doi: 10.1016/j.ejvs.2003.12.002, available online at http://www.sciencedirect.com on SCIENCE
`Eur J Vasc Endovasc Surg 27, 311-318 (2004)
`
`DIRECT?
`
`@
`
`Stent-graft: Mid-term Results
`The Vanguard Endovascular
`from a
`Single Centre
`S. J. Holtham, J. D. G. Rose, R. W. Jackson, T. A. Lees and M. G.
`
`Wyatt”
`
`Northern Vascular Centre, Freeman
`Freeman Road, High Heaton,
`Hospital,
`NE7 7DN, UK
`Newcastle upon Tyne
`endovascular aortic
`initial enthusiasm
`repair, few descriptions of longer-term follow-up of any
`Purpose. Despite
`for
`a
`centre with the
`endovascular device have been
`device
`This paper represents the
`experience of
`single
`Vanguard
`published.
`over a
`5-year period.
`with a median age of
`59 mm (45—
`71 years (range
`45-87
`and aneurysm diameter
`Methods.
`Fifty-five patients
`years)
`of
`84 mm)received a
`was
`to the
`between December 1995 and
`1999.
`bifurcated Vanguard stent-graft
`July
`Follow-up
`according
`at 1, 3, 6, 12, 18 and 24 months
`Eurostarcriteria (clinical assessment, plain film radiography
`and
`computed tomography)
`and then
`annually thereafter.
`were
`was 120 min (70-360 min). Median
`stent
`Results. All
`successful. Median duration
`of surgery
`primary
`deployments
`was 3
`with a
`5.5%. In the
`follow-up period (median 40
`days (1-19 days)
`post-operative stay
`peri-operative mortality of
`aneurysm associated death, and 14 deaths due to other causes. There have been
`months, range 6—64 months) there was one
`II endoleaks and nine type III endoleaks. At 48 months, this has
`12 occluded
`three device
`graft limbs, four type
`migrations,
`resulted in a survivalrate
`of 67%, an endoleak
`59%
`81% and intervention
`survival
`survival
`free
`of
`free
`of
`(Kaplan—Meier).
`Conclusion. Medium term results with the
`device appearto beat least
`to
`to open repair
`with
`Vanguard
`equivalent
`regard
`delayed complications appear to be related to
`mortality. Nevertheless, several
`and
`limb distortion.
`morbidity
`endograft
`to reduce the incidence
`Important lessons have been learntin relation to the
`deploymentofbifurcated endografts
`limb related
`problems.
`
`ofsecondary
`
`Key Words:
`
`Vanguard;
`
`Endovascular
`
`stent-graft; Mid-term reliability.
`
`Introduction
`
`of ‘Endovascular Aortic
`Since the
`inception
`Aneurysm
`Repair’ (EVAR)in the last decade of the 20th century,
`the
`of the
`has been demonstrated
`feasibility
`procedure
`with many different home made and commercial
`devices. The earliest reports described the
`application
`fixed to the endoluminal aspect of the
`of tube
`grafts
`aorta with either Palmaz or Gianturco Z stents.'7
`Thesefirst studies showed that endoluminal methods
`were sufficient to exclude an
`aneurysm in the short
`data demonstrated an
`term, but further
`follow-up
`incidence of distal endoleak. This was
`unacceptable
`related to the
`short distal aortic necks
`relatively
`and also to the
`in the
`of
`present
`patients
`majority
`there is continued
`natural
`expansion
`history, whereby
`of the distal aortic neck despite aneurysm exclusion.°**
`were
`The next
`of
`generation
`endograft designs
`*Corresponding author. M. G. Wyatt, Northern Vascular Centre,
`Freeman Hospital, Freeman Road, High Heaton, Newcastle upon
`Tyne NE7 7DN, UK.
`
`1078-5884/030311 + 08 $35.00/0 © 2003 Published by Elsevier Ltd.
`
`centred on the
`aorto-iliac
`with femoro-
`tapered
`graft
`femoral crossover” or the bifurcate configuration. The
`‘aorto-mono-iliac’
`the range of
`endografts expanded
`in which EVAR could be
`anatomical
`settings
`applied
`be made up
`and could
`in theatre, whereas the
`easily
`bifurcate systems were
`trials
`the
`emerging through
`by
`in a ‘semi-commercial’ setting. The first
`pioneers®”
`were the
`available bifurcated
`commercially
`endografts
`EVT device (Endo Vascular
`Menlo Park,
`Technologies,
`CA) and the Stentor (Mintec Ltd, Bahamas; precursor
`of the
`Vanguard).
