CLINICAL INVESTIGATION ARTERIAL INTERVENTIONS

Ten Years of Experience with the GORE EXCLUDER�

Stent-Graft for the Treatment of Aortic and Iliac Aneurysms:Outcomes from a Single Center Study

G. Maleux • H. Claes • A. Van Holsbeeck •

R. Janssen • A. Laenen • S. Heye • S. Houthoofd •

I. Fourneau

Received: 10 March 2011 / Accepted: 15 July 2011 / Published online: 6 August 2011

� Springer Science+Business Media, LLC and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2011

Abstract

Purpose This study was designed to assess the long-term

outcome of selected patients with aortic, aortoiliac, and

isolated common iliac aneurysms treated with the GORE

EXCLUDER� stent-graft.

Methods Between December 1998 and June 2010, 121

nonconsecutive patients underwent insertion of a GORE

EXCLUDER� stent-graft to treat an aortic (n = 80; 66%),

aortoiliac (n = 25; 21%), or isolated common iliac

(n = 16; 13%) aneurysm. Procedural and follow-up data

were collected prospectively. Primary endpoints are overall

survival, intervention-free survival, and freedom from

aneurysm rupture. Secondary endpoints are device- and

procedure-related complications, including all types of

endoleaks or endotension, and reintervention.

Results The mean follow-up is 4.98 years (standard

deviation, 3.18; median follow-up, 4.05 years). The esti-

mated percentage overall survival (with 95% confidence

interval) after respectively 5 and 10 years of follow-up is

74.5% (65.8; 81.3) and 57.8% (47.7; 66.7). The estimated

intervention-free survival after respectively 5 and 10 years

is 90% (84.3; 96.1) and 77.7% (67; 88.4). There was no

aneurysm rupture during follow-up. Early postoperative

complications occurred in 16 patients (13%); none were

fatal. Late reinterventions were performed in 18 patients

(15%). Finally, throughout the follow-up period, endoleaks

were identified: type I (n = 4; 3%); type II (n = 39; 32%);

type III (n = 0; 0%); endotension was seen in 11 patients

(9%).

Conclusions Aneurysm exclusion with use of the GORE

EXCLUDER� stent-graft is durable through a mean fol-

low-up of nearly 5 years. There was no postprocedural

aneurysm rupture. Complications occurred throughout the

follow-up period, requiring continued clinical and radio-

logical surveillance.

Keywords Abdominal aortic aneurysm � Stent-graft �Computed tomography � Arterial intervention

Introduction

Endovascular aortic repair (EVAR) is considered a valu-

able treatment alternative to open, surgical repair with

beneficial early outcome and equivalent survival at mid-

term follow-up [1–3]. Long-term outcome after EVAR,

using currently available, third-generation stent-grafts, is

not yet determined. However, several reports concerning

the use of first- and second-generation stent-grafts, dem-

onstrate a considerable risk for early and late stent-graft

failure and aneurysm-related death [4, 5]. The GORE

EXCLUDER� stent-graft (W.L. Gore & Associates,

Flagstaff, AZ) is one of the currently available third-

generation, FDA-approved stent-grafts on the market [6, 7].

The authors state that they haven’t received any funding for research

from any of the following organizations: National Institutes of Health

(NIH), Wellcome Trust, Howard Hughes Medical Institute (HHMI).

G. Maleux (&) � H. Claes � A. Van Holsbeeck � S. Heye

Department of Radiology, University Hospitals Leuven,

Herestraat 49, 3000 Leuven, Belgium

e-mail: geert.maleux@uzleuven.be

R. Janssen � S. Houthoofd � I. Fourneau

Department of Vascular Surgery, University Hospitals Leuven,

Herestraat 49, 3000 Leuven, Belgium

A. Laenen

Department of Biostatistics and Statistical Bioinformatics,

Catholic University of Leuven,

Kapucijnenvoer 35 Blok d - Bus 7001,

3000 Leuven, Belgium

123

Cardiovasc Intervent Radiol (2012) 35:498–507

DOI 10.1007/s00270-011-0235-6

Early and mid-term results have shown encouraging

outcome with very low rates of stent-graft failure or

associated aneurysm-related morbidity and mortality

[8–12]. Long-term outcome still has to be determined. This

report, based on a single-center experience of more than

10 years, presents the long-term outcome of patients with

aortic, aortoiliac, or isolated common iliac aneurysms

treated with the GORE EXCLUDER� stent-graft.

