Fenestrated endovascular aneurysm repair

Systematic review

Fenestrated endovascular aneurysm repair

J. Cross1, K. Gurusamy2, V. Gadhvi1, D. Simring1, P. Harris1, K. Ivancev1 and T. Richards1

1Multidisciplinary Endovascular Team, University College Hospital, and 2Department of Surgery, University College London, London, UKCorrespondence to: Miss J. Cross, Multidisciplinary Endovascular Team, University College London Hospitals, 235 Euston Road, London NW1 2BU, UK(e-mail: [email protected])

Background: Fenestrated endovascular aneurysm repair (FEVAR) is a technically challenging operation.The duration, blood loss, and risk of limb ischaemia, contrast-induced nephropathy and reperfusioninjury are likely to be higher than after standard endovascular aneurysm repair (EVAR). Benefits ofFEVAR over open repair may be less than those seen with standard infrarenal EVAR. This paper is ameta-analysis of observational studies of all published data for FEVAR, with the aim to highlight currentissues around the evidence for the potential benefit of FEVAR.Methods: A search was performed for studies describing FEVAR for juxtarenal abdominal aorticaneurysms. Small series of fewer than ten procedures and studies describing predominantly branchedendografts or FEVAR for aortic dissection were excluded. Authors of included papers were contacted toeliminate patient duplication.Results: Eleven studies were identified describing a total of 660 procedures. Definitions of aneurysmmorphology were variable, and clear inclusion and exclusion criteria were not always documented. Doublefenestrations were more common than triple or quadruple fenestrations. Target vessel perfusion ratesranged from 90·5 to 100 per cent. Eleven deaths occurred within 30 days, giving a 30-day proportionalmortality rate of 2·0 per cent. Morbidity was poorly reported.Conclusion: FEVAR for repair of suprarenal and juxtarenal aneurysms is a viable alternative to openrepair. However, there is no level 1 evidence for FEVAR, and current evidence is weak with manyunanswered questions.

Paper accepted 17 October 2011Published online 19 December 2011 in Wiley Online Library (www.bjs.co.uk). DOI: 10.1002/bjs.7804

Introduction

Endovascular aneurysm repair (EVAR) is an establishedalternative to open surgery for the management ofabdominal aortic aneurysm (AAA)1–3. EVAR confersreduced postoperative complications and blood transfusionrequirements, and shorter intensive care unit (ICU)and in-hospital stay2. Commercially available devicesare limited in application by anatomical morphologyof the AAA, in particular the infrarenal landing zone.Guidelines for the length of normal aorta below the renalarteries suggest a minimum of 15 mm, with angulationof less than 60°. Newer stent-grafts have marginallyextended these indications: neck length greater than10 mm when straight, or angulation of less than 90°

where neck length is more than 20 mm. Use of standardEVAR outside these parameters has been advocated4,5,although long-term reintervention rates are likely to behigher4. Currently, 25–75 per cent of all AAAs remain

unsuitable for standard EVAR6,7. In patients anatomicallyunsuitable for infrarenal EVAR, options include openrepair, conservative management or complex endograftrepair. The latter refers to branched and fenestratedendovascular aneurysm repair (FEVAR)8.

FEVAR (Fig. 1), first described in 19969, uses fenestra-tions (holes) in the graft or scallops (gaps in the uppergraft fabric margin) to access visceral arteries (Fig. 2). Thisallows the graft sealing zone to be extended to an adequate,more proximal, landing zone incorporating the visceral ves-sels. Fenestrations are cannulated and sealed with a coveredstent into the visceral vessels (Fig. 3). Each stent is custom-made for the individual patient based on measurementsfrom computed tomography angiography. Fenestrationsare reinforced with a nitinol ring, and radio-opaque mark-ers allow visualization at fluoroscopy. The design of thesegrafts is evolving and newer techniques include the use ofpreloaded cannulating wires, double reducing ties and anenlarged proximal scallop.

