early results of endovascular treatment of the thoracic aorta using the valiant endograft

CLINICAL INVESTIGATION

Early Results of Endovascular Treatment of the Thoracic AortaUsing the Valiant Endograft

Matt Thompson Æ Stella Ivaz Æ Nicholas Cheshire Æ Rosella Fattori ÆHerve Rousseau Æ Robin Heijmen Æ Jean-Paul Beregi Æ Frederic Thony ÆGillian Horne Æ Robert Morgan Æ Ian Loftus

Received: 3 April 2007 / Revised: 9 July 2007 / Accepted: 14 July 2007 / Published online: 21 August 2007

� Springer Science+Business Media, LLC 2007

Abstract Endovascular repair of the thoracic aorta has

been adopted as the first-line therapy for much pathology.

Initial results from the early-generation endografts have

highlighted the potential of this technique. Newer-genera-

tion endografts have now been introduced into clinical

practice and careful assessment of their performance

should be mandatory. This study describes the initial

experience with the Valiant endograft and makes compar-

isons with similar series documenting previous-generation

endografts. Data were retrospectively collected on 180

patients treated with the Valiant endograft at seven

European centers between March 2005 and October 2006.

The patient cohort consisted of 66 patients with thoracic

aneurysms, 22 with thoracoabdominal aneurysms, 19 with

an acute aortic syndrome, 52 with aneurysmal degeneration

of a chronic dissection, and 21 patients with traumatic

aortic transection. The overall 30-day mortality for the

series was 7.2%, with a stroke rate of 3.8% and a para-

plegia rate of 3.3%. Subgroup analysis demonstrated that

mortality differed significantly between different indica-

tions; thoracic aneurysms (6.1%), thoracoabdominal

aneurysms (27.3%), acute aortic syndrome (10.5%),

chronic dissections (1.9%), and acute transections (0%).

Adjunctive surgical procedures were required in 63

patients, and 51% of patients had grafts deployed proximal

to the left subclavian artery. Comparison with a series of

earlier-generation grafts demonstrated a significant

increase in complexity of procedure as assessed by graft

implantation site, number of grafts and patient comorbid-

ity. The data demonstrate acceptable results for a new-

generation endograft in series of patients with diverse

thoracic aortic pathology. Comparison of clinical outcomes

between different endografts poses considerable challenges

due to differing case complexity.

Keywords Aortic aneurysm � Endograft � Thoracic �Dissection � Transection

Introduction

Endovascular repair has rapidly become the first line

therapy for much thoracic aortic pathology with defined

indications for surgical repair. Comparison of endovascular

and conventional surgical techniques have shown a clear

mortality advantage to the endovascular technique with

M. Thompson (&) � S. Ivaz � G. Horne � R. Morgan � I. Loftus

St George’s Vascular Institute, 4th Floor St James Wing, St

George’s Hospital NHS Trust, Blackshaw Road,

London SW17 0QT, UK

e-mail: [email protected]

N. Cheshire

St Mary’s Regional Vascular Unit, London, UK

R. Fattori

Department of Cardiovascular Radiology, University Hospital,

Bologna, Italy

H. Rousseau

Department of Radiology, Centre Hospitalier Universitaire,

Toulouse, France

R. Heijmen

Department of Cardiothoracic Surgery, St Antonius Hospital,

Nieuwegein, The Netherlands

J.-P. Beregi

Department of Vascular Radiology, Hopital Cardiologique,

CHRU de Lille, Lille, France

F. Thony

Service de Radiologie Centre, Hospitalier Universitaire de

Grenoble, Grenoble, France

123

Cardiovasc Intervent Radiol (2007) 30:1130–1138

DOI 10.1007/s00270-007-9147-x

reference to treatment of thoracic aneurysms, transections,

and symptomatic Type B thoracic dissections [1–3]. The

encouraging results of early endovascular therapy have led

many investigators to speculate that the technique may

expand the indications for interventional treatment of the

thoracic aorta and several randomized trials are underway

to define specific indications for these techniques [4].

Despite the relative infancy of thoracic endograft design,

the technique has been extended to treat an increasing

number of challenging lesions [5] including those with

severe tortuosity, difficult proximal fixation zones, and

diseases of both the aortic arch [6] and the thoraco-

abdominal aorta [7]. Treatment of challenging lesions has

often revealed deficiencies with thoracic graft design that

were adapted from endografts intended to treat the abdom-

inal aorta and were not marketed to meet the challenges of

complex thoracic pathology. Common problems with early

thoracic endografts included difficulty with accurate

deployment, inability to conform to the aortic arch, insecure

proximal fixation, difficulties with graft passage through the

distal vasculature, and aortic trauma [8].