Materials and Methods

Inclusion and Exclusion Criteria

The inclusion and exclusion criteria for aortic stent-graft

implantation were defined by the Belgian National Health

Insurance Office (RIZIV) and are summarized in Table 1.

The major goals for assessing these national guidelines for

aortic stent-graft implantation were: (1) creation of a

national, well-defined database for aortic stent-grafting and

follow-up of patients treated with this new interventional

technology, and (2) subsequently regulate the reimburse-

ment for aortic stent-grafts in Belgium. Additionally, all

patients gave written, informed consent before the endo-

vascular aortic repair (EVAR-) procedure both for the

procedure itself and for follow-up schedule, as proposed

by the RIZIV, including prospective collection of pre-,

peri-, and postoperative data into a National Database.

Finally, the institutional Ethics Committee approved this

single center, retrospective analysis of prospectively col-

lected data on patients treated with a bifurcated GORE

EXCLUDER� stent-graft (S52917).

Stent graft Implantation Procedure

Assessment of anatomic criteria for stent-graft implantation

and planning of the stent-graft were performed based on

helical computed tomography (CT) in all patients and on

calibrated angiography if available. Depending on the time

period of treatment, a 4-, 16-, or 64-row CT scanner was

used, and routinely an unenhanced and an arterial phase

helical scan were performed. The arterial phase, using

iomeprol 400 mgI/ml (Iomeron 400, Bracco Imaging, Milan,

Italy) with a flow rate of 3 to 4 ml/s was performed after

optimal aortic triggering. From 1998 to 2008, a calibrated

angiography also was performed before EVAR, including

anteroposterior and lateral image views of the aorta and two

oblique views of the iliac arteries. Since 2008, preoperative

imaging was solely based on multidetector row CT scan with

axial, coronal, and sagittal reconstructed images. All EVAR

procedures were performed by a team of interventional

radiologists and vascular surgeons in the operating room

with use of a standard mobile image intensifier (Siremobil

2000 from 1998 to 2006 and Arcadis Avantic from 2006 to

2010; Siemens, Forchheim, Germany).

After gaining access to the femoral arteries, antibiotic

prophylaxis (cefazolin 2 g) and full heparinization (5,000–

7,500 IU depending on the body weight) were administered

intravenously. A detailed description of all characteristics of

the EXCLUDER� stent-graft and the implantation proce-

dure are described elsewhere [11, 13]. Briefly, the two parts

of the bifurcated stent-graft are mounted on a catheter-like

device. The 18-French (F) main device, consists of a prox-

imal tube (trunk), a flow divider, a full-length ipsilateral

iliac limb and a short contralateral end for attachment of the

12-F contralateral limb, which is the second component of

this modular stent-graft device. Finally, both components of

the stent-graft are made by a nitinol skeleton and an

expanded poly-tetra-fluoro-ethylene (e-PTFE) fabric.

Table 1 Inclusion and exclusion criteria for the implantation of

aortic stent-grafts as defined by the Belgian National Health Insurance

Office (RIZIV)

INCLUSION CRITERIA

Aneurysm size

Fusiform aortic aneurysm with diameter [ 5 cm

Fusiform aortic aneurysm with diameter \ 5 cm if:

• 2 9 diameter of the native aorta

• [5 mm growth in 6 months

• Symptomatic patient with back or abdominal pain

• Aneurysm tender on palpation

• Patient \ 65 years

• Family history of aneurysm (first degree)

Saccular aneurysm of any size

Fusiform (common) iliac artery aneurysm [ 2 cm

Anatomical aortoiliac criteria

Minimal proximal neck length of 1 cm, 10-20% smaller than

diameter of available device;

Minimal distal landing area of 1 cm, 10-20% smaller than diameter

of available device;

Iliofemoral and/or brachial access suitable for available device

EXCLUSION CRITERIA

General criteria

\2 years life expectancy

Mycotic aneurysm or infectious arteritis

Active remote infection

Hemophilia or known bleeding diathesis

Marfan’s syndrome and other genetic connective tissue diseases

Anatomical criteria

• 70% proximal neck angulation and/or heavily calcified proximal

neck (circular calcifications)

