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The Multilayer Stents— A New Progress of
Endovascular Treatment of Aneurysms
Authors: ZHANG Yong-xue1, LU Qing-sheng2, JING Zai-ping2
Department of Vascular Surgery, Changhai Hospital, Shanghai, China
1. First author: Dr. ZHANG Yong-xue, MD. Dept. of Vascular Surgery, Changhai
Hospital, Shanghai, China. E-mail: [email protected]
2. Corresponding author: Dr. Prof. LU Qing-sheng, Dept. of Vascular Surgery,
Changhai Hospital, Shanghai 200433, China. (Tel and Fax: 021-31161666, E-mail:
[email protected])
Corresponding author: Dr. Prof. JING Zai-ping, Military Institute of Vascular
Disease, Changhai Hospital, Shanghai 200433, China. (Tel and Fax:
021-31161670. E-mail: [email protected]).
Classification: literature review
Abstract:
Objective: To review the recent progress of multilayer stents in treating arterial
aneurysms and draw an initial conclusion about its paradigm.
Data sources: PubMed database and ELSEVIER database were searched with
keywords of “Cardiatis” or “multilayer stent” for relevant articles from Jan 2008 to
Sep 2012 . Relevant websites (provided by Cardiatis) were also involved in the review
process.
Study selection: well-controlled, relatively large-scale, retrospective studies as well
as meaningful individual cases were all selected as materials.
Results: In total 23 articles were involved in this review. The newly introduced
Cardiatis multilayer stent aim at creating an active flow-modulating barrier between
normal blood flow and aneurismal sac, which can induce thrombosis within
aneurismal sac and preserve collateral circulation at the same time. Meanwhile it
retains the virtue of flexibility and low-profile of uncovered stents. Currently, it has
been applied in complicated aneurysms located in different segments of arterial
system.
Conclusion: This new concept of multilayer uncovered stent offers a promising
alterative in the treatment of arterial aneurysms. However, a further large-scale
clinical and hemodynamic study is required to evaluate the long-term effect.
Key words: multilayer stents; grafted stents; aneurysm ; hemodynamics
An aneurysm is defined as a dilatation more than 50% in diameter of a normal artery
[1], and has a natural propensity to rupture without surgical intervention. The
treatment of aneurysms has experienced an evolution from complex open surgical
repair to minimally invasive endovascular therapy since the first case of endovascular
repair of an abdominal aortic aneurysm conducted by Parodi and his colleagues in
1991 [2]. With rapid development of endovascular technique as well as instruments in
the recent decade, this minimally invasive therapy has been applied in more and more
cases [3]. The current endovascular approach for treatment of aneurysms depends on
the use of grafted stents that mechanically block the aneurysm, prevent blood flow
from entering the aneurismal sac, and thereafter lead to a reduction in wall pressure
and shear stress of an aneurysm. Despite its advantages of lower mortality rate and
less complications, the application of covered stents is restricted in some complex
aneurysms located at aortic arch or next to vital visceral arteries. Meanwhile, the
inflexibility and high-profile of its deliver system impedes its utilization in
small-diameter arteries such as superior mesenteric artery and renal artery.
In 2008, Henry M reported a renal artery aneurysm successfully treated with a new
type of 3-dimensional multilayer stent [4], in which the multilayer stent was deployed
in front of the aneurysm neck with the inferior renal artery covered. Angiogram
showed blood flow inside the sac was immediately and significantly reduced and all
the renal artery branches remained patent. At 6-month follow-up, angiography showed
complete shrinkage of the aneurysm wall while all the inferior renal artery branches
remained patent. This accidental discovery offered an attractive and promising
alternative to covered stents in complex aneurysms’ management, and attracted
attention of vascular surgeons in the study of its hemodynamic mechanism. We briefly
review the recent progress of this new concept of uncovered stents, in terms of its
mechanism, features, indications and contraindications.
METHODS
A comprehensive literature review was performed in PubMed database and
ELSEVIER database through Sep 2012, using keywords of "cardiatis" or "multilayer
stent". Same reports from the two databases were identified and excluded. Relatively
large-scale investigations, as well as meaningful case reports were included in the
analyse process. Relevant websites (provided by Cardiatis) were also studied to draw
a comprehensive conclusion.
RESULTS
A total of 15 relevant articles were identified in PubMed. A search in ELSEVIER
database found 66 articles, of which 25 were relevant. 2 articles were literature review,
2 was commentary, and 15 were reduplicative reports when compared with articles
from PubMed. The remaining 6 articles were therefore selected for analyze. Another 2
articles were found on website provided by Cardiatis. In total 23 relevant articles were
involved in our review.
