J CARDIOVASC SURG 2009;50:159-64
`
`Results of endovascular abdominal aortic aneurysm repair
`with selective use of the Gore Excluder
`
`W. T. G. J. BOS 1, I. F. J. TIELLIU 1, J. J. A. M. VAN DEN DUNGEN 1, C. J. ZEEBREGTS 1,
`A. 0. SONDAKH 1, T. R. PRINS 2, E. L. G. VERHOEVEN 1
`
`Aim. To evaluate single center results with selective
`use of the Gore Excluder stent-graft for elective abdo(cid:173)
`minal aortic aneurysm repair.
`Methods. Retrospective analysis of a prospective data
`base. Primary endpoints were technical success, all(cid:173)
`cause and aneurysm-related mortality and aneury(cid:173)
`sm rupture. Secondary endpoints were late compli(cid:173)
`cations including migration, endoleak, aneurysm
`growth, limb occlusion, and re-intervention.
`Results. The Gore Excluder stent-graft was used in
`92 elective cases, mainly in cases with difficult iliac
`anatomy. There were 81 (88%) male patients. Mean
`age was 70.4±7.5 (range, 53-87). Primary assisted
`technical success rate was 98.9% (91/92 patients).
`Thirty-day mortality was 0%. Median follow-up was
`35-7 months (range, 2-99). Overall survival was
`95.2±2.4% at 1 year, 89.2±3.7% at 2 years, 83.9±4.5%
`at 3 years and 70.2±6.8% at 5 years. During follow-up
`there were 3 (3.3%) Type I endoleaks and 20 (21. 7%)
`Type II endoleaks. Proximal migration of more than
`5 mm without endoleak occurred in two patients. In
`total 13 re-interventions were performed in 12 (13%)
`patients. No graft limb occlusion occurred. No aneury(cid:173)
`sm ruptured during follow-up.
`Couclusio11. Selective use of the Gore Excluder demon(cid:173)
`strates excellent short- and long-term results. Despite
`being used in challenging iliac anatomy no graft
`limbs occluded.
`KEY WORDS: Aortic aneurysms, abdominal, surgery - Endo(cid:173)
`vascular surgical procedures - Stents.
`
`Endovascular aortic anernysm repair (EVAR) has
`
`become a valid alternative to open repair for
`
`COl{/lict of i11terest.-EV has received consulting fees and research
`funding from W.L. Gore & Associates and William Cook Europe.
`
`Corresponding author: E. L. G. Verhoeven, JVID, PhD, Department of
`Surgery, Division of Vascular Surgery, University i'vieclical Center
`Groningen, P.O. Box 30 001, 9700 RB Groningen, The Netherlands.
`E-mail: e.l.g.verhoeven@chir.urncg.nl
`
`1 Department of Surgery, Division of Vascular Surgery
`University Medical Center Groningen
`Groningen, The Netherlands
`2Department of Surgery, Division of Radiology
`University Medical Center Groningen
`Groningen, The Netherlands
`
`patients with suitable infrarenal abdominal aortic
`aneu1ysms (AAA). Two randomized t.Iials have demon(cid:173)
`strated the short-term benefits ofEVAR.1.2 In the mid(cid:173)
`term, these advantages are not sustained due to a
`higher complication rate and re-intervention rate,
`resulting in a lower efficiency of the procedure and
`additional costs-3- 4 However, EVAR outcomes are
`improving rapidly. Modern third generation devices,
`such as the Excluder (W.L. Gore & Associates, Flagstaff,
`AZ, USA), have demonstrated good short- and mid(cid:173)
`term results, with excellent track records of safety
`and efficacy.;-7 The number of late complications and
`reinte1ventions with these third generation devices
`has markedly diminished, roughly from 15% to 8%,
`therefore also reducing associated costs.s-10
`A comparison between third generation devices is
`difficult in view of the obvious clinical selection bias
`that applies for most large centres.6- 11 Indeed, differ(cid:173)
`ences in device design and introduction systems allow
`for tailor made graft selection according to the patients'
`specific anatomy.'• 12
`The aim of this study is to report a single centre
`experience in a te1tia1y centre with selective use of the
`Gore Excluder, and define the advantages of the
`device.
`
`Vol. 50 - No. 2
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`ENDOVASCULAR AAA REPAIR \VITH GORE EXCLUDER
`
`Materials and methods
`
`Device selection
`Availability of several commercial devices with dif(cid:173)
`ferent properties with regard to proximal fixation,
`deployment accuracy, graft flexibility, and size of
`introduction system enables to tailor the device selec(cid:173)
`tion according to each patient's anernysm anatomy.