2011 British Journal of Surgery Society Ltd British Journal of Surgery 2012; 99: 152–159Published by John Wiley & Sons Ltd

Fenestrated endovascular aneurysm repair 153

a Juxtarenal aneurysm

b Aneurysm after FEVAR

Fig. 1 a Reconstruction of computed tomography angiogramshowing a juxtarenal aneurysm. b Aneurysm after fenestratedendovascular aneurysm repair (FEVAR)

Cannulation of the visceral vessels is technicallychallenging and the length of the procedure is often muchlonger than for standard EVAR. Subsequently blood loss,limb ischaemia, renal dysfunction10 and reperfusion injuryare likely to be higher with FEVAR than with standardEVAR. It can therefore be argued that the benefits ofFEVAR over open repair may be less than those seen withstandard infrarenal EVAR.

Fig. 2 Endograft with fenestration shown for a renal artery(arrowhead) and scallop for the superior mesenteric artery(arrow)

There is currently no level 1 evidence for the useof FEVAR. Evidence is of poor quality, relying onlyon published case series. Previous reviews of FEVARhave been published. Nordon and colleagues11 comparedFEVAR (8 studies with a total of 368 patients) with openrepair (12 studies with a total of 1164 patients) for juxtarenalAAA. They found the 30-day mortality rate to be lowerafter FEVAR (1·4 versus 3·6 per cent). A further analysisby the Ontario Medical Advisory Secretariat12 comparedfive FEVAR studies with seven open repair studies andfound a 1·8 per cent versus 3·1 per cent 30-day mortalityrate, and a 12·8 per cent versus 23·7 per cent late mortalityrate, in favour of FEVAR. However, these studies werepotentially flawed, with inaccurate statistical methods andpossible duplication of patient data owing to overlappingcohort studies. Further case series have been publishedsince these reviews were written.

In the present paper, a Meta-analysis of ObservationalStudies in Epidemiology (MOOSE) was carried out on allpublished data for FEVAR, with the aim of highlightingcurrent issues.

2011 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2012; 99: 152–159Published by John Wiley & Sons Ltd

154 J. Cross, K. Gurusamy, V. Gadhvi, D. Simring, P. Harris, K. Ivancev and T. Richards

Fig. 3 Insertion of the fenestrated graft showing cannulation andbridging stents to the renal arteries

Methods

A computer-assisted search was performed (from January2000 to Oct 2011) of the medical databases MED-LINE, Embase, Science Citation Index and the Cochranedatabase of systematic reviews, using the keywords ‘fen-estrated endovascular stent graft’, ‘fenestrated endovascu-lar aneurysm repair’, and ‘juxta-renal abdominal aorticaneurysm’. An additional search was performed usinga combination of the following Medical Subject Head-ing (MeSH) terms: juxtarenal aortic surgery, fenestratedaneurysm repair, fenestrated stent grafts, type 4 thora-coabdominal aortic surgery, thoracoabdominal aneurysms.After identifying relevant titles, abstracts of these stud-ies were read by two of the authors. Abstracts of articlesprinted in languages other than English were translatedusing ‘Google translate’ and, if suitable, underwent a moreaccurate formal translation of the full paper.

Clinical studies eligible for inclusion were those thatdescribed use of fenestrated endovascular stent-graft tech-nology for juxtarenal aortic aneurysms. Eligible articlesdescribed original patient series with information onoperative technique, procedure duration, hospital stay,mortality, complications, conversions and follow-up out-comes. Small series of fewer than ten procedures andstudies describing the use of predominantly branched

Articlesidentified usingsearch terms

n = 276

Articlesincludedn = 26

Articles rejected asnot relevant, orexcluded underexclusion criterian = 250

Articlesincludedn = 11

Articles excludedas duplicate data

n = 15

Fig. 4 Literature search

endovascular stent-graft technology or use of fenes-trated technology in aortic dissections were excluded.Authors of the included papers were contacted andreplicate data from overlapping cohort studies wereexcluded. Outcomes assessed were intraoperative com-plications, target vessel patency, mortality, morbidityand late outcomes. Outcomes were analysed using ameta-analysis of proportion calculation (StatsDirect sta-tistical software, version 1.0; StatsDirect, Altrincham,UK).

Results

Eleven studies were identified that met the inclusioncriteria (Table 1). The flow diagram for included andexcluded studies is shown in Fig. 4.

