DepartmenUniversity, Wu

CorrespondSurgery, RenmWuhan, Hubewangzhiwp@y

Ann Vasc SurDOI: 10.1016/� Annals of VPublished onli

454

Endovascular Stent-Graft Placement or OpenSurgery for the Treatment of Acute Type BAortic Dissection: A Meta-Analysis

Zhang Hao, Wang Zhi-Wei, Zhou Zhen, Hu Xiao-Ping, Wu Hong-Bing, and Guo Yi, Wuhan,

People’s Republic of China

Background: Acute type B aortic dissection (ATBAD) is a life-threatening condition. Openchest surgical repair using a prosthetic graft has been a conventional treatment for ATBAD.During the past decade, thoracic endovascular aortic repair (TEVAR), which is consideredas a less invasive and potentially safer technique, has been increasingly used to treat thiscondition. Evidence is needed to support the use of TEVAR for these patients. The aim ofthis review was to assess the efficacy of TEVAR versus conventional open surgery in patientswith ATBAD.Methods: For this review, we searched the Cochrane Central Register of Controlled Trials(CENTRAL) in The Cochrane Library (last searched: 2010, issue 4), MEDLINE, EMBASE,CINAHL, Web of Science, and the Chinese Biomedicine Database for clinical trials until January18, 2011. Controlled trials in which patients with ATBAD were assigned to TEVAR or opensurgical repair were included. For each outcome, we evaluated the quality of the evidencewith reference to the Grading of Recommendations Assessments, Development, and Evaluationcriteria. At the end, we used RevMan 5.0 software to analyze the datum.Results: Five trials (318 participants) are included in this review. As determined by the Gradingof Recommendations Assessments, Development, and Evaluation approach, the result qualitywas low for 30-day mortality and very low for other variables. TEVAR can significantly reducethe short-term mortality for ATBAD (ManteleHaenszel fixed odds ratio [95% confidenceinterval]: 0.19 [0.09e0.39], P < 0.001). TEVAR cannot significantly improve postoperativecomplications or long-term mortality.Conclusions: TEVAR can be weakly recommended as an alternative for the selective treat-ment of ATBAD but cannot always be used in case of surgery.

INTRODUCTION

Acute type B aortic dissection (ATBAD) was defined

as any nontraumatic dissection that involves the

descending thoracic aorta, with the tear site distal

to the left subclavian artery, and with delay from

t of Cardiothoracic Surgery, Renmin Hospital of Wuhanhan, People’s Republic of China.

ence to:WangZhi-Wei,MD,Department of Cardiothoracicin Hospital of Wuhan University, 99 Ziyang Road,i Province 430060, People’s Republic of China; E-mail:ahoo.cn

g 2012; 26: 454–461j.avsg.2011.09.004ascular Surgery Inc.ne: January 30, 2012

onset of symptoms to presentation shorter than 14

days.1 The optimal treatment strategy for patients

with ATBAD remains controversial.2 Open surgical

(OS) repair using prosthetic graft interposition is

the conventional treatment for ATBAD. Despite

remarkably improved operative techniques, surgical

resection of the descending thoracic aorta is still

associated with high morbidity and mortality.3 In

1999, the concept of endovascular stentegraft

closure of the proximal laceration was introduced

as a novel treatment option for patients with type

B aortic dissection (TBAD).4,5 Thoracic endovascu-

lar aortic repair (TEVAR), through a minimally

invasive incision, closes the laceration, resulting in

thrombosis of the false lumen, thereby providing

an attractive and less invasive alternative to surgical

Vol. 26, No. 4, May 2012 Endovascular stent or open surgery for ATBAD 455

repair.6 There are several studies about TEVAR for

ATBAD,7e9 although the samples are small.

According to the National Guidelines for aortic

aneurysm and dissection published by the U.S.

Department of Health and Human Services,10 the

immediate treatment of a dissectionof thedescending

aorta is conservative (i.e., reduction of blood pressure

andheart rate).With the improvement of endovascu-

lar stent andOS technology, themajority of surgeons

prefer positive treatment rather than medication.

Ideally, new and emerging treatment strategies

should undergo robust evaluation before their adop-

tion into routine clinical practice. However, no

randomized controlled trial (RCT) of TEVAR versus

OS for ATBAD has been reported to date. Although

there are several systematic reviews and meta-

analyses of aortic dissection (AD), ATBAD is seldom

referred.11e13 We, therefore, present a review of

non-RCTs that compared TEVAR with OS to prove

whether TEVAR improves short-term and long-

term outcomes for patients with ATBAD.

