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May 2010Issue 46

The international newspaper for vascular specialists BIBA Publishing

I N T E R N A T I O N A L

The EVAR (United Kingdom endovascular

aneurysm repair) 1 and 2 10-year follow-up results

were presented by Roger Greenhalgh, principal

investigator, and Louise Brown, Imperial College,

London, UK, manager of the trials. The final results of the

two trials were published online in the New England

Journal of Medicine following the presentations at the

symposium.

Brown told delegates that the EVAR 1 trial included

male and female patients, aged at least 60 years, with

aneurysm diameter greater than 5.5cm and anatomically

suitable for EVAR. Patients considered fit for open and

endovascular repair were included. A total of 1,252

patients were randomised to endovascular or open repair

from September 1999 to August 2004. There were no dif-

ferences in baseline characteristics between randomised

groups. Mean age was 74 years, 90% of the participants

were male, and average aneurysm diameter was 6.4cm.

Overall compliance was 93%.

Thirty-day operative mortality was 1.8% for EVAR and

4.3% for open repair, Brown said. “Patients were fol-

lowed until December 2009 for a minimum follow-up of

five years, and a maximum of 10 years.”

On aneurysm-related mortality, Brown said the previous

2005 results had demonstrated a significant early mortality

benefit in the EVAR group, which was maintained at four

years and remained significantly low at that time-point,

and this was seen again in the later analysis. “However,”

Brown added, “with an additional four years of follow-up

you can see that this benefit has been eroded away, such

that at six years no difference is seen between the groups,

and this is reflected by a non-significant hazard ratio.”

Brown said that the reason for this convergence may be

explained by the late aneurysm deaths in the EVAR group.

There were 25 graft ruptures in the EVAR groups and no

ruptures in the open repair group.

Re-interventions were higher with endovascular repair,

and new complications occurred up to eight years after

randomisation, contributing to higher overall costs.

Greenhalgh summarised the late follow-up conclusions

of EVAR 1: “The benefits for EVAR include that it still

reduces operative mortality, it is the lesser procedure,

involves a shorter stay and can be done under local anaes-

thetic. Against it, it has increased costs, surveillance and

re-interventions.” He concluded that the benefits of EVAR

versus open repair are therefore in the balance. The burn-

ing question is what patients will make of the new data.

EVAR 2

The 10-year results of the unique EVAR 2 trial showed

that endovascular repair is significantly better than no

intervention in terms of aneurysm-related mortality in

Key new messages from the long-term

follow-up of the EVAR 1 and 2 trials were

delivered at the CX Symposium. EVAR 1

showed that at 10 years, compared with open

repair, endovascular repair has a lower

operative mortality, but at six years the

advantage of aneurysm-related mortality is

lost. For patients physically too frail for open

repair, EVAR 2 showed that endovascular

repair is better than no intervention in terms

of aneurysm-related mortality. However,

there is no all-cause mortality benefit as so

many patients had died

On the final day of

CX32, there was

excitement and

discussion at the Renal

Session. The recent ran-

domised trials which found

that renal artery stenting

showed no benefits over

medical therapy, STAR and

ASTRAL, came in for con-

siderable criticism from

some speakers. The session

was chaired by Jon Moss,

principal investigator of

ASTRAL. Delegates were

told that unless the

CORAL trial, the results of

which are awaited in early

2011, unveils data clearly

showing the benefit of

intervention, the future of

renal artery stenting is very

much in doubt, even

though most clinicians

believe a subgroup of

patients do benefit from

revascularisation.

Thomas Zeller, Bad

Krozingen, Germany, pre-

sented on the topic

“Critical review of indica-

tions for renal artery stent-

ing: Do randomised data

give the answer?” He told

delegates,“Do not base

your decisions entirely on

randomised controlled tri-

als alone because real

world registries are more

likely to reflect reality.”

Zeller said the ran-

domised trials prior to

ASTRAL (Angioplasty and

stent for renal artery

Future of renal artery stenting in peril

With thisissue

After the presentation of the ICSS

(International Carotid Stenting

Study) results by Martin Brown

and Jonathan Beard, which showed that

carotid endarterectomy is a safe

option for symptomatic patients,

CX delegates heard two differing

interpretations of the CREST

(Carotid revascularisation

endarterectomy vs. stenting) trial

results. The CREST data have

been anxiously awaited and the organis-

ers of the symposium were grateful that

two investigators of the trial, Wesley

Moore, vascular surgeon, Division of

Vascular Surgery, University of

California, Los Angeles, USA, and

William Gray, interventional cardiologist,

New York, USA, presented and

discussed data from the study.

Moore gave the impression that

surgery seemed to be safer and

described the results as a “game

modifier” rather than a “game

changer” for carotid stenting.

Gray argued that the data show carotid

artery stenting still has a role and put the

Differing views on CREST

BIBA Publishing

Continued on page 2

Continued on page 8 Continued on page 12

CX Office BasedVeins Practice

Page 34

St George’s VascularAccess Course at CX

Page 26

patientswereenrolled in CREST

2,522

Landmark EVAR trials deliver new messages at Charing Cross

Roger Greenhalgh Louise Brown

September 2010

BIBA Publishing

2 Aortic aneurysm May 2010

patients unfit for open repair. However, there is no all-

cause mortality benefit as so many patients had died.

“The lines cross and then diverge from two years. Our

previous publication in 2005 had not seen any significant

benefit at four years,” Brown said.

She told delegates that in EVAR 2 aneurysm-related

mortality was 3.6 deaths per 100 person-years and 7.3 per

100 person-years in the no intervention group (adjusted

hazard ratio, 0.53; 95% CI, 0.32 to 0.89; p=0.015).

The results received a positive response from the audi-

ence. Questioned “Will you recommend EVAR in

patients unfit for open repair?” 92% of the delegates

answered yes.

Brown reported that within 30 days, 13 (7.3%) of the

179 patients in the endovascular-repair group had died.

“Thus the operative mortality was markedly higher than

the 1.8% mortality rate seen in the EVAR 1 trial,” she

added, “However, this is to be expected given the differ-

ence in fitness between the two cohorts.” Overall, there

was no significant difference between the two groups in

terms of all-cause mortality.

“Given the crossover, we felt that a per-protocol analy-

sis was justified,” Brown said. The Kaplan-Meier curves

showed that there was a trend towards lower all-cause

mortality in the EVAR group, with the curves diverging

slightly at eight years, but this is only of borderline statis-

tical significance. A similar per-protocol analysis per-

formed for aneurysm-related mortality showed that the

benefit of EVAR is increased, with a 60% reduction in

aneurysm-related deaths in the EVAR group.

Comparing rates of complications between EVAR 1

and EVAR 2, the investigators were surprised to see that

the rates were almost identical across the two trials,

showing that this more physically fragile group did not

appear to have a strong influence on the subsequent rate

of graft complications. However, Brown said, this may

be because patients in EVAR 2 are not living long enough

to experience complications.

Brown then highlighted the issue of reintervention

and reported that investigators were surprised to find,

again, an almost identical result across EVAR 1 and

EVAR 2. In both, around 25% experienced a reinterven-

tion within the first six years. In terms of cost, she

added, this was higher in the EVAR group – due to the

number of reinterventions.

Brown then handed over to Greenhalgh, who sum-

marised the findings of EVAR 2. “Once again,” he said,

“We will weigh it up.” The benefits, he said, were the

reduced aneurysm-related mortality. “That is the single

main finding in addition to what we had at four years,” he

said. The per-protocol all-cause mortality trend which he

said was looking close to being significant. However, to

the detriment of EVAR are the increased costs, and the

same increased surveillance, complications and reinter-

ventions that were found in EVAR 1.

In a discussion following the presentation, Frank Veith,

who originally criticised the EVAR 2 trial as being

“flawed”, yesterday congratulated the investigators on

the results and said he was pleased to see a benefit in

decrease of aneurysm-related death. Greenhalgh replied,

“You told me it was flawed, remember, so you cannot

now say you believe a word of it! Is this because you

now like the results?”

Alun Davies also posed the question of how the results

will alter practice during the next five years. Greenhalgh

replied that he predicted good things to come, with the

new generation of devices available. He said, “I think

that this opens the door for the justification of endovascu-

lar procedures in the frail patient situation. Even though

so few are alive at the end of this long follow-up I think

that for those who know they have an aneurysm and live

every day with the expectation that it might explode, that

is exactly the message. As far as EVAR 1 is concerned I

think that is more difficult to predict.”

Traffic light system

A “traffic light” system was used asthe underlying recommendationfor entry into EVAR Trial1 or 2. Cardiac, respiratory andrenal function questions wereasked on the case recordforms and these helped classifythe patients into three groupsdepending on how fit they were foropen repair:

RED – Failure to be consideredsuitable for any procedure at that

time on the basis of cardiac factors.Patients were put in the red category if they hadhad a myocardial infarction or angina within thepast three months or unstable angina at night orrest.

AMBER – Failure to satisfy criteria for openrepair but possibly suitable for EVAR 2. Patientswere put in the yellow category of poorcandidates for surgery if they had a history ofangina or myocardial infarction, valve disease,congestive heart failure, or arrhythmia.

GREEN – Satisfying criteria for open repairand/or endovascular repair in EVAR 1

Landmark EVAR trials deliver new messages at Charing CrossContinued from page 1

8 No

92 Yes

Will you recommend EVAR in patientsunfit for open repair?

37 Open repair9

63 EVAR

Given the EVAR 1, DREAM, ACE, OVERand registry data, will you offer more fre-quently:

CX voting results

EVAR 2EVAR 1

September 2010

BIBA Publishing


Giovanni Pratesi,

University of Florence,

Florence, Italy, present-

ed his team’s experience with

the Anaconda stent graft

(Vascutek-Terumo) at the CX

Symposium.

“The unique characteristics

of the Anaconda system are the

repositionability of the main

body and the magnet-wire

facilitated cannulation of the

contralateral gate,” he said.

“Anaconda has been released

on the market in 2005 after CE

approval. The system has been

recently updated, mainly with a

smoother tip configuration of

delivery system and a

hydrophilic-coated sheath,

besides new markers and a

wider lengths range of flared

leg,” Pratesi said.

Mid-term outcomes with the

system were reported in two

single-centre experiences with

an estimated 82% freedom

from endoleak and a 91% free-

dom from secondary procedure

at a median follow-up of 16

months and a primary clinical

success of 80% with a freedom

from reintervention of 88% at a

median follow-up of 23

months, respectively. A recent

multicentre experience with 61

patients treated at five different

European centres confirmed

these results by reporting an

88% secondary clinical success

with 11% serious adverse event

rate in absence of migration

and abdominal aortic

aneurysm-related mortality,

Pratesi told delegates.

“Our experience with the

Anaconda system started in

October 2005 and since then we

have used this endograft in 105

patients. We use Anaconda in

‘ideal’ cases as well as in com-

plex anatomies in terms of aortic

neck angulation and iliac tortu-

osity and calcification,” he said.

“Regarding the main body

oversize, which represents an

important issue in relation to the

influence on the proximal con-

figuration of the graft, an over-

sizing between 10 and 15% was

used in most of the cases, with a

mean oversizing of 13.7%.”

Endurant

Hence Verhagen, Rotterdam,

The Netherlands, presented the

final results from the European

prospective Endurant trial.

“Outcomes up to 12 months

for safety and effectiveness are

very positive with 100% deliv-

erability, zero ruptures, no type I

and III endoleaks and a high

technical success rate,” he said.

Verhagen told delegates that

his personal conclusions are that

Endurant seems to combine a

few unique features: Ability in

the deployment, ease to use, con-

formability to the original anato-

my, low-profile. There were also

very positive outcomes reported

in the European trial.

Datascope-Maquetendograft

Aortic morphology is critical in

determining the successful out-

come of endovascular

aneurysm repair. Inadequate

proximal aortic neck is the

most frequent exclusion criteri-

on for EVAR, Ralf Kolvenbach,

Vascular Centre Augusta

Hospital and Catholic Clinics,

Düsseldorf, Germany, told del-

egates. “Patients with large

aneurysms and short, heavily

calcified necks are at increased

risk for proximal type I

endoleaks and an ongoing risk

of rupture. Endografting of

juxtarenal abdominal aortic

aneurysm is associated with a

greater incidence of adverse

events. In addition, difficult

aortic neck morphology com-

promises successful outcome

after EVAR because there is an

increased incidence of device

migration, type I and II

endoleaks,” he said.

Kolvenbach reported for the

first time his group’s experience

in more than 20 patients with

juxtarenal aneurysms who were

treated with a combination of

unilateral or bilateral parallel

grafts, the balloon expandable VI

– Maquet Endo cuff and a regu-

lar stent graft. “Most of these

cases fulfilled exclusion criteria

for EVAR, yet using the tech-

nique described we could suc-

cessfully offer this approach to

all our patients with juxtarenal

aneurysms,” he said. Kolvenbach

presented the group’s technique

of endovascular exclusion of a

thoracoabdominal aortic

aneurysm type III. “In this case

also a combination of parallel

grafts for the renal and visceral

arteries, balloon expandable

stents and regular endografts was

used,” he told delegates.

“In summary, using a combi-

nation of techniques we can offer

endovascular repair to the major-

ity of symptomatic patients with

juxtarenal and thoracoabdominal

aneurysms without having to

wait for custom made grafts with

all the costs involved.”

Aorfix

Mark Fillinger, Lebanon, USA,

presented an update on the US

PYTHAGORAS clinical trial of

the Aorfix endograft for abdom-

inal aortic aneurysms.

“The implant has been used at

multiple centres to treat highly

angulated necks (>60°) and very

tortuous anatomy with excellent

success rates,” he said. “Pilot

study results are good, and mir-

ror the European results

(RADAR registry). Unprece-

dented neck angulation and gen-

der distribution were found in

this trial: This device may ex-

pand the number of patients

who can be treated with EVAR.”

Secondary ruptures after EVAR explaincatch-up in aneurysm-related mortalityrelative to open repair in 10-year follow-up

Wyss presented on “Rate and

predictability of graft rupture

after endovascular and open

abdominal aortic aneurysm repair: Data

from the EVAR trials” at the European

Surgical Association annual meeting,

Budapest, Hungary, in May.

The aim of the graft rupture analysis,

Wyss said, was to establish the incidence

of secondary rupture after abdominal aor-

tic aneurysm correction by endovascular

and open repair and to investigate factors

associated with secondary rupture. In total,

848 elective endovascular repairs and 594

elective open repairs were performed in

EVAR 1 and 2, he told delegates.

No ruptures after openrepair

The main finding of Wyss and colleagues

after looking at all endovascular and open

repairs performed for up to 10 years was

that there were no ruptures after open

repair. This was a surprise because rup-

tures after open repair have been docu-

mented in the past as in the UK Small

Aneurysm Trial.

Aneurysm-related mortalitycatch-up explained

The EVAR 1 trial aneurysm-related

mortality converged at the six-year

point, having been significantly higher

for open repair at four years (See EVAR

1 aneurysm-related mortality graph on

page 2). In these later years of follow-up

there had to be an explanation for this

relative deterioration in the EVAR group

at late stages. “This relative improve-

ment of open repair is due to ruptures

after EVAR,” he told delegates.

Wyss has demonstrated that 27 rup-

tures occurred after endovascular repair –

25 in EVAR 1 and two in EVAR 2. A

possible explanation for EVAR 2 is that

there are so few patients alive towards

the end of this follow-up period. The 27

ruptures occurred in three groups – five

within 30 days (group A) and the sixth at

32 days. Wyss recommended that in the

future any patients being discharged

early must have a predischarge CT scan

because he assumed in retrospect that a

technical problem had led to this rupture.

“We assume that there was a technical

problem behind all of group A and the

first rupture (32 days) of group B. A

change of protocol, to always perform a

predischarge scan could have revealed

problems, which could have been

addressed,” Wyss said.

There are four additional sac ruptures

which occurred without complications –

one failed to attend CT scan follow-up.

This left three (11%) which ruptured out

of the blue. The patient and clinician,

Wyss said, assumed that all was well and

“out of the blue” a rupture occurred.

Fortunately this is rare. But, two out of

these three died.

The remaining 17 patients (group C)

had a cluster of recognisable and known

endovascular complications particularly

endoleaks with sac expansion, and one

patient had migration, in addition.

The mortality from EVAR secondary

rupture explains catch-up in EVAR

aneurysm-related mortality and the better

performance of open repair at later stages

in EVAR 1.

Wyss said that the next steps are to

“implement a predischarge computed

tomography scan to reduce perioperative

rupture, confirm the collection and

sequence of EVAR complications which

predispose to rupture, re-examine the

threshold for conversion to open repair

and prospectively react to high risk

scenarios.”

Thomas Wyss

CX session provides EVAR device updates

Read more onEVAR devices inthe InnovationShowcase, pg 18

Thomas Wyss, Bern, Switzerland, spent a year as vascular

research fellow at the Charing Cross Vascular Surgery Research

Group, became adept at three-dimensional imaging and

established a core laboratory. He had access to CT scans of all the

EVAR trials’ long follow-up data and conducted an analysis on graft

rupture. The data were presented in Budapest in May and are to be

published in the Annals of Surgery

September 2010

BIBA Publishing


DREAM and DREAM-ON

Jan Blankensteijn, Amsterdam, The

Netherlands, presented long-term results

of the DREAM (Dutch randomised

endovascular aneurysm management) and

DREAM-ON trials. At six years after ran-

domisation, survival was similar for both

EVAR and open repair, he told delegates.

The investigators also found that there

was a higher rate of secondary interven-

tions after EVAR. However, the sharp

increase of reinterventions four years after

EVAR is alarming, but this requires con-

firmation from other long-term studies.

“These are finally the long-term results

that we have been anticipating for years

and I think it is important for the vascular

community to have these long-term out-

comes,” Blankensteijn told Vascular

News.

OVER

Frank Lederle, Minneapolis, USA, then

presented two-year results of the OVER

(Open vs. endovascular repair) trial.

OVER is a multicentre randomised clini-

cal trial comparing open repair to any

Food and Drug Administration-approved

EVAR system, Lederle told delegates.

