Midterm results of endovascular versus open surgical repair for

infrarenal abdominal aortic aneurysms in low surgical risk patients

Ernesto Arenas Azofra, MD,a Cristóbal Iglesias Iglesias, MD,a Carmen Canga Gonzalez, MD,a Francisco Álvarez
Marcos, MD,a Carlota Fernandez Prendes, MD,b Amer Zanabili Al Sibbai, MD,a and Manuel Alonso Perez, MD,a
Oviedo, Spain and Munich, Germany

ABSTRACT
Objective: The objective of this study was to analyze midterm outcomes of endovascular repair (EVAR) versus open repair
(OR) for treatment of infrarenal abdominal aortic aneurysms (AAAs) in low surgical risk patients.
Methods: Elective patients with AAAs undergoing treatment from 2003 to 2017 in a single, tertiary-care institution were
evaluated. All patients with a low preoperative risk of complications and perioperative mortality (Medicare Aneurysm
Scoring System <3) were included, and rates of perioperative and long-term mortality, adverse events, and reintervention
were evaluated for EVAR and OR. A propensity score-matched cohort, leveling age, risk factors, and comorbidities was
additionally performed.
Results: A total of 227 patients were included (EVAR 59.9% and OR 40.1%) and followed for a mean of 80 6 48 months.
Patients undergoing EVAR were older (66.6 6 5 vs. 64.1 6 6 years; P <.001), had a higher body mass index (29.6 6 4 vs
28.1 6 3 kg/m2; P ¼ .005), a higher prevalence of chronic obstructive pulmonary disease (27.3% vs 9.9%; P ¼ .001), and
lower prevalence of dyslipidaemia (46.3% vs 65.9%; P ¼ .004). Patients undergoing OR had a higher rate of major adverse
events (19.7% vs 2.6%; P ¼ .001) and 30-day reinterventions (8.8% vs. 1.5%; P ¼ .016), with 30-day mortality being 0% in both
groups. The propensity-score matched cohort included 76 matched pairs (1:1), with differences in hospital stay and major
complications remaining significant, without affecting mortality. At 5-year follow-up, there were no significant differences
in the reintervention rate (EVAR 18.5% vs OR 17.6%; P ¼ .67) or survival (EVAR 85% vs OR 91%; P ¼ .195).
Conclusions: In low surgical risk patients with AAAs, EVAR may offer comparable midterm results to OR, with a lower rate
of major adverse events and a shorter in-hospital stay. With the current OR-first paradigm in low-risk patients, several
factors should be taken into account for decision-making (anatomic suitability, risk of sexual dysfunction, risk of type 2
endoleaks, and need for follow-up). (J Vasc Surg 2021;-:1-7.)
Keywords: Abdominal aortic aneurysm; Endovascular procedures; Postoperative complications; Risk assessment; Young
adult

Endovascular abdominal repair (EVAR) has become the
first treatment option for infrarenal abdominal aortic an-
eurysms (AAAs) in many patients.1,2 The superiority of
EVAR over open repair (OR) is based on a lower 30-day
mortality rate, which is especially relevant when treating
elderly or high-risk patients.3,4 However, this short-term
superiority has not been proven long-term, with EVAR
mortality rates equaling those of OR, and associated
higher reintervention rates.5,6 Furthermore, the
From the Department of Angiology and Vascular Surgery, Hospital Universitario
Central de Asturias (HUCA), Oviedoa; and the Department of Vascular Surgery,
University Hospital, Ludwig-Maximilians University Munich, Munich.b
Author conflict of interest: none.
Correspondence: Ernesto Arenas Azofra, MD, Department of Angiology and
Vascular Surgery, Hospital Universitario Central de Asturias (HUCA), Avenida
de Roma, s/n, 33011 Oviedo, Asturias, Spain (e-mail: ernesto.arenas@usal.es).
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 2021 by the Society for Vascular Surgery. Published by Elsevier Inc.
https://doi.org/10.1016/j.jvs.2021.10.047
significance and resolution of EVAR-intrinsic issues like
sealing and type 2 endoleaks continue to be disadvan-
tages of this technique.7
Younger and low surgical risk patients show a lower
perioperative risk and a longer life expectancy, so the
long-term durability and absence of reinterventions
and/or complications is of paramount importance.8
With these concerns in mind, OR is still the preferred
treatment strategy for most surgeons in this subgroup.
Although high-risk and aging populations have been
studied in detail, analyses with a focus on low-risk pa-
tients are scarce. The objective of this study was to
compare the perioperative and long-term results of
EVAR vs OR in low surgical risk patients, stratified using
the Medicare Score.9
METHODS
A retrospective analysis was performed on a prospec-
tively maintained database, including all patients under-
going elective AAA treatment between January 2003
and December 2017 in a single referral center. After indi-
vidualized patient assessment by a vascular surgical