In response to these observations, graft design has

evolved and several new iterations of endografts have been

introduced into clinical practice. The assessment of the

performance of these new grafts is difficult due to the

changing indications for their use and a lack of large scale

clinical trials. Trials performed primarily for regulatory

purposes often utilize strict anatomical criteria for inclu-

sion which are not representative of day-to-day clinical

practice [9]. Similarly, the single-center literature relating

to endovascular thoracic procedures is sparse and series are

often too small to offer comment regarding device specific

outcomes. It would appear that collection of multicenter

registry data offers the best opportunity for evaluating new

endovascular grafts and techniques, as large numbers of

cases can be collected in relatively short periods of time.

The present study reports a retrospective, multicenter

European registry of initial clinical outcomes with the

Valiant endograft.

Methods

Data Collection

The cohort consisted of 180 patients with thoracic aortic

pathology who were treated with the Valiant endograft

between March 2005 and October 2006. Data were retro-

spectively collected from seven European centers that

contributed the following numbers of patients to the study:

St. George’s London, 48, St. Mary’s London, 30; Bologna,

27; Toulouse, 20; Niewegein, 20; Lille, 18; and Grenoble,

17. Data were collected on a standard proforma, which was

retrospectively filled in at each individual centre and

checked for authenticity by the corresponding author.

Unfortunately, the retrospective nature of the study was

reflected in a number of missing observations, particularly

with respect to patient risk factors. To allow for these data,

the denominator for all percentages has been included in

the results.

Indications for repair, endovascular technique, sub-

sequent management and post-implantation surveillance

followed the normal practice at each centre.

Patient Characteristics

The pathology, demographics, and comorbidities of the

patient cohort are listed in Table 1. The acute aortic syn-

drome group contained 15 classic Type B dissections, 1

intramural hematoma, and 3 penetrating ulcers. All patients

were within 1 month of presentation. These were all classi-

fied as acute aortic syndromes and analyzed together. The

patients with acute aortic syndromes that were repaired in an

emergent fashion included four patients with rupture, eight

with unremitting pain, four with visceral ischemia, and one

with lower limb ischemia. The group comprising thoracic

aneurysms contained 58 degenerative aneurysms, 6 false

aneurysms, and 2 mycotic aneurysms, which again were

analyzed as a single group. Indications for surgery were an

aneurysm size > 5.5 cm, a saccular configuration or symp-

toms. Patients classified as having thoraco-abdominal

aneurysms had pathology that extended into the abdomen

and whose distal extent involved the celiac axis or the more

distal aortic segment. In the 22 patients with thoraco-

abdominal aneuerysms, 16 required revascularization of

renal and visceral vessels, whereas 6 required visceral vessel

revascularization alone. There were nine patients with

Marfan syndrome in the entire cohort; four presented with

thoracic aneurysms and five with chronic dissections. The

mean follow-up of the entire cohort was 5 months and this

study therefore primarily reports in-hospital outcome.

Valiant Endovascular Graft

The Valiant endovascular graft is manufactured by Med-

tronic (Santa Rosa, CA, USA) and is an evolution from the

Talent endovascular graft, which has been described

extensively in previous publications [10]. The Valiant

endograft has included modifications to stent design, deliv-

ery sheath, graft configuration, deployment methodology,

and markers. Some of the most significant changes to the

Valiant graft include incorporation of an eight peak spring to

provide proximal fixation. This allows better apposition to

the vessel and distributes the radial force over more apices.

M. Thompson et al.: Early Results of Endovascular Treatment of the Thoracic Aorta 1131

123

The proximal stent comes in free-flow and closed web

configurations and the body of the graft may be straight or

tapered. The distal fixation may also be closed or have a bare

spring. The graft is manufactured without a connecting bar to

increase flexibility and is available in a range of lengths up to

227 mm and diameters from 24 to 46 mm.

The graft is now deployed by a mechanism which incor-

porates an integrated handle for deployment (same platform

as the Talent AAA stent graft), which provides a mechanical

advantage and a lower user-sensed deployment force. The

sheath of the system has been improved, which has been

designed to manifest less stretching, improved trackability,

and lower force of deployment. A fuller description of the

graft system has been published previously [8].

Statistical Analysis

Incidence rates are given as absolute numbers and as per-

centages. Missing data comprised up to 10% of the data set

with respect to some comorbidity information and follow-

up CT measurements. The data set on mortality and major

complications was complete. Continuous variables are

reported as mean and standard deviation if normally dis-

tributed. Comparison of proportions used the Fischer exact

test.

