L E I P Z I G
I N T E R V E N T I O N A L
The official newspaper of LINC 2016
CONTENTS
Stents: ‘The good,
the bad and the
ugly’
2
CO U R S E
Issue 3 Thursday/Friday 28/29 January 2016
See you in 2017!
ILLUMENATE
FIH asks is predilatation always
necessary?
4
Debating EVAR
vs. open repair
10
Thank you all for making LINC 2016 such a great success! Over the last
few days we’ve all shared in a wealth of cutting-edge lectures, trial updates, tips and tricks, procedural prowess, and more. Of course, the live
cases have been a significant part of the stimulating programme, and have
sparked plenty of intrigue and discussion!
And there is plenty more to come – with a packed programme on Thursday,
as well as two key sessions on Friday morning.
Once again thank you for the continued support, and we look forward to
welcoming you again next year!
Stepping up
to lower limb
revascularisation
12
Who will benefit
from early
TEVAR?
22
Oxygen
microsensors
tipped for CLI
future
24
Has renal
denervation still
lost its nerve?
30
Patient-focused technologies
Aorfix and Altura take centre stage
A
live case yesterday morning saw the treatment
of an abdominal aortic aneurysm using the
ultra-low profile Altura endograft system (Lombard Medical, USA). Shortly before this, Dierk Scheinert
introduced Altura’s core concepts.
“This is a brand new device which only a few
months ago received European approval,” he said.
“It is repositionable when it is deployed in the landing zones, both proximally and distally. It is basically
designed to maximise the seal zones by allowing offset
positioning at the renal arteries. Because it consists of
two compounds, it completely avoids cannulation of
the contralateral limb.”
The stent graft has a ‘double-d’ design, the backbone of which is a highly flexible braided nitinol stent.
It also possesses, on its suprarenal part, hooks for fixation. The graft material itself is woven polyester.
“The device comes loaded into the delivery system,”
continued Professor Scheinert. “The proximal part is
deployed in the typical fashion from proximal to distal.
The distal aspect is deployed from distal to proximal to
allow very precise positioning.
“There is a built-in contrast injection feature, which
allows for precise targeting of the landing zones. One
of the major advantages is that it is really only a sixpiece inventory.”
So far, data on the Altura system is being collected
in two registries. “At the moment, we have 57 patients
from a first-in-man registry,” said Professor Scheinert.
“Then we have another registry, the ELEVATE registry,
which is a multicentre European registry.”
Continued on page 20
2 January 2016 LINC TODAY Thursday/Friday
Global Expert Exchange: Selected challenging cases – peripheral interventions Speaker’s Corner Thursday 10:15–11:15
Peripheral artery disease
The Wild West of Endovascular surgery
S
alman Arain (University of
Texas Health Centre, USA) is
an interventional cardiologist
who specialises in angioplasty and
stenting. LINC Today caught up with
Dr Arain ahead of the today’s session
on selected challenging cases, in which
he will be commenting on the ‘good,
the bad and the ugly’ stents for the
common femoral artery.
“It is not so much that there has
been a shift in philosophy – I think
there is a shift in the types of technologies that we have at our disposal
to treat patients with peripheral arterial disease,” he said.
Dr Arain pointed out that treatment indications have expanded – and
with this, a greater awareness of
these diseases and their treatment by
multiple sub-specialties, such as GPs
or in internal medical clinics, as well as
cardiology and radiology specialists.
He added: “Even surgeons themselves are choosing endovascular
options wherever possible to minimise
morbidity; not just because the evolution of new treatment paradigms
affects the outcomes, but also because
they affect the cost-effectiveness of
some of these therapies.”
Delving deeper into his presentation, he said: “The common femoral
artery is traditionally considered, along
with the popliteal artery, to be a nostent zone. The whole idea is that arteries in this location not only have to
go through tremendous changes with
normal daily activities such as walking,
running, kneeling and climbing stairs,
but also have important branches
coming off at these locations providing
collaterals, so the feeling always has
been that we shouldn’t put stents in.”
He explained that this belief largely
stemmed from an inherent lack of
faith in the stents, where they may
fracture, causing complications, there-
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deployed. If you stent into one artery
or the other (i.e. the profunda or the
SFA), the other artery usually becomes
difficult to access, because of the way
that nitinol is cut; and here you can’t
really do a kissing stent or a bifurcation.”
The Ugly
by removing further surgical options.
Dr Arain suggested that complicated
open procedures (such as complex
aneurysms spanning into a ligament)
may preclude stent usage, and in such
cases, an endovascular approach may
be taken.
“Focussing on the good, the bad,
and the ugly, I think the ‘good’ stent,
or the one that has really made us
more confident in treatment, is the
Supera stent [Abbott Vascular, USA],”
said Dr Arain.1
The Good
“I think what has changed now is that
we have better stents, with improved
radial strength, yet with preserved
flexibility. So the shift there is that we
have newer stent types. We are accruing data – there isn’t a randomised
study using the stent – but basically
we are using this particular stent’s
performance in the popliteal, and we
are extrapolating that to the common
femoral.”
Unlike laser-cut nitinol tube stents,
the Supera stent has a woven nitinol
structure that maintains its radial force.
Consequently, data shows very good
patency rates in short lesions within
the SFA, and in the femoral-popliteal
junction. Dr Arain spoke of his own
experience with this stent: “It has been
“The common
femoral artery
is traditionally
considered, along
with the popliteal
artery, to be a nostent zone.”
Salman Arain
used by many physicians in an off-label
manner to treat the popliteal, including myself, with very good results, so
the question whether we can use this
in in the common femoral artery.”
Dr Arain continued, with another
‘good’ example: “Stents that are not
necessarily the best, but are good
alternatives, are the flexible PTSE-covered stents, and the GORE VIABAHN is
an example.”
Dr Arain emphasised that this stent
has recently been made smaller and
shorter, resulting in potentially different deployment mechanisms; it can
now be used in smaller sheath sizes
and can also be deployed in the common femoral artery without necessarily
excluding the profunda femoris or
even being used as far up as the iliac.
Adding his own experience, Dr
Arain said: “One of the problems with
the VIABAHN is that you still have to
deal with edge restenosis, so anecdotally it is possible to go back into the
Supera with its unique nitinol cage
architecture with openings in it. You
can stent that area, put a sheath in,
go and do what you have to do, and
then pull the sheath out with the stent
architecture restored, whereas, with
the VIABAHN, it is harder to do that.”
Dr Arain continued: “I don’t think
I would use it as a primary choice. I
would use the Supera. However if
you had an area where you wanted to
exclude extravasation … then you can
go ahead and use it.”
The bad
Referring to what makes a ‘bad’
stent, Dr Arain commented: “The bad
stents would be the stents that we
have used in the past, but with less
efficacy. Those are balloon-expandable
stents, with or without PTFE covering,
because those stents are prone to fracture. Also, because the longer stents
tend to stent fracture, you really need
a very wide yet short stent and typically you don’t get those lengths and.
These stents can also get caught up
behind the inguinal ligament, where a
lot of wear and tear takes place.
“Another bad stent is the typical
nitinol laser-cut stent because there
are issues with how well it can be can
Dr Arain clarified what, in his experience, made an ugly stent, “I think
that ‘ugly’ refers to any stent that is
deployed without adequate lesion
preparation.”
“This is where we run into the
issue of performing atherectomy to ascertain the underlying vessel anatomy,
using imaging to get a better idea of
what the anatomy looks like with the
stent in. For example, whether the
vessel appropriately-sized, whether
bailout stenting should be considered,
and if there is restenosis then you go
ahead and do your stent placement.
He then commented on vessel
preparation using different scoring
balloons depending on the disease
type, “In diffuse disease, I will often
treat with something like CSI; for focal
disease I will treat with something like
TurboHawk or SilverHawk [Medtronic,
USA]; and the for lesions that actually
are very focal and calcified, I think you
need something like an AngioSculpt
[Spectranetics, USA] or a cutting balloon.”
Dr Arain’s overarching message was
that the treatment options using stents
is both lesion and patient specific, and
also about the technological advances
available.
Regarding the particular treatment
choice of patients, Dr Arain spoke
anecdotally: “In a patient who has
critical limb ischaemia, who is not a
surgical candidate, but needs restoration of straight-line flow to the foot,
we would treat from the iliacs down to
the below-knee vasculature.
“You really can’t treat everything
else and then leave the common
femoral for an atherectomy: you really
have to treat everything.”
“Other patients in whom, for
whatever reason, the SFA either has
not worked out (someone who has
had a below the knee an amputation), and also disease in the profunda
that is threatening wound healing
at the stump or the limb at a much
higher level, we would stent from the
common femoral into the profunda
femoris artery.”
Dr Arain concluded by describing
his approach in complex patients with
complex pseudoaneurysms that are
not amenable to open surgical treatment. “We basically kept the surgeons
from approaching it, and we tackled
it that percutaneously, the patient
subsequently had a bypass procedure
and did really well.
“Lastly patients with failed prior
procedures with fibrotic, recurrent
restenotic lesions just really aren’t
amenable to a surgical procedure, and
so therefore if you can do something
percutaneously, you can definitely
restore flow.”
References
1. Scheinert D, et al. A novel self-expanding interwoven nitinol stent for complex femoropopliteal
lesions: 24-month results of the SUPERA SFA
registry. Journal of endovascular therapy : an
official journal of the International Society of
Endovascular Specialists. 2011;18(6):745-52.
Epub 2011/12/14.
4 January 2016 LINC TODAY Thursday/Friday
Symposium: Advancing DCB therapy in complex SFA lesions Main Arena 1 Thursday 09:30–11:00
Is pre-dilatation always a necessary step?
Lessons from ILLUMENATE FIH
T
he two-year findings of
the ILLUMENATE firstin-human (FIH) study
emerged last year, with
impressive primary patency rates achieved in the superficial
femoral artery (SFA) and/or popliteal
arteries using the Stellarex drug-coated
balloon (DCB; Spectranetics Corporation, USA).1
The prospective, non-randomised
multicentre study was designed to
assess the safety and efficacy of
the Stellarex DCB inpatients with
symptoms of claudication or rest pain
due to femorpopliteal arterial disease.
The single-arm study included two
sequentially enrolled cohorts who
were treated with DCB either with or
without pre-dilatation.
Speaking to LINC Today,
ILLUMENATE FIH principle investigator Henrik Schröder (Jewish Hospital,
Berlin, Germany) described the DCB,
which received CE mark approval
in December 2014. “The Stellarex
balloon is based on a next generation
coating technology,” he said. “The
coating technology combines – we
hope – the best features of both
crystalline and amorphous coatings,
which leads to optimal drug transfer
to the tissue and long retention of
drug in the arterial wall.
“This coating is designed to
balance two conflicting needs. It is durable; a characteristic that is essential
to get the paclitaxel to the target site
(and not lost downstream in transit),
while maintaining the ability to be
released from the balloon upon inflation and be available for uptake and
retention in the arterial wall.” Recently
published evidence demonstrates the
significance of the coating make-up
and stability on drug transfer rates.2
ILLUMENATE FIH enrolled a total
of 80 subjects. The first cohort (n=50)
included 58 lesions of up to 15 cm in
length (mean lesion length 7.2 cm),
which underwent pre-dilatation with
an uncoated angioplasty balloon prior
to the DCB. The second cohort (n=28,
two patients were excluded from the
analysis who were inadvertently pre-dilated) included 37 lesions (mean lesion
length 6.4 cm) that underwent direct
DCB treatment without pre-dilatation.
cohort was 89.5% after one year and
80.3% after two years. Comparing
this to the other cohort, the ‘direct
DCB’ cohort, we found that primary
patency was 86.2% after one year
and 78.2% and two years. In the
pre-dil cohort, clinically-driven TLR
was 90.0% after one year and 85.8%
after two years. In the direct cohort, it
was 85.4% after one year and 81.7%
after two years.”
One amputation was recorded,
in the direct cohort. Dr Schröder
explained that the patient possessed
thrombotic occlusions, although was
not compliant with antithrombotic
medications.
“Importantly, we used the same
inflation times and pressures in both
groups.” Up to two DCBs were used
per lesion, and were sized to ensure
the full lesion length was treated and
good wall apposition was achieved.
Importantly, rates of post-dilatation
and adjunctive stenting were higher
in the direct cohort than in the pre-dil
cohort (35.1% versus 12.1%, and
8.1% versus 5.2%, respectively).
These higher post-dilatation and
stenting rates observed in the direct
cohort suggest the benefit of predilatation to reduce the need for
additional treatment steps following
use of the DCB.
“It is important to do a prolonged
post-dilatation if you do not have a
good enough result following DCB
treatment,” concluded Dr Schröder.
“We want to minimise stenting to
preserve future treatment options and
avoid the occurrence and burden of
in-stent restenosis. Additionally, we
saw a lot of positive remodelling after
prolonged post-dilatation,” noted Dr
Henrik Schröder Schröder. “In the follow-up angiograms [performed at six months] we
often saw very good remodelling, and
“In this first trial, we saw excellent
two-year results in both groups,” com- we were in some cases surprised about
the good remodelling after DCB PTA.”
mented Dr Schröder. “We compared
“We can conclude from this
the long-term outcomes and found
that we would recommend DCB PTA
there were no statistical differences.
without pre-dilatation for simple
The primary patency for the ‘pre-dil’
and short lesions. But we would not
recommend it for complex lesions,
such as, long lesions, occlusions, or
lesions with calcifications. We think
that in these complex lesions we still
need pre-dilatation or some kind of
vessel preparation before performing
DCB PTA.”
“To optimise the effectiveness of
DCBs, I think it is important that we
use undersized balloons for pre-dilatation and perform long (≥ 3 minutes)
DCB inflations. If necessary, post-dilate
and stent only if required in cases of
persistent flow-limiting dissections or
relevant residual stenosis.”
ILLUMENATE FIH lays the foundation for the ILLUMENATE series of trials
which are currently fully enrolled and
in the follow-up phase. ILLUMENATE
Global is a single-arm multicentre
study which includes 371 patients who
will be followed for up to five years.
ILLUMENATE EU-RCT is a randomized
trial which enrolled 327 patients across
Europe and will compare Stellarex
with POBA for de novo and restenotic
lesions in the SFA and popliteal segment. Similarly, ILLUMENATE Pivotal,
the US randomized study (Stellarex vs.
POBA), enrolled 300 patients and will
follow those patients for five years.
Finally, ILLUMENATE PK is a pharmacokinetic study looking at blood
concentrations of paclitaxel following treatment with Stellarex which
enrolled 25 patients.
Dr Schröder will present ‘The when and
why of pre-dilatation before DCB: lessons from ILLUMENATE FIH,’ during this
morning’s Spectranetics symposium on
advancing DCB therapy in complex SFA
lesions. The session takes place in Main
Arena 1 between 09:30 and 11:00.
References
1. Schroeder H et al. Two-year results of a lowdose drug-coated balloon for revascularization
of the femoropopliteal artery: outcomes from
the ILLUMENATE first-in-human study. Catheter
Cardiovasc Interv. 2015 Aug;86(2):278-86. 2. Kempin W et al. In vitro evaluation of paclitaxel coatings for delivery via drug-coated balloons.
Eur J Pharm Biopharm. 2015 Oct;96:322-8.
Are all DCBs equal?
W
hat is the evidence status of DCBs in
the SFA and is there a need for vessel
preparation? These will be the hot topics
of discussion in this morning’s symposium:
Advancing DCB therapy in complex SFA
lesions, sponsored by device manufacturer,
Spectranetics (USA)
ILLUMENATE FIH’s two-year patency of
80.3% is a strong indicator that the Stellarex
DCB’s proprietary EnduraCoat™ technology
provides a durable coating that reduces drug
loss during transit and facilitates efficient
drug delivery to the treatment site. Stellarex
uses 50% to 75% lower drug dosage den-
sity than other drug-coated balloons on the
market. The data both demonstrates positive
patient outcomes and indicates economic impacts as it reduces the need for retreatments
to keep vessels open and blood flowing.
Challenging lesions with calcium or
ISR may require specific vessel preparation
techniques for favorable long-term outcomes. Data from the PANTHER registry, which
comprises a real world prospective, threecohort, non-randomised study in 101 patients
and 124 femoro-popliteal lesions shows a primary patency at 12 months of 83.9% with the
AngioSculpt scoring balloon in combination
with a DCB, that exceeds either AngioSculpt
alone, or AngioSculpt in combination with a
stent. This registry also included 43.5% of patients with severe calcification, yet 81.8% of
patients achieved 12-month primary patency.
“After vessel preparation with AngioSculpt, calcium was not a predictor for loss of
patency at 12 months,” said vascular surgeon,
Professor Erwin Blessing from the Karlsbad
Clinic, Germany.
Also in the symposium, Professor Thomas
Zeller from Bad Krozingen, Germany, will
discuss how DCBs are moving towards
standard of care, presenting evidence for
DCBs used in SFA. Today, with a wide range
of DCBs on the market, and long-term outcomes forthcoming, many experts are beginning to find that differences between DCBs
are starting to emerge.
Neatly summarising the current status
among DCBs, Craig Walker (Clinical Professor of Medicine, LSU School of Medicine,
New Orleans, USA), who is speaking last in
the session, commented: “Not all DCBs are
created equal.”
Stellarex drug-coated balloon is not FDA approved.