1
2 Arenas Azofra et al
committee, EVAR or OR was indicated. The vascular sur-
gical committee integrates both open and endovascular
practitioners and jointly assesses both imaging and sur-
gical risk as informed by anesthesiologists, based on bi-
weekly meetings. Decisions are made based on the
most recent clinical practice guidelines (both European
Society for Vascular Surgery and Society for Vascular Sur-
gery),10,11 taking into account anatomy, inferior mesen-
teric artery and lumbar patency, access, and patient
preferences.
The primary endpoints were perioperative and 5-year
mortality, and occurrence of major adverse events
(MAEs). MAEs were defined and analyzed as a composite
end point, which included acute myocardial infarction,
acute respiratory failure (PaO2 <60 mm Hg), acute kid-
ney injury (increase in serum creatinine by $0.3 md/dL
within 48 hours or urine volume <0.5 mL/kg/hour for
6 hours), cerebrovascular accident, visceral or lower
limb ischemia, or acute pulmonary thromboembolism.
Secondary end points were in-hospital stay and the
need for reintervention over follow-up. Ethical approval
and specific patient consent was not deemed necessary
by the Institutional Review Board, given the retrospective
nature of the study and the use of anonymized data.
Inclusion and exclusion criteria. Patients were strati-
fied according to their surgical risk using the Medicare
Aneurysm Scoring System. This scale was developed
and validated as a prediction tool for perioperative death
in patients treated for AAA.9 Variables in this model
include age, sex, congestive heart failure, peripheral
arterial disease, chronic kidney disease, and cerebrovas-
cular disease. After cumulative scoring, patients are
classified into three groups: low, moderate, and high risk.
For this study, patients with a score under 3 (low surgical
risk) were included. Patients with symptomatic aneu-
rysm, non-scheduled repair or isolated iliac aneurysms
were excluded (Table I).
Follow-up protocol. The post-EVAR follow-up protocol
included a 30-day, 6-month, and 12-month contrast-
enhanced computed tomography (CT) angiography,
including delayed-phase series. If no endoleaks or com-
plications were detected in the first post-EVAR control,
the 6-month CT-scan was not performed. Patients
without significant findings after a year of CT scan-based
follow-up were put into an ultrasound-based surveillance
protocol, repeating the CT scan evaluation each 5 years
post-implantation. Post-OR surveillance was performed
with duplex ultrasound yearly and a CT angiography at
5-year intervals post-procedure.
Data collection and statistical analysis. Data collected
included demographics, associated comorbidities, intra-
procedure details, perioperative results, and events dur-
ing follow-up.
Journal of Vascular Surgery
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ARTICLE HIGHLIGHTS
d
Type of Research: Single-center retrospective anal-
ysis of prospectively collected registry data
d
Key Findings: In low surgical risk patients with
abdominal aortic aneurysms (n ¼ 227), both endo-
vascular aneurysm repair (EVAR) and open repair
(OR) showed a perioperative mortality of 0%. At 5-
year follow-up, no differences were found in terms
of survival (85% EVAR vs 91% OR; P ¼ .195). A higher
rate of postoperative mayor complication was evi-
denced in the OR group (19.7% vs 2.6%; P ¼ .001).
d
Take Home Message: In low surgical risk patients
with abdominal aortic aneurysms, both EVAR and
OR seem to offer comparable good and durable re-
sults. The decrease in perioperative mortality associ-
ated with EVAR vs OR was not found in this group
of patients.
Table I. Medicare aneurysm scoring system
Risk factor Score
Age >80 years 11
Age 76-80 years 6
Age 71-75 years 1
Female 4
ESRD 9
CRI, no dialysis 7
CHF 6
PVD or CBVD 3
CBVD, Cerebrovascular disease; CHF, congestive heart failure; CRI,
chronic renal insufficiency; ESRD, end-stage renal disease; PVD, pe-
ripheral vascular disease.
High risk >11; moderate risk 3-11; and low risk <3.
Categorical variables are described as frequencies.
Quantitative variables are described with mean and
standard deviations, using median and interquartile
range if non-normally distributed. The normality of vari-
able distribution was assessed using the Shapiro-Wilk
test. Differences between groups were tested using the
Pearson c2, Fisher exact, and Student t tests when appro-
priate. A Kaplan-Meier survival model was built, and the
differences between groups were compared using the
Mantel-Cox log-rank test. To increase EVAR and OR
comparability, a propensity-score matched cohort was
created, including 76 matched pairs (1:1). Variables
included in the propensity score regression model were
age, body mass index (BMI), American Society of Anes-
thesiologists risk score, smoking status, hypertension, dia-
betes, coronary disease, and chronic pulmonary
obstructive disease (COPD). The c-statistic value for this
model was 0.87.
Journal of Vascular Surgery Arenas Azofra et al 3
Volume -, Number -