METHODS

Criteria for Considering Studies for ThisReview

Controlled trials that evaluate TEVAR compared

with conventional OS for patients with ATBAD

were included. All patients in whom a thoracic AD

was diagnosed by computed tomography, magnetic

resonance angiography, or conventional angiog-

raphy within 14 days from the onset of symptoms

were included. Patients who presented with trau-

matic dissection of the aorta, type A AD, or chronic

TBAD were excluded from the present review. All

types of endovascular stent were considered for

comparison with conventional OS.

End points evaluated in the study included

30-day or in-hospital mortality rates, short-term

complications (paraplegia, acute renal failure,

stroke, myocardial infarction, respiratory failure,

bowel ischemia, and lower-limb ischemia), reinter-

vention rates, and long-term mortality rates.

Search Methods for Identification ofStudies

For this review, we searched the Cochrane Central

Register of Controlled Trials (CENTRAL) in The

Cochrane Library (last searched: 2010, issue 4),MED-

LINE, EMBASE, CINAHL, Web of Science, and

Chinese Biomedicine Database for studies until

January18,2011.Clinical trials andadditional sources

for published and unpublished trials were searched

using the followingkeywords:aort*, thorac*,dissecti*,

surger*, surgical*, endovasc*, repair*, or endogra*.

The reference lists of all relevant studies found were

screened. Authors of relevant papers and stent device

manufacturerswerecontacted to identify furtherpub-

lished and unpublished studies. We also hand

searched relevant surgical and radiology journals.

Data Collection and Analysis

Two authors (Z.H. and W.Z.) assessed all trials iden-

tified from the described literature search. Disagree-

ments were resolved through discussion. The

controlled trials comparing TEVAR with conven-

tional OS for patients with ATBAD were identified.

The two authors independently extracted the

following information using a specifically designed

data collection form for each included trial: first

author and year of publication, study population,

interventions (TEVAR or conventional OS repair)

used, and outcomes (short-term mortality, short-

term complications, long-term complications, and

long-term mortality rates). Data were extracted on

the relevant methodological domains to minimize

bias in the analysis of trials by using the Cochrane

methods for assessing risk of bias14 and Grading

of Recommendations Assessments, Development,

and Evaluation (GRADE) methods.15e17 We used

GRADE profile software to assess the quality of

evidence with regard to inconsistency (heteroge-

neity), indirectness, imprecision, andother potential

sources of bias, such as publication and reporting

bias. We used Review Manager (RevMan) Version

5.1 (The Nordic Cochrane Centre, Copenhagen,

Denmark). To analyze the outcome (mortality and

complications). Resultswere expressed as odds ratios

(OR) with 95% confidence intervals (CI) for dichot-

omous variables. Statistical heterogeneity was

measured using the Q statistic (P< 0.10 was consid-

ered indicative of statistically significant heteroge-

neity) and I2 test.18 A fixed effects model was used

when no heterogeneity existed among studies.

Otherwise, the random effects model was used.

Visual inspection of asymmetry in funnel plots was

conducted to estimate the potential publication bias.

RESULTS

Description of Studies

The search string was used for MEDLINE, result-

ing in 318 articles. A similar search string was

used for EMBASE, which resulted in 656 articles.

The Cochrane library CENTRAL database was

browsed manually and did not reveal any relevant

Diabetes

(%)

Aneurysm

4(6.2)

NS

6(10.9)

NS

5)

9(19.6)

35(75.0)

0)

1(20.0)

5(100)

6)

1(7.7)

NS

6)

2(18.2)

NS

8(18)

3(7)

1(5)

2(10)

3(11)

3(11)

1(4)

4(17)

456 Hao et al. Annals of Vascular Surgery

articles. No results were obtained by searching

other resources. All titles and abstracts were read

by two independent investigators. At the end,

five relevant articles were identified and included

in our final selection, these articles are by Fattori

et al.,19 Garbade et al.,20 Mastroroberto et al.,21

Tsai et al.,22 and Zeeshan et al.23 The characteris-

tics of patients in the five studies are summarized

in Table I.

COPD

n(%

)

NS

NS

9(19.

1(20.

8(61.

7(63.