DISCUSSION
Hemodynamic mechanisms
To understand the mechanism of the multilayer stents, one has to be familiar with
basic theories of hemodynamics. When a multilayer stent is placed across the
aneurysm, flow velocity within the aneurysm is reduced while laminar flow in the
main artery is improved [4]. Computational fluid dynamics (CFD) study indicates that
a stent with an overall porosity of 50% to 70% will significantly reduce the inflow
rate into an aneurismal sac [5]. Optimal flow modulation effect is reached with a 65%
mean porosity. Secondary to this porosity level, when an aneurysm is covered, the
stent laminates the blood flow by pressure drop. Using particle image velocimetry,
Augsburger et al. demonstrated that velocity in the aneurismal sac decreases by an
average of 88% when a multilayer stent is placed [6].
Unique features:
Unlike grafted stents, the multilayer uncovered stent is a 3-dimensional interlocked
porous stent system which has several unique features. The first characteristic is its
porosity, which means it is incapable of preventing blood flow from entering the
aneurismal sac. However, due to a hemodynamic flow-modulating effect,
, the flow
velocity within the aneurismal sac is reduced, causing an organized thrombus to form
[7]. Therefore, if we consider the mechanism of covered stents as “passive mechanical
barrier”, this multilayer stent, on the other hand, creates an “active physiological
barrier”, which means that it causes the body to form thrombus actively within the
aneurysm sac. Exactly because of its new concept of exclusion mechanism, some
inevitable drawbacks of traditional covered stents such as side branches obstruction
and the requirement of branch embolization to avoid type 2 endoleak might be
overcome.
The second feature is its capacity of preserving vital collaterals. In fact, a
hemodynamic study conducted by C. Wailliez and G. Coussement with help of CFD
software has confirmed that the collateral circulation is few or with difficulty supplied
with blood when a local aneurysm forms, and when there is a multilayer stent, the
collateral is correctly supplied and has a more regular flow [8]. In comparison with
traditional covered stents which may cause problems like endoleaks and don’t permit
blood flow of collateral arteries, this new uncovered stent has obvious advantages.
The third feature of the multilayer stent lies in its flexible low-profile deliver system.
Traditional stent-graft applied in aortic aneurysms requires a deliver system with a
diameter of 18 French to 26 French, the inflexibility and high profile impedes its
application in small-diameter arteries like renal artery and superior mesenteric artery.
The uncovered stent, on the contrary, can be compressed into 6 French to 10 French
deliver system and therefore could be applied in these small arteries.
Finally, due to its active exclusion mechanism, this new multilayer stent requires less
landing zone than covered stents that rely on mechanical block of an aneurysm.
Applications in aneurysms:
A 3-dimensional interlocked multilayer stent is now commercially available (Cardiatis,
Isnes, Belgium) and has been tested successfully in patients with hard-to-treat
aneurysms at various anatomical locations. A large-scale clinical study is now
ongoing and the outcome has been encouraging so far. Its application has been
reported in different complex aneurysms.
