an early type IA endoleak treated with
sac embolization. The exact cause of limb occlusion is un-
known. However, the average iliac diameters of all of these
patients were 6.9 mm (right) and 7.0 mm (left), suggesting
that there was underlying iliac artery disease resulting in
the limb occlusion rate. In studies of fEVAR patients, sec-
ondary endovascular procedures were required in 8.2%
to 11.5% of patients within the first year.24,25 Rates of sec-
ondary endovascular interventions after chEVAR have a
wider range but on average are similar.5,26,27 There were
no conversions to open repair after ESAR.
The 30-day mortality in the short-neck cohort was
5.7%, all related to patients’ comorbidity, which falls
Journal of Vascular Surgery
September 2019
in line with published mortality rates after fEVAR
and chEVAR, again noting potential differences of
patients in the studies. Previously published series
have shown 30-day mortality rates for fEVAR ranging
from 1.4% to 4.1%.7,20 Banno et al5 reported similar
30-day mortality for fEVAR and chEVAR at 6.3% and
7.9%, respectively.
ESAR offers patients who might otherwise only be
considered for complex endovascular repair a less tech-
nically demanding endovascular alternative for short-
neck AAA. Total fluoroscopy time to complete ESAR
averaged 35.3 minutes, with a mean duration of implant
procedure of 148 minutes. A meta-analysis of fEVAR and
chEVAR by Li et al26 found that procedure length aver-
aged 261 minutes for fEVAR and 178 minutes for chEVAR.
Implantation of EndoAnchor implants on average
required an additional 17 minutes to complete, an insig-
nificant increase in total operative time.
Importantly, both the Endurant and EndoAnchor
devices are available off-the-shelf without the 3- to
6-week lead time required for the Zenith fenestrated
endograft (Cook Medical, Bloomington, Ind). This is
particularly important in urgent or emergent clinical
situations, such as symptomatic or ruptured aneurysm
patients, thus widening ESAR applicability. The shorter
procedure time reported for ESAR may also be a signifi-
cant benefit in ruptured patients who are not stable
enough to allow completion of a multivessel renovisceral
stent repair.
Perhaps most significant, the lack of renal artery manip-
ulation and stenting during ESAR may minimize the
potential for early and late renal impairment. Only a sin-
gle patient (1.4%) developed renal insufficiency within
12 months after ESAR, a notable finding considering
that eight patients in the cohort (11.4%) had renal disease
at baseline. In comparison, Grimme et al28 reported that
13 patients (9.4%) developed permanent renal impair-
ment in a series of 138 patients treated with fEVAR, all
being associated with renal stent stenosis or occlusion.
Another study comparing fEVAR and chEVAR for treat-
ment of pararenal AAA demonstrated that persistent
renal impairment after the index procedure occurred in
12 of 80 fEVAR patients (15%) and in 5 of 38 chEVAR
patients (13.2%).5 These data may suggest that patients
with preoperative renal insufficiency may be more
appropriately treated with ESAR instead of fEVAR or chE-
VAR if there is suitable anatomy to limit the amount of
contrast material and manipulation within the renal
arteries.
Limitations. There are inherent limitations to a retro-
spective analysis of a relatively small subset of patients
from ANCHOR. Patients were included in this study
solely on the basis of infrarenal neck length, but certainly
multiple other features of the proximal neck can play a
Journal of Vascular Surgery
Volume 70, Number 3
significant role in the outcome of complex EVAR,
including ESAR. The decision to use ESAR and to enroll
the patient into ANCHOR was left to the discretion of
the investigator and thus may be representative of less
calcified, thrombus-laden, or angulated proximal neck
cohort of patients. The impact of these neck character-
istics was not analyzed in these data. Finally, the
comparative analysis made to other treatment options
was based on historical published data, and patients’
aneurysm characteristics were likely to be different
between studies, preventing any direct comparisons. For
example, the referenced fEVAR studies included patients
with greater extent and more complex aneurysms
compared with these patients, all of whom had short-
neck infrarenal aneurysms. Moreover, the 12-month
follow-up is limited, and longer term evaluations are
necessary to evaluate the durability of ESAR. Additional
studies of the EndoAnchor population with longer term
follow-ups are recommended to better assess this
treatment option for these complex patients.
CONCLUSIONS
These short-term outcomes suggest that the Endurant
II/IIs endograft in conjunction with Heli-FX EndoAnchor
(ESAR) is a safe and effective treatment option for aneu-
rysm patients with an infrarenal neck length <10 mm
down to 4 mm. Technical success and incidence of
type IA endoleak are comparable to the reported out-
comes of fEVAR or chEVAR, but with a shorter procedure
and less fluoroscopy time and a low incidence of second-
ary procedures. In addition, very low rates of renal impair-
ment were observed as a result of infrarenal positioning.