6 January 2016 LINC TODAY Thursday/Friday
LINC Expert Course: Pioneering techniques for CLI and CTOs (Part I) Main Arena 1 Thursday 13:30–15:00
Carotid micro-mesh stent has its eye on the peripherals
T
his afternoon’s LINC Expert Course session
on ‘Pioneering techniques for CLI and
CTOs’ will feature an array of stimulating
live cases, as well as several informative lectures.
To that end, speaking about micro-mesh stent
technology during the seeion will be Daniel Périard (Hôpital Cantonal de Fribourg, Switzerland),
who took the time to walk though his main talking points with LINC Today.
The arrival of micro mesh stents has gathered
a lot of interest – especially, it would seem, in
carotid applications. With the hybrid technology
hoping to mimic the plaque coverage of closedcell stents, but the apposition and flexibility of
open-cell, can you give us your thoughts on the
technology, and the core benefits?
Cerebral embolisation during carotid artery
stenting (CAS) has been reduced by the systematic use of embolism protection device, but
the risk of delayed stroke after CAS remains
an important issue (67% of strokes occur after
procedure). The morphology of the plaque probably influences this risk. Soft plaque may allow a
good stent apposition to the artery wall, but
fragments may protrude through the stent cells,
and calcified plaque may favour stent malapposition and thrombi formation on the floating stent
struts.
Recently, a novel carotid stent design has
been developed: the double layer mesh stent.
The design allows a high flexibility to accommodate tortuous anatomy and artery flexion, and
also has excellent scaffold properties for optimal
plaque coverage. The stent is an assemblage of
an internal micromesh layer for plaque coverage
and an external self-expanding nitinol layer for
scaffolding, offering the flexibility and resistance
to external compression. The cell size of the
micromesh is the smallest (0.381mm2) allowing
for extensive plaque coverage.
What have results or trials pointed to thus far
– especially in terms of safety and patency?
The Roadsaver carotid stent manufactured by
Terumo [Japan], is the only stent available with
this new design. The low-profile and the rapid
exchange 5 Fr platform enhance the crossability,
and the design allows an excellent apposition
and transition between common and internal
carotid arteries.
Preliminary reports have shown excellent success of implantation without any adverse event.
In three Italian registries, more than 150 patients
received a Roadsaver carotid stent without com-
“The Roadsaver carotid stent
manufactured by Terumo
is the only stent available
with this new [micro-mesh]
design.”
Daniel Périard
plication, without plaque prolapse and with fewer new brain lesion on MRI than the comparator.
In the ClearRoad trial, almost 100 patients were
included in nine centers in Germany and Italy,
without any peri- or post-interventional stroke.
You will be framing the use of micro mesh
devices in the peripheral arteries. What considerations will you be focusing on primarily when
discussing this peripheral application?
The double mesh design of the Roadsaver
stent cumulates different extremely interesting
properties. The double mesh design allows an
excellent wall apposition. The outer larger mesh
provides resistance to radial crush but comforms
to all anatomy and tortuosity. The inner micromesh layer enhance the wall apposition, and
spread the opposition to crushing force more
regularly. This property may be interesting in
preventing delayed restenosis. The micro-mesh
also protects from plaque protrusion, a property
that may also be interesting for the periphery.
These properties are promising for the complex
lesions of SFA-pop such as in bending segment
or in extremely calcified lesions, where the standard laser-cut nitinol cylinders stents may lack of
resistance to external compression, and provide
disappointing results.
Also, the micro-mesh design allows for sidebranch patency but acts as a metallic covered
stent. There is a great potential for treating SFA/
pop aneurysms or post-stenotic ectasia, with a
5 Fr platform instead of the much larger platform
required for covered stent.
Considering these extremely promising
properties, we performed a pilot study with the
first implantation in SFA/pop arteries in 21 patients (19 occlusive PAD and 2 cures of popliteal
aneurysms). We included patients with extremely
calcified and complex lesions where implantation
of a standard stent was supposed to be disap-
pointing. The mean treated lesion length was
170 mm, and mean degree of stenosis 90%. Lesions were treated by repeated angioplasty. The
mean stented segment length was 35 mm.
Primary success of the implantation was
100%, and the primary permeability and the absence of restenosis at duplex scan was 100% at
30 days (n=21) and 100% at six months (n=14).
Based on these preliminary results, we consider
that the Roadsaver has great potential for the
most severe SFA/pop lesions. The security of the
Roadsaver implantation seems to be established,
since no stent thrombosis was observed. The
absence of restenosis after six months in these
challenging lesions are extremely promising and
this will be closely surveyed the next six months. Note: The Roadsaver stent is manufactured for CAS
and is not indicated up to now for the periphery.
Dr Périard’s study was initiated independently of
the manufacturer Terumo.
8 January 2016 LINC TODAY Thursday/Friday
mediAVentures
mediAVentures is a Belgian AV production company specialising in highend support for medical congresses. We have supported LINC from the
very first edition.
A crew of 80 mediAVentures technicians is working here in Leipzig, while
another 40 are on the road for the live transmissions. We start building
everything in the conference hall 10 days before the start of the congress,
and dismantling and loading out takes two days. 27 trailers of equipment
were brought in from Belgium this year.
We have 13 live centres transmitting this year, of which 12 are completely
handled by mediAVentures teams.
We use 218 hours of satellite capacity on three satellites, and up to eight
different channels at the same time. Transmissions from Mount Sinai,
New York arrive via transatlantic optical fibre from Washington DC to Leik,
Switzerland. All centres are now transmitting a minimum of two feeds –
one with the medical images and one with camera images. used on the big screens. Leipzig University Hospital is connected with the
congress venue via microwave and wifi, over a distance of 10 kilometres
with a data rate of 240 Mbps.
Including back-up feeds, we have up to 36 video feeds at the same time
arriving in the Master Control Room backstage of Main Arena 1.
New features at this year’s congress are of course the prominent glass
walled Main Arena 1, with its side screens and headphone system that
allows people to follow cases shown in Main Arena 2 and the Technical
Forum at the same time. The electronic Moderated Poster islands are
new and quite successful. The Speaker’s Corner has also been a welcome
addition as the 6th meeting room. Over all, we paid a lot of attention to the acoustic insulation of all function
rooms and the small meeting rooms, using a total of 1,300 sound baffles.
If anybody is interested in a backstage tour to see the Master Control
Room don’t hesitate to drop us an email at wimvanrenterghem@
mediaventures.be!
Wim Van Renterghem
The three cathlabs in University Hospital in Leipzig are each transmitting
four feeds – in Main Arena 1 in particular one can see how these feeds are mediAVentures CEO
Thursday/Friday LINC TODAY January 2016 9
Early results of sinus-Obliquus in May-Thurner and
sinus-Venous continues to deliver
“O
ne stent does not fit all”, is the overriding message at today’s symposium
entitled New horizons in the treatment of
deep venous disease, sponsored by German
device manufacturer, optimed.
Renowned for their sinus-Venous stent
that has received acclaim for its unique
combination of strength and flexibility, the
discussion will also turn to optimed’s most
recent development, the sinus-Obliquus, the
first oblique venous stent on the market.
The sinus-Obliquus is specifically designed for treating venous obstructions close
to the bifurcation of the inferior vena cava,
allowing the stent to be placed directly at the
bifurcation. This is a particular requirement
for the anatomical anomaly May-Thurner
Syndrome.
Nils Kucher, Extraordinary Professor
for Vascular Medicine and Director of the
Venous Thromboembolism Consult Service
at the University Hospital Bern, Switzerland,
will discuss more about how the sinusObliquus, which provides the perfect balance
between radial force at the compression site
and flexibility to accommodate the anatomy
of the curved iliac vein, addresses this problem. Along with the presentation of novel
three-month results, more generally, he will
discuss clinical outcomes and patency rates of
the new generation of venous stents.
Rick de Graaf, an interventional radiologist from the Department of Radiology,
Maastricht University Medical Centre, the
Netherlands, will report three-year follow-up
results of the dedicated sinus-Venous stent
used in deep venous stenting that has become
the primary treatment option for chronic
venous obstructive disease, both for iliac vein
compression and post-thrombotic venous
lesions.
optimed have had experience with dedicated products for the treatment of venous
diseases since 2012. There have been significant changes over the last three years with
thrombolysis, thrombectomy and venous
stenting dominating over conventional compression therapy and oral anticoagulation.
The growing interest is not only becoming
neously exerting a pulsation force on the vein.
If a standard stent is used in May-Thurner
Syndrome, it can protrude into the vena cava
and obstruct the blood-flow in the contralateral iliac vein, and a standard stent might
be placed in such a way that the compressed
vessel section is not completely covered.
“The proximal close cell design part of
the sinus-Obliquus enables high radial force,
while the distal open cell design part provides
flexibility. This is the rationale for the hybrid
design,” said Professor Kucher. “The tip of
the sinus-Obliquus is oblique to an angle of
35 degrees, as calculated from the anatomy of
May-Thurner patients.
“With the sinus-Obliquus, the stent is
placed on the confluence, just a few millimetres over the confluence of the common iliac
veins so the blood flow is not obstructed.”
In a small study on 23 young patients
(mean age 38 years), Professor Kucher has
treated May-Thurner Syndrome with the
novel venous self-expanding oblique hybrid
nitinol stent. “We found 100% patency at
Nils Kucher
Rick de Graaf three months,” said Professor Kucher. “Nine
patients had acute iliofemoral thrombosis
increasingly evident among specialists but pa- ibility but no loss of radial force.
after catheter-directed thrombolysis, 10 patients too are becoming aware of the options
“I like the way we can work with this stent tients with post-thrombotic syndrome (PTS),
that are emerging.
and four patients with non-thrombotic iliac
– I can make it shorter or longer. If you’re
vein compression.”
too fast with it then you get a configuration
Results will be presented in their comwhere segments are not close to each other.
sinus-Venous ensures the
pleteness tomorrow, showing that a primary
Deployment technique is important,“ Dr de
physician retains control
patency rate of 100% (23/23) with complete
Venous stents are most commonly used for
Graaf highlighted. “If a stent can only be deresolution of clinical symptoms in in 39%, an
post-thrombotic syndrome, residual thrombo- ployed one way then you cannot manipulate
improvement in 52%, and no change in 9%.
sis as well as May-Thurner Syndrome.
it at all, you are constrained. I prefer to have
the versatility to manoeuvre and have control There were no procedural complications.
In an interview with LINC Today, Dr
Professor Kucher concluded: “These are
de Graaf mentioned that stents used in the
as the physician.”
early days and we need to await the longer
venous anatomy had to take into account
term results. These are also young patients.
characteristics that are different to stents de- sinus-Obliquus early results
We will follow these patients for many years
signed for the arteries. Constant angles and
in May-Thurner
with annual review.”
the range of movements inside the pelvis
Discussing the sinus-Obliquus stent, ProfesIn addition to improving stent perforduring ambulation, as well as longevity of
sor Kucher emphasised the need for a dedimance and novel clinical data, optimed is
function all need to be considered, he noted. cated May-Thurner Syndrome stent and how
going one step further still by aiming to
Ideally, a venous stent needs to have an opthe sinus-Obliquus hybrid stent meets this
give everyone the possibility to experience
timal combination of flexibility where this is unmet medical need.
required, yet strength at points of high presIn May-Thurner Syndrome, an anatomical the clinical pathways of established venous
sure. He explained that the sinus-Venous is
anomaly causes the right common iliac artery centres, and to learn from their protocols and
a design whereby the rings of the stent are
to overlie and compress the left common iliac competence in developing new horizons in
connected at only two points so there is flex- vein against the lumbar spine, whilst simulta- the treatment of venous disease.
10 January 2016 LINC TODAY Thursday/Friday
THE GREAT DEBATE: Treatment of ruptured aortic aneurysm – what is the best solution? Discussion Forum Thursday 12:30–13:30
EVAR takes the vote in Great AAA Debate
T
he treatment of ruptured abdominal aortic aneurysms
(rAAA) with either open or endovascular repair (EVAR) is a
thorny issue that has sparked a great deal of discussion in
recent years. With that in mind, LINC will frame a ‘Great Debate’
on the subject during today’s programme, letting experts share
their perspectives for all to hear.
With studies on the subject of open versus endovascular repair
now fresh in the minds of the speakers, results such as those from
the IMPROVE trial1, which concluded that endovascular repair was
not associated with significant reduction in either 30-day mortality
or cost, would on paper seem like a useful tool for speakers to
rely on in order to make their arguments. But in reality, both Frank
Veith (New York, USA) and Thomas Larzon (Örebro University
Hospital, Sweden) – and possibly others – will use their time during the session to explain how recent trials are “misleading” or
“irrelevant”, with their own experiences in endovascular aneurysm
repair (EVAR) being key.
“The design of IMPROVE is good. However, you cannot really
generalise the data you get from that trial,” Dr Larzon told LINC
Today. “There are so many patients – and only minor proportion
of the patients are actually randomised – and there is a lot of
crossover in this study. So actually you cannot draw any occlusions
about the cohort of patients with ruptured aneurysms. That is the
big problem with this trial, even though the intention is good.”
Based on this kind of data, Dr Larzon stressed that for good
candidates, open repair or EVAR will likely have similar outcomes,
and those unfamiliar with EVAR could still use open repair. However, such data has been open to criticisms of “cherry picking”
patients best-suited to the procedures, which is why Dr Larzon’s
experience – which quite remarkably has
relied on 100% EVAR since 2009 – is a
clearer standpoint, as all patients are taken
“The design of IMPROVE
said, it is hard to implement change:
down the EVAR route when possible.
is good. However, you
“There is resistance because if you are
Dr Larzon lies on the side of an EVARgood at open repair, it is hard to get peofirst, open-second (i.e. when EVAR is not
cannot really generalise
ple to move in a new direction, especially
possible) perspective for ruptured aneurysm
the data you get.”
if they have experience and are really
cases. But convincing others is not easy, as
good surgeons with really good results,”
he described: “I think it comes very much
Thomas Larzon
said Dr Larzon.
down to the organisation, because you do
“But EVAR is already in its third genneed to do a lot of elective EVAR… If you
eration now… the trend has shifted, so it will be very natural in
don’t do it electively, you will probably not be familiar enough to
the future to use EVAR. Yes, a few cases will not be a fit for EVAR,
do a ruptured case.”
[e.g.] infections, and so on, but probably we will see a few selecAs such, he reasoned that if physicians accept that elective
tive centres [emerge] that will collect these patients, so that they
EVAR is at least as good as open repair in the majority of patients
get enough volume to do open repair.”
then surely the choice for EVAR is a “non-question”. That being
Moving on to discuss the adjunctive therapies that are important in the EVAR procedure itself, Dr Larzon commented: “First of
all you have to have a method to control patients that are in deep
shock. In open repair you have a cap on the aorta, but the tool
we have is balloon occlusion. And you can actually do the whole
procedure … using two occlusion balloons. Normally people are
thinking about one, but if you have two and shift them, you start
to have a high occlusion above the visceral arteries and the renal
arteries, and when you have the stent graft in place, you move
the second aortic balloon below the renals, and then you can get
circulation to the critical organs.”
Dr Larzon’s second touching point was the chimney technique: “We were the first centre that demonstrated the chimney
technique as an intentional technique to cover a branch organ and
then reopen it with a parallel
stent. That was 10 years ago,”
he said, adding: “That was
“There is
very important tool, so we can
preserve at least one renal artery
resistance
with this technique.”
because if you
Finally, Dr Larzon mentioned
are
good at
the importance of embolic protection using the Onyx liquid embolic
open repair,
agent. “With that we can cover
it is hard to
the iliac arteries, have the stent
get people to
placed in the external renal, and
then we can embolise the hymove in a new
pogastric artery,” he said, adding
direction.”
that they could also use it in type
IA endoleak, sealing the gutter.
Thomas Larzon
Reflecting on the main messages for the future, Dr Larzon
concluded by noting that trials should not be our main focus:
“They are a waste of energy I would say. It is must better that
people concentrate on the logistics and the right infrastructure.”
Dr Larzon will present ‘The main conclusions of RCTs for ruptured
AAAs are irrelevant as 100% of rAAAs can be treated by EVAR and
adjunctive techniques’ today during the session ‘THE GREAT DEBATE:
Treatment of ruptured aortic aneurysm – what is the best solution?’,
12:30–13:30, Discussion Forum.
References
1. IMPROVE trial investigators. Endovascular or open repair strategy for ruptured
abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial. BMJ
2014; 34
Critical issues and pioneering solutions in aortic endografting Main Arena 1 Friday 09:00–12:30
Parallel and Chimney Grafts
The future of high-risk aortic endografting?
F
rank Criado (Union Memorial Hospital,
Baltimore, USA), one of the leaders of the
parallel/chimney evolution will take centre
stage tomorrow as he presents his talk ‘Chimneys
and parallel grafts will remain useful for many
years to come: Summary of current techniques
and results’ in the final session of LINC 2016.
LINC Today caught up with Dr Criado before his
presentation to discuss these grafts and how their
role may play out in years to come.
Open surgical repair aortic segment is associated with considerable periprocedural risks.
Successful endovascular repair is dependent
on the exclusion of the target aortic segment
by the stent-graft device; this is achieved by
optimal landing at the proximal and distal necks
in addition to secure circumferential fixation. The
presence of important branches within the target
segment can be challenging and the chimney
graft techniques have evolved in the effort to
preserve such vessels as well as optimize or
lengthen the landing zones.
Dr Criado began with a short history of the
development of parallel and chimney grafts:
“Chimney and parallel grafts emerged in the
early 2000s and have evolved over the past 15
years. Interestingly, in near-perfect parallel with
fenestrated grafts.”