Table II. Demographics and comorbidities in patients undergoing OR and EVAR, both in the global cohort of patients and
in the propensity matched cohort
Global cohort (n ¼ 227) Propensity-matched cohort (n ¼ 152)
Variables OR (n ¼ 91) EVAR (n ¼ 136) P-value OR (n ¼ 76) EVAR (n ¼ 76) P-value
Age, years 64.1 6 6 66.6 6 5 <.001 65.1 6 5 65.0 6 6 .978
BMI, kg/m 2
28.1 6 3 29.6 6 4 .005 28.3 6 4 28.6 6 4 .588
Comorbidities
ASA 3-4 46 80 .219 41 41 1.000
Smoker (ex or active) 87 123 .200a 73 71 .468
Hypertension 50 74 .937 40 43 .625
Diabetes mellitus 12 25 .299 11 13 .656
Dyslipidemia 60 63 .004 48 37 .072
Cardiovascular disease 27 47 .441 23 22 .859
Coronary artery disease 21 43 .161 18 20 .708
Coronary revascularization 10 25 .131 10 14 .374
Atrial fibrillation 5 5 .527a 3 1 .620a
COPD 9 37 .001 8 12 .337
Preoperative serum creatinine, mg/dL 0.95 6 0.1 0.94 6 0.1 .611 0.94 6 0.1 0.91 6 0.2 .238
ASA, American Society of Anesthesiologists; BMI, body mass index; COPD, chronic obstructive pulmonary disease; EVAR, endovascular aneurysm
repair; OR, open repair.
Data are presented as percentage or mean 6 standard deviation.
Boldface P values indicate statistical significance.
a
Fisher exact test.