• Thrombus [ 3 mm or [ 1/3 of the circumference at the level of

the proximal neck

• Iliac tortuousities and calcifications preventing deployment of

the introducer sheath

G. Maleux et al.: Outcomes from a Single Center Study 499

123

Follow-Up Protocol

Radiological follow-up was in accordance to the EURO-

STAR criteria [14] and included abdominal plain film and

contrast-enhanced triphasic helical CT scan [15] at 3, 6, 12,

18, and 24 months postoperatively and yearly thereafter. In

case of intolerability to iodinated contrast medium (e.g.,

renal insufficiency or severe allergy to iodinated contrast

medium), the contrast-enhanced CT scan was replaced by a

nonenhanced CT scan and an additional color-coded

duplex ultrasound (CCDU). Indication for the treatment of

an endoleak was mainly based on the type of endoleak.

Type I and type III endoleaks are always treated immedi-

ately. Type II endoleaks are treated if concomitant gradual

increase in diameter of the aneurismal sac is depicted.

Indication to treat endotension is less clear; based on a

pragmatic approach endotension was treated if the aneur-

ismal diameter increased rapidly on sequential CT scans or

when the diameter became 2 cm or greater than the initial

sac diameter. Treatment of endotension by open repair or

by endovascular repair (=relining the endograft with a low-

porosity e-PTFE covered stent-graft) was based on the

patient’s fitness for open repair: if a patient was considered

fit for open repair, then it was decided to perform surgery.

If not, then relining was preferred. Potential stent fracture

and stent-graft migration ([1 cm) were evaluated by both

abdominal plain film and CT scan.

Study Endpoints and Definitions

Primary endpoints are overall survival, intervention-free

survival, and freedom from aneurysm rupture. Secondary

endpoints are procedural success and early and late device-

and procedure-related complications, including all types of

endoleaks or endotension. Endotension is defined as

increase of the excluded aneurismal sac diameter without

endoleak detection on contrast-enhanced CT or color-coded

duplex ultrasound.

Procedural or primary technical success is defined as

successful introduction and deployment of the stent-graft in

the absence of conversion to open repair or intraoperative

mortality, type I or type III endoleaks, or graft limb

occlusion. In the case of unplanned additional requisite

endovascular and/or surgical procedures within 24 hours

after the initial EVAR procedure, the term primary-assisted

procedural success is used.

Aneurysm-related mortality is defined as death resulting

from aneurysm rupture or any death occurring within

30 days after initial EVAR or reintervention. Reinterven-

tion is any procedure, endovascular or open surgical, per-

formed after initial EVAR to restore the function of the

stent-graft.

Statistical Analysis

Summary statistics for continuous variables are the mean

and standard deviation. Categorical variables are summa-

rized by means of frequency tables.

Kaplan–Meier estimates are used to construct a curve

for the overall survival. Cumulative incidence estimates

were used to construct the survival curve for intervention-

free survival [16]. In the latter, death without intervention

is considered as a competing risk. The date of intervention

is used as the start date for the follow-up times. Analyses

have been performed using the statistical package SAS

version 9.2 (Cary, NY, USA).

Results

Patient Demographics

Between December 1998 and June 2010, a total of 121

nonconsecutive patients (4 women (3%) and 117 men

(97%)) with a mean age of 72.8 years (standard deviation

(SD), 7.64 years; range, 50.4–85.3 years) were selected

for GORE EXCLUDER� stent-graft implantation at the

University Hospitals of Leuven, Belgium.

Preoperative patient risk stratification using the Society

of Vascular Surgery/International Society of Cardiovascu-

lar Surgery (SVS/ISCVS) risk scoring system is summa-

rized in Table 2 and the preoperative risk stratification

according to the American Society of Anesthesiology

(ASA) classification is summarized in Table 3.

With regard to the inclusion and exclusion criteria as

defined by the RIZIV, in seven patients a protocol violation

was noted: in two patients a mycotic aneurysm was treated

by EVAR and in the remaining five patients a neck length

shorter than 15 mm was measured (10, 10, 12, 13, and

14 mm, respectively).

