Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured...

18
Endovascular treatment for ruptured abdominal aortic aneurysm (review) Dillon, M. (Author), Cardwell, C. (Author), Blair, P. (Author), Ellis, P. (Author), Kee, F. (Author), & Harkin, D. (Author). (2007). Endovascular treatment for ruptured abdominal aortic aneurysm (review). Web publication/site, Unknown Publisher. Queen's University Belfast - Research Portal: Link to publication record in Queen's University Belfast Research Portal General rights Copyright for the publications made accessible via the Queen's University Belfast Research Portal is retained by the author(s) and / or other copyright owners and it is a condition of accessing these publications that users recognise and abide by the legal requirements associated with these rights. Take down policy The Research Portal is Queen's institutional repository that provides access to Queen's research output. Every effort has been made to ensure that content in the Research Portal does not infringe any person's rights, or applicable UK laws. If you discover content in the Research Portal that you believe breaches copyright or violates any law, please contact [email protected]. Download date:10. Aug. 2021

Transcript of Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured...

Page 1: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

Endovascular treatment for ruptured abdominal aortic aneurysm(review)

Dillon, M. (Author), Cardwell, C. (Author), Blair, P. (Author), Ellis, P. (Author), Kee, F. (Author), & Harkin, D.(Author). (2007). Endovascular treatment for ruptured abdominal aortic aneurysm (review). Web publication/site,Unknown Publisher.

Queen's University Belfast - Research Portal:Link to publication record in Queen's University Belfast Research Portal

General rightsCopyright for the publications made accessible via the Queen's University Belfast Research Portal is retained by the author(s) and / or othercopyright owners and it is a condition of accessing these publications that users recognise and abide by the legal requirements associatedwith these rights.

Take down policyThe Research Portal is Queen's institutional repository that provides access to Queen's research output. Every effort has been made toensure that content in the Research Portal does not infringe any person's rights, or applicable UK laws. If you discover content in theResearch Portal that you believe breaches copyright or violates any law, please contact [email protected].

Download date:10. Aug. 2021

Page 2: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

Endovascular treatment for ruptured abdominal aortic

aneurysm (Review)

Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin DW

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library2007, Issue 1

http://www.thecochranelibrary.com

1Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 3: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

T A B L E O F C O N T E N T S

1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4CRITERIA FOR CONSIDERING STUDIES FOR THIS REVIEW . . . . . . . . . . . . . . . . . .

4SEARCH METHODS FOR IDENTIFICATION OF STUDIES . . . . . . . . . . . . . . . . . . .

4METHODS OF THE REVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4DESCRIPTION OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5METHODOLOGICAL QUALITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7POTENTIAL CONFLICT OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . .

7ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11Characteristics of excluded studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12Table 01. Search strategy used to search CENTRAL . . . . . . . . . . . . . . . . . . . . . . .

12Table 02. Mortality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13Table 03. Length of ICU stay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13Table 04. Length of Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14Table 05. Blood loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14Table 06. Transfusion requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14GRAPHS AND OTHER TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14COVER SHEET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iEndovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 4: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

Endovascular treatment for ruptured abdominal aorticaneurysm (Review)

Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin DW

Status: New

This record should be cited as:

Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin DW. Endovascular treatment for ruptured abdominal aortic aneurysm. CochraneDatabase of Systematic Reviews 2007, Issue 1. Art. No.: CD005261. DOI: 10.1002/14651858.CD005261.pub2.

This version first published online: 24 January 2007 in Issue 1, 2007.

Date of most recent substantive amendment: 01 November 2006

A B S T R A C T

Background

An abdominal aortic aneurysm (AAA) (the pathological enlargement of the aorta) can develop in both men and women as they grow

older. It is most commonly seen in men over the age of 65 years. Progressive aneurysm enlargement can lead to rupture and massive

internal bleeding, a fatal event unless timely repair can be achieved. Despite improvements in perioperative care, mortality remains

high (approximately 50%) after conventional open surgical repair. A newer minimally invasive technique, endovascular repair, has

been shown to reduce early morbidity and mortality, as compared to conventional open surgery, for planned AAA repair. Emergency

endovascular repair (eEVAR) has been used successfully to treat ruptured abdominal aortic aneurysm (RAAA), proving that it is feasible

in selected patients. However, it is not yet known if eEVAR will lead to significant improvements in outcomes for these patients or

indeed if it can replace conventional open repair as the preferred treatment for this lethal condition.

Objectives

To compare the advantages and disadvantages of eEVAR in comparison with conventional open surgical repair for the treatment of

RAAA.

Search strategy

The Cochrane Peripheral Vascular Diseases Group searched their trials register (last searched October 2006) and the Cochrane Central

Register of Controlled Trials (CENTRAL) database (last searched Issue 4, 2006). We searched a number of electronic databases and

handsearched relevant journals until March 2006 to identify studies for inclusion.

Selection criteria

Randomised controlled trials in which patients with a confirmed ruptured abdominal aortic aneurysm were randomly allocated to

eEVAR, or conventional open surgical repair.

Data collection and analysis

Studies identified for potential inclusion were independently assessed for eligibility by at least two reviewers, with excluded studies

further checked by the agreed arbitrators. As no randomised controlled trials were identified at present no tests of heterogeneity or

sensitivity analysis were performed.

Main results

There were no randomised controlled trials identified at present comparing eEVAR with conventional open surgical repair for the

treatment of RAAA.

Authors’ conclusions

There is no high quality evidence to support the use of eEVAR in the treatment of RAAA. However, evidence from prospective

controlled studies without randomisation, prospective studies, and retrospective case series suggest that eEVAR is feasible in selected

1Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 5: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

patients, with outcomes comparable to best conventional open surgical repair for the treatment of RAAA . Furthermore, endovascular

repair in selected patients may be associated with a trend towards reductions in blood loss, duration of intensive care treatment, and

mortality.

P L A I N L A N G U A G E S U M M A R Y

Endovascular repair for ruptured abdominal aortic aneurysm

The abdominal aorta is the main artery supplying blood to the lower part of the body. An abnormal ballooning and weakening of

the wall of the aorta (aortic aneurysm) particularly affects men as they grow older. An aneurysm may progressively enlarge without

obvious symptoms yet it is potentially lethal as the aneurysm can burst (rupture) causing massive internal bleeding. Death is inevitable

unless the bleeding can be stopped and blood flow to the lower body restored promptly. Until recently this required an open operation

(laparotomy) to clamp the abdominal aorta and replace the segment of the aorta with a synthetic artery tube-graft. Many patients do not

survive this major operation due to the effects of massive bleeding or failure of vital organs, such as the heart, lungs, and kidneys despite

improvements in surgical technique and care of the critically ill patient. A recent minimally invasive technique, termed endovascular

repair, allows the surgeon to pass a stent graft through the blood vessels from the groin to the site of rupture where it is positioned,

attached to healthy artery above and below the aneurysm to stop bleeding and form a new channel for blood flow. This technique is

successful in suitable patients for the planned treatment of non-ruptured aneurysms and can reduce early post-operative complications

and deaths. The present review looked at the available evidence for its effectiveness compared with open surgery for ruptured aneurysms.

The review authors searched the medical literature but found no completed randomised controlled trial. Evidence from case series, 10

prospective and 21 retrospective reports, indicates that emergency endovascular repair is feasible and may reduce blood loss, duration

of stay in intensive care and deaths in selected patients. These reports were from vascular surgery centres with considerable experience

of the technique.