Results

Endovascular Procedure and Technical Success

One hundred sixty-six patients had their procedure per-

formed under general anesthesia and 14 under

locoregional anesthesia. Adjunctive surgical procedures

performed prior to the endovascular procedure included 3

ascending aortic bypasses to the brachiocephalic and left

common carotid arteries, 17 carotid-carotid bypasses, 14

carotid-subclavian revascularizations, 18 visceral bypas-

ses, and 11 access procedures. The access sites for

introduction of the endograft were the femoral artery in

93% of cases, the iliac vessels in 7% cases, and the

axillary artery in 1 case. Five cases required use of a

brachial-to-femoral wire. The endovascular procedure

Table 1 The pathology, demographics, and comorbidities of the patient cohort

Thoracic

aneurysm

Thoracoabdominal

aneurysm

Acute aortic

syndrome

Chronic

dissection

Aortic

transection

All

Number 66 (36%) 22 (12%) 19 (11%) 52 (29%) 21 (12%) 180

Age (SD) 66 (11%) 72 (6%) 68 (10%) 62 (14%) 39 (14%) 64 (15%)

ASA I/II 18/56 1/19 3/17 20/42 17/21 59/155

(32%) (5%) (18%) (48%) (81%) (38%)

ASA III–V 38/56 18/19 14/17 22/42 4/21 96/155

(68%) (95%) (82%) (52%) (19%) (62%)

Previous aortic surgery 25/56 7/19 3/17 25/42 1/21 61/155

(45%) (37%) (18%) (60%) (5%) (39%)

BP 30/56 17/19 9/17 34/42 0/21 90/155

(53%) (89%) (53%) (81%) (58%)

Cardiac 19/56 2/19 1/17 14/42 0/21 36/155

(34%) (11%) (6%) (33%) (23%)

Renal 26/56 2/19 2/17 9/42 0/21 39/155

(46%) (11%) (12%) (21%) (25%)

Pulmonary 41/56 18/19 3/17 19/42 0/21 81/155

(73%) (95%) (18%) (45%) (52%)

Elective procedure 45/66 16/22 2/19 47/52 7/21 117/180

(68%) (73%) (11%) (90%) (33%) (65%)

Urgent/emergency 21/66 6/22 17/19 5/52 14/21 63/180

(32%) (27%) (89%) (10%) (67%) (35%)

Follow-up, mo (mean ± SD) 5.5 ± 4.2 6 ± 3.7 4.7 ± 2.8 5.3 ± 3.5 2.9 ± 2.1 5 ± 3.7

Note. Patients with acute aortic syndrome comprised acute Type B dissections, intramural hematoma, and penetrating atherosclerotic ulcers. Data

on patients with differing ASA grades, modes of presentation, comorbidities, and previous aortic surgeries are absolute numbers and percentages.

Missing data are indicated by the differing denominators in each group. BP—patients with hypertension grades 2 and 3 according to the SVS

grading system for common conditions; cardiac—patients with SVS grade 2 and 3 cardiac morbidity; renal—patients with SVS grades 1–3 renal

morbidity; pulmonary—patients with SVS grades 1–3 pulmonary morbidity

1132 M. Thompson et al.: Early Results of Endovascular Treatment of the Thoracic Aorta

123

failed in three cases due to access problems. There were

13 immediate technical problems (7%) including one iliac

perforation, seven Type I endoleaks, three Type III

endoleaks, and two retrograde Type A dissections. There

were no immediate conversions to open surgery. Tech-

nical details of the endovascular procedure for all patient

categories are reported in Table 2.

In-Hospital Mortality and Major Morbidity

Thirteen patients died during the initial hospital admission,

for an in-hospital (or 30 day if higher) mortality rate of

7.2%. The mortality rate was 6.8% for elective procedures

and 8.6% for urgent/emergency procedures. The mortality

and major complications for the patient cohort, separated

for pathology, are reported in Table 3.

There were 13 in-hospital deaths. Four patients with

thoracic aneurysms died, two from significant strokes, one

from cardiac tamponade following rupture of an ascending

aortic aneurysm following discharge, and one from sepsis.

Six patients with thoraco-abdominal aneurysms died; three

had neurological problems, with one stroke and two cases

of paraplegia. The remaining three patients died of multiple

organ failure. In patients with acute aortic syndromes there

were two in-hospital deaths, which resulted from one ret-

rograde Type A dissection and one multiple organ failure.

The sole death in a patient with a chronic Type B dissec-

tion was from a massive hemothorax postoperatively

following a difficult procedure in a tortuous aorta.

Table 2 Technical details of the endovascular procedure in the patient cohort

Thoracic

aneurysm

Thoraco-abdominal

aneurysm

Acute aortic

syndrome

Chronic

dissection

Aortic

transection

All

No. of stents

1 31/65 0/22 11/18 26/50 21/21 51/176

(48%) (61%) (52%) (100%) (51%)

2 20/65 3/22 4/18 20/50 0/21 47/176

(31%) (13%) (22%) (40%) (27%)

3 10/65 9/22 2/18 2/50 0/21 23/176

(15%) (41%) (11%) (4%) (13%)

>3 4/65 10/22 1/18 2/50 0/21 17/176

(6%) (46%) (6%) (4%) (10%)