`success in abdominal
`Several groups reported early
`aortic aneurysm (AAA) exclusion
`the Stentor/
`using
`to
`I
`The device had been subjected
`Vanguard
`systems.°
`two main
`after Boston Scientific took
`design changes
`over manufacture in 1996:
`of a seamless
`application
`Meadox
`material
`surgical grade polyethylene graft
`in the number and
`of
`(Fig. 1) and
`improvements
`grade
`sutures betweenthe
`material and the
`supporting
`graft
`stent framework. However, the
`enthusiasm for
`early
`was
`the
`Vanguard system
`subsequently tempered by
`reports of suture
`distortion and
`breakage, endograft
`
`MEDTRONIC 1125
`
`

`

`312
`
`S. J. Holtham etal.
`
`Vanguard Bifurcated
`
` Fig.
`
`1. The Vanguard bifurcated endovascular aortic
`graft
`(Boston Scientific Ltd). The device comprises of a
`primary
`with an attach-
`component(the aorto-iliac endoprosthesis)
`ment site for a
`secondary componentor contralateral iliac
`limb. The device is made up
`a nitinol framework covered
`of
`a
`polyester fabric.
`by
`
`perhaps
`term.®
`The
`
`junctional disconnections.*’ These complications
`to indicate
`weaknesses in the
`appeared
`potential
`basic structure of the
`early Vanguard system and
`in the medium
`heralded further
`problems
`
`devicefell out of favour in the United
`Vanguard
`in 1998, when rival stent
`graft systems
`Kingdom
`with a wider
`to offer more robust
`appeared
`designs
`to the AAA
`size range and thus greater applicability
`In addition, the Medical Devices
`Agency
`population.
`(of the UK National Health Service) issued a
`‘safety
`users of the
`notice’ later in 1999, warning
`of
`possibility
`suture
`and to follow strict
`in
`guidelines
`breakages'®
`terms of the
`surveillance of each
`regular
`implanted
`Vanguard system.
`the initial world-wide enthusiasm for
`Despite
`EVAR, and
`because of the
`mechan-
`reported
`perhaps
`with several of the first and second
`ical
`problems
`term
`of the
`generation devices, few
`longer
`descriptions
`follow up of any endovascular device have been
`of a
`This paper represents the
`experience
`published.
`device over a
`centre with the
`single
`Vanguard
`period
`of 5 years and which
`includes the
`effectively
`‘learning
`curve’ for EVAR.
`
`Materials and Methods
`
`Recruitment of AAA
`for endovascular
`repair
`patients
`between December 1995 and
`1999. The
`took
`place
`July
`was
`EVAR programme
`approvedby
`Local Ethical
`the
`informed of the inves-
`Committee and every patient
`All devices were
`nature of the
`tigational
`technique.
`an ‘endovascular team’ which contained
`implanted by
`both vascular surgeons and interventional radiol-
`were
`The first 25 EVAR
`ogists.
`procedures
`performed
`in the
`suite in
`The sub-
`Radiology.
`Angiographic
`cases have been undertaken in a dedicated
`sequent
`Theatre on a fixed
`Endovascular
`angio-
`Operating
`table with a
`C-arm. All cases
`ceiling-mounted
`graphic
`were done under
`anaesthetic.
`general
`
`Eur J Vasc Endovasc Surg Vol 27, March 2004
`
`Study patients
`received a bifurcated
`Fifty-five patients
`Vanguard
`These 55
`the
`patients
`stent-graft during
`study period.
`consisted of 49 men
`(89.1%) and six women
`(10.9%)
`with a median age of 71 years (range
`45-87
`years).
`with an
`Forty-eight patients presented
`asymptomatic
`were
`and one
`aneurysm, six
`patients
`symptomatic
`with a contained rupture. Pre-
`patient presented
`anaesthetic risk was measured
`the
`operative
`by
`score.
`American
`of
`Anaesthesiologists’ (ASA)
`Society
`were
`as ASA II,
`nine (52.7%) patients
`Twenty
`graded
`were
`were
`ASAIII and three (5.5%)
`23 (41.8%)
`graded
`ASAIV.
`Median aneurysm diameter was 59 mm
`(range
`84 mm) with a median neck diameter of 22 mm
`(range
`was
`14.7-24.5 mm). Median
`neck
`proximal
`length
`21 mm
`14-100 mm).
