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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_4016_Библиотеки_им_академика_М_И_Перельмана
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CHAPTER 13 Clinical results of the EUROSTAR thoracic registry 97
incidence of 18 (3%) compared to 15 (2.5%). This
finding highlights the risks associated with the
manipulation of wires, catheters and introducer
sheaths withinthe arch,which havepotential tooff-
set or even cancel out the benefit of a reduced risk
of paraplegia in comparison to open surgery.
An analysis of the risk factors for paraplegia in
14 patients is shown in Table 13.1. The most im-
portant result from a clinical perspective is a highly
significant increase in the risk of paraplegia when
three or more stent grafts are used. This applied in
nearly 20% of patients and presumably correlates
with the length of aorta covered, i.e. the greater the
length the higher the risk.Interestingly,there was no
correlation between the length of the aneurysm and
the risk of paraplegia and it may be speculated that
the greatest risk relates to relatively healthy aorta
being covered.
The risk of paraplegia associated with endovas-
cular repair of degenerative thoracic aneurysms was
Table 13.1 Neurological complications following endovascular thoracic aortic repair.
Paraplegia N = 14 Other N = 495
N (%) N (%) P-value
Degenerative aneurysm 12 (85.7) 300 (60.6) 0.057
Chronic 8 (66.7) 227 (75.7) NS
Acute 4 (33.3) 56 (18.7) NS
Unknown — 17 (5.7) NS
Dissection 2 (14.3) 195 (39.4) 0.057
Chronic 0 (0) 102 (52.2) NS
Acute 2 (100) 93 (47.7) NS
Localization
A (prox) 5 (35.7) 189 (38.2) NS
B (prox+mid) 2 (14.3) 38 (7.7) NS
C (mid) 1 (7.1) 64 (12.9) NS
D (dist) 1 (7.1) 46 (9.3) NS
E (mid+dist) 2 (14.3) 27 (5.5) NS
F (prox+mid+dist) 3 (21.4) 39 (7.9) 0.069
Length aneurysm (mean ± SD) 128.3 ± 116.7* 98.1 ± 63.5* NS
Anesthesia
General 14 (100) 460 (92.9) NS
Regional — 21 (4.2) NS
Local — 14 (2.8) NS
Number of stent grafts
≥ 3 7 (50.0) 101 (20.4) <0.0001
Duration operation (mean ± SD) 159.1 ± 89.6 132.9 ± 86.7 NS
Replaced blood volume (mean ± SD) 362.5 ± 639.3 485.4 ± 5092.4 NS
Blocking side branches
T9 – occlusion by device 5 (35.7) 124 (25.1)
T10 – occlusion by device 7 (50.0) 99 (20.0)
T11 – occlusion by device 5 (35.7) 76 (15.4)
T12 – occlusion by device 4 (28.6) 45 (9.1)
Conversion 1 (7.1) 10 (2.0) NS
Early (30-day) 1 (7.1) 2 (0.4) 0.0012
Late (>30-day) 0 (0) 8 (1.6) NS
Death 8 (57.1) 97 (19.6) 0.0006
Early (30-day) 6 (42.9) 43 (8.7) <0.0001
Late (>30-day) 2 (14.3) 54 (10.9) NS
Risk factors for paraplegia.
*N = 11 and 258.
https://t.me/med1917
98 PA R T I I Thoracic aortic aneurysm
12/312 (3%) while that associated with treatment
of dissections was 2/97 (1%). Paraplegia was asso-
ciated with a very high mortality risk 8/14 (67%).
Most of these deaths occurred within 30 days of
operation.
Follow-up
Currently follow-up extends to a maximum of 5
years. However data are available on just 10 out
of a total of 34 patients in whom the procedure
was carried out more than 5 years ago. A total of
108 patients have died, 67 within 30 days of their
operation and 41 after this period. Fourteen have
been converted to open repair, three have suffered
late rupture of their aneurysm and eight patients
have been lost to follow-up.