In the trial, patients with an abdominal

aortic aneurysm of 5cm or greater were

candidates for both procedures. The pri-

mary outcome (for the full study) was

mortality.

The study began in 2002, was re-con-

figured in 2005 and is due to end in 2011.

Eight hundred and eighty one patients

were enrolled from 42 centres and, to date,

there has been one planned short-term

report, with a cut-off of October 2008.

The purpose of this was to ensure that

short-term post-operative outcome data

would be disseminated while still remain-

ing maximally relevant, Lederle

explained. The original plan was to look at

one-year data only, but this was changed

to two-year follow-up (without knowledge

of the results) because of important

changes in the second year of the EVAR 1

(United Kingdom endovascular aneurysm

repair) and DREAM trials, in both of

which, for total mortality, EVAR looks

better at one year, but not at two years.

In OVER, 5,161 patients were assessed

for eligibility, Lederle said. Of those, 881

were eligible and were randomised to

either endovascular or open repair.

Lederle reported that the mean age of

patients was 70 years and 99.3% were

male. Their mean weight was 90kg. Forty

three per cent had an abdominal aortic

aneurysm diameter of less than 5.5cm and

27% were 6cm or over.

Various devices were used for

endovascular repair, Lederle said. Thirty

nine per cent received Cook’s Zenith

EVAR system, 37% had the Gore

Excluder, 21% had Medtronic’s Aneurx

and 3% received Guidant/Endologix.

Lederle reported that, at two years,

EVAR reduced the duration of the proce-

dure and mechanical ventilation, amount

of blood loss and transfusions, and hospi-

tal and intensive care unit stay, but added

substantial exposure to radiation and con-

trast.

The cause of death in six (1.4%)

patients receiving EVAR was abdominal

aortic aneurysm-related (including 30

days and hospitalisation) compared to 14

(3.2%) patients having open repair,

Lederle reported. In addition, no ruptures

were identified at two years. There were

also four late abdominal aortic aneurysm-

related deaths in the EVAR group and

only one in the open repair group.

Lederle compared mortality within 30

days or inpatient in the EVAR 1,

DREAM and OVER trials. Interestingly,

there was a lower mortality rate in OVER

than DREAM or EVAR 1, at 0.5% in the

EVAR group and 4.6% in the open repair

group.

The possible reasons for this, Lederle

said, could be due to a difference in tim-

ing. OVER was intentionally started later

(2002–2007) to study a more mature

technology, whereas EVAR 1 and

DREAM took place from 1999–2003.

These improvements over time are anoth-

er good argument for surveillance to

5.5cm, he added.

In summary, Lederle said that perioper-

ative mortality was lower for EVAR than

open repair, and lower for both procedures

than in earlier trials. EVAR also reduced

duration of procedure and mechanical

ventilation, amount of blood loss and

transfusions, and hospital and intensive

care unit stay. However, he said, there was

no difference in major morbidity, proce-

dure failure, secondary procedures,

abdominal aortic aneurysm-related hospi-

talisations, quality of life, erectile func-

tion, or total mortality. The data led

Lederle to conclude that longer-term data

are needed to fully assess the relative mer-

its of the two procedures.

ACE

Following Lederle’s presentation, Jean-

Pierre Becquemin, Paris, France, gave an

overview of the ACE (Anevrysme de

l’aorte abdominale, chirurgie versus endo-

prothese) trial, a multicentre, prospective

randomised trial aimed at assessing the

results of EVAR and of open surgery in

relatively good-risk patients presenting

with an asymptomatic abdominal aortic or

aortoiliac aneurysm. But he stopped short

of giving away the results, citing the fact

that the paper has been submitted for pub-

lication to a peer-review journal and the

results could not therefore be discussed.

EVAR registry

Marc Schermerhorn, Boston, USA, pre-

sented the data from a registry on open

versus endovascular abdominal aortic

aneurysm repair. Giving some background

to the registry, Schermerhorn highlighted

the benefits of a registry over randomised,

controlled trials. In randomised, controlled

trials, he said, the subjects represent a

homogeneous sample, are highly motivat-

ed to participate and significant comorbid-

ity/complications are exclude. In addition,

physicians work in selected institutions

with a coordinated research team, follow-

ing a specific protocol.

Schermerhorn looked at Medicare data

(100%), targeting hospital and physician

claims (ICD9 and CPT codes) for all

non-ruptured abdnominal aortic

aneurysm repairs 2001–2004.

Extrapolating the data, Schermerhorn

said that the average age of patients was

≥67. Two years of claims data were

required prior to repair for comorbidity

coding. Overall perioperative mortality

(in-hospital or 30-day) was found to be

1.8% for EVAR and 5.3% for open repair

(relative risk 2.9). Schermerhorn found

that endovascular abdominal aortic

aneurysm repair is more often utilised for

older, sicker patients. There is also lower

perioperative mortality with EVAR and

fewer perioperative complications.

Furthermore, he added, survival advan-

tage of EVAR is more durable in older,

sicker patients. Late abdominal aortic

aneurysm-related reinterventions are

more common after EVAR, the majority

of reinterventions after EVAR are minor.

These are balanced by an increase in

laparotomy related re-interventions and

readmissions after open repair, he said.

In general, Schermerhorn noted, over-

all mortality rates for abdominal aortic

aneurysm repair are decreasing due to

increased utilisation of EVAR. Also,

overall aneurysm-related mortality, due

to ruptures and elective repair, is decreas-

ing as EVAR utilisation rises.

CX session gathers leaders inrandomised aneurysm trialsThe Aortic Day at CX 2010 gathered together the latest evidence on EVAR. Following the presentation of

the EVAR 1 and EVAR 2 10-year results, the five-year results of DREAM, the two-year OVER results, and

the results of a registry on EVAR and open repair were discussed

Jan Blankensteijn

Frank Lederle Marc Schermerhorn

Jean-Pierre Becquemin

September 2010

BIBA Publishing

8 Renal arteries May 2010

lesions), had results limited by

the fact that in about 50% of

lesions, stenosis was less than

70%: “In the DRASTIC trial,

15% of lesions showed less than

50% stenosis. Other limitations

included small numbers.”

Zeller told delegates that

STAR and ASTRAL were limit-

ed by patient selection bias and

poor study design. He said, “The

lesson learned from ASTRAL is

that patients with atherosclerotic

renal artery stenosis in whom the

need for revascularisation is

uncertain do not get better with

revascularisation, as with opti-

mised drug therapy.”

Also, said Zeller, patients with

the highest probability of treat-

ment effect are frequently

excluded from randomised trials.

To overcome the selection bias

of a randomised trial comparing

revascularisation with conserva-

tive therapy, upcoming studies

should include a registry arm

enrolling all eligible patients who

refused randomisation. The reg-

istry arm with the same restric-

tions in enrolment criteria as the

randomised study arm might be

more representative for a real

world scenario because even the

most severe lesions including

bilateral stenoses and stenoses of

single kidney providing renal

arteries will be enrolled in such a

registry arm, he said.

Michael R Jaff, Boston, USA,

spoke on the patient selection in

these trials and said, “We are

missing a window of opportunity,

and it is closing really fast. I am

worried that CORAL is not going

to solve this problem, because

not every patient with renal artery

stenosis was enrolled in CORAL.

We have not selected the right

patients properly. We have

missed an opportunity, we have

not studied renal artery interven-

tion necessarily in the right popu-

lation. Depending on the results

of CORAL, the Federal

Government will tell us what to

do, because we were not able to

provide them definitive data.”

Jim Reekers, Amsterdam, The

Netherlands, presented on

“Primary stent placement for

renal artery stenosis and renal

functional impairment: Outcome

of the randomised trials”. He

drew attention to the fact that he

was speaking on the newer ran-

domised trials – the STAR study,

ASTRAL and NIDER which is

an Italian study.

Reekers identified some of the

issues with the STAR study.

“There was a very small number

in each group, a short follow-up,

and no corelab for quantitative

vessel analysis. Additionally,

28% randomised to stent did not

receive a stent and medical thera-

py was poorly defined,” he said.

ASTRAL too came in for

some stick. “This trial was

underpowered with a short fol-

low-up. Of 403 patients assigned

to stent, 23.6% did not receive a

stent. Seven per cent of patients

who were randomised to receive

a stent, only had percutaneous

transluminal renal angioplasty.

Twelve per cent who had a stent

had a residual stenosis >50%,

there was a high complication

rate, medical therapy was poorly

defined, there was no corelab

adjudication and there was a

selection bias toward enrolling

asymptomatic or minimally

symptomatic patients with non-

obstructive renal artery lesions,

i.e. patients unlikely to benefit

from revascularisation,” he said.

Reekers said, “Results from

the recent randomised trials are

inconclusive due to inadequately

powered, poorly defined medical

treatment, crossovers, short fol-

low-up, inconsistent use of

stents, enrolment of patients with

<50% stenosis, use of surrogate

endpoints and lack of angio-

graphic corelab adjudication.”

He said that the questions that

still remain are: Does renal stent-

ing improve survival? Does

stenting improve quality of life?

Is renal stenting cost-effective?

Is there a test that will accurately

predict the clinical effects of a

renal artery stenosis?

Roger Greenhalgh, chairman

of CX32, highlighted he sympa-

thised with the investigators of

ASTRAL because the findings

are counter-intuitive, just as

some other trials had turned out.

“EVAR 2 was one such trial,” he

said. “There may be a subgroup,

as Jon Moss implies, but overall

the intervention has not produced

the expected result,” he noted.

Future of renal artery stenting in peril

After the Renal Session at CX32,

Vascular News organised a

roundtable, freewheeling conver-

sation between Jon Moss, Jim A Reekers

and Thomas Zeller to touch on the vari-

ous aspects which emerged in the plenary.

Zeller began by stressing that his key

criticism of the ASTRAL trial was the

assumption made in the trial that moder-

ate lesions lead to any impairment of clin-

ical functions such as renal function, or

hypertension. He said half of the patients

included in ASTRAL had moderate

lesions, which meant that if they were

treated with stents, nothing would change.

On the other hand, the medical treatment

alone would also not result in a significant

deterioration of clinical functions.

Zeller: The other criticism I have is that

there was a high selection bias in

ASTRAL. At the very end, there was only

one trial centre including more than 10%

of the patients. Most of the centres includ-

ed 2–5% of the patients. If you enrol only

2% of the patients that could have been

enrolled and they do not benefit, you can-

not tell the community that the other 98%

will not benefit either. I would expect that,

in order to demonstrate the benefit of the

procedure, we would have to include only

patients with severe renal artery stenosis.

This needs to be measured by some tech-

nical tool, and so far, the only non-inva-

sive one we have is duplex ultrasound,

which is a very cheap procedure.

Moss: I will tell you why intelligent

men and women in the UK had to do it

this way. We initially wanted to use

Doppler wire, computed tomography

scan, nuclear medicine assessment of

renal function, but were told it was not

possible. It is like trying to say we need to

land on Venus, it is a nice idea, but it is not

going to work. We are relying on hospitals

from all over the UK and Europe to enrol

patients and if they had to do all of that,

we would have ended up with very few

patients. That is why we were forced to

cast the net wider.

Reekers: Jon is so right, if you want to

run a trial, you have to compromise, other-

wise you cannot get your data. Of course

there are flaws here, but you cannot blame

the investigators. The problem is that there

is no consistency within our interventional

community. If there was consistency, there

would not be a problem. I always point to

what cardiologists do. Cardiologists typi-

cally randomise 3,000–4,000 patients and

come out with very good evidence. In-

stead of blaming the investigators, we

could also blame ourselves.

Zeller (returning to the concept of

duplex ultrasound) said it was important

to identify the relevant difference in

resistance index which is significant for

relevant stenoses.

Zeller: My group has looked into the

question and proved that a slight differ-

ence of more than 0.05 in the resistance

index clearly correlates to at least 70%

renal artery stenosis. If you do this meas-

urement, the comparison of resistance

index, then you will have the haemody-

namic relevance of the lesion.

At this point, Moss replied that in the

UK, the problem of obesity resulted in

too many patients being excluded from

this procedure because the acoustic win-

dow was not very good. He also said,

there were training issues with techni-

cians who did not use this tool often.

Reekers: Maybe we should just stop

thinking about renal artery stenosis. We

have known for decades that there is no

direct relation between stenosis and renal

function. Even in the old days when we

saw bilateral stenosis, there was no renal

function and hypertension, the correlation

is not one to one, so maybe we should

start looking at something else – maybe a

combination of renal artery stenosis and as

you said (to Zeller) increased index. How-

ever, just looking at the renal artery, eye-

balling it and saying, well, 60% stenosis –

that is not enough. That is not science.

Zeller: The key message from all these

trials is that we must focus more on our

selection criteria and ensure that we do not

treat every lesion which seems relevant.

We must focus on severe lesions. There

are some good papers out there that show

a relationship between functional success

and the degree of stenosis which has been

treated. But all the trials published so far

are flawed from including too many

patients that clearly have no indication.

Moss: Statisticians at the trial unit tell

us that it is a lot better to have 3,000

patients in the study and a little bit of

dirty data in there, than to have 30

patients, all very tightly selected. Results

from a study with a small group of

patients can be skewed.

Reekers: You can also turn it around

and say what is absolutely clear is that

stenting is not a fantastic option – be-

cause if it was, it would have been clear,

even in your trial, Jon, that there would

have been a huge difference in the results

of those patients who had been treated by

this procedure and those that had not. It

would have been absolutely clear.

The three participants agreed that a few

patients who showed dramatic improve-

ment with stenting did not find their way

into the trials. They also agreed that ath-

erosclerotic disease meant that any

impairment of body function whether

hypertension or renal dysfunction was

caused by multiple causes, not just

malperfusion.

Zeller: My major criticism is that

ASTRAL included too many patients with

insignificant lesions resulting in too much

noise. What was a little surprising and dis-

appointing for me, was that your subgroup

analysis looking at bilateral lesions did not

show any benefit. This does not match

with my clinical experience.

Moss: When we set up the trial, we

looked at three specified subgroups, base-

line renal function, renal size and percent

stenosis. None of them showed any bene-

fit. We still felt there was a subgroup in

there, perhaps with a single kidney or bi-

lateral stenoses. We persuaded the statisti-

cians to look at these after the trial was fin-

ished, as this group was not prespecified,

Continued from page 1

Continued on page 10

Jim Reekers, Jon Moss and Thomas Zeller

Experts discuss role of renal artery stenting in roundtable

September 2010

BIBA Publishing

10 Awareness May 2010

The traditional understand-

ing of radiation safety is

being proven wrong,

Lindsay Machan, University of

British Columbia, Vancouver,

Canada, told delegates at the

CX Symposium. With the aim

of alerting interventionalists to

the hazards of radiation in the

endovascular suite, Machan saw

that the audience was very keen

to discuss this worrying subject.

“We have always said that

there were thresholds at some

levels that you had to be exposed

to before you were likely to have

problems. But it turns out that

probably there is no threshold.

There is no safe amount of radia-

tion whatsoever,” Machan said.

“The reasons why we have not

realised this is because in a lot of

studies radiation was not compa-

rable. In Hiroshima, Nagasaki

and Chernobyl it was a com-

pletely different type of radiation

and it acted in a different way to

the radiation in the X-ray.”

Machan said that with the in-

creasing number of endovascular

procedures, exposure to radiation

has grown in the last decades.

“Because of cath scanning, there

was a huge increase in radiation

for the general public and we are

now understanding a lot more of

the deleterious effects of X-rays.

Now we have the data and they

look really scary” he said. In the

early 1980s, 15% of the radiation

to which Americans were ex-

posed came from medical diag-

nostics and treatment. Two

decades later, the rate is 48%.

“Fluoroscopic-guided proce-

dures have become democra-

tised. Traditionally, it was for

people who had a lot of training

with radiation. Now, naturally

these procedures have become

available, but not necessarily to

people who fully understand

what radiation is. Not even radi-

ologists realise how big the

problem is,” he said.

Machan mentioned a study

which started in New York with

interventional radiologists, by

Basil Worgul. “To our astonish-

ment we found a higher rate of

radiation-induced cataract that we

had ever thought. We even saw it

on a 27-year-old radiology resi-

dent. Worgul found that some

people are genetically predis-

posed to radiation disease. Unfor-

tunately, he died before he could

publish this work. He was getting

to point where he was really go-

ing to alert people with this study.

One of the reasons I am aware of

this is because I am one of the

people who got cataract.”

Machan summarised his key

messages. These are that:

n The knowledge-base about

radiation effects is in evolution;

n There are no safe doses of

radiation;

n There is increasing public and

governmental concern about

medical radiation;

n It is better to be seen to be

leading than react to regulations.

“Use radiation the same way as

iodinated contrast, as much as

necessary, but no more, and be

prudent about back care,” he said.

In the discussions, Michael

Lee said that he has conducted a

study which found that the legs

of operators in the suite were be-

ing inadequately protected. He

said he felt vulnerable without

protection in this area and asked

Machan to comment on this.

Machan replied, “I feel naked in

the interventional suite.”

A delegate drew Machan’s

attention on the rising number of

breast cancer cases in relation to

radiation exposure. She said that

no protection shields are

designed specifically for women.

Dangers of radiation in the endovascular suite

Lindsay Machan

Experts discuss role of renalartery stenting in roundtable

and we found 160 patients, but we could not show benefit.

We could not believe it. It went against the grain. In the

group stented, 30% did benefit from stenting, but in the

control group taking medical therapy, 30% also improved,

so how can the benefit be from the stent? Is it the tablets?

Or maybe it is the natural progression of renal disease.

Going forward

Moss: I think it is going to be difficult after the publica-

tion of the CORAL trial for anybody worldwide to drum

up any enthusiasm or get any grant money to look for the

benefits of renal stenting. Even the investigators of

CORAL are struggling with recruitment. With 250 mil-

lion patients in America, where are they recruiting? They

are recruiting in South America, and indeed we had some

problems with recruitment too and had to enrol patients

in Australia and New Zealand. The message is that it is

getting difficult to persuade doctors and patients to take

part. I suspect at the end of the day that there will not be

much research into stenting in the foreseeable future.