As one of the leaders in chimney and parallel graft evolution, in 2003 Dr Criado placed
a bare-metal stent in the left common carotid
artery to re-establish antegrade flow after an
unintentional stent-graft coverage during a
thoracic endovascular aortic repair procedure
for treatment of a distal aortic arch aneurysm1.
Since then, his reasoning that longer chimneys
traversing a lengthier course inside the aorta
would be feasible set the stage for subsequent
developments2.
Dr Criado commented on chimneys comparison to branched and fenestrated grafts, and to
whether they have cemented their place in the
modern arsenal quite as firmly, “In the last five
years, chimney and parallel grafts have definitely
established themselves as an important and valid
option for complex aortic repair, especially in
those cases where more traditional and proven
surgical options for aortic debranching are
deemed impractical or unfeasible.”
Continued on page 11
Frank Criado
Thursday/Friday LINC TODAY January 2016 11
Critical issues and pioneering solutions in aortic endografting Main Arena 1 Friday 09:00–12:30
He added: “Particularly in the face of non- underpinned by a much larger body of evidence and good clinical data, but parallel graft
availability or non-access to fenestrated and
experts are finally meeting this need as well.”
branched technologies.”
Regarding tomorrow’s talk, Dr Criado will
With regards to efficacy and safety,
outline the long-term picture for chimney
chimneys and parallel grafts demonstrate
and parallel grafts and also weighed-up the
very high technical success with relatively
limitations, “I will
few complications,
comment on the
although large rannext five years, and
domised study data
“In the last five years,
illustrate how these
is not yet available,
chimney and parallel
techniques are sure
the midterm to longto remain useful.
term results are very
grafts have definitely
“Additionpromising3. Dr Criado
established themselves
ally, I will review a
expanded: “Technias an important and
few areas where
cal success rates are
improvements are
extremely high, and
valid option for complex
likely to become a
they clearly represent
aortic repair.”
reality in the foreseeexcellent options for
Frank Criado
able future, further
urgent and middle-ofsubstantiating the
the-night situations,
tremendous utility of
plus those described
above.” However, in spite this data, Dr Criado parallel graft technique in a variety of situapointed out that “many experts remain some- tions surrounding complex aortic repair.”
References:
what sceptical, and continue to resist use in
elective procedures where other solutions are 1. Criado FJ. A percutaneous technique for preservation of
arch branch patency during thoracic endovascular aortic
available.”
repair (TEVAR): retrograde catheterization and stenting.
Journal of endovascular therapy : an official journal of
A retrospective analysis of over 500
the International Society of Endovascular Specialists.
2007;14(1):54-8. Epub 2007/02/13.
patients demonstrates comparable outcomes
2. Criado FJ. Chimney grafts and bare stents: aortic branch
with chimneys and parallel grafts to those in
preservation revisited. Journal of endovascular therapy :
an official journal of the International Society of Endovaspublished reports of branched/fenestrated
cular Specialists. 2007;14(6):823-4. Epub 2007/12/07.
devices, suggesting broader applicability
3. Bin Jabr A, et al. Efficacy and durability of the chimney
graft technique in urgent and complex thoracic
for these devices4 and a literature review
endovascular aortic repair. Journal of vascular surgery.
published in 2013 demonstrated impres2015;61(4):886-94 e1. Epub 2015/01/27.
5
sive technical success rates (99.2%) , but
4. Donas KP, et al. Collected world experience about the
performance of the snorkel/chimney endovascular techmore data is still required to strengthen the
nique in the treatment of complex aortic pathologies: the
evidence. Dr Criado explained: “Undoubtedly
PERICLES registry. Annals of surgery. 2015;262(3):546-53;
discussion 52-3. Epub 2015/08/11.
we need more evidence and it is beginning to
5. Moulakakis KG, et al. The chimney-graft technique for
emerge at the present time.
preserving supra-aortic branches: a review. Annals of cardiothoracic surgery. 2013;2(3):339-46. Epub 2013/08/27.
“However, use of fenestrated devices is
12 January 2016 LINC TODAY Thursday/Friday
Symposium: Strategies, devices, and techniques to optimize solutions for endovascular aortic repair Main Arena 2 Thursday 13:30–15:00
A
Approved for Dr Kelly’s IDE only in the United States
A VALIANT effort in thoracoabdominal aortic aneurysm treatment
new graft to simplify the treat- a design where you don’t have to do
that. Where you have clear perfument of thoracoabdominal
sion, uninterrupted and unimpeded,
aortic aneurysms (TAAA) will
throughout the procedure.”
be presented today at LINC, pushing
To address the conundrum of
forward the boundaries of minimallymaking a graft that fitted all of the reinvasive treatment in the thoracoabquirements, Dr Kelly had to take some
dominal space.
intuitive steps: “I thought ‘Why can’t
The concept of the novel device,
I use the aorta as a conduit to run
the Valiant Thoracic Stent Graft
my bypasses?’, one at a time … and
(Medtronic, USA), came from Patrick
Kelly, a vascular surgeon from Sanford then once that is done, extend further
down to the iliac.”
Health, Sioux Falls, USA.1 Dr Kelly
He added: “And even though our
has collaborated with the company
graft looks pretty strange – it doesn’t
to manufacture the device and take
look like anybody’s anatomy – it actually
it forward in studies such as the
follows all of the rules that we learned
physician-sponsored (PS) investigational device exemption (IDE) trial that from open surgery. You have got have
good inflow (we have a 20mm pipe that
is currently underway.1,2
flows into four 9mm branches), a good
“I started this project, at least in
conduit (a pipe that is wide open), and
terms of the design criteria, back in
you have to have good outflow, which
2012,” recounted Dr Kelly in an interview with LINC Today, “I came up with means that, because we use balloonsome design parameters that I thought expandable stents, even if an artery has
a restenosis, we can angioplasty that
we figured out was that it is actually
every stent graft that was going to
very difficult to find a patient that
to get that opened up, and have better
take on abdominal aortic aneurysms
meets the inclusion criteria for an ‘ideblood flow to the kidney.”
needed to have. Obviously it needed
As Dr Kelly emphasised, the Valiant alistic’ thoracoabdominal aneurysm.
seal and fixation, but it also needed to
“Because of that we have actube able to handle almost any anatomy, benefits from branch diameters that
ally gone back to the Food and Drug
and what I realised was that every time are almost as large as the main chanAdministration [FDA] with our IDE and
nel in other current devices, meaning
we tried to build a graft that looked
have expanded our inclusion criteria.”
improved flow overall.
like the natural aorta, we started
He added: “Right now
limiting ourselves because evewe have five patients treated
rybody is a little different.”
under the IDE, and only one
As well as attempting to
“I came up with some design
of them met the inclusion
create a graft with favourable
parameters that I thought every
criteria … and we actually
flow dynamics, Dr Kelly was
had to ask for a waiver for
also keen that the graft should
stent graft that was going
this patient to even meet the
be deployable in such a way
to take on abdominal aortic
inclusion criteria. Fortunately
that would maintain perfusion
aneurysms needed to have.”
as we move forward in 2016
to all the vital organs should a
we are going to see a lot
situation arise where the opPatrick Kelly
more patients meeting the inerator needed to quickly step
clusion criteria for our graft.”
away from implantation. This
Discussing the wider results
Speaking of the experience in using
is in stark contrast to other devices:
“[They] actually deploy over the open- the Valiant graft thus far, Dr Kelly went from 29 patients treated so far, Dr
Kelly relayed that there has been no
on to relay some talking points from
ings of the celiac, the SMA and the
in-hospital or 30-day mortality, in a
the ongoing IDE study, beginning with
renal arteries,” he said.
“They may do so in a way that you a note about patient enrolment: “Most patient cohort ranging from 58 years
old, to 87 years old.
of these patients either have some
don’t completely cover them, but you
Dr Kelly stressed that if you look at
evidence of peripheral vascular disease
still have to cover those connections
the people who don’t meet the criteria
– with either an iliac artery stenosis or
before you walk away from a case,
for an idealistic thoracoabdominal
a renal artery stenosis – or have had
for the most part, or you are going to
aneurysm, most of them also wouldn’t
a previous infrarenal graft or thoracic
have a very compromised patient. So I
be open surgical candidates. Delving
graft,” he said. “So one of the things
thought we really needed to develop
into open repair data, he continued:
“If you look at the some of the most
recent publications for open repair,
they are quoting a 1 in 4 mortality rate
for open surgical candidates …but
open surgical candidates for thoracoabdominal aneurysms are pretty
healthy patients. They cannot have
any renal insufficiency, they cannot
have any COPD [chronic obstructive
pulmonary disease] etc.”
In fact, the disparity in patient and
disease characteristics in open versus
endovascular repair is something Dr
Kelly was keen to point out. “I think
what is really scary is that if we take
even the healthiest thoracoabdominal
patients to open surgery, we’re going
to expose them to a 25% mortality rate
just in the hospital,” he said. “Whereas
we can take pretty much whoever you
send us, and we still have a zero inhospital and 30-day mortality rate.”
Looking to the future, Dr Kelly
commented on the prospective revolution that the Valiant off-the-shelf
design brings to the field. “With four
different grafts, you can probably take
on pretty much the entire aorta. All
you have to do is match the thoracic
diameter for the bifurcation, and then
“You can probably
take on pretty much
the entire aorta.. So
this is exciting, and
I think it is going to
get some traction.”
Patrick Kelly
after that it is all just graft-to-graft
interactions, and not dependent on
anyone’s anatomy. So this is exciting,
and I think it is going to get some
traction.”
Dr Kelly will introduce the Valiant Thoracic Stent Graft during the symposium
‘Strategies, devices, and techniques to
optimize solutions for endovascular
aortic repair;, held this afternoon at
13:30–15:00 in Main Arena 2.
References
1. Medtonic / Sanford Health. Medtronic to
Develop Stent Graft System for Endovascular
Repair of Thoracoabdominal Aortic Aneurysms
Under Exclusive Patent License Agreement with
Sanford Health. Press release, April 14, 2015
(Available from newsroom.medtronic.com)
2. Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms. ClinicalTrials.gov
(Available at https://clinicaltrials.gov/ct2/show/
NCT02294435; Accessed January 2016)
14 January 2016 LINC TODAY Thursday/Friday
The last frontiers: Retrograde tibial interventions and below-the-ankle angioplasty Main Arena 1 Thursday 08:00–09:30
Stepping up to the challenges of lower
open, probably you should stop your procedure
in that sector.”
He added: “Every patient is different. You
must tailor your procedure for the patient, based
on your technical opportunities.”
A crucial component of the whole angiosome
concept is proper wound healing and ‘functional’
limb salvage, i.e. setting the bar high enough
to recognise that a saved limb does not always
equal a healthy limb. “Limb salvage is in some
ways an old concept,” said Dr Ferraresi, adding
that wound healing, time to wound healing and
restoration of ability are measures that should
receive more focus.
“Every patient is different. You
must tailor your procedure
for the patient, based on your
technical opportunities.”
Roberto Ferraresi
Thursday’s Main Arena 1 programme kicks off with an exploration
of retrograde tibial interventions and below-the-ankle (BTA) and
below-the-knee (BTK) treatment. Coined as a ‘last frontiers’ session, the topics that will be presented represent the cutting-edge
paradigms and techniques for difficult anatomies.
The angiosome concept
I
n his presentation, Roberto Ferraresi from
Bergamo, Italy will be framing the implications of the ‘wound-related artery’ concept
(a.k.a. angiosome concept) for revascularisation
strategies below the knee.
By delineating body tissue into three-dimensional blocks that are fed by specific arterial and
venous sources known as ‘angiosomes’, the
concept hopes to improve revascularisation of
ischaemic tissue lesions.1
While the angiosome concept is a “thing of
beauty”, as Dr Ferraresi put it, in the real world
of angioplasty, critical limb ischaemia and so on,
to follow the model is very difficult for many
reasons. “First of all, every one of us tries to do
what he or she is able to do for a patient, and
not what could have been done in a perfect
case. Not always can the wound-related artery be
opened,” he told LINC Today.
“So we must try to open what is realistic to
open, from a technical point of view. And this is
very important I think because you cannot lose
time, and effort, or increase the X-ray time and
the amount of contrast dye, only to try to open
what is impossible to open from a technical point
of view. First of all, I think you must try to open
what is easy to open, because the best procedure
for these types of patients, who are always very
fragile, with a lot of comorbidities, is the procedure with the least amount of contrast dye, X-ray
time, or stress related to the procedure.”
He continued, turning his attention to the collateral vessels, saying: “Not all collateral vessels
are involved in the disease. So if you are able, for
example, to open the dorsalis pedis artery and
you have good collateral vessels sending blood
to the plantar system, probably you need not
open the posterior tibial artery as well. Obviously
if to open this artery is an easy task, you can and
must do it, but if it is calcified and difficult to
Similarly, Dr Ferraresi cautioned that quality
of life (QoL) after revascularisation was not being
properly considered, saying: “We must remember that patients with critical limb ischaemia
– and we use that term: critical limb ischaemia
– are in this huge ‘bag’ that we put every patient
in. Some have lesions in the foot, and some have
lesions in the arterial tree in the limb, but they
are not the same… There are families of different
situations and different diseases that can go
together into this bag that we call critical limb
ischaemia.
“For example in very old patients, with some
degree of heart failure, and some degree of peripheral artery disease … critical limb ischaemia
is sometimes an expression of the final part of
life, something like cancer. In other cases we are
talking about critical limb ischaemia in a very
young patient, for example with a history of type
I diabetes, or end-stage renal disease, on dialysis.
This patient, at 30 or 40 years old has a diffuse
calcification of the vessel tree, with diffuse disease of the small vessels of the foot. This is also
critical limb ischaemia, but obviously in this type
of patient, we must try to do the best to avoid
amputation, because this is a young patient.
Probably their survival will not be very good, but
we must try to give months or years to them.”
He continued: “In the middle of these two
expressions of critical limb ischaemia, we have
a lot of middle-aged patients, say 60-70 years,
with disease of the vessel, with a neuropathy,
for example, due to diabetes. These patients
probably can have the best result because the
lesion in the foot is not the final expression
of the final feed of the vascular tree, but an
expression of neuropathy for example, or
trauma. So critical limb ischaemia is something
very rough as a concept. We need to divide
these patients into different categories, and to
standardise every type of treatment for every
type of patient.”
As Dr Ferraresi described, historically, foot
vessels were not well-considered in CLI, with
studies dominated by retrospective cohorts.
With that in mind, what are his perspectives
on the next steps to improve knowledge of
when, and how vigorously, to pursue revascularisation? “In the past, all of the physicians
concentrated on big vessels, and this is for
“Additional below-the
ankle angioplasty should
be considered for patients
with pedal artery disease
when they do not show
sufficient wound blush after
conventional above-the
ankle angioplasty.”
Hiroyoshi Yokoi
Thursday/Friday LINC TODAY January 2016 15
limb revascularisation
“You cannot lose time, and
effort, or increase the X-ray
time and the amount of
contrast dye, only to try to
open what is impossible.”
Roberto Ferraresi
many reasons,” he said. “The first reason is
probably that, in the past, the main risk factor
for peripheral artery disease was not diabetes
and age, but hypercholesterolaemia. In the
last century we had a prevalence of big vessel
disease, but today we can an epidemic of
diabetes, and a [prevalence] of old men and
women, so we have a shift of the obstructive
disease to the peripheral field, below the knee
and below the ankle.”
He added: “And the second reason was
that treating big vessels is easier than treating
the small vessels. Vascular surgery was born as
a war against big vessel disease, for example
artery disease, and bypasses. To do a bypass you
need something very good above and below the
obstruction, but today we have patients with
disease that is so distal that to do a bypass is very
difficult.”
Hence the huge prevalence of small vessel
distal disease below the ankle is a new era,
which Dr Ferraresi believes is an indicator to
change our way of thinking. “For example, after Advanced wiring techniques for BTK with pedal artery disease when they do not show
the collection that I made of about 2000 angisufficient wound blush after conventional aboveand BTA interventions
ographies in patients with critical limb ischaemia As the session continues, Hiroyoshi Yokoi – a
the ankle angioplasty.”
with claudication … small vessel disease below
Of course retrograde approaches below the
cardiologist from Kitakyusyu, Japan, will step up
the ankle, the foot vessel disease, is absolutely
knee will be a particular focus in his presento the podium to talk through advanced wiring
dominant in pathophysiology of critical limb
techniques for BTK and BTA interventions. Given tation, and Dr Yokoi explained the basics of
ischemia, so we cannot treat it without having
that chronic total occlusions represent one of
this access method, referring to real experia clear idea of what is the below-the-ankle
the most challenging endovascular interventions, ence: “When the 0.014-inch guidewire could
disease of that patient.”
not cross through an occlusion, subintimal
he commented on the techniques that have
One of Dr Ferraresi’s wrap-up messages will
historically, and more recently, been employed to angioplasty with a looped 0.014-inch hydrobe following the same theme of when to pursue tackle them. “Generally, it has been considered
philic guidewire was attempted. If that failed,
opening a difficult wound-related artery, esperetrograde access techniques (distal tibial/
that the blood supply through a percutaneously
cially below the ankle. At the very least, he said,
peroneal puncture or a transcollateral approach)
revascularised infrapopliteal artery is poorer, and
there needs to be a clear indication to go that
more limited, than after bypass surgery,” he told were employed, and a bidirectional approach
far, as below the knee, every artery has a huge
LINC Today.
was established using the kissing wire, CART
restenosis rate, and there isn’t a durable solution
(controlled antegrade and retrograde subintimal
“Several treatment strategies have been
to correct it.
tracking), double balloon, or wire
“So every time I have a lot of doubt
rendezvous technique.”
whether it is really useful for the patient
As for guidewire selection, Dr
“Critical limb ischaemia is something very
to go below the ankle, i.e. to perform
Yokoi prefers a 0.014-inch hyrough as a concept. We need to divide
drophilic guidewire such as the
the pedal plantar loop technique or
Regalia XS 1.0 (Asahi Intecc, Japan
not,” he said. “I just don’t know. If I
these patients into different categories,
think that in a few weeks or months,
). If a lesion is hard, he chooses the
and to standardise every type of
stiffer CTO wire such as Astato XS 20
everything will be restenosic or octreatment for every type of patient.”