1. Application in peripheral aneurysms.
Popliteal artery aneurysms (PAAs) account for approximately 70% of all peripheral
aneurysms [9, 10]. Prior to the occurrence of endovascular techniques, open surgical
repair including ligation and bypass had been the only valid solution to prevent
clinical consequence of arterial embolization, thrombosis and rupture. However, there
are significant rates of peri-operative complications including neurologic event,
infection, seroma and hematoma [11], and there remains a 30% chance of aneurismal
expansion over time in spite of open repair [12，13]. Given the associated surgical
morbidity and risk, the endovascular therapy was introduced in clinical practice
[14-18]. A retrospective cohort study conducted in 2007 consisting of 41 cases of
open and 15 cases of endovascular repair has documented similar 1 to 2 years patency
rate, and the latter approach has been considered as the first treatment option in
high-risk patients. Raffaele Pulli reported in 2012 a retrospective study including 64
PAAs in 59 patients, 21 cases were treated with endovascular repair, including 1 case
in which Cardiatis multilayer stent was utilized, whereas in the remaining 43 cases
open repair was performed. Estimated primary patency rates at 24 months were 59.4%
in endovascular group and 78.1% in open group (P=0.1); estimated 24-month
secondary patency rates were 78.4% and 81.6% respectively. The result indicated no
significant difference in terms of patency rate in two groups but the need for
reintervention to maintain the patency of graft was significantly higher among
patients endovascularly treated [19]. Michel Henry et al. reported 4 PAAs treated with
the multilayer stents in 2011, all of which thrombosed after surgery. Mid-term
follow-up is now ongoing [20]. So far the largest sample of PAAs with multilayer
stents came from Antoniou GA et al. who reported 6 patients underwent multilayer
stents placement, with a primary and secondary patency rate at 6 months of 67 % and
100 %, respectively [21]. Meanwhile, attempts were made to treat aneurysms at other
location including iliac artery and femoral artery with this bare stent by Michel Henry
and the results obtained seemed promising [22]. In 2010 he reported a short-term
follow-up of a multicenter prospective study to assess the safety, feasibility and
efficacy of Cardiatis multilayer stents for treatment of common iliac artery aneurysms
(n=8). Technical success (defined as successful deployment of the stent) was achieved
in all cases and at a mean follow-up time of 4 months no post-procedural
complications were observed. The occlusion rate was 100%, with all collateral
branches patent [23 ]. Although there has been so far no paradigm of its indication in
peripheral artery, the clinical outcome so far has been promising and has presented an
effective alternative to surgical and grafting approaches.
2. Application in visceral aneurysms.
Visceral artery aneurysms (VAAs) are a relatively rare pathological lesion with a
prevalence thought to be approximately 0.01% to 0.2% in general population [24].
Currently, there is a general consensus in the literature for the treatment of
asymptomatic VAAs of size > 2 cm, and for symptomatic ones, regardless of size
[25-27]. The reference standard for the treatment is considered to be open surgical
repair [28, 29], especially in emergency cases. Nevertheless, when it is technically
feasible, the endovascular approach is indicated in high-risk patients with suitable
anatomy [30]. Modern endovascular technique in treating VAAs comprises coil
embolization, stent-graft mechanical occlusion and the recent multilayer stent
physiologic exclusion. A. Balderi et al. retrospectively analyzed the endovascular
treatment of 30 patients affected by VAAs (26/31 were treated metal coil, 1/31 with
covered stent, 1/31 with coils and Amplatzer plug and 3/31 with Cardiatis multilayer
stents). During follow-up all VAAs remained excluded, with parenchymal ischemia
observed in 8/31 cases. One of the three patients treated with multilayer stents died 10
days after surgery as a result of new-onset hemorrhage; In the remaining two cases a
reduction of sac diameter from 81mm to 71mm (13%) and from 40mm to 36mm
(10%) respectively was documented [24]. Meanwhile, in another center, Emanuele
Ferrero et al. repoted their experience of visceral artery aneurysms with treatment
strategies ranging from surgery to multilayer stents. His retrospective study included a
series of 32 patients with different locations of VAAs (18/32 of splenic artery, 5/32 of
hepatic artery, 3/32 of superior mesenteric artery, 3/32 of pancreaticoduodenal artery,
2/32 of celiac axis and 1/32 of gastroduodenal artery). The difference of
morbidity/mortality rate between open and endovascular group was of no statistical
significance (9/24 versus 4/8; p=0.6597). The multilayer stents was applied in 4 cases
(all were hepatic artery aneurysms). In three cases the multilayer stent successfully
slowed down blood flow within the aneurysm, along with consequent thrombus
formation and preservation of collateral circulations. However, in another case of
multilayer stent, a technical complication with hepatic artery dissection was reported.
The reason was considered to be improper stent deployment [30]. But to some extent,
this case indicated lack of experience rather than methodological mistake. The largest
series with multilayer stents was reported by Ruffino et al. including 19 patients with
VAAs. In 6-month follow-up, a stent patency rate of 87.5%, a collateral artery patency
rate of 100%, a complete sac thrombosis rate of 87.5%, and a sac shrinkage rate of
75% were reported [31].
Beside the above mentioned relatively large series of
retrospective studies of VAAs, there were in addition several successful cases of
multilayer stents reported. Ferrero E et al. analyzed two cases with hepatic artery
aneurysms (34 mm and 48 mm in diameter, respectively) which were treated with
multilayer stents. At 12 months, a computed tomography scan showed thrombosis of
the aneurysmal sac and patency of all the branches of the hepatic artery [32].