7(16)

3(15)

NS

NS

Assessment of the Quality of Evidence

Marfan

syndromen(%

)Hypertension

n(%

)CAD

)3(4.6)

54(81.8)

NS

)6(10.5)

41(70.7)

NS

)NS

40(87.0)

NS

)NS

5(100)

NS

)NS

10(76.9)

1(7.7)

)NS

9(81.8)

1(9.1)

NS

39(87)

5(11)

NS

11(55)

3(15)

1(4)

22(82)

NS

3(12)

13(50)

NS

d.

Table II describes in detail the principal findings of

this review and the quality of the evidence for each

outcome using the GRADE approach. It can be

seen that only the quality of outcome was low

for 30-day mortality, whereas the quality of the

other parameters examined was very low. Obser-

vational studies without special strengths or impor-

tant limitations constitute low-quality evidence.

The five studies were limited by lack of allocation

concealment and blinding, and the sample sizes

of studies were small. The outcomes of different

studies were not consistent. GRADE criteria were

then applied to downgrade the quality of evidence,

when indicated, on an outcome-specific basis;

therefore, the recommendation for this approach

is weak.

nder

le(%

)

(71.2

(78.0

(69.6

(60.0

(53.8

(72.7

(71)

(80)

(66)

(85)

tstate

Effects of Interventions

Table

I.Characteristicsofthepatients

ofthefivestudies

Reference

Intervention

Number

Age

Mean±SD,yr

Ge

Ma

Fattorietal.,2008

Endovascular

66

58.8

±11.1

47

Surgery

59

61.9

±14.7

46

Garbadeetal.,2010

Endovascular

46

65±25

32

Surgery

560±12.5

3

Mastrorobertoetal.,

2010

Endovascular

13

74.3

±8.4

7

Surgery

11

70.2

±7.8

8

Zeeshanetal.,2010

Endovascular

45

59.1

±13.2

32

Surgery

20

56.0

±18.8

16

Tsaietal.,2006

Endovascular

27

60.2

±10.5

18

Surgery

26

55.3

±13.8

22

CAD,coronary

artery

disease;COPD,ch

ronic

obstructivepulm

onary

disease;NS,no

Short-term Mortality Rates. Thirty-day mortality.

Information regarding 30-daymortalitywas provided

by 4 studies, totaling 265 patients (170 TEVAR, 95

OS). There was no evidence of heterogeneity (c2 ¼3.98, df ¼ 3 [P ¼ 0.26]; I2 ¼ 25%). There were 18

deaths in the TEVAR group and 33 deaths in the OS

group. Endovascular stenting showed significantly

lowered 30-day mortality than in the OS group (OR

for death: 0.19; 95% CI: 0.09e0.39; P < 0.001,

Fig. 1). The funnel plot shows that the publication

bias was not significant (Fig. 2).

Short-term Complications. Paraplegia. Thirteen pa-

tients in the TEVAR group and eight in the OS group

were paralyzed after treatment. There was no

evidence of heterogeneity (c2 ¼ 2.65, df ¼ 3 [P ¼0.45]; I2 ¼ 0%). However, there was no significant

differencebetweenthe twogroups (ManteleHaenszel[M-H] fixed OR [95%CI]: 1.16 [0.46e2.93]) (Fig. 3).The funnel plot shows that the publication bias was

not significant (Fig. 4).

Acute renal failure. Acute renal failure during post-

operative periods was reported in all five studies.

While the heterogeneity was not significant, the

Table II. GRADE assessment of short-term mortality and complications and long-term mortality and complications

Qualityassessment

Summary of findings

Importance

Number of patients Effect

QualityNumber ofstudies Design Limitations Inconsistency Indirectness Imprecision

Otherconsiderations

Endovascularstent

Opensurgery

Relative(95% CI) Absolute

30-d mortality

4 Observational

studies

Seriousa No serious

inconsistency

No serious

indirectness

Seriousb Strong associationc

increased effect

for RR w1d

18/170

(10.6%)

33/95

(34.7%)

RR: 0.26

(0.14e0.48)

257 fewer per 1,000 (from

181 fewer to 299 fewer)

Low Critical

35.1% 260 fewer per 1,000 (from

183 fewer to 302 fewer)

Paraplegia

4 Observational

studies

Seriousa No serious

inconsistency

No serious

indirectness

Seriousb None 13/151

(8.6%)

8/116

(6.9%)

OR: 1.16

(0.46e2.93)

10 more per 1,000 (from

36 fewer to 109 more)

