' Premio Publicación Indexada 2
' Premio Publicación Indexada 2
' Premio Publicación Indexada 2
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 significance and resolution of EVAR-intrinsic issues like
first treatment option for infrarenal abdominal aortic an- sealing and type 2 endoleaks continue to be disadvan-
eurysms (AAAs) in many patients.1,2 The superiority of tages of this technique.7
EVAR over open repair (OR) is based on a lower 30-day Younger and low surgical risk patients show a lower
mortality rate, which is especially relevant when treating perioperative risk and a longer life expectancy, so the
elderly or high-risk patients.3,4 However, this short-term long-term durability and absence of reinterventions
superiority has not been proven long-term, with EVAR and/or complications is of paramount importance.8
mortality rates equaling those of OR, and associated With these concerns in mind, OR is still the preferred
higher reintervention rates.5,6 Furthermore, the 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-
From the Department of Angiology and Vascular Surgery, Hospital Universitario tients are scarce. The objective of this study was to
Central de Asturias (HUCA), Oviedoa; and the Department of Vascular Surgery, compare the perioperative and long-term results of
University Hospital, Ludwig-Maximilians University Munich, Munich.b EVAR vs OR in low surgical risk patients, stratified using
Author conflict of interest: none.
the Medicare Score.9
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: [email protected]). METHODS
The editors and reviewers of this article have no relevant financial relationships to
A retrospective analysis was performed on a prospec-
disclose per the JVS policy that requires reviewers to decline review of any
manuscript for which they may have a conflict of interest.
tively maintained database, including all patients under-
0741-5214 going elective AAA treatment between January 2003
Copyright Ó 2021 by the Society for Vascular Surgery. Published by Elsevier Inc. and December 2017 in a single referral center. After indi-
https://doi.org/10.1016/j.jvs.2021.10.047 vidualized patient assessment by a vascular surgical
1
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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 another technique. Perioperative and 30-day mortality
package (IBM Corp. Version 23.0, Armonk, NY). A P-value were 0% for both groups. The blood pool volume, sur-
under .05 was considered statistically significant. gical time, and time in the surgical intensive care unit
were significantly longer in the OS group, both in the
RESULTS general and paired population (P < .001) (Table III). Pa-
A total of 891 patients with AAA underwent treatment tients undergoing OR had a longer postoperative
between January 2003 and December 2017, of whom in-hospital stay (OR 11.8 6 6 vs EVAR 5.2 6 3 days; P < .001;
227 (25.5%) had a Medicare Aneurysm Score System un- range, 2-41 days) and a higher rate of MAEs (19.7% vs 2.6%;
der 3 (low surgical risk). EVAR was performed in 136 pa- P ¼ .001) than patients undergoing EVAR. The 30-day
tients (59.9%) and OR in 91 (40.1%). The endografts reintervention rate was higher in the OR group,
implanted in the EVAR group were Excluder (W.L. Gore, although this difference did not reach statistical signifi-
Flagstaff, Ariz) 59.6% (n ¼ 81), Endurant II (Medtronic cance (9.2% vs 2.6%; P ¼ .098). In this group, reinterven-
AVE, Santa Rosa, Calif) 19.9 % (n ¼ 27), Anaconda (Vascu- tions were due to acute limb ischemia (n ¼ 2), groin
tek, Terumo, Inchinnan, Scotland) 11.0% (n ¼ 15), Incraft incision infection (n ¼ 2), bleeding (n ¼ 2), and abdominal
(Cordis Corp, Bridgewater, NJ) 3.7% (n ¼ 5), Talent (Med- eventration (n ¼ 1).
tronic AVE) 3.7% (n ¼ 5), and Zenith (Cook Inc, Blooming- Long-term results. The mean follow-up was 80 6
ton, Ind) 2.1%% (n ¼ 3). 48 months, significantly longer in the OR group (93 6 53
Univariate analysis of the whole sample revealed patients vs 70 6 44 months; P ¼ .004). A total of 61.2% of patients
undergoing EVAR to be significantly older (P < .001), with a (n ¼ 139) completed at least 5 years of follow-up
higher BMI (P ¼ .005) and prevalence of COPD (P ¼ .001). (Table IV). Survival at 1 (96% vs 95%), 5 (91% vs 85%),
Patients undergoing OR had a significantly higher preva- and 10 years (57% vs 42%) was superior in the OR group,
lence of dyslipidemia (P ¼ .004). After propensity-score without reaching statistical significance (P ¼ .195). The
matching, two comparable samples regarding demo- global reintervention rate was 19.7% (n ¼ 15) in the OR
graphic and comorbidities were generated (Table II). group and 17.1% (n ¼ 13) in the EVAR group (P ¼ .676)
Thirty-day outcomes. No differences were found (Figs 1 and 2).