Proximal stent position

Proximal to BCA 1/54 0/21 1/14 1/44 0/20 3/153

(2%) (7%) (2%) (2%)

Proximal to LCCA 10/54 1/21 2/14 6/44 8/20 27/153

(19%) (5%) (14%) (14%) (25%) (18%)

Proximal to LSCA 15/54 7/21 6/14 14/44 6/20 48/153

(28%) (33%) (43%) (32%) (38%) (31%)

Distal to LSCA 28/54 13/21 5/14 23/44 6/20 75/153

(51%) (62%) (36%) (52%) (37%) (49%)

Endoleak postendograft

Type I 3/65 0/19 1/19 3/52 0/20 7/175

(5%) (0%) (5%) (6%) (0%) (4%)

Type III 1/65 0/19 1/19 1/52 0/20 3/175

(2%) (0%) (5%) (2%) (0%) (2%)

Endoleak at follow-up

Type I 4/50 4/18 2/14 5/42 0/17 15/141

(8%) (22%) (14%) (12%) (0%) (11%)

Type III 0/50 0/18 0/14 0/42 0/17 0/141

(0%) (0%) (0%) (0%) (0%)

Note. BCA, brachiocephalic artery; LCCA, left common carotid artery; LSCA, left subclavian artery. Details on the number of stents inserted,

proximal fixation zone, and incidence of endoleak are given as absolute numbers and percentages. Missing data are indicated by the differing

demoninators in each group. Endoleak postendograft—percentage of patients with an endoleak within 30 days of the procedure; endoleak at

follow-up—percentage of patients with an endoleak at a mean of 5 months’ follow-up


123

There were a total of seven strokes in all patients (four

in thoracic aneurysms, one in thoraco-abdominal aneu-

rysms, and two in patients with chronic Type B

dissections). Six of the seven patients who suffered strokes

had a proximal fixation site, proximal to the left subclavian

artery. In this group of patients only one had prior revas-

cularization of the left subclavian artery. In all, the

incidence of stroke in patients with left subclavian artery

occlusion was 5 in 56 (9%), compared to a stroke rate of 1

in 124 (0.8%), with no coverage or revascularization of the

left subclavian (p = 0.012).

Six patients developed paraplegia related to the proce-

dure. These were predominantly in patients with thoraco-

abdominal aneurysms (four episodes) or thoracic aneurysms

(two patients).

Outcome at Follow-Up

Due to the short follow-up time in the series, limited

information was available. At a mean of 5 months’ fol-

low-up there were a total of seven deaths. Importantly,

however, six of these deaths appeared to be aortic-related.

The majority of these deaths [4] occurred in patients with

chronic dissections. Two patients required reintervention

for increasing false lumen diameter and died during the

secondary procedures (one endovascular intervention and

one visceral hybrid procedure). One patient died of a

ruptured thoracic aorta which showed false lumen perfu-

sion, and there was one death from a retrograde Type A

dissection. The other two aortic-related deaths involved

patients with thoracic aneurysms. There was one case of

Staphylococcus aureus graft infection and the final death

was again due to a late retrograde Type A aortic

dissection.

Fifteen patients required repeated intervention after the

primary admission. The majority of these [6] were for

high-pressure endoleaks (Types I and III) or for left

subclavian artery embolisation [3]. One patient presented

with an ischemic left arm and required a left carotid-

subclavian bypass. The remaining reinterventions were for

a variety of indications, which included an abdominal

aortic aneurysm repair, an aortic valve replacement, a

visceral hybrid procedure, and a renal artery stent. There

was an increased number of high-pressure endoleaks at

follow-up compared to the incidence during the primary

admission. The endoleak rate at follow-up is given in

Table 2.

During follow-up some limited radiological information

was available. In acute dissections, the false lumen was

thrombosed at the left subclavian artery, the mid

descending thoracic aorta, and the diaphragm in 100%,

90%, and 46% of cases, respectively. The corresponding

figures for chronic dissections were 86%, 78%, and 29%.

Expansion of treated thoracic aneurysms was observed in

11% of cases and these were associated with high-pressure

endoleaks. The majority of aneurysms demonstrated

regression (52%), whereas the rest remained static (37%).

Patients with Marfan Syndrome

In the cohort there were nine patients with Marfan syn-

drome, four with thoracic aneurysms, and five with

aneurysmal expansion of a chronic dissection. All patients

were successfully treated with a Valiant endograft. One

patient required a preoperative carotid-subclavian bypass.