All calculations were performed using the SPSS statistical
package (IBM Corp. Version 23.0, Armonk, NY). A P-value
under .05 was considered statistically significant.
RESULTS
A total of 891 patients with AAA underwent treatment
between January 2003 and December 2017, of whom
227 (25.5%) had a Medicare Aneurysm Score System un-
der 3 (low surgical risk). EVAR was performed in 136 pa-
tients (59.9%) and OR in 91 (40.1%). The endografts
implanted in the EVAR group were Excluder (W.L. Gore,
Flagstaff, Ariz) 59.6% (n ¼ 81), Endurant II (Medtronic
AVE, Santa Rosa, Calif) 19.9 % (n ¼ 27), Anaconda (Vascu-
tek, Terumo, Inchinnan, Scotland) 11.0% (n ¼ 15), Incraft
(Cordis Corp, Bridgewater, NJ) 3.7% (n ¼ 5), Talent (Med-
tronic AVE) 3.7% (n ¼ 5), and Zenith (Cook Inc, Blooming-
ton, Ind) 2.1%% (n ¼ 3).
Univariate analysis of the whole sample revealed patients
undergoing EVAR to be significantly older (P < .001), with a
higher BMI (P ¼ .005) and prevalence of COPD (P ¼ .001).
Patients undergoing OR had a significantly higher preva-
lence of dyslipidemia (P ¼ .004). After propensity-score
matching, two comparable samples regarding demo-
graphic and comorbidities were generated (Table II).
Thirty-day outcomes. No differences were found
regarding the aneurysm diameter at the time of repair
(OR 59.8 6 13 vs EVAR 58.0 6 9 mm; P ¼ .366) or the pres-
ence of symptoms (P ¼ .719). Technical success was 100%
in both groups, with none requiring conversion to
another technique. Perioperative and 30-day mortality
were 0% for both groups. The blood pool volume, sur-
gical time, and time in the surgical intensive care unit
were significantly longer in the OS group, both in the
general and paired population (P < .001) (Table III). Pa-
tients undergoing OR had a longer postoperative
in-hospital stay (OR 11.8 6 6 vs EVAR 5.2 6 3 days; P < .001;
range, 2-41 days) and a higher rate of MAEs (19.7% vs 2.6%;
P ¼ .001) than patients undergoing EVAR. The 30-day
reintervention rate was higher in the OR group,
although this difference did not reach statistical signifi-
cance (9.2% vs 2.6%; P ¼ .098). In this group, reinterven-
tions were due to acute limb ischemia (n ¼ 2), groin
incision infection (n ¼ 2), bleeding (n ¼ 2), and abdominal
eventration (n ¼ 1).
Long-term results. The mean follow-up was 80 6
48 months, significantly longer in the OR group (93 6 53
vs 70 6 44 months; P ¼ .004). A total of 61.2% of patients
(n ¼ 139) completed at least 5 years of follow-up
(Table IV). Survival at 1 (96% vs 95%), 5 (91% vs 85%),
and 10 years (57% vs 42%) was superior in the OR group,
without reaching statistical significance (P ¼ .195). The
global reintervention rate was 19.7% (n ¼ 15) in the OR
group and 17.1% (n ¼ 13) in the EVAR group (P ¼ .676)
(Figs 1 and 2).
DISCUSSION
EVAR has demonstrated a lower perioperative mortality
and morbidity as compared with OR in the major clinical
4 Arenas Azofra et al Journal of Vascular Surgery
--- 2021

Table III. Surgical results

Global cohort (n ¼ 227) Propensity-matched cohort (n ¼ 152)
Variables OR (n ¼ 91) EVAR (n ¼ 136) P-value OR (n ¼ 76) EVAR (n ¼ 76) P-value
Aneurysm characteristics
Maximum diameter, mm 59.8 6 13 58.0 6 9 .223 60.3 6 14 58.5 6 10 .366
Symptomatic AAA 5 6 .759a 5 3 .719a
Periprocedural variables
Local or epidural anesthesia 0 29 <.001 0 17 <.001
Transfusion volume, mL 729.0 6 750 127.2 6 324 <.001 805.2 6 776 121 6 264 <.001
Surgical time, minutes 217 6 59 169 6 59 <.001 222.3 6 60 162.7 6 54 <.001
Postoperative ICU stay, hours 59.5 6 30 23.1 6 6 <.001 59.1 6 32 23.3 6 8 <.001
AAA, Abdominal aortic aneurysm; EVAR, endovascular aneurysm repair; ICU, intensive care unit; OR, open repair.
Data are presented as percentage or mean 6 standard deviation.
Boldface P values indicate statistical significance.
a
Fisher exact test.