Patient factors

A total of 660 patients were included (582 men). Althoughthe ages were similar (Table 1), reports included bothmeans and medians. Nine papers reported informationon patient co-morbidities and all nine specified coronaryartery disease, giving a pooled proportion of 52·5(95 per cent confidence interval (c.i.) 48·4 to 56·4) percent with coronary artery disease. A pooled proportionof 73·0 (69·3 to 76·5) per cent had hypertension,39·7 (35·8 to 43·7) per cent had chronic obstructivepulmonary disease, and 17·2 (14·8 to 20·4) per centhad diabetes. Although data were given on preoperativerenal function, comparison was difficult as definitions



Table 1 Demographics of 660 patients undergoing fenestrated endovascular aneurysm repair

Reference Year CountrySingle or

multi-centreNo. of

patientsAge

(years)Aneurysmdiameter

Verhoeven et al.13 2010 The Netherlands Single 100 (87) Mean 72.6 Median 60 mmSemmens et al.14 2006 Australia Multi 58 (51) Mean 75.5 NDAnderson et al.15 2001 Australia Single 13 (10) Mean 74 Mean 6.5 cmAmiot et al.16 2010 France Multi 134 (129) Median 73 Median 56 mmKristmundsson et al.17 2009 Sweden Single 54 (46) Median 72 Median 60 mmO’Neill et al.18 2006 USA Single 119 (98) Mean 75 Mean 65 mmZiegler et al.19 2007 Germany Single 63 (57) Mean 70.5 Mean 55.1 mmScurr et al.20 2008 UK Single 45 (41) Median 73 Median 68 mmBicknell et al.21 2009 UK Single 15 (12) Mean 70 Median 64 mmGreenberg et al.22 2009 USA Multi 30 (24) Mean 75 Mean 61.4 mmTambyraja et al.23 2011 UK Single 29 (27) Median 74 Mean 68 mm

Values in parentheses are numbers of men. ND, not documented.

Table 2 Total number of fenestrations and scallops in 660 fenestrated endovascular aneurysm repairs

Right renal arterySuperior

mesenteric arteryCoeliacartery

Reference S F S F S F Combined total

Verhoeven et al.13 27 165 74 4 5 0 106S, 169FSemmens et al.14 25 66 21 3 0 1 46S, 70FAnderson et al.15 0 24 0 9 ND ND 33FAmiot et al.16 ND ND ND ND ND ND 133S, 269FKristmundsson et al.17 ND ND ND ND ND ND 133S, 91FO’Neill et al.18 231 combined S and F 76 combined S and F 0 1 308Ziegler et al.19 24 64 10 12 7 2 41S, 78FScurr et al.20 10 68 28 7 1 1 39S, 76FBicknell et al.21 1 29 5 8 4 1 10S, 38FGreenberg et al.22 10 47 20 0 0 0 30S, 47FTambyraja et al.23 4 48 23 2 0 2 27S, 52F

S, scallops; F, fenestrations; ND, not documented.

of renal impairment varied (definitions used includedcreatinine level above 100, 105 and 120 µmol/l, estimatedglomerular filtration rate below 60 ml/min and serumcreatinine level greater than 2·0 mg/dl). Only one paperreported that 87 per cent of the patients were taking astatin, and none documented antiplatelet, beta-blocker orangiotensin-converting enzyme inhibitor use. Five papersdocumented smoking status, giving a pooled proportionof 64·3 (95 per cent c.i. 59·4 to 69·1) per cent of patientswith a smoking history. Previous major abdominal surgerywas reported in five papers, with a pooled proportionof 34·6 (23·0 to 39·5) per cent having previously had alaparotomy and 21 patients previous open AAA repair.American Society of Anesthesiologists (ASA) grade waspoorly reported and groups were often combined, makingit difficult to extrapolate exact numbers. ASA grade III wasthe modal grade. No papers reported other preoperativescoring systems.