`During the study period, from 1999 to 2008, three
`devices were mainly used. Zenith stem-grafts (Cook
`Inc., Bloomington, IN, USA) were mainly used for
`shott proximal necks in view of the suprarenal fi.Jrn(cid:173)
`tion of the bare stent with hooks and barbs. In addi(cid:173)
`tion, in view of the versatility of the Zenith Tri-Fab sys(cid:173)
`tem in which the length of both limbs can be chosen
`after insertion of the main body, the graft also became
`our first choice in aneurysms where accurate length
`measurement proved difficult (e.g. angulation or short
`common iliac arteries). Talent stem-grafts (Medtronic
`World Medical, Sunrise, FL, USA) were initially used
`for proximal necks with a large diameter, but this
`advantage was lost when the Zenith equally featured
`larger proximal diameter sizes. Excluder stent-grafts
`were preferred in patients with narrow and angulat(cid:173)
`ed iliac arteries because of flexible and thinner wall
`device limbs. In July 2004 the Excluder underwent
`an important modification with the introduction of a
`lower porosity graft material.13
`For completeness, we report that a number of
`patients were treated with a Zenith body in conjunc(cid:173)
`tion with one or two Excluder limbs, but these patients
`were excluded from the main analysis.
`
`Patients and procedures
`Between July 1999 and June 2008, a total of 448
`patients underwent elective EVAR for an AAA. Patients
`treated with the Gore Excluder graft were included in
`this study. Pre-operatively a multi-slice computed
`tomography (CT) scan was performed to evaluate the
`anatomy of the proximal and distal landing zones and
`the access through the femoral arteries. Only in select(cid:173)
`ed cases additional angiography was requested.
`Indications for surgery and device selection were eval(cid:173)
`uated by a team of senior staff members including
`an inteiventional radiologist.
`All procedures were performed in an operating
`theatre using a mobile image intensifier. Local anes(cid:173)
`thesia was used in 71 (77.2%), spinal anesthesia in
`15 (16.3%) and general anesthesia in 6 (6.5%) cases.
`
`Patients received antibiotic prophylaxis (cefazoline 1
`g) and heparin (5 000 IU) intravenously.
`
`Follow-up
`Multiplanar abdominal radiography was always
`done before discharge as a reference for comparison.
`At one month, a contrast-enhanced CT-scan was per(cid:173)
`formed. Routine follow-up thereafter consisted of
`duplex ultrasound scanning (DUS) and multiplanar
`abdominal radiography at six months, one year and
`annually thereafter. CT-scan (or angiography) was
`done on indication only (endoleak, growth of
`aneurysm, migration >5 mm, kinking). 10 All patients
`were treated with antiplatelet therapy, usually aspirin
`100 mg daily, after the procedure.
`
`Statistical analysis
`Data were collected prospectively but analysed in
`a retrospective manner with SPSS 15.0 (SPSS, Chicago,
`IL, USA). Definitions and endpoints were used accord(cid:173)
`ing to the reporting standards for EVAR.14 Primary
`endpoints were technical success, all-cause and
`aneu1ysm related mortality and aneurysm rupture.
`Secondary endpoints were late complications includ(cid:173)
`ing migration (>5 mm), endoleak, aneurysm sac diam(cid:173)
`eter growth >5 mm, limb occlusion, and re-inteiven(cid:173)
`tion.
`Primary technical success was defined as a suc(cid:173)
`cessful introduction and deployment of the device in
`the absence of conversion or imraoperative mortali(cid:173)
`ty, Type I or III endoleaks or graft limb occlusion.
`When unplanned procedures were necessitated dur(cid:173)
`ing the procedure or within 24 hours, the term assist(cid:173)
`ed primary technical success, was used. Aneurysm
`related mortality was defined as death resulting from
`aneurysm rupture (as proven by autopsy, surgery or
`CT-scan) or any death occurring within 30 days after
`the original procedure or a re-intetvemion. In case
`an autopsy was not available, death was classified as
`probably unrelated if the clinical picture was consis(cid:173)
`tent and documented with reliable obseivations dur(cid:173)
`ing the terminal illness. When these criteria could not
`be met, the cause of death was considered indeter(cid:173)
`minate. Re-inteivention was defined as any endovas(cid:173)
`cular or open surgical inteivention performed after
`the initial EVAR in order to maintain or restore the
`function of the endograft. Variables were expressed as
`mean±standard deviation or median (range) by
`
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`ENDOVASCULAR AAA REPAIR \VITI·! GORE EXCLUDER
`
`BOS
`
`skewed data. Nominal variables were compared by
`Fisher exact test. Continuous variables were analyzed
`using Mann-Whitney U test. P values of 0.05 or less
`were considered statistically significant. Time-to-event
`variables were studied with Kaplan-Meier survival
`analysis.