`(range
`
`45—
`
`Device
`
`bifurcated endovascular aortic
`The
`Vanguard
`graft
`(Boston Scientific Ltd, St Albans, Herts.) is a modular
`in 1996.
`device derived from the Mintec Stentor system
`It is composedof a
`primary component, the aorto-iliac
`with an attachmentsite for a second-
`endoprosthesis,
`ary componentor contralateraliliac limb
`(Fig. 1). Both
`are made ofa nitinol wire frame-
`these components
`a
`fabric. On exposure to
`work covered
`polyester
`by
`blood at
`the nitinol wire self-
`body temperature,
`to a
`pre-set diameter. In this way the stent-
`expands
`to the endoluminal
`becomes
`graft
`closely applied
`neck andtheiliac
`surfaces of the aorta in the
`proximal
`vessels at the distal attachmentsites. Three
`of
`pairs
`to further anchor the
`barbs
`externally projecting
`help
`device in the
`neck. The contralateral limb
`proximal
`area of the aorto-iliac
`within the
`junctional
`expands
`a combination of
`and is thus stabilised
`prosthesis
`by
`radial force and friction. The
`and
`primary
`secondary
`are each
`sealed within
`components
`completely
`poly-
`introduction catheters, 22 French
`Gauge (FG)
`ethylene
`and 12 FG, respectively.
`Each introduction system
`with ice-cold saline.
`required preparation by flushing
`
`Procedure
`
`received a
`
`anaesthetic in this
`All
`patients
`early
`general
`was covered bya single
`series. The
`intra-
`procedure
`venous
`and metroni-
`of
`gentamicin (160 mg)
`injection
`The main device was
`inserted
`dazole (400 mg).
`usually
`via the common femoral artery through
`a small
`transverse
`incision. A bolus of 50001IU
`inguinal
`was
`to device insertion. The
`given prior
`
`heparin
`
`

`

`Mid-term Results of Vanguard
`
`313
`
`was
`inserted into the
`secondary component
`generally
`a standard percuta-
`contralateral femoral artery using
`neous
`Seldinger technique.
`was
`in two
`after
`planes
`Angiography
`performed
`device insertion in order to assess the
`of the
`integrity
`as well as the
`and distal fixation sites,
`proximal
`area of the
`If
`bifurcated
`graft.
`completed
`junctional
`there was evidenceofa
`leak of contrast into
`significant
`sac then a further intervention was
`the aneurysm
`usually indicated, either additional balloon
`expansion
`insertion of a
`cuff or a distal
`of the
`graft,
`proximal
`extension.
`
`Follow up
`
`Regis-
`clinical
`
`were entered into both the National
`All
`patients
`European (EUROSTAR) EVAR
`(RETA) and the
`tries and underwent
`evaluation
`regular
`by
`film
`and
`assessment, plain
`radiography
`computed
`tomography (CT). These tests were
`in the
`performed
`EVARandthenat
`1, 3, 6, 12, 18
`first week
`following
`assessments were at 12-
`and 24 months.
`Subsequent
`were
`month intervals.
`and
`mortality
`Morbidity
`limb occlusions or
`recorded. All endoleaks, graft
`were
`other device related
`investigated.
`complications
`When re-intervention was
`indicated, endovascular
`methods of treatment were considered
`to open
`prior
`surgery.
`
`Statistical
`
`analysis
`
`were
`
`calculated, with
`Median values and ranges
`the Wilcoxon
`statistical
`determined
`by
`significance
`tables were
`rank test. Cumulative survival
`signed
`calculated
`the
`method.
`
`by
`
`Kaplan—Meier
`
`Results
`
`were
`stent
`in this
`All
`primary
`study
`graft deployments
`successful and there were no
`open conversions. The
`was 120 min
`70-
`median duration of surgery
`(range
`360 min) with an estimated median blood loss of
`had a total
`200 ml
`30-1000 ml). One
`patient
`(range
`blood loss of 2500 ml, due to an additional
`procedure
`that was unrelated to the
`insertion.
`Vanguard
`the stent was found in 18
`in
`deploying
`Difficulty
`additional
`(32.7%) patients. Twenty-four
`procedures
`were
`performedintraoperatively (Table 1) to
`improve
`access, to treat an endoleak or to resolve a
`limb
`graft
`contributed to success-
`occlusion. All these
`ful stent
`
`procedures
`deployment.