(Asahi Intecc).
cluded … must I touch these vessels to
Commenting on the re-entry
improve something, or not? This is a
Roberto Ferraresi
huge decision.”
challenges, he concluded: “Because
BTK and BTA lesions are very small
Offering his conclusions, he said: “As
vessels, it is difficult to use re-entry devices. Only
I said before every patient is different. This is the
proposed to overcome the limited blood supply
multifunctional catheters would [likely] work in
main message: try to tailor your procedure for
after endovascular therapy [EVT]. In multi-vessel
every patient, and try to understand why this
that situation.”
infrapopliteal arterial disease, including CTO
patient has developed critical limb ischemia, and
lesions, complete recanalisation seemed to be a
References
1. V Alexandrescu , M Söderström, M Venermo. Angiosome
really whether is necessitates something more to reasonable strategy. Additional below-the ankle
theory: fact or fiction? Scand J Surg. 2012;101(2):125-31
get blood to the wound.”
angioplasty should be considered for patients
16 January 2016 LINC TODAY Thursday/Friday
Embolization therapy for visceral aneurysms, bleeding and beyond Technical Forum Wednesday 08:00–09:30
Transcatheter embolisation
Prevention is better than cure
W
ednesday morning’s
‘Embolisation therapy for
visceral aneurysms, bleeding and beyond’ session played host
to Steffen Basche (HELIOS Hospital
Erfurt, Germany), who discussed prophylactic transcatheter embolisation
with LINC Today and whether this is
the new gold standard in peptic ulcer
bleeding.
Massive bleeding from peptidic ulcers remains a challenge with
significant morbidity and mortality,
with about half of all cases of upper
gastrointestinal bleeding being caused
by gastric and duodenal ulcers1.
Although first-line endoscopy achieves
bleeding control in most patients2 if
this is not achieved, the mortality rate
can be 5% to 10%3 due to multiple
co-morbidities, advanced age and high
transfusion requirements.
Surgery is also associated with high
mortality, therefore selective transcatheter embolisation (TAE) is considered a
safer alternative due to the avoidance
of laparotomy, particularly in high-risk
patients4. In fact, in many institutions, TAE is now considered to be
the first-line intervention for massive
gastroduodenal bleeding for recurrent
or refractory ulcer bleeding resistant to
endoscopic intervention.
Professor Basche described an
update of a study performed by coworkers5 investigating prophylactic TAE
after successful endoscopic haemostasis, and whether this approach
improved outcomes and reduced
rebleeding episodes. The data he
presented was a re-designed follow-up
whereby both the number of patients
and the period of time were extended;
this larger cohort and longer followup allowed conclusions have been
sharpened greater understanding of
the topic.
“Between January 2008 and
December 2013, 147 patients were
examined and medically treated due
to peptic ulcer bleeding. All patients
underwent an initial endoscopy with
follow-up treatment of different techniques and pharmaceutical support. In
129 cases– that is 88% of the group
“Rebleeding rates
seem to depend
above all on the
right choice of
material, the
situation of the
vessels and personal
experience.”
Steffen Basche
– the therapy was successful. In the
other 18 cases (12%), the endoscopic
therapy failed. Those patients received
an urgent treatment with TAE.”
“The group who had successfully
received endoscopy (129 patients) was
then divided into two sub-groups: one
low-risk group with recurrent bleeding
(58 patients, 40%) and one high-risk
group (71 patients, 48%).”
Patients were stratified into the
high-risk or low-risk groups by determining by several factors including
age, comorbidities, Forrest classification, medical drugs, ulcer size and
localisation and the potential harm of
the endoscopic therapy.
“The sub-group of high-risk
patients were fitting candidates for
prophylactic TAE, which should ideally
take place as soon as possible, at the
latest during the first 12 hours as recurrent bleeding as well blood transfusion and shock lead to higher mortality
and lethality,” said Professor Basche.
Describing the results, he said:
“After embolisation and prophylactic
TAE, we found that early rebleeding occurred in 11% of the high risk
group and recurrent bleeding in 7% of
the high-risk group, without any late
rebleedings.”
He added: “Altogether we have
witnessed 10 minor complications
(such as coil dislocation and groin haematoma) and two major complications
(one patient with a Child-Pugh score
of C, who had a massive bleed died
three days after TAE with a complete
liver failure; another patient suffered
from a thrombosis of the AIE).”
Commenting on a recent metaanalysis that showed higher rebleeding
rate after TAE6, Professor Basche said,
“The meta-analysis showed a rebleeding rate in a TAE group in a ranging
from 15% to 42%, versus between
8% and up to 23% in a surgery
group. However, mortality ranged
from 3% to 26% in TAE and 14% to
34% in surgery. The high rebleeding
rate probably resulted from the choice
of material as most these authors used
coils and gel foam, and Wong et al
(2011) used glue in 10% of the cases7.
for both prophylactic treatment and as
Also the TAE patients tended to be
an alternative to surgery and should
older and in poorer health.”
Professor Bache continued: “Oppo- be considered the salvage treatment
of choice after failed endoscopic treatsite to that, Jae et al (2007) reported
ment.
the use of NBCA-TAE in 32 patients
with an angiographic success rate of 100%, a clinical
success in 91% without any
“TAE in peptic ulcer bleeding
ischaemic complications
whatsoever8. Those results
is the gold standard these
are enviable but a bit hard
days.”
to believe.
Steffen Basche
“Rebleeding rates seem
to depend above all on the
right choice of material, the
References
situation of the vessels and personal
1. Laine L, Peterson WL. Bleeding peptic
experience. As to material, my recomulcer. The New England journal of medicine.
mendation is to never use gel foam. As
1994;331(11):717-27. Epub 1994/09/15.
to the vessels, I recommend to always
2. Liou TC, Lin SC, Wang HY, Chang WH. Optimal
injection volume of epinephrine for endoscopic
check the backflow from SMA.”
treatment of peptic ulcer bleeding. World jour“In the high-risk prophylactic
nal of gastroenterology. 2006;12(19):3108-13.
Epub 2006/05/24.
subgroup we used coil in 83%, glue
3. Goldman ML, et al. Transcatheter therapeutic
in 3% and combined coil and glue
embolization in the management of massive
upper gastrointestinal bleeding. Radiology.
in 14%; whereas in the low-risk
1976;120(3):513-21. Epub 1976/09/01.
subgroup, we used coil in 61%, glue
4. Aina R, et al. Arterial embolotherapy for upper
in 22% and combined coil and glue
gastrointestinal hemorrhage: outcome assessment. Journal of vascular and interventional
in 17%.”
radiology : JVIR. 2001;12(2):195-200. Epub
Professor Basche concluded by say2001/03/27.
ing: “In the groups mentioned above,
5. Mille M, et al. Prophylactic Transcatheter Arterial Embolization After Successful Endoscopic
TAE in peptic ulcer bleeding is the gold
Hemostasis in the Management of Bleeding
standard these days. We need excelDuodenal Ulcer. Journal of clinical gastroenterology. 2015;49(9):738-45. Epub 2014/10/17.
lent technical equipment, excellent
6. Kyaw M, et al. Embolization versus surgery
staff and hospitals, which can afford
for peptic ulcer bleeding after failed endoto provide these requirements 24/7.
scopic hemostasis: a meta-analysis. Endoscopy
international open. 2014;2(1):E6-E14. Epub
Given their less invasive approach,
2014/03/01.
superior efficacy rates, morbidity and
7. Wong TC, et al. A comparison of angiographic
embolization with surgery after failed endomortality rates, endovascular therapies
scopic hemostasis to bleeding peptic ulcers.
are often favoured over surgery; they
Gastrointestinal endoscopy. 2011;73(5):900-8.
remain the first treatment modality in
Epub 2011/02/04.
8. Jae HJ, et al. Transcatheter arterial embolization
the management of bleeding peptic
of nonvariceal upper gastrointestinal bleeding
ulcers, even in those presenting with
with N-butyl cyanoacrylate. Korean journal of
radiology. 2007;8(1):48-56. Epub 2007/02/06.
massive bleeding. TAE is a good option
18 January 2016 LINC TODAY Thursday/Friday
Symposium: Pioneering solutions for aortic diseases Main Arena 2 Thursday 11:00–12:30
Promising outlook for EXCLUDER iliac branch EVAR device
E
arly data surrounding the
GORE EXCLUDER Iliac Branch
Endoprosthesis (IBE) from W. L.
Gore & Associates, Inc., USA, will be
presented at LINC this morning. Introducing the device and its associated
data in endovascular aneurysm repair
(EVAR) will be Robert Rhee (Maimonides Medical Center, Brooklyn, NY,
USA), who gave some early news to
LINC Today.
“The GORE EXCLUDER Iliac Branch
Endoprosthesis is intended to provide
continuous blood flow from the aorta
to both external and internal iliac arteries, while isolating a large aortoiliac
segment, or isolated common iliac
artery aneurysms,” he said.
“In the United States, current treatment methods include open surgical
bypass, intentional embolisation of the
internal iliac artery prior to the EVAR
procedure, or a combination of offlabel devices to preserve flow to the
internal iliac artery. Embolisation of the
internal iliac artery has been shown to
carry significant negative risks related
to patient quality of life, as patients
can experience buttock claudication,
sexual dysfunction, colonic ischemia,
and/or spinal cord ischaemia.”
The GORE EXCLUDER IBE therefore
offers a dedicated system allowing
for off-the-shelf treatment of these
patients while preserving blood flow
to the internal iliac artery. “The device
is composed of two components:
the iliac branch component and the
internal iliac component,” continued
Dr Rhee.
As he described, the iliac branch
component can be repositioned during
deployment (via a two-stage deployment) to aid in internal iliac artery
cannulation, and to ensure accurate
device placement. Additionally, the
iliac branch component features precannulation of the internal iliac artery
gate, a feature which aids in ease-ofuse. The iliac branch component is 16
Fr compatible, and the internal iliac
component is 12 Fr compatible.
“The device also offers a broad
treatment range, including an
external iliac artery treatment range
of 6.5–25mm, and an internal
iliac artery treatment range of
6.5–13.5mm,” said Dr Rhee.
He explained that the GORE
EXCLUDER IBE is engineered to be
used in conjunction with the GORE
EXCLUDER AAA Endoprosthesis, and
overall, the system offers an all-in-one,
easy-to-use system that can preserve
blood flow to the internal iliac artery
whilst providing a durable solution for
aneurysm exclusion.
A central thread running through
his presentation at LINC will be to
discuss preservation of the hypogastric
“Now we have an
option to preserve
flow that is minimallyinvasive, off-the-shelf,
and easy-to-use.”
Robert Rhee
artery. He dived into this topic, saying:
“The debate regarding preservation
has identified that intentional embolisation of the internal iliac artery is not
benign, and is indeed a concern. The
concern regarding preservation is not
new, but the treatment approaches
available now are new.
“When EVAR was first introduced,
durable and minimally-invasive treatment options for common iliac artery
aneurysms did not exist. Now we
have an option to preserve flow that
is minimally invasive, off-the-shelf,
and easy-to-use. In the past, embolisation may have been considered in
patients to help ensure a minimisation
of adverse complications related to
the then-existing invasive preservation
techniques. Now we can treat these
patients with an option that allows
them to maintain their quality of life
while avoiding risks related to more
invasive procedures.”
Delving deeper into the data surrounding the GORE EXCLUDER IBE
device, Dr Rhee said: “Various studies
have shown that this intentional
embolisation has risks of buttock
claudication (15-55%), sexual dysfunction (5-45%), colonic ischaemia, and
considerations include overall length
from the lowest renal artery to the
internal iliac bifurcation, as well as
aortic bifurcation diameter and iliac
bifurcation diameter,” he said.
When the question was posed as
to whether the GORE EXCLUDER IBE
is a prime example of the aortoiliac
aneurysm field entering a new era
of treatment, Dr Rhee commented:
“I think that his device offers a great
opportunity to provide patients with
an effective treatment option which
may not have previously existed. Early
results have demonstrated that the device is effective to treat these patients,
but long-term data will be needed to
evaluate the durability.
“The US Clinical Trial has continued enrolment through Continued
Access, and the trial now has over 90
total patients enrolled to date, and
will continue to collect data through
5 years. Additionally, the GORE
EXCLUDER IBE is being evaluated in
multiple registries, including the Global
Registry for Aortic Endovascular Treatment (GREAT) which includes sites
spinal cord ischaemia.1. The GORE
worldwide, the Iliac Branch Excluder
mercial European experience, with
ReGistry (IceBERG) in the Netherlands,
EXCLUDER iliac branch endoprosthesis reports demonstrating high technical
and CARIBE (Comparison of Aortoiliac
has demonstrated that it offers a solu- success and positive clinical outcomes
Repair with Iliac Branch Endoprosthesis
tion to treat these same patients while while avoiding complications related
versus hypogastric occlusion
decreasing the risk for these
in aorto-iliac aneurysms)
complications.”
in Italy. These Registries
Dr Rhee relayed data from
“The debate regarding
will gather information on
the US Clinical Study (an invesreal-world use of the device,
tigational device exemption/IDE
preservation has identified that
as well as offer worldwide
study), for 62 patients enrolled
intentional embolisation of the
experience with this device to
in the primary enrolment, in
internal iliac artery is not benign,
support its use.”
which an overall technical
He added: “I believe the
success rate was 95.2%, with
and is indeed a concern.”
concept of intentional sacrian average procedure time of
Robert Rhee
fice of a vital pelvic artery will
151.8 minutes for implantation
no longer be acceptable as a
of both the GORE EXCLUDER
standard of care, and internal
IBE and GORE EXCLUDER
to sacrificing blood flow to the internal iliac artery preservation will most likely
AAA endoprostheses. “There have
be routine in patients with aortoiliac
iliac artery.2,3”
been zero abdominal aortic aneurysm
and common iliac artery aneurysms.”
enlargements (0%) reported through
Moving on to the anatomical
six months, with 100% patency of the considerations when using this device, References
1. Lin P H, Chen AY and Vij A. Hypogastric
external iliac artery and 95% patency
Dr Rhee first noted that it is indicated
artery preservation during endovascular aortic
of the internal iliac artery,” he said.
and designed to treat patients with a
aneurysm repair: is it important? In:Seminars in
vascular surgery, 2009;22(3):193-200
“Additionally, there have been zero
common iliac artery diameter greater
2. Schönhofer S, Mansour R, and Ghotbi R. Initial
reports of buttock claudication (0%)
than 17mm. Additionally, the device
results of the management of aortoiliac aneurysms with GORE® Excluder® Iliac Branched
on the IBE treatment side, and zero
offers an external iliac artery treatEndoprosthesis. The Journal of cardiovascular
surgery, 2015;56(6):883-888.
reports of new-onset sexual dysfuncment range of 6.5-25mm, and an
C, et al. Early experience with the Extion (0%).
internal iliac artery treatment range of 3. Ferrer
cluder® Iliac Branch Endoprosthesis. The Journal
“This data is supported by com6.5-13.5mm. “Additional anatomical
of cardiovascular surgery, 2014;55(5):679-683.
Thursday/Friday LINC TODAY January 2016 19
20 January 2016 LINC TODAY Thursday/Friday
Symposium: Aorfix & Altura innovations – patient focussed technologies Main Arena 2 Wednesday 09:30–11:00
Patient-focused technologies
sociated with poor treatment outcomes. Freedom from mortality
(all-cause) was 78.1% in the > 60-degree group.
Results in those with less than 60-degree angulations were
also impressive, with freedom from sac expansion being 93.0%,
freedom from all-cause mortality at 86.6%, and freedom from
device migration at 95.2%.1 “Despite the majority of the patients
treated having severely angulated necks, the outcomes were
similar to other devices and IDE studies with less than 60-degree
angulation,” Dr Malas told LINC Today. “We found that severely
angled necks imply other factors that are known to be hostile to
good EVAR outcomes such as older age, a very high percentage of
female patients and substantially tortuous iliac systems.”
When quizzed as to what the data will mean for the device
moving forward, Dr Malas commented: “This is the first time that
we have had long-term data in such challenging anatomy, and
it has certainly encouraged me to change my usage and to have
Aorfix as one of my go-to grafts.”
“I believe the Aorfix implant performed very well in normal
anatomy too, and I would like my trainee to become familiar with
it in more straightforward cases, as the results are good and the
experience they gain will be invaluable in tougher anatomies.”
As per his presentation title, Dr Malas will also be touching the
longer-term data past three years, as he explained: “We are completing our five year follow up on the IDE study patients. There is
also a post-approval registry under the Vascular Quality Initiative of
the Society of Vascular Surgery. In Europe and at some hospitals
in the US, the ARCHYTAS registry is also collecting data on 300 to
500 patients.”