Table IV. Outcomes in patients undergoing OR and EVAR, both in the global cohort of patients and in the propensity
matched cohort
General cohort (n ¼ 227) Propensity-matched cohort (n ¼ 152)
Variables OR (n ¼ 91) EVAR (n ¼ 136) P-value OR (n ¼ 76) EVAR (n ¼ 76) P-value
Postoperative hospital 11.7 ± 6 5.8 6 4 <.001 11.8 ± 6 5.2 6 3 <.001
stay, days
30-day mortality 0 0 e 0 0 e
MAEs 16 (17.6) 8 (5.9) .005 15 (19.7) 2 (2.6) .001a
Reinterventions 16 27 .669 15 13 .676
30-day reintervention rate 8 (8.8) 2 (1.5) .016 7 (9.7) 2 (2.8) .098
Death at the end of follow-up 19 34 .472 17 17 1.000
Aneurysm-related mortality 1 5 .406a 1 2 .500a
Follow-up, months 95.9 ± 51 69.4 6 42 <.001 93.1 ± 53 70.1 6 44 .004
Survival rate estimates
1-year survival rate 97 96 .032b 96 95 .195b
3-year survival rate 94 87 93 89
5-year survival rate 91 80 91 85
8-year survival rate 79 66 78 71
10-year survival rate 61 51 57 42
EVAR, Endovascular aneurysm repair; MAE, Major adverse events; OR, open repair.
Data are presented as percentage, number (%), or mean 6 standard deviation.
Boldface P values indicate statistical significance.
a
Fisher exact test.
b
Mantel-Cox log-rank test.