Table 2 Preoperative patient risk stratification using the Society of

Vascular Surgery/International Society of Cardiovascular Surgery

(SVS/ISCVS) risk scoring system

SVS/ISCVS risk scoring 0 1 2 3 No. of patients

with available data

Tobacco risk 49 36 23 9 117

Hypertension risk 30 43 43 5 121

Diabetes risk 101 18 2 0 121

Hyperlipidemia risk 37 25 7 52 121

Cardiac status risk 66 36 19 0 121

Carotid disease risk 77 27 11 3 118

Renal status risk 105 16 0 0 121

Pulmonary status 34 60 18 1 113

500 G. Maleux et al.: Outcomes from a Single Center Study

123

Aneurysm Characteristics

The majority of included patients presented with an aortic

aneurysm (n = 80; 66%); in the remaining patients aorto-

iliac (n = 25; 21%) or isolated common iliac aneurysm

(n = 16; 13%) was identified. In the group of aortic and

aortoiliac aneurysms (n = 105), the mean maximal diam-

eter of aortic aneurysm was 58.07 mm (range, 36–108 mm;

SD, 11.76 mm); the mean diameter of the neck of the

aneurysm was 21.58 mm (range, 17–27 mm; SD, 2.24 mm)

and the mean length of the neck of the aneurysm was

32.9 mm (range, 10–74 mm; SD, 13.31 mm). The indica-

tion for EVAR in abdominal aortic aneurysm (AAA) with

an aortic diameter \5 cm (n = 9) was: symptomatic

(painful) aneurysm (n = 1); traumatic pseudoaneurysm of

the abdominal aorta (n = 1); and rapidly growing AAA

([5 mm in \6 months; n = 7). In the group of isolated

common iliac aneurysms, the mean maximal diameter of

the iliac aneurysm is 44.56 mm (range, 27–70 mm; SD,

11.13 mm). The degree of aortic tortuosity according to the

SVS/ISCVCS reporting standards for infrarenal endovas-

cular abdominal aortic repair is summarized in Table 4. The

etiology of the aneurysm was: atherosclerotic aneurysm

(n = 109; 90%); inflammatory aneurysm (n = 4; 3.3%);

mycotic aneurysm (n = 2; 1.7%); and false aneurysm

(n = 6; 5%). In the latter group, the false aneurysm was

located at the proximal anastomosis of an aortobifemoral

graft (n = 5). In the remaining patient, the false aneurysm

was a result of a penetrating abdominal trauma [17].

Additional Preoperative and Perioperative Procedures

Preoperative internal iliac artery coil embolization was

performed in 26 patients (22%) using standard coil

Table 3 Preoperative risk stratification according to the American

Society of Anesthesiology (ASA) classification

ASA classification No. of patients

I 12 (10%)

II 59 (49%)

III 47 (39%)

IV 3 (2%)

Table 4 Anatomic aortic aneurismal characteristics (n = 105a)

according to the SVS/ISCVS reporting standards for infrarenal en-

dovascular abdominal aortic repair

Degree of aortic tortuosity Grade I Grade II Grade III

Number 76 21 8

Percentage 72% 20% 8%

a Patients with isolated common iliac aneurysm were excluded

Fig. 1 A 60-year-old man

presented with (a) a growing

AAA with a maximum diameter

of 50 mm. Follow-up CT scan

after (b) 1, (c) 3 and (d) 4 years

clearly reveals a decrease in

aneurysm diameter of 45,

34 and 30 mm, respectively

G. Maleux et al.: Outcomes from a Single Center Study 501

123

embolization techniques as described elsewhere [18]. In the

large majority of cases general anaesthesia (n = 114; 94%)

was performed. In six patients (5%), the procedure was

performed under local and in one patient (1%) under per-

idural anaesthesia. Access to the femoral arteries was

obtained after surgical cut-down in 104 patients (86%). In

17 patients (14%), bilateral percutaneous femoral access

was created and closed at the end of the procedure with use

of a suture-based percutaneous closure device (Perclose,

Abbott Inc., Redwood City, CA, USA).