`
`Post-operative
`
`course
`
`admission to the
`Twelve (21.8%) patients required
`intensive care unit
`Median stay for
`post-operatively.
`was 12h
`4-48 h). The median
`these
`patients
`(range
`total
`ICU and ward
`post-operative stay (including
`was 3
`1-19
`days (range
`days).
`stay)
`There were a total of 10 (19%) post-operative
`systemic complications (renal impairment 5, myocar-
`dial infarction 2, stroke 1, transient ischaemic attack 1,
`transfusion reaction 1) and three false aneurysms, each
`at a site of femoral artery puncture for the
`deployment
`of an introducer (Table 2). All were treated
`surgically.
`was 5.5%(Table 3).
`The
`peri-operative mortality
`
`device related
`
`Early
`complications
`CT scans revealed six endoleaks (11.5%).
`Pre-discharge
`andfive
`These consisted of one
`I endoleak (1.9%)
`type
`II endoleaks (9.6%). The
`I
`with the type
`type
`patient
`endoleak underwent
`with external band-
`laparotomy
`of the
`neck. This
`patient subsequently
`ing
`proximal
`died in the
`II
`Of the five type
`post-operative period.
`the time
`endoleaks, four had sealed
`spontaneously by
`of the first CT scan at 1 month. The typeII endoleak in
`and was embolised at 6 and
`the fifth
`patient persisted
`12 months.
`
`Survival
`
`for the 51
`who
`The median
`patients
`follow-up period
`was 40 months
`30
`6-64
`survived
`(range
`beyond
`days
`months), with a mean of 38.6 + 14.9 months. There
`were 15 further deaths (29.4%)in this
`follow-up period
`and the causes of death are listed in Table 4. One
`waslost to
`after 18 months. CT scans
`patient
`follow-up
`had shown noevidenceofa leak or
`up to this
`any
`point
`increase in aneurysm size
`(Fig.2).
`Twoofthe late deaths were related to the AAA and
`The first was a 74-
`endovascular
`repair.
`subsequent
`female (ASA II) who underwentan unevent-
`year-old
`She was admitted as an
`ful
`primary procedure.
`emergency to an
`16 months after
`outlying hospital,
`The cause of death was a
`the initial
`operation.
`CT scan at 12 months
`AAA. The
`protocol
`ruptured
`had shown no
`of an endoleak
`in
`sign
`although,
`film demonstrated
`retrospect, the
`distal
`plain
`possible
`of the stent
`It
`of the
`migration
`proximal margin
`graft.
`that an endoleak had
`is
`probable
`developed shortly
`to aneurysm rupture.
`prior
`a
`female (ASA II)
`The second
`patient,
`71-year-old
`with no
`renal
`renal disease
`pre-existing
`developed
`obstruction of the left
`impairment following partial
`
`EurJ Vasc Endovasc Surg Vol 27, March 2004
`
`

`

`314
`
`S. J. Holtham etal.
`
`(%)
`Survival
`
`100
`90
`80
`70
`60
`50
`40
`30
`20
`
`
`
`
`
`
`Endoleak Free Survival
`Intervention Free Survival
`
`10 0
`
`10
`
`20
`
`30
`
`40
`
`50
`
`#60
`
`£70
`
`Month
`2. Kaplan-Meier survival curves of patient survival,
`Fig.
`freedom from intervention and freedom from secondary
`endoleak.
`
`was treated
`to 36 months)
`(Fig. 4). One
`patient
`patients (with 11
`10
`The
`remaining
`conservatively.
`were
`of
`treated
`graft occlusion)
`episodes
`successfully
`by embolectomy (1), thrombectomy (1), thrombolysis
`(1) and femoro-femoral crossover
`graft (8).
`There has been one disconnection of an occluded
`and no
`limb at 3 years. This was
`asymptomatic
`graft
`treatment has been necessary. One
`patient developed
`at the contra-limb
`at 3
`of the
`junction
`buckling
`graft
`years and this has
`been observed. One
`patient
`simply
`intermittent claudication due to
`pre-exist-
`developed
`atheromatous disease at 12 months and
`ing
`improved
`the insertion of bilateral iliac Wallstents.
`following
`
`Endoleaks
`
`13 endoleaks have been
`
`In the
`follow-up period,
`identified in
`eight patients (15.7%).
`median onset
`Of the 13 endoleaks that
`developed,
`24 months
`3-59 months), during
`the
`follow-up
`(range
`II endoleaks and
`there have been four type
`period,
`III endoleaks.
