Drs. Saratz1Warwicks

Hospital Coven2Division o

Coventry, UK.3Departme

niki, Thessalon4Departme

Health Service

CorrespondHospitals CoveCoventry, CliffE-mail: saratz

Ann Vasc Surhttp://dx.doi.or� 2014 Elsevi

Manuscript rec

2013; publishe

816

Obesity as an Independent Predictor ofOutcome after Endovascular AbdominalAortic Aneurysm Repair

Athanasios Saratzis,1,3,4 Mahmud Saedon,1,2 Nikolaos Melas,3 George D. Kitas,4

and Asif Mahmood,1 Coventry and Dudley, UK, and Thessaloniki, Greece

Background: Obesity is increasingly common in patients referred for the management of anabdominal aortic aneurysm (AAA). Evidence of the effect of obesity on outcomes after endovas-cular repair (EVAR) is not well established. We sought to compare the immediate and midtermoutcomes of elective EVAR between obese and nonobese patients in a case control study.Methods: Patients undergoing elective EVAR were divided in 2 groups: obese (defined asa body mass index [BMI] �30 kg/m2) and nonobese (mean BMI [kg/m2] ± SD: 33 ± 1 vs 25 ±

3). Both groups were case-matched for age, sex, smoking, and AAA diameter. One hundredfifty-nine patients were included (mean age: 69 ± 9 years; 10 women [9%]; mean BMI: 28 ± 5kg/m2; 53 were obese and 106 were nonobese). All aneurysms were successfully excluded.Mean follow-up was 34 ± 13 months.Results: All patients who developed a complication within the perioperative period (�30 days)were obese (P ¼ 0.01). Thirteen patients (8.2%) died during follow-up (8 obese versus5 nonobese; P ¼ 0.76). Survival and noneprocedure-related morbidity did not differ significantlybetween the obese and nonobese groups (P ¼ 0.64 and 0.16; log-rank test). BMI was not asso-ciated with mortality or noneprocedure-related morbidity on multivariate analysis(mortalitydhazard ratio: 1.0 [95% confidence interval: 0.9e1.2]; P ¼ 0.37; noneprocedure-related morbiditydhazard ratio: 1.0 [95% confidence interval: 0.9e1.1], P ¼ 0.2).Conclusions: This is the first case control study to assess the independent impact of obesityin the outcome after EVAR. No difference was documented with regards to mortality or noneaneurysm-related morbidity.

is and Saedon contributed equally to this article.

hire Vascular and Endovascular Unit, Universitytry and Warwickshire, Coventry, UK.

f Metabolic and Vascular Health, University of Warwick,

nt of Vascular Surgery, Aristotle University of Thessalo-iki, Greece.

nt of Research and Development, Dudley Group NationalFoundation Trust, Russells Hall Hospital, Dudley, UK.

ence to: Athanasios Saratzis, MBBS, MRCS, Universityntry and Warwickshire National Health Service Trust,ord Bridge Road, Coventry, CV2 2DX, United Kingdom;is@doctors.net.uk

g 2014; 28: 816–822g/10.1016/j.avsg.2013.07.008er Inc. All rights reserved.

eived: November 3, 2012; manuscript accepted: July 25,

d online: December 30, 2013.

INTRODUCTION

Obesity, defined as a body mass index (BMI) �30

kg/m2, has become epidemic in the developedworld

and has been directly associated with the risk of

developing an abdominal aortic aneurysm

(AAA).1,2 As a result, there has been a significant

increase in the prevalence of obesity among those

undergoing vascular or endovascular procedures.3

Obesity has also been associated with increased

postoperative morbidity after general surgery and

noncardiac vascular surgery.4,5 Various investiga-

tors have attempted to link obesity with postopera-

tive outcome after open or endovascular AAA

repair (EVAR).5e11 However, the currently avail-

able literature is based on retrospective registries

where the 2 groups are not comparable with regard

to cardiovascular risk factors, and the results are

largely confounding. EVAR avoids large incisions,

Vol. 28, No. 4, May 2014 Obesity and outcome in EVAR 817

like in open aneurysm repair (OR), and confers

a clear immediate and midterm benefit over OR in

terms of cardiovascular morbidity according to

randomized studies.12e15 As a result, EVAR is an

appealing alternative to OR in obese patients, who

are more likely to suffer from such morbidity. This

study aims to assess whether obesity affects

outcome, in terms of mortality and morbidity, after

elective EVAR, using a nested case controlled design

and prospectively collected data.