Adding his take-home messages, Dr Malas spoke of the
considerations that are important to pay attention to: “I believe
if this device implanted properly, it could provide an additional
suprarenal fixation,” he said. “This is essentially additional fixation
without fenestration. Careful attention to at least 12 mm distance
between the lowest renal artery and the SMA origins is essential
when hugging the renals with the device troughs. In irregular and
conical necks it is somewhat more forgiving than devices using Zstents, and its ability to work in angled necks where the seal zone
on the inner curve can be very short is valuable.”
Continued from page 1
With a number of cases behind him using the Altura, Professor
Scheinert explained where he sees its place being: “I think very
clearly, Altura is designed to be a mainstream device. I think it is
not necessarily the special solution for the very rare case with very
challenging anatomies.
“I don’t want to say that it wouldn’t also work in challenging
situations, but I think the real concept is to make the standard
EVAR procedure somewhat more straightforward – avoiding
cannulation and making positioning easier and make the case
planning easier with much
lower inventory needed.
This is the key objective
“This is the first time
here.
that we have had
“Potential advantages
over currently available
long-term data in
devices include a simplified
such challenging
case plan, a quicker proceanatomy, and it has
dure, accurate placement
both proximally and distally
certainly encouraged
by the ability to resheath
me to change my
and reposition as you like,
usage and to have
and also this retrograde deployment mode of the iliac
Aorfix as one of my
arteries. There is no need
go-to grafts.”
for cannulation; I think that
Mahmoud Malas
is certainly a step where you
can lose time in unfavourable anatomies.
Having said that, it is of course a low profile device, with a big
potential for percutaneous implantation. In fact, we have done OR
cases percutaneously in our institution. This of course offers interesting options for day-surgery patients in the healthcare environment where this is a requirement.”
Aorfix PYTHAGORAS data unveiled
In his presentation during the session, Mahmoud Malas (Johns
Hopkins Bayview Medical Center, Baltimore, USA) revealed threeyear data from the Aorfix PYTHAGORAS US trial – a pre-marketing
approval study evaluating the Aorfix stent graft from Lombard
Medical. Aorfix is the first endovascular stent graft with global approvals for the treatment of patients with aortic neck angulations
from 0 to 90 degrees.1
Three year results from PYTHAGORAS have shown 100%
freedom from Type I & III endoleaks, 92.9% freedom from aneurysm sac expansion and 92.9% freedom from device migration
in patients with 60 to 131 degree aortic neck angulations.1 This
is a group that is typically considered difficult to treat, and is as-
References
1. Lombard Medical. Three-Year Follow-Up Data From Lombard Medical Aorfix(TM) PYTHAGORAS Pivotal Trial Presented at 42nd Annual VEITHsymposium(TM). (Available
at http://investors.lombardmedical.com/; November 2015)
“Potential advantages [of
Altura] over currently available
devices include a simplified
case plan, a quicker procedure,
accurate placement both
proximally and distally by
the ability to resheath and
reposition as you like.”
Dierk Scheinert
22 January 2016 LINC TODAY Thursday/Friday
New insights and advanced techniques for treatment of TAA and aortic dissections Main Arena 2 Thursday 08:00–09:30
Who benefits from early TEVAR?
T
his morning’s early session on
new insights and advanced
techniques for the treatment
of thoracic aortic aneurysm and aortic
dissection teases apart what we currently know about treatment thresholds, as well as articulating unanswered questions. Panel members are
joined by Dittmar Böckler (University
Hospital Heidelberg, Germany), who
concludes the session with a presentation of evidence supporting the shift
towards earlier intervention for acute
uncomplicated type B dissection.
Speaking to LINC Today, Professor
Böckler explained that a line exists between risk and benefit in early TEVAR
– and that new data describing those
who might benefit most could tell us
where this line should be drawn.
“Guidelines so far still recommend
conservative treatment in patients with
acute type B dissections but being
so-called asymptomatic or uncomplicated,” he began.
“But we know from at least
the INSTEAD trial1 that after three
years these patients have severe late
complications like aneurysm extension, rupture and malperfusion.
There is another randomised trial,
ADSORB2, but it only had 30 patient
being randomised between conservative treatment and TEVAR in the early
setting. This study was underpowered
and could not prove that early TEVAR
is really a recommendation of evidence
level 1.”
Despite this, he added, neither INSTEAD nor ADSORB provide evidence
for the use of early TEVAR as a first
treatment choice. Even so, a clear
shift in clinical practice has occurred
whereby those who might benefit
from early treatment are picked out for
TEVAR. The aim of Professor Böckler’s
presentation will be to provide some
basis for this shift.
“I will give new data (single centre
data) and new image-based predictors,
which help the clinician and physician
to select the right patients that will
benefit from early treatment,” he said.
Earlier treatment with TEVAR can
also optimise remodelling that contributes to the prevention of serious
complications such as rupture and
related mortality. “In complicated patients with hypertension and malperfusion, you want to restore perfusion,”
explained Professor Böckler, “But in
uncomplicated patients you really
want to get a remodelled aorta that
really heals, that doesn’t expand and
cause late problems.
“So there are two issues that are
the treatment goals of TEVAR: false lumen thrombosis, induced by covering
the entry tiers of the dissection, and
restoring and optimising perfusion.
“As always, this is a balance of risk
and benefit. On the one hand, you
want to remodel the aorta and prevent
late problems, but the risks of TEVAR
on the other hand are procedure-related complications. First of all, these are
retrograde dissections in a very early
stage because the aortic wall is very
vulnerable. So if you precisely deploy
a stent graft in the arch you have a
risk of (less than) 1% of a retrograde
dissection – a very fatal complication
that needs immediate open surgery.
The second complication is paraplegia,
which is also a catastrophe. Then you
have stroke. These are associated with
TEVAR, especially at the early stage.”
With everything else in place – the
anatomical understanding, the devices,
the technical skill – the stage is set for
developing patient selection strategies,
such that those acute uncomplicated
type B dissection patients who are
prime candidates for early TEVAR can
“In the last three
or four years we
do have very good
predictors, based on
imaging, that can
predict late adverse
outcome.”
Dittmar Böckler
be selected out from the category of
best medical therapy. This will not only
help them, but it will prevent the rest
of this category from being exposed
to unnecessary procedural risk. Then,
once the early TEVAR patients have
been selected, the optimal treatment
window must also be understood.
“These questions do not have a
high evidence-based decision-making
process,” said Professor Böckler. “But
in the last three or four years we do
have very good predictors, based
on imaging, that can predict late
adverse outcome. These are of course
literature-based high risk predictors on
a retrospective imaging evaluation.”
The first of the six predictors is
the diameter of the primary entry tier
of the dissection, which commonly
occurs in the distal aortic arch. If this
is greater than 10 mm it predicts poor
outcome, because its consequence is
high perfusion in the false lumen and
the negative consequences thereof.
The second predictor is the location
of the primary entry tier, continued
Professor Böckler, adding that some
evidence suggests that an entry on the
concavity of the arch predicts negatively relative to an entry occurring on
the outer curve of the arch.
Total aortic diameter is another predictor, with diameters over 4 cm at the
entry side being a predictor of late adverse events and mortality. False lumen
diameter of more than 22 mm, partial
false lumen thrombosis, and fusiform
index are the final three predictors; the
latter being a mathematically calculated
index between false and true lumen,
whereby indices smaller than 0.64
predict late adverse outcomes.
Clarification: Turbo-Power, and Turbo-Tandem with Turbo-Elite to create a
pilot channel, are the only FDA cleared atherectomy technologies for ISR.
Addressing the second unanswered
question, relating to the optimal timing of early TEVAR treatment, Professor Böckler suggested that the window
is probably somewhere before seven
months. “We know that more or less
after six to nine months, aortic remodelling gets difficult because the dissection membrane becomes stiff. And
we also know that to treat chronic
patients is much more challenging and
difficult to achieve remodelling.
“So you don’t want to treat patients
too early because of the complications
I mentioned early, but not too late
either. The window of opportunity is
still uncertain. So far, today, from our
registry data, the window is somewhere
between six or seven months. That may
be the optimal window for not really
early TEVAR, but staged TEVAR, during
the still early stages of the disease.”
Citing retrospective analysis of the
MOTHER registry (the Medtronic Thoracic Endovascular Registry), Professor
Böckler suggested that this window
may be occur between two weeks and
six months. Similar results were found
in INSTEAD, he added, cautioning that
it was not a primary endpoint of the
trial, and that INSTEAD patients underwent TEVAR anywhere between week
2 and 52 after their first onset.
In short, while evidence linking
positive remodelling with long-term
reduction in mortality (that would
balance out the early hazards of
endografting) is lacking, the questions
around this can only be answered
fully once the high-risk subgroup of
initially uncomplicated patients that
might benefit from early TEVAR can be
recognised in the clinical setting and
accordingly treated.
“The conclusion is that we don’t
have long term results,” confirmed
Professor Böckler. “We have one-year
results from ADSORB. I already tried
to analyse the ADSORB CT data to
prove that objective, but we have
not got far enough because we only
have one-year results. The other trial,
INSTEAD, has five-year results, but a
very small number of patients. So, first
of all, we need longer follow-up to
prove that this preselected group of
patients will benefit.
“We also have to keep in mind
that it is aortic mortality that is the
main goal. We are not treating imaging, we are treating patients. It sounds
very basic, but we have to keep it
“You don’t want to
treat patients too
early because of
the complications,
but not too late
either. The window
of opportunity is still
uncertain.”
Dittmar Böckler
in mind because medicine is really
becoming technically a very theoretical discussion.
“We need to do retrospective
analysis. We are doing that at the moment, with our long-term database in
Heidelberg. We also identified patients
having two or three years follow-up
and an early TEVAR. But retrospective
analysis is not the same as prospective
for the value of the evidence. So we
still need prospective data, to prove
that these predictors are really proving
a better outcome for the patients.”
Despite the need, prospective
trialling remains, for now at least, a
pipe dream. “I don’t know of a new
trial coming up soon,” said Professor Böckler. “And the problem is the
limitation of money and of in- and
out- criteria, to have a sample size
with enough power for statistical
analysis.
“The ADSORB trial needed to
be finished because they ran out of
money, and they also ran out of enrolling patients. It was difficult for them
to enrol patients because the exclusion
criteria were so strict, so many patients
could not be enrolled.
“For many years there has been the
IRAD3.They enrolled all patients – type
A, type B, open surgical, conservative
and endovascular treatment. Such a
registry is planned to retrospectively
answer the kinds of questions we have
been asking over these past minutes.”
Professor Böckler presents, ‘Is a paradigm shift towards early endovascular
treatment of Type B dissections justified?’ during the session ‘New insights
and advanced techniques for treatment
of TAA and aortic dissections,’ taking
place this morning between 8:00 and
9:00 in Main Arena 2.
References
1. Investigation of Stent-grafts in Aortic Dissection
(INSTEAD). www.clinicaltrials.gov/ct2/show/
NCT01415804 (retrieved January 2016).
2. A European Study on Medical Management
Versus TAG Device + Medical Management for
Acute Uncomplicated Type B Dissection (ADSORB). https://www.clinicaltrials.gov/ct2/show/
NCT00742274 (retrieved January 2016).
3. International Registry of Acute Aortic Dissections
(IRAD). http://www.iradonline.org/irad.html
24 January 2016 LINC TODAY Thursday/Friday
LINC Expert Course: Pioneering techniques for CLI and CTOs (Part II) Main Arena 1 Thursday 16:30–18:00
Are oxygen microsensors the future in CLI?
D
etermining how aggressively to
tive needs are of a certain patient to achieve
revascularise in critical limb ischemia
wound healing. So you will have operators all
– or rather, how much is sufficient
over the spectrum: you have physicians that
to facilitate wound healing that
will aggressively treat every single arterial lesion
leads to limb salvage – is a question with few
they find in a patient with the objective of trydirect answers. This afternoon, Miguel Montero- ing to heal the wound; at the other end of the
Baker (Baylor College of Medicine, Houston,
spectrum you have very passive physicians that
Texas, USA) will discuss the use of implantable
might treat one or two lesions, who may leave
microsensors to measure oxygen saturation as a
a patient below the level of oxygen perfusion
possible answer, as part of a session on pioneerrequired for wound healing. Within that, where
ing techniques in CLI and CTO.
is the balance? Unfortunately, we don’t have
Making accurate wound healing predictions
the answer.”
hinges on precise tissue oxygen measurement.
Dr Montero-Baker and colleagues published
Existing methods include transcutaneous oxygen their first-in-human study of the Lumee last
pressure (TcpO2, measuring skin oxygenation),
year.1 The study was carried out in 10 patients
partial oxygen pressure (PaO2) and haemoglowith limb-threatening ischemia. The patients
bin oxygen saturation (measured in vessels).
were injected with three microsensors and dyThese methods, explained Dr Montero-Baker to
namic oxygen concentration data were collected
LINC Today, are all indirect measures of oxygen
content in tissue; and he offered yet further
disadvantages: “These are all external systems
“I think that we will also come
that need a lot of technician-driven techniques
to find very curious things
that give you a better read.
“Unfortunately, a lot of these systems that
about how different the
are out there are variable and inconsistent in
angiosome coverage is from
these data that they produce. In the event that
one human being to the next
they could become more objective, by way of
some mathematical correction, still the measurehuman being.”
ment devices are really bulky and cumbersome
Miguel Montero-Baker
and usually not utilised in the intra-operative
phase of care.
“Quite another thing is what is the oxythroughout the revascularisation procedures.
gen concentration is in a specific tissue,” said
The study concluded that the device was safe
Dr Montero-Baker. “This is different. This is
and feasible to use, although further work is
the amount of oxygen molecules that have
necessary to characterise how exactly it could
separated themselves from the haemoglobin
be used to shape clinical decision-making both
and actually made it into the tissue where they
within revascularisation procedures and during
become functional.”
follow-up.
Tissue oxygen concentration in a particular
“Certainly, because we got so much data,
locality perhaps gives the best impression of
we have certain flags that have lit up that show
how the microcirculation around it is functionus that within four seconds, we can demoning. The fact that the microsensor device is
strate a change in oxygen concentration when
implantable throws up a number of exciting
an intervention has been effective,” said Dr
potential applications. ‘Wearable’ devices have
Montero-Baker.
already permeated culture significantly, with
“And certainly there will be a greater phase
mobile devices providing users with feedback
by which we will need to validate this data.
on biological facets such as heart rate, steps
What we want to do is to say what will be the
walked, and calories consumed.
target oxygen concentration, to provide good
“Thirty years ago, this was unimaginable,”
feedback to the operator that they have done a
said Dr Montero-Baker. “Now we have all of this good procedure; that it is okay to stop; that the
information in our hands just by wearing a watch patient will probably do really well. That comes
in the next phase, and I am very excited that we
or a simple device in our shoe or on our belt.
are already starting to find and select sites for
This is, for me, an exciting revolution in the next
our first global trial that will include some faciliphase of biofeedback.
ties in the US and some in Europe.”
“What we are talking about now is creatAs part of this global trial, the team will ating something that is not wearable but rather
implantable. This means that you would agree to tempt to validate the microsensor data by way of
carry something around with you in your body in parallel measurements of more well-understood,
classic parameters.
a safe way – a sensor that allows you to have a
much more scientifically precise and objective way to determine certain parameters
of your biochemistry.”
“Nowadays we don’t have a very
The microsensor in question employs a
clear standard of care as to what
porphyrin-type molecule, associated to a
biogel, as both sensor and transducer of
the objective needs are of a certain
oxygen concentration. Previously known as
patient to achieve wound healing.”
MOXY, now Lumee Oxygen Sensing SysMiguel Montero-Baker
tem (Profusa Inc., USA), the device’s biogel
matrix is already used for many other
applications in the human body, such as
Devices like the Lumee throw a stark light
ocular implants.
on just how blindly operators must make deci“When I first got in contact with this parsions as to how far to revascularise particular
ticular technology – approximately three years
patients. This is especially so given the variago – I was über-excited about the fact that I
ability in individual patients’ normal levels of
thought it would really help us by potentially
tissue- and vessel-related oxygen concentragiving us some acute, on-table data during our
tions. Thus, would Dr Montero-Baker expect,
intervention that would allow us to make our
even after developing an analytical underinterventions much more targeted, safer and
standing of tissue oxygen concentration, to use
more effective.
an intra-subject reference measurement from
“Unfortunately nowadays we don’t have a
very clear standard of care as to what the objec- another limb?
The answer, he said, is more complex even
than that when real-world factors are taken into
account: “There are also external parameters;
for example, if you have a micro-oxygen sensor
at a certain level and I give you oxygen, which
most of these patients will have during this
procedure, then your oxygen concentrations will
tend to go up! This is such a volatile parameter
we are measuring.
“If you look at the details of this first-inhuman study, one of the things that I was very
emphatic about was the need to install
a control sensor in an area of his body
that is non-ischemic. I think we studied
only 10 or 15 patients. If they had palpable pulses in their arm, we would create
a control, or sub-control, there. It really
doesn’t change any external parameters
then, because we are now creating a
ratio of what is normal in the arm versus
what is abnormal in the leg. So even if
the patient receives oxygen, both areas
should come up in oxygen concentration to a
certain extent in equilibrium.”