Life table analyses for survival, freedom from
endoleak, freedom from persistent endoleak, per-
sistent endoleak-free survival, freedom from sec-
ondary intervention, secondary intervention-free
survival, and freedom from rupture are shown in
Figs. 13.1–13.7.
Of the patients treated for aortic dissection com-
plete or partial thrombosis of the false lumen was
observed in53% at1 month after operation. Forthe
whole population of patients the cumulative rate of
survival at 5 years was 62%. The secondary inter-
vention rate was lower than that associated with ab-
dominal endovascular procedures at less than 20%
at 5 years. The incidence of secondary intervention
after the first year was very low. Almost 99% of the
whole population of patients remained free from
aortic rupture after 5 years.
0
Interval (months)
Number of patients at risk
0
20
Cumulative percentage
Period (months)
40
60
80
100
12
24 36 48
60
72
84
12
326
24
186
36
157
48
87
60
35
Figure 13.1 Life table analysis – survival.
https://t.me/med1917
0
Interval (months)
Number of patients at risk
0
20
Cumulative percentage
Period (months)
40
60
80
100
12
24 36 48
60
72
84
12
312
24
173
36
146
48
80
60
32
Figure 13.2 Life table analysis – freedom from endoleak.
0
Interval (months)
Number of patients at risk
95
96
Cumulative percentage
Period (months)
97
98
99
100
12
24
36 48
60
72
84
12
332
24
188
36
161
48
88
60
35
Figure 13.3 Life table analysis – freedom from persistent endoleak.
https://t.me/med1917
0
Interval (months)
Number of patients at risk
0
20
Cumulative percentage
Period (months)
40
60
80
100
12
24 36 48
60
72
84
12
323
24
184
36
155
48
85
60
33
Figure 13.4 Life table analysis – freedom from death and persistent endoleak.
0
Interval (months)
Number of patients at risk
0
20
Cumulative percentage
Period (months)
40
60
80
100
12
24 36 48
60
72
84
12
308
24
171
36
144
48
79
60
32
Figure 13.5 Life table analysis – freedom from secondary intervention.
https://t.me/med1917
0
Interval (months)
Number of patients at risk
0
20
Cumulative percentage
Period (months)
40
60
80
100
12
24 36 48
60
72
84
12
303
24
168
36
141
48
77
60
31
Figure 13.6 Life table analysis – freedom from death and secondary intervention.
0
Interval (months)
Number of patients at risk
95
96
Cumulative percentage
Period (months)
97
98
99
100
12
24 36 48
60
72
84
12
335
24
190
36
162
48
90
60
37
Figure 13.7 Life table analysis – freedom from rupture.
https://t.me/med1917
102 PA R T I I Thoracic aortic aneurysm
Key points
1 A variety of thoracic aortic pathologies were
treated by endovascular stent/grafting.
2 Complete technical success was achieved in 90%
of patients.
3 The total incidence of endoleak on completion
of the procedure was 9%. Type 2 endoleak was ob-
served in only 2% of the patients.
4 The incidence of paraplegia was low (2.5%).
5 Deployment of three or more endografts within
the aorta was ahighly significant risk factorfor para-
plegia.
6 Sixty seven per cent of patients with paraplegia
died.
7 The incidence ofintracranial stroke (3%) equaled
that of paraplegia.
8 Partial orcomplete thrombosis of the false lumen
occurred within 1 month in 53% of the patients
treated for aortic dissection.
9 Late complications have occurred infrequently
to date. Freedom from secondary intervention ex-
ceeded 80% at 5 years.
10 Durability of endovascular treatment of tho-
racic aortic pathologies beyond 5 years remains to
be established. But, within this period late device
related complications have been rare. Contrary to
expectations migration of stent/grafts was reported
in one patient only to date.