There was one in-hospital death due to T4 paraplegia, but

no other complications in the perioperative period. One late

reintervention, in the form of a renal stent, was required to

Table 3 Immediate mortality following thoracic endografting

Thoracic

aneurysm

Thoraco-abdominal

aneurysm

Acute aortic

syndrome

Chronic

dissection

Aortic

transection

All

Elective mortality 2/45 5/16 0/2 1/47 0/7 8/117

(4.4%) (31.3%) (0%) (2.1%) (0%) (6.8%)

Emergency mortality 2/21 1/6 2/17 0/5 0/14 5/63

(9.5%) (16.7%) (11.8%) (0%) (0%) (7.9%)

Total mortality 4/66 6/22 2/19 1/52 0/21 13/180

(6.1%) (27.3%) (10.5%) (1.9%) (0%) (7.2%)

Stroke 4/66 1/22 0/19 2/52 0/21 7/180

(6.1%) (4.5%) (0%) (3.9%) (0%) (3.8%)

Paraplegia 2/66 4/22 0/19 0/52 0/21 6/180

(3%) (18.2%) (0%) (0%) (0%) (3.3%)

Note. Mortality is given as in-hospital or 30-day mortality—whichever is the highest figure. All data are absolute numbers and percentages


123

correct a renal artery stenosis. No aneurysms expanded in

the follow-up period.

Discussion

The present series describes the initial outcome of a cohort

of patients treated with the Valiant endograft. The data

were collected retrospectively from seven European cen-

ters and represent the first significant clinical results of

endovascular therapy using this new-generation endograft.

The data set used in the analysis suffers from the retro-

spective nature of the study, as it is not complete in all

areas. Nevertheless, the results comprise a significant

number of patients compared to most series in the litera-

ture, and several conclusions may be drawn.

In common with other registry series [2, 3] this study

confirmed the low mortality associated with elective and

emergency endovascular repair of thoracic aneurysms.

Low perioperative mortality was also observed follow-

ing treatment of Type B thoracic dissections, with the

chronic dissections having a lower mortality rate than the

acute dissections [11, 12]. The study also revealed

acceptable mortality rates following emergent therapy for

patients with acute aortic syndromes and aortic transec-

tions. In particular, the absence of mortality following

endovascular repair of traumatic thoracic aortic transection

was encouraging and adds further evidence to recent

reports which have demonstrated good results for endo-

vascular treatment of these lesions [13, 14]. The mortality

for the emergent treatment of acute aortic syndrome was

12%, which compares favorably with other series reporting

patients with urgent indications for treatment [11, 15].

In contrast to these favorable results, the outcome of

patients with thoraco-abdominal aneurysms was poor.

These patients were treated with a hybrid approach com-

prising retrograde visceral artery bypass and endovascular

repair of the thoraco-abdominal aneurysm [7]. Overall

there were 6 deaths in 22 patients, equating to a mortality

rate of 27%, with half the deaths being due to neurological

complications. Although this mortality figure seems high

compared to series from specialized centers [16, 17], it is

similar to community-based figures which report the out-

come of open thoraco-abdominal aortic surgery [18]. Many

of the patients treated with hybrid surgery in the present

study would not have been candidates for open surgery, as

95% had an ASA grade of III–V and 95% had significant

pulmonary comorbidity. Clearly, the hybrid approach to

treating thoraco-abdominal aneurysms could not be rec-

ommended based on the present results; results from larger

series will be required before the role of the visceral hybrid

approach to treating thoraco-abdominal aneurysms can be

fully defined. It is unclear whether the relatively poor

results from the present series represent part of a learning

curve.

As the indications for thoracic endografting become

better defined, it is likely that the number of endovascular

thoracic procedures will increase and endograft design will

evolve rapidly. The introduction of new endografts into

clinical practice offers some considerable challenges with

respect to assessment of performance, as the interpretation

of clinical outcome must be adjusted for case-mix and

technical complexity. The present study gives a good

example of the difficulties inherent in comparing different

generations of endografts. Ideally, new endografts would

be compared in a prospective manner, but this is neither

practical nor realistic. Analysis of outcome must therefore

rely on historical comparisons. It would seem reasonable to

compare the present series of Valiant endografts against a

similar retrospective series of 457 patients treated with

Talent endografts between 1996 and 2004 (Table 4) [10].

The Talent case-mix was different from the present series;

it contained 33% thoracic aneurysms, 48% dissections, and

18% posttraumatic aneurysms, compared to the Valiant

series, with 48% aneurysms (thoracic and thoraco-abdom-

inal), 40% dissections, and 12% transections.