Another question centres around the placement of microsensors within the tissues. The
depth of tissue insertion is controlled using a
tailored insertion device (important because
sensors implanted too deeply are rendered
impossible to read). Stressing that there is still
much to learn about their behaviour with both
tissue depth and milieu, Dr Montero-Baker
noted that several aspects that must be re-
spected – principally, of course, sensors should
sit within viable live tissue: “If you put a sensor
into necrotic tissue, that is not going to help!”
He said. “We try to come as close to the edge
of the area of tissue that has perfusion issues
but that is still viable.
“In the FIH study we actually used three sensors per lesions, and pretty much made a triangle
around the ulcer, placing the sensors in three
different areas. We found that most of these
sensors behaved in the same way, so I think we
could probably gear towards the implementation
of one or two sensors per foot.
“You could make the case for considering
different angiosomes – so making angiosomedirected implantations. But I think that we will
also come to find very curious things about
how different the angiosome coverage is from
one human being to the next human being. I think that now we utilise this very rigid
scheme, which is to a certain extent useless
because I believe that humans have different
anatomies that behave very differently. This is
especially the case in of chronic and diffuse
disease that has allowed different collateral
pathways to emerge.”
One of the great surprises of his work, said
Dr Montero-Baker, was the realisation that this
microsensor technology could be adapted to
work for patients during follow-up, as well as
being useful within the interventional suite.
“When I initially came into contact with this
Continued on page 26
26 January 2016 LINC TODAY Thursday/Friday
LINC Expert Course: Pioneering techniques for CLI and CTOs (Part II) Main Arena 1 Thursday 16:30–18:00
Are oxygen microsensors the future in CLI?
Continued from page 24
technology, my bulbs lit up and I said that this
was going to be like having a GPS while you
are operating. But what excites me the most
now in retrospect is when I think about creating a whole new paradigm of follow-up for
these patients that have CLI.”
CLI patients are characteristically frail and
debilitated often by a number of comorbidities.
On top of this, explained Dr Montero-Baker,
they may at any time have difficult access to
care, perhaps if their family does not have a
means of transportation, or reside in nursing homes. Follow-up, as an extension of the
original intervention, must be as stringent in
order to avoid or minimise any complications
that might arise.
“These patients need such close observation.
They are very much like cancer patients; you create a status of remission, but because of in-stent
restenosis and intimal hyperplasia we know that
a lot of times we need to reintervene. So when
I came to realise that these particles creates a
stable sensing platform that was already proven,
then that excited me.
“I could even see in the future a simple app
that could be mediated by smartphone; you
could wand on top of a sensor, get a signal,
and it could then be relayed to the healthcare
provider by means of cloud technology. This
way, you could have a close tap on a patient
– a patient who potentially is going to come
out of remission. Imagine if we could have
the power of daily measurements, and all of a
sudden we get a reading from a patient who
went into remission with complete wound
healing, that his concentrations of oxygen start
plummeting. This could provide a signal that
alerts the healthcare provider that this patient
needs to come in for a Duplex ultrasound or
skin evaluation.”
As well as being convenient, this technology
could save healthcare systems and patients both
time and money. Currently, explained Dr Montero-Baker, follow-up is done arbitrarily at two
weeks, three months, six months, 12 months,
but individual patients’ needs may differ.
“I genuinely hope that, as physicians, the
time has come to stop focussing on what the
next great device is going to be to open an
artery. I hope that we can start focussing on
what artery needs to be open in the procedure. I
think this is the next phase of our care. We need
to come together and create really objective
performance goals.”
References
1. Montero-Baker M et al. The Use of Micro-Oxygen Sensors
(MOXYs) to Determine Dynamic Relative Oxygen Indices in the
Foot of Patients with Critical Limb Ischemia (CLI) During an
Endovascular Therapy: The First-in-Man ‘Si Se Puede’ Study. J
Vasc Surg. 2015 Jun;61(6):1501-9.e1.
25 years of EVAR: How far have we come, remaining controversies and what’s on the horizon? Main Arena 2 Wednesday 11:00 – 12:30
Are national population-based AAA screening
programmes too challenging for public health systems?
S
creening programmes for
the detection of abdominal
aortic aneurysm (AAA) have
the potential to reduce mortality from
aneurysmal rupture in a cost-effective
way.1 However, their effective implementation hinges upon a thorough
understanding of locally relevant
factors within both healthcare and
political spheres – as Vicente Riambau
(University of Barcelona, Spain)
explained during his presentation
yesterday morning at LINC 2015.
AAA screening is offered on a
voluntary basis in several countries
internationally. But such things cannot simply be rolled out world-wide,
explained Dr Riambau to LINC Today:
“You need to convince politicians
or health administrations that it is
important to have a specific screening
programme, so you need to demonstrate that it is at least effective – that
you can detect in advance some
kind of pathology to improve
the results, and even to reduce
“It is not possible to
the costs and with very rational
make widespread
resources.”
Inextricable from the
recommendations for all
issue of cost is the national
the countries in Europe.
socio-political attitude toward
So
we would expect to
health. Healthcare is a social
phenomenon (although there
perform pilot studies in
are examples of profit-oriented
every different country.”
as well as non-profit-oriented
Vicente Riambau
organisations), but, again,
healthcare ideals of quality and
necessity must be balanced
by a particular provider’s ability to
recommendations for all the countries
shoulder the financial burden. “We
in Europe. So we would expect to
need to think about the feasibility of
perform pilot studies in every different
these particular idealistic things,” said
country. We need to be sure that from
Dr Riambau. “For sure, this is different the beginning we are investing public
in every single country, because when
money in the correct way, not just
you are talking about cost-effectiveperforming huge screening without
ness, and the price that any country is
any kind of effectiveness.”
willing to pay, it depends on the global
Demonstrating the potential efand national income – and this is not
fectiveness of a screening programme
the same for every country.”
means factoring in a number of
Healthcare system structures and
conditions, Dr Riambau explained,
budgets will vary, with more or less of
which need to be understood by way
a burden on the individual as opposed of up-to-date epidemiological data.
to the state, he continued: “It is not
Individual countries, or even regions,
therefore possible to make widespread will have differences in cardiovascular
disease prevalence. Recent study by
Linne et al highlights the possibility of
prevalence being dependent on socioeconomic factors as well as geography,
suggesting that there is a need to push
screening harder in poorer areas where
adherence is low.2 A review of contemporary reporting of AAA prevalence
and mortality noted the inaccuracy of
cited figures, finding that only 5 out of
the 40 articles studied were completely
accurate.3
“Prevalence is one of the important factors in justifying any kind of
screening programme for any kind of
disease. If prevalence is high enough,
it could be cost effective. One of the
recommendations of my talk is to perform a pilot study on a smaller scale
in order to know what is happening in
one specific territory.”
Elaborating on this proposal, Dr Ri-
“Prevalence is one
of the important
factors in justifying
any kind of screening
programme for any
kind of disease.”
Vicente Riambau
ambau continued to say that in Spain,
pilots could be carried out in each
of its autonomies, or simply in the
north and the south of the country.
“The first point is to know what the
real prevalence is. The second point is
to know if the inclusion criteria are
sensitive enough to detect enough
people with AAA, and whether that
justifies the economic effort later
on. If we have this kind of information then you can implement this on
a national level, and you can more
easily convince health administrators.
It is better to start on a local scale,
and then to transform that onto the
national scale.”
Overall, prevalences of AAA seem
to have decreased over the past two
decades, thanks to improvements in
awareness and in medical therapies
Continued on page 28
Thursday/Friday LINC TODAY January 2016 27
28 January 2016 LINC TODAY Thursday/Friday
25 years of EVAR: How far have we come, remaining controversies and what’s on the horizon? Main Arena 2 Wednesday 11:00 – 12:30
Continued from page 26
and procedure outcomes. “Recent
literature are showing (especially in a
very well-known UK national screening
programme) the prevalence of up to
1.6% is not the same figure we had
10 or 20 years ago when the prevalence of AAA was, in the same kind of
population, four or five times higher,”
noted Dr Riambau.
“In the last 25 years – with EVAR
and another ten years of medical
improvements (in statin use, and more
healthy values added to our population in the occidental part of the
world and specifically in Europe – has
changed health in a positive way. This
particular improvement in health has
also impacted the prevalence of AAA.
So this is one of the reasons why we
need to move the focus – to move the
target population for the screening
programmes, and probably to move
up to the older population and to
make another kind of inclusion criteria,
different to that of the past 20 years.
“So something for sure is improving in the last 20 years. On the other
hand, we have new technology –
EVAR for example. But EVAR has all
sorts of complications, and we need to
justify the treatment relative to screening programmes, and also to justify it
from the economical point of view.”
More effective selection of the
screening population is one way to
bring down its cost. A recent UKbased study found that while AAA
prevalence in the younger population
is decreasing, it may be increasing at
the other end of the age spectrum,
suggesting that more frequent screening should be carried out for those 75
years of age and older, as well as for
smokers and those with hypertension
of 65 years and up.4
One of the dangers of screening is
over-diagnosis, especially of those with
small- or medium-sized aneurysms.
Not only can this skew the projected
cost-effectiveness of an AAA screening
programme, but it can have serious
ethical implications for individual
patients and their quality of life, explained Dr Riambau.
“AAA pathology before diagnosis doesn’t represent any kind of
change from normal quality of life,
because there are no symptoms – it
is not a painful condition. Quality
of life changes a lot after diagnosis;
the diagnosis of AAA is an unknown
pathology for the patient, without any
kind of relationship with the feeling
of healthiness. You are given this kind
of information and it is like being
informed of a diagnosis of cancer
without any kind of symptoms.
“To be sensitive to that is part of
the job of screening programmes. We
need to detect people who can benefit
from the screening programmes,
rather than to detect those for whom
screening will impart psychological
harm. Not all AAAs should be operated on or fixed via the screening
programme. You might be detecting people and putting them in the
chronic disease group for life, but if
the aneurysm is small (between 3mm
All grown up: 25 years of EVAR
O
pening yesterday morning’s
session on the past, present
and future of EVAR, Roger
Greenhalgh (Imperial College London,
UK) presented the design of a new
meta-analysis looking back through
15 years at the changing role of EVAR
in the treatment of large abdominal
aortic aneurysm.
“I think at the end of this you will
be encouraged to rewrite a lot of
guidelines on endovascular repair,”
began Professor Greenhalgh, referring
to the results of the analysis, which
will be presented at the Charing Cross
Symposium in April.
The analysis encompasses
follow-up data from four randomised
controlled trials, he explained: EVAR
11, DREAM2, ACE3,4 and OVER5. “The
EVAR [1 and 2] trials started in 1999,
with really much older technology
now. The design of EVAR against
open repair had a similar design to
that which Jan Blankensteijn used in
the DREAM trial in Holland, the ACE
trial in France, and the OVER trial in
America.
“We now have all the data from
those trials at the Charing Cross site.
All of us are great friends, and the statistical analysis will take place at
Cambridge University.”
“I think at the end of this
One of the issues in combining such data, he continued, is
you will be encouraged to
in their durations. EVAR 1 went
rewrite a lot of guidelines
on for 15 years, but OVER conon endovascular repair.”
tinued only for nine, ACE for
five years, and DREAM for eight
Roger Greenhalgh
(albeit with further follow-up
planned). EVAR 2 included
“The 15 year EVAR follow-up is
much sicker patients, all of whom
have since died. “There is a lot to learn the only one, regrettably, that goes
out that far. So it is the only one from
about the early years by combining
which we can learn about the later
data,” said Professor Greenhalgh,
“But less to learn in the late follow-up, stages of follow-up. As you recall, the
term ‘aneurysm-related mortality’ is
except from the EVAR 1 trial.”
where people die and it is thought to
The resulting mean follow-up
duration in the meta-analysis emerges be as a result of an aneurysm, and the
way you find that is by way of certain
as 4.7 years. Common variables were
selected out between the trials, which accepted codes relating to cause of
death. Simon Thompson [Imperial Colare thought at this stage to include
lege London, UK], the statistician, used
age, sex, BMI, diabetes, smoking
history, ABPI and creatinine, previous
it for population screening, and in the
EVAR trial, and it has now become
history of angina, myocardial infarccommonplace.”
tion, maximum aneurysm diameter,
Out of the total 1,252 initially
aneurysm neck diameter, and neck
recruited to the study, only 68% of the
length.
EVAR group and 34% of the open
group remained at 15 years. This
poor follow-up from open repair was
understandable, explained Professor
Greenhalgh: “People don’t follow
open repair aortic aneurysms forever.
So we had to look at so-called hospital
episode statistics that the government
has for all of the population.”
Hence, hospital episode statistics were obtained for 663 patients
from the EVAR 1 trial. The 15-year
follow-up of EVAR 1 looked primarily
at aneurysm-related mortality as well
as all-cause mortality, complications,
reinterventions, secondary rupture
rates, and costs.
At the start of the last five years,
365 of the EVAR group patients were
alive and 361 of the open repair
patients were alive. Within the EVAR
group, of which 68% were still in
follow-up locally, 8% were still alive
although ceased follow-up, and 24%
were dead. In open repair, of which
34% were still being followed-up locally, 26% of patients were alive without follow-up and 40% were dead.
“The RCTs gave
confidence to the
user that [EVAR] was
safer to do.”
Roger Greenhalgh
Data pertaining to these within the
latter category can be obtained from
hospital statistics, confirmed Professor
Greenhalgh.
He went on to show that after ten
or 4mm) it is in fact hard to operate on
it. It could remain stable for 20 years.
This over-diagnosis is an ethical issue
and one that is difficult to solve.
“There are a lot of questions –
more that there are answers. But this
is part of the business, and we need to
talk about these unmet needs.”
References
1. Stather PW et al. International variations in
AAA screening. Eur J Vasc Endovasc Surg. 2013
Mar;45(3):231-4.
2. Linne A et al. Reasons for non-participation in
population-based abdominal aortic aneurysm
screening. Br J Surg. 2014 Apr;101(5):481-7.
3. Stather PW et al. A Review of Current Reporting
of Abdominal Aortic Aneurysm Mortality and
Prevalence in the Literature. Eur J Vasc Endovasc
Surg. 2014 Mar;47(3):240-2.
4. Howard DPJ et al. Population‐Based Study of
Incidence of Acute Abdominal Aortic Aneurysms
With Projected Impact of Screening Strategy. J
Am Heart Assoc.2015; 4: e001926
years of follow-up, the percentage of
patients surviving without aneurysmrelated death was formerly greater
with EVAR, but now approaching
equality with open repair. “We shall
learn what happens between ten and
15 years in terms of aneurysm-related
mortality,” he said.
The effect of the increasing
evidence regarding the efficacy of
EVAR has of course had a knock-on
effect on its prevalence. It has become,
said Greenhalgh, a new benchmark:
“everyone now uses aneurysm-related
mortality [as a clinical endpoint]. The
companies, for example, compare the
four-year data of latest technologies
against what they call the benchmark
of EVAR.”
Key publication of EVAR trial data
appearing in Lancet in 20046 and
20057; as well as in the New England
Journal of Medicine in 20058, bore a
significant impact in increasing the
adoption of EVAR, noted Professor Greenhalgh. At the same time,
he said, it reduced number of open
repairs. “The RCTs gave confidence to
the user that it was safer to do,” he
said, concluding: “We shall find out
in April at the Charing Cross meeting
whether that confidence was deserved
or whether it was a great mistake. I
hope to see you there.”
References
1. Endovascular Aneurysm Repair trials. http://
www.evartrials.org (retrieved January 2016).
2. Dutch Randomised Endovascular Aneurysm
Management (DREAM-) Trial. clinicaltrials.gov/
ct2/show/NCT00421330 (retrieved January
2016).
3. Becquemin JP.The ACE trial: a randomized
comparison of open versus endovascular repair
in good risk patients with abdominal aortic
aneurysm. J Vasc Surg. 2009 Jul;50(1):222-4;
discussion 224.
4.Becquemin JP. A randomized controlled trial
of endovascular aneurysm repair versus open
surgery for abdominal aortic aneurysms in lowto moderate-risk patients. J Vasc Surg. 2011
May;53(5):1167-1173.e1.
5.Lederle FA et al. Open Versus Endovascular
Repair (OVER) Veterans Affairs Cooperative
Study Group.Outcomes following endovascular
vs open repair of abdominal aortic aneurysm: a
randomized trial. JAMA. 2009; 302:1535-1542.
6.Greenhalgh RM et al. Comparison of endovascular aneurysm repair with open repair in
patients with abdominal aortic aneurysm (EVAR
trial 1), 30-day operative mortality results:
randomised controlled trial. Lancet. 2004 Sep
4-10;364(9437):843-8.
7. EVAR Trial Participants. Endovascular aneurysm
repair and outcome in patients unfit for open
repair of abdominal aortic aneurysm (EVAR trial
2): randomised controlled trial. Lancet. 2005 Jun
25-Jul 1;365(9478):2187-92.
8. Lederle FA. Endovascular Repair of Abdominal
Aortic Aneurysm — Round Two. N Engl J Med
2005; 352:2443-2445.
30 January 2016 LINC TODAY Thursday/Friday
Controversies, challenges and new concepts in renal and visceral interventions … Main Arena 1 Thursday 15:00–16:30
Renal ablation for hypertension
told to ‘keep its nerve’
R
enal denervation of treatment-resistant
hypertension will be placed under the
microscope today in a session that hopes
to rebuild a branch of interventional medicine
that has had a troubled past recently. Not least
because of the big hit It suffered just over two
years ago when the SYMPLICITY HTN-3 trial – a
major study that had been testing the Symplicity
renal denervation system (Medtronic, USA) for
treatment-resistant hypertension – had failed its
primary endpoint to show sustained reduction in
systolic blood pressure (compared to control) at
six months.[1]
The trial design itself featured 535 subjects
with severe treatment-resistant hypertension
(systolic blood pressure ≥ 160 mmHg) undergoing either renal denervation or sham procedure
(including a renal angiogram) in a 2:1 randomisation. The final patient pool was reached from an
original enrolment of 1,441 subjects.