11 These results are consistent with the expecta-
tion of superior outcome from endovascular re-
pair in comparison to the known results of con-
ventional open surgery at least in the medium
term.
To review updates of the EUROSTAR Thoracic
and abdominal aortic aneurysm databases visit the
website at:
www.eurostar-online.org
Participating institutional
coordinators of the EUROSTAR
Thoracic Registry
Prof A. Nevelsteen, Louvain, Belgium
Dr J. Buth, Eindhoven, The Netherlands
Prof H. Myhre, Trondheim, Norway
Dr P. Harris, Liverpool, England
Dr E. Verhoeven, Groningen, The Netherlands
Prof W. Stelter, Frankfurt, Germany
Dr M. Wyatt, Newcastle, England
Dr V. Riambau, Barcelona, Spain
Dr P. Peeters, Bonheiden, Belgium
Dr R. Balm, Amsterdam, The Netherlands
Dr R. H. Geelkerken, Enschede, The Netherlands
Dr R. Verhelst, Brussels, Belgium
Prof P. C. Maurer, Munich, Germany
Prof H. Kortmann, Hamburg, Germany
Dr A. de Smet, Rotterdam, The Netherlands
Mr S. Darke, Bournemouth, England
Dr P. Stabel, Turnhout, Belgium
Dr M. van Betsbrugge, Antwerp, Belgium
Dr H. Massin, Gilly, Belgium
Dr F. van Elst, St Truiden, Belgium
Prof. G. Shanik, Dublin, Ireland
Dr Schro
¨
e, Genk, Belgium
Dr van Sambeek, Rotterdam, The Netherlands
Dr M. Scoccianti, Rome, Italy
Dr Th. Nordh Larzon, Orebro, Sweden
Dr Sanchez-Corral, Madrid, Spain
Dr I. Degrieck, Aalst, Belgium
Dr D. de Roover, Antwerp, Belgium
Dr E. Sebrechts, Vilvoorde, Belgium
Dr H. Tubbax, Brugge, Belgium
Dr V. Pierat, Brussels, Belgium
Dr L. Verougstraete, Tongeren, Belgium
Prof M. Storck, Leipzig, Germany
Dr J. Hendriks, Edegem, Belgium
Dr J. de Letter, Brugge, Belgium
Dr J. P. Dereume, Brussels, Belgium
Dr E. Vandueren, Charleroi, Belgium
Dr M. Bosiers, Dendermonde, Belgium
Dr J. Bleyn, Deurne, Belgium
Dr F. Vermassen, Gent, Belgium
Dr J. Vandekerkhof, Hasselt, Belgium
Dr M. Buche, Mont Godine, Belgium
Dr J. Demelenne, Namur, Belgium
Dr P. Dujardin, Roeslare, Belgium
Dr P. van den Brande, Brussels, Belgium
Dr C. Choghari, Brussels, Belgium
Dr P. Dormal, Mouscron, Belgium
Dr P. van Ruyssevelt, Haint Saint Paul, Belgium
Dr A. Flamme, Gent, Belgium
Dr J. Poniewierski, La Louviere, Belgium
Dr G. Guillaume, Namur, Belgium
Dr Vahl, Amsterdam, The Netherlands
Dr Fishwick, Leicester, England
Dr Munoz, Malaga, Spain
https://t.me/med1917
CHAPTER 13 Clinical results of the EUROSTAR thoracic registry 103
Reference
1 Leurs LJ, Bell R, Degrieck Y, Thomas S, Hobo R, Lund-
boam J on behalf the EUROSTAR and UK Thoracic
Endograft Registry. Endovascular treatment of tho-
racic aortic diseases: Combined experience from the
EUROSTAR and UK Thoracic Endograft Registries. J Vasc
Surg 2004; 40(4): 670–679.
https://t.me/med1917
14
CHAPTER 14
Management of aortic aneurysms
and dissections with the Zenith
TX2 stent graft
W. Anthony Lee
The prevalence of thoracic aortic aneurysms is ap-
proximately 8–12 cases per 100,000. This estimate
is largely based on historical data predating the en-
dovascular era and high-speed spiral computed to-
mographic (CT) scans. With the more liberal use
of CT scans for vascular and nonvascular diagnos-
tic imaging, this estimate is likely to increase in the
future.