Additional perioperative surgeries (n = 10; 8%) were:

bypass between distal external iliac artery and the ligated

Fig. 2 A 69-year-old man with

(a) a left isolated proximal

common iliac aneurysm

underwent insertion of a

bifurcated EXCLUDER� stent-

graft. Sequential follow-up CT

scan after respectively 1 (b),

2 (c), and 5 (d) years

demonstrates clear shrinkage

of the aneurismal sac with

virtual disappearance of the

sac at 5 years of follow-up

Table 5 Detection of endoleaks during follow-up

Type of endoleak No. of patients

Type Ia 2

Type Ib 2

Type II 39

Type III 0

Endotension 11a

a Patients presenting with endotension (n = 11) had OP-ePTFE

stent-grafts implanted; they were followed-up by contrast-enhanced

CT scan (n = 9) or by nonenhanced CT scan ? color-coded ultra-

sound (n = 2)

Table 6 Early postoperative morbidity

Complication No. of patients

(total 121)

Cardiac (myocardial infarction) 1

Pulmonary (lung embolism) 2

Stroke 1

Delirium 1

Urinary tract infection 1

Gastrointestinal bleeding 1

Fever of unknown origin 3

Anemia of unknown origin 1

Sepsis (graft infection) 1

Access site complications

Groin hematoma 2

Lymph leakage 2

502 G. Maleux et al.: Outcomes from a Single Center Study

123

internal iliac artery (n = 3), repair of distal anastomoses of

aortofemoral graft (n = 2), iliofemoral graft (n = 2),

femoropopliteal bypass (n = 1), iliorenal bypass (n = 1),

and patch angioplasty of the common femoral artery

(n = 1). The indication for iliorenal bypass surgery was:

the AAA (true aortic lumen) was associated with thora-

coabdominal aortic dissection, previously treated with a

thoracic stent-graft; the right renal artery, as the only vis-

ceral artery, originated from the false lumen; additionally,

renal scintigraphy showed a right renal function of 33%.

This was considered clinically significant to perform

bypass surgery to protect the right renal function.

Additional endovascular perioperative procedures

(n = 6; 5%) were: proximal aortic cuff extension (n = 3),

balloon angioplasty of the common iliac artery prior to

stent-graft insertion: (n = 1), and stenting of the external

Table 7 Causes of late postoperative mortality

Mortality cause No.of patients,

total n = 35

Cardiac 7

Cancer 19

Bowel ischemia 2a

Septicaemia 3b

Pulmonary 1

Neurovascular 2

Unknown 1

a Bowel ischemia most probably was not related to the device or to

the EVAR procedure: the devices were placed as planned and none of

both patients had symptoms of bowel ischemia immediately after the

procedure or during the first year after EVAR. However, it must be

noted that one of both patients underwent unilateral internal iliac

artery coil embolization before EVARb Septicemia in one patient related to stent-graft infection

Fig. 3 Kaplan-Meier overall

survival curve shows an

estimated survival at 5 and

10 years’ follow-up of 74.5%

(65.8; 81.3) and 57.8% (47.7;

66.7), respectively

Table 8 Late adverse events/complications and late reinterventions

Adverse event/

complication

No. of

patients

reintervention

Proximal type I

endoleak

2 Cuff-extension (n = 1)

Coil and glue embolization

(n = 1)

Distal type I endoleak 2 Distal stent-graft extension

(n = 2)

Limb thrombosis 2 Femorofemoral cross-over

bypass (n = 1)

Conservative management

(n = 1)

Proximal stent-graft

infolding

2 PALMAZ� stenta (n = 1)

Conservative management

(n = 1)

Limb kinking 1 WALLSTENT� (n = 1)

Stent-graft infection 1 Resection (n = 1)

Occlusion of external-to-internal

Iliac bypass 1 Conservative management

(n = 1)

Groin pseudoaneurysm 1 Surgical repair (n = 1)

Type II endoleak Elective conversion (n = 1)

Translumbar embolization

(n = 3)

Conservative management

(n = 37)

Endotension Elective conversion (n = 1)

Relining (n = 4)

Conservative management

(n = 6)

a PALMAZ� stent (Cordis, Johnson & Johnson, Miami Lake, FL,

USA)

WALLSTENT� (Boston Scientific, Natick, MA, USA)

G. Maleux et al.: Outcomes from a Single Center Study 503

123

iliac artery (n = 2). From 1998 to July 2004, the stent-graft

was constructed with the original permeability (OP)

e-PTFE fabric (n = 55; 45%); from July 2004 until the end

of the study the stent-grafts incorporate a low-permeability

(LP) e-PTFE fabric (n = 67; 55%).