`nine type
`II endoleaks sealed
`Half of the type
`spontaneously
`identified and no further
`within 2 months of
`
`Table 1. Additional intra-operative procedures required
`
`Procedure Number
`Additional introducer required
`Additional limb extension
`Proximal cuff
`Wallstent
`Fem-fem crossover
`Endarterectomy
`Thrombolysis
`Placementof second stent
`
`co-axially
`
`NRPRPRrPONWU
`
`renal artery ostium with the
`of the
`proximal margin
`to
`material.
`the renal function
`graft
`Initially,
`appeared
`andserial CT scans to 18 months showed no
`improve
`endoleak. However,the left
`did reducein size
`kidney
`over a
`of months. The
`died
`patient eventually
`period
`22 monthsafter stent insertion, having developed
`end-
`renalfailure.
`stage
`
`Delayed
`
`device related
`
`complications
`
`after the first month,
`the
`During
`follow-up period
`in 20
`there have been 26 device related
`complications
`
`patients.
`
`Device
`
`migration
`
`The first,
`There have been three device
`migrations.
`was
`which was not associated with an
`endoleak,
`treated with an aortic cuff at 33 months
`successfully
`(Fig. 3). The second, which wasassociated with a
`III endoleak, required graft
`revision
`proximal type
`with an aorto-uni-iliac device at 59 months. The third
`was associated with
`of the
`graft migration
`buckling
`is
`limbs and this
`currently awaiting
`patient
`graft
`and treatment.
`further
`
`investigations
`
`limb occlusions
`
`Graft
`
`There were 12 occluded
`limbs (12%)in 11 (21.6%)
`graft
`with a median onset of 18 months
`24h
`(range
`
`Eur J Vasc Endovasc Surg Vol 27, March 2004
`
`being
`
`patients
`Table 2. Post-operative complications
`Accesssite
`Systemic
`False aneurysm (3)—All required intervention
`Renal impairment(5)
`Renal artery embolization (1)
`Cholesterol microembolization (1)
`Graft occluded single renal artery (1)
`Cause not determined (2)
`Myocardialinfarction (2)
`Stroke (1)
`Transient ischaemic attack (1)
`Transfusion reaction (1)
`
`

`

`Mid-term Results of Vanguard
`
`315
`
`Table 3. Peri-operative mortality (30 days)
`Timeof event
` Age
`Sex
`ASA
`Causeof death
`F
`Il
`Day 6 post-op
`79
`Myocardialinfraction (following laparotomy for proximal endoleak)
`M
`IV
`81
`Day 3 post-op
`Myocardialinfraction
`24 h post-op
`M
`Il
`61
`Spontaneouscerebral haemorrhage (following thrombolysis for
`occluded graft limb)
`30 days post-op
`Sepsis (unknownaetiology)
`Peri-operative mortality: 5.5%. 30-day mortality: 7.3%.
`
`M
`
`I
`
`74
`
`treatment was
`two
`II
`necessary. The
`type
`remaining
`occurred and are under
`endoleaks have
`only recently
`III endoleaks
`observation. Of the nine type
`(Fig. 5(A)
`one
`a
`III
`and (B)),
`proximal type
`patient developed
`tear in the
`endoleak
`and
`following graft migration
`and the main
`device between the upper body ring
`at 59 months. This wastreated
`Six
`by re-stenting.
`body
`III endoleaks have
`limb extensions and
`type
`required
`a further aorto-uni-iliac device. All
`two have
`required
`have remained sealed at
`
`follow-up.
`
`Aneurysm
`
`evolution
`
`there has been
`Within the
`only
`follow-up period,
`small decrease in the median aneurysm diameter
`(Fig.
`6) and this has not been shownto be
`statistically
`significant (Table 5).
`
`a
`
`Discussion
`
`centre
`with the
`This
`experience
`Vanguard
`single
`endovascular device is based on the
`comprehensive
`treated since the device
`follow up of all
`patients
`conver-
`became available in 1995. No
`patient required
`sion to open repair during
`in
`the
`primary procedures
`endoleak was
`this series. The rate of
`only 11%,
`primary
`whichis well within the rate
`in the literature of
`quoted
`10-47%.'"!* Mostof these early leaks were dealt with
`Table 4. Cause of death in follow-up period
`
`
` Cause of death Months survived
`
`Debility/MRSA
`Carcinoma bronchus
`Unknowncause
`Congestive cardiac failure
`Oesophageal carcinoma
`AAArupture
`UTI/Septicaemia
`Myocardialinfarction
`Gastric carcinoma
`Chronic renalfailure
`Non-Hodgkins lymphoma
`Bladder carcinoma
`Pneumonia
`
`6
`12
`14
`14
`15
`16
`17
`20/20
`21
`21/22
`24
`35
`43
`
`surgical
`
`endovascular means and noneresulted in
`by
`conversion.