B A C K G R O U N D

Abdominal aortic aneurysm (AAA), the pathological enlargement

of the main artery in the abdomen, affects between 1.2% and

7.6% of the population over 50 years of age in the United King-

dom. The prevalence of AAA in men is approximately three times

greater than in women, and the incidence increases with advancing

age (Scott 1991; Scott 1995). The cause of AAA is unknown but

its development is associated with many of the cardiovascular risk

factors that predispose to atherosclerosis and arterial occlusive dis-

ease, perhaps most importantly tobacco smoking (Lederle 1997;

Wilmink 1999). Genetic factors are also important, as the risk of

aneurysm development is significantly greater in relatives of those

with a diagnosed AAA (Powell 2003; van Vlijmen 2002). Unfortu-

nately, many aneurysms progressively enlarge without overt symp-

toms, presenting only when the aneurysm ruptures, a catastrophic

event causing massive internal bleeding that results in death in

the majority of those affected. Recent randomised controlled tri-

als have shown that mortality can be reduced by mass popula-

tion ultrasound screening in men, with early detection and inter-

vention preventing future rupture and aneurysm-related mortality

(Ashton 2002; Norman 2004). The risk of aneurysm rupture has

been shown to be proportional to aneurysm size, with aneurysms

measuring less than 5.4 cm having an annual rupture rate of ap-

proximately 1% whereas those greater than 7.0 cm in diameter

have an annual rupture rate of 32.5% (Gorham 2004). The UK

Small Aneurysm Trial has shown that in general, patients benefit

from aneurysm repair when maximum aneurysm diameter exceeds

5.5 cm, at which stage the risk of spontaneous rupture exceeds

the risks of conventional open surgical repair (Greenhalgh 1998).

Currently, rupture leads to death in over 80% of those affected,

including 30% to 65% of those who receive conventional open

surgical repair (Gorham 2004; Veith 2003), and is responsible for

over 6800 deaths per annum in the United Kingdom and 2.1% of

all deaths in men over 65 years (Ashton 2002; Scott 1991). These

findings contrast with the significantly better outcome if conven-

tional open surgical repair of the AAA is planned before rupture

can occur.

Historically, conventional open surgical repair was the only effec-

tive treatment for AAA, involving open surgical exposure of the

aorta, and replacement of the aneurysm with a synthetic tube-

graft. This complex major operation carries a significant morbid-

ity and mortality, due to the combined effects of surgical expo-

sure, haemorrhage, and aortic clamping with related lower torso

ischaemia-reperfusion injury. However, with improvements in pa-

tient selection and perioperative care excellent results can now be

achieved with open repair, with some specialist centres reporting

mortality rates of less than 2% and surgeons in non-specialist units

achieving mortality rates of 5% to 8% (Gorham 2004; Green-

halgh 1998; Veith 2003). However, in the last two decades this

approach to treatment of patients with AAA has been challenged

2Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 6: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

by the arrival of a new minimally-invasive technique, endovascular

aneurysm repair (EVAR). The EVAR technique was first reported

by Parodi in 1991 (Parodi 1991). He described the placement of

a home-made, material-covered metal stent across an abdominal

aneurysm to exclude this from the circulation and to form a new

channel for blood flow. The stent is delivered to the aorta from

a remote accessible vessel such as the femoral artery at the groin.

Since this seminal report, outcomes have progressively improved

with significant advancements in commercial stent design, deliv-

ery, and implantation technique (Harris 2005; Thomas 2005),

making this a valuable alternative to open repair in selected suitable

cases (Lee 2004). Modern aortic stent grafts are available in a range

of sizes and can be custom designed. The addition of fenestrations

and side-branches can adapt the stent to suit difficult anatomi-

cal variations encountered. These modular devices are most com-

monly delivered remotely by open exposure of the femoral arter-

ies, although percutaneous access is possible and are broadly de-

scribed as, the aorto-uni-iliac graft (single-lumen) and aorto-bi-

iliac (bifurcated-lumen) graft. The minimally invasive nature of

this technique allows it to be performed under regional or even lo-

cal anaesthesia, rather than general anaesthesia. This increases the

availability of this technique to those patients with significant con-

comitant medical disease who may otherwise have been consid-

ered unfit for surgery (Lachat 2002; Veith 2003). Two recent large

prospective randomised controlled trials have compared EVAR

with conventional open repair for the treatment of large abdom-

inal aortic aneurysms, and have shown significant reductions in

early complications and mortality (EVAR 2004; Prinssen 2004).

However, whilst endovascular repair for un-ruptured abdominal

aortic aneurysm clearly has a role in “healthy” patients, these trials

have also reinforced the knowledge that open repair is a success-

ful technique and will remain a common form of treatment for

over half of those patients presenting with a large abdominal aortic

aneurysm for whom EVAR is unsuitable on anatomical grounds

or due to other factors (EVAR 2004; EVAR 2005). Furthermore,

it is now clear that those patients who are unfit for open surgical

repair can expect such a high mortality rate from their co-mor-

bid disease, that even successful EVAR of their aneurysm is un-

likely to alter overall prognosis and life expectancy, which remains

guarded (EVAR2 2005). It is also clear from these studies that

EVAR is associated with a higher re-intervention rate than open

repair (EVAR 2004; EVAR 2005), and registry data would suggest

that these re-intervention rates can remain constant and may even

increase with time (Harris 2005; Thomas 2005). As such long-

term surveillance is essential after EVAR to monitor for endoleaks

and stent integrity in order to reduce the small but significant in-

cidence of late aneurysm rupture.

Rupture of an Abdominal Aortic Aneurysm (AAA) is a catastrophic

event which is occurring with increasing frequency in our increas-

ingly elderly population. Despite improved surgical techniques

and advances in intensive care support, ruptured AAA (RAAA)

continues to confer overall a 35% to 70% mortality (Adam 1999;

Huber 1995). The rupture of an AAA exposes the patients to the

combined injury of a period of haemorrhagic shock and lower

torso ischaemia followed by a reperfusion injury on successful

revascularisation. This ’two hit’ mechanism of injury, initiates a

systemic inflammatory response syndrome (SIRS) (Lindsay 1999),

characterized by increased microvascular permeability and neu-

trophil sequestration, leading to a multiple organ dysfunction syn-

drome (MODS), the primary cause of 70% of such deaths and a

contributory cause of the remainder (Bown 2003; Harris 1991).

Haemorrhagic shock occurs due to an acute loss of circulating

blood volume resulting in a period of prolonged hypotension and

the resultant decreased perfusion of the tissues leads to tissue in-

jury (Roumen 1993). Disruption of the blood supply to the lower

limbs, during rupture and surgical repair induces a lower torso

tissue ischaemia. Restoration of the blood supply to the temporar-

ily ischaemic tissue gives rise to the ischaemia-reperfusion injury.

These combined injuries activate multiple inflammatory pathways

in the body inducing a harmful proliferative systemic inflamma-

tory response syndrome characterized by immune cells activation,

pro-inflammatory mediator production and widespread vital or-

gan injury (heart, lungs, liver, kidney, gut, etc.). The sequential fail-

ure of these organs despite intensive care support, once established

leads to death in over 70% of cases (Bown 2003; Roumen 1993).

The high mortality associated with open repair has led many to

look for alternative treatments for the management of RAAA. Sev-

eral studies have confirmed that the use of EVAR, especially un-

der local anaesthesia, reduces the physiological insult to the body

as compared to conventional open surgical repair (Cuypers 2001;

Peppelenbosch 2003). Emergency endovascular aneurysm repair

(eEVAR) has been successfully carried out using a variety of proto-

cols and techniques and would appear to offer a feasible alternative

to conventional open repair in selected patients (Peppelenbosch

2003; van Sambeek 2002). These early reports have suggested a

trend toward reduction in perioperative morbidity and mortality

in selected patients.

The EVAR technique has been successfully used in the planned

treatment of non-ruptured aneurysms of the abdominal aorta and

when compared to conventional open surgical repair, has been

shown to reduce early post-operative complications and death. In

this review we have assessed the available evidence to support the

use of eEVAR to treat ruptured abdominal aortic aneurysm.

O B J E C T I V E S

This review will draw together available trial evidence to allow

assessment of the advantages and disadvantages of EVAR for pa-

tients with RAAA (eEVAR). This will be determined by the effect

on short-term mortality, major complication rates, aneurysm ex-

clusion, and late complications when compared with patients who

have had conventional open repair of RAAA.

3Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 7: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

C R I T E R I A F O R C O N S I D E R I N G

S T U D I E S F O R T H I S R E V I E W

Types of studies

Prospective randomised controlled trials (RCTs) comparing eE-

VAR with conventional open surgical repair.