On a superficial level, the elective and emergent mor-

tality in the Talent series (4.1% and 7.9%) was lower than

that for the Valiant endografts (6.8% and 7.9%). However,

the Valiant series was biased due to the inclusion of

patients with thoraco-abdominal aneurysms with high

mortality rates. Removing these patients from the analysis

(Table 4) gives a Valiant cohort with 42% thoracic aneu-

rysms, 45% dissections, and 13% transections. Comparison

of the two cohorts without the thoraco-abdominal patients

revealed similar mortality, stroke, and paraplegia rates for

the patients treated with Talent and Valiant endografts. The

crude outcome measures do not take into account the

increasing complexity of the case load. The technical

complexity of thoracic endografting may be indicated by

the proximal implantation zone and the number of endo-

grafts used in the procedure, although a measure of the

total length of stented aorta would be preferable. Previous

studies have demonstrated that the more proximal the

implantation zone, the higher the number of technical

complications [19, 20] and, similarly, that the length of

aorta covered was related to the incidence of paraplegia

[10]. Comparison of the present data with the retrospective

Talent registry [10] demonstrated that the current series

had a significant increase in complexity, with the current

patients requiring a higher incidence of proximal implan-

tation, with supra-aortic branch reconstruction and a higher

incidence of multiple stents. In addition, the patients

receiving the Valiant grafts had a significantly higher

incidence of renal insufficiency and pulmonary dysfunc-

tion. The outcome measures from the Valiant series


123

therefore reveal mortality and morbidity rates similar to

those of previous studies, but with significantly increased

technical complexity and comorbidity.

Analysis of the present data set suggests that the Valiant

endograft performed well in an increasingly complex series

of patients with thoracic aortic pathology. The spectrum of

endograft-related complications was similar to that in pre-

viously reported series and included retrograde Type A

dissections, stroke, and paraplegia. In the present series

there were four retrograde Type A dissections, 2 compli-

cating the initial endovascular procedure and two following

patient discharge. The two immediate Type A retrograde

dissections involved treatment of aortic dissections, one

acute and one chronic. The two late presentations were from

one chronic dissection and one thoracic aneurysm. Retro-

grade Type A aortic dissections have been observed

previously to complicate thoracic endografts in the early and

late periprocedural period [21–23]. There are insufficient

data to clearly define the incidence and etiology of this

complication, but observations have suggested that there

may be a higher incidence in treatment of aortic dissections

and that the complications do not appear to be device spe-

cific [24]. Additionally, Neuhauser et al. revealed that some

apparent retrograde dissections may be revealed after a Type

A dissection was mistakenly diagnosed as a Type B dis-

section and treated with an endograft [25].

The incidence of stroke and paraplegia reported in the

present study is similar to that in previous series [26]. The

high incidence of paraplegia that complicated thoraco-

abdominal aneurysm repair confirmed previous reports

suggesting that paraplegia rates were increased with the

length of aorta covered [10]. Similarly, the stroke rate was

within previously published limits, although the relation-

ship between intentional coverage of the left subclavian

artery and the occurrence of stroke deserves further com-

ment. Initial experience with endovascular repair of

thoracic pathology suggested that intentional coverage of

the left subclavian artery was a relatively safe procedure,

with low rates of limb ischemia and posterior circulation

stroke [27, 28]. However, recently investigations have

revealed an increasing incidence of both anterior and

posterior circulation strokes in patients who had intentional

coverage of the left subclavian artery without revasculari-

zation [10, 20]. In the Talent retrospective registry, Fattori

et al. [10] reported that coverage of the left subclavian

artery was an independent predictor of stroke. In the

present study the incidence of stroke in patients with

coverage of the left subclavian artery without revasculari-

zation was 9%, in comparison to an incidence of 0.8% in

patients with the left subclavian left in circulation. These

data appear to make a compelling argument for revascu-

larization of the left subclavian artery in patients who

Table 4 Comparative results from the present study (Valiant) with and without the results from treatment of thoraco-abdominal aneurysms (not

TAAA)

Talent Valiant Valiant, not TAAA p: Talent vs Valiant,

not TAA

Elective mortality 14/344 8/117 3/101 0.77

(4.1%) (6.8%) (3.0%)

Emergency mortality 9/113 5/63 4/57 1.0

(7.9%) (7.9%) (7.0%)

Stroke 17/457 7/180 6/158 1.0

(3.7%) (3.8%) (3.8%)

Paraplegia 8/457 6/180 2/158 1/0

(1.7%) (3.3%) (1.3%)

>2 stents 40/457 40/176 31/154 0.0004

(8.7%) (22.7%) (20.1%)

Fixation proximal LSCA 54/457 78/153 70/134 <0.0001

(11.8%) (50.1%) (52.2%)

Renal insufficiency 72/457 39/155 37/117 0.0002

(15.7%) (25%) (31.6%)

COPD (%) 102/457 81/155 63/136 <0.0001

(22.3%) (52%) (46.3%)

Note. Results are given as absolute numbers and percentages. The results are compared to those for a series of Talent grafts (REF). Statistical

analysis of the differences between the Talent series and the Valiant series excluding thoraco-abdominal aneurysms uses Fischer’s exact test.

Absolute p values are given. Fixation proximal LSCA—proximal fixation of the endograft proximal to the left subclavian artery. Renal

insufficiency and COPD utilize definitions as in Table 1


123

require intentional coverage of this segment. However, the

design of the present trial cannot exclude the possibility

that patients requiring proximal endografts have a higher

stroke rate than patients with more distal grafts. Analysis of

pooled data from many sources will be required to define

whether stroke rate can be decreased by left subclavian

artery revascularization.