`There was no evidence to
`or
`
`that
`
`suggest
`peri-
`was
`operative morbidity
`mortality
`significantly
`A
`increased
`this
`early experience.
`peri-operat-
`during
`of 5.5%is similar to that associated with
`ive
`mortality
`It has been
`that
`the less
`open repair.
`suggested
`procedure may be a more
`traumatic endovascular
`methodof treatmentfor
`at
`patients
`appropriate
`higher
`who are
`is that
`risk. Our
`experience
`patients
`surgical
`ASA IV appear to do
`in the
`graded
`relatively poorly
`andthis has led us to consider
`post-operative period
`the use of
`or local anaesthesia for selected
`regional
`cases. The Zurich endovascular group have
`reported
`local
`lower
`peri-operative mortality using
`significantly
`anaesthesia for EVAR
`procedures.’
`was to
`However, the main reason for our
`study
`assess the
`outcome after EVAR and
`longer-term
`at least one of our stented
`the
`follow-up period
`during
`died with a
`AAA. The CT scans
`patients
`ruptured
`to this event had not shown any evidence of an
`prior
`endoleak or
`increasing aneurysm diameter. It has been
`a
`that this
`patient may have
`developed
`postulated
`increased the size of
`endoleak that
`proximal
`rapidly
`the aneurysm and caused the
`subsequentrupture. The
`of such an event drawsattention to the fact
`possibility
`that EVAR is still an
`Never-
`investigational procedure.
`theless, whilst surveillance is
`important, present
`and the sudden nature of some
`protocols
`problems
`suggests that even extreme
`to follow up will
`diligence
`not
`At present, however,
`prevent all
`complications.
`surveillance is a
`for
`mandatory requirement
`regular
`the UK EVAR trials or the national
`'*
`patients entering
`registry.
`or
`device
`incidence of
`The
`secondary
`delayed
`high
`in this series (35%) is related to
`related
`complications
`or
`occurrence of
`the
`of
`frequent
`‘kinking’
`angulation
`sac. The
`the stent
`within the aneurysm
`graft
`Liverpool
`group has extensively investigated this
`problem'”'®
`and suggests the causeis related to
`of the
`shortening
`sac as it reduces in volume with
`excluded aneurysm
`are
`time. The endoleaks that result from limb
`kinking
`type III endoleaks"’in relation to either disconnection
`of the contralateral limb from the main device or due
`
`EurJ Vasc Endovasc Surg Vol 27, March 2004
`
`

`

`316
`
`S. J. Holtham etal.
`
`Fig. 3. Plain abdominalantero-posterior
`showing
`at the
`with
`radiograph
`kinking
`proximal graft migration
`significant
`area.
`junctional
`
`s
`
`5. (A) CT appearance ofa
`large type III endoleakarising
`Fig.
`from the area
`just proximalto the junctional region. (B) Type
`III endoleak: a
`distal endoleak just above the junctional
`large
`to a hole in the stentfabric.
`area
`secondary
`
`to
`
`
` _—_—
` Fig. 4.
`
`appearance of occludedleft limb. This
`a femoro-femoral crossover
`successfully treated by
`Angiographic
`
`was
`
`graft.
`
`Eur J Vasc Endovasc Surg Vol 27, March 2004
`
`of either limb from the distal
`upward migration
`site in the commoniliac artery. These
`implantation
`endoleaks can
`be
`treated
`by percuta-
`usually
`easily
`neous endovascular means.
`The incidence of endoleaks and occlusions related
`and
`limb
`
`to
`delayed
`the
`importance
`
`(or) migration highlights
`kinking
`a
`in
`of
`allowing
`significant ‘overlap’
`
`

`

`Mid-term Results of Vanguard
`
`317
`
`neck diameters is due to the
`underlying pathological
`process. This aspect of the disease process holds great
`for the future fixation of endovascular
`implications
`devices andis the
`of
`studies.