Types of participants

All patients in whom a ruptured abdominal aortic aneurysm had

been diagnosed by computerised tomography (CT), angiography,

or magnetic resonance angiography (MRA) were considered for

inclusion. There must have been evidence of rupture on imaging or

objective acute symptoms suggestive of impending rupture of the

aneurysm (abdominal or back pain in a patient with an aneurysm)

to warrant inclusion.

We planned to perform sub-group analysis to evaluate the impact

of patients treated with aorto-uni-iliac devices and those treated

with aorto-bi-iliac devices.

Studies where objective evidence of RAAA is not clear were ex-

cluded.

Types of intervention

All types of endovascular device were considered in comparison

with conventional open surgical treatment for patients considered

fit for surgery.

Types of outcome measures

The following outcome measures were considered:

(1) short-term mortality (30 day, or in-hospital mortality, i.e. pro-

cedure related);

(2) aneurysm exclusion (no flow in the AAA sac, or further ex-

travasation (escape of blood from the vessel into the tissues) be-

yond the sac on follow-up imaging 30 days after the procedure);

(3) major complications for example, open conversion, haemor-

rhage, myocardial infarction, stroke, renal failure (20% rise in

creatinine levels), respiratory failure (need for post-operative me-

chanical ventilation), pneumonia, bowel ischaemia, lower limb is-

chaemia, etc;

(4) minor complications for example, catheter site haematoma,

wound infection, etc;

(5) long term complications and mortality; re-intervention rates

for problems related to the RAAA or its treatment will be sought

where possible, as will cause of death, with or without re-interven-

tion, i.e., device-related;

(6) quality of life, (standardised questionnaires);

(7) economic analysis (cost per patient).

S E A R C H M E T H O D S F O R

I D E N T I F I C A T I O N O F S T U D I E S

See: Cochrane Peripheral Vascular Diseases Group methods used

in reviews.

This review drew on the search strategy developed for the

Cochrane Peripheral Vascular Diseases (PVD) Group. The

Cochrane Peripheral Vascular Diseases Group searched their

trials register (last searched October 2006) and the Cochrane

Central Register of Controlled Trials (CENTRAL) database (last

searched Issue 4, 2006) for trials describing endovascular repair

of ruptured or symptomatic abdominal aortic aneurysm. For

search strategy used to search CENTRAL see Table 01.

We handsearched relevant surgical and interventional radiological

journals, and performed electronic searches of the following

bibliographic databases:

(1) AMED (Allied and Complementary Medicine Database);

(2) Best Evidence;

(3) Biological Abstracts

(4) HMIC (Health Management of Information Consortium -

comprising DH-data, the King’s Fund Database and Helmis);

(5) NHS DARE (Database of Assessments of Reviews of Effects);

(6) NHS EED (Economics Evaluations Database);

(7) NHS HTA (Health Technology Assessment);

(8) PubMed (last 180 days) ;

(9) Science Citation Index;

(10) MEDLINE .

Searches were not restricted by publication type, study design or

language of publication.

The initial use of methodological filters in electronic databases to

limit the search results to controlled trials and systematic reviews

was abandoned as it proved fruitless. The search terms were

widened using the keywords “endovascular ” AND “abdominal

aortic aneurysm” AND “ruptured” in all databases. The last

search prior to preparation of the first draft of this review was

performed in March 2006 and the PVD Group re-ran searches

of their trials register and CENTRAL in October 2006. No

additional trials were found.

M E T H O D S O F T H E R E V I E W

Selection and quality assessment of trials

MD

and DWH evaluated the trials under consideration independently

for appropriateness for inclusion and for methodological quality.

Disagreements were resolved on discussion with the review team

and agreed arbitrators.

D E S C R I P T I O N O F S T U D I E S

No randomised controlled trials comparing endovascular treat-

ment and open repair for ruptured abdominal aortic aneurysm

were identified. A number of case reviews comparing outcomes of

eEVAR for RAAA with open surgical repair were found and ex-

cluded due to lack of randomisation and in some cases the eEVAR

4Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 8: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

had been compared to historical controls (see Table of Excluded

Studies).

M E T H O D O L O G I C A L Q U A L I T Y

There are no included studies.

R E S U L T S

There are no completed randomised controlled trials comparing

eEVAR with conventional open surgical repair for the treatment of

RAAA. Seven case reports (Corso 2005; Hinchcliffe 2002; Kumar

2002; Morales 2005; Seelig 2000; Verhagen 2003; Yusuf 1994)

and thirty-one case series (21 retrospective and 10 prospective)

describing eEVAR were identified (see list of excluded studies).

D I S C U S S I O N

The extremely high mortality rate from RAAA is well recognised.

Detailed risk analysis and scoring systems have been shown to pre-

dict non-survivors in certain groups but individual patient out-

comes cannot be accurately predicted. Clinicians have been reti-

cent to apply these scoring systems rigidly as to do so would serve

to preclude most patients with RAAA from surgical repair, con-

demning them to certain death (Alsac 2005b; Korhonen 2004;

Neary 2003). It is also now clear that those patients who undergo

successful open repair of RAAA enjoy a post-operative quality of

life similar to the “normal population” (Hinterseher 2004; Tam-

byraja 2004)

Since the first description of the EVAR technique (Parodi 1991),

many specialised vascular surgery centres have adopted its use in

the elective treatment of abdominal aortic aneurysm, where its use

has contributed to a reduction in early postoperative morbidity

and mortality (EVAR 2004; Prinssen 2004). Many of these centres

have been integral to the clinical development of the techniques

and devices employed for endovascular repair and all reports on

eEVAR studies considered for this review are from centres with

considerable experience of elective EVAR.

Selection of cases on the basis of precise anatomical suitability for

elective EVAR has been shown to be associated with a much lower

rate of re-intervention and associated procedures, with consequent

reductions in morbidity and procedure-related cost. Most authors

have used established criteria derived from elective EVAR to de-

termine anatomical suitability for eEVAR. Evidence from several

studies has shown that the aneurysm morphology is significantly

more challenging for endovascular techniques in those assessed

for RAAA compared with those undergoing elective EVAR (Alsac

2005b; Hinchliffe 2003). However the excluded studies revealed

substantial variation in the inclusion and exclusion criteria em-

ployed, in particular many groups accept inferior proximal neck

anatomy which would preclude patients from elective EVAR, sug-

gesting a trend to be more inclusive in these high risk patients. This

would account for the wide range in the excluded studies, where

anywhere between 40% to 80% of RAAA were considered to be

anatomically suitable for eEVAR (Lee 2004;Lloyd 2004; Peppe-

lenbosch 2003; Reichart 2003; Wilson 2004). There is no long

term follow-up data available for patients undergoing eEVAR and

therefore, there is no evidence to suggest whether or not the relax-

ation of the criteria for anatomical suitability will lead to future

problems, such as increased rates of endoleak, graft displacement,

complications, re-interventions or the need for open conversion.

In the excluded studies, the majority of centres use contrast-en-

hanced computed tomographic angiography (CTA) to assess the

anatomical suitability of aneurysms for eEVAR. Other centres de-

scribe using intra-operative calibration angiography as an effective

alternative in order to reduce pre-operative delays. This has po-

tential disadvantages as it does not show the presence of atheroma

or thrombus at the proximal fixation site, which could make the

procedure technically more difficult and could adversely affect the

outcome of the procedure. Performing CTA, though more accu-

rate, can result in a procedural delay. A recent prospective study

of 100 patients with RAAA treated by open surgery demonstrated

no significant difference in outcome whether or not a pre-opera-

tive CT scan had been performed (Boyle 2005), suggesting such

delays may not be clinically important. Another study has shown

that the majority of patients with RAAA who are not operated

upon survive for more than two hours after hospital admission and

maintain a satisfactory systolic blood pressure greater than 80 mm

Hg with minimal fluid resuscitation (Lloyd 2004), which would

allow sufficient time for radiological assessment in most specialist

centres.