Reekers: We have to do better selection of patients and

look at different parameters which will help us identify

those patients who will benefit. The conclusion from the

trial was that a vast majority of patients with renal artery

stenoses will probably not benefit from a stent, but a sub-

group that will benefit must be found, because I am pretty

convinced there is such a group. It will be difficult, but our

clinical experience tells us stenting can work, what we

need to find out is, for whom.

Moss: Even in ASTRAL, there was a trend towards

better renal function in the stented group, and we only

followed up for a mean of three years. It is possible that

we have not looked for a long enough period of time.

Maybe we need long-term follow-up, up to 10 years for

these kidneys.

Zeller: We still have the chance to prove the concept, if

we could finish the RADAR trial. I am struggling with the

company supporting this trial, as they are also affected by

the results of published data so far, and the low inclusion

rate into the trial. RADAR focuses on the relevant lesions.

I would like to ask everyone to support me in convincing

the company to proceed with the study, because if we are

not able to finish this trial, we will have no chance in the

near future to start a new trial, even if we clearly define the

selection criteria which might be appropriate to identify

the right patients for this helpful treatment option.


Lindsay Machan shared a personal story at CX 2010.

He warned delegates that radiation may have played a

role in the development of his cataract

September 2010

BIBA Publishing

12 Carotid disease May 2010

technique firmly back in the game. It is

known that carotid artery stenting can be

good in experienced hands, with careful

patient selection, and that some

anatomies are not suitable to stenting.

The CREST trial did not provide the

results separately for the asymptomatic

and symptomatic patients. In the discus-

sion, there were calls from the panel and

delegates for future analyses to look sep-

arately at these two different patient

groups. The differing messages and ways

in which the CREST data were presented

and interpreted by two investigators of

the same trial reinforced the need for

these subset analyses to be performed.

The results of ICSS and CREST are

difficult to compare because ICSS stud-

ied only patients in whom the carotid

stenosis was recently symptomatic,

whereas 47% of patients in CREST were

asymptomatic.

The question is whether CREST

results will be similar to those from ICSS

with regard to symptomatic patients.

Brown told Vascular News: “In the com-

bined results from CREST, the complica-

tion rate of stenting was a little lower in

CREST than it was in ICSS, but this is

likely to reflect the fact that half the

patients had asymptomatic stenosis,

which we would expect to have a lower

risk of stenting as well as a lower risk of

endarterectomy.” Otherwise, he contin-

ued, “the results look very similar to

ICSS in that in CREST there were signif-

icantly more procedural strokes in the

stenting arm than in the endarterectomy

arm (4.1% vs. 2.3%, which was statisti-

cally significant). There were more

myocardial infarctions in both arms of

the trial in CREST than ICSS, but

CREST had a different protocol for

ascertaining myocardial infarctions,

which is likely to account for the differ-

ence. I will await the publication of the

results of individual endpoints in the

symptomatic patients in CREST with

interest. In the meantime, I do not believe

the results of CREST should alter the

conclusion that endarterectomy remains

the treatment of choice for symptomatic

patients.”

Another question that remains is

whether it will be possible to identify the

group that will benefit from stenting. A

subset analysis of CREST data is likely

to shed light on the role for stenting in

asymptomatic patients in the future.

“Patients will always choose the lesser

procedure, provided they can be sure it is

equally effective” said Roger Green-

halgh, chairman of the CX Symposium.

Moore delivered a similar message. He

said, “Carotid stenting may offer a rea-

sonable alternative to endarterectomy,

particularly in younger patients and those

who prefer a less invasive procedure.”

Gray said that the results of CREST

establish both carotid endarterectomy and

carotid artery stenting as two very safe

and effective therapies for stroke preven-

tion in carotid bifurcation disease. He

emphasised that the carotid endarterecto-

my event rate in CREST is the lowest

ever seen in a prospective multicentre

trial, matched by stenting.

Placing the results among other recent-

ly released data, Gray said that the

CREST results fit well into the progres-

sion of carotid stenting outcome

improvement in the past decade.

He argued that any differences in the

subsets of the composite endpoint are

balanced, represent opportunities for

improvement, and do not otherwise dif-

ferentiate the therapies.

Gray told delegates that, given the trial

conduct and operator inexperience that

characterise much of the European data,

CREST represents the largest, most rig-

orous and complete examination of the

two therapies to date.

Ultimately, he said, the two therapies

are not mutually exclusive but comple-

mentary. “The wise physician will advise

patients accordingly,” he said.

“Endarterectomy stillsafer”

Moore said: “I would say that the CREST

results were more of a game modifier

than a game changer for carotid stenting.

If you look at the three primary endpoints

of the study which were death, stroke and

myocardial infarction, in aggregate there

were no differences between carotid

endarterectomy and carotid angioplasty

and that is certainly at variance with the

ICSS trial, the French trial (EVA 3S) and,

to some degree, the German trial

(SPACE-2) as well.

“However, if one dissects out what I

consider to be the important elements of

the study i.e. the issue of death and

stroke, in these areas, carotid endarterec-

tomy still seems to be the safer of the

procedures,” said Moore.

One of the largest randomised stroke

prevention trials ever, CREST enrolled

2,522 symptomatic and asymptomatic

carotid stenosis patients. The trial took

place at 117 centres in the United States

and Canada over a nine-year period and

compared the safety and effectiveness of

endarterectomy and stenting in patients

with or without a previous stroke.

When investigators looked at the num-

bers of myocardial infarctions and

strokes, they found differences. The

investigators found that there were more

heart attacks in the surgical group, 2.3%

compared to 1.1% in the stenting group;

and more strokes in the stenting group,

4.1% vs. 2.3% for the surgical group in

the weeks following the procedure.

Moore said, “Results of the CREST

trial can be interpreted differently by cli-

nicians who choose to emphasise certain

aspects, in support of their own

approach. Those who are enthusiastic

about stenting will look at the overall pri-

mary endpoints and say ‘Look we are

doing as well as endarterectomy’. Those

more inclined towards surgery will

say−as I did at the session− if the objec-

tive of doing anything to the carotid

artery is to prevent stroke and stroke-

related death, as the more important end-

point, then carotid endarterectomy comes

out ahead of angioplasty. You can spin

this in any way you choose to do.”

ICSS

Jonathan Beard, Sheffield, UK, present-

ed the results of ICSS, an international

multicentre, randomised, controlled,

clinical trial evaluating carotid artery

stenting in symptomatic patients in

comparison to endarterectomy for the

long-term prevention of disabling and

fatal stroke.

Beard focused on short-term morbidi-

ty and mortality outcomes during the

period from randomisation to 120 days

post-randomisation, including the 30-

day post procedural period. The results

showed that there is a significantly high-

er risk of the primary outcome of stroke,

death or peri-procedural myocardial

infarction for stenting.

Regarding the MRI substudy of ICSS,

Beard said that there are significantly

more cerebral ischaemic events in

patients who undergo stenting. “There

has been some further subset analysis to

do with cerebral protection devices. One

of the big questions was that whether

there was any relationship between cere-

bral protection and cerebral events. In

CREST, cerebral protection was manda-

tory; in ICSS, it was recommended but

not mandatory, and 25% patients did not

have cerebral protection. The subset

analysis shows that there is not of a bene-

fit and it is very expensive.”

Differing views on CREST

Jonathan Beard William GrayMartin Brown

Wesley Moore

72 No

28 Yes

After the CREST and ICSS results will you offer carotidstenting for symptomatic disease?

68 No

32 Yes

After the CREST results willyou offer carotid stenting forasymptomatic disease?

CX voting results


BIBA Publishing

September 201014 Carotid disease May 2010

Naylor showed the ICSS (International Carotid

Stenting Study) procedural risks results. In the

intention to treat analysis, procedural risk of

stroke, death and myocardial infarction was 8.5% for

carotid artery stenting and 5.2% for endarterectomy

(p=0.006), and for stroke and death, the risk was 8.5%

for stenting and 4.7% for surgery (p=0.001). In the per-

protocol analysis, procedural risk for the composite of

stroke, death and infarction was 7.4% for stenting and

4% for endarterectomy (p=0.003), whilst stroke and

death risk was 7.4% for stenting and 3.4% for surgery.

“Although these are only the procedural risks, I am

firmly convinced that once you get past 30 days, the long-

term risk of death and stroke is similar. So whoever wins

the battle of the procedural risk will win the long-term

battle. On an intention-to-treat and a per-protocol analy-

ses everything favoured endarterectomy,” Naylor said.

He mentioned a meta-analysis by Peter Rothwell,

published in The Lancet this year that included ICSS

along with EVA-3S and SPACE, with nearly 4,000

patients. “There was a very significant two-fold excess

risk of death and stroke in stented patients,” Naylor told

delegates. “And these data led Rothwell in an editorial

in The Lancet Neurology last October to point out that

the poor outcomes were systematic occurring along all

the trials and it was time for moratorium, time to stop

stenting. However, we cannot ignore the CREST data.”

Naylor said that for the principal endpoint of death,

stroke and infarction, CREST results are very similar for

stenting and surgery. “In CREST, stroke is twice as

common, significantly against stenting, and myocardial

infarction is twice as common with surgery and cranial

nerve injury is more common with surgery. So how can

I defend that stenting should stop?

In CREST, 429 carotid stenting operators applied to

participate in the trial, and 225 (52%) were approved for

randomisation. “Half of the applicants for CREST were

rejected. So the data you see is the best of the best, elite

of the elite. Moreover, the outcomes contained both

symptomatic and asymptomatic patients. And this debate

is about symptomatic patients. The stroke risk was twice

as high following stenting (p=0.01) but we know that the

stroke risk in asymptomatic patients will be much less

and higher in symptomatic patients,” Naylor said.

“This is my prediction for when the results are strati-

fied: 30 days death and stroke rate will be about 6% for

symptomatic patients with stenting and 3% with

endarterectomy. But my speculation did not include

perioperative myocardial infarction, which was signifi-

cantly higher in CREST but which made no difference

in ICSS. Peter Gaines said on Saturday [after the presen-

tation of the CREST results] that surgeons were indiffer-

ent to perioperative myocardial infarction and that we

had to take it more seriously. I quite agree. But if we

accept that as a reason to be taken into account, should

not we also take in magnetic resonance imaging evi-

dence of ischaemic brain injury as well?

“This is probably the most important part of the ICSS

study. Two hundred and thirty one patients who were

randomised had serial magnetic resonance imaging stud-

ies one to three days and 30 days post-operatively. Five

times as many stenting patients had at least one new

acute lesion in the early postoperative period and one-

third had multiple lesions. When you look at the lesions

at 30 days, i.e. the persistent ones, one-third of stent

patients had persistent lesions of the site of the first ini-

tial acute injury, again, a fivefold excess risk.”

Naylor continued, “Compared to surgery, stenting is

associated with equivalent mortality, twofold excess

stroke risk, half the risk of infarction and a fivefold

increased risk of new and persisting cerebral ischaemic

lesions. If you undertake stenting, you are required to

inform your patient that they have an increased risk of

silent injuries to the brain that may or may not lead to

dementia in the future. But will these risks also increase

in the ‘new world’ of treating patients within days of

onset of their symptoms? Intuition says yes.”

Against the motion, Cremonesi argued that it is not

time to stop carotid artery stenting, but to stop inappropri-

ate approach to carotid artery stenting. “Inappropriate in

this case should be defined as any action which can

expose our patients to foreseeable and unacceptable com-

plication rates. We have reliable predictors for carotid

stenting complications and it is inappropriate not to apply

these scientific principles in the randomised trials design,

as well as in the indication for our daily practice,” he said.

He said that, like CREST, other randomised and non-

randomised controlled trials have showed data in favour

of carotid stenting also in symptomatic patients.

Cremonesi told delegates that undertraining is an

important factor in carotid artery stenting outcomes. He

mentioned a study published in The Lancet Neurology

by Roffi et al, titled “Inexperience of the EVA-3S,

SPACE and ICSS investigators”, which showed that

patients are exposed to a twofold increased risk in stent-

ing linked to undertraining. “Insufficient operator skills

and inappropriate patient selection are the source of any

complication,” Cremonesi affirmed.

Anatomy, Cremonesi said, is another important point

to predict carotid stenting complications. “Anatomy is

able to tell us if a patient is suitable or not for a safe

carotid stenting procedure. Aortic arch lesions are great

predictors and have to point out that supra-aortic anato-

my before the procedure and not during the procedure.

That is the right way for carotid artery stenting.”

He criticised the ICSS design. “Unfortunately, non-

invasive imaging of the carotid artery, including duplex

ultrasound, was acceptable for study entry. Aortic arch

imaging before randomisation was not required. The pro-

tocol recommended that a cerebral protection device

should be used whenever the local investigator thought

that one could be used safely, but this was not mandatory.

“A minimum of 10 carotid artery stenting procedures in

a lifetime was deemed to be sufficient for an intervention-

alist to treat patients in the study. It is not acceptable

mostly because if you look at trial design impact on out-

come you see here immediately that the poor outcomes

are always in literature (ICSS, EVA-3S and SPACE)

linked to no embolic protection device consistency and

inexperienced operators. On the other hand, positive

results like in CREST and other randomised or prospec-

tive trials are linked to credentialed carotid artery stenting

operators and embolic protection device being mandatory.

“ICSS and EVA-3S compared therapies where doctor

inexperience, rather than the procedure, played the

major role for outcomes. Trial design and operator com-

petence were the real risk for patients, either in the

intention-to-treat randomisation phase or during proce-

dure. The time has come not to stop carotid artery stent-

ing, but to rethink the appropriate design of clinical tri-

als in the field,” Cremonesi concluded.

For symptomatic patientscarotid stenting shouldstop, say 70% of delegatesCX delegates voted for the motion “Given the ICSS results for symptomatic patients,

carotid stenting should stop”, backing Ross Naylor, Leicester, UK. Naylor received 70% of

the votes, against 30% for Alberto Cremonesi, Cotignola, Italy

If you undertake stent-

ing, you are required

to inform your

patients that they

have an increased risk

of silent injuries to the

brain that may or may

not lead to dementia

in the future

We have reliable pre-

dictors for carotid

stenting complica-

tions and it is inap-

propriate not to apply

these scientific prin-

ciples in the ran-

domised trials design

30 No

70 Yes

Given the ICSS results for symptomaticpatients, carotid stenting should stop?

Ross Naylor Alberto Cremonesi

September 2010

BIBA Publishing

16 Thoracic aorta May 2010

Anatomically straightfor-

ward aneurysms of the

descending aorta can

today be safely treated with most

of the stent grafts, said Giovanni

Torsello, Munster, Germany. He

continued, “The use of grafts in

the arch requires perfect con-

formability and apposition of the

device to both greater and lesser

curves of the arch. Shortcomings

during the procedure including

collapse, migration, or disloca-

tion of specific endografts have

not been fully resolved.”

Patients, he added, with

lesions of the thoracic aorta often

have thin, tortuous and calcified

access vessels and require low-

profile and flexible delivery sys-

tems. Additional tortuosity of the

supravisceral aorta and aortic

arch makes the trackability of

most delivery systems difficult,

increasing the risk of complica-

tions. “Our daily practice shows

that different configurations,

materials, and fixation systems in

current thoracic endografts have

different potential drawbacks and

advantages,” Torsello said.

In the next session, four speak-

ers told CX delegates the reasons

why they prefer either the TX2

(Cook), Valiant (Medtronic),

Relay (Bolton), or TAG (Gore).

Valiant

Hervé Rousseau, Toulouse,

France, discussed the Valiant

device. The new FreeFlo design

has eight peaks instead of five, it

allows the same radial force with

reduced flare, and distributes

radial force across more points of

contact with less force and stress

per point. The hydrophilic coat-

ing of the new Captivia delivery

system, he said, facilitates vascu-

lar access and deliverability. “It

is probably,” Rousseau said,

“one of the smallest devices on

the market.” He showed the 3D

reconstruction of a case of large

aneurysm with tortuous vessels.

“The tip capture provides precise

and controlled deployment for

optimal procedural results,”

Rousseau said. The sinusoidal

shape and placement of the niti-

nol springs, he added, is

designed to provide flexibility

for greater conformability to the

anatomy. The use of Valiant is

being investigated in a number of

trials for different pathologies

like type B dissection and trau-

matic transaction.

“The Valiant device gives safe

access, deployment accuracy,

conformability and durability,”

Rousseau concluded.

TX2

Matt Thompson, London, UK,

focused on the TX2 device.

“The first thing you have to

consider when choosing a graft

for thoracic pathologies is how

you are going to get the graft

from the femoral artery up to the

region that you want to treat.

The TX2 device is attractive

with this regard because of the

sheath that it is packaged in.

This a lot flexible hydrophilic

sheath that goes round corners

extremely well,” he said.

The TX2 is usually stable in

the arch, he said, because it is

constrained by the proximal and

distal trigger wires. “The recent

Pro-form modification that

slightly deforms the proximal

stent and allows it to make early

contact with the aorta is a sig-

nificant advantage.”

He said, “the TX2 should be

used particularly for the sort situ-

ation when you have a descend-

ing aneurysm finishing just

between the level of the superior

mesenteric artery and the coeliac

access. We want to deploy at the

level of the superior mesenteric

artery and have distraction forces

constrained by the axial fixation

disc.” The TX2 is also designed

to be used in dissections. “I

would use the TX2 as a dissec-

tion device when in a patient

with malperfusion, when I want

to make that the true lumen is

completely open in the end the

procedure.”

The evolution of TX2,

Thompson said, is the Cook low

profile device.

Relay

Vicente Riambau, Barcelona,

Spain, discussed the Relay

device. He said, “The Bolton

device represents a more versa-

tile platform by offering both

bare and covered proximal con-

figuration to treat by endovascu-

lar means any pathology. The

mechanical features in proximal

capturing allowing precise

deployment are key.

“Additionally,” he added, “the

Bolton platform has the possi-

bility to offer custom-made

adaptations. At the moment,

Relay represents one of the best

options for thoracic endograft-

ing. One stent graft is enough in

most cases.”