`
`subject
`
`ongoing
`
`[= Range
`—*— Median
`
`Conclusions
`
`Changein Median Aneurysm Diameter
`
`= 60
`50
`5
`40
`2
`o 30
`
`SO
`
`0
`
`3
`
`6
`
`18
`12
`Follow up (months)
`Fig. 6. Evolution of maximum aneurysm diameter.
`
`24
`
`36
`
`48
`
`the
`
`areas of all modular devices and the
`junctional
`of
`the
`distal
`necessity
`ensuring
`longest possible
`‘attachment’ to the commoniliac artery. The further
`of all stent
`should include par-
`development
`grafts
`ticular attention to the radial
`of the ‘endo-
`strength
`in those
`limbs’. This factor is
`particularly important
`on
`the aortic bifur-
`device
`that
`rely
`‘raising
`designs
`to a
`and thus result in
`cation’
`significant degree
`that the use of
`endolimbs.It is
`likely
`relatively long
`main bodies and with
`devices with
`junctional
`longer
`areas
`to the native aortic bifurcation
`only just superior
`related to limb
`will result in fewer
`long-term problems
`distortion or dislocation.
`sac should lead
`Effective exclusion of the aneurysm
`to diameter reduction of the
`but this
`aneurysm,'*”’
`visible in the data from our
`is not
`immediately
`change
`series. If the data collected
`the follow up of
`during
`stented aneurysms that had endoleaks is
`separated
`from those of the AAAsthat continue to show
`primary
`a different
`freedom from endoleak,
`picture may
`emerge. The available literature on the
`post-endograft
`in diameter of the aneurysm neck suggests
`changes
`that the disease process in the aorta continues
`despite
`This is consistent with
`the exclusion of the
`aneurysm.”°
`our
`further careful
`of
`experience although
`tracking
`to assess whetherthe increase in
`neck sizes is
`required
`
`Table 5. Change in aneurysm diameter
`CT scans available Median (range)
`Significance
`59 nm
`51
`(45-84)
`Pre-operative
`58 mm
`12 months
`NS
`45
`(42-80)
`56 mm
`NS
`18 months
`32
`(41-80)
`56.5 mm
`24 months
`29
`(42-80) NS
`56 mm
`36 months
`16
`NS
`(34-81)
`53 mm
`48 months
`9
`NS
`(33-81)
`
`Wilcoxon-signed rank.
`
`of AAAs has been shown to be
`Endovascular
`repair
`feasible and the medium term results appear accep-
`table and are at least
`to open repair
`with
`equivalent
`to
`and
`The
`mortality.
`delayed
`regard
`morbidity
`to distortion
`complications appear to be related
`mainly
`of the
`limbs. Further
`modifications of
`endograft
`design
`were
`the
`to
`Vanguard system
`strengthen
`implemented
`lessons have been learnt in
`the endolimbs.
`Important
`so
`relation to the
`of bifurcated
`endografts
`deployment
`as to reduce the incidence of
`limb related
`secondary
`outcomes remain to be
`The
`
`longer-term
`
`problems.
`observed.
`
`References
`
`RB Paropt JC, PALMAz JC, BARONE HD.Transfemoral intraluminal
`graft implantation for abdominal aortic aneurysms. Ann Vasc
`Surg 1991;5(6):491—499.
`2 Mrricu D, WricHt KC, WALLACE S, YosHIOKA T, LAWRENCEJr
`DD, CHARNSANGAVE] C, GIANTURCO C. Percutaneously placed
`endovascular grafts for aortic aneurysms: feasibility study.
`Radiology 1989;170(3 Pt 2):1033—1037.
`3 EVT Investigators, Endovascular Technologies Inc., MATSUMARA
`JS, Cuarxor EL. Continued expansion of aortic necks after
`Endovascular repair of abdominalaortic aneurysms. J Vasc Surg
`1998;28(3):422—430.
`DE Nrz AJ, BLANKENSTEIJN JD, BROEDERS I, MALI W,
`4 WEVERJJ,
`neckof infrarenalaortic
`ErxeLsoooB.Dilatation of the proximal
`aneurysmsafter endovascular repair. Eur J Vasc Endovasc Surg
`2000;19:197—201.
`5 Yusur SW, BAKER DM, HIND RE, CHuTER TA, WHITAKER SC,
`WENHAM PW, GrEGSON RH, Hopxinson BR. Endoluminal
`transfemoral abdominalaortic aneurysm repair with aorto-uni-
`Br J Surg 1995;82(7):916.
