Endovascular Aortic Aneurysm Repair (EVAR)

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Original Article

Endovascular Aortic Aneurysm Repair (EVAR) Has


Significantly Lower Perioperative Mortality in
Comparison to Open Repair: A Systematic Review

Muhammad S. Sajid, Mittal Desai, Zishan Haider, Daryll M. Baker and George Hamilton,
Department of Vascular Surgery, Royal Free Hospital, Hampstead, London, UK.

OBJECTIVE: The objective of this meta-analysis was to evaluate the effectiveness of endovascular
abdominal aortic aneurysm repair (EVAR) in reducing inhospital mortality against open graft replace-
ment for aortic aneurysm.
METHODS: Generic terms including EVAR, endovascular aneurysm repair and aortic endografting were
used to search a variety of electronic databases. Based on selection criteria, decisions regarding inclusion
and exclusion of primary studies were made.
RESULTS: A total of three randomized controlled trials on 1,468 patients were included. In the EVAR
group, 12 of 759 (1.5%) patients died, compared to 33 of 709 (4.6%) patients who died in the open surgery
group. In both the fixed and random effect models, EVAR was associated with statistically significantly
lower perioperative mortality when compared to open surgical repair of aortic aneurysm. The risk ratio
of 0.33 indicates that mortality is 3.3 times more likely in the open surgery group compared to the EVAR
group.
CONCLUSION: EVAR carries a threefold lower risk of perioperative death in comparison to open repair
of abdominal aortic aneurysm. This early advantage must be offset against the increased need for later
re-intervention and probable equivalence of long-term outcome. In older and high operative risk patients,
EVAR should be the treatment of choice. [Asian J Surg 2008;31(3):119–23]

Key Words: aortic aneurysm, endograft, endovascular aneurysm repair, EVAR

Introduction rupture and its fatal consequences. The incidence of symp-


tomatic AAA is known to increase with age, occurring
In the last six decades, open aortic surgery has remained in 25 per 100,000 men aged 50 years, rising to 78 per
the treatment of choice for elective infrarenal abdominal 100,000 in those over 70 years of age.2 Minimally invasive
aortic aneurysm (AAA). Endovascular AAA repair (EVAR) endovascular repair is associated with less physiological
was first reported in 1991 by Parodi et al.1 It involves stress on the body, more than three times less mortality,3
inserting an endograft through the common femoral less morbidity and less intensive therapy unit/anaesthetic
arteries or iliac arteries and positioning it within the requirements. However, apart from causing less routine
aneurysm, thus excluding the aneurysm sac from circula- systemic complications, EVAR can cause unique technical
tion, reducing systemic pressure on the sac and avoiding problems like endoleak (perigraft blood flow, sometimes

Address correspondence and reprint requests to Mr Muhammad S. Sajid, Washington Suite, North Wing, Worthing
Hospital, West Sussex BN11 2DH, United Kingdom.
E-mail: surgeon1wrh@hotmail.com ● Date of acceptance: 3 January 2008

© 2008 Elsevier. All rights reserved.

ASIAN JOURNAL OF SURGERY VOL 31 • NO 3 • JULY 2008 119


■ SAJID et al ■

responsible for aneurysm rupture), endograft migration Two authors to assess the eligibility for inclusion
and endograft fracture. These technical problems need (Table 1) critically reviewed each article. The study method
further intervention after endovascular repair and are of all potentially eligible publications was reviewed.
responsible for the uncertain long-term success of this Studies on EVAR were eligible for inclusion in the analysis
procedure. if they satisfied our predefined methodological criteria,
This study evaluated the effectiveness of EVAR in i.e. randomized.
reducing perioperative mortality by a systematic review of Statistical analyses were performed by a senior statis-
available evidence in the literature. tician using Microsoft Excel 2003 for Windows XP. Binary
data (mortality) were summarized as risk ratios (RR)
Methods using the Mantel-Haenszel method under the fixed
effects model and the DerSimonian and Laird method
Studies published between January 1996 and December under the random effects model.4 In each case, a hetero-
2007 were identified through the MEDLINE, EMBASE, geneity test was carried out to determine whether the
CINAHL, and COCHRANE LIBRARY databases with a fixed effects model was appropriate. Forest plots were
search in all languages, through review of Current Contents. used for the graphical display of results from this review.
Generic terms including EVAR, endovascular aneurysm repair, Subgroup and sensitivity analyses were not feasible due
and aortic endografting were used to search the electronic to the limited number of studies. Publication bias was
databases. The search was also performed with a combina- also difficult to assess due to the small number of studies
tion of medical subject headings such as “mortality after in this review.
EVAR”, “complications of EVAR”, and “endovascular versus
open abdominal aortic aneurysm surgery”. Other electronic
databases covering biomedical issues, health-related arti- Table 1. Inclusion criteria
cles, science and social science were also searched. Hand
searching and looking through references quoted in use- • Prospective randomized controlled trial on endovascular
versus open abdominal aortic aneurysm repair
ful articles were also carried out and yielded a few more
• Trial on patients of any age and sex
articles. The detailed search strategy is given in Figure 1.