trials (EVAR-1, DREAM, and OVER).5,12,13 However, this
benefit is not so well-established in low surgical risk pa-
tients.14 Siracuse et al published a series comparing
EVAR vs OR in low-risk patients, showing no significant
differences in the 30-day mortality rate (P ¼ .45).15 Like-
wise, Liang et al (n ¼ 2641), reported mortality rates under
1% in both groups (OR, 0.9%; EVAR, 0.2%; P < .001).16 Our
findings, with no perioperative mortality in both groups,
are in line with these results, contrasting with the estab-
lished benefit of EVAR regarding perioperative mortality
(OR 4.6% vs EVAR 1.6%; P ¼ .007).5 After propensity score
matching, the perioperative reintervention rate (OR 9.2%
vs EVAR 2.6%; P ¼ .098) and the long-term reintervention
rate follow-up (OR 19.73% vs EVAR 17.1%; P ¼ .676) did not
show statistically significant differences between groups,
although this finding may represent a type 2 error (small
sample size). This is also in line with the findings reported
by Liang et al (incidence rate ratio, 1.35; 95% confidence
interval, 0.57-3.21; P ¼ .5).5,16 The lack of differences in
terms of long term reinterventions, contrary to many
studies that attribute a higher long-term reintervention
rate after EVAR, could be due to several reasons5,16:
Journal of Vascular Surgery
Volume -, Number -
Fig 1. Survival estimates after open repair (OR) and endovascular aneurysm repair (EVAR) in the global (A) and
paired cohorts (B).
Fig 2. Reintervention rate estimates after open repair (OR) and endovascular aneurysm repair (EVAR) in the global
(A) and paired cohorts (B).
(1) Insufficient sample size;
(2) A lower rate of reinterventions with newer genera-
tion endografts; technological advance allows
increasingly complex procedures to be carried
out with safety and durability.17 A majority of pa-
tients were treated with the Excluder device (W.L.
Gore), which presents the lowest rate of graft
limb thrombosis in the literature and has improved
the fixation system (barbs) while decreasing its pro-
file and enhancing a precise deployment with a
repositioning mechanism.18
(3) The strict instructions for use criteria followed in a
large percent of patients undergoing EVAR in this
study; and
(4) All EVAR procedures were performed by operators
with a wide experience in endovascular
techniques.
Based on this data, we can infer that in this subgroup of
patients, differences in terms of perioperative mortality
and reoperation rate are much less marked in the short-
and medium-term between both techniques.
In this study, the MAE rate was significantly higher in the
OR group (OR 19.7% vs EVAR 2.6%; P ¼ .001). However, this
finding did not translate into an increase in mortality,
perhaps suggesting better tolerance for perioperative
Arenas Azofra et al 5
complications in this subgroup of patients. These results
can make us question whether an increased perioperative
risk, without a subsequent increased mortality risk, is accept-
able in low surgical risk patients.
Despite our study being restricted to low-risk patients,
those undergoing EVAR were significantly older (66.6 6
5 vs 64.1 6 6 years; P < .001), with a higher BMI (29.6 6
4 vs 28.1 6 3 kg/m2; P ¼ .005) and higher prevalence of
COPD (27.2% vs 9.9%; P < .001). These data open the pos-
sibility that perhaps the definition of low-risk patients
within the Medicare Aneurysm Score System is too
wide, and that there is an inherent tendency to favor
EVAR even in low surgical risk patients, expecting a lower
perioperative mortality and complication rate. This could
explain, at least in part, why there were no survival differ-
ences in the propensity-matched cohorts.
The long-term safety and durability of EVAR or OR ac-
quires a particular importance in this patient population,
with good general conditions and a long-life expectancy.
Therefore, following the instructions for use should be
nearly mandatory, and exceptions should be limited to
those patients who are also not good candidates for
OR.19 Currently, there is a reasonable concern about the
long-term durability of certain endovascular devices,
which are sometimes biomechanically complex and
6 Arenas Azofra et al
with a long-term behavior yet to be determined.20-22
Likewise, we must not forget that the follow-up protocol
will be stricter in patients treated by EVAR, with greater
exposure to radiation and the use of nephrotoxic
contrast agents. Another relevant consideration is the
anxiety created by the potential development of even-
tual endoleaks. On the other hand, the patient must be
aware of the increased risk of sexual dysfunction associ-
ated with OR.23 Wrapping up, an individualized and
comprehensive evaluation of AAA cases needs to be
made, taking into account not only surgical risk and
anatomy, but also the preference of the patient after ad-
vantages and disadvantages of each modality have been
clearly explained. EVAR could be considered the first op-
tion of treatment in low-risk patients in cases with favor-
able anatomy and with no risk of type 2 endoleak, mainly
if the OR option is not a straight tube graft in younger
patients.
Despite the use of a propensity-matched cohort anal-
ysis, certain limitations can be noticed in this study. First
of all, it is a retrospective study with a limited sample size.
Second, as a consequence of the application of the Medi-
care criteria for surgical risk stratification, women are
excluded as low-risk patients. Therefore, the results pre-
sented can only be extrapolated to male patients. There
are also potential issues regarding follow-up, especially
considering the long survival rates of this population, in
whom it would be of great significance to obtain
>10 years of follow-up. Additionally, when considering
between EVAR and OR, one must take into account
the short and long-term health-economic burden of
both procedures, something that we could not evaluate.
Finally, given that it is only a single-center study, the pop-
ulation of interest in this study may not be representative
of low surgical risk patients in other countries. Finally, this
analysis includes not only new generation devices, but
also some patients treated before 2010 with older
endografts.
CONCLUSIONS
In low surgical risk patients with AAA, EVAR may offer
comparable midterm results to open repair, with a lower
rate of major adverse events and a shorter in-hospital
stay. With the current OR-first paradigm in low-risk pa-
tients, several factors should be taken into account for
decision making (anatomic suitability, risk of sexual
dysfunction, risk of type 2 endoleaks, and need for
follow-up).
AUTHOR CONTRIBUTIONS
Conception and design: EA, CI, CC, FM, CP, AA, MP
Analysis and interpretation: EA, CI, FM, AA, MP
Data collection: EA, CI, AA
Writing the article: EA, CI, CC, FM, CP, AA, MP
Critical revision of the article: EA, CI, CC, FM, CP, AA, MP
Final approval of the article: EA, CI, CC, FM, CP, AA, MP
Journal of Vascular Surgery
--- 2021
Statistical analysis: EA, FM, MP
Obtained funding: Not applicable
Overall responsibility: EA
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Submitted May 8, 2021; accepted Oct 23, 2021.