Radiological Follow-Up

In 112 patients (94%), the follow-up was performed based

on contrast-enhanced CT (Figs. 1A–D; 2A–D) and

abdominal plain film. In the remaining seven patients (6%),

suffering from chronic renal insufficiency, the radiological

follow-up was accomplished with color-coded ultrasound,

unenhanced CT, and abdominal plain film. Numbers

and types of different endoleaks, including endotension,

detected during the follow-up, are summarized in Table 5.

Early Postoperative Morbidity and Mortality

Early postoperative complications occurred in 16 of 121

patients (13%) and are summarized in Table 6. None of the

early complications were fatal.

Late Postoperative Morbidity and Mortality

Causes of (late) mortality are summarized in Table 7. In

total, 35 patients (29%) died during follow-up; the majority

died from cancer. Kaplan–Meier survival analysis (Fig. 3)

shows estimated survival at 5 and 10 years of follow-up of

74.5% and 57.8%, respectively.

Late adverse events or complications and late reinter-

ventions are summarized in Table 8 (Fig. 4). No stent

fracture was depicted. Two patients presented with a distal

stent-graft migration of 11 mm and 13 mm, respectively,

both of which were identified 6 years after EVAR. In one

patient, the stent-graft migration was potentially related to

a progressive growth of the aneurysmal sac diameter

without endoleak. The patient was treated by elective open

repair. The other patient was treated with placement of a

proximal cuff-stent graft resulting in complete exclusion of

the type I endoleak. An additional reintervention through-

out the follow-up period was required in 18 patients (15%;

Figs. 5A–C; 6A–B; 7A–D). All four cases of relining were

technically successful and based on a follow-up of 28, 22,

7, and 2 months, respectively. No clear regrowth of the

aneurismal sac has been observed. Event-free survival

analysis estimated event-free survival at 5 and 10 years of

90% and 77.7%, respectively (Fig. 8).

Discussion

This report shows that endovascular exclusion of aortic and

iliac aneurysms with use of the GORE EXCLUDER� stent-

graft is safe, efficient, and durable with a mean follow-up of

nearly 5 (range, 0.09–11.82) years. Earlier reports already

demonstrated the very high technical success rate of the

EVAR-procedure with use of the GORE EXCLUDER�

stent-graft with a success rate between 97% and 100%

[8, 11, 12, 19]. Also, short- and midterm clinical and

radiological follow-up (mean follow-up ranging between

21.5–35.7 months) could demonstrate freedom from aneu-

rysm rupture or a low aneurysm-related death rate. In the

present study, with a mean follow-up of nearly 5 years, we

also did not identify any late aneurysm rupture, suggesting

that the GORE EXCLUDER� stent-graft seems to be

effective at avoiding aneurysm rupture during a longer fol-

low-up period. In one patient, the endograft became infected

and despite successful surgical conversion the patient died

as a result of septicemia and multiple organ failure.

The overall reintervention rate is low (15%) and pri-

marily consisted of the management of type I and type II

endoleaks and endotension. The incidence of late type I

endoleaks (3.3%) is in the same range as the series by

Melissano et al. [12] and equal to the series of Bos et al.

[19]. With the use of other stent-graft systems, such as the

Fig. 4 A 72-year-old man with a previous history of aortofemoral

grafting for aortoiliac occlusive disease underwent EXCLUDER�

stent-graft insertion for the treatment of a proximal anastomotic false

aneurysm. One year after stent-grafting, the patient underwent left

lower limb amputation because of irreversible chronic distal ischemia.

Control CT scan with 3D reconstruction 3 months later shows

occlusion of the left limb of the stent-graft (white arrows)

504 G. Maleux et al.: Outcomes from a Single Center Study

123

Zenith stent-graft, similar reintervention rates at midterm

follow-up are published [20].

All type I endoleaks could be repaired by endovascular

procedures: placing a proximal cuff (n = 1), distal exten-

sion stent-graft (n = 2), and perigraft coil embolization

(n = 1) [21, 22]. Importantly, we could not identify any

early or late type III endoleak, underlining the long-term

durable nature of both the e-PTFE fabric and the modular

construction of the stent-graft.