Database searched Articles identified Duplicates = 312


MEDLINE 213
EMBASE 289 Total citations =
PubMed 517 1,044
CENTRAL 16
CINAHL 6
From bibliography 2 Abstracts reviewed = 732

Excluded = 701 Full text analyses = 31


Trials comparing nonsurgical techniques
Trials comparing other procedures
Trials comparing laparoscopic techniques Excluded = 28
Trials comparing open techniques Nonrandomized trials
Trials comparing endovascular devices Comparative trials
Reviews Duplicate publications
Meta-analyses of same trial
Case series

Included trials = 3 (on 1,468 patients)

Figure 1. Flow chart of the literature search.

120 ASIAN JOURNAL OF SURGERY VOL 31 • NO 3 • JULY 2008


■ PERIOPERATIVE MORTALITY AFTER EVAR ■

Table 2. Characteristics of included trials

Number of patients
Trial Year Type of trial
EVAR Open surgery

Cuypers et al5 2001 Randomized 57 19


DREAM trial6 2004 Randomized 171 174
EVAR I trial3 2005 Randomized 531 516

Results Table 3. Outcome variables

Trial Perioperative mortality


Three trials3,5,6 on EVAR encompassing 1,468 patients
were retrieved from the electronic databases. The charac- Cuypers et al5
teristics of each trial are given in Table 2. There were 759 Endovascular repair 1/57
patients in the EVAR group and 709 patients in the open Open repair 1/19

surgery group. If standard deviations were not reported DREAM trial6


in the studies, then where necessary, they were estimated Endovascular repair 2/171
either from the ranges or p values. The outcome variables Open repair 8/174
extracted from these trials are shown in Table 3. In the EVAR I trial3
EVAR group, 12 of 759 (1.5%) patients died in hospital, Endovascular repair 9/531
compared to 33 of 709 (4.6%) patients who died in the Open repair 24/516
open surgery group.

Methodological quality of included studies the age of 65 years. This review considered the use of
The methodological quality of included trials is explained EVAR for asymptomatic AAA. Despite a general reduction
comprehensively in Table 4. The Mantel-Haenszel fixed in mortality and morbidity due to cardiovascular ailments,
effects model was used to compute robustness and sus- there is evidence of an increasing incidence of aneurysm
ceptibility to any outliers among these trials. The alloca- disease in the Western world.7 Conventional treatment of
tion concealment and blinding of investigator or assessor AAA involves a major laparotomy, opening of the aneurysm
was clearly reported; consequently, the methodological sac and replacing it with either tube or bifurcated graft.
quality of all three trials was considered adequate. Aneurysm repair is carried out to reduce the subsequent
risk of complications, particularly rupture, which is associ-
Perioperative mortality ated with significant mortality and morbidity. Conven-
Both in the fixed (RR, 0.33; 95% confidence interval [CI], tional treatment has been considered the treatment of
0.17−0.65; z = −3.23; p < 0.001) and random (RR, 0.23; 95% choice for more than six decades. Yet, according to the
CI, 0.12−0.43; z = −4.6; p = 0.0001) effects models (Figure 2), Vascular Society’s National Vascular Database, the aver-
EVAR was associated with statistically significantly lower age postoperative mortality rate for open aneurysm repair
perioperative mortality as compared to open surgical is 6.8% in the UK. The efficacy and safety of a new proce-
repair of aortic aneurysm. The RR of 0.33 indicates that dure needs to be considered in the context of the natural
mortality was 3.3 times more likely in the open surgery history of the condition and outcome after conventional
group than in the EVAR group. There was no heterogeneity treatment.8 The last decade has seen a dramatic shift towards
(Q = 0.16; p = 0.91) among trials. EVAR after a giant leap in technology. With more sophis-
ticated devices, about 90% of AAA can be excluded from
Discussion systemic circulation, and the risk of subsequent rupture
has become markedly low, particularly in the early years of
More than 6,000 patients die from leaking AAA every year follow-up. There are significant reductions in periopera-
in the UK, which corresponds to 2% of deaths in men over tive mortality, postoperative pain, critical care admissions

ASIAN JOURNAL OF SURGERY VOL 31 • NO 3 • JULY 2008 121


■ SAJID et al ■

Table 4. Methodological quality of included trials

Quality variables Cuypers et al5 DREAM trial6 EVAR I trial3

Inclusion criteria Listed Listed Listed


Exclusion criteria Listed Listed Listed
Randomization technique Computer-based Computer-based Computer-generated
Sample size calculation Stated Stated Stated
Baseline comparable Listed Listed Listed
Masked/blinded Yes Yes Yes
Crossover Not stated Not stated No
Lost to follow-up No Stated Stated
Allocation concealment Yes Yes Yes
Analysis by intention-to-treat Yes Yes Yes