“Renal denervation was hyped by every-
“We have a lot of trials that
are now ongoing, where
all of the learnings from
previous trials have been
taken into consideration
when conducting the study
protocol.”
Felix Mahfoud
body,” said Felix Mahfoud, a cardiologist from
Homburg, Germany, who will be discussing the
latest in renal denervation during the session. “It
was a great treatment option for patients with
resistant hypertension, and though the evidence
was good, it was not very solid.
“We had smaller randomised trials, and we
had a huge database already ongoing in an open
label registry. All of these were pretty promis-
ing in terms of lowering of blood pressure, and
safety profile the procedure. And then HTN-3
was believed to be the trial to answer all questions about renal denervation. The paper was
published and presented, although the authors
already acknowledged very early that something
went wrong in the trial.
“They did a lot of work, a lot of post-hoc
analysis, and figured out some of the confounding factors and published them. So we have
learned a lot about the anatomy, about the
catheter that had been used in HTN-3, the patient population (40% of the patients changed
anti-hypertensive drugs during their treatment),
and we also learned about the weaknesses of
blood pressure as a primary endpoint. Therefore
all trials now have changed to ambulatory blood
pressure.”
Ironically, as Dr Mahfoud stressed, it took this
negative outcome to actually fire-up the future
emphasis and drive it in the right direction.
“That was indeed needed to base renal denervation on solid ground, and on an evidence-based
ground,” he said.
Turning to the data, Dr Mahfoud underlined
that while there are still some conflicting data,
it is imperative to realise that more trials actually
support the concept of renal denervation for
reduction of treatment-resistant hypertension
than those that do not. “Even when you take
a look at only randomised controlled trials, the
number of positives is higher than the number
of negatives,” he said. “And we have a lot of
trials that are now ongoing, where all of the
learnings from previous trials have been taken
into consideration when conducting the study
protocol. And these trials are including patients
and they will hopefully help us to address of all
the open questions.”
Indeed, according to Dr Mahfoud, several
positive signs indicate that renal denervation may
be on the verge of a brighter existence. For one,
he noted that all of the companies that were
hesitant to continue renal denervation studContinued on page 32
32 January 2016 LINC TODAY Thursday/Friday
Controversies, challenges and new concepts in renal and visceral interventions … Main Arena 1 Thursday 15:00–16:30
Renal ablation for hypertension told to ‘keep its nerve’
failed, why shouldn’t I at least offer them a renal
denervation procedure?”
ies are now back in the field. In addition, renal
In his presentation, Dr Mahfoud will be
denervation in the clinic has not disappeared – in
touching upon the SPYRAL HTN Global Clinical
fact far from it. “We are still treating patients
Trial Program[2] – a
with renal denervation,”
natural successor of
he said. We have paSYMPLICITY HTN-3
tients who are referred
“We have patients who
that is designed in
for renal denervation,
are referred for renal
part to address the
those who have severe
confounding factors
hypertension of which
denervation, those who
encountered, includmedical or conservative
have severe hypertension
ing medication, the
treatment failed, and I
of which medical or
patient population and
think for those so-called
procedural variability.
‘no option’ patients,
conservative treatment
“With respect to the
renal denervation is
failed, and I think for
SPYRAL programme,
still a better treatment
those so-called ‘no option’
it is interesting and
modality.”
I think important to
And SYMPLICITY
patients, renal denervation
note that we will treat
HTN-3 can be thanked
is still a better treatment
patients off medicahere to some degree,
modality.”
tion, so milder forms
as it did demonstrate
of hypertension will
the procedure was very
Felix Mahfoud
be treated, and those
safe: “Exactly, and if I
patients are intended
take a look at our data,
to either be drug nait is pretty solid and
ïve, or washed out, so
robust,” commented Dr
they are really drug free when they receive renal
Mahfoud. “We do see significant drops, not in
denervation,” said Dr Mahfoud.
all patients, but in most of the patients. Safety
“We will have shorter follow-up, so a primary
is not an issue, so I think that those patients,
endpoint collection after three months, and
in case they have therapy-resistant hypertenthose patients on medication – that is a separate
sion, and in case conservative treatment options
Continued from page 30
vessels (everything above 3 mm will be treated).
group of the study – those patients will receive
Furthermore, we will ask for quadrantic treatment,
a triple, fixed combination of anti-hypertensive
i.e. all four quadrants will be treated on both sides.”
drugs. There will be no excuse, and no excepLooking to the future, Dr Mahfoud concluded
tions to other anti-hypertensive drugs.”
that the core issues
He added: “This will
lay outside the device
hopefully help patients
technology itself. “The
remain on a stable drug
“The problem is we need
problem is we need
regimen throughout
convincing evidence
convincing evidence
the study period, so
– not for me, because
we do not have the up
– not for me, because
I am convinced it is
and down titration of
I am convinced it is
working – but for our
anti-hypertensives that
working – but for our
community physicians
created the noise docuand patients showing
mented in HTN-3.”
community physicians
that renal denervation,
Another criticism of
and patients showing
in the presence of a
HTN-3 was the operator
that renal denervation, in
sham treatment, lowskill, which will also be
ers blood pressure.”
addressed in this new
the presence of a sham
He added: “Once
trial. “Every case will be
treatment, lowers blood
we have shown that,
proctored by a physipressure.”
we can work on
cian, and every case
catheter refinement,
will be reviewed by a
Felix Mahfoud
technology, treatblinded review commitment and technique
tee (only physicians),”
improvements.”
said Dr Mahfoud. “We
have very, very strict treatment recommendations References
1. Medtronic. Medtronic Announces U.S. Renal Denervation
and rules. It is no longer ‘put 4-6 ablation spots
Pivotal Trial Fails to Meet Primary Efficacy Endpoint While
anywhere in the renal artery’.
Meeting Primary Safety Endpoint (Press release, accessed at
newsroom.medtronic.com, January 2014)
“It is very strict and straightforward – and we are
2. Medtronic Announces New SPYRAL HTN Global Clinical Trial
extensively treating the distal part of the renal artery:
Program for Renal Denervation (Available at http://newsroom.
medtronic.com/; Accessed January 2016)
we are going into the branches, treating smaller
LINC Review is the support publication
to LINC 2016. With follow-ups on live
cases, consensus summaries on the
most important debates and digests of
key presentations, it offers a valuable
overview of all the hot topics and issues
discussed at LINC 2016.
To find out more
Contact MediFore: [email protected]
sidebar
Thursday/Friday LINC TODAY January 2016 33
Q3 Registry on the POLARIS Bi-Directional Stent System
– Recruitment will be Completed Soon
Principal Investigator, for the Q3 Registry
Investigators*
he prospective, multicenter, post market
surveillance Q3 registry is designed to
evaluate the performance of the POLARIS
bi-directional, self-expanding stent system
(QualiMed, Winsen, Germany) for the
treatment of superficial femoral artery (SFA)
disease in the routine clinical practice. The
POLARIS stent was developed to assure
resistance against torsional forces in both
directions (bi-directional) and therefore, to
treat both, left and right leg arteries equally.
T
Patients. Eligible for inclusion are patients
with a significant SFA stenosis (>50% diameter stenosis) or occlusion and clinical symptoms of chronic limb ischemia according
Rutherford category 2-4. The popliteal artery
and at least one of the infrapopliteal vessels
have to be patent for sustained distal run-off.
Major exclusion criteria are acute or subacute
thrombosis, hypercoagulopathy, or impossibility to cross the lesion with the guide wire.
The ethics committee of the Medical School
Hannover, Germany, approved the registry.
Intervention. Access to the lesion can be
achieved either by contralateral cross-over or
by ipsilateral antegrade approach via a 6F introducer sheath. After successful wire passage
of the lesion, the POLARIS stent should be
advanced over the guide wire. In case of long
lesions over 200mm in length, it is mandatory to implant additional POLARIS stents
to fully cover the lesion. Postdilation should
be performed in any case. Dual antiplatelet
therapy has to be administered consistent
with the standard of care.
Study end points. The primary end point
is the 12-month freedom from clinically driv-
en target lesion revascularization. Secondary
outcomes are acute technical and procedural
success, hemodynamic and clinical improvement at 12 and 24 months and safety issues
such as binary restenosis or reocclusion
(≤50% diameter stenosis as defined by peak
systolic velocity ratio <2.4), lower extremity amputation and all cause mortality at 12
months.
Interim results. Between December 2014
and October 2015 (date of this interim analysis) we consecutively enrolled 95 patients at
8 experienced sites in Germany. Mean age
of the patients was 69.9±12.2 years, 71.6%
of them were men, 35.8% had diabetes and
42.7% were current smokers. The majority of patients presented with Rutherford
category 2 (37.2%) or 3 (46.8%). In 55.8%
the left leg was affected. Mean lesion length
was 9.9±8.5cm with a 22.8% share of long
lesions (≥15cm). Sixty-two percent of all
lesions were moderately or heavily calcified,
and 40% were occluded. The treated length
was 12.4±9.1cm with 1.4 stents implanted
per lesion on average. Eighty percent of the
lesions were accessed by the contralateral
cross-over approach. Acute procedural success (≤30% stenosis and the absence of floe
limiting dissection or major adverse events
within 72 h of the index procedure, Peripheral Academic Research Consortium (PARC)
(1)) was achieved in 93.7% (74/79) of the
patients, and procedural success (increase in
ankle brachial index ≥0.1 from baseline) at
30 days in 86.2% (56/65). Averaged symptom classification changed from Rutherford
category 2.8 at baseline to 0.3 at 30 days.
Periprocedural complications were observed
in 8 patients. These were 6 dissections (left
leg lesions) with 4 of them flow limiting, 1
distal embolization and 1 false aneurysm.
Dissections were resolved by stenting. There
was no need for repeat target lesion revascularization or lower extremity amputation at
30 days. No patient died.
Perspective. Recruitment will be closed in
April 2016 with a targeted enrollment of 250
patients. Estimated primary completion will
be in April 2017.
Preliminary conclusion. We preliminarily conclude that the treatment of superficial
femoral artery lesions with the POLARIS
stent system in a real world setting is effective up to 30 days. So far, no safety concerns
were raised. ClinicalTrials.gov Identifier:
NCT02307292.
* Investigators
Hans Krankenberg, M.D.; Jarwed Arjumand,
M.D.; Markus Spanagel, M.D.; Gunnar Tepe,
M.D.; Erwin Blessing, M.D.; Viktor Reichert, M.D.;
Ralph Wickenhöfer, M.D.; Jörg Teßarek, M.D.
Department for Angiology, Asklepios Klinikum
Harburg, Germany (H.K.); Department of Angiology and Interventional Vascular Medicine, Agaplesion Bethesda Hospital Wuppertal, Germany
(J.A.); Department of Radiology and Nuclear
Medicine, Klinikum Oberberg- Kreiskrankenhaus
Waldbröl, Germany (M.S.); Department of Diagnostic and Interventional Radiology, Academic
Hospital RoMed Clinic of Rosenheim, Germany
(G.T.); Department of Internal Medicine, SRH Klinikum Karlsbad-Langensteinbach; Germany (E.B.);
Department of Vascular and Endovascular Surgery, Klinikum Sindelfingen-Böblingen, Germany
(V.R.); Department of Radiology, Interventional
Radiology and Nuclear Medicine, Herz-JesuKrankenhaus Dernbach, Germany (R.W.); Department of Vascular Surgery, Bonifatius Hospital
Lingen, Germany (J.T.)
Reference
1. Patel MR, Conte MS, Cutlip DE et al. Evaluation and treatment of patients with lower extremity peripheral artery
disease: consensus definitions from Peripheral Academic
Research Consortium (PARC). Journal of the American College of Cardiology 2015;65:931-41.
Thursday/Friday LINC TODAY January 2016 35
The guide wire, critical success factor in many of our cases
Dr. Koen Deloose Vascular surgeon at St Blasius
hospital, Dendermonde, Belgium
aizen is a Japanese word for the practice of
continuous improvement. Due to the increasing needs of today’s patients, both the physician
and medical device companies need to continuously improve. It has never been more critical for
physicians to have better equipment in order to treat
more challenging disease, using established and new
techniques.
The development of brand new guide-wire
technology is a perfect example of this continuous
improvement. The guide-wire is a tool we use in
every endovascular procedure. We use it all the time,
and although it may seem obvious, quite often the
success of our procedures depends on it.
The ‘first generation’ wires are the stainless steel
guide wires. They are characterized by a good support, and a 1:1 torquability, however they are easily
damaged.
The second generation guide wires are the nitinol, hydrophilic coated wires. They are highly durable
and flexible, but due to their elastic characteristics,
they miss the 1:1 torquability and steerability.
One of the most used second generation guide
wires is still today, the Terumo Radifocus guide
wire. It celebrated its 30th anniversary in 2015, and
we all still use it on a daily basis.
However, device companies are always looking
for new possibilities, new techniques to test, creating
new and better products to tackle more complex and
challenging endovascular situations.
The third generation guide wires are combinations of both worlds. They combine the advantages
K
of the stainless steel wires and the nitinol wires.
One of the best wires in my hands currently in
this category is the Glidewire Advantage, also made
by Terumo. It has a distal nitinol hydrophilic coated
part, combined with a stiff nitinol, spiral PTFE
coated proximal part.
It is available in 0,035”, 0,018” and 0,014”
diameters. The 0,035” Glidewire Advantage is a
wire I use as a backup, as in most of the cases the
normal Radifocus Terumo wire still does the job.
However, the 0,018” Glidewire Advantage is in my
opinion unique, because I can use it for the fast
spinning technique in long occlusions at femoropopliteal as well as BTK- levels. The angled tip and
the distal hydrophilic coating help me to navigate
through tortuous anatomy. The radiopaque tip
provides for me excellent visibility. In addition to
easy crossing, the Advantage wire also offers optimal support, as it tracks easily a variety of devices
because of the spiral PTFE coating that reduces the
friction inside different tools. I use it combined with
several (balloon) catheters to cross occlusions and
tight stenosis, with the Rotarex® (Straub Medical)
device or with retrograde punctures through a micro
puncture set to enter the tibial arteries and cross the
lesions retrogradely
To conclude, the Glidewire Advantage from
Terumo, especially the 0,018” is the third generation guide-wire I use the most. In my experience,
the combination of its sliding properties, flexibility,
perfect grip, 1:1 torquability and durability, makes
this workhorse wire a real winner and, in my opinion, has to be used in every endovascular lab facing
challenging cases.