`
`Results
`The Gore Excluder stent-graft was used in 92/ 448
`(21%) elective cases. The original permeability (OP)
`graft was used in 54 patients, and the low perme(cid:173)
`ability (LP) graft in 38 patients. There were 81 (88%)
`male and 11 (12%) female patients. Mean age was
`70.4±7.5 (range 53-87). In an additional 29 (6.5%)
`patients Excluder limbs were used in conjunction with
`a Zenith body, but these are not included in this analy(cid:173)
`sis.
`Mean diameter of the aneurysm sac was 58.8±8.9
`mm (range 48-90 mm). The mean aortic neck diam(cid:173)
`eter was 23.6±1.8 mm. In twelve patients, one com(cid:173)
`mon iliac artery was too large for sealing, which
`required sealing into the external iliac artery in con(cid:173)
`junction with embolization of the internal iliac artery.
`The mean proximal neck length was 33.2±10 mm
`(range 15-80 mm). Only one patient had a neck length
`shorter than 20 mm, and in five patients the neck
`length equalled 20 mm.
`Primary technical success rate was 97 .8% (90/92
`patients), with a primary assisted technical success
`rate of 98.9% (91/92). One patient had a Type I
`encloleak at completion angiography which was suc(cid:173)
`cessfully corrected with a proximal extension. In the
`second patient, a proximal Type I encloleak was re-bal(cid:173)
`looned but still showed a small proximal encloleak,
`which was accepted in a 50 mm long neck. This
`encloleak disappeared within one month. At one year
`follow-up there were no complications in this patient.
`Thirty clay mortality was 0%. According to reporting
`standards for EVAR, there were four moderate and
`seven mild surgical complications in 10 (10.8%)
`patients. 14 One patient required re-inte1vention with(cid:173)
`in the hospital stay. First, he had a re-exploration of
`a large groin hematoma a few hours after the proce(cid:173)
`dure. Second, one clay later, the abdominal X-ray
`revealed a rather short sealing length in the left com(cid:173)
`mon iliac arte1y. This was corrected with a limb exten(cid:173)
`sion.
`Median follow-up was 35.7 months (range 2-99).
`Four patients were lost to follow-up between 12 and
`
`46 months, clue to progress of co-morbidity disease
`and advanced age. During follow-up, 20 (21.7%)
`patients died between 5 and 79 months (median 32
`months). In 14 patients, death was classified as prob(cid:173)
`ably unrelated in view of consistent clinical findings:
`malignancy (7), cardiac (2), pulmonary disease (2),
`bleeding gastric ulcer (1), type B dissection (1) and
`dehydration with renal insufficiency clue to gas(cid:173)
`troenteritis (1). In six patients death was classified as
`indeterminate anemysm related. No patient ruptured
`during follow-up. Overall survival was 95.2±2.4% at 1
`year, 89.2±3.7% at 2 years, 83.9±4.5% at 3 years and
`70.2±6.8% at 5 years (Figure 1).
`
`Endoleak, aneurysm sac growth, device migration,
`graft limb occlusion and re-intervention
`Encloleaks were observed in 23 (25%) patients.
`There were three (3.3%) Type I encloleaks. A proxi(cid:173)
`mal Type I encloleak occurred in two patients. In the
`first patient, as discussed before, a proximal cuff was
`used intra-operatively to correct an encloleak in a 25
`mm long, but severely angulatecl neck (80 degrees).
`Although initially successful, a new encloleak occurred
`after six months. This was corrected with a second
`cuff. At last follow-up (six months after the reinter(cid:173)
`vention) there was no sign of an encloleak or migra(cid:173)
`tion. In the second patient, the graft migrated during
`follow-up clue to extension of disease of the proximal
`aorta. Due to the short working length and the small
`renal arteries, a fenestratecl cuff was not considered,
`and conversion
`to open repair undertaken.
`Postoperative recove1y in this patient was uneventful.
`
`[
`-,;
`> -~
`"
`~ -~
`3
`E
`0 u
`
`100
`90
`80
`70
`60
`50
`40
`30
`20
`10
`0
`0
`
`Number at risk:
`11
`16
`84 74 61
`54 49 44 39 20 35 28 23 20
`6
`12 18 24 30 36 42 48 54 60 66 72 78
`Follow-up time (months)
`
`Figure 1.-0verall survival.