Due to the short follow-up in the present study, long-

term data were limited. The series did, however, suggest

that patients treated for chronic dissections had a high

incidence of aortic-related death and intervention during a

short follow-up period. The treatment of chronic dissec-

tions by endovascular repair has been reported to have a

very low perioperative mortality [11, 29], but the long-term

outcome is less well defined. Eggebrecht et al. [29]

reported a 9% incidence of fatal aortic rupture after treat-

ment of chronic dissection and also demonstrated that

patients with chronic dissection had increased rates of

postoperative complications and reintervention. The pres-

ent study has demonstrated that false lumen perfusion is

greater in the cohort of patients with chronic dissections

compared to patients with acute aortic syndromes. All

available data suggest that the long-term outcome of

treatment for chronic dissections is not fully defined and

that the incidence of late aortic-related complications are

high. Clearly further information is required to delineate

the place and mode of endovascular therapy in these

lesions. In the meantime, the high rate of postoperative

complications mandates careful and regular surveillance.

These sentiments may be particularly applied to patients

with Marfan syndrome. Previous experience with treatment

of thoracic pathology in Marfan syndrome has been mixed.

Baril et al. [30] reported no aneurysm-related deaths in a

group of six patients with Marfan syndrome. In contrast,

Ince et al. [31] reported on six patients, three of whom

failed treatment and were considered for open surgical

conversion. In the present series there were nine patients

with Marfan syndrome. The short-term outcomes were

acceptable, but the follow-up period was too short for

meaningful analysis.

The design of the present study clearly has significant

limitations. The retrospective nature of the study made data

collection incomplete with respect to comorbidity and fine

details of the technical procedure. The relatively small

number of patients in the study, together with the diversity

of the thoracic pathology, makes subgroup analysis diffi-

cult. The low number of adverse events similarly makes

regression analysis unreliable.

In summary, the present study reports the outcome of a

cohort of patients treated with a new-generation endograft.

The clinical outcomes were acceptable although disparate

between differing pathologies. The study illustrated the

difficulties inherent in assessing outcomes when the

complexity of the case-mix is evolving. Long-term data are

clearly required both to assess the performance of the en-

dograft and to define subgroups of patients who require

modification of current treatment protocols.

Acknowledgment This study was funded by an unrestricted

educational grant from Medtronic Inc.

References

1. Makaroun MS, Dillavou ED, Kee ST, et al. (2005) Endovascular

treatment of thoracic aortic aneurysms: results of the phase II

multicenter trial of the GORE TAG thoracic endoprosthesis.