Conformable TAGDittmar Böckler, Heidelberg,

Germany, spoke about the new

Gore Conformable TAG. The

stent, he said, did not change in

relation to the previous TAG

device. It is a nitinol stent,

wound in sinusoidal pattern, the

graft material is ePTFE, on lumi-

nal and abluminal surfaces. The

sutureless graft attachment did

not change, neither the deploy-

ment or the sealing cuffs. The

main modifications bring advan-

tages and strengths in clinical

practice. The flared scallops have

been eliminated, which make it

very useful in short landing

zones. “The stent frame was

modificated with the addition of

ninth apex and increased device

diameter. This contributed to

flexibility and telescoping effect

to improve conformability.”

Michael Jenkins, London,

posed a question to the panel:

“We seem to want a specific

device to do specific jobs. If you

own a company and are design-

ing a stent graft you want “one

size fits all”. Most of the devices

seem to be getting more similar

and not different. Is there a con-

flict of interest?”

In Böckler’s opinion, it is a

good wish to have one device

that fits all pathologies. He said,

“We need to have two or three

devices in stock and you have to

adapt the device you are familiar

with to pathology, age, gender,

and many factors that influence

your decision. The solution is

one device that fits to all the sit-

uations, including emergency or

elective cases.

Next generation of TEVAR devicesunder scrutinyThoracic endovascular aortic repair is a promising technique for various diseases

of the descending thoracic aorta, CX delegates were told on 12 May 2010 during a

session that discussed the new generation of devices and the indications by

pathology. One of the discussions was centred on whether the interests of

physicians and manufacturers differ when developing thoracic devices

Giovanni Torsello Hervé Rousseau Matt Thompson Vicente Riambau Dittmar Böckler

2 Any other stent graft

32 TAG

13 Relay

7

38 Valiant

15 TX2

What is your preferreddevice for aortic dissection:


21 TAG

10 Relay

145 Valiant

22 TX2

What is your preferreddevice for atheroscle-rotic aneurysmal disease in the thorax:


39 TAG

9 Relay

142 Valiant

9 TX2

What is your preferreddevice for aortic transection in the thoracic aorta:

Voting results

Valiant and Captivia

TX2

Relay

CTAG

September 2010

BIBA Publishing

18 Development May 2010

Drug-eluting balloonsDrug-eluting balloons are being

hailed as a promising new toy

on the block. A key message

was that although there are more

than five different drug-eluting

balloons available or under

development including

Paccocath, Advance, Lutonix,

In.Pact, and EuroCor, they are

not the same, according to

Gunnar Tepe. He told dele-

gates,“Two independent trials

have shown the efficacy of

Paccocath balloons. These drug-

eluting balloons are safe and

effective in the prevention of

restenosis up to 24 months, but

this enthusiasm is based on 100

patients in the Thunder and

FemPac trials. We still have to

learn about limitations of this

technology as we did with

stents.”

Then Nicholas Diehm pre-

sented on the MEDRAD

Interventional/Possis paclitaxel-

coated balloon. He clarified that

Paccocath was a word that stood

for paclitaxel coated catheter.

This name was used by inven-

tors in initial European clinical

trials. “Cotavance is the term

used by MEDRAD

Interventional/Possis as brand-

ing for its drug-eluting balloon

that uses the Paccocath technol-

ogy,” he said.

Diehm noted that the

Cotavance product with

Paccocath technology was a

very promising novel technolo-

gy. “It is the only drug-eluting

balloon with proven clinical

benefits in peripheral arterial

disease (based on the THUN-

DER and FemPac trials). He

said that a variety of prospective

randomised studies would illus-

trate the clinical utility of this

technology in different peripher-

al arterial disease scenarios.

Diehm told delegates about

the future studies including the

RIVER study (Plain old balloon

angioplasty vs. paclitaxel-coated

balloon angioplasty [Cotavance]

for prevention of restenosis in

atherosclerotic lesions of the

femoral-popliteal arteries), a

prospective, multicentre, ran-

domised trial for safety and effi-

cacy; the COPA CABANA

study (Cotavance Paccocath vs.

uncoated balloon angioplasty

for treatment of in-stent resteno-

sis in peripheral arteries), an

investigator-sponsored prospec-

tive, multicentre, randomised

trial for safety and efficacy in

Europe; the EURO CANAL

study (European study of plain

old balloon angioplasty vs.

Cotavance Paclitaxel coated bal-

loon for infrapopliteal lesions in

critical limb ischameia), a

prospective, multicentre, ran-

domised trial conducted in

Europe; the US CANAL study

(Investigational Device

Exemption study of plain old

balloon angioplasty vs.

Cotavance – Paclitaxel coated

balloon for infrapopliteal lesions

in critical limb ischaemia); and

the DEFINITIVE-AR study

(Plaque Excision with

SilverHawk/TurboHawk plus

Cotavance vs. Cotavance alone).

Next generationEVAR devices

This year, the session on the

next-generation of EVAR

devices was bursting at the

seams with participants throng-

ing to learn about the latest

updates.

Aorfix

John Hardman spoke on

“Innovation for angulation: The

Aorfix stent graft.” He told the

audience that the flexible helical

ring design and absence of a

suprarenal fixation with this

stent graft helps it conform to

angulated anatomy. Also, the

audience learned that the reg-

istry and prospective studies

have revealed that Aorfix has

good clinical outcomes in angu-

lated anatomy and very low

limb occlusion rate.

Aptus

David Deaton spoke on “The

Aptus endograft: Early clinical

results from trials in the USA”.

He said independent fixation

with the helical staple, the low-

est crossing profile (16F), and

being a proximal stent designed

for specifically for short seal

zone and locking modular limbs

were some of the innovations

seen in the endograft.

Ovation

Michael Chobotov spoke on

how the Ovation from

TriVascular had for the very first

time separated fixation from the

seal and said clinical evaluation

of the abdominal stent graft sys-

tem is underway with encourag-

ing results. “The innovative,

low-profile system is designed

to expand the patient population

suitable for endovascular aortic

repair,” he said.

Nellix

Bob Mitchell emphasised that

the Nellix device has been

specifically designed for EVAR

limitations. It is a sac-anchoring

device which is not dependent

on proximal or distal fixation. It

is a device with unmatched sta-

bility, suitable in adverse “no-

neck” anatomy and can treat

complex iliac aneurysms, he

said.

CX Innovation Prize

Since innovators typically

thrive on competition, the

Innovation Showcase also hosts

an exciting Dragon’s Den-style

competition. This year, Claude

Mialhe won the competition

with his presentation on the

HQS introducer for percuta-

neous EVAR. He said the HQS

device could provide a percuta-

neous access in 100% of cases

from November 2008 to March

2010. Mialhe faced stiff com-

petition from Matt Ogle and

Frank Criado who spoke on

drug-eluting stent grafts. They

said the goal of this new tech-

nology was to deliver stabilis-

ing agents that bind, strengthen,

and protect proteins within the

diseased abdominal aortic

aneurysm aortic wall. “Could

this optimise stent graft out-

comes and reduce complica-

tions and re-intervention rates?”

they asked. Also competing for

the innovation prize was

Alexander De Vries who said

that as Aortic Customize dimin-

ishes wall movement and wall

stress, it will lead to a success-

ful exclusion of the aneurysm

sac from the circulation.

Stephen Greenhalgh is co-

chairman of the CX Innovation

Showcase with Nick Cheshire.

CX Innovation Showcase: The next decadeof vascular and endovascular technologyEvery year, the CX Innovation Showcase is designed to ensure that it is one of the

most interactive and exciting sessions of the programme. The response to this

year’s event was overwhelming. Briefly, the CX Innovation Showcase is where

physician-inventors, venture capitalists and the industry can find all that they

need to know about in the next decade of medtech innovation

Nick Cheshire and Stephen Greenhalgh

Gunnar Tepe

Nicolas Diehm John Hardmann

Claude MialheDavid Deaton

Michael Chobotov

September 2010

BIBA Publishing

20 Education May 2010

Giancarlo Biamino and Frank

Vermassen chaired the morning

session on Sunday 11 April,

2010. The live cases were on chronic

total occlusions in peripheral arteries.

After one of the transmissions, Erich

Minar, Vienna, Austria, spoke on

“Stenting the superficial femoral artery:

Current strategies and device selection.”

He said that the underlying clinical

indication for treatment, whether it is

intermittent claudication or critical limb

ischaemia, should be one of the main

relevant factors considered in the

context of superficial femoral artery

stenting. Aside from the clinical

indication, the length and complexity of

the lesion form the second major

determinant for the decision to

deploy a stent.

It has been proven that nitinol

stenting improves the mid-term patency

in superficial femoral artery TASC II

type B lesions, and therefore primary

stenting can be recommended, compared

to provisional stenting, in TASC II type

B lesions. “Otherwise, treatment of in-

stent restenosis, which occurs in about

30–40% of these patients within one

year, currently remains an unresolved

issue,” Minar said. “Therefore, we

prefer an angioplasty-first therapy in

patients with intermittent claudication

and proceed with stenting only in cases

of insufficient percutaneous

transluminal angioplasty. This strategy

helps to preserve the stent as a treatment

option in case of late failure and this

may help to improve long-term

patency.” Otherwise, Minar said, in

critical limb ischaemia patients, the

indication for stenting has to be

established quite liberally to obtain an

optimal revascularisation to guarantee

resolution of the critical perfusion

deficit. “Currently there is no evidence

for any impact of stent design on

restenosis. Stent selection is therefore

mainly influenced by degree of

calcification and lesion length.

Deployment of a single long stent is

preferred over implantation of multiple

overlapping stents,” he added.

“From a theoretical point of view, drug-

eluting stents may offer an exciting

approach to reduce restenosis by combin-

ing the advantages of mechanical scaf-

folding with the antiproliferative action of

drugs. Unfortunately, however, the coro-

nary results could not be reproduced in

the femoropopliteal arteries, at least

according to the currently available data.”

Below the knee

In the afternoon the course was chaired

by Dierk Scheinert and Iris

Baumgartner. The focus was on innova-

tive techniques for below-the-knee

angioplasty. Marco Manzi, Abano

Terme, Italy, spoke on the “Basic arma-

mentarium and approaches for complex

below-the-knee disease.” In the last few

years, he said, it has been possible to

define a clear evolution in the treatment

of below-the-knee disease in diabetic

patients. “It has been demonstrated in

many papers, most from Italian authors,

that at least one vessel to ankle levels

enough to obtain a limb salvage but not

for wounds healing,” Manzi said. A sal-

vaged limb is not necessary a healed

limb and the limb salvage concept is not

the same as the deambulation function

salvage, he told delegates. “Therefore,

we must try to make efforts in order to

revascularise as many tibial vessels as

possible, and foot arteries too,” he

added. “Low-profile long dedicated per-

cutaneous transluminal angioplasty bal-

loons, coronary-like guidewires are now

available for a safe treatment of com-

plex below-the-knee lesions. To obtain a

complete leg and foot revascularisation

we must think to different arterial

approaches and strategy including distal

retrograde/antegrade punctures or

transcollateral, rendez-vous and pedal-

plantar loop techniques,” he said. In

conclusion, with dedicated tools and dif-

ferent, unconventional techniques it is

possible to treat a huge number of

patients avoiding major amputations

with a very high deambulation function

salvage rate.

LINC: Critical limb ischaemialive cases at Charing CrossCX 32 saw the launch of a new session in partnership with the Leipzig Interventional Course (LINC). The LINC @ CX course, “Interventional

solutions for patients with critical limb ischaemia,” featured transmissions from Park Hospital/Heart Center, University of Leipzig, Germany

Dierk Scheinert

Erich Minar Iris Baumgartner Giancarlo Biamino and Frank Vermassen

CX Programme Chairman: Roger M GreenhalghCX Programme Co-Chairs: Frans MollPeter Taylor

��

VASCULAR & ENDOVASCULAR

CONSENSUSUPDATE

Incorporating theGlobal Endovascular Forum

New Technologies | New Techniques | New Horizons

Additional CX events:CX Office-Based Vein Practice Course

CX Innovation Showcase ilegx @ CX LINC @ CX

CX Vascular Revision CourseCX Complex Case Review

CX EVEREST Simulation CourseCX St George’s Vascular Access Course

CX Advanced Vascular Access Skills CourseCX Training VillageCX Learning Centres

9 - 12 Apr i l 2011

��

��

CX 2010 Pavilion Sponsors CX 2010 Major Sponsors

email: [email protected] symposium hotline: +44 (0) 20 7736 8788 fax: +44 (0) 20 7736 8283

September 2010

BIBA Publishing

22 Education May 2010

The use of live cases raised a lively

discussion on the ethics of this

kind of educational method at the

CX Symposium. The subject was

addressed by Wesley Moore, Los

Angeles, USA, and Dierk Scheinert,

Leipzig, Germany, who presented the

LINC @ CX a new course that focuses

on live transmissions.

From the audience, Moore said that he

finds questionable the ethics in live case

transmissions. He noted that, at a recent

cardiology meeting, there seemed to be a

swing in favour of taping cases, which,

he admitted may not be as exciting as

watching live cases, but in his opinion,

the operator’s attention should be 100%

on the patient. This could be jeopardised

during a transmission to a conference. He

suggested the use of taped cases and

asked for Scheinert’s opinion on this.

Scheinert said in response that, at

LINC, the organisers are always

evaluating and trying to reinvent

educational tools. He said, “One of the

key elements of the live cases is that it is

real, you can see it as it is happening.

Nobody obviously wants to show

complications, but if you have one, you

will show it, and you will show how the

situation can be managed. This way you

avoid showing the best cases you have

ever done and show the standard cases,

with the techniques and also some

problems along the way.”

Barry Katzen, who runs ISET, told

Vascular News that it is very important

that when live cases are used for

education that attention be paid to patient

care. “Somebody has to be permanently

focused on taking care of the patient. To

deal with that we have a couple of

protections for the patient,” he said. “One

is that there are always two senior

physicians working on the case.

Secondly, there has to be some

educational value in the case, so there has

to be some reason to put the patient in

that situation. We work very hard to

identify for each patient what the

teaching message is and make sure that it

is communicated to the audience and

delivered specifically. Finally, we

constantly monitor outcomes to make

sure we are not putting patients at risk.

There have been several papers looking

at outcomes, from EuroPCR, PCT and

others, showing that it does not increase

risk. However, In the United States some

surgical societies have officially banned

live cases. My feeling is that in every

patient I treat I am teaching someone, it

is a natural part of what I do. I think the

most important thing is not to put a

physician who is not used to doing that in

that position. Live case transmission is

not for every physician. You can be the

best technician but there is a skill set that

involves multitasking and it has to come

naturally. You have to be comfortable

with teaching while you work. Our goal

with live cases is to make every

registrant feel they are there at the table

and are acting with the operator.”

Edward Diethrich has been doing live

cases for over 20 years for both

endovascular and vascular cases at the

International Congress on Endovascular

Interventions in Phoenix, USA. He told

Vascular News: “We performed the first

live coronary bypass operation in the

1970s. This was even picked up by

English television near tea time.

Obviously, I am a strong supporter of the

‘live’ presentation as long as it is well

controlled and performed by highly

experienced operators.”

Diethrich said that, in his experience,

operators’ attention is not jeopardised.

“On the contrary, in a live case, great

attention is directed to every detail in

order to show the proper sequence of the

procedure from an educational

standpoint. The operator also has the

option – ‘We are going off camera for a

while and will be back as soon as we sort

out the next steps in the procedure.’

When live cases are interspersed with

didactic lecturers, this type of transition

is smooth and comfortable. That has been

our format.”

Diethrich affirmed that, as the overall

goal of the case is educational, every

effort should be made to present the case

and procedure to assure the viewer a

complete understanding of the rationale

for each step and the options available.

He said that a question has arisen

about commercialising the procedure by

placing the product or device name on

the screen. “I believe this is an important

part of the educational experience. The

viewer needs to know what the operator

is using and why for any particular

situation. This is not unethical in my

opinion,” he said. “I am, however, also

an advocate of taped cases. These can be

very effective in teaching conferences

and there is the advantage of unlimited

time to discuss any particular steps in the

procedure.”

Frank Veith, from New York, USA said

he is not very enthusiastic about live

cases in most instances. “I do not think

patient’s interests are served. Live cases

take a lot of time, and most of the time

they have little teaching value. I believe

recorded, edited cases are more valuable,

more efficient and safer for patients.”

“Operators are definitely distracted by

the live case setting and often do things

they would otherwise not do –

occasionally harming patients. There are

rare times when live cases are well done

and have good teaching value – but they

are the exception not the rule.”

CX discussion: A close lookat the ethics of live cases

“I am a supporter of

the live presentation

as long as it is well

controlled and

performed by highly

experienced

operators”

“There is a skill set

that involves

multitasking. You

have to be

comfortable with

teaching while you

work”

“With live cases you

avoid showing the

best cases you have

ever done and show

the standard cases,

with techniques and

also problems”

“There are rare times

when live cases are

well done and have

good teaching

value – but they are

the exception not

the rule”

Edward Diethrich Barry Katzen Dierk Scheinert Frank Veith

September 2010

BIBA Publishing

24 Interview May 2010

When did you decide you wanted acareer in medicine and has it livedup to your expectations?From an early age, I was fascinated by surgery. I remem-

ber being captivated by the first heart transplant by Dr

Barnard in 1967. I did not dare think of that kind of revo-

lution in my career. I have witnessed seemingly crazy

ideas being turned into effective therapies. It is hard to

describe the delight of practicing vascular surgery in this

day and age. Imagine the thrill of discharging home an

80-year old patient two days after endovascular repair of

a ruptured abdominal aneurysm, while having been

involved with the development of this exact technique.

It fills my heart with pride to see the people that trained

me, the people I have trained with, and the people that I

have trained grow into amazing physicians and scientists.