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- DISCUSSION
ence of symptoms (P ¼ .719). Technical success was 100% EVAR has demonstrated a lower perioperative mortality
in both groups, with none requiring conversion to and morbidity as compared with OR in the major clinical
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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 matching, the perioperative reintervention rate (OR 9.2%
benefit is not so well-established in low surgical risk pa- vs EVAR 2.6%; P ¼ .098) and the long-term reintervention
tients.14 Siracuse et al published a series comparing rate follow-up (OR 19.73% vs EVAR 17.1%; P ¼ .676) did not
EVAR vs OR in low-risk patients, showing no significant show statistically significant differences between groups,
differences in the 30-day mortality rate (P ¼ .45).15 Like- although this finding may represent a type 2 error (small
wise, Liang et al (n ¼ 2641), reported mortality rates under sample size). This is also in line with the findings reported
1% in both groups (OR, 0.9%; EVAR, 0.2%; P < .001).16 Our by Liang et al (incidence rate ratio, 1.35; 95% confidence
findings, with no perioperative mortality in both groups, interval, 0.57-3.21; P ¼ .5).5,16 The lack of differences in
are in line with these results, contrasting with the estab- terms of long term reinterventions, contrary to many
lished benefit of EVAR regarding perioperative mortality studies that attribute a higher long-term reintervention
(OR 4.6% vs EVAR 1.6%; P ¼ .007).5 After propensity score rate after EVAR, could be due to several reasons5,16:
Journal of Vascular Surgery Arenas Azofra et al 5
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; complications in this subgroup of patients. These results
(2) A lower rate of reinterventions with newer genera- can make us question whether an increased perioperative
tion endografts; technological advance allows risk, without a subsequent increased mortality risk, is accept-
increasingly complex procedures to be carried able in low surgical risk patients.
out with safety and durability.17 A majority of pa- Despite our study being restricted to low-risk patients,
tients were treated with the Excluder device (W.L. those undergoing EVAR were significantly older (66.6 6
Gore), which presents the lowest rate of graft 5 vs 64.1 6 6 years; P < .001), with a higher BMI (29.6 6
limb thrombosis in the literature and has improved 4 vs 28.1 6 3 kg/m2; P ¼ .005) and higher prevalence of
the fixation system (barbs) while decreasing its pro-
COPD (27.2% vs 9.9%; P < .001). These data open the pos-
file and enhancing a precise deployment with a
sibility that perhaps the definition of low-risk patients
repositioning mechanism.18
(3) The strict instructions for use criteria followed in a within the Medicare Aneurysm Score System is too
large percent of patients undergoing EVAR in this wide, and that there is an inherent tendency to favor
study; and EVAR even in low surgical risk patients, expecting a lower
(4) All EVAR procedures were performed by operators perioperative mortality and complication rate. This could
with a wide experience in endovascular explain, at least in part, why there were no survival differ-
techniques. ences in the propensity-matched cohorts.
The long-term safety and durability of EVAR or OR ac-
Based on this data, we can infer that in this subgroup of quires a particular importance in this patient population,
patients, differences in terms of perioperative mortality with good general conditions and a long-life expectancy.
and reoperation rate are much less marked in the short- Therefore, following the instructions for use should be
and medium-term between both techniques. nearly mandatory, and exceptions should be limited to
In this study, the MAE rate was significantly higher in the those patients who are also not good candidates for
OR group (OR 19.7% vs EVAR 2.6%; P ¼ .001). However, this OR.19 Currently, there is a reasonable concern about the
finding did not translate into an increase in mortality, long-term durability of certain endovascular devices,
perhaps suggesting better tolerance for perioperative which are sometimes biomechanically complex and
6 Arenas Azofra et al Journal of Vascular Surgery
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18. Tsolakis IA, Kakkos SK, Papageorgopoulou CP, Zampakis P, 21. Singh AA, Benaragama KS, Pope T, Coughlin PA, Winterbottom AP,
Kalogeropoulou C, Papadoulas S, et al. Improved effectiveness Harrison SC, et al. Progressive device failure at long term follow up of
of the repositionable GORE EXCLUDER AAA endoprosthesis the Nellix EndoVascular Aneurysm Sealing (EVAS) system. Eur J Vasc
featuring the C3 delivery system compared with the original Endovasc Surg 2021;61:211-8.
GORE EXCLUDER AAA endoprosthesis for within the instructions 22. Chang RW, Rothenberg KA, Harris JE, Gologorsky RC, Hsu JH,
for use treatment of aortoiliac aneurysms. J Vasc Surg 2019;69: Rehring TF, et al. Midterm outcomes for 605 patients receiving
394-404. Endologix AFX or AFX2 Endovascular AAA Systems in an integrated
19. Speziale F, Sirignano P, Setacci F, Menna D, Capoccia L, Mansour W, healthcare system. J Vasc Surg 2021;73:856-66.
et al. Immediate and two-year outcomes after EVAR in “on-label” 23. Regnier P, Lareyre F, Hassen-Khodja R, Durand M, Touma J, Raffort J.
and “off-label” neck anatomies using different commercially avail- Sexual dysfunction after abdominal aortic aneurysm surgical repair:
able devices. analysis of the experience of two Italian vascular cen- current knowledge and future directions. Eur J Vasc Endovasc Surg
ters. Ann Vasc Surg 2014;28:1892-900. 2018;55:267-80.
20. Lee LK, Faries PL. Assessing the effectiveness of endografts: clinical
and experimental perspectives. J Vasc Surg 2007;45(Suppl A):
A123-30. Submitted May 8, 2021; accepted Oct 23, 2021.