TAA is a disease of the elderly with its peak inci-
dence occurring in the eighth decade of life. There
is relatively greater proportion of women present-
ing with TAA as compared to abdominal aortic
aneurysms (AAA).Whereasin theabdominal aorta,
the ratio of men to women is approximately 4:1, in
the thoracic aorta it is approximately 3:2, and in
some series approach 1:1.
Similar to femoral and popliteal aneurysms, the
presence of a TAA is a strong marker for the pres-
ence of a concomitant AAA. Almost half of those
who present with a thoracic aortic aneurysm will
have or had a repair of an AAA. Conversely, those
who present with an AAA have a 5% incidence of a
concomitant TAA, and thus anyonebeing evaluated
for an AAA should have a thoracic CT scan at least
once during their initial workup.
The indications for treatment of TAA include
symptoms of back pain,rupture, orsize greater than
5.5–6.0 cm. Conventional surgical repair involves
prosthetic aortic replacement under left heart by-
pass using variety of adjunctive measures such as
distal perfusion and spinal cord drainage to mini-
mize the risk of spinal cord ischemia. Endovascular
repair involves tubular stent grafts that are deliv-
ered through the femoral or iliac arteries and de-
ployed over uninvolved segments of the thoracic
aorta proximal and distal to the aneurysm. Cur-
rently, the only FDA-approved commercially avail-
able device in the United States with this indica-
tion is the TAG thoracic endograft from W.L. Gore
(Flagstaff, AZ).
In addition to thoracic aneurysm, thoracic aortic
dissection is another significant disease which can
affect this vasculature. Thoracic aortic dissections
are primarily classified according to their chronic-
ity and site of the primary intimal tear relative to
the left subclavian artery. In the Stanford classifi-
cation system, A-type refers to dissections that in-
volve the ascending aorta, and the B-type refers to
those that begin distal to the left subclavian artery
with or without abdominal extension. Acute and
chronic dissections are differentiated by whether
onset of symptoms is older than 2 weeks. While
most Stanford A dissections require urgent repair
due to the risk of pericardial rupture, aortic regur-
gitation, and death, most Stanford B dissections are
managed medically.
The clinical presentation of thoracic aortic dis-
sections is distinctly different from atherosclerotic
aneurysms. The patients are typically younger in
their third and fourth decades of life and uniformly
present with severe hypertension. Therefore, the
mainstay of medical management is aggressive con-
trol of their blood pressure and heart rate using a
combination of short acting beta-blocker and ni-
troprusside infusions. The physiologic aim of these
two maneuvers is to reduce the dp/dt and prevent
105
Advanced Endovascular Therapy of Aortic Disease
Edited by Alan B. Lumsden, Peter H. Lin, Changyi Chen, Juan C. Parodi
Copyright © 2007 by Blackwell Publishing
https://t.me/med1917
106 PA R T I I Thoracic aortic aneurysm
the risk of progression of the dissection and acute
rupture.
The natural history of uncomplicated and un-
repaired chronic Stanford B dissections is that of
progressive aneurysmal dilation of the false lumen
in up to 30–40% of cases within 5 years, most of
whom will require surgical repair to prevent rup-
ture. Currently, the only indication for endovascu-
lar or surgical intervention for acute dissections is
complications refractory to medical management.
These include unremitting back pain, refractory hy-
pertension, visceral or lower extremity malperfu-
sion, and rarely acute expansion and rupture of the
false lumen.