Whereas long-term follow-up is still needed to assess the
durability of this repair strategy, ESAR may be considered
a viable off-the-shelf, complementary endovascular
treatment option for patients with short-neck AAAs,
particularly to minimize postoperative renal dysfunction
and for urgent or emergent clinical presentations.
The Aneurysm Treatment Using the Heli-FX Aortic
Securement System Global Registry (ANCHOR;
NCT01534819) was funded by Medtronic, Inc (Santa
Rosa, Calif). The authors acknowledge Pei Li and Ming-
Jay Chow, both of Medtronic, Inc, and Jocelyn K. Ballast,
Sanger Heart and Vascular Institute, for their assistance
with the statistical analysis and in the preparation of
the manuscript.
AUTHOR CONTRIBUTIONS
Conception and design: FA
Analysis and interpretation: FA, GS, BP, JH, MF, MM, GT,
JP, HG
Data collection: FA, GS, BP, JH, MF, MM, GT, JP, HG
Writing the article: FA, GS
Critical revision of the article: FA, GS, BP, JH, MF, MM, GT,
JP, HG
Arko et al 739
Final approval of the article: FA, GS, BP, JH, MF, MM, GT,
JP, HG
Statistical analysis: Not applicable
Obtained funding: Not applicable
Overall responsibility: FA
REFERENCES
1. Lee JT, Ullery BW, Zarins CK, Olcott Ct, Harris EJ Jr,
Dalman RL. EVAR deployment in anatomically challenging
necks outside the IFU. Eur J Vasc Endovasc Surg 2013;46:
65-73.
2. Leurs LJ, Kievit J, Dagnelie PC, Nelemans PJ, Buth J. Influ-
ence of infrarenal neck length on outcome of endovascular
abdominal aortic aneurysm repair. J Endovasc Ther 2006;13:
640-8.
3. Antoniou GA, Georgiadis GS, Antoniou SA, Kuhan G,
Murray D. A meta-analysis of outcomes of endovascular
abdominal aortic aneurysm repair in patients with hostile
and friendly neck anatomy. J Vasc Surg 2013;57:527-38.
4. Mendes BC, Oderich GS, Macedo TA, Pereira AA, Cha S,
Duncan AA, et al. Anatomic feasibility of off-the-shelf
fenestrated stent grafts to treat juxtarenal and pararenal
abdominal aortic aneurysms. J Vasc Surg 2014;60:839-47;
discussion: 847-8.
5. Banno H, Cochennec F, Marzelle J, Becquemin JP. Com-
parison of fenestrated endovascular aneurysm repair and
chimney graft techniques for pararenal aortic aneurysm.
J Vasc Surg 2014;60:31-9.
6. Lee JT, Lee GK, Chandra V, Dalman RL. Comparison of
fenestrated endografts and the snorkel/chimney technique.
J Vasc Surg 2014;60:849-56; discussion: 856-7.
7. Medical Advisory Secretariat. Fenestrated endovascular
grafts for the repair of juxtarenal aortic aneurysms: an
evidence-based analysis. Ont Health Technol Assess Ser
2009;9:1-51.
8. Hiramoto JS, Chang CK, Reilly LM, Schneider DB, Rapp JH,
Chuter TA. Outcome of renal stenting for renal artery
coverage during endovascular aortic aneurysm repair. J Vasc
Surg 2009;49:1100-6.
9. Shahverdyan R, Majd MP, Thul R, Braun N, Gawenda M,
Brunkwall J. F-EVAR does not impair renal function more
than open surgery for juxtarenal aortic aneurysms: single
centre results. Eur J Vasc Endovasc Surg 2015;50:432-41.
10. Anderson JL, Berce M, Hartley DE. Endoluminal aortic
grafting with renal and superior mesenteric artery incorpo-
ration by graft fenestration. J Endovasc Ther 2001;8:3-15.
11. Jordan WD Jr, Mehta M, Varnagy D, Moore WM Jr, Arko FR,
Joye J, et al. Results of the ANCHOR prospective, multi-
center registry of EndoAnchors for type Ia endoleaks and
endograft migration in patients with challenging anatomy.
J Vasc Surg 2014;60:885-92.e2.