In the haemodynamically unstable patient with RAAA, rapid con-

trol of progressive haemorrhage at the aortic rupture site is of-

ten considered paramount. This may be achieved in conventional

open surgery by laparotomy and application of an aortic clamp

proximal to the aneurysm. In the setting of endovascular repair,

this control may be achieved endoluminally by the placement and

inflation of a balloon occlusion device in the aorta proximal to

the rupture site (often the supra-celiac aorta) or by swift endograft

placement and deployment. The excluded studies describe the

use of both aorto-uni-iliac (AUI) or aorto-bi-iliac (ABI) devices.

Aorto-uni-iliac devices have the advantage of ease in deployment

and therefore rapid control of haemorrhage is possible. As they are

not anatomical a surgical femoro-femoro crossover bypass graft is

required following graft deployment to provide blood flow to the

contralateral lower limb. Aorto-bi-iliac devices, or modular bifur-

cated grafts, give a better anatomical result without the need for

crossover bypass grafts, but often require more deployment time.

Many units now advocate a policy of permissive hypotension to

reduce bleeding and prevent re-bleeding from the contained aortic

rupture site. In general this policy is applied in the excluded stud-

ies, but there was wide variation in the lowest tolerated systolic

5Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 9: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

blood pressures (SBP). It is notable that even when SBP as low as

50 mm Hg were permitted, no increased incidence of end-organ

injury, such as visceral ischaemia, was reported (Scharrer-Pamler

2003).

Two recent large prospective randomised controlled trials have

compared EVAR with conventional open repair for the treat-

ment of large abdominal aortic aneurysms and have shown sig-

nificant reductions in early complications and mortality (EVAR

2004; Prinssen 2004). Paradoxically, recent data from the afore-

mentioned EVAR 1 Trial have shown that despite early advantages

in morbidity and mortality at one-year, mortality is not signifi-

cantly different between those randomised to EVAR compared to

open surgery and at an increased cost (EVAR 2005). Interestingly,

high-risk patients deemed unfit for elective open surgical repair,

faired no better with EVAR than with best medical management

in terms of aneurysm-related or all-cause mortality, suggesting that

unfitness for open surgery as judged in these studies may be an

indicator for reduced life-expectancy (EVAR2 2005). Notable also

from the EVAR 2 Trial is that the peri-procedural morality rate of

9% in these high-risk patients was significantly greater than their

lower risk counterparts in EVAR 1 Trial (EVAR 2004; EVAR2

2005). However, the risk / benefit analysis is different in patients

with RAAA as failure to treat means inevitable death and conven-

tional open surgery continues to carry a very significant risk of

mortality, 35% to 70%. Emergency endovascular repair (eEVAR)

is less invasive, reduces surgical stress, reduces haemodynamic in-

stability, and can be achieved with a local or loco-regional anaes-

thesia. In the excluded studies the reported reductions in mortality

rates with eEVAR, compared to contemporary or historical con-

trols undergoing open repair, mirrors a procedural-related reduc-

tion blood loss, transfusion requirements, and length of ICU stay

(see additional tables Table 02; Table 03; Table 04; Table 05; Table

06). These perceived benefits are generally attributed to a reduc-

tion in the physiological insult to the patients, as eEVAR obvi-

ates the need for laparotomy, exposure and handling of abdominal

contents, and aorto-iliac dissection and clamping. In the major-

ity of the excluded studies eEVAR was conducted under general

anaesthetic, although even AUI device placement with surgical

femoro-femoral bypass graft can be achieved under local anaes-

thetic regimes. However, as there were no randomised controlled

trials identified and few of the results from the excluded studies

reached a level of statistical significance, we are unable to draw

definite conclusions without further evidence.

A distinct learning curve effect is noted in the excluded studies

involving eEVAR. The more recent studies show a greater reduc-

tion in procedure times, mortality and complication rates. Earlier

reports included hand-made or hand-customized devices, whereas

more recent series make use of a range of commercial stent grafts

of modular design with size ranges designed to suit most conceiv-

able requirements. As has been seen with elective EVAR practice,

advancements in stent-graft design and endovascular techniques

have lead to improved outcomes (Harris 2005; Thomas 2005).

Re-intervention rates from the excluded studies appear compara-

ble with those seen with elective endovascular repair (EVAR 2004;

EVAR 2005; Harris 2005; Thomas 2005). Long-term data are

needed in order to truly assess if eEVAR is a durable treatment in

relation to rate of endoleak, maintenance of stent-graft integrity

and late rupture risk. It is clear that the introduction of an eEVAR

service has substantial cost implications, in terms of staff, fixed

resources and procedure-associated equipment. This may impact

on the transferability of this technique beyond specialist centres.

In order to provide a comprehensive 24-hour service the necessary

team of surgeons, radiologists, anaesthetists, radiographers, nurses

and technicians need to be available at all times. Furthermore, in

most excluded studies a wide range of stent-graft stock was avail-

able to cope with the variable anatomy encountered, which can

prove costly for a single institution unless a satisfactory arrange-

ment can be achieved with a commercial partner. These obvious re-

source implications are further compounded by the need for post-

operative follow up and imaging surveillance, as in elective setting.

The elective use of EVAR has shown the need for long-term post

procedure graft surveillance to confirm stent-graft integrity and

persistent aneurysm exclusion. Complications may require a high

rate of re-intervention by endovascular or open means, in relation

to endoleak, device migration, strut fracture, limb occlusion or

late rupture.

In the absence of randomised controlled trials, we are unable to

fully evaluate the role of emergency endovascular repair of rup-

tured abdominal aortic aneurysms (eEVAR). Early results from

specialist centres in the excluded studies show this technique is

feasible. Data suggesting reduced morbidity and mortality in se-

lected patients must be interpreted with caution due to the lack of

randomised controlled trials. The authors are concerned that there

may be ethical difficulties in designing a prospective randomised

controlled trial comparing eEVAR and conventional open repair

for RAAA given the lack of capacity for informed consent in many

of these patients and the growing body of literature which though

unrandomised, describes reductions in mortality and morbidity

following eEVAR.

A U T H O R S ’ C O N C L U S I O N S

Implications for practice

The benefit of endovascular repair for abdominal aortic aneurysm

rupture (eEVAR) has not been established as no randomised con-

trolled trials were found. The reductions in mortality rates, Inten-

sive Care Unit (ICU) stay and blood loss seen in the larger series

identified are encouraging and may suggest a future role for eE-

VAR in the treatment of RAAA but cannot be interpreted confi-

dently due to the nature of the studies.

6Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 10: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

Implications for research

Further trials to evaluate the role of eEVAR in the treatment of

RAAA are required. These trials should be methodologically ade-

quate in terms of sample sizes, treatment standardization and du-

ration of follow up. Clinically-relevant outcomes such as rate of

major complications, open-conversion, aneurysm exclusion, en-

doleak, rupture, and mortality should be assessed. However, accu-

mulating evidence from non-randomised studies, which show sig-

nificant reductions in mortality in selected patients deemed suit-

able for endovascular repair, may raise ethical concerns in relation

to randomising these patients to open repair. Large prospective

studies are required to validate the acceptable anatomical criteria

for eEVAR in RAAA. Furthermore, longitudinal studies are re-

quired to assess the long-term durability of this form of treatment

in terms of re-intervention rate, open-conversion rate, and rup-

ture-free survival.

P O T E N T I A L C O N F L I C T O F

I N T E R E S T

None known.

A C K N O W L E D G E M E N T S

We would like to thank the external referee, Mr Paul Tisi for his

helpful comments and the Consumer Network for their contribu-

tion to the Plain Language Summary.

S O U R C E S O F S U P P O R T

External sources of support

• Chief Scientist Office, Health Department, The Scottish Exec-

utive UK

Internal sources of support

• Cochrane Fellowship, Research & Development Office, North-

ern Ireland UK

R E F E R E N C E S

References to studies excluded from this reviewAlsac 2005

Alsac JM, Desgranges P, Kobeiter H, Becquemin JP. Emergency en-

dovascular repair for ruptured abdominal aortic aneurysms: feasibil-

ity and comparison of early results with conventional open repair. Eu-

ropean Journal of Vascular & Endovascular Surgery 2005;30(6):632–9.

[MedLine: doi: 10.1016/j.ejvs.2005.06.010].