Mortality and morbidity of surgical repair for
complicated acute aortic dissections can be signifi-
cant. Therefore, “minimalist” orsymptom-directed
approach to restore perfusion to the ischemic bed is
reasonable if anatomically possible. Surgical treat-
ments include prosthetic aortic replacement under
cardiopulmonary bypass, with or without circula-
tory arrest, and extra-anatomic bypasses to restore
lower extremity perfusion. Endovascular therapies
haveincluded percutaneousfenestrations ofthe dis-
section septum to equalize blood flow from one lu-
men to the other and more recently deployment of
a stent graft to cover the primary tear, redirect the
blood flow into the true lumen, and induce false
lumen thrombosis. There are no endovascular de-
vices currently approved in the Unted States for use
in thoracic aortic dissections.
Differences between endovascular
treatment of the thoracic and
abdominal aorta
There are substantive differences during the execu-
tion and mechanics of endovascular treatment of
the thoracic and abdominal aorta that belies the
apparent similarities of the twotypes ofdevices and
delivery methods. Everything in the thoracic aorta
is more remote from the entry point of guidewires,
catheters, and delivery systems. This means longer
catheters and wires with reducedtorque controland
pushability. This physical distance is compounded
by serial iliac, abdominal, and thoracic aortic tor-
tuosity, most commonly present in the supradi-
aphragmatic segment and near the apex of the arch.
(Fig. 14.1). There can also be significant motion
Figure 14.1 Severe abdominal and thoracic aortic
tortuosity.
of the thoracic aorta that occurs during respiratory
and cardiac cycles. All of these factors make pre-
cise deployment of the devices near the delimiting
branch vessels (proximally: left subclavian or left
common carotid arteries, distally: celiac artery) sig-
nificantly more challenging than in the abdominal
aorta. Andlastly,thoracic devicesare larger than ab-
dominal devices and require proportionately larger
access vessels. This with a relatively higher inci-
dence of females with thoracic aortic aneurysms
and their smaller iliac arteries and occlusive disease
contribute to a higher incidence of local vascular
https://t.me/med1917
CHAPTER 14 Aortic aneurysms and dissections 107
Figure 14.2 Retroperitoneal iliac conduit using a 10-mm Dacron graft anastomosed to the distal common iliac artery.
complications and need for iliac conduits for de-
vice delivery (Fig. 14.2).
Advantages of endovascular
thoracic aortic repair
The advantages of endovascular thoracic aortic re-
pair over conventional surgery parallel those of the
abdominal aorta. Specifically, endovascular repair
avoidsthe morbidityof a thoracotomy andthe pleu-
ral adhesions that canoccur with prior chest surgery
or certain lung conditions [1–4]. The procedure
typically requires only a single groin cutdown and a
contralateral 5-Fr percutaneous femoral access. In
the cases of small or diseased iliac arteries, a limited
retroperitoneal pelvic exposure is required for an
iliac conduit. Unlike open repair, endovascular re-
pair can be performed under regional or even local
anesthesia. These aspectsof theprocedure obviously
have significant benefits in those who have compro-
mised pulmonary function and may become ven-
tilatory dependent with a thoracotomy and a pro-
longed period of general anesthesia.
Physiologically, endovascular repair offers even
greater potential benefitsby avoidance ofcardiopul-
monary bypass and need for aortic occlusion. The
deleterious effects of visceral and lower extremity
ischemia, reperfusion, and cytokine activation are
entirely avoided.These benefits have translated into
decreasedearly morbidity, shorterhospital lengthof
stay, and faster recovery to baseline function.
Zenith TX2 thoracic endovascular
graft
Currently, the only FDA-approved commercially
available thoracic endograft in the Unted States is
the TAG device (W.L. Gore, Flagstaff, AZ). At the
timeof thiswriting, three otherdevices areundergo-
ing various stages of IDE (investigational device ex-
emption) clinical trials including ZenithTX2 (Cook
Endovascular, Bloomington, IN), Talent Thoracic
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