Dr. Koen Deloose
36 January 2016 LINC TODAY Thursday/Friday
Faculty@LINC 2016
Michael Dake Cardiologist Stanford USA
Ahmed Koshty Vascular Surgeon Giesen Germany
Gianmarco de Donato Vascular Surgeon Siena Italy
Hans Krankenberg Cardiologist Hamburg Germany
Eric Dippel Interventional Cardiologist Davenport USA
Albrecht H. Krämer Vascular Surgeon Santiago Chile
Rick de Graaf Interventional Radiologist Maastricht The Netherlands
Prakash Krishnan Interventional Cardiologist Ryebrook USA
Costantino del Giudice Interventional Radiologist Paris France
Steven Kum Vascular Surgeon Singapore
Brian DeRubertis Vascular Surgeon Los Angeles USA
Mario Lachat Vascular Surgeon Zurich Switzerland
Jean-Paul de Vries Vascular Surgeon Nieuwegein The Netherlands
Johannes Lammer Interventional Radiologist Vienna Austria
Erik Debing Vascular Surgeon Brussel Belgium
Thomas Larzon Vascular Surgeon Orebro Sweden
Sebastian Debus Vascular Surgeon Hamburg Germany
Michael Lichtenberg Angiologist Arnsberg Germany
Nuno Dias Vascular Surgeon Malmo Sweden
Francesco Liistro Cardiologist Arezzo Italy
Larry Diaz-Sandoval Interventional Cardiologist Grand Rapids USA
Edelgard Lindhoff-Last Angiologist Frankfurt Germany
Nicolas Diehm Angiologist Aarau Switzerland
Armando Lobato Vascular Surgeon Sao Paulo Brazil
Dai-Do Do Angiologist Berne Switzerland
Romaric Loffroy Interventional Radiologist Dijon France
Suhail Dohad Interventional Cardiologist Beverly Hills USA
Charmaine Lok Nephrologist Toronto Canada
Konstantinos Donas Vascular Surgeon Munster Germany
Madeleine Luther Angiologist Leipzig Germany
Eric Ducasse Vascular Surgeon Bordeaux France
Sean Lyden Vascular Surgeon Cleveland USA
Stephan Duda Interventional Radiologist Berlin Germany
Sumaira Macdonald Interventional Radiologist San Francisco USA
Dariusz Dudek Cardiologist Krakow Poland
Lieven Maene Vascular Surgeon Aalst Belgium
Michael Edmonds Diabetologist London UK
Felix Mahfoud Cardiologist Homburg Germany
Rolf Engelberger Angiologist Lausanne Switzerland
Mahmoud Malas Vascular Surgeon Baltimore USA
Andrej Erglis Cardiologist Riga Latvia
Geert Maleux Interventional Radiologist Leuven Belgium
Fabrizio Fanelli Vascular and Interventional Radiologist Rome Italy
Martin Malina Vascular Surgeon London UK
Jorge Fernández Noya Vascular Surgeon Santiago de Compostela Spain
Marco Manzi Interventional Radiologist Abano Terme Italy
Roberto Ferraresi Interventional Cardiologist Milan Italy
Enrico Marone Vascular Surgeon Pavia Italy
Bruno Freitas Vascular Surgeon Leipzig/Petrolina Germany/Brazil
Klaus Mathias Interventional Radiologist Hamburg Germany
INVITED FACULTY
Jochen Fuchs Radiologist Leipzig Germany
Raul Mattassi Vascular Surgeon Castellanza Italy
George Adams Interventional Cardiologist Wake Forest USA
Massimiliano Fusaro Interventional Cardiologist Munich Germany
Robbert Meerwaldt Vascular Surgeon Enschede The Netherlands
Ayman Al-Sibaie Interventional Radiologist Dubai United Arab Emirates
Torsten Fuß Angiologist Berne Switzerland
Robert Melder Preclinical Development Santa Rosa USA
Thomas Albrecht Interventional Radiologist Berlin Germany
Pierre Galvagni Silveira Vascular Surgeon Florianopolis Brazil
Gerard Mertikian Vienna Austria
Jean-Marc Alsac Vascular Surgeon Paris France
Giuseppe Galzerano Vascular Surgeon Sienna Italy
Chris Metzger Interventional Cardiologist Kingsport USA
Mohammad AlTwalah Interventional Radiologist Riyadh Saudi Arabia
Alexander Gangl Interventional Radiologist Graz Austria
Ross Milner Vascular Surgeon Chicago USA
Klaus Amendt Angiologist Mannheim Germany
Lawrence Garcia Cardiologist Boston USA
Zoran Milosevic Neuroradiologist Ljubljana Slovenia
Max Amor Cardiologist Essey les Nancy France
Mauro Gargiulo Vascular Surgeon Bologna Italy
Erich Minar Angiologist Vienna Austria
Hiroshi Ando Interventional Cardiologist Kasukabe Japan
Bernd Gehringhoff Vascular Surgeon Munster Germany
David Minion Vascular Surgeon Lexington USA
Michele Antonello Vascular Surgeon Padua Italy
Philipp Geisbüsch Vascular Surgeon Heidelberg Germany
Michael Moche Interventional Radiologist Leipzig Germany
Carsten Arnoldussen Interventional Radiologist Venlo The Netherlands
Reza Ghotbi Vascular Surgeon Munchen Germany
Bijan Modarai Vascular Surgeon London UK
René Aschenbach Interventional Radiologist Jena Germany
Manjit Gohel Consultant Vascular Surgeon Cambridge UK
Frans Moll Vascular Surgeon Utrecht The Netherlands
Stanislaw Bartus Cardiologist Krakow Poland
Yann Gouëffic Vascular Surgeon St. Herblain France
Miguel Montero-Baker Vascular Surgeon San Jose Costa Rica
Steffen Basche Interventional Radiologist Erfurt Germany
Peter Goverde Vascular Surgeon Antwerp Belgium
Piero Montorsi Interventional Cardiologist Milan Italy
Rupert Bauersachs Angiologist Darmstadt Germany
William Gray Cardiologist New York USA
Lorenzo Paolo Moramarco Pavia Italy
Yvonne Bausback Angiologist Leipzig Germany
Roger Greenhalgh Vascular Surgeon London UK
Nilo Mosquera Vascular Surgeon Ourense Spain
Daniel Behme Gottingen Germany
Jochen Grommes Vascular Surgeon Aachen Germany
Bart Muhs Vascular Surgeon New Haven USA
Ulrich Beschorner Angiologist Bad Krozingen Germany
Grzegorz Halena Vascular Surgeon Gdansk Poland
Piotr Musialek Cardiologist Krakow Poland
Hans Biemans Interventional Radiologist Gorinchem The Netherlands
Alison Halliday Vascular Surgeon Oxford UK
Jihad Mustapha Interventional Cardiologist Wyoming USA
José Ignacio Bilbao Jaureguizar Interventional Radiologist Pamplona Spain
Olivier Hartung Marseille France
José Antonio Muñoa Prado Vascular Surgeon Chiapas Mexico
Theodosios Bisdas Vascular Surgeon Munster Germany
Markus Haumer Angiologist Modling Austria
Patrice Mwipatayi Vascular Surgeon Perth Australia
Stephen Black Vascular Surgeon London UK
Paul Hayes Vascular Surgeon Cambridge UK
Katja Mühlberg Angiologist Leipzig Germany
Erwin Blessing Cardiologist Angiologist Karlsbad Germany
Jörg Heckenkamp Vascular Surgeon Osnabruck Germany
Stefan Müller-Hülsbeck Interventional Radiologist Flensburg Germany
Emanuele Boatta Interventional Radiologist Strasbourg France
Thomas Heller Interventional Radiologist Rostock Germany
Tatsuya Nakama Cardiologist Miyazaki Japan
Dittmar Böckler Vascular Surgeon Heidelberg Germany
Tobias Hirsch Angiologist Halle Germany
Christoph Nienaber Cardiologist London UK
Amman Bolia Consultant Radiologist Leicester UK
Ulrich Hoffmann Angiologist Munich Germany
Sigrid Nikol Cardiologist Angiologist Hamburg Germany
Marc Bosiers Vascular Surgeon Dendermonde Belgium
Andrew Holden Interventional Radiologist Auckland New Zealand
Thomas Nolte Vascular Surgeon Bad Bevensen Germany
Spiridon Botsios Vascular Surgeon Engelskirchen Germany
Emmanuel Houdart Neuroradiologist Paris France
Thomas Noppeney Vascular Surgeon Nuremberg Germany
Karin Brachmann Vascular Surgeon Borna Germany
Peter Huppert Interventional Radiologist Darmstadt Germany
Gerard O’Sullivan Interventional Radiologist Galway Ireland
Sven Bräunlich Angiologist Leipzig Germany
Osamu Iida Cardiologist Amagasaki Japan
Christopher Owens Vascular Surgeon San Francisco USA
Daniela Branzan Vascular Surgeon Leipzig Germany
Krassi Ivancev Interventional Radiologist Hamburg Germany
Luis Mariano Palena Interventional Radiologist Abano Terme Italy
Mark Bratby Consultant Interventional Radiologist Oxford UK
Donald Jacobs Vascular Surgeon St. Louis USA
Jean Panneton Vascular Surgeon Norfolk USA
Marianne Brodmann Angiologist Graz Austria
Michael Jacobs Vascular Surgeon Maastricht The Netherlands
Giuseppe Panuccio Vascular Surgeon Munster Germany
Jocelyn Brookes Consultant Interventional Radiologist London UK
Jeffrey Jim Vascular Surgeon St. Louis USA
Patrick Peeters Vascular Surgeon Bonheiden Belgium
Jan Brunkwall Vascular Surgeon Cologne Germany
Robert Jones Consultant Interventional Radiologist Birmingham UK
Daniel Périard Angiologist Freiburg Switzerland
Sebastian Büchert Hechingen Germany
Johannes Kalder Vascular Surgeon Aachen Germany
Tim Ole Petersen Interventional Radiologist Leipzig Germany
Miroslav Bulvas Angiologist Praha Czech Republic
Dimitrios Karnabatidis Interventional Radiologist Patras Greece
Michael Piorkowski Angiologist Frankfurt Germany
Carlo Caravaggi Vascular Surgeon Milan Italy
Piotr Kasprzak Vascular Surgeon Regensburg Germany
João Martins Pisco Interventional Radiologist Lisbon Portugal
Jeffrey G. Carr Tyler USA
Konstantinos Katsanos Interventional Radiologist London UK
Giovanni Pratesi Vascular Surgeon Rome Italy
Gianpaolo Carrafiello Interventional Radiologist Varese Italy
Sashko Kedev Interventional Cardiologist Skopje Macedonia
Claudio Rabbia Interventional Radiologist Turin Italy
Fausto Castriota Cardiologist/Interventional Radiologist Cotignola Italy
Patrick Kelly Vascular Surgeon Sioux Falls USA
Boris Radeleff Interventional Radiologist Heidelberg Germany
Ian Cawich Interventional Cardiologist Little Rock USA
Arne Kieback Angiologist Cardiologist Leipzig Germany
Dieter Raithel Vascular Surgeon Nuremberg Germany
Roberto Chiesa Vascular Surgeon Milan Italy
Lars Kock Vascular Surgeon Hamburg Germany
Dheeraj Rajan Interventional Radiologist Toronto Canada
David Cohen Cardiovascular Research Kansas City USA
Jaydeep Kokate Biotechnology Engineer Maple Grove USA
Steve Ramee Cardiologist New Orleans USA
Gioachino Coppi Vascular Surgeon Modena Italy
Tilo Kölbel Vascular Surgeon Hamburg Germany
Thomas Rand Interventional Radiologist Vienna Austria
Alberto Cremonesi Cardiologist Cotignola Italy
Raghu Kolluri Angiologist Columbus USA
Michel Reijnen Vascular Surgeon Arnhem The Netherlands
Frank Criado Vascular Surgeon Baltimore USA
Ralf Kolvenbach Vascular Surgeon Dusseldorf Germany
Bernhard Reimers Cardiologist Milan Italy
The LINC organisers would like to thank this
year’s faculty for their time and effort
SCIENTIFIC COMMITTEE
Iris Baumgartner Angiologist Berne Switzerland
Giancarlo Biamino Cardiologist Angiologist Impruneta Italy
Piergiorgio Cao Vascular Surgeon Rome Italy
Michael Jaff Angiologist Boston USA
Nils Kucher Cardiologist Berne Switzerland
Ralf Langhoff Angiologist Berlin Germany
Friedrich Wilhelm Mohr Cardiac Surgeon Leipzig Germany
Dierk Scheinert Cardiologist Angiologist Leipzig Germany
Andrej Schmidt Cardiologist Angiologist Leipzig Germany
Giovanni Torsello Vascular Surgeon Munster Germany
Thomas Zeller Cardiologist Angiologist Bad Krozingen Germany
LIVE CASE COMMITTEE
Gary Ansel Cardiologist Columbus USA
Martin Austermann Vascular Surgeon Munster Germany
Koen Deloose Vascular Surgeon Dendermonde Belgium
Ralf Langhoff Angiologist Berlin Germany
Felix Mahler Angiologist Berne Switzerland
Antonio Micari Cardiologist Palermo Italy
Frank Vermassen Vascular Surgeon Gent Belgium
Thursday/Friday LINC TODAY January 2016 37
Robert Rhee Vascular Surgeon New York USA
Gunnar Tepe Interventional Radiologist Rosenheim Germany
Robert Beasley Interventional Radiologist Miami Beach USA
Vicente Riambau Vascular Surgeon Barcelona Spain
Jörg Teßarek Vascular Surgeon Lingen Germany
I-Ming Chen Vascular Surgeon Taipei Taiwan
Götz Richter Interventional Radiologist Stuttgart Germany
Fabien Thaveau Vascular Surgeon Strasbourg France
Paramjit Chopra Interventional Radiologist Chicago USA
Olaf Richter Vascular Surgeon Leipzig Germany
Matt Thompson Vascular Surgeon London UK
Napoleon Delgado Vascular Surgeon Lima Peru
Wolfgang Ritter Interventional Radiologist Nurnberg Germany
Mathias Tischler Angiologist Vienna Austria
Sanjay Desai Vascular Surgeon Bangalore India
Martin Rössle Gastroeinterologist Freiburg Germany
Marcus Treitl Interventional Radiologist Munich Germany
Alejandro Fabiani Vascular Surgeon Monterrey Mexico
Marco Roffi Cardiologist Geneva Switzerland
Santi Trimarchi Vascular Surgeon San Donato Milanese Italy
Mark Fleming Vascular Surgeon Rochester USA
Christian Rosenberg Interventional Radiologist Berlin Germany
Abraham Tzafriri Lexington USA
Masahiko Fujihara Interventional Cardiologist Kishiwada Japan
Kenneth Rosenfield Cardiologist Boston USA
Matthias Ulrich Angiologist Leipzig Germany
Karan Garg Vascular Surgeon Bronx USA
Ralph-Ingo Rückert Vascular Surgeon Berlin Germany
Kazushi Urasawa Cardiologist Sapporo Japan
Mark Goodwin Interventional Cardiologist Napperville USA
John Rundback Interventional Radiologist Teaneck USA
Jos van den Berg Interventional Radiologist Lugano Switzerland
Amit Gupta Interventional Cardiologist Oxford USA
Ravish Sachar Interventional Cardiologist USA
Marc van Sambeek Vascular Surgeon Eindhoven The Netherlands
Steve Henao Vascular Surgeon Albuquerque USA
Andreas Saleh Interventional Radiologist Munich Germany
Laurens van Walraven Vascular Surgeon Sneek The Netherlands
Daisuke Kamoi Interventional Cardiologist Nakagawa Japan
Marc Sapoval Interventional Radiologist Paris France
Ramon Varcoe Vascular Surgeon Sydney Australia
Chang-Won Kim Interventional Radiologist Busan Korea
Daniele Savio Vascular and Interventional Radiologist Turin Italy
Frank Veith Vascular Surgeon New York USA
Ashwani Kumar Interventional Cardiologist Richmond USA
Philipp Schäfer Interventional Radiologist Kiel Germany
Hence Verhagen Vascular Surgeon Rotterdam The Netherlands
Jason Lee Vascular Surgeon Stanford USA
Roland E. Schmieder Nephrologist Erlangen Germany
Eric Verhoeven Vascular Surgeon Nuremberg Germany
Chang Hoon Lee Interventional Cardiologist Seoul Korea
Darren Schneider Vascular Surgeon New York USA
Fabio Verzini Vascular Surgeon Perugia Italy
James McGuckin Interventional Radiologist Philadelphia USA
Peter Schneider Vascular Surgeon Honolulu USA
Renu Virmani Pathologist Gaithersburg USA
James McKinsey Vascular Surgeon West Harrison USA
Maria Schoder Interventional Radiologist Vienna Austria
Robert Vogelzang Interventional Radiologist Chicago USA
Anderson Mehrle Cardiologist Barlesville USA
Henrik Schröder Interventional Radiologist Berlin Germany
Hendrik von Tengg-Kobligk Interventional Radiologist Berne Switzerland
Ana Mollon Interventional Cardiologist Caba Argentina
Johannes Schuster Angiologist Leipzig Germany
Craig Walker Cardiologist Lafayette USA
Shogo Morisaki Interventional Cardiologist Kasuga Japan
Arne Schwindt Vascular Surgeon Munster Germany
Jeffrey Y. Wang New York USA
Sang Woo Park Interventional Radiologist Seoul Korea
Sven Seifert Vascular Surgeon Chemnitz Germany
Eberhard Wedell Angiologist Bad Neustadt Germany
Sang Ho Park Interventional Cardiologist Cheonan Korea
Carlo Setacci Vascular Surgeon Siena Italy
Martin Werner Angiologist Vienna Austria
Virendra Patel Vascular Surgeon Boston USA
Nicolas Shammas Interventional Cardiologist Davenport USA
Mark Whiteley Vascular Surgeon London UK
John Phillips Cardiologist Columbus USA
Horst Sievert Cardiologist Frankfurt Germany
Rob Williams Consultant Interventional Radiologist Newcastle UK
Venkatesh Ramaiah Vascular Surgeon Phoenix USA
Elisabeth Singer Angiologist Vienna Austria
Andrew Winterbottom Consultant Int. Radiologist Cambridge UK
Seung-Woon Rha Cardiologist Seoul Korea
Sebastian Sixt Cardiologist Angiologist Hamburg Germany
Christian Wissgott Radiologist Heide Germany
Eric Scott Vascular Surgeon Clive USA
Yoshimitsu Soga Cardiologist Kokura Japan
Cees Wittens Vascular Surgeon Maastricht The Netherlands
Tom Shimshak Cardiologist Sebring USA
Peter Soukas Interventional Cardiologist Providence USA
Walter Wohlgemuth Interventional Radiologist Regensburg Germany
Yoshinori Tsubakimoto Interventional Cardiologist Kyoto Japan
Holger Staab Vascular Surgeon Leipzig Germany
Florian Wolf Interventional Radiologist Vienna Austria
Jinsong Wang Vascular Surgeon Guangzhou China
Kate Steiner Consultant Interventional Radiologist Stevenage UK
Wayne Yakes Vascular and Interventional Radiologist Englewood USA
Mike Watts Interventional Radiologist Haddonfield USA
Sabine Steiner Angiologist Leipzig Germany
Hiroyoshi Yokoi Cardiologist Kitakyusyu Japan
Zhidong Ye Vascular Surgeon Beijing China
Andrea Stella Vascular Surgeon Bologna Italy
Stephan Zangos Interventional Radiologist Frankfurt Germany
Nam Yeol Yim Interventional Radiologist Gwangju Korea
Martin Storck Vascular Surgeon Karlsruhe Germany
ASSOCIATED FACULTY
Shuiting Zhai Vascular Surgeon Guangzhou China
Ulf Teichgräber Interventional Radiologist Jena Germany
Salman Arain Cardiologist Houston USA
Ting Zhu Vascular Surgeon Shanghai China
Thursday/Friday LINC TODAY January 2016 39
LINC Floor plan – Hall 4