Brandt 2005

Brandt M, Walluscheck KP, Jahnke T, Graw K, Cremer J,

Muller-Hulsbeck S. Endovascular repair of ruptured aneurysm:

feasibility and impact on early outcome. Journal of Vascular

& Interventional Radiology 2005;16(10):1309–12. [MedLine: doi:

10.1097/01.RV1.0000175332.44635.49].

Castelli 2005

Castelli P, Caronno R, Piffaretti G, Tozzi M, Lagana D, Car-

rafiello G, et al. Ruptured abdominal aortic aneurysm: endovascular

treatment. Abdominal Imaging 2005;30(3):263–9. [MedLine: doi:

10.1007/s00261-004-0272-6].

Doss 2002

Doss M, Martens S, Hemmer W. Emergency endovascular inter-

ventions for ruptured thoracic and abdominal aortic aneurysms.

American Heart Journal 2002;144(3):544–8. [MedLine: doi:

10.1067/mhj.2002.123578].

Franks 2006

Franks S, Lloyd G, Fishwick G, Bown M, Sayers R. Endovascular

treatment of ruptured and symptomatic abdominal aortic aneurysms.

European Journal of Vascular & Endovascular Surgery 2006;31(4):

345–50. [MedLine: doi: 10.1016/j-ejvs.2005.08.037].

Gerassimidis 2005

Gerassimidis TS, Papazoglou KO, Kamparoudis AG, Konstantini-

dis K, Karkos CD, Karamanos D, et al. Endovascular management

of ruptured abdominal aortic aneurysms: 6-year experience from a

Greek center. Journal of Vascular Surgery 2005;42(4):615–23. [Med-

Line: doi: 10.1016/j.jvs.2005.05.061].

Greco 2006

Greco G, Egorova N, Anderson PL, Gelijns A, Moskowitz A,

Nowygrod R, et al. Outcomes of endovascular treatment of ruptured

abdominal aortic aneurysms. Journal of Vascular Surgery 2006;43(3):

453–9. [MedLine: doi: 10.1016/j.jvs.2005.11.024].

Greenberg 2000

Greenberg RK, Srivastava SD, Ouriel K, Waldman D, Ivancev K,

Illig KA, et al. An endoluminal method of haemorrhage control and

repair of ruptured abdominal aortic aneurysms. Journal of Endovas-

cular Therapy 2000;7(1):1–7.

Hechelhammer 2005

Hechelhammer L, Lachat ML, Wildermuth S, Bettex D, Mayer D,

Pfammatter T. Midterm outcome of endovascular repair of ruptured

abdominal aortic aneurysms. Journal of Vascular Surgery 2005;41(5):

752–7. [MedLine: doi: 10.1016/j.jvs2005.02.023].

Hinchliffe 2001

Hinchliffe RJ, Yusuf SW, Macierewicz JA, MacSweeney STR, Wen-

ham PW, Hopkinson BR. Endovascular repair of ruptured abdom-

inal aortic aneurysm - a challenge to open repair? Results of a

single centre experience in 20 patients. European Journal of Vas-

7Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 11: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

cular & Endovascular Surgery 2001;22(6):528–34. [MedLine: doi:

10.1053/ejvs.2001.1513].

Kapma 2005

Kapma MR, Verhoeven EL, Tielliu IF, Zeebregts CJ, Prins TR,

Van der Heij B, et al. Endovascular treatment of acute abdominal

aortic aneurysm with a bifurcated stentgraft. European Journal of

Vascular & Endovascular Surgery 2005;29(5):510–5. [MedLine: doi:

10.1016/j.ejvs.2005.01.007].

Lachat 2002

Lachat ML, Pfammatter T, Witzke HJ, Bettex D, Kunzli A, Wolfens-

berger U, Turina MI. Endovascular repair with bifurcated stent-grafts

under local anaesthesia to improve outcome of ruptured aortoil-

iac aneurysms. European Journal of Vascular & Endovascular Surgery

2002;23(6):528–36. [MedLine: doi: 10.1053/ejvs.2002.1622].

Lagana 2006

Lagana D, Carrafiello G, Mangini M, Fontana F, Caronno R, Castelli

P, et al. Emergency endovascular treatment of abdominal aortic

aneurysms: feasibility and results. Cardiovascular & Interventional Ra-

diology 2006;29(2):241–8.

Larzon 2005

Larzon T, Lindgren R, Norgren L. Endovascular treatment of rup-

tured abdominal aortic aneurysms: a shift of the paradigm?. Journal

of Endovascular Therapy 2005;12(5):548–55. [MedLine: doi:].

Larzon T, Lindgren R, Norgren L. Endovascular treatment possible

in ruptured abdominal aortic aneurysm [Endovaskular metod mojlig

vid rupturerade bukaortaaneurysm]. Lakartidningen 2005;102(17):

1320–5.

Lee 2004

Lee WA, Herniese CM, Tayyarah M, Huber TS, Seeger JM. Impact of

endovascular repair on early outcomes of ruptured abdominal aortic

aneurysms. Journal of Vascular Surgery 2004;40(2):211–5. [MedLine:

doi: 10.1016/j.jvs.2004.05.006].

Lombardi 2004

Lombardi JV, Fairman RM, Golden MA, Carpenter JP, Mitchell M,

Barker C, et al. The utility of commercially available endografts in

the treatment of contained ruptured abdominal aortic aneurysm with

haemodynamic stability. Journal of Vascular Surgery 2004;40(1):154–

60. [MedLine: doi: 10.1016/j.jvs.2004.02.042].

Mehta 2005

Mehta M, Darling RC 3rd, Roddy SP, Fecteau S, Ozsvath KJ, Kreien-

berg PB, et al. Factors associated with abdominal compartment

syndrome complicating endovascular repair of ruptured abdominal

aortic aneurysms. Journal of Vascular Surgery 2005;42(6):1047–51.

[MedLine: doi: 10.1016/j.jvs.2005.08.033].

Ohki 2000

Ohki T, Veith FJ. Endovascular grafts and other image-guided

catheter-based adjuncts to improve the treatment of ruptured aor-

toiliac aneurysms. Annals of Surgery 2000;232(4):466–79.

Okhi 1999

Okhi T, Veith FJ, Sanchez LA, Cynamon J, Lipsitz EC, Wain RA, et

al. Endovascular graft repair of ruptured aortoiliac aneurysms. Journal

of the American College of Surgeons 1999;189(1):102–12.

Orend 2002

Orend KH, Kotsis T, Scharrer-Pamler R, Kapfer X, Liewald F, Gorich

J, et al. Endovascular repair of aortic rupture due to trauma and

aneurysm. European Journal of Vascular & Endovascular Surgery 2002;

23(1):61–7. [MedLine: doi: 10.1053/ejvs.2001.1546].

Peppelenbosch 2003

Peppelenbosch N, Yilmaz N, van Marrewijk C, Buth J, Cuypers P,

Duijm L, et al. Emergency treatment of acute symptomatic or rup-

tured abdominal aortic aneurysm. Outcome of a prospective intent-

to-treat by EVAR protocol. European Journal of Vascular & Endovas-

cular Surgery 2003;26(3):303–10. [MedLine: doi: 10.1016/S1078-

5884(03)00244-2].

Peppelenbosch 2005

Peppelenbosch N, Cuypers PW, Vahl AC, Vermassen F, Buth

J. Emergency endovascular treatment for ruptured abdomi-

nal aortic aneurysm and the risk of spinal cord ischaemia.

Journal of Vascular Surgery 2005;42(4):608–14. [MedLine: doi:

10.1016/j.jvs.2005.06.023].

Reichart 2003

Reichart M, Geelkerken RH, Huisman AB, van Det RJ, de Smit P,

Volker EP. Ruptured abdominal aortic aneurysm: endovascular repair

is feasible in 40% of patients. European Journal of Vascular & Endovas-

cular Surgery 2003;26(5):479–86. [MedLine: doi: 10.1016/S1078-

5884(03)00346-0].

Resch 2003

Resch T, Malina M, Lindblad B, Dias NV, Sonesson B, Ivancev K.

Endovascular repair of ruptured abdominal aortic aneurysms: logis-

tics and short-term results. Journal of Endovascular Therapy 2003;10

(3):440–6. [MedLine: doi:].