METHODS

Design of the Study

A nested case control design was used (1 obese

individual was matched to 2 nonobese controls).

Both cases (individuals with a BMI �30 kg/m2)

and controls were derived from a prospective

cohort of patients undergoing elective EVAR

between February 2008 and October 2011 in

a tertiary referral center. All patients had provided

written informed consent for participation in

a registry aiming to investigate predictors of

outcome after EVAR. Indication for repair was

aortic diameter >5 cm, a rapidly increasing sac

(>1 cm/year), or a symptomatic AAA. Patients

with ruptured or leaking aneurysms were excluded

from this analysis. The study was approved by the

institutional ethics committee. Overall, 367

patients fulfilled the inclusion criteria and had

a weight and height recorded at baseline, to allow

for BMI calculation. Of these, 53 patients had

a BMI �30 kg/m2 (14%). Five patients were

morbidly obese (BMI: >35 kg/m2). In order to

include 2 balanced groups, 2 investigators (A.S.

and M.S.), blinded to patient data apart from age,

sex, aortic diameter, and BMI, matched the 53

cases with a BMI �30 kg/m2 with 106 subjects

with a BMI <30 kg/m2 (ratio: 1:2), for age (within

1 year), sex, AAA diameter (within 0.5 cm) and

smoking history (never, current smoker, and

exsmoker).

Protocol

For each subject, demographics and comorbidities

were recorded at recruitment and a computed

tomography angiography (CTA) scan with 3-

dimensional reconstruction was obtained. Follow-

up included a visit 30 days, 6 and 12 months after

the repair, and annually thereafter. Imaging during

follow-up included plain abdominal radiography

(anteroposterior and lateral views) and a CTA scan

at 6 and 12 months and annually thereafter, per

the department’s standard protocol.

Procedures

The following devices were deployed: Anaconda

(Vascutek; Inchinnan, Scotland, UK), Gore Ex-

cluder (Gore Medical, Flagstaff, AZ), EndoFit tube

graft (LeMaitre Vascular, Burlington, MA), Endolo-

gix Powerlink bifurcated device (Endologix, Irvine,

CA), Talent (Medtronic, Minneapolis, MN), and

Endurant (Medtronic). Indications and specifica-

tions for the implantation of each device and selec-

tion criteria have been described elsewhere.16,17

Procedures were performed in an operating room

with the patient under general or regional anes-

thesia and fluoroscopic control using iopromide

(Ultravist 300; Bayer Schering Pharma AG, Berlin,

Germany). In accordance with our standard

protocol for elective EVAR, aspirin and clopidogrel

were administered the day of the procedure.18

Aspirin was discontinued on postoperative day 30,

and clopidogrel was continued as a lifelong treat-

ment. An abdominal radiograph was obtained

before discharge to assess stent integrity. The patient

was usually ambulated as soon as possible and was

discharged on day 2 or 3.

Definition of Outcomes

The primary outcome was all-cause mortality;

the secondary outcome was noneprocedure-

related morbidity. All complications and events

were classified and reported according to the report-

ing standards for EVAR by Chaikof et al.19 Noneprocedure-related morbidity was defined as any

type of major morbidity that was not directly related

to the implant or the procedure, according to Chai-

kof et al.19 A type 2 endoleak was not considered as

a major complication, unless it required additional

intervention or additional imaging, which was not

the case in any patient throughout follow-up.

Statistical Analysis

All analyses were performed using SPSS software

(version 17.0; SPSS, Chicago, IL). Continuous para-

metric data are presented as mean value ± standard

deviation (SD). Categorical data are presented as

absolute values and percentages. Baseline differ-

ences between the 2 study groups for continuous

or categorical variables were evaluated with the

unpaired t or Fisher’s exact test, respectively.