Similarly, Balderi A et al. presented a case of hepatic artery aneurysm successfully
excluded by multilayer stents [33]. Carsten Meyer reported in 2010 a complex renal
artery aneurysm of 26mm in diameter with large middle-branch artery arising from
the aneurismal sac. Immediate post-interventional angiogram documented decreased
blood flow inside the aneurismal sac, and angiography performed at 3 month
follow-up demonstrated a complete exclusion of the aneurysm with preservation of
the middle-artery [34]. Ahmed M. Elsharkawy et at. used the multilayer stent for the
treatment of a hepatic artery pseudoaneurysm after liver transplantation, the
multilayer stent was placed from the native hepatic artery into the transplant right
hepatic artery, and the result was satisfactory: Computed tomography angiography
(CTA) performed 2 weeks after surgery demonstrated patent arterial flow to both
lobes of the liver and a thrombosed pseudoaneurysm [35]. Giampaolo Carrafiello et al.
made attempts in 2011 to treat a celiac trunk aneurysm with the uncovered stents, and
CTA at 12 month follow-up showed the patency of the stents without signs of stenosis
or myointimal hyperplasia, as well as the complete thrombosis of the sac, and direct
perfusion of the liver and spleen [36]. The above mentioned series and cases have
shown an encouraging and promising prospect of the utilization of multilayer stents.
However, despite all these successful cases with multilayer stents, there is still lack of
large scale of studies concerning its long-term outcome. And already, there have been
unsuccessful cases reported by Balderi and Emanuele in their relatively large series.
Further clinical studies are needed to evaluate its reliability.
3. Application in aortic aneurysms.
Similar to peripheral and visceral artery aneurysms, aortic aneurysms (including
thoracic aortic aneurysms and abdominal aortic aneurysms, TAAs and AAAs) are
treated conventionally with open surgical repair. But in more and more cases
endovascular repair has been applied and in term of short-term outcome, it seems
superior to open approach [37, 38]. However, it has been demonstrated that various
complications including endoleaks, limb occlusion, and device failure can develop
during long-term follow-up [39-44]. The braided multilayer stent has been applied in
several TAAs/AAAs’ treatment with purpose of avoiding some major complications.
In Michel Henry’s center, 10 aortic aneurysms (6 TAAs and 4 AAAs) were
experimentally treated with multilayer stents, all of which were thrombosed during
follow-up. In some of them shrinkage of aneurismal sac was observed [45]. A
longer-term evaluation concerning the patency of collaterals, the time needed for
complete thrombosis, and pressure change within the aneurismal sac is required to
draw a final conclusion of its reliability. In addition, other individual cases were also
reported which seemed to be in favor of multilayer stents’ therapeutic effect. Wulf
Euringer et al. reported a case of HIV-related multi-aneurysms successfully treated
with the multilayer stents. The patient was a 45-year-old male with AIDs who was
diagnosed by computed tomography with multiple aneurysms at the following
locations: bilateral subclavian arteries (right side:39×42mm，left side:28×25mm );
suprarenal
abdominal
aorta
(20×26mm);
and
infrarenal
abdominal
aorta
(51×49×46mm). The proximity of the subclavian artery aneurysms to the sprouting
vertebral artery, as well as the immediate vicinity of aortic aneurysms to the orifices
of the renal and visceral arteries prohibited the application of grafted stents, and
therefore the multilayer stents were chosen. In total 4 multilayer stents were
implanted (2 for the left subclavian artery aneurysm, 1 for the right subclavian artery
aneurysm,
and 1
for the two abdominal
aortic
aneurysms).
Immediate
post-intervention angiogram demonstrated a flow decrease in all aneurysms and
patency of all collateral circulations. A follow-up CTA at 18 months revealed only the
suprarenal aneurysm was persistent but with minimal perfusion. However, a reduction
in size was achieved in all aneurysms [46], which indicated an aneurismal pressure
decrease occurred. Benjelloun A, et al. reported a case of multiple thoracoabdominal
aneurysms of tuberculous origin treated with an endovascular procedure with the
multilayer stent. At 18 months, serial imaging studies showed disappearance of some
aneurysms and regression of others [47]. Tolva VS et al. presented a
thoracoabdominal aortic aneurysm which was discovered in a 57-year-old female with
severe comorbidity, three multilayer stents were implanted in the thoracoabdominal
aortic tract, obtaining at a 20-month follow up, a complete exclusion of the TAAA,
with normal patency of visceral vessels [48]. Natrella M
et al. recently reported a
complicated juxtarenal aortic aneurysm successfully treated with multilayer stents, in
which aneurismal shrinkage was observed [49]. Another case reported by Sidney
Chocron et al. was a thoracic-abdominal residual type B dissection, in which two
multilayer stents were implanted. A CT at 1-month follow-up showed the false lumen
was not completely thrombosed. However, at 3 months, CT documented the thoracic
false lumen was no longer patent, leaving only a false lumen in the abdominal aorta
with a maximal diameter of 36mm [7]. The results of successful cases of multilayer
stents seem convincing to support its application in aortic diseases. However, Lazaris
et al. reported a case of ruptured aortic aneurysm which was previously treated with
multilayer stents, suggesting that the issue of blood flow persistence inside the
aneurismal sac had not completely been solved, keeping the aneurysm enlargement
and rupture a probability [50]. In France, the Cardiatis multilayer stents are currently
under massive evaluation in the treatment of TAAs/AAAs (AFSSAPS, protocol#
2008-A01396-49/A). An outcome of large-scale clinical studies is expected in the
near future.