I continue to be inspired by people like Mark Fillinger,

Michel Makaroun, Martin Malina, Ross Milner, Hence

Verhagen, Geoff White, and Willem Wisselink, to name a

few. These colleagues make me realise that they have not

only greatly enhanced my career, but many of them also

have become close friends. All of this is far beyond any-

thing I could have imagined for a career in medicine.

Why did you decide to specialise invascular surgery?

It was not a conscious decision. When close to complet-

ing my surgical residency in Rotterdam, I had decided

that I wanted additional surgical experience in the United

States. The Department of Surgery at the University

Hospital in Rotterdam had collaborations with the

Department of Surgery at the Massachusetts General

Hospital (MGH) in Boston, MA. This helped me attain a

position as clinical and research fellow at the Department

of Vascular Surgery at the MGH. This year of vascular

surgery training turned out to be one of the most inspiring

and defining periods of my life. I always remember (and

repeat to my residents) the lessons I have learned from

Drs Bill Abbott, David Brewster, Rich Cambria, and

Glenn LaMuraglia. They are really the ones that ignited

the “vascular fire” in me. I remain grateful to them.

Which areas of vascular surgeryfascinate you most?

Near the end of my term at the MGH, Dr Bill Abbott

invited me to his office and handed me a current issue of

the Journal of Vascular Surgery. He pointed to an adver-

tisement with an angiogram of a large abdominal aortic

aneurysm with the subtitle: “A typical case for aneurysm

repair, right?” With his typical rebellious expression in

his eyes, he told me to turn the page. There it read:

“WRONG! A typical case for percutaneous repair”, and a

rudimentary endoprosthesis had been edited in the

angiogram. The advertising company was ahead of the

existing technology, but I understood Dr Abbott’s mes-

sage. Ever since then, I have been fascinated by endovas-

cular techniques to replace conventional invasive vascu-

lar surgery procedures.

Vascular surgery has undergonemany changes over the years – whatdo you think the most fundamentalchanges have been?

Vascular imaging. Today’s three-dimensional real-time

vascular imaging seems nothing less than magic.

Vascular surgeons who have been at the cutting edge of

imaging development are the same physicians who have

been crucial for understanding where and how the

devices needed to be improved. Roy Greenberg, Mark

Fillinger, Jon Matsumura, and Hence Verhagen have all

excelled in aneurysm imaging research. It is not surpris-

ing to find these brilliant physicians team-up with the

most innovative engineers from Cook, Cordis, Gore, and

Medtronic and with ground breaking imaging companies

like M2S, Philips, and TeraRecon. The most fundamental

changes occur where partnership between physicians and

industry operate, at the crossroads of cutting-edge imag-

ing and out-of-the-box thinking in device technology.

Who are the people who haveinfluenced you and what advice oftheirs do you always remember?

This list is long, and continues to grow. My first teacher

in surgery, Prof van Vroonhoven inspired me in many

ways. His most important lesson for me as a surgeon was

probably to stay humble. The day a surgeon believes he

can achieve anything is the day he becomes a

threat to his patients.

My later mentor Prof Hero van Urk

taught me to never settle for any-

thing less than the best. At the end

of every operation, I still find

myself closely evaluating myself

(and residents) about all aspects of

the procedure.

Prof Eikelboom, a visionary man

who implanted the first human

endograft (EVT) in Europe, in

January 1994, hired me at the

University Medical Center of Utrecht and

allowed me to make endovascular aneurysm repair

my project. He is the one who taught me to always chal-

lenge the new and exciting and prove it with scientific

rigor. In this way, he inspired me to organise the

DREAM trial.

Apart from these founding fathers of vascular sur-

gery in The Netherlands, I consider Roger

Greenhalgh and Frank Veith as my most inspiring

vascular surgery role models. They are passionate

about cutting-edge therapies and equipped with

relentlessly inquisitive minds.

I also continue to be influenced by con-

temporary and younger colleagues like

my current partner in the department of

vascular surgery in Amsterdam,

Willem Wisselink – the first to

file a patent on side-branched

endografts. He has a wealth

of preclinical data on side-

branch technology and

never stops astound-

ing me with his

thought-provoking

ideas; Mark Fillinger, a

partner in many of our imag-

ing studies, always seems to be

one step ahead of me with imaging

research; and Martin Malina, David

Profile Jan BlankensteijnJan Blankensteijn, Division of Vascular Surgery, VU Medical Center, Amsterdam, The

Netherlands, and principal investigator of the DREAM trial, has EVAR as his first research

interest. He told Vascular News that his work includes the pathogenesis of aneurysm,

advanced imaging techniques and genetic factors of aneurysmal disease. He also spoke

of his career, influences, and interests outside medicine

May 2010

BIBA Publishing

25Interview

Training1977–1984 Medical School, University of Utrecht, The

Netherlands

1984–1985 Resident in Surgery, St Elisabeth Hospital,

Tilburg, The Netherlands

1985 Foreign Medical Graduate Examination in the

Medical Sciences (FMGEMS) and ECFMG

English Test

1985–1986 Resident Surgery, St Maartensgasthuis, Venlo,

The Netherlands.

1986–1989 Resident Surgery, University Hospital

“Dijkzigt”, Rotterdam, The Netherlands

1988 Course on Microsurgery, Laboratory for Surgical

Research, Erasmus University, Rotterdam

1989–1992 Resident Surgery, Zuiderziekenhuis, Rotterdam

1992 PhD Thesis: “Orthotopic and Heterotopic Liver

Transplantation. Circulatory and hemodynamic

effects of long-term graft preservation”, Erasmus

University

1992–1993 Clinical fellow Vascular Surgery, Massachusetts

General Hospital, Boston, USA

Positions

1993–1994 Department of Vascular Surgery, University

Hospital “Dijkzigt”

1994–2003 Division of Vascular Surgery, Department of

Surgery, University Hospital Utrecht

2003–2008 Division of Vascular Surgery, Radboud

University Nijmegen Medical Centre, The

Netherlands

2009–Present Division of Vascular Surgery, VU Medical

Center, Amsterdam, The Netherlands

Professional societies

The Netherlands Society for Surgery (1985–Present), The

Netherlands Society for Vascular Surgery (1993–Present), The

Netherlands Society for Vascular Medicine (1993–Present),

European Society for Vascular Surgery (1993–Present),

International Society for Endovascular Specialists (1994–Present),

Dutch Endovascular Forum (1996–2001), Society for Vascular

Surgery (2002–Present; 2003 Distinguished Fellow), International

Society for Vascular Surgery (2004–Present, founding member)

Positions at professional societies,committees and organisations

President of the Dutch Endovascular Forum (1996–2003),

Secretary of The Netherlands Society for Vascular Surgery (1998–

2002), Ad Hoc Committee on Reporting Standards of the Society

for Vascular Surgery and the American Association of Vascular

Surgeons (1999–2001), member UEMS-VASC/European Board of

Vascular Surgery (2003–current), chairman Vascular Surgery

Certification Committee (2004–2006).

Positions at peer-reviewed scientificjournals

Editorial secretariat Journal of Cardiovascular Surgery, editorial

board Journal of Endovascular Therapy, editorial board Journal

of Vascular Surgery (2004–2008), associate editor Vascular, asso-

ciate editor Journal of Vascular Surgery, publications committee

Journal of Endovascular Therapy.

Visiting professorships

2002 Department of Vascular Surgery, Royal Prince

Alfred Hospital Sydney, Australia

2003 Division of Vascular Surgery, Emory University

Atlanta, USA, Ross Milner

2003 Division of Vascular Surgery and Endovascular

Therapy, University of Pennsylvania Health

System, Philadelphia, USA

2006 Division of Vascular Surgery, University of

Pittsburgh School of Medicine, USA, Michael S

Makaroun

Fact File

Minion and Eric Verhoeven who

drive the existing device technolo-

gy beyond the boundaries of

what is considered possible,

fueling device evolution.

What are yourcurrent areas ofresearch?

EVAR is my primary

interest. We are finalising

the seven year analyses

of the DREAM trial

cohort. My basic

research focuses on

unravelling the pathogen-

esis of aneurysm and try-

ing to improve patient

selection using advanced

imaging techniques (like

PET-CT) and on identify-

ing genetic factors of

aneurysmal disease. I

believe we are still at the

beginning of understanding

vascular disease and I am

excited about the new areas

of vascular research and

device technology

emerging. I can see a

whole host of young

motivated vascular

surgeons stepping up

to explore

unchartered territories. I feel privileged being able

to do research in an era with such great opportuni-

ties around the corner.

How do you analyse the findingsof the DREAM and DREAM-ONtrials so far?

Together with EVAR-1 and OVER, these trials

indicate that there is an advantage of EVAR over

open repair in the short-term, while the results are

not different in the long run, thus EVAR is the bet-

ter option. There are still many questions remain-

ing that can only be answered by merging the trial

data at the individual patient level. I cannot wait to

cooperate with Drs Greenhalgh, Lederle, and

Becquemin to get that project off the ground. Now

that the long-term results of the DREAM trial have

been published, it is appropriate to note that we

have been fortunate to have had three New England

Journal of Medicine publications out of this “small

country” trial. I would like to emphasise that none

of this would have been possible without the Dutch

and Belgian participants. I would like to sincerely

thank them for their diligent involvement.

You have developed somemedical software along yourcareer. How did this start andwhich applications you considermost useful?

When I started surgical training, personal comput-

ers had just arrived and there were few applications

for researchers available. This is when I started

making applications for patient databases and sta-

tistical analysis. Later in my career, I continued

using a combination of understanding patient

logistics and the ability to manipulate computers

and software to design applications for instance to

assist in the complex follow-up schemes of

EVAR, and to support multidisciplinary meetings.

You developed your career inThe Netherlands but also havehad experience in the USA.What have you learnt from it?

My experience in the USA is from almost two

decades ago and things have changed significant-

ly on both sides of the Atlantic. However, despite

the obvious big differences in healthcare between

the USA and the Netherlands, once you get down

to the basics of surgery, things are always

remarkably similar and operator-dependent.

Outside of medicine andcomputer programming, whatother interests do you have?

My wife will laugh when she reads this, because

she feels there is little that interests me besides

these two. I like to spend time with my loved

ones, travel, and visit museums, concert-halls,

and theatres. We all love nature, hiking, skiing,

and snowboarding. I also have a passion for

music, both passive and active. Whenever I get

a chance I play my electric guitar.

BIBA Publishing

September 201026 Education May 2010

Vascular accesscourses debut at CX

The fifth interna-

tional St George’s

Vascular Access

course focussed on the

current debate on how

best to rescue vascular

access; is it by open, or

endovascular means?

Eric Chemla, London,

UK, course director of

the St George’s Vascular

Access Course told

Vascular News,

“Currently, there is much

debate about what is the

best means of rescuing

vascular access. It is not

very clear in everybody’s

mind whether we should

favour surgery or angio-

plasty, or indeed both of

them. When you compare

this with rest of vascular

surgery, for example in

the treatment of abdomi-

nal aortic aneurysm,

which is guided by big

trials, evidence and long-

term study, there is very

little evidence for vascu-

lar access. In reality

today, the choice of

approach largely depends

on the availability of

local expertise.” This

message was echoed by

Chris Gibbons, Swansea,

UK, who presented on

“Vascular access rescue:

The magnitude of the

problem”. Gibbons said

that the preferred treat-

ment approach often

depended on local expert-

ise. “About 89% of our

patients are rescued by

surgery and only 11% by

interventional radiology. I

suspect that in many of

your units this might be

slightly different. The sit-

uation in our unit comes

about simply because

there is more local opera-

tive expertise than radio-

logical,” he stated.

Gibbons said vascular

access rescue represents

about 40–50% of the

units workload.

“Prevention is certainly

better than cure. We do

tend to use surgery for

distal arteriovenous fistu-

lae occlusions/stenoses.

On the other hand, we

find the endovascular

treatment ideal for graft

occlusions and stenoses,”

he said. Prabir Roy

Chaudhury, Cincinnati,

USA, spoke on rescuing

vascular access and dis-

cussed both surgery and

endovascular approaches.

He focussed on the ques-

tion: Is there a molecular

and pharmacological

background? Chaudhury

began by explaining that

the current therapies for

dialysis access stenosis

(endovascular or surgical)

are not very effective.

“We need to think out of

the box to develop new

approaches for this prob-

lem,” he said. He told

delegates there was a

need to link up angioplas-

ty and revision surgery

with anti-stenotic thera-

pies that focus on both

neointimal hyperplasia

and the pattern of vascu-

lar remodelling. “What

happens when you do an

angioplasty? It increases

luminal size as a result of

outward remodelling, but

it also results in an

aggressive restenosis due

to neointimal hyperplasia

as a result of endothelial

cell and smooth muscle

injury that occurs at the

time of angioplasty.

It is also important to

remember that while clin-

ically we use angioplasty

to open up the vessels, all

over the world in vascular

biology laboratories,

angioplasty is used as a

model to create neointi-

mal hyperplasia and vas-

cular stenoses,” he said.

With regard to restenosis

due to neointimal hyper-

plasia, Chaudhury high-

lighted that there were

two points of view. The

interventional point of

view believes that angio-

plasty is good, minimal

post-angioplasty stenosis

is better and big lumens

are best, but cell biolo-

gists would view these

three points as vessel

wall injury ( which is

seen as bad), more injury

, and big lumens being

worst. He then clarified

that restenosis after

angioplasty or surgery is

a balance between vascu-

lar remodeling and neoin-

timal hyperplasia, and

then went on to describe

the combination approach

i.e., angioplasty or sur-

gery with therapy to

inhibit neointimal hyper-

plasia and cell prolifera-

tion and intervention to

enhance positive remod-

elling. Chaudury said

there was a real need to

individualise therapy.

“We need to apply the

technological advances in

bioengineering, in

devices and drug delivery

to improve the results

from both angioplasty

and surgery,” he said. He

concluded by answering

some key questions. To

the question “Does

venous angioplasty work

in the setting of dialysis

access stenosis?”: Yes,

said Chaudhury, but mul-

tiple angioplasties are

often needed for a

durable result . He also

said that while angioplas-

ty may not be better than

surgery as a first-line

intervention in terms of

primary patency, but that

cumulative patency

appeared to be similar.

Speaking in general on

the course, director

Chemla said, “A very

important feature of this

meeting is that it is very

international, the faculty

and participants are from

all around the world, The

Middle East, North

America and Europe.

This is the first time it is

being held at Charing

Cross and I hope it is the

first of a long series. Of

interest is that the session

is split in to two with one

session dedicated to

nurses.” Chemla

highlighted that the

course is the only

meeting in the world of

vascular access which

caters to nurses as much

as doctors. Patrick Haage,

Wuppertal, Germany,

president of the Vascular

Access Society,

introduced the course and

the session was chaired

by Steve Nelson,

London, UK.

The second course, CX

Advanced vascular access

skills course, under the

umbrella of the Vascular

Access Society of Britain

and Ireland, was a hands-

on course to demonstrate

practical skills such as

clinical examination,

duplex scan assessment

and how to perform both

surgical and endovascular

access techniques.

Domenico Valenti,

London, UK, was the

course director.

The course used four

practical skills stations.

Station 1 was dedicated

to training in initial

vascular access and

Station 2 addressed

surgical techniques such

as arteriovenous fistula

anastomosis. Station 3

was devoted to

endovascular techniques

such as arteriovenous

fistuloplasty and Station

4 to performing

arteriovenous

thrombectomy by

endovascular means.

The St George’s Vascular Access course, under the auspices of the Vascular Access

Society, and the Vascular Access Skills Course, under the auspices of the Society of

Vascular Access of Britain and Ireland were held at Charing Cross for the very first time

Eric Chemla

Chris Gibbons

September 2010

BIBA Publishing

28 Clinical news May 2010

The DUET study, a

randomised trial

conducted to com-

pare standard catheter-

directed thrombolysis vs.

ultrasound-accelerated

thrombolysis in The

Netherlands, has begun

enrolment of its 60 throm-

bo-embolic infra-inguinal

disease patients.

To be eligible, patients

should have recently

(between one and seven

weeks) thrombosed infra-

inguinal native arteries or

bypass grafts with acute

limb ischaemia

Rutherford class I and

IIa. Patients will be

randomly allocated to

either standard

thrombolysis or EKOS

ultrasound-accelerated

thrombolysis. The

anticipated duration of

recruitment will be

one year.

Jean-Paul de

Vries and AM

Schrijver, investigators at

St Antonius Hospital,

Nieuwegein, included

patients number eight and

nine in the beginning of

April 2010. In May, four

other Dutch institutions

began enrolment.

De Vries spoke to

Vascular News on the

DUET trial.

The DUET trial hypoth-

esis is that ultrasound-

accelerated throm-

bolysis will

reduce thera-

py time by at

least 12

hours com-

pared to

standard

thrombolysis

with no difference in

complication rates. If

confirmed, what other

benefits will this time

reduction bring to physi-

cians and patients?

Jean-Paul de Vries:

Twelve-hour reduction of

thrombolysis might pre-

vent patients from severe

bleeding complications

which are increased with

thrombolysis time and

doses. It will reduce hos-

pital stay, which is of

benefit for both

patients and

physicians.

Furthermore the

overall costs will

decrease with

shorter thromboly-

sis time.

What is the current sta-

tus of the trial?

De Vries: The St Antonius

Hospital will include

patient number eight and

nine next week. Four

other large vascular Dutch

hospitals will start to

include within six weeks.

The trial is expected to

complete enrolment by the

beginning of 2011.

Could you tell us about

your personal experi-

ence with ultrasound-

accelerated thromboly-

sis?

De Vries: My personal

experience with ultra-

sound accelerated throm-

bolysis is mainly on arte-

rial occlusion of the native

peripheral arteries or

occluded femoropopliteal

bypasses. Until now we

have treated more than 15

patients in our hospital

and more than 85% had

successful clot lysis with-

in 24 hours. Most of the

patients suffered from

arterial obstruction for

more than two weeks.

If ultrasound-accelerat-

ed thrombolysis is suc-

cessful in this study,

what would be the next

step in the investigation?

De Vries: If the benefit of

ultrasound accelerated

thrombolysis is proven in

the DUET study, the next

step is to refine the

technique and determine

whether more intensive

ultrasound techniques will

further reduce

thrombolysis time.