Anatomical factors

Definitions of aneurysm morphology were variable, andclear inclusion and exclusion criteria were not alwaysdocumented. Twenty AAAs were defined as Crawfordtype IV, 165 as short neck, 228 as juxtarenal and 27 assuprarenal. There was some variation in the diameter ofaneurysm treated, and reports of both means and mediansprecluded statistical comparison (Table 1).

Procedure details

Five papers commented on anaesthesia. There was somevariation, presumably owing to unit policies. In France theprocedure was carried out under general anaesthetic (GA)in 96·3 per cent of patients16, whereas in the USA only18·4 per cent of patients had a GA and 81·5 per cent hadthe procedure done under regional blockade18. No recordwas made of anaesthetic monitoring.



Femoral access was documented in three papers: 77patients had an open femoral cut-down and 35 a successfulpercutaneous approach. A planned ilial conduit was usedin seven patients. The number of fenestrations is shownin Table 2. Although the breakdown was not available inall papers, grafts with double fenestrations (one for eachrenal artery) were used more commonly than those with atriple fenestration (fenestrations for both renal arteries andthe superior mesenteric artery). Interestingly, the ratio ofdouble to triple fenestrations varied: one centre performedmore than half of FEVARs as triple fenestrations whereasanother used only triple fenestrations for 4 per cent of pro-cedures. A quadruple fenestration graft was reported foronly seven grafts.

The procedure duration was reported using both meansand medians, and ranged from 180 to 375 min. Fluoroscopytime ranged from 26 to 111 min and was proportional tothe operating time.

Target vessel cannulation was reported in seven papers,with failure of target vessel cannulation in 21 vessels. Therewere five reports of arterial perforation (1 requiring conver-sion to laparotomy), four intraoperative stent occlusions,three arterial dissections and one stent dislocation. Therewere three reports of intraoperative kidney loss, and six seg-mental renal infarcts were shown but none developed renalimpairment (definition varied, but was most commonlydefined as a postoperative rise in serum creatinine levelmore than 30 per cent over baseline). Overall target vesselperfusion rates ranged from 90·5 to 100 per cent (Fig. 5shows endoleaks reported on completion imaging). Sixty-seven additional intraoperative procedures were reportedincluding Palmaz stent, extension grafts, junctional stentsand covered stent placement.

Other reported immediate complications included threereports of leg ischaemia, one requiring a femorofemoral

0

5

10

15

No.

of e

ndol

eaks

20

25

30

35

At intraoperativecompletion angiography

Early Late

Type 1Type 2Type 3

Fig. 5 Total number of reported type 1–3 endoleaks afterfenestrated endovascular aneurysm repair

Table 3 Deaths within 30 days of fenestrated endovascularaneurysm repair

Patient Details

1 Co-morbidities included an ejection fraction of 23%; nointraoperative difficulties; readmitted on day 6; died fromcolonic ischaemia; autopsy showed a patent SMA

2 Sudden death from MI/pulmonary embolus3 Co-morbidities included aortic valve stenosis and chronic

renal failure; patient underwent prolonged procedure; diedfrom MI and subsequent MOF

4 Large-vessel blood loss following iliac rupture; developedsubsequent MOF

5 Died following pulmonary oedema6 Large-vessel blood loss following iliac rupture; developed

subsequent MOF7 Bowel ischaemia secondary to mesenteric embolization8 Uncontrollable retroperitoneal bleed9 Known COPD; aspirated and developed subsequent sepsis

and MOF10 Mesenteric ischaemia11 MI

SMA, superior mesenteric artery; MI, myocardial infarction; MOF,multiorgan failure; COPD, chronic obstructive pulmonary disease.

Table 4 Definition of juxtarenal aneurysm used by clinicians whoemployed fenestrated endovascular aneurysm repair

Reference Definition

Ziegler et al.19 Inadequate proximal sealing zoneVerhoeven et al.13 Short neck: 4–12 mm below RA

Juxtarenal: neck < 4 mm below RAScurr et al.20 Juxtarenal: infrarenal neck < 10 mmBicknell et al.21 Juxtarenal: 4 mm or less below RAKristmundsson et al.17 Neck < 8 mmAmiot et al.16 Short neck: < 10 mm