Reference Favours EVAR Favours open surgery Estimate L95% CI U95% CI

Cuypers et al
0.33 0.31 4.47
(2001)5

DREAM trial
0.25 0.20 0.93
(2004)6

EVAR I trial
0.36 0.19 0.41
(2004)3

Overall fixed
0.34 0.16 0.31
effects

Overall
0.24 0.11 0.20
random effects

0.01 0.10 1.0 10.0 100.0


Risk ratio (95% CI)

Figure 2. Perioperative mortality.

and total length of hospital stay.3 However, due to EVAR- with its fewer requirements, will have many advantages.
related unique complications such as endograft migra- However, there is also a clear need for a highly skilled vas-
tion or occlusion, renal infarction, endoleak and higher cular team, vascular theatre nurse and interventional
re-intervention rate, this procedure is still controversial radiologist with appropriate facilities of technology in
among vascular surgeons. The early advantages of EVAR order to carry out a successful EVAR. This review provides
must be offset against the increased need for later re- food for thought and suggests continuing with EVAR due
intervention and probable equivalence of long-term out- to very significant early advantages. Based on the avail-
come because early and late results of the UK EVAR trials able evidence, patients, media and industry will no doubt
have confirmed markedly low 30-day mortality after EVAR. drive EVAR forward due to its minimal invasiveness and
This review, from the point of view of service provi- a 3% improvement in early survival. However, long-term
sion, has demonstrated that EVAR carried threefold less assessment of secondary outcome measures such as
risk of perioperative mortality when compared with con- re-intervention rate, cost-effectiveness and psychological
ventional repair. When planning an open procedure in impact on patients due to frequent scanning need further
a high-risk patient, it can be difficult to organize the exploration before EVAR can be accepted as a standard
required critical care services and, consequently, EVAR, procedure for the management of AAA.

122 ASIAN JOURNAL OF SURGERY VOL 31 • NO 3 • JULY 2008


■ PERIOPERATIVE MORTALITY AFTER EVAR ■

The cost of the procedure itself and cost of continuous 3. Greenhalgh RM, Brown LC, Kwong GP, et al, for EVAR trial
long-term surveillance following EVAR are major con- participants. Comparison of endovascular aneurysm repair with
open repair in patients with abdominal aortic aneurysm (EVAR
cerns for health sector managers. Although the conclusions
I trial), 30-day mortality results: randomised controlled trial.
regarding the cost-effectiveness of aneurysm treatment Lancet 2004;364:843–8.
options are time-dependent and vary by institutional per- 4. Egger M, Smith GD, Altman DG. Systematic Reviews in Healthcare.
spective, EVAR is still considered an expensive procedure.9 London: BMJ Publishing, 2006.
5. Cuypers PWM, Gardien M, Buth J, et al. Randomised study com-
Despite the cost implications of EVAR and its failure to
paring cardiac response in endovascular and open abdominal
improve mid-term all-cause mortality10 over open AAA aortic aneurysm repair. Br J Surg 2001;88:1059–65.
repair, it is likely that the bias of both patients and sur- 6. Prinssen M, Verhoven EL, Buth J, et al. A randomised trial
geons toward this minimally invasive procedure means (DREAM) comparing conventional and endovascular repair of
that it will continue to have a significant role. Experience abdominal aortic aneurysm. N Engl J Med 2004;351:1607–18.
7. Filipovic M, Goldacre MJ, Roberts SE, et al. Trends in mortality
and endograft developments have the potential to reduce
and hospital admission for abdominal aortic aneurysm. Br J Surg
postoperative complications; surveillance strategies could 2005;92:968–75.
then be amended to reduce cost implications. 8. The Vascular Society of Great Britain and Ireland. Fourth National
Vascular Database Report 2004. Oxfordshire: Dendrite Clinical
Systems, 2005. [ISBN 1-903968-12-7]
References
9. Jonk YC, Kane RL, Lederle FA, et al. Cost-effectiveness of abdomi-
nal aortic aneurysm repair: a systematic review. Int J Technol Assess
1. Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal Health Care 2007;232:205–15.
graft implantation for abdominal aortic aneurysm. Ann Vasc Surg 10. Brooks MJ, Brown LC, Greenhalgh RM. Defining the role of
1991;5:491–9. endovascular therapy in the treatment of abdominal aortic
2. Yii LG. Epidemiology of abdominal aortic aneurysm in an Asian aneurysm: results of a prospective randomized trial. Adv Surg
population. ANZ J Surg 2003;73:393–5. 2006;40:191–204.

ASIAN JOURNAL OF SURGERY VOL 31 • NO 3 • JULY 2008 123

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