Very low Critical

7.5% 11 more per 1,000 (from

39 fewer to 117 more)

Acute renal failure

5 Observational

studies

Seriousa No serious

inconsistency

No serious

indirectness

Seriousb Strong

association

40/197

(20.3%)

21/121

(17.4%)

OR: 0.85

(0.45e1.61)

22 fewer per 1,000 (from

87 fewer to 79 more)

Very low Critical

20% 25 fewer per 1,000 (from

99 fewer to 87 more)

Long-term mortality

3 Observational

studies

Seriousa Seriouse No serious

indirectness

Seriousb Strong

association

47/86

(54.7%)

24/42

(57.1%)

OR: 1.4

(0.24e8.18)

80 more per 1,000 (from

329 fewer to 345 more)

Very low Critical

61.5% 76 more per 1,000 (from

338 fewer to 314 more)

Reintervention

3 Observational

studies

Seriousa Seriouse No serious

indirectness

Seriousb Strong association

increased effect

for RR w1d

18/104

(17.3%)

1/36

(2.8%)

OR: 3.48

(0.78e15.55)

63 more per 1,000 (from 6

fewer to 280 more)

Very low Important

0% 0 more per 1,000 (from

0 fewer to 0 more)

aThe studies were limited by lack of allocation concealment and blinding.bThe number of patients is small.cThe endovascular treatment significantly decreased the 30-d mortality.dThe old patients with high risks were treated with endovascular stent.eThe outcomes of different studies were not consistent.

Vol.26,No.4,May2012

Endova

scularsten

tor

open

surgery

forATBAD

457

Fig. 2. Funnel plot of comparison: 30-day mortality.

Fig. 1. Comparison of thoracic endovascular aortic repair (TEVAR) versus open surgery (OR) with regard to 30-day

mortality.

458 Hao et al. Annals of Vascular Surgery

investigators found no significant difference

between the TEVAR group and the OS group

(M-H fixed OR [95% CI]: 0.85 [0.45e1.61])

(Fig. 5). The publication bias was significant

(Fig. 6).

Stroke. Stroke was reported in five TEVAR and five

OS patients by three studies. There was no signifi-

cant heterogeneity (c2 ¼ 1.69, df ¼ 2 [P ¼ 0.43];

I2 ¼ 0%). The risk of stroke was not significantly

reduced by endovascular stenting (M-H fixed OR

[95% CI]: 0.68 [0.20e2.29]) (Fig. 7).

Myocardial infarction. Myocardial infarction inci-

dence did not differ significantly between the

TEVAR group and the OS group (OR [95% CI]:

0.73 [0.14e3.69]), and the heterogeneity of the

three studies was not significant (c2 ¼ 0.19, df ¼ 2

[P ¼ 0.91]; I2 ¼ 0%).

Respiratory failure. Two studies reported respiratory

failure. TEVAR did not significantly reduce the

odds of respiratory failure (OR [95% CI]: 1.36

[0.38e4.86]).

Bowel ischemia. In this study, 12 TEVAR and 7 OS

patients were diagnosed with bowel ischemia. The

investigators did not find any significant difference

between the two groups (OR [95% CI]: 1.39

[0.51e3.76]).

Lower-limb ischemia. Lower-limb ischemia was

reported by two studies. The difference in odds

was not significant between the two groups (OR

[95% CI]: 1.41 [0.50e3.95]).

Long-term Mortality Rates and Long-term Compli-

cation. Long-term mortality rates. Garbade et al.,

Mastroroberto et al., and Tsai et al. reported on

long-term mortality. The heterogeneity was signifi-

cant (c2¼ 6.24, df¼ 2 [P¼ 0.04]; I2¼ 68%), possibly

owing to the varying length of follow-up. The inves-

tigators found no significant difference between the

TEVAR group and the OS group (M-H random OR:

1.40; 95% CI: 0.24e8.18) (Fig. 8).

Reintervention. Reinterventions were performed on

18 stent patients and 1 OS patient. The heterogeneity

of three correlative studies was not significant. There

were no significant difference between the TEVAR

group and the OS group (M-H fixed OR [95% CI]:

3.48 [0.78e15.55]), although there was a tendency

toward fewer reinterventions in the OS group

(Fig. 9). The publication bias was significant (Fig. 10).