Infolding of the endograft is a rare adverse event and

typically seen in the proximal part of a thoracic endograft

[23]. Analogous to thoracic stent-graft collapse, we

recovered significant infolding in one patient by placing an

additional PALMAZ� stent over the collapsed proximal

part of the stent-graft.

Of 121 patients, limb graft stenosis or thrombotic

occlusion occurred in 1 and 2 patients, respectively, which

seems to be fewer than in other series dealing with unsup-

ported and other supported endografts [24]. Moreover, the

two limb occlusions identified in this follow-up study most

likely were not related to stent-graft failure. This is illus-

trated by the first patient who had thrombotic occlusion,

which was due to absence of outflow occurring after lower

limb amputation for chronic limb ischemia. Similarly in the

Fig. 5 An 80-year-old man

presented with left-sided

claudication 6 months after

insertion of a bifurcated

EXCLUDER� stent-graft.

a Coronal CT reconstruction

demonstrates a kinking with

focal narrowing (white arrow)

of the left limb of the stent-

graft. b Catheter angiography

with use of Carbon dioxide

(CO2) confirms the focal high-

grade stenosis. c Control

angiography after deployment

of a WALLSTENT� (Boston

Scientific, Natick, MA, USA)

over the stenosis shows a good

patency of the left limb of the

stent-graft

Fig. 6 a Unenhanced axial CT

scan 3 months after stent-

grafting shows a clear infolding

of the body of the body of the

EXCLUDER� stent-graft.

b Unenhanced CT scan after

insertion of a giant PALMAZ�

stent (Cordis, Johnson &

Johnson, Miami Lake, FL,

USA) shows complete

disappearance of the infolding

G. Maleux et al.: Outcomes from a Single Center Study 505

123

second patient, the limb occlusion probably was related to

instent-restenosis in the WALLSTENT�, placed distal to

the stent-graft in the external iliac artery.

Endotension was observed in ten patients (12%), which

is in the same range as other studies with GORE

EXCLUDER� stent-graft: Kibbe et al. [8] found aneurysm

enlargement of[5 mm in 14% of cases and Goodney et al.

[25] found sac expansion without demonstrable endoleak in

12 of 97 patients. All of these patients were treated with the

original permeability e-PTFE fabric. In the present study,

11 of 121 patients (9%) developed endotension during

follow-up. In all of the patients, an OP-stent-graft was

implanted [26, 27]. However, patients with an OP graft

were treated earlier in the series and subsequently have

longer follow-up and potentially greater time to develop

endotension than the LP group. Overall, adverse events,

both with and without the need for invasive management

occurred throughout the follow-up period stressing the

Fig. 7 A 77-year-old man

presented with (a, b) a proximal

type I endoleak, 4 years after

initial stent-graft procedure,

most probably due to distal

migration of the stent-graft

body. c, d After insertion of a

proximal cuff-extension, the

type I endoleak was completely

excluded

Fig. 8 The intervention-free

survival curve (based on

cumulative incidence estimates)

shows that in the population

where patients might die from

other causes, it is expected that

90% (84.3; 96.1) of the patients

is free from reintervention after

5 years and 77.7% (67; 88.4) of

patients is free from

reintervention after 10 years

506 G. Maleux et al.: Outcomes from a Single Center Study

123

need for continued radiological follow-up, even in patients

with a stable graft function for several years.

This study has identified limitations. First, the study

population is a nonconsecutive group of patients treated

with a GORE EXCLUDER� stent-graft for aortic or iliac

aneurysm. Second, despite a long follow-up period, the

total number of included patients is relatively low: not all

patients suitable for an EVAR procedure were treated with

a GORE EXCLUDER� stent-graft in our institution. This

is attributable to the reduced number of available proximal

and distal diameter sizes of the stent-graft.

In conclusion, this report demonstrates the durability of

the GORE EXCLUDER� stent-graft for the exclusion of

aortic and iliac aneurysms during a long-term follow-up

period. No late aneurysm rupture and a very low aneurysm-

related mortality were noted. Adverse stent-graft-related

events are infrequent; however, they may occur throughout

the follow-up period, thereby necessitating a continued

radiological follow-up.

Conflict of interest None.

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