Preliminary experiences:
In term of aneurysm exclusion, the Cardiatis multilayer stent is a new concept of
active, physiological barrier that has several unique features in comparison with
traditional grafted stent. The main advantage lies in its capacity of excluding the
aneurysm and preserving the vital collateral circulation at the same time. Meanwhile
it retains the virtue of flexibility and low-profile of uncovered stents. At present, a lot
of successful cases have indicated the safety and reliability in a preliminary
experience. However, because its concept is newly introduced, there has been so far
no paradigm of its utilization. A further large-scale clinical and hemodynamic study is
required to evaluate the long-term effect of multilayer stents. Here we try to draw a
conclusion in following fields according to the initial experiences from different
centers.
1. Indications and contraindications
Due to lack of large series of clinical study, it is too early to determine the indications
and contraindications of multilayer stents. However, according to the above
mentioned series of studies and individual cases, the application in aneurysms with
vital collateral circulations or with complicated anatomy is indicated, especially
among high-risk patients with multiple co-morbid conditions. Ruptured aneurysms
with hemorrhage seem to be a contraindication with regards to the failed case reported
by A. Balderi, in which the patient died of new-onset bleeding. In mechanism, a
bleeding aneurysm may have a different hemodynamic status within the sac. However,
this conclusion is far from accurate and requires further verification.
2. Criterion of success
In the literature, most authors choose to utilize the multilayer uncovered stents with
the intention to maintain vital collateral circulations while achieve the exclusion of
aneurysms. During follow-up period, the following effects are expected to achieve:
The patency of stent; The patency of collateral arteries; The complete exclusion and
thrombosis of aneurismal sac; The shrinkage and pressure reduction of sac. The
endovascular repair of an aneurysm aims at the prevention of rupture, therefore, the
pressure reduction within the aneurismal sac is considered as gold standard of
success.
3. The time needed to achieve complete thrombosis
In most reported cases, CTA at 3 to 6 months is most likely to demonstrate a complete
thrombosis of the aneurysm sac. The length of time needed may be associated with
the morphological feature of the aneurysm, with/without branches sprouting from the
aneurysm, and the coagulation system of the individual. A failed case is considered if
the aneurismal sac remains patent 6 months after intervention.
4. Post-surgery medication
For aortic aneurysms, an antiplatelet therapy after implantation of traditional
stent-graft is not necessary in most situations. For peripheral and visceral artery
aneurysms, however, anticoagulation or antiplatelet medication is often recommended
after endovascular stent deploymen. After multilayer stents’ approach, In Wulf
Euringer’s opinion, an antiplatelet therapy is needed to preserve side branch patency.
On the other hand, the thrombosis process might be impeded by aggressive
antiplatelet or anticoagulation medications. There seems to be a paradox situation here,
and given the few data available on multilayer stents, the optimal post-surgery
medication remains uncertain [46]. However, according to previous experience in
traditional stents and the few available initial experience in multilayer stents, a
antiplatelet therapy including 100mg/d acetylsalicylic acid and 75mg/d clopidogral is
recommended in peripheral and visceral aneurysms treated with multilayer stent in
order to prevent parenchymal ischemia caused by stent stenosis.
CONCLUSION
In conclusion, the recently introduced multilayer uncovered stent is a promising
therapeutic option for the treatment of aneurysms in different locations from aorta to
peripheral and visceral arteries. The results obtained so far demonstrate its safety and
reliability. But a further large-scale clinical study with long-term follow-up is
warranted to draw a robust conclusion.
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