Juxtarenal: short neck extending tobut not involving RA

O’Neill et al.18 Compromised proximal neck anatomyGreenberg et al.22 Proximal neck 4–15 mm in lengthSemmens et al.14 Juxtarenal not definedTambyraja et al.23 Neck too short for standard EVAR

RA, renal artery; EVAR, endovascular aneurysm repair.

crossover graft following iliac limb occlusion secondaryto graft malplacement, and two requiring a femoralembolectomy. One patient required fasciotomies, andanother developed skin necrosis of the buttocks and legweakness following overstenting of the internal iliac artery.There were six reports of external iliac artery rupture.Blood loss was reported in only four papers, with meanlosses of 739 and 601 ml and two median losses of 200and 600 ml. Four procedures were converted to openoperations during surgery.



Verhoeven et al.13

Semmens et al.14

Anderson et al.15

Amiot et al.16

Kristmundsson et al.17

O'Neill et al.18

Ziegler et al.19

Scurr et al.20

Bicknell et al.21

Greenberg et al.22

Tambyraja et al.23

Combined

0 0·1

Proportion

0·2 0·3

0·010 (0·000, 0·055)

0·035 (0·004, 0·119)

0·000 (0·000, 0·247)

0·022 (0·005, 0·064)

0·019 (0·001, 0·099)

0·008 (0·000, 0·046)

0·016 (0·000, 0·085)

0·022 (0·001, 0·118)

0·000 (0·000, 0·218)

0·000 (0·000, 0·116)

0·000 (0·000, 0·119)

0·020 (0·011, 0·032)

Fig. 6 Meta-analysis of mortality after fenestrated endovascular aneurysm repair (fixed-effects plot). Proportions are shown with95 per cent confidence intervals

Morbidity and mortality

Morbidity was not reported in all series and was reportedselectively in others; it is likely to be underrepresented. Thecommonest perioperative morbidity was renal impairment(81 patients). Ten patients required early dialysis,eight permanently. Fifty-three patients remained withpermanent reduction in renal function. Fifteen patients hada cardiac event, and nine a respiratory event. There wereonly eight reported wound problems. Length of hospitalstay was reported in seven papers with a range of 3–9 days.

Eleven deaths occurred within 30 days, giving a 30-day pooled proportion mortality rate of 2·0 (95 per centc.i. 1·1 to 3·2) per cent (Fig. 6). Causes of death areshown in Table 3. During follow-up (mode 24 (range12–225) months) there were 92 deaths after 30 days. Ofthese, six were aneurysm-related deaths.

Reports of late morbidity included 54 late target vesselocclusions, ten stent fractures, nine cases of significant stentmigration and one distraction of the modular components.Fig. 5 shows the total number of reported endoleaks.Patient survival was not widely reported; Verhoeven andco-workers13 reported a survival rate of 90·3 per cent at1 year, 84·4 per cent at 2 years and 58·5 per cent at 5 years.

Discussion

This review suggests that FEVAR is a viable alternative toopen surgical repair for juxtarenal/short neck aneurysms.

In this review, the 30-day pooled proportional mortalityrate of 2·0 per cent compares favourably with that of opensurgical repair, which has reported 30-day mortality ratesof 2·5–5·8 per cent24,25.

A significant problem with current published case seriesof FEVAR is the differing definitions of juxtarenal/shortneck aneurysms. Previously, with open surgery, a juxtarenalaneurysm was defined as one in which the surgeon wasunable to place an infrarenal cross-clamp safely; commonlythis occurred when the infrarenal aortic neck was less than5 mm. It is not so clear with FEVAR and there is currentlyno universal classification system to allow accurateanatomical comparison. This has led to wide variationsbetween centres in the indications for use of fenestratedgrafts (Table 4). Although the data were pooled, it is notclear that aneurysms with the same anatomical parametersare being compared. True comparisons of FEVAR canbe made only with anatomical homogeneity. Recently,several classification systems have been proposed, includinga fenestration-based system and a sealing zone systemproposed by the present authors (unpublished results).