Mortality and noneprocedure-related morbidity

was compared between the groups using KaplaneMeier curves and the log rank test. Cox regression

analysis was performed, adjusted for hypertension,

peripheral arterial disease, and diabetes (factors

with a P value <0.25 at univariate analysis), to

Table I. Baseline characteristics and between-group comparisonsa

BMI <30 kg/m2 % BMI �30 kg/m2 % P value

Hypertension 72 68 43 81 0.08

Smoking 18 17 9 17 0.8

Exsmoker 60 57 30 57 0.8

Cholesterolemia 46 43 24 45 0.9

Statin use 60 57 35 66 0.31

Beta-blocker use 36 34 15 28 0.47

COPD 12 11 6 11 1

MI 6 6 5 9 0.37

PAD 8 8 9 17 0.1

Diabetes 24 15 7 13 0.16

Stroke 4 4 5 9 0.15

Serum urea (mmol/L) 4.9 ± 2.5 5.5 ± 3.3 0.28

Serum creatinine (mmol/L) 118 ± 127 128 ± 138 0.64

Hemoglobin (g/dL) 13.1 ± 1.9 13.1 ± 1.7 0.58

BMI (kg/m2) 25 ± 3 33 ± 3 <0.001

AAA diameter (cm) 5.9 ± 1 5.9 ± 1 0.82

AAA, Abdominal aortic aneurysm; BMI, body mass index; COPD, chronic obstructive pulmonary disease; MI, myocardial infarction;

PAD, peripheral arterial disease.aData presented as mean ± standard deviation for continuous variables.

818 Saratzis et al. Annals of Vascular Surgery

determine the role of BMI in postoperativemortality

and noneprocedure-related morbidity. P < 0.05

was considered statistically significant.

RESULTS

Baseline Characteristics

A total of 159 patients (mean age: 69 ± 9 years; 15

women [9%];mean BMI: 28 ± 5 kg/m2)who under-

went elective EVAR (infrarenal AAAs) with a mean

diameter of 5.9 ± 0.9 cm were included; 53 with

a BMI �30 kg/m2 and 106 matched controls with

a BMI <30 kg/m2. Baseline characteristics of the 2

case-matched groups of patients are shown in

Table I. There were no significant differences with

regard to hypertension, diabetes, hypercholesterol-

emia, chronic obstructive pulmonary disease,

myocardial infarction, peripheral arterial disease

(defined as the presence of symptoms [claudication]

with an ankleebrachial index <0.9), stroke, use of

statin, use of beta-blockers, serum urea, and creati-

nine concentration.

Periprocedural Events (£30 Days)

All devices were deployed successfully with no

intraoperative conversion to open repair and no

device-related complications as determined by

completion angiograms (100% technical success).

Operative time did not differ significantly between

the obese and nonobese groups (88 ± 11 vs 91 ±

10 min; P ¼ 0.17). Twenty (19%) nonobese versus

11 (21%) obese patients were offered regional anes-

thesia (P ¼ 0.83). None required a stay in the inten-

sive care unit. Eleven patients (7%) required a blood

transfusion, all within 24 hours after EVAR; 4 of

whom were obese (7.5%). Two obese patients

(1.8%) developed a superficial groin wound infec-

tion within the first postoperative week, treated

successfully with empirical intravenous antibiotics

with no additional sequelae (P¼ 0.1). Swab cultures

were negative in both cases. Neither developed clin-

ical signs of sepsis or graft infection.20 One patient

(BMI: 34 kg/m2; Talent device) developed a right

iliac limb thrombosis 6 days after the repair and 1

patient (BMI: 31 kg/m2; Anaconda device) devel-

oped a left iliac limb thrombosis. Both were under-

going dual antiplatelet therapy, and the devices

were intact. In addition, none had iliac disease at

baseline. They eventually underwent a femorofe-

moral bypass after an unsuccessful attempt to

perform a thrombectomy or thrombolysis. No addi-

tional complications occurred in these 2 patients.