12. Makaroun MS, Tuchek M, Massop D, Henretta J, Rhee R,
Buckley C, et al. One year outcomes of the United States
regulatory trial of the Endurant Stent Graft System. J Vasc
Surg 2011;54:601-8.
13. Bockler D, Fitridge R, Wolf Y, Hayes P, Silveira PG, Numan F,
et al. Rationale and design of the Endurant Stent Graft
Natural Selection Global Postmarket Registry (ENGAGE):
interim analysis at 30 days of the first 180 patients enrolled.
J Cardiovasc Surg (Torino) 2010;51:481-91.
14. Stokmans RA, Teijink JA, Forbes TL, Bockler D, Peeters PJ,
Riambau V, et al. Early results from the ENGAGE registry:
real-world performance of the Endurant Stent Graft for
endovascular AAA repair in 1262 patients. Eur J Vasc Endo-
vasc Surg 2012;44:369-75.
740 Arko et al
15. Torsello G, Troisi N, Donas KP, Austermann M. Evaluation of
the Endurant stent graft under instructions for use vs off-
label conditions for endovascular aortic aneurysm repair.
J Vasc Surg 2011;54:300-6.
16. Chisci E, Kristmundsson T, de Donato G, Resch T, Setacci F,
Sonesson B, et al. The AAA with a challenging neck:
outcome of open versus endovascular repair with standard
and fenestrated stent-grafts. J Endovasc Ther 2009;16:137-46.
17. Katsargyris A, Oikonomou K, Klonaris C, Topel I, Verhoeven EL.
Comparison of outcomes with open, fenestrated, and chim-
ney graft repair of juxtarenal aneurysms: are we ready for a
paradigm shift? J Endovasc Ther 2013;20:159-69.
18. Lo RC, Bensley RP, Hamdan AD, Wyers M, Adams JE,
Schermerhorn ML. Gender differences in abdominal aortic
aneurysm presentation, repair, and mortality in the Vascular
Study Group of New England. J Vasc Surg 2013;57:1261-8. e1-5.
19. Lo RC, Lu B, Fokkema MT, Conrad M, Patel VI, Fillinger M,
et al. Relative importance of aneurysm diameter and body
size for predicting abdominal aortic aneurysm rupture in
men and women. J Vasc Surg 2014;59:1209-16.
20. Suominen V, Pimenoff G, Salenius J. Fenestrated and
chimney endografts for juxtarenal aneurysms: early and
midterm results. Scand J Surg 2013;102:182-8.
21. Ziegler P, Avgerinos ED, Umscheid T, Perdikides T,
Stelter WJ. Fenestrated endografting for aortic aneurysm
repair: a 7-year experience. J Endovasc Ther 2007;14:609-18.
22. Coscas R, Kobeiter H, Desgranges P, Becquemin JP. Tech-
nical aspects, current indications, and results of chimney
Journal of Vascular Surgery
September 2019
grafts for juxtarenal aortic aneurysms. J Vasc Surg 2011;53:
1520-7.
23. O’Callaghan A, Greenberg RK, Eagleton MJ, Bena J,
Mastracci TM. Type Ia endoleaks after fenestrated and
branched endografts may lead to component instability
and increased aortic mortality. J Vasc Surg 2015;61:908-14.
24. Kristmundsson T, Sonesson B, Dias N, Törnqvist P, Malina M,
Resch T. Outcomes of fenestrated endovascular repair of
juxtarenal aortic aneurysm. J Vasc Surg 2014;59:115-20.
25. Verhoeven EL, Vourliotakis G, Bos WT, Tielliu IF, Zeebregts CJ,
Prins TR, et al. Fenestrated stent grafting for short-necked
and juxtarenal abdominal aortic aneurysm: an 8-year
single-centre experience. Eur J Vasc Endovasc Surg 2010;39:
529-36.
26. Li Y, Hu Z, Bai C, Liu J, Zhang T, Ge Y, et al. Fenestrated and
chimney technique for juxtarenal aortic aneurysm: a sys-
tematic review and pooled data analysis. Sci Rep 2016;6:
20497.
27. Scali ST, Feezor RJ, Chang CK, Waterman AL, Berceli SA,
Huber TS, et al. Critical analysis of results after chimney
EVAR raises cause for concern. J Vasc Surg 2014;60:865-74.e1.
28. Grimme FA, Zeebregts CJ, Verhoeven EL, Bekkema F,
Reijnen MM, Tielliu IF. Visceral stent patency in fenestrated
stent grafting for abdominal aortic aneurysm repair. J Vasc
Surg 2014;59:298-306.
Submitted Jun 14, 2018; accepted Nov 7, 2018.