It is not possible to differentiate the outcome betweenpatients with double, triple and quadruple fenestrations inthese papers owing to data presentation. Increasing numberof fenestrations leads to longer procedures and a higher riskof cannulation failure or target vessel loss26. It is misrepre-sentative to group double, triple and quadruple fenestratedstents together. The difference in ratio between double and



triple fenestration grafts used between centres indicatesthat different units may have different planning policies.

FEVAR is a new technique with small numbersperformed worldwide each year. Each series had a relativelysmall number of patients. There is a learning curveassociated with the technique, and as larger numbersare performed results may improve. No series comparedthe early results from their series with the later results.The small numbers performed each year suggest thatthis intervention should be confined to specialist referralcentres that perform a minimum number each year.

Other than current anatomical licensing guidelines,there are currently no recommendations concerningpatient factors used to decide suitability for FEVAR. TheEVAR 2 trial27 showed no short-term survival benefit forEVAR in those deemed unfit for surgery, and this is likelyto be true also for FEVAR. However, selection criteriafor open repair of a juxtarenal/suprarenal aneurysm arerigorous, and a number of patients in the present serieswould not have been deemed suitable for open repair. Ifthe cohort of patients in this review has, in general, a worseco-morbid status than those undergoing open repair, thenthe results provide further support for an advantage forFEVAR. However, no series compared co-morbidities withpatient outcome, and the reporting of the co-morbiditiesin these series made a direct comparison impossible.

A good indication for FEVAR would be the presence ofa hostile abdomen (previous laparotomy), which was thecase for approximately one-third of patients in the presentseries. With increasing age, the prevalence of previousabdominal surgery increases, probably representing theelderly age group that is affected by aneurysms.

The number of perioperative cardiac and respiratoryevents appears to be much lower than expected for a majorprocedure. The level of detail in reporting complicationsvaried between papers and was probably underreported.However, eight patients (1·2 per cent) needed permanentrenal dialysis. This is likely to be multifactorial – a com-bination of contrast-induced nephropathy, intraoperativehypotension and microemboli following manipulation ofthe renal arteries. Although some papers recorded the vol-ume of contrast used, reporting methods precluded relatingcontrast volumes to postoperative renal function, and it isalso unclear whether renal stent problems occurred in thisdialysis group. Details of intraoperative blood loss and pro-cedure duration were given; however, it was not possibleto relate these to outcome.

In the UK, the Small Aneurysm Trial28 has led to analmost universal of adoption of 5·5 cm as the interventionsize. In this review, one series had a mean AAA diameterof 5·51 cm and another a median diameter of 5·6 cm.

It is not clear whether diameters were assessed usingultrasonography or computed tomography. This indicatesthat a number of procedures were done for aneurysmswith a diameter of less than 5·5 cm. Potentially this mayaffect aneurysm morphology and ease of procedure; smallaneurysms may have less neck angulation or iliac tortuosity.However, the CAESAR trial29 failed to show an advantagefor early EVAR in small aneurysms.

A criticism of EVAR compared with open aneurysmrepair is the higher reintervention rate. Unfortunately, inmany papers reintervention was not clearly documented,making a true comparison with EVAR or open repairimpossible. It is not known whether FEVAR has a higherreintervention rate than EVAR; it may be that the additionof side branches makes FEVAR more stable. Comparisonwith open repair is also difficult as complications such asincisional hernia and small bowel obstruction are oftenunderreported following open surgery.

FEVAR is an expensive procedure owing to the unitprice of the graft, which is manufactured specifically toindividual patient anatomy. A formal cost–effectivenessanalysis is needed to compare costs with open repair;FEVAR is likely initially to be more expensive, but savingsmay be made in reduced ICU or hospital length of stay.Off-the-shelf FEVAR devices30, suitable for approximately80 per cent of patients who currently require a fenestratedgraft, are in development.

FEVAR is a relatively new technique for repair ofsuprarenal and juxtarenal aneurysms that may be aviable alternative to open repair. There are currently nocontrolled trials comparing FEVAR with open repair, andcurrent evidence is weak with many unanswered questions.An anatomical classification of the aortic neck to clarifycomparisons between patients is a necessary step towardscreating clear indications for FEVAR.

Disclosure

The authors declare no conflict of interest.

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Fenestrated endovascular aneurysm repair