Another project is the

evaluation of the optimal

anticoagulant regimen

during thrombolysis. The

third interesting study

which is running is the use

of ultrasound accelerated

thrombolysis in patients

with arterial occlusions

more than 12 weeks old.

DUET compares standard catheter-directedvs. ultrasound-accelerated thrombolysis

Jean-Paul de Vries

EkoSonic Endovascular System

In a talk on the future of ilegx, Roger

Greenhalgh, chairman of CX32,

emphasised that delegates should

remember two key messages that needed

to be spread in order to bring down the

unacceptably high rates of major ampu-

tation across Europe. “It is unacceptable

that there are still so many major ampu-

tations. In the first ilegx meeting in

October 2008, in Imperial College,

London, we recognised that slow referral

from the community had a bearing on

the rate of major amputations. This is the

first message,” he said.

“Most of the doctors in this room are

doctors who receive patients in a special-

ist facility, and we are all equally frus-

trated by the fact that some of these

patients arrive in our hands too late. We

all need to help the programme directors

to spread awareness on that. It is not

easy and will take time, but we must all

spread the word that patients are not get-

ting to the specialists in time,”

Greenhalgh noted.

The second key action point, he said, is

that it is absolutely fundamental that

there should be interdisciplinary man-

agement of patients with regard to the

diagnosis and treatment. He introduced

the ilegx wheel to delegates and

explained that the initiative is about sav-

ing legs. The ilegx emblem stands for

interdisciplinary leg management.

Two of the three programme directors

present, Michael Edmonds, London, a

renowned diabetologist and Dieter Mayer,

Zurich, Switzerland, surgeon and wound

care expert, then shared a series of cases.

The ilegx initiative tosave legs

HOLD THE DATE!

The next ilegx meetingwill be held on 16–17October 2010, at ImperialCollege, London, UK

Roger Greenhalgh

September 2010

BIBA Publishing

30 Endovascular aortic repair May 2010

The chairman, Matt

Thompson, London, UK,

opened the workshop,

explaining that the purpose of

the session was to introduce

Globalstar and discuss why it is

needed and how it will work.

Rao Vallabhaneni, Liverpool,

UK, who is principal investiga-

tor of the registry, said that,

because of the increasing usage

of stent graft technology, there

is now a role for a collaborative

international registry to com-

pile pragmatic results, rather

than these results coming from

a select few expert centres.

However, “There are no estab-

lished, uniform reporting stan-

dards,” Vallabhaneni said, “so

we need to harmonise reporting

standards before we start col-

lecting data”. Nomenclature is

important to establish uniformi-

ty across what is being report-

ed, he said. He went on to give

an overview of the definitions

used in the project, explaining

what is meant by terms includ-

ing Chimney techniques, in-situ

fenestrated endovascular repair

(FEVAR) and target vessel.

He then went on to discuss

complications and phenomena

associated with advanced stent

graft techniques, including

paraostial endoleak, where the

blood flow enters the aneurysm

sac through an imperfect seal

between the junction of the tar-

get-vessel stent or the side

branch and the main body of

the stent graft. He also men-

tioned adverse transition of tar-

get vessel, a consequence of

rigidity of target vessel stent;

target vessel loss; and

aneurysm-related mortality.

“These are the few things

which we would record

which are not covered in the

existing reporting standards

and we would welcome any

further suggestions,”

Vallabhaneni said.

Following Vallabhaneni,

Simon Hobbs, Lickey, UK, dis-

cussed ideal follow-up protocol

for FEVAR and rationale.

Currently patients undergoing

EVAR are followed up indefi-

nitely. Protocols are now largely

standardised, with most centres

in Europe relying on duplex

sonography and plain radiogra-

phy, Hobbs said. Patients under-

going FEVAR should remain

under surveillance indefinitely

and there is little evidence to

justify routine discontinuance of

surveillance. A consensus is

needed, Hobbs said, to establish

what would constitute adequate

surveillance based on limited

available evidence.

Andrew England, Liverpool,

discussed corelab processes.

Pointing out the logistical, cost

and timing issues of multiple

centres submitting data,

Thompson said, “It might be

only the most enthusiastic cen-

tres submitting corelab data”.

The investigators then gave a

demonstration of Globalstar

online, a user-friendly, compre-

hensive data collection tool.

Concluding, Vallabhaneni

highlighted some of the hurdles

to the project, including issues

with sharing data and different

countries’ regulations on the

sharing and use of patient data.

In summary, he said, “This is

not a study or a trial, but an

open-ended audit where partici-

pation is not influencing the

decision to operate or which

technique to use.”

The time is right for an open-ended audit for EVARThe Globalstar Workshop, which took place at CX 2010, aimed to give an overview

of the project, which will propose reporting standards and follow-up protocols for

fenestrated and side-branched EVAR

Rao Vallabhaneni

Matt Thompson

BIBA Publishing

May 2010

Radiofrequency ablation,

endovenous laser abla-

tion, ultrasound guided

foam sclerotherapy and strip-

ping are efficacious treatments

for varicose veins, but the tech-

nical failure rate is higher after

foam sclerotherapy, the first ran-

domised trial comparing the

four techniques has shown.

Data from the study conduct-

ed in the Danish Vein Centres

and surgical Centre Roskilde,

Naestved, Denmark, were pre-

sented by Lars H Rasmussen at

the Charing Cross Symposium.

“Endovenous ablation of the

saphenous veins are in many

places replacing high ligation

and stripping as the standard

treatment of varicose veins due

to great saphenous veins insuffi-

ciency,” Rasmussen told dele-

gates. The new treatments, he

said, radiofrequency ablation,

endovenous laser ablation and

ultrasound-guided foam scle-

rotherapy are thought to min-

imise postoperative morbidity

and reduce time off work com-

pared to conventional surgery.

However, no randomised trials

comparing the new treatment

modalities with surgery have

been performed so far. “We

undertook such a trial,”

Rasmussen said.

In the Danish study, 500

patients (575 legs) with great

saphenous vein insufficiency and

varicose veins were randomised

to treatment with radiofrequency

(ClosureFast, VNUS), laser

(ELVES, Biolitec), foam scle-

rotherapy (Polidocanol,

Chemische Fabrik Kreussler) or

high ligation and stripping.

Miniphlebectomies were also

performed. The patients were

examined clinically and with

duplex, preoperatively, three

days and one month postopera-

tively and yearly thereafter.

At one-year follow-up,

Rasmussen said, 5.7%, 5.4%,

15% and 4% of the great saphe-

nous veins were open and

refluxing in the radiofrequency,

laser, foam and surgery groups

respectively (p<0.01).

One patient developed deep

vein thrombosis after foam scle-

rotherapy. No other major com-

plications were recorded. The

pain score for the first 10 days

were significantly lower in the

patients treated with radiofre-

quency and foam. The time to

normal function was 1 (0–30), 5

(0–46), 1 (0–30) and 4 (0–39)

days in the radiofrequency,

laser, foam and surgery groups

respectively (p<0.0001). The

days off work were 4 (0–14), 5

(0–46), 4 (0–33) and 6 (0–42)

respectively (p<0.01).

Varicose veins severity score

and Aberdeen clinical severity

score improved similarly in all

the groups. In the SF-36 quality

of life scores, domains bodily

pain and physical functioning

the radiofrequency and foam

sclerotherapy groups performed

better than the other groups.

Within two years of follow-up,

the distribution of new varicose

veins (REVAS), were not differ-

ent between the groups.

The investigators concluded

that all treatments are effica-

cious, but the technical failure

rate is higher after foam scle-

rotherapy. Radiofrequency and

foam sclerotherapy lead to faster

recovery, less postoperative pain

and superior quality of life

scores than laser and surgery.

“Longer follow-up is manda-

tory to evaluate recurrence

rates. Safety aspects should be

followed in registries of larger

groups of patients as phase IV.

Follow-up will continue for

five years,” Rasmussen con-

cluded.

Randomised trial shows highertechnical failure rate with foamRadiofrequency ablation, endovenous laser ablation, ultrasound-guided foam

sclerotherapy and stripping are efficacious, but the technical failure rate is higher

after foam sclerotherapy, one-year results from a Danish study have shown.

Radiofrequency and foam sclerotherapy lead to faster recovery, less

postoperative pain and superior quality of life scores than laser and surgery

Lars Rasmussen

The majority of

patients do not

know what venous

treatment they would like

to have and consider the

opinion of a venous spe-

cialist the most important

factor for their choice,

Manj Gohel, Cheltenham,

UK, told delegates at the

CX Symposium.

“In every area of medi-

cine, our patients will have

desires, preferences and

expectations. We want to

meet these expectations.

However, for conditions

such as aortic aneurysm

disease and carotid

stenoses, the condition is

serious, treatments have a

clear benefit and there may

only be one or two treat-

ment options, so prefer-

ences have a limited role.

Venous disease is very dif-

ferent and patient prefer-

ence is particularly impor-

tant,” Gohel said.

Firstly, he went on,

venous disease is relative-

ly benign and the majority

of patients have C1, C2

disease. The aim of treat-

ment in these patients is to

improve quality of life.

And therefore a detailed

understanding of their

symptoms and their

expectations is essential.

Gohel showed examples

of newspaper headlines,

the NHS website, and a

patient outcome measures

questionnaire to sustain

that there are strong politi-

cal and media pressures for

physicians to take greater

account of patient prefer-

ence.

“In the past the only

treatment decision to make

was whether or not to offer

surgery. But with the

recent endovenous revolu-

tion things are very differ-

ent. In 2010, not only do

we have to decide how to

treat the main truncal great

or small saphenous reflux

we have also to decide

when and how to treat

varicosities and even

where to offer treatment,

let alone the type of anaes-

thetic. Each of these

approaches has advantages

so it is up to us to try and

find the best treatment for

each individual patient. We

are all aware of the inherit-

ed risk of litigation after all

venous interventions. But

these are all strong incen-

tives for us to take a

greater role and interest in

patient preferences.”

Gohel’s group per-

formed a survey of patients

treated for varicose veins

and asked which treatment

they prefer. “It is interest-

ing that a majority of

patients do not know. The

concept of choice is only

valid if patients are well

informed,” he said. “We

also asked patients what

sort of factors would influ-

ence their treatment

choice. Interestingly, the

opinion of a vascular sur-

geon or venous specialist

has the greatest influence,

whereas factors such as the

anaesthetic or the informa-

tion from magazines or

friends have relatively lit-

tle influence.”

In conclusion, Gohel

said, “there are many pow-

erful drivers for us to take

a greater interest in patient

preference and to offer

greater patient choice.

Most patients are not sure

about which treatments

they want, and therefore

there is a great emphasis

on the venous specialist to

offer good information and

use all the available treat-

ments to adapt treatment

for the individual patient.”

What is the patient’s preference in venous disease treatment?

Manj Gohel

September 2010

BIBA Publishing

34 May 2010

Nearly 200 people were trained in

one day on 31 skills stations. The

course convenor, Ian Franklin,

said, “The Charing Cross Office Based

Vein Course has got off to a cracking

start and we have far more people want-

ing to come than we expected. We have

expanded into a much bigger space, we

have got 31 trainee stations addressing

lots of different aspects of office based

veins practice, so that we can include all

the different techniques that are available

to help people get started on a predomi-

nantly local anaesthetic based veins prac-

tice.” He added, “We have been particu-

larly lucky with the calibre of the faculty.

The room is studded with the stars of the

venous world, some really excellent

teachers who have given us their time to

teach all day. There is a very dynamic,

interactive atmosphere here.”

Steam thermoablation for the treatment

of varicose veins was demonstrated by the

world’s foremost expert in the procedure,

Rene Milleret, Montpellier, France, who

drew many attendees to watch him

demonstrate how steam can safely be used

to treat a wide variety of varicose veins.

A large crowd gathered around JJ

Guex, Nice, France, who was demon-

strating foam sclerotherapy. Using a bio-

logical simulator (an ox liver with a plas-

tic tube to emulate the vein), in a

hands-on workshop, Guex instructed

trainees on the technique of cannulating

veins, and injecting foam sclerosant.

“This is exactly what it looks like when

you are injecting a patient. The liver has

some artefacts within it that makes it

more realistic than any silicon or gel sim-

ulation, so the trainees are able to take

different options for punctures.”

Barrie Price from the Whitely Clinic,

UK, demonstrated the highly effective

Whitely-Holdstock technique for percuta-

neous treatment of incompetent perforator

veins under local anaesthetic, and how to

deal with accessory veins. Price told

Vascular News, “Our clinic invented this

technique around nine years ago. We use a

standard intravenous cannula and we

insert the perforator under local anaesthet-

ic, and we can then choose from a variety

of different devices but the most common-

ly used is still a radiofrequency stylet. The

entire procedure take around one to two

minutes to complete and do a perforator. It

works by passing energy through the vein

wall and this kills it – it is the same princi-

ple as the venous closure – the radiofre-

quency ablation techniques.” Price said,

“Perforators tend to get ignored by many

clinicians because some of the surgeons

remember the days when we were making

huge incisions, but this could lead to

infections and complications such as deep

vein thromboses.”

Vikas Pandey, London, UK, showed

attendees at the course how to position

catheter tips correctly. Poor positioning

can result in deep vein damage and throm-

bosis. Pandey used a simulator to allow

delegates to practice correct tip position-

ing. He said, “It is important to utilise the

ultrasound to visualise exactly where the

superficial vein meets the deep vein and

then position the laser fibre.” Of the evo-

lution in venous treatment, Pandey said,

“The technology has been around for 10

years and has been increasingly used in

the UK and wordwide. The procedure is

safe, very well tolerated outside of the

operating theatre under local anaesthetic.”

Ravi Singh Ranger, who was demon-

strating venous closure for the treatment

of varicose veins, said the reason for the

slow implementation of office based vein

practices is “a combination of political,

training and cost issues.” On the future of

office based practice, Franklin predicted

that, “Local anaesthetic based, office

based practice will completely replace

conventional surgical practice. I am sur-

prised it has not happened quicker than it

has but I have no doubt it will over the

next few years.”

CX Office Based VeinsCourse “studded with thestars of the venous world”

Tumescent anaesthesia Foam sclerotherapy

Steam thermoablationUltrasound-guidedcanulation

The CX Office Based Veins Course is now the biggest skills course of its kind in Europe. Ever popular,

this year’s course was packed with delegates eager to find out about the latest skills needed to treat

varicose veins in an office environment.

Ian Franklin

BIBA Publishing

May 2010 35

58% of delegates vote for medicaltreatment of superficial vein thrombosis

In the debate “The treat-

ment of ascending

superficial vein throm-

bosis should be mechani-

cal”, 58% of CX delegates

backed Lowell Kabnick

against the motion. His

opponent, Anthony

Comerota, received 42%

of the votes.

Superficial vein throm-

bosis can extend into the

deep venous system

resulting in deep vein

thrombosis and pulmonary

embolism. There are

125,000 cases each year in

the United States.

Comerota, Jobst

Vascular Center, Toledo,

USA, mentioned a series

of papers showing risk

factors and morbidity

associated with superficial

vein thrombosis.

“Acute venous throm-

bosis is not limb threaten-

ing, and is easy to antico-

agulate, but it is

associated with signifi-

cant morbidity and recur-

rence, and yet physicians

continue to treat with

anticoagulation alone,” he

said.

“The most rational

therapeutic option should

be to eliminate the super-

ficial thrombus, remove

contiguous deep vein

thrombus if present, and

excise branch varicosi-

ties.”

The involved great or

small saphenous vein, he

said, should then be oblit-

erated using a contempo-

rary technique. Since

stripping is no longer

required, concerns regard-

ing operative haematomas

should be eliminated, as

large saphenous side

branches are no longer

being avulsed.

Anticoagulation

appears to be indicated in

the majority of patients

for at least a month or

longer in the high-risk

patients. This strategy

will eliminate the high

recurrence rate in patients

in whom the

disease/thrombosed veins

remain because of nonop-

erative treatment, and

will avoid the majority of

the deep venous throm-

boembolic complications

observed in patients not

otherwise treated with

anticoagulation.

“All this can be done

very quickly, safely and

effectively,” Comerota

said.

Against the motion,

Kabnick sustained that

studies continue to point

to medical management

with anticoagulant thera-

py as superior to surgical

treatment in decreasing

the risk for complications

and preventing deep vein

thrombosis and pulmonary

embolism.

“Ultrasonography of

the affected limb should

be performed to assess

for degree of superficial

vein thrombosis, presence

of superficial, deep, and

perforator competency,

and clot extension into

the deep venous system.

Less extensive superficial

vein thrombosis in the

lower thigh should be

treated with non-steroidal

anti-inflammatory drugs

and warm compresses.

More involved superficial

vein thrombosis (upper

thigh with or without

thrombus extension),

patients with history of

malignancy, prior deep

vein thrombosis or pul-

monary embolism, or

thrombophilia should be

treated with a four-week

course of prophylactic

doses of low molecular

weight heparin.”

Anthony Comerota Lowell Kabnick

58 No

42 Yes

The treatment of ascending superficialvein thrombosis should be mechanical?

The CLASS trial is a study

comparing laser, surgery and

foam sclerotherapy in the

treatment of varicose veins, Michael

Gough, Leeds, UK told delegates at

the CX Symposium on behalf of the

CLASS study group. The aim is to

recruit 1,015 patients.

“One of the reasons to present this

trial here is to see if any other UK

centres would be interested in join-

ing us,” Gough said.

The study is funded by the

National Institute of Health Research

– Health Technology Assessment

(NIHR HTA). In August 2006, the

Health Technology Assessment iden-

tified foam sclerotherapy for vari-

cose veins as a priority area and put

out a call for study proposals to be

submitted, specifically that the pri-

mary outcome should be quality of

life at six months.

This is a multicentre controlled

trial of three treatment options: 1)

conventional surgery, 2) foam scle-

rotherapy of trunk and non-trunk

varicosities with further treatment at

six weeks to residual non-truncal

varicosities if required using Fibro-

Vein, and 3) endovenous laser abla-

tion of truncal varicosities with foam

sclerotherapy of residual non-trunk

varicosities at six weeks if required.