DISCUSSION

This review is based on the results of the five trials

that were suitable for inclusion. The results are rele-

vant to current clinical practice throughout the

world. It can be weakly recommended that TEVAR

can be an alternative to treat ATBAD, but it cannot

replace surgery in all situations.

There is a general consensus that patients

with an initially uncomplicated ATBAD should

receive medical therapy.24 Interventional therapy

is normally recommended for acute complicated

TBAD, as the expected mortality without therapy

may be as high as 50% to 85% in such patients.

Complicated TBAD was defined as the presence

of one or more of the following conditions: resis-

tant hypertension, despite adequate medical

Fig. 3. Comparison of TEVAR versus OS for paraplegia.

Fig. 4. Funnel plot of comparison: paraplegia.

Fig. 5. Comparison of TEVAR versus OS for acute renal failure.

Fig. 6. Funnel plot of comparison: acute renal failure.

Vol. 26, No. 4, May 2012 Endovascular stent or open surgery for ATBAD 459

therapy; recurrent or refractory pain; impending

rupture; rupture with end-organ malperfusion;

and extension of dissection. Because of high

morbidity and mortality associated with surgery

of the descending aorta, TEVAR has been proposed

for patients especially with high-risk and those

patients excluded from TEVAR were operated by

OS. Patients presenting with a landing zone of

<1.5 cm, with need to cover critical branch vessels,

severe calcification at the fixation site of the graft,

and significantly tortuous and inadequate access

vessels, were excluded from TEVAR. In fact, the

five articles included are all retrospective studies,

in which the indications are not very clear. This

happens to reflect the fact that there are controver-

sial understandings with respect to the treatment

of ATBAD.

We rated the methodological quality and risk of

bias in studies meeting predefined inclusion and

exclusion criteria using the GRADE approach. Since

2006, the British Medical Journal has requested

authors should preferably use the GRADE system

for grading evidence when submitting a clinical

guidelines article. The results show that the quality

of the evidence considered here was low or very

low, which may be because of the limitations of

the research design. Owing to the unusual nature

and high risk of the ATBAD, it is very difficult to

carry out allocation concealment and blinding treat-

ment, which are the basic requirements of the RCT,

in clinical practice. The choice of the patient may

greatly influence the prognosis of a treatment

program. It can be seen from the present results

that TEVAR represents an effective and less invasive

treatment for selected patients with ATBAD rather

than for all patients.

Fig. 7. Comparison of TEVAR versus OS for stroke.

Fig. 8. Comparison of TEVAR versus OS for long-term mortality.

Fig. 9. Comparison of TEVAR versus OS for reintervention.

Fig. 10. Funnel plot of comparison: reintervention.

460 Hao et al. Annals of Vascular Surgery

After the appearance of the endovascular stent,

there were many studies and reviews about treat-

ment for thoracic aortic disease, including AD and

aortic aneurysm. Nienaber et al.25 prospectively

evaluated the safety and efficacy of elective TEVAR

in 12 consecutive patients with descending (type

B) AD and compared the results with surgery in 12

matched controls. These preliminary observations

suggest that elective nonsurgical insertion of an

endovascular stentegraft is safe and efficacious in

selected patients. However, these studies selected

the subacute or chronic TBAD patients rather than

acute patients, groups with vastly different prog-

noses. Abraha et al.26 found endovascular repair of

thoracic aneurysms could be a good alternative,

technically, toOS repair. However, its benefit cannot

be established, as there is no published RCT. The

available information comes from nonrandomized

studies, which show benefit in terms of early

mortality and complications such as paraplegia.

Although such evidence may suggest that endovas-

cular repair can be appropriate in selected patients,

high-quality studies are needed to produce general-

izable conclusions. In summary, the comparison

between TEVAR and conventional OS in patients

with ATBAD is valuable for vascular surgeons.

CONCLUSIONS

Implications for Practice

The TEVAR can significantly reduce the short-term

mortality of ATBAD. However, the benefit of

reducing the postoperative complications and

long-term mortality could not be proven. Consid-

ering the low quality of the evidence, the TEVAR

can be weakly recommended as a good alternative

for the treatment of ATBAD, but it cannot replace

surgery in all situations.

Vol. 26, No. 4, May 2012 Endovascular stent or open surgery for ATBAD 461

Implications for Research

A high-quality prospective RCT of TEVAR versus OS

may provide powerful data to determine whether

the TEVAR is more efficient than OS.

The authors of the present study are indebted to the authors of the

primary studies.

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