One patient (BMI: 33 kg/m2) developed a nondebili-

tating stroke 2 weeks after EVAR, despite taking

aspirin and clopidogrel. All patients who developed

a complication within the perioperative period were

obese (P ¼ 0.01). No deaths or any additional

complications occurred perioperatively.

Follow-up (>30 Days)

The mean follow-up was 34 ± 13 months. A total of

13 patients (8.2%) died (5 patients with a BMI �30

kg/m2 versus 8 with a BMI<30 kg/m2). Survival did

Fig. 1. Survival curve: mortality during follow-up.

Table II. Perioperative events and events during

follow-up

BMI <30 BMI �30 P value

Perioperative events (�30 days)

Regional anesthetic 20 11 0.83

Blood transfusion 7 4 1

Wound infection 0 2 0.1

Device (iliac-limb)

thrombosis

0 2 0.1

Nonfatal stroke 0 1 0.3

Events during follow-up

Type 1 endoleak 6 2 0.8

Type 2 endoleak 2 4 0.09

Death 8 5 0.76

Critical lower limb

ischemia

3 1 1

Nonfatal stroke 4 1 1

Nonfatal myocardial

infarction

5 2 1

Wound infection 0 2 0.1

Sepsis 2 1 0.5

Vol. 28, No. 4, May 2014 Obesity and outcome in EVAR 819

not differ significantly between groups at univariate

(P ¼ 0.76; chi-squared test) or survival analysis

(P ¼ 0.64; log-rank test; Fig. 1). Seven (4.4%)

patients died because of myocardial infarction (5

obese and 2 nonobese), 2 (1.3%) because of stroke

(both obese), 2 (1.3%) because of sepsis (1 obese

and 1 nonobese), 1 (0.6%) because of a malignancy

undiagnosed at the time of EVAR (nonobese), and 1

(0.6%) because of unknown causes (nonobese).

Table II summarizes implant-related and noneprocedure-related morbidity; interestingly, there

was a trend for slightly higher incidence of type 2

endoleak among obese patients. The latter did not

differ significantly between groups (P ¼ 0.16; log-

rank test; Fig. 2). In addition, BMI was not associ-

ated with mortality or noneprocedure-related

morbidity according to regression analysis, adjusted

for hypertension, peripheral arterial disease, and

diabetes (hazard ratio [HR]: 1.0 [95% confidence

interval {CI}: 0.9e1.2]; P ¼ 0.37 and HR: 1.0 [95%

CI: 0.9e1.1], P ¼ 0.2, respectively; Table III).

BMI, Body mass index.

DISCUSSION

This study suggests that BMI is not an independent

risk factor with regard to mortality for patients

undergoing elective EVAR of an AAA over a mean

follow-up of almost 3 years. However, during

the first 30 postoperative days, all patients who

Fig. 2. Survival curve: noneprocedure-related morbidity during follow-up.

Table III. Regression analyses for mortality

and noneprocedure-related morbidity during

follow-up

P value HR 95% CI

Mortality

Hypertension 0.44 0.6 0.2e2.1

PAD 0.42 1.9 0.4e9.8

BMI 0.37 1.0 0.9e1.2

Diabetes 0.07 2.9 0.9e9.9

Noneprocedure-related

morbidity

Hypertension 0.35 .7 0.3e1.5

PAD 0.02 3.0 1.2e7.8

BMI 0.2 1.0 0.9e1.1

Diabetes 0.3 1.5 0.7e3.4

BMI, Body mass index; CI, confidence interval; HR, hazard ratio;

PAD, peripheral arterial disease.

820 Saratzis et al. Annals of Vascular Surgery

developed a complication were obese, including 2

cases of superficial wound infection, 2 iliac-limb

thrombosis, and 1 stroke.