`
`Vol. 50 - No. 2
`
`THE JOURNAL OF CARDIOVASCULAR SURGERY
`
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`ENDOVASCULAR AAA REPAIR WITH GORE EXCLUDER
`
`Figure 2.-A)First post-operative er-scan (6 weeks), showing a folding of the proximal graft material. B) Plain abdominal X-ray after place(cid:173)
`ment of the Palmaz-stent. C) CT-scan after placement of the Palmaz-stent.
`
`100
`90
`80
`
`V
`
`t
`" 70
`>
`E 60
`a
`50
`> .E
`40
`"5
`30
`E
`" u
`20
`10
`0
`0
`
`I
`
`Number at risk:
`10
`14
`17
`26 22
`32
`36
`40
`45
`50
`81
`72
`57
`6
`12 18 24 30 36 42 48 54 60 66 72 78
`Follow-up time (months)
`
`Figure 3.-Cumulative intervenlion free survival.
`
`The third patient had a distal Type I endoleak, which
`was successfully treated with an endovascular exten(cid:173)
`sion.
`Type II endoleaks were diagnosed in 20 (21.7%)
`patients. In 13 (65%) patients spontaneous resolution
`occurred, mainly during the first six months. In five
`patients the endoleak persisted but no treatment was
`initiated because of absence of anemysm sac growth.
`In two patients, the Type II endoleak resulted in
`aneu1ysm sac growth. In the first case a coil-emboliza(cid:173)
`tion of a patent inferior mesenteric arte1y (I!v!A) was
`performed which resulted in endoleak-free anemysm
`sac shrinkage. In the second case embolization of
`IlvIA and lumbar arteries was unsuccessful. Finally, it
`was decided to perform a laparotomy in order to clip
`both the Ilv!A and lumbar arteries.
`Aneu1ysm sac growth without evidence of endoleak
`
`was seen in one (2.6%) patient in the LP group versus
`four (7.4%) patients in the OP group (P=0.4). In two
`patients with an OP Excluder relining of the prosthe(cid:173)
`sis was performed which resulted in anemysm sac
`shrinkage in both cases. 13 Overall, n1ean AAA sac
`diameter in the OP group decreased from 58.2±9.2 nm1
`to 54.7±13.6 mm versus 59.6±8.6 mm to 48.9±12.1
`mm in the LP group, respectively (P=0.005).
`Proximal migration of more than 5 mm without
`endoleak occurred in two patients. In the first patient
`this was treated with a proximal cuff. No fu1ther migra(cid:173)
`tion occurred in this patient over his four years follow(cid:173)
`up. The second patient was left untreated in view of
`a long (35 mm) proximal neck. No additional migra(cid:173)
`tion occurred in this patient during fmther follow-up.
`None of the patients experienced graft limb occlu(cid:173)
`sion.
`Re-interventions were performed in 12 (13%)
`patients. In addition to the above mentioned nine
`patients, inte1ventions were performed in three more
`patients. In the first patient, a Palmaz stent had to be
`positioned to correct a folding in the graft (Figure 2).
`In the second patient the proximal sealing zone was
`thought to be insufficient on the first post-operative
`CT-scan. This was corrected with a cuff. The third
`patient had extension of disease distally, which was
`diagnosed at eight years follow-up. A conversion to
`open repair was decided in order to prese1ve his last
`patent IIA because endovascular options (e.g. iliac
`branched device) were regarded impossible. Details
`of all re-interventions are shown in Table I. The cumu(cid:173)
`lative intervention-free smvival is shown in Figure 3.
`
`162
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`Tl·IEJOUR.1'\1AL OF CARDIOVASCULAR SURGERY
`
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`

`ENDOVASCULAR AAA REPAIR \XTITH GORE EXCLUDER
`
`BOS
`
`TABLE !.-Details of all re-interoentions.
`
`Type graft
`(OP/LP)
`
`Indication for primary re-intervention
`
`Procedure
`
`Interval (m)
`
`LP
`OP
`OP
`LP
`OP
`OP
`OP
`
`OP
`OP
`OP
`OP
`
`OP
`
`Hematoma groin
`Short proximal sealing
`Folding of the proximal stenrgraft
`Proximal type I endoleak
`Type II endoleak
`Proximal migration
`Type II endoleak
`
`Distal type I endoleak
`Endotension
`Endotension
`Extension disease with proximal
`type I endoleak
`Extension disease distally
`
`Re-exploration groin
`Proximal aortic cuff
`Balloon-expandable stent
`Proximal aortic cuff
`Coil embolization IMA
`Proximal aortic cuff
`Laparotomb, suture ligation IMA
`and !um ar branch
`Extension limb
`Relining
`Relining
`Laparotomy, conversion
`to bifurcated graft
`Laparotomy, conversion to bifurcated graft
`
`0
`2
`4
`9
`13
`22
`65
`
`65
`66
`74
`95
`
`96
`
`I.MA: inferior mesenteric artery.