J Vasc Surg 41(1):1–9

2. Sayed S, Thompson MM (2005) Endovascular repair of the

descending thoracic aorta: evidence for the change in clinical

practice. Vascular 13(3):148–157

3. Leurs LJ, Bell R, Degrieck Y, Thomas S, Hobo R, Lundbom J

(2004) Endovascular treatment of thoracic aortic diseases: com-

bined experience from the EUROSTAR and United Kingdom

Thoracic Endograft registries. J Vasc Surg 40(4):670–679

4. Nienaber CA, Zannetti S, Barbieri B, Kische S, Schareck W,

Rehders TC (2005) INvestigation of STEnt grafts in patients with

type B Aortic Dissection: design of the INSTEAD trial—a pro-

spective, multicenter, European randomized trial. Am Heart J

149(4):592–599

5. Sayed S, Choke E, Helme S, et al. (2005) Endovascular stent

graft repair of mycotic aneurysms of the thoracic aorta. J Car-

diovasc Surg (Torino) 46(2):155–161

6. Bergeron P, Coulon P, De Chaumaray T, et al. (2005) Great

vessels transposition and aortic arch exclusion. J Cardiovasc Surg

(Torino) 46(2):141–147

7. Black SA, Wolfe JH, Clark M, Hamady M, Cheshire NJ, Jenkins

MP (2006) Complex thoracoabdominal aortic aneurysms: endo-

vascular exclusion with visceral revascularization. J Vasc Surg

43(6):1081–1089

8. Brooks M, Loftus I, Morgan R, Thompson M (2006) The Valiant

thoracic endograft. J Cardiovasc Surg (Torino) 47(3):269–278

9. Cho JS, Haider SE, Makaroun MS (2006) US multicenter trials of

endoprostheses for the endovascular treatment of descending

thoracic aneurysms. J Vasc Surg 43(Suppl A):12A–19A

10. Fattori R, Nienaber CA, Rousseau H, et al. (2006) Results of

endovascular repair of the thoracic aorta with the Talent Thoracic

stent graft: the Talent Thoracic Retrospective Registry. J Thorac

Cardiovasc Surg 132(2):332–339

11. Bockler D, Schumacher H, Ganten M, et al. (2006) Complica-

tions after endovascular repair of acute symptomatic and chronic

expanding Stanford type B aortic dissections. J Thorac Cardio-

vasc Surg 132(2):361–368

12. Eggebrecht H, Nienaber CA, Neuhauser M, et al. (2006) Endo-

vascular stent-graft placement in aortic dissection: a meta-

analysis. Eur Heart J 27(4):489–498

13. Tehrani HY, Peterson BG, Katariya K, et al. (2006) Endovascular

repair of thoracic aortic tears. Ann Thorac Surg 82(3):873–877

14. Reed AB, Thompson JK, Crafton CJ, Delvecchio C, Giglia JS

(2006) Timing of endovascular repair of blunt traumatic thoracic

aortic transections. J Vasc Surg 43(4):684–688

15. Dias NV, Sonesson B, Koul B, Malina M, Ivancev K (2006)

Complicated acute type B dissections—an 8-years experience of

endovascular stent-graft repair in a single center. Eur J Vasc

Endovasc Surg 31(5):481–486

16. Miller CC III, Porat EE, Estrera AL, Vinnerkvist AN, Huynh TT,

Safi HJ (2003) Analysis of short-term multivariate competing


123

risks data following thoracic and thoracoabdominal aortic repair.

Eur J Cardiothorac Surg 23(6):1023–1027

17. Safi HJ, Miller CC III, Huynh TT, et al. (2003) Distal aortic

perfusion and cerebrospinal fluid drainage for thoracoabdominal

and descending thoracic aortic repair: ten years of organ pro-

tection. Ann Surg 238(3):372–380

18. Rigberg DA, McGory ML, Zingmond DS, et al. (2006) Thirty-

day mortality statistics underestimate the risk of repair of tho-

racoabdominal aortic aneurysms: a statewide experience. J Vasc

Surg 43(2):217–222

19. Tse LW, Mackenzie KS, Montreuil B, Obrand DI, Steinmetz OK

(2004) The proximal landing zone in endovascular repair of the

thoracic aorta. Ann Vasc Surg 18(2):178–185

20. Peterson BG, Eskandari MK, Gleason TG, Morasch MD (2006)

Utility of left subclavian artery revascularization in association

with endoluminal repair of acute and chronic thoracic aortic

pathology. J Vasc Surg 43(3):433–439

21. Sunder-Plassmann L, Orend KH (2005) Stentgrafting of the

thoracic aorta-complications. J Cardiovasc Surg (Torino)

46(2):121–130

22. Zhang R, Kofidis T, Baus S, Klima U (2006) Iatrogenic type A

dissection after attempted stenting of a descending aortic aneu-

rysm. Ann Thorac Surg 82(4):1523–1525

23. Hansen CJ, Bui H, Donayre CE, et al. (2004) Complications of

endovascular repair of high-risk and emergent descending tho-

racic aortic aneurysms and dissections. J Vasc Surg 40(2):228–

234

24. Fattori R, Lovato L, Buttazzi K, Di Bartolomeo R, Gavelli G

(2005) Extension of dissection in stent-graft treatment of type B

aortic dissection: lessons learned from endovascular experience.

J Endovasc Ther 12(3):306–311

25. Neuhauser B, Czermak BV, Fish J, et al. (2005) Type A dis-

section following endovascular thoracic aortic stent-graft repair.

J Endovasc Ther 12(1):74v–81

26. Sullivan TM, Sundt TM III (2006) Complications of thoracic

aortic endografts; spinal cord ischemia and stroke. J Vasc Surg

43A:85A–88A

27. Gorich J, Asquan Y, Seifarth H, et al. (2002) Initial experience

with intentional stent-graft coverage of the subclavian artery

during endovascular thoracic aortic repairs. J Endovasc Ther

9(Suppl 2):II39–II43

28. Burks JA Jr, Faries PL, Gravereaux EC, Hollier LH, Marin ML

(2002) Endovascular repair of thoracic aortic aneurysms: stent-

graft fixation across the aortic arch vessels. Ann Vasc Surg

16(1):24–28

29. Eggebrecht H, Herold U, Kuhnt O, et al. (2005) Endovascular

stent-graft treatment of aortic dissection: determinants of post-

interventional outcome. Eur Heart J 26(5):489–497

30. Baril DT, Carroccio A, Palchik E, et al. (2006) Endovascular

treatment of complicated aortic aneurysms in patients with

underlying arteriopathies. Ann Vasc Surg 20:464–471

31. Ince H, Rehders TC, Petzsch M, Kische S, Nienaber CA (2005)

Stent-grafts in patients with marfan syndrome. J Endovasc Ther

12(1):82–88


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early results of endovascular treatment of the thoracic aorta using the valiant endograft

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