Obesity may have a significant impact on

outcome after any type of surgery or interven-

tion.3e5 Increased BMI is associated with increased

oxygen consumption, decreased oxygenation index,

pulmonary compliance, and functional residual

capacity during general anesthesia, which may

lead to respiratory and cardiac adverse events.21e23

In addition, obese individuals have a greater number

of comorbid conditions, increased levels of vascular

inflammation, and have been shown to have signif-

icantly higher wound infection rates after various

operations.3e5,8 We recently pooled data from

4 retrospective registryebased studies comparing

EVAR and OR (1,444 EVARs and 996 ORs) in obese

individuals and found a significant benefit in favor of

EVAR for 30-day mortality (risk ratio [RR]: 0.34

[95% CI: 0.25e0.48]; 4 studies; 2,440 patients)

and postoperative complications, including myocar-

dial infarction (RR: 0.29 [95%CI: 0.13e0.64]), chest

infection (RR: 0.21 [95% CI: 0.12e0.38]), renal

failure (RR: 0.24 [95% CI: 0.11e0.51]), and wound

infection (RR: 0.59 [95% CI: 0.48e0.74]).7,8,10,11,24

However, it is still unclear whether EVAR performs

equally well among obese and nonobese individuals

and what type of morbidity it may confer to obese

patients. The 2 largest studies to date that

have specifically attempted to assess the perfor-

mance of EVAR among obese patients were initially

Vol. 28, No. 4, May 2014 Obesity and outcome in EVAR 821

comparing EVAR andORusing results fromnational

registries (retrospective multicenter analyses) in the

United States.7,8 Morbidly obese patients (BMI �35

kg/m2) were at increased risk for death after EVAR

compared to moderately nonobese patients in one

of these analyses, including 3,358 EVARs.7 The

second study disclosed no differences between obese

and nonobese patients undergoing EVAR in terms

of all-cause morbidity and death.8 Both studies

reported a significantly higher wound infection

rate for obese individuals. Additional single-center

reports using retrospective EVAR registries have dis-

closed similar results in terms ofmortality; however,

during the immediate perioperative period, inten-

sive care unit stay, wound infection rates, and oper-

ative time have been significantly higher for obese

patients.5e11 Our analysis also suggests that perio-

perative results are inferior for obese individuals. A

total of 2 wound infections occurred in this group,

both treated conservatively, in patients who under-

went surgical exposure of the femoral vessels for

device insertion. Meticulous surgical technique is

important to reduce wound infection rates. Percuta-

neous EVAR with the use of closure devices could

assist in limiting the number of such complica-

tions25; however, percutaneous insertion of the

devices would be complex in these obese patients.

Platelet-rich plasma has been shown to prevent

wound-related complications in femoral cutdowns

in a previous study of patients undergoing EVAR in

our center, but the use of such modalities is limited

by cost.26

Another 2 obese individuals in this series devel-

oped iliac-limb thromboses within a few days after

EVAR, despite dual antiplatelet therapy and the

fact that no device-related complication was seen

on completion angiography. None of them had iliac

disease before undergoing EVAR. Our groups were

matched for age, sex, AAA diameter, and smoking

status, which are all significant cardiovascular risk

factors. In addition, the 2 groups did not differ in

terms of frequency of hypercholesterolemia.

However, obesity per se may lead to a hypercoagu-

lable state and increased vascular inflammation.27

Another interesting observation is that there was

a trend toward a higher incidence of type 2 endoleak

among obese individuals (Table II). However, the

numbers are not sufficient to allow safe interpreta-

tion. Overall, the results of this study suggest that

close follow-up, and aggressive lipid-lowering

therapy should be considered for obese patients.18,28

The limitations of this analysis include the rela-

tively small number of patients, which is related to

the case control design, chosen to minimize bias at

baseline and provide 2 balanced groups of patients.

In addition, although mean follow-up was approxi-

mately 3 years, none of the patients were lost, the

follow-up protocol was uniform and standardized,

and data were collected prospectively, as opposed

to previous analyses that were retrospective in

nature. Finally, there were only 5 morbidly obese

patients (BMI: >35 kg/m2) in our series, which

prohibits separate analysis of this group.

CONCLUSION

This study suggests that there are no significant

differences in terms of mortality and noneproce-

dure-related morbidity between nonobese and

obese patients undergoing elective EVAR. Overall,

EVAR in obese individuals seems to be efficacious

and safe over the short- and longer-term, despite

the fact that this cohort is at higher risk. EVAR

should be considered as the favorable method in

obese patients.

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