`iliac graft and femorofemoral bypass.
`6 MIALHE C, AMICABILE C, BECQUEMINJP. Endovascular treatment
`of infrarenal abdominalaortic aneurysmsby the stentor system:
`preliminary results of 79 cases. J Vasc Surg 1997;26:199—209.
`7 QUINONONES-BALDRICH WJ, DEATON DH, MITCHELL RS etal.
`Preliminary experience with the endovascular technologies
`in a calf model. J Vasc
`bifurcated endovascularaortic prosthesis
`Surg 1995;22:370-381.
`8 GuIDOIN R, Marots Y, DouvILlE Y, KiInc MW, Castoncuay M,
`TRAORE A, Formicut M, STAxruD LE, NorGREN L, BERGERON P,
`BEQUEMIN JP, Ecana JM, Harris PL. First generation aortic
`endografts: analysis of explanted Stentor devices from the
`EUROSTARRegistry. J Endovasc Ther 2000;7(2):105—122.
`9 Rreve G, HEtntz C, CHAFKE N, Mortock M, Gross-FENGELS W,
`in
`Imic H. Stent wire fractures and mesh loosening
`explanted
`endovascular prosthesis. Zentralbl Chir 2000;125(1):22—26.
`10 Medical Device Agency Safety Notice. SN 1999 (03) Vanguard
`endovascularaortic graft: late complications: February; 1999.
`11 BECQUEMIN J-P, LarteV, Favre J-P, Rousseau H. Mid-term results
`of a second generation bifurcated endovascular graft for
`
`Eur J Vasc Endovasc Surg Vol 27, March 2004
`
`

`

`318
`
`S. J. Holtham etal.
`
`abdominal aortic aneurysm repair: the French Vanguard Trial.
`J Vasc Surg 1999;30(2).
`12 Scuurink G, Aarts N, vAN BockJ. Endoleak after stent-graft
`treatment of abdominal aortic aneurysm: a
`meta-analysis of
`clinical studies. Br J Surg 1999;86(5):581—587.
`13 Lacuat M, PFAMMATTER T, SCHNEIDER D, SCHMIDLIJ, HILFIKER
`P, KoprENsTEINER R, Voct PR, Turtna M. Endovascular
`treatment of the abdominal aortic aneurysm: assessment,
`implantation technique, after-care and results. Schweiz Med
`Wochenschr 1999;129(4):113-119.
`14 BRENNANJ, Harris PL, GILLING-SMITH GL, BAKRANA.Vascular
`Surgical Society of Great Britain and Ireland: endovascular
`aneurysm repair: the need for randomized controlled trials. Br J
`Surg 1999;86(5):711.
`15 GouLp D, Epwarps R, McWILiiAMs R, ROwLANDsP, MARTIN J,
`Waite D, FEAR S, BAKRAN A, BRENNAN J, GILLING-SMITH G,
`Harris PL. Graft distortion after endovascular repair of
`abdominal aortic aneurysm: association with sac
`morphology
`and mid-term complications. Cardiovasc Intervent Radiol 2000;23:
`358-363.
`
`16 Harris P, BRENNANJ, MARTIN J, GOULD D, BAKRAN A, GILLING-
`SmitH G, Butu J, Gevers E, Wuite D.
`Longitudinal aneurysm
`a source of
`shrinkage following endovascular aortic repair:
`intermediate and late complications. J Endovasc Surg 1999;6(1):
`11-16.
`17 Harris PL. The highs and lows of endovascular aneurysm
`repair:the first two yearsof the Eurostar Registry. Ann R Coll Surg
`Engl 1999;81(3):161-165.
`18 Matsumura JS, Pearce WH.Pre-existing thrombus and aortic
`aneurysm size change after endovascular repair. J Surg Res 1999;
`81(1):11-14.
`19 Rugs RY, EskANpARI MK, Zayko AB, MAKAROUN MS. Long-term
`sac after endoluminal exclusion of
`fate of the aneurysmal
`abdominalaortic aneurysms. J Vasc Surg 2000;32(4):689-696.
`20 Resco T,
`IvANcEV K, BRUNKWALL J, NrrHov N, MALINA M,
`LrnpBALD B. Midterm changes
`in aortic aneurysm morphology
`after endovascular repair. J Endovasc Ther 2000;7(4):279-285.
`
`Accepted 4 December 2003
`
`Eur J Vasc Endovasc Surg Vol 27, March 2004
`
`