The study duration is three years,

and patient recruitment commenced

in December 2008. By the end of

October 2009, 150 patients had

been recruited. Currently 10 UK

centres are enrolling patients.

The trial will assess outcomes up

to six months, but with possible

long-term follow-up of five years

through a separate funding applica-

tion. The primary patient outcome

is disease-specific (Aberdeen

Varicose Vein Questionnaire) and

generic quality-of-life at six months

and five years. Primary economic

outcome is incremental cost per

quality-adjusted life years at six

months and five years.

Secondary outcomes are costs to

the health service and patients and

any subsequent care, technical and

clinical success of venous interven-

tion at six weeks, six months and

five years, and behavioural recovery.

CLASS will compare endovenous techniques in 1,015 patients

September 2010

BIBA Publishing

36 May 2010

Cook expandsNavAlign forinferior venacava filterplacement withfemoral accessoptionCX delegates had the

opportunity to trial first

hand Cook Medical’s

NavAlign inferior vena

cava filter delivery

system. NavAlign,

available for Cook’s

Celect and Günther Tulip

filters, is designed to

minimise trauma and

streamline the placement

of filters to help prevent

fatal pulmonary

embolism in patients at

risk of venous

thromboembolism.

The NavAlign simulator

consists of a modeled

cross section of the

inferior vena cava and a

specialised camera which

will allow delegates to

feed the deployment

device into the inferior

vena cava and judge the

correct deployment

position using the image

displayed on screen.

NavAlign is the landmark

product of Cook’s new

Venous Program, an

integrated line of

products engineered to

treat the spectrum of

venous disease – from

superficial venous

insufficiency to deep

system conditions like

deep vein thrombosis.

NavAlign incorporates a

haemostasis valve to

minimise blood loss.

With an accompanying

multipurpose dilator,

radiopaque sizing marker

bands and flushing

sideports designed to

decrease fluoroscopy

time and contrast medium

amounts, the NavAlign

system is ideal for

physicians using image

guidance to place inferior

vena cava filters to help

protect patients from

deep vein thrombosis and

pulmonary embolism.

Final results withthe ClariVeincatheter forvaricose veinsare announcedResults from the initial

clinical trial of the

ClariVein catheter

(Vascular Insights), used

in a new minimally

invasive treatment for

varicose veins, have been

announced. The device

combines mechanical and

chemical modalities to

accomplish vein treatment

in an in-office setting.

Steve Elias was the

principal investigator of

this IRB-regulated trial

conducted at Englewood

Hospital and Medical

Center, USA. “Results

were excellent,” Elias,

associate professor of

Surgery at Mount Sinai

Hospital, and the director

of The Centers for Vein

Disease at Mount Sinai

and Englewood Hospitals,

said. “The initial success

rate is equal to that from

radiofrequency or laser

treatment of great

saphenous vein disease.”

Thirty patients with an

average age of 55 were

part of this first-in-man

trial. Most patients had

symptomatic varicose

veins, with some having

more advanced vein

disease such as swelling

and skin changes. Mean

vein diameter was 8.1mm.

Treatment for each vein

averaged five minutes and

overall procedure time

was 14 minutes.

At six-month follow-up,

29 of the 30 veins treated

were successfully closed.

The only vein that did not

respond was that of the

first patient. Subsequent

to the trial, to date 22

other patients have had

the ClariVein procedure,

with all being successful.

“The main advantage of

this new technique in

comparison to older

endovenous therapies,”

Elias said, “is that it does

not require tumescence

anaesthesia infusion,

saving significant time

and decreasing patient

discomfort. In addition, a

generator is not required,

and therefore capital and

maintenance cost is

reduced. This in-office

procedure takes about 15

minutes to perform and

patients resume normal

activity that day, including

exercise. All patients

would recommend the

procedure to others.”

Vascular Insights has

received 510(k) clearance

from the FDA to market

ClariVein for infusion of

physician-specified agents

in the peripheral

vasculature.

FDA approvesAsclera to treatsmall varicoseveinsThe FDA has approved

Asclera (polidocanol)

injection for the treatment

of small types of

abnormally swollen or

twisted veins called

varicose veins.

“Asclera is indicated for

the treatment of small

types of varicose veins

when the aim of treatment

is to improve

appearance,” said Norman

Stockbridge, director of

the Division of

Cardiovascular and Renal

Products at the FDA’s

Center for Drug

Evaluation and Research.

Asclera is approved to

close spider veins (tiny

varicose veins less than

1mm in diameter) and

reticular veins (those that

are 1–3mm in diameter).

Asclera acts by damaging

the cell lining of blood

vessels. This causes the

blood vessel to close, and

it is eventually replaced

by other types of tissue.

Common adverse reactions

to Asclera include leakage

and collection of blood

from damaged blood

vessels at the injection site

(haematoma), bruising,

irritation, discoloration,

and pain at the injection

site.

Asclera is distributed by

BioForm Medical of

Franksville, USA, and

manufactured by

Chemische Fabrik

Kreussler & Co of

Wiesbaden, Germany.

TB-402 showspositive resultsin phase IIvenousthromboembolism study BioInvent International

AB and ThromboGenics

NV announced on 6 May

2006 positive results from

their phase II trial of TB-

402. TB-402 is a novel,

long acting anticoagulant

that is being developed as

a single injection for the

prevention of venous

thromboembolism

following orthopaedic

surgery. The phase II

results demonstrate that

TB-402 has superior

antithrombotic activity to

enoxaparin (Lovenox,

Sanofi-aventis) with

comparable safety.

Enoxaparin is currently

the standard treatment to

prevent venous

thromboembolism in this

setting.

The phase II trial was a

multicentre, dose-

escalating, randomised,

open-label trial,

evaluating TB-402 against

enoxaparin for the

prophylaxis of venous

thromboembolism after

knee surgery. All patients

received enoxaparin 40

mg pre-operatively. Post

operatively, patients were

randomised in a sequential

cohort design to one of

three doses of TB-402

(0.3mg/kg, 0.6mg/kg or

1.2mg/kg) or enoxaparin

40mg (3:1; n=75 per

group).

TB-402 was administered

as a single intravenous

bolus injection 18–24

hours after orthopaedic

surgery, whereas

enoxaparin was given as a

40mg subcutaneous

injection once daily for a

period of at least 10 days.

The primary efficacy

endpoint was based on

measuring all occurrences

of venous

thromboembolism in

patients by day 7–11,

whether they were

symptomatic or

asymptomatic. The

primary safety endpoint

was the number of

patients with major or

clinically relevant non-

major bleeding from

randomisation until the

end of the study at 3

months. The study

enrolled a total of 316

patients across 30 centres

in Europe.

For the pooled TB-402

treated group, 47 out of

218 (or 22%) patients

experienced venous

thromboembolism; for the

enoxaparin treated group,

30 out of 77 (or 39%)

patients experienced

venous thromboembolism

(p<0.05). The difference

of reduction between the

two groups is statistically

significant. The study also

showed that TB-402 and

enoxaparin had a similar

safety profile.

The results of this trial

(“Single intravenous

administration of TB-402

for the prophylaxis of

venous thromboembolism

after total knee

replacement surgery”) will

be presented by Peter

Verhamme, University of

Leuven, Belgium, at the

21st International

Congress on Thrombosis

on 8 July 2010 in Milan,

Italy.

TB-402 is a recombinant

human monoclonal

antibody that partially

inhibits factor VIII, a key

component of the

coagulation cascade. This

novel mode of action is

expected to reduce the

risk of undesirable

bleeding events, even at

high doses, as well as the

need for patient

monitoring. These are the

two main drawbacks

associated with current

anticoagulant therapy. In

addition, TB-402 is a

long-acting agent, which

means it could be given as

a single dose to prevent

the development of deep

vein thrombosis in

patients undergoing

surgery. This simple

approach to prophylaxis

would be an attractive

option, as all current

anticoagulant treatment

options require daily

treatment for up to several

weeks.

Product News

NavAlign

ClariVein

September 2010

BIBA Publishing

38 Awards May 2010

Gore honoured eight physicians as “Pioneers in Performance” for their exceptional work in the field of vascular and endovascular

therapy, including aortic and lower-limb bypass and dialysis access surgery. The ceremony was held at the CX Symposium. The

eight practitioners were recognised by Gore for their unrelenting dedication to advancing vascular and endovascular therapy and

the advancement of minimally invasive treatment options for patients worldwide. The work performed by these individuals has

expanded therapeutic options for at-risk patients

“Pioneers in Performance” honoured by Gore

Eric Chemla, consultant

Renal Transplant and vascu-

lar surgeon, St George’s

Hospital, London, UK

Gary Ansel, cardiologist,

internist, clinical director of

Peripheral Vascular Intervention,

Riverside Methodist Hospital,

Columbus, USA

Jan Brunkwall, professor,

University of Cologne, Chief

of the Department of Vascular

Surgery, University Clinics

Cologne, Germany

Roger Greenhalgh, emeri-

tus professor of surgery and

head of the Imperial College of

Vascular Surgical Research

Group, London, UK, medical

director of BIBA Medical, editor-

in-chief of Vascular News

Thomas Larzon, consultant

vascular surgeon, Örebro

University Hospital, Sweden

EricVerhoeven, specialist in

Surgery and Vascular

Surgery, medical director of the

Department of Vascular Surgery,

Nuremberg Hospital South,

Nuremberg, Germany

Peter Taylor, consultant

vascular surgeon, Guy’s &

St Thomas’ Hospital, London, UK

Marty Sylvain, global sales

leader at Gore

Jan Tordoir, associate pro-

fessor of Surgery, University

Hospital Maastricht, The

Netherlands

1

1

23

45

6

7

8

9

2 3 4 5 6 7 8

9

Promising talentrecognised at CX surgeons intraining session

Three up-and-com-

ing stars of the

vascular world

were rewarded for their

work during a presenta-

tion at the end of the

European Vascular

Surgeons in Training

event, which was held as

part of the CX Complex

Case Review on Tuesday

13 April 2010.

Twenty-one trainees

presented on varying top-

ics, from, among many

others, 2D-3D image reg-

istration for complex

endovascular repair of

aortic aneurysm, to

unusual aneurysm of bra-

chiocephalic arteriove-

nous fistula, and acute

upper limb ischaemia.

In first place was

Tawqeer Rashid, Leeds

Teaching Hospitals, UK,

for his paper, ‘Tuberous

sclerosis and paediatric

aortic aneurysm’.

Awarded second place for

his paper, ‘Thoraco-

abdominal aneurysm

(Type II Crawford):

Resolution by complex

hybrid procedure’, was

Fernando

Gallardo, Department of

Vascular Surgery of the

CHU A Coruña, Spain.

Finally, in third place was

Oliver Lyons, Department

of Vascular Surgery,

Guy’s & St Thomas’ NHS

Foundation Trust, United

Kingdom for his paper,

‘Endovascular manage-

ment of retrograde Type A

aortic dissection.’

1st place 2nd place 3rd place

Tawqeer Rashid Fernando Gallardo Oliver Lyons

Vikas Pandey (centre, first row) and the trainees

Gore has announced

the first patient

case involving the

Gore DrySeal Sheath. The

sheath aids in minimally

invasive treatment for

patients with abdominal

aortic aneurysms (AAA)

with the Gore Excluder

AAA Endoprosthesis and

thoracic aortic aneurysms

with the Gore TAG

Thoracic Endoprosthesis.

The successful procedure

was performed by Alan

Lumsden, chairman of the

Department of

Cardiovascular Surgery,

The Methodist Hospital in

Houston, USA, during a

Gore-sponsored Acute

Symptomatic AAA

Workshop conducted in

The Methodist DeBakey

Heart and Vascular Center.

Gore received FDA

clearance in April 2010 to

market the Gore DrySeal

Sheath, which is comprised

of the innovative haemo-

static Gore DrySeal Valve

attached to the introducer

sheath. The Gore DrySeal

Valve is truly unique in that

it is pressurised to create a

seal, thereby minimising

blood loss and accommo-

dating multiple wires and

catheters simultaneously.

The valve consists of a sili-

cone outer tube and an

inner film tube that create

an effective haemostatic

seal that easily adapts to

the profiles of the inserted

devices. The device is

available in profiles from

12 to 26F, in 2F incre-

ments, and has a working

length of 28cm.

Lumsden said, “The abil-

ity of the Gore DrySeal

Valve to accommodate

multiple devices during dif-

ficult procedures with min-

imal blood loss keeps the

operating field free from

excess blood, while helping

to prevent unnecessary

blood loss to the patient.”

First patient is treated withnew Gore DrySeal Sheath

September 2010

BIBA Publishing

40 Gallery May 2010

CX 32 through the lens

May 2010

BIBA Publishing

41Gallery

September 2010

BIBA Publishing

42 Market watch May 2010

ENGAGE globalstudy of Endurantcelebratescompletion of500 enrolments

Medtronic Cardiovascular

has announced that

ENGAGE, the post mar-

ket clinical study of

Medtronic’s next genera-

tion device, Endurant, has

reached a significant mile-

stone in April 2010. A lit-

tle over a year since it

started, ENGAGE has

crossed 500 enrolments,

significantly ahead of

schedule, and is well on

its way to complete 1,200

implants worldwide. The

500th patient was enrolled

on 8 April. Patients 499

and 500 were enrolled on

this day by Dittmar

Boeckler, from University

Clinic Heidelberg in

Germany, who is also an

ENGAGE executive com-

mittee member, and by

Van Sterkenburg, from

Alysis Zorggroep

Rijnstate Hospital Arnhem

in The Netherlands.

ENGAGE aims to

expand the clinical knowl-

edge base by generating

clinical data with real

world Endurant patients.

ENGAGE will enrol

1,200 patients at up to 100

sites spanning six conti-

nents. The follow-up peri-

od will be five years.

The study demonstrates

Medtronic's commitment

to the pursuit of evidence

based medicine and exem-

plifies Medtronic’s confi-

dence in the real-world

application of the

Endurant stent graft sys-

tem. Endurant,

Medtronic’s leading

abdominal aortic

aneurysm stent graft is

designed with evolution-

ary precision for accurate

placement in straightfor-

ward and challenging

anatomies, to which it

adapts extremely well due

to a highly flexible and

conformable body. The

device has been widely

adopted by endovascular

specialists worldwide and

recently completed 15,000

commercial implants

globally since its launch

in 2008. This feat under-

scores how quickly the

device has changed the

lives of many patients

worldwide.

The endovascular com-

munity’s confidence in the

Endurant device is also

reflected in the speed at

which ENGAGE is pro-

gressing. Valuable clinical

insights supporting

Endurant’s clinical effec-

tiveness are starting to

become available from

ENGAGE.

“As an ENGAGE

Executive Committee

member, it is my pleasure

to present ENGAGE data

for the first time to the

European clinical commu-

nity” said Boeckler.

“ENGAGE is a ground-

breaking study and by

generating meaningful

clinical evidence, it will

enable the clinical com-

munity to further the

advances in EVAR with

confidence.”

The ENGAGE enrol-

ment began last year in

March at Queen Elizabeth

Hospital in Adelaide,

Australia when Robert

Fitridge treated a patient

using Endurant. Since

then, 53 sites have been

activated worldwide and

all the sites are expected to

be active by 2010.

Clinical safety and per-

formance data on the

Endurant Stent Graft

System have also been

collected recently during

the European market trial.

Hence Verhagen, the prin-

cipal investigator of the

EU trial presented the

one-year follow-up data at

the symposium. A US IDE

Clinical trial with 150

patient enrolments is also

currently in the follow-up

phase in the USA.

First patientsenrolled in Cordistrial of new stent

Cordis announced in April

2010 that the first patients

have been enrolled in the

INNOVATION trial,

which will assess the safe-

ty and performance of a

new stent graft system,

called Incraft, to treat

abdominal aortic

aneurysm.

“The need for improved

abdominal aortic

aneurysm treatments is

significant,” said

Campbell Rogers, chief

scientific officer and head,

Global Research and

Development, Cordis

Corporation. “Current

abdominal aortic

aneurysm stent grafts limit

the range of patients suit-

able for endovascular

aneurysm repair and make

delivery and placement

accuracy challenging and

complex, which can com-

promise the short- and

long-term safety of the

EVAR procedure. We are

very excited about the

first-in-human use of our

Incraft stent graft system,

which we believe has the

potential to set a new stan-

dard in the field of

EVAR.”

INNOVATION, a multi-

centre, open-label,

prospective, non-ran-

domised study, will enrol

up to 25 patients in three

sites throughout Germany.

The trial investigators are

Jan Brunkwall, chairman

of the Department of

Vascular Surgery at

Universitatkliniken,

Cologne, Dierk Scheinert,

head of the Department of

Medicine, Angiology and

Cardiology at Park-

Krankenhaus Hospital in

Leipzig and Giovanni

Torsello, chief of Vascular

Surgery at St Franziskus

Hospital in Muenster.

The initial procedures

using Incraft were per-

formed by Scheinert, who

is serving as principal

investigator of the INNO-

VATION trial. “We have

been excluding a signifi-

cant portion of our

abdominal aortic

aneurysm patients, espe-

cially women, from

EVAR because current

stent grafts have large and

bulky delivery systems,

making device introduc-

tion impossible for small

or diseased access vessels.

The ultra-low profile

delivery system of Incraft

will make EVAR a possi-

ble treatment alternative

for a wider range of

patients,” Scheinert said.

Currently available

EVAR devices have a sys-

tem profile ranging from

18 to 24 French. Incraft’s

delivery system profile is

13 French.

Cordis has been devel-

oping Incraft with input

from a multidisciplinary

physician advisory panel

that includes Takao Ohki,

chairman of the Depart-

ment of Surgery at Jikei

University School of

Medicine in Tokyo; Corey

Teigen, managing physi-

cian partner, MeritCare

Vascular Center, Fargo,

USA; Robert Bersin, med-

ical director, Endovascu-

lar Services, Seattle Cardi-

ology and Swedish

Medical Center, USA.