`
`Secondary
`re-intervention
`
`Extension limb
`
`Discussion
`
`This study shows that the use of the Excluder endo(cid:173)
`graft in selected patients appears to be safe, with a pri(cid:173)
`mary assisted technical success rate of 98.9% and no
`surgical mortality. The Excluder is mounted on a
`catheter, in contrast to most other devices that are
`preloaded into an introduction system. The catheter
`can be introduced through an 18 F sheath for the
`main graft, and a 12 F sheath for limbs up to 14.5
`mm in diameter. Therefore, the graft needs to be
`unpacked only if access proves possible. The finan(cid:173)
`cial risk in case of doubt over access is limited to the
`prize of a simple sheath. Deployment is simple and
`quick without risks, as demonstrated by a 100% suc(cid:173)
`cessful deployment and zero surgical mortality.
`The major advantage of the graft, however, lies in
`the limbs. The fabric of the limb is thinner than in
`most competitors and the limbs are very flexible, able
`to adapt to difficult iliac anatomy, as published by
`our group before.15 In this series, there were no limb
`occlusions, which is remarkable in view of the selec(cid:173)
`tion towards narrow and angulated iliac arteries. Limb
`occlusion rate in our Zenith series was 1. 7%, which
`compares well with other published Zenith series,
`and is probably due to our selection algorithm. 4, 10
`Indeed, Zeniths were mainly used in easier iliac anato(cid:173)
`my. In the 29 patients where we used a Zenith body
`(in view of a short neck) with one or two Excluder
`limbs (in view of difficult iliac anatomy), none of the
`41 Excluder limbs occluded either.
`
`The deployment of the main body, although easy
`and rapid, is not the most accurate, especially in
`angulated anatomy. This is the precise reason why
`we prefer not to select the graft in short-necked
`aneurysms (i.e. <20 mm). Other centres, however,
`have described the use of this asymmetrical deploy(cid:173)
`ment in angulated anatomy in order to gain an extra
`3-4 mm of proximal seal,16, 17 The use of cuffs can be
`needed, as demonstrated in our series. In our opin(cid:173)
`ion, the cuffs should be longer than the 3.3 cm they
`feature now. This would allow for a longer overlap
`with the main body. We are aware of efforts by the
`manufacturer to completely redesign the proximal
`deployment system: both repositionable proximal
`deployment systems and controlled orientation of
`the proximal sealing stent could greatly improve the
`device.
`Concerns about the Excluder have been expressed,
`as long term studies documented higher rates of
`absence of shrinkage and even sac enlargement, com(cid:173)
`pared to other endografts.13, 17, 18 Investigations sug(cid:173)
`gested graft porosity as a possible cause. Therefore,
`in 2004, the graft material of the Excluder was modi(cid:173)
`fied in order to reduce its permeability. In our study,
`shrinkage of the aneurysm sac was significantly greater
`in tl1e LP device compared to the OP device (P-0.005).
`Aneurysm rupture, especially without endoleak, was
`not seen in our series, but has been reported in the lit(cid:173)
`erature.19 In accordance to other studies, we have
`successfully relined two patients who were initially
`treated with an OP device.13, 11, 18
`
`Vol. 50- No. 2
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`IBEJOURNAL OF CARDIOVASCULAR SURGERY
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`ENDOVASCULAR AAA REPAIR WITH GORE EXCLUDER
`
`Limitations qf the study
`As already acknowledged, this study has limita(cid:173)
`tions due to the inherent clinical selection bias, and
`results should be interpreted with caution. The fact
`that we used the Excluder only in fairly long neck
`lengths could explain the low occurrence of prox(cid:173)
`imal migration. This limitation due to selection bias,
`however, is true for most literature on a specific
`device.s, io, 12
`
`Conclusions
`
`In conclusion, selective use of the Gore Excluder
`presents with excellent sho1t- and longer-term results.
`The device is safe and easy to use. Although the prox(cid:173)
`imal deployment could do with a higher degree of
`accuracy or even be repositionable, the limbs per(cid:173)
`form exceptionally well, even in challenging iliac
`anatomy!
`
`References
`
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`Balm R et al. A randomized trial comparing conventional and
`endovascular repair of abdominal aortic aneurysms. N Engl J Med
`2004;351'1607-18.
`2. Greenhalgh RivI, Brown LC, Kwong GP, Powe!IJT, Thompson SG.
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`2004;28:357-64.
`12. Faries PL, Dayal R, Lin S, Trociolla S, Rhee], Craig KK. Endovascular
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