Rubin 2004

Rubin BG, Sanchez LA, Choi ET, Sicard GA. Endoluminal repair of

ruptured abdominal aortic aneurysms under local anaesthesia: initial

experience. Vascular & Endovascular Surgery 2004;38(3):203–7.

Scharrer-Pamler 2003

Scharrer-Pamler R, Kotsis T, Kapfer X, Gorich J, Sunder-Plassmann

L. Endovascular stent-graft repair of ruptured aortic aneurysms. Jour-

nal of Endovascular Therapy 2003;10(3):447–52.

Vaddineni 2005

Vaddineni SK, Russo GC, Patterson MA, Taylor SM, Jordan WD Jr.

Ruptured abdominal aortic aneurysm: a retrospective assessment of

open versus endovascular repair. Annals of Vascular Surgery 2005;19

(6):782–6. [MedLine: doi: 10.1007/s10016-005-7975-1].

van Herzeele 2003

van Herzeele I, Vermassen F, Durieux C, Randon C, De Roose

J. Endovascular repair of aortic rupture. European Journal of Vas-

cular & Endovascular Surgery 2003;26(3):311–6. [MedLine: doi:

10.1016/S1078-5884(03)00297-1].

van Sambeek 2002

van Sambeek MR, van Dijk LC, Hendriks JM, van Grotel M, Kuiper

JW, Pattynama PM, et al. Endovascular versus conventional open

repair of acute abdominal aortic aneurysm: feasibility and preliminary

results. Journal of Endovascular Therapy 2002;9(4):443–8.

Verhoeven 2002

Verhoeven EL, Prins TR, van den Dungen JJ, Tielliu IF, Hulsebos

RG, van Schilfgaarde R. Endovascular repair of acute AAAs under

local anaesthesia with bifurcated endografts: a feasibility study. Jour-

nal of Endovascular Therapy 2002;9(6):729–35.

8Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 12: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

Yilmaz 2002

Yilmaz N, Peppelenbosch N, Cuypers PW, Tielbeek AV, Duijm LE,

Buth J. Emergency treatment of symptomatic or ruptured abdominal

aortic aneurysms: the role of endovascular repair. Journal of Endovas-

cular Therapy 2002;9(4):449–57.

Additional references

Adam 1999

Adam DJ, Mohan IV, Stuart WP, Bain M, Bradbury AW. Commu-

nity and hospital outcome from ruptured abdominal aortic aneurysm

within the catchment area of a regional vascular surgical service. Jour-

nal of Vascular Surgery 1999;30(5):922–8.

Alsac 2005b

Alsac JM, Kobeiter H, Becquemin JP, Desgranges P. Endovascular

repair for ruptured AAA: a literature review. Acta Chirurgica Belgica

2005;105(2):134–9.

Ashton 2002

Ashton HA, Buxton MJ, Day NE, Kim LG, Marteau TM, Scott RA,

Thompson SG, Walker NM, Multicentre Aneurysm Screening Study

Group. The Multicentre Aneurysm Screening Study (MASS) into

the effect of abdominal aortic aneurysm screening on mortality in

men: a randomised controlled trial. Lancet 2002;360(9345):1531–9.

Bown 2003

Bown MJ, Nicholson ML, Bell PR, Sayers RD. The systemic inflam-

matory response syndrome, organ failure and mortality after abdom-

inal aortic aneurysm repair. Journal of Vascular Surgery 2003;37(3):

600–6.

Boyle 2005

Boyle JR, Gibbs PJ, Kruger A, Shearman CP, Raptis S, Phillips MJ.

Existing delays following the presentation of ruptured abdominal

aortic aneurysm allow sufficient time to assess patients for endovascu-

lar repair. European Journal of Vascular & Endovascular Surgery 2005;

29(5):505–9.

Corso 2005

Corso JE, Kasirajan K, Milner R. Endovascular Management of rup-

tured, mycotic abdominal aortic aneurysm. American Surgeon 2005;

71(6):515–7.

Cuypers 2001

Cuypers PWM, Gardien M, Buth J, Peels CH, Charbon JA, Hop

WC. Randomized study comparing cardiac response in endovascular

and open aortic aneurysm repair. British Journal of Surgery 2001;88

(8):1059–65.

EVAR 2004

Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG.

EVAR trial participants. Comparison of Endovascular aneurysm re-

pair with open repair in patients with abdominal aortic aneurysm

(EVAR trial 1), 30-day operative mortality results: randomised con-

trolled trial. Lancet 2004;364(9437):843–8.

EVAR 2005

EVAR trial participants. Endovascular aneurysm repair versus open

repair in patients with abdominal aortic aneurysm (EVAR trial 1):

randomised controlled trial. Lancet 2005;365(9478):2179–86.

EVAR2 2005

EVAR trial participants. Endovascular aneurysm repair and outcome

in patients unfit for open repair of abdominal aortic aneurysm (EVAR

trial 2): randomised controlled trial. Lancet 2005;365(9478):2187–

92.

Gorham 2004

Gorham TJ, Taylor J, Raptis S. Endovascular treatment of abdominal

aortic aneurysm. British Journal of Surgery 2004;91(7):815–27.

Greenhalgh 1998

Greenhalgh RM, Forbes JF, Fowkes FG, Powell JT, Ruckley CV,

Brady AR, et al. Early elective open surgical repair of small abdom-

inal aortic aneurysms is not recommended: results of the UK Small

Aneurysm Trial. Steering Committee. European Journal of Vascular

& Endovascular Surgery 1998;16(6):462–4.

Harris 1991

Harris LM, Faggioli GL, Fiedler R, Curl GR, Ricotta JJ. Ruptured

abdominal aortic aneurysms: factors affecting mortality rates. Journal

of Vascular Surgery 1991;14(6):812–8.

Harris 2005

Harris P, Buth J, Eurostar, Beard J, RETA. What is the future for reg-

istries on endovascular aneurysm repair and who should be respon-

sible?. European Journal of Vascular & Endovascular Surgery 2005;30

(4):343-5 2005;30(4):343–5.

Hinchcliffe 2002

Hinchliffe RJ, Yung M, Hopkinson BR. Endovascular exclusion of

a ruptured pseudoaneurysm of the infrarenal abdominal aorta sec-

ondary to pancreatitis. Journal of Endovascular Therapy 2002;9(5):

590–2.

Hinchliffe 2003

Hinchliffe RJ, Braithwaite BD, Hopkinson BR. The endovascu-

lar management of ruptured abdominal aortic aneurysms. European

Journal of Vascular & Endovascular Surgery 2003;25(3):191–201.

Hinterseher 2004

Hinterseher I, Saeger HD, Koch R, Bloomenthal A, Ockert D, Berg-

ert H. Quality of life and long-term results after ruptured abdominal

aortic aneurysm. European Journal Vascular & Endovascular Surgery

2004;28(3):262–9.

Huber 1995

Huber TS, Harward TR, Flynn TC, Albright JL, Seeger JM. Oper-

ative mortality rates after elective infrarenal aortic reconstructions.

Journal of Vascular Surgery 1995;22(3):287–93.

Korhonen 2004

Korhonen SJ, Ylonen K, Biancari F, Heikkinen M, Salenius J-P, Lep-

antalo M. Finnvasc Study Group. Glasgow Aneurysm Score as a pre-

dictor of immediate outcome after surgery for ruptured abdominal

aortic aneurysm. British Journal of Surgery 2004;91(11):1449–52.

Kumar 2002

Kumar V, Campbell JH, Andy OJ, Hatten LE. Emergent repair of

a ruptured abdominal aortic aneurysm using an AneuRx stent-graft.

Journal of Endovascular Therapy 2002;9(2):194–7.

Lederle 1997

Lederle FA, Johnson GR, Wilson SE, Chute EP, Littooy FN, Bandyk

D, et al. Prevalence and associations of abdominal aortic aneurysm

detected through screening. Aneurysm Detection and Management

(ADAM) Veterans Affairs Cooperative Study Group. Annals of Inter-

nal Medicine 1997;126(6):441–9.

9Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 13: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

Lindsay 1999

Lindsay TF, Luo XP, Lehotay DC, Rubin BB, Anderson M, Walker

PM, et al. Ruptured abdominal aortic aneurysm, a “two-hit” is-

chaemia/reperfusion injury: evidence from an analysis of oxidative

products. Journal of Vascular Surgery 1999;30(2):219–28.

Lloyd 2004

Lloyd GM, Bown MJ, Norwood MG, Deb R, Fishwick G, Bell PR,

et al. Feasibilty of preoperative computer tomography in patients

with ruptured abdominal aortic aneurysms: a time-to-death study in

patients without operation. Journal of Vascular Surgery 2004 2004

2004;39(4):788–91.

Morales 2005

Morales JP, Irani FG, Jones KG, Taylor PR, Dourado R, Sabharwal T.

Endovascular repair of a ruptured abdominal aortic aneurysm under

local anaesthesia. British Journal of Radiology 2005;78(925):62–4.

Neary 2003

Neary WD, Crow P, Foy C, Prytherch D, Heather BP, Earnshaw JJ.

Comparison of POSSUM scoring and the Hardman Index in selec-

tion of patients for repair of ruptured abdominal aortic aneurysm.

British Journal of Surgery 2003;90(4):421–5.

Norman 2004

Norman PE, Jamrozik K, Lawrence-Brown MM, Le MT, Spencer

CA, Tuohy RJ, et al. Population based randomised controlled trial on

impact of screening on mortality from abdominal aortic aneurysm.

BMJ 2004;329(7477):1259.

Parodi 1991

Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft

implantation for abdominal aortic aneurysms. Annals of Vascular

Surgery 1991;5(6):491–9.

Powell 2003

Powell JT. Familial clustering of abdominal aortic aneurysm-- smoke

signals, but no culprit genes. British Journal of Surgery 2003;90(10):

1173–4.

Prinssen 2004

Prinssen M, Verhoeven ELG, Buth J, Cuypers PW, van Sambeek MR,

Balm R, Buskens E, et al. A randomized controlled trial comparing

comparing conventional and endovascular repair of abdominal aortic

aneurysms. New England Journal of Medicine 2004;351(16):1607–

18.

Roumen 1993

Roumen RM, Hendriks T, van der Ven-Jongekrijg J, Nieuwenhuijzen

GA, Sauerwein RW, van der Meer JW, et al. Cytokine patterns in

patients after major vascular surgery, haemorrhagic shock and severe

blunt trauma. Relation with subsequent adult respiratory distress

syndrome and multiple organ failure. Annals of Surgery 1993;218(6):

769–76.

Scott 1991

Scott RA, Ashton, HA, Kay DN. Abdominal aortic aneurysm in

4237 screened patients: prevalence, development and management

over 6 years. British Journal of Surgery 1991;78(9):1122–5.

Scott 1995

Scott RA, Wilson NM, Ashton HA, Kay DN. Influence of screen-

ing on the incidence of ruptured abdominal aortic aneurysm: 5-year

results of a randomized controlled study. British Journal of Surgery

1995;82(8):1066–70.

Seelig 2000

Seelig MH, Berchtold C, Jakob P, Schonleben K. Contained rupture

of an infrarenal abdominal aortic aneurysm treated by endoluminal

repair. European Journal of Vascular & Endovascular Surgery 2000;19

(2):202–4.

Tambyraja 2004

Tambyraja AL, Fraser SC, Murie JA, Chalmers RT. Quality of life

after repair of ruptured abdominal aortic aneurysm. European Journal

of Vascular & Endovascular Surgery 2004;28(3):229–33.

Thomas 2005

Thomas SM, Beard JD, Ireland M, Ayers S. Vascular Society of Great

Britain and Ireland, British Society of Interventional Radiology. Re-

sults from the propsective registry of endovascular treatment of ab-

dominal aortic aneuryms (RETA): mid-term results to five years. Eu-

ropean Journal of Vascular & Endovascular Surgery 2005;29(6):563–

70.

van Vlijmen 2002

van-Vlijmen-van Keulen CJ, Pals G, Rauwerda JA. Familial abdomi-

nal aortic aneurysm: a systematic review of a genetic background. Eu-

ropean Journal of Vascular & Endovascular Surgery 2002;24(2):105–

16.

Veith 2003

Veith FJ, Ohki T, Lipsitz EC, Suggs WD, Cynamon J. Treatment of

ruptured abdominal aortic aneurysms with stent grafts: a new gold

standard?. Seminars in Vascular Surgery 2003;16(2):171–5.

Verhagen 2003

Verhagen HJ, Prinssen M, Milner R, Blankensteijn JD. Endoleak

after endovascular repair of ruptured abdominal aortic aneurysm: is

it a problem?. Journal of Endovascular Therapy 2003;10(4):766–71.

Wilmink 1999

Wilmink TB, Quick CR, Day NE. The association between cigarette

smoking and abdominal aortic aneurysms. Journal of Vascular Surgery

1999;30(6):1099–105.

Wilson 2004

Wilson WR, Fishwick G, Bell SP, Thompson MM. Suitability of

ruptured AAA for endovascular repair. Journal of Endovascular Ther-

apy 2004;11(6):635–40.

Yusuf 1994

Yusuf SW, Whitaker SC, Chuter TA, Wenham PW, Hopkinson BR.

Emergency endovascular repair of leaking aortic aneurysm (letter).

Lancet 1994; Vol. 344, issue 8937:1645.

10Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 14: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

T A B L E S

Characteristics of excluded studies

Study Reason for exclusion

Alsac 2005 Case series of consecutive patients with RAAA 2001-2004.

17/34 eEVAR compared to 20/34 OPEN.

Brandt 2005 Retrospective review of consecutive patients with RAAA 2001-2004. Patients 01/02 group (OPEN only) were

used as historical controls compared to 03/04 group (OPEN and eEVAR).

Castelli 2005 Retrospective review of patients treated with eEVAR for RAAA 2001-2004. 46 eEVAR.

Doss 2002 Retrospective review of endovascular stenting of ruptured thoracic or abdominal aortic aneurysms 1996-1998.

6/9 abdominal eEVAR.

Franks 2006 Retrospective study of eEVAR compared to historical OPEN repair controls in symptomatic and ruptured

AAA. 21 eEVAR, 23 OPEN.

Gerassimidis 2005 Retrospective review of 40 consecutive patients with RAAA 1998-2004. 23/40 underwent eEVAR.

Greco 2006 Retrospective data collection from discharge summaries in 4 USA states comparing outcomes between eEVAR

and OPEN repair of RAAA.

Greenberg 2000 Case reports of 3 patients treated with eEVAR for RAAA

Hechelhammer 2005 Retrospective Review of 37 patients with RAAA treated with eEVAR

Hinchliffe 2001 Prospective study of RAAA patients 1994-2000. 20 patients underwent eEVAR. No controls.

Kapma 2005 Retrospective review of 262 patients with RAAA 1998- 2004. 40 underwent eEVAR. Subgroup analysis of

2003-2004 cohort to evaluate applicability and suitability.

Lachat 2002 Prospective study of 21 consecutive patients who underwent eEVAR for ruptured aorto-iliac aneurysms. No

controls.

Lagana 2006 Retrospective review of 30 patients who underwent eEVAR 01-04. No controls.

Larzon 2005 Retrospective review of 50 consecutive patients with RAAA 2001-2004. 15/50 eEVAR, 26/50 OPEN , 9/50

Not operated on.

Lee 2004 Retrospective review of records of 36 consecutive patients with RAAA 1997-2004. 19/36 OPEN treated 1997-

2001 compared to 4/36 OPEN and 13/36 eEVAR treated 2001-2004

Lombardi 2004 Case Series of 5 patients with RAAA treated with eEVAR who were deemed unfit for conventional open surgical

repair.

Mehta 2005 Retrospective Review of 30 eEVAR patients 2002-2004 to evaluate risk factors for Abdominal Compartment

Syndrome

Ohki 2000 Retrospective Review of RAAA 25 patients 1994-2000. 20 underwent eEVAR.