TriVascularbegins Europeanand US studies ofOvation

TriVascular announced in

March 2010 the first

European clinical study

implants of its Ovation

Abdominal Stent Graft.

The innovative, low-pro-

file system is designed to

expand the patient popula-

tion suitable for endovas-

cular aortic repair by

addressing a wider range

of diseased anatomy.

Cases were performed in

Germany by Thomas

Nolte, chief of Vascular

Surgery at Herz- und

Gefäßzentrums Bad

Bevensen, and Horst

Sievert, director of the

CardioVascular Center

Frankfurt.

“The Ovation

Abdominal Stent Graft

performed exceptionally

well,” said Nolte, princi-

pal investigator for the

European study. “The

clinical benefits of the

reduced profile and

unique sealing technology

were evident immediately.

I believe this offering will

expand the pool of

patients to whom I can

offer an endovascular

solution.”

The European clinical

study will evaluate the

safety and performance of

the Ovation system.

“I was very pleased

with the performance of

the Ovation stent graft,”

said Sievert. “The system

was easy to use and

addresses many of the

limitations of current gen-

eration devices, especially

in cases of difficult anato-

my and iliac access.”

Sievert utilised a bilateral

percutaneous approach to

gain femoral access.

“The start of our

European clinical study is

a significant milestone for

our organisation,” said

Mike Chobotov, president

and CEO of TriVascular.

“We are fortunate to part-

ner with thought leading

clinicians in Europe. More

importantly, we are excit-

ed to provide next genera-

tion endovascular solu-

tions to patients suffering

from aortic disease.”

On 3 May 2010,

TriVascular announced the

first US clinical study

implant of Ovation.

Gregory Mishkel, co-

director, Cardiac

Catheterization Lab,

Prairie Heart Institute, St

John’s Hospital,

Springfield, USA, per-

formed the first case. “The

Ovation abdominal stent

graft performed very well

and was easy to use,” said

Mishkel. “We are excited

to participate in the clini-

cal study of this novel,

next-generation device.

The significantly reduced

profile of the delivery

catheter will increase the

pool of patients to whom I

can offer EVAR.”

The US Investigational

Device Exemption study

will evaluate the safety

and effectiveness of the

Ovation system. The

national principal investi-

gator for the trial is

Manish Mehta, director of

Endovascular Services at

The Vascular Institute for

Health & Disease in

Albany.

“I am pleased to be

partnering with

TriVascular on this impor-

tant clinical effort,” said

Mehta. “I believe the

Ovation abdominal stent

graft has the potential to

considerably improve

upon currently available

stent grafts, particularly in

its ability to accommodate

Product News

Endurant

Incraft

May 2010

BIBA Publishing

43Market watch

complex aortic necks and

difficult iliac access. With

Ovation we may be able

to offer minimally inva-

sive EVAR to a broader

group of patients.”

Ovation is an investiga-

tional device and currently

not approved for sale.

Bolton Medicallaunches the newRelay NBS withPlus DeliverySystem

Bolton Medical launched

the new Relay NBS

Thoracic Stent Graft with

Plus Delivery System at

the CX Symposium. The

Relay NBS (non-bare

stent) Thoracic Stent

Graft with Plus Delivery

System allows for

improved covered graft

apposition in tightly

curved aortas and greater

expansion control in

larger diameter anatomies

during the treatment of

complex thoracic aortic

aneurysms. The new

system was CE marked in

March 2010.

When a covered (or

non-bare) stent is used in

a tightly curved aorta, it

can cause a gap or “bird

beak” in which the

proximal end of the stent

fails to lay flat against the

inner curvature of the

aortic arch, increasing the

incidence of endoleaks

and graft complications.

Additionally, in larger

diameter anatomies, the

graft may “retroflex” or

in-fold toward its inner

curvature during

deployment. The Relay

NBS Thoracic Stent Graft

with Plus Delivery

System has incorporated

key design changes to

reduce the potential

for both these

complications.

The Relay NBS

Thoracic Stent-Graft with

Plus Delivery System

represents the latest

innovation for the

Relay aortic product

line and is part of

Bolton Medical’s

ongoing commitment

to develop high

quality,

innovative

technologies

for aortic

repair.

Relay and Relay

NBS Endovascular

Stent Grafts are

indicated for

the treatment

of main thoracic aortic

pathologies such as

aneurysms, penetrating

ulcers, pseudoaneurysms

and intramural

haematomas in adult

patients.

Enrolment in USRelay thoracicstent graft trialis concluded

Bolton Medical

announced on 5 May

2010 that patient enrol-

ment in the US clinical

trial to evaluate the

Realy thoracic stent

graft for the

treatment of

thoracic aortic aneurysms

has been concluded. The

study included 120

endovascular patients at

30 hospitals across the

country.

The device is already

approved for use in

Europe and international

markets, and to date,

more than 3,000 Relay

stent grafts have been

implanted worldwide.

“Completing enrolment

is an exciting step in the

study,” said Mark Farber

national principal investi-

gator and associate pro-

fessor of Surgery and

Radiology, University of

North Carolina, Chapel

Hill. “We expect to see

excellent results in the

patient follow-up data

and anticipate the

device to be

approved for sale in

the US in 2011.”

The Relay

Thoracic Stent

Graft system has

the longest device

length options

(90–250mm).

The system is

also available

in a wide

range of diam-

eters (22–

46mm) including smaller

caliber sizes which allow

for repair of patients with

smaller diameter aortas.

In addition, the device

features a unique delivery

system that allows for

excellent proximal con-

formability and con-

trolled deployment.

First Zenith TX2Low Profileimplants areperformed inGermany

Cook Medical announced

on 12 May 2010 the com-

pletion of the first

implants of its Zenith

TX2 Low Profile TAA

Endovascular Graft, as

part of a clinical investi-

gation, by assistant pro-

fessor Piotr Kasprzak,

head of vascular surgery

at the University Hospital

Regensburg, Germany.

He was assisted by

Alexander Loibnegger.

At 16F or 18F, the TX2

Low Profile delivery sys-

tem is smaller than a

standard TX2 device and

is engineered to allow

patients with challenging

anatomies to be treated

percutaneously. As a

result, patients who pre-

viously may not have

been suited to thoracic

endovascular repair, for

example those with nar-

rowed, small or tortuous

arteries, may now benefit

from minimally invasive

treatment.

Up to ten medical cen-

tres across Europe may

take part in the TX2 Low

Profile TAA study. The

first two patients were

treated in Regensburg on

17 March 2010. One

patient was treated for an

aneurysm measuring

approximately 10cm in

diameter and the other

patient was treated for an

ulcer, the latter of which

was notable for narrow

access vessel anatomy

(measuring approximate-

ly 5mm in diameter).

Kasprzak said:

“Treating an aneurysm

with the TX2 Low Profile

TAA from Cook Medical

shows great promise.

With this stent we’re able

to treat patients with

TEVAR. The TX2 Low

Profile may provide a

viable alternative to open

surgery that may result in

lower risks of complica-

tions to a larger patient

population.”Relay NBS Plus

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September 2010

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Registry willcollect data onValiant andCaptiviaMedtronic will conduct a

post-market registry to

collect acute clinical data

on the Valiant Thoracic

Stent Graft with the

Captivia Delivery System.

The recent launch of

Captivia for its market

leading Valiant Thoracic

Stent Graft provides

physicians with the ability

to treat a wide range of

anatomies with a highly

conformable stent graft,

with accuracy and ease of

delivery to achieve opti-

mal clinical results.

Indicated for the treat-

ment of a variety of tho-

racic aortic lesions, the

Valiant Thoracic Stent

Graft has emerged as the

minimally invasive “sys-

tem of choice”. In five

years of clinical experi-

ence, over 18,000 patients

have received the Valiant

Thoracic Stent Graft

worldwide with 650

implanted with the

Captivia Delivery System.

Captivia incorporates a

tip capture feature which

provides physicians with

the ultimate in accuracy

and control of stent graft

deployment, while main-

taining the hallmark attrib-

ute of the Valiant graft: Its

conformability. The addi-

tion of hydrophilic coating

to the graft cover facili-

tates iliac access and stent

graft deliverability. These

new features in combina-

tion with the Valiant graft

will expand the treatment

range to more patients with

complex aortic disease and

ultimately improve patient

outcomes.

The post market reg-

istry will be conducted at

several European sites and

will begin enrolling in the

near future.

Medtronicreceives FDAapproval for newindication forComplete stent

Medtronic has received

approval from the FDA for

the Complete self-expand-

ing vascular stent system to

be used for the treatment of

peripheral arterial disease

in the iliac arteries.

“The Complete SE Vas-

cular Stent System pro-

vides physicians with a

new treatment option that

offers significant benefits

for patients with narrowed

iliac arteries due to periph-

eral vascular disease,” said

Robert Molnar, of Michi-

gan Vascular Research

Center in Flint, USA. “The

system enables highly ac-

curate stent placement in

the iliacs, reducing the like-

lihood of stent ‘jumping’,

which we commonly see

during deployment with

the use of many self-ex-

panding stent systems.”

Molnar and William

Gray, New York-Presbyter-

ian Hospital/Columbia

University Medical Center,

led the study (as co-princi-

pal investigators) that con-

tributed to this approval.

The Complete system

features advances, includ-

ing a dual-deployment de-

livery system with a unique

triaxial design. The deliv-

ery system is made up of

an inner shaft, a retractable

sheath and a stabilising

sheath that reduces friction

and allows the retractable

sheath to move back freely.

This decreases the amount

of force required to deploy

the stent, thereby making

deployment easy and

precise.

Anacondareceives CEapproval forisolated iliacaneurysm repair

Vascutek, a Terumo

Company, has announced

that it has received CE

approval for use of the leg

devices of the Anaconda

AAA Stent Graft System

for isolated iliac aneurysm

repair. The multiple inde-

pendent ring stent design

provides maximum flexi-

bility to cater for varying

patient anatomies and min-

imises the potential for

kinking.

The Anaconda AAA

Stent Graft System, with

state-of-the-art hydrophilic

coating technology and of

a modular design, is the

only repositionable device

that also offers exceptional

flexibility. The BluGlide

sheath’s low friction

hydrophilic coating

smoothes the passage of

the delivery system

through the arteries. The

integral kink resistant

sheath also provides con-

trolled delivery with excel-

lent trackability and

maneuverability.

A smooth low profile tip

aids system introduction

and the highly radiopaque

sheath tip marker aids

accurate deployment of the

device.

The Anaconda AAA

Stent Graft System’s avail-

ability and indications are

subject to local regulatory

approval. The device is

undergoing clinical study

in the USA.

Product NewsCaptivia

Anaconda

September 2010

BIBA Publishing

46 Companies May 2010

Medtroniccompletesacquisition ofInvatec Medtronic announced on

21 April 2010 that it has

completed the acquisition

of Invatec. The acquisition

includes two affiliated

companies: Fogazzi,

which provides propri-

etary polymer technology

to Invatec; and Krauth

Cardio-Vascular, which

has successfully grown

Invatec’s market position

in Germany.

Invatec has been recog-

nised for developing novel

devices for the treatment

of coronary and peripheral

vascular disease.

“With this acquisition,

Medtronic is enhanc-

ing its international

presence by further

developing our

global business with

additions to our

European operations,”

said Scott Ward, presi-

dent of the

CardioVascular busi-

ness and senior vice presi-

dent at Medtronic.

The newly added busi-

ness will be led by general

manager, Ross Allen, a 19-

year veteran of Medtronic

with leadership experience

across four divisions, most

recently as vice president

of finance for the

CardioVascular

business.

Invatec’s founders

will stay with the

new business in

senior leadership

positions: Andrea

Venturelli as vice

president of

research and

development

and chief

technology

officer; and

Stefan

Widensohler as vice

president of global sales.

Medtronic plans to

maintain Invatec’s

European operations in

order to stay close to

the existing core cus-

tomer base in Europe,

the source of many col-

laborative innovations that

have advanced the treat-

ment of cardiovascular

disease. To ensure the

continuity of these opera-

tions, Medtronic pur-

chased Invatec facilities in

Brescia, Italy, and the

lease on an existing facili-

ty in Frauenfeld,

Switzerland, has been

extended.

Invatec pioneered the

development and commer-

cialisation of lesion-spe-

cific solutions for coro-

nary and peripheral

vascular disease.

For below-the-knee dis-

ease, Invatec was the first

company to make and

market a percutaneous

transluminal angioplasty

balloon, self-expanding

stent, balloon-expandable

stent and guidewire

specifically designed for

that indication.

For carotid disease,

Invatec designed and

commercialised a stent to

provide ease of delivery

and adequate coverage of

the lesion. Products also

include a proximal and

distal embolic protection

device, providing a com-

plete solution for the treat-

ment of atherosclerosis in

the carotid artery. In addi-

tion, Invatec led the intro-

duction of a new treat-

ment platform with its

four drug-eluting bal-

loons, covering the coro-

naries and lower-extremi-

ty vessels.

Of these therapies, only

devices for the treatment

of below-the-knee disease

are currently approved for

use in the United States.

CID announcesacquisition ofDatascope’sPeripheralVascular Stentsassets

CID (Carbostent &

Implantable Devices)

announc ed on 6 April

2010 that it has signed an

agreement to acquire

Datascope’s Peripheral

Vascular Stents Assets,

including intellectual

property. This acquisition

allows CID to extend its

portfolio to the large

peripheral vascular prod-

ucts field, including self-

and balloon-expandable

stents and angioplasty

catheters. CID has now

the full ownership of the

know-how and intellectu-

al property of the entire

stent and catheter angio-

plasty field, both coro-

nary and peripheral.

Franco Vallana, CID’s

CEO, considers this the

first stage to access a new

market with huge opportu-

nities. “This important

step”, Vallana said,

“shows the quality and

consistence of CID project

confirming this company

as an inspiring reality

patient driven solutions”.

CID is dedicated to

contributing to human

welfare by improving the

quality of patient care and

after-care through the

development of

innovative, minimally

invasive implantable

devices, procedures and

therapies.

A strong background in

the field of implantable

cardiovascular devices

and haemocompatible

materials, expressed in a

remarkable intellectual

property portfolio, and a

management with an

expertise gained in many

years of research,

development and clinical

experience, allow CID to

offer the investors a fair

return and its customers

the necessary tools to

meet new challenges.

Industry News

26–28 May

EWMA 2010

Geneva, Switzerland

Geneva Palexpo

T +45 7020 0305

F +45 7020 0315

E [email protected]

W www.ewma2010.org

27–30 May

LIVE 2010 – Leading

Innovative Vascular Education

Corfu, Greece

Corfu Chandris Hotel, Dassia

T +30 26510 68610

F +30 26510 68611

E [email protected]

W www.LIVE2010.gr

28–29 May

4th Mediterranean Meeting of

Venous Disease

Nice, France

Boscolo Hotel Plaza

T +33 (0)4 9109 7053

F +33 (0)4 9615 3308

E [email protected]

W www.mmvd-cmpv.com

2–5 June

11th Annual New

Cardiovascular Horizons

New Orleans, USA

T +1 (337) 993 7920

F +1 (337) 993 7922

E [email protected]

W www.ncvhonline.com

10–13 June

2010 Vascular Annual Meeting

Boston, USA

Hynes Convention Center

T +1 (312) 334 2300 or 800 258 7188

F +1 (312) 334 2320

E [email protected]

W www.vascularweb.org

16–19 June

ISMICS 2010 – International

Society for Minimally Invasive

Cardiothoracic Surgery

Berlin, Germany

InterContinental Hotel

W www.ismics.org

17–19 June 2010

MEET – Multidisciplinary

European Endovascular

Therapy

Marseille, France

Palais Du Pharo

T +33 (0)4 9109 7053

E [email protected]

W www.meetcongress.com

18–19 June

14th International Symposium

on Critical Issues on Aortic

Endografting

Malmö, Sweden

T +46 40 338087

E [email protected]

W www.criticalissues.se

24–25 June

8th Western Vascular Institute

Symposium – New Horizons in

Vascular & Endovascular

Therapy

Galway, Ireland

Radisson Blu Hotel

T +353 91 542535

E [email protected]

W www.wvisymposium.com

24–26 June

11th Annual Meeting of the

European Venous Forum

Antwerp, Belgium

Hilton International Hotel

T +44 (0) 20 8575 7044

F +44 (0) 20 8575 7044

E [email protected]

W www.europeanvenousforum.org

6–9 July

21st International Congress on

Thrombosis 2010

Milan, Italy

Marriott Hotel

T +39 02 58102846

F +39 02 50320723

E [email protected]

W www.thrombosis2010.org

6–8 September

Adriatic Vascular Summit

Split, Croatia

Le Méridien Lav

W www.adriatic-vascular-summit.org

9–10 September

Inaugural Annual Meeting of

the Vascular Access Society of

Britain and Ireland

Manchester, UK

T +44 1419 428104

E [email protected]

W www.vasbi.org.uk

16–19 September

European Society for Vascular

Surgery Annual Meeting

Amsterdam, The Netherlands

T +31 679 3411

F +31 673 7306

E [email protected]

W www.esvs.org

20–24 September

46th Annual Meeting of the

European Association for the

Study of Diabetes

Stockholm, Sweden

T +49 211 758 469 0

F +49 211 758 469 29

E [email protected]

W www.easd.org

Calendar of events

Editor-in-chief:

Roger Greenhalgh

Publisher:

Stephen Greenhalgh

Editor:

Marcio [email protected]

Assistant editor:

Lisa Glass

Editorial contribution:

Urmila Doraswami

Design:

David Reekie

Layout:

Matt Hadfield

Advertising:

Marianne [email protected]

Website:

David Reekie

Please contact the

Vascular News team

with news or advertising

queriesTel: +44 (0)20 7736 8788

Published by:

BIBA Medical,

44 Burlington Road,

Fulham, London,

SW6 4NX, UKTel: +44 (0) 20 7736 8788

Fax: +44 (0) 20 7736 8283

Printed by:Buxton Press© BIBA Medical Ltd, 2010All rights reserved.

Printed by Buxton Press.

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