Okhi 1999 Case Series of 12 consecutive patients with ruptured aortoiliac aneurysms treated with customized stent grafts

Orend 2002 Retrospective review of endovascular treatment of thoracic and abdominal aortic rupture due to aneurysm and

trauma

Peppelenbosch 2003 Prospective study of 40 consecutive patients with symptomatic or RAAA in whom eEVAR was the preferential

management compared with 28 historical controls who underwent OPEN repair for symptomatic or RAAA.

Peppelenbosch 2005 Retrospective multicentre study of 35 patients treated with eEVAR for RAAA 2001-2004 to evaluate the risk

of spinal cord ischaemia.

Reichart 2003 Prospective study of consecutive patients with symptomatic of ruptured AAA. 6/26 underwent eEVAR

11Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 15: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

Resch 2003 Prospective study of 21 patients with RAAA undergoing eEVAR (1997-2002). Retrospective analysis to evaluate

why 23 patients underwent OPEN repair compared to 14 contemparaneous patients who underwent eEVAR

for RAA (2001-2002).

Rubin 2004 Case Review of 5 patients undergoing eEVAR

Scharrer-Pamler 2003 Prospective study of eEVAR in 24 patients with RAAA.

Vaddineni 2005 Retrospective review of 24 consecutive patients with RAAA 1999-2004. 9/24 eEVAR compared to 15/24

OPEN

Verhoeven 2002 Prospective Study of 47 patients with acute AAA (RAAA and Symptomatic). 16 underwent eEVAR compared

to OPEN surgical cohort.

Yilmaz 2002 Retrospective review of 24 patients with ruptured or symptomatic AAA treated with eEVAR 1999-2001. No

controls.

van Herzeele 2003 Retrospective non randomised study evaluating use of eEVAR in thoracic and abdominal aortic rupture. 9

RAAA included. No controls

van Sambeek 2002 Retropsective review of eEVAR compared to OPEN repair of RAAA in 22 consecutive patients with RAAA

(January - July 2001). 6/22 eEVAR

A D D I T I O N A L T A B L E S

Table 01. Search strategy used to search CENTRAL

Search terms

#1 MeSH descriptor Aortic Aneurysm, Abdominal explode all trees

#2 abdominal next aortic next aneurysm* in All Text

#3 aortic next aneurysm* in All Text

#4 (abdominal in All Text near/6 aortic in All Text near/6 aneurysm* in All Text)

#5 (abdominal in All Text near/6 aneurysm* in All Text)

#6 MeSH descriptor AORTIC ANEURYSM explode trees 1 and 2

#7 MeSH descriptor AORTIC RUPTURE explode trees 1, 2, 3 and 4

#8 (aortic next aneurysm in All Text near/6 rupture* in All Text)

#9 traumatic next aortic next rupture* in All Text

#10 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9)

#11 endovascular next repair in All Text

#12 endovascular next aneurysm next repair in All Text

#13endovascular next aneurysm next treatment in All Text

#14endovascular next treatment in All Text

#15(#11 or #12 or #13 or #14)

#16(#10 and #15)

Table 02. Mortality

Study EVRAR group OPEN group p value (if quoted)

Alsac 2005 4/17 (23.5%) 10/20 (50%) 0.09

Brandt 2005 0/11 (0%) 2/13 (15%) NS

Franks 2006 11% 54% 0.02

Greco 2005 114/290 (39.3%) 2627/5508 (47.7%) 0.05

12Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 16: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

Table 02. Mortality (Continued )

Study EVRAR group OPEN group p value (if quoted)

Kapma 2005 5/40 (13%) 64/213 (30%) 0.02

Larzon 2005 2/5 (13%) 12/26 (46%) >0.05

Ohki 2000 2/20 (10%) 0/5 (0%)

Peppelenbosch 2003 4/26 (15%) 4/14 (28%)

Peppelenbosch 2005 8/35 (23%) 19/66 (29%)

Reichart 2003 1/6 (16.6%) 4/13 (30%)

Resch 2003 4/14 (29%) 8/23 (35%)

Vaddenini 2005 2/9 (22%) 4/15 (26%)

Verhoeven 2002 1/16 (6%) 7/31 (23%)

Yilmaz 2002 4/24 (17%) 13/40 (32%)

Table 03. Length of ICU stay

Study EVRAR group OPEN group p value (if quoted)

Alsac 2005 3 13 <0.01

Brandt 2005 4.8 8.5 NS

Franks 2006 1.3 6.1 0.01

Kapma 2005 median 0 hours 48 hours <0.001

Peppelenbosch 2003 median 46 hours 154 hours

Reichart 2003 2.25 days 13 days

Resch 2003 median 1 day 3 days 0.02

Vaddenini 2005 median 5 days 20 days

van Sambeek 2002 median 8 hours 62 hours 0.004

Yilmaz 2002 mean 2.2 days 5.2 days <0.05

Table 04. Length of Procedure

Study EVRAR group OPEN group p value (if quoted)

Alsac 2005 156 min 2222 min <0.1

Brandt 2005 178 min 207 min NS

Franks 2006 156 min 186 min 0.04

Kapma 2005 median 110 min 180 min <0.001

Ohki 2000 median 336 min 492 min

13Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 17: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

Table 04. Length of Procedure (Continued )

Study EVRAR group OPEN group p value (if quoted)

Peppelenbosch 2003 mean 154 min 155 min

Vaddenini 2005 mean 143 min 181 min

Verhoeven 2002 mean 110 min 122.5 min

van Sambeek 2002 mean 193 min mean 203 min NS

Yilmaz 2002 mean 173 min 273 min p<0.05

Table 05. Blood loss

Study EVRAR group OPEN group p value (if quoted)

Kapma 2005 median 200ml 3500ml <0.001

Ohki 2000 median 400ml 2000 ml

Peppelenbosch 2003 1100ml 2600ml

Reichart 2003 mean 300ml 4500ml

Resch 2003 800ml 4000ml 0.0001

Vaddenini 2005 475ml 2880ml 0.0001

van Sambeek 2002 median 125ml 3400ml 0.01

Yilmaz 2002 660ml 3550ml <0.05

Table 06. Transfusion requirements

Study EVRAR group OPEN group p value ( if quoted)

Alsac 2005 1520ml 3075ml <0.1

Brandt 2005 964ml 1986ml 0.02

Franks 2006 0.86units 10.7units <0.01

Kapma 2005 median 0 units 6 units <0.001

Ohki 2000 median 3 units 6 units

Reichart 2003 0 1600ml

Resch 2003 2 units 9 units 0.02

Vaddenini 2005 3.78 units 6.93 units 0.014

G R A P H S A N D O T H E R T A B L E S

This review has no analyses.

C O V E R S H E E T

Title Endovascular treatment for ruptured abdominal aortic aneurysm

14Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Page 18: Endovascular treatment for ruptured abdominal aortic ......Endovascular treatment for ruptured abdominal aortic aneurysm (Review) Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin

Authors Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin DW

Contribution of author(s) Marianne Dillon and Denis W Harkin performed the literature searches, identified all

possible trials, considered them for inclusion and assessed trial quality.

Paul Blair, Peter Ellis, Chris Cardwell and Frank Kee acted as arbitrators where disagreements

over inclusion and quality of studies occurred during the review process.

Issue protocol first published 2005/2

Review first published 2007/1

Date of most recent amendment 14 November 2006

Date of most recent

SUBSTANTIVE amendment

01 November 2006

What’s New Information not supplied by author

Date new studies sought but

none found

30 October 2006

Date new studies found but not

yet included/excluded

Information not supplied by author

Date new studies found and

included/excluded

11 November 2005

Date authors’ conclusions

section amended

Information not supplied by author

Contact address Dr Marianne Dillon

Vascular Surgery Unit

Royal Victoria Hospital

Grosvenor Road

Belfast

Northern Ireland

UK

E-mail: [email protected]

Tel: +44 028 90240503

DOI 10.1002/14651858.CD005261.pub2

Cochrane Library number CD005261

Editorial group Cochrane Peripheral Vascular Diseases Group

Editorial group code HM-PVD

15Endovascular treatment for ruptured abdominal aortic aneurysm (Review)

Copyright © 2007 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd