9
Original article Indications for fenestrated endovascular aneurysm repair J. Cross 1 , R. Raine 2 , P. Harris 1 and T. Richards 1 , on behalf of the FEVAR Consensus Working Group of the British Society of Endovascular Therapy* 1 Multidisciplinary Endovascular Team, University College London Hospitals, and 2 Epidemiology & Public Health, University College London, London, UK Correspondence to: Miss J. Cross, Multidisciplinary Endovascular Team, University College London Hospitals, 235 Euston Road, London NW1 2BU, UK. (e-mail: [email protected]) Background: Endovascular technology has advanced rapidly in the development of fenestrated endovas- cular aneurysm repair (FEVAR). Current evidence for endovascular aneurysm repair is limited to infra- renal aortic aneurysms. With increased costs and complexity of FEVAR, its current role is unclear. A national multicentre, cross-disciplinary consensus model was developed to propose indications for FEVAR. Methods: All UK FEVAR centres and a wide selection of high-volume aneurysm treatment centres were invited to participate. The RAND appropriateness methodology was used. Five key steps were under- taken: meta-analysis of current literature; survey of current UK practice; nominal group establishment and definition of key clinical attributes; round 1 – online survey of case vignettes; and round 2 – nominal group consensus meeting. Results: More than 90 per cent of UK FEVAR centres participated. Literature review showed hetero- geneous case series with no clear indications for use of FEVAR. Survey of current practice showed wide variations in aneurysm management. Consensus agreement on the role of FEVAR was achieved in 68·8 per cent of cases. Consensus for FEVAR was agreed in areas of moderate risk from open repair and need for suprarenal clamping, but it was less likely to be indicated in patients aged 85 years or more with 5·5–6-cm aneurysms, or short-necked infrarenal aortic aneurysms. Conclusion: These data record areas of agreement and define the grey area of equipoise. Consequently, guidelines and recommendations can be developed on the indications for FEVAR to inform clinicians, commissioners and health economists. *A full list of contributors can be found under the heading Contributors Paper accepted 17 October 2011 Published online in Wiley Online Library (www.bjs.co.uk). DOI: 10.1002/bjs.7811 Introduction The management of infrarenal abdominal aortic aneurysm (AAA) is well established with level 1 evidence to guide practice. Over the past decade endovascular aneurysm repair (EVAR) has emerged as a viable alternative to open repair 1 . Use of EVAR has increased rapidly and the National Vascular Database 2009 audit showed EVAR to be the management choice for approximately 44 per cent of all aneurysms 2 . EVAR confers reduced periprocedural mortality, postoperative complications, blood transfusion requirement, and intensive care unit and hospital stay 3 . Commercially available devices are limited in application by the anatomical morphology of the AAA, in particular the infrarenal landing zone. Although instructions for use vary according to graft model, recent guidelines 4 of min- imum requirements for standard commercially available endografts are an infrarenal neck length of 10 mm, neck diameter of less than 32 mm and angulation of less than 60–90° . Approximately 25 – 75 per cent of all AAAs remain unsuitable for standard EVAR 5,6 and in these patients options include open repair, conservative management or complex endograft repair. Fenestrated endografts are the most commonly used complex endovascular technique in the UK. Fenestrated endovascular repair (FEVAR), first des- cribed in 1996 7 , allows the graft sealing zone to be extended to an adequate, more proximal landing zone incorporating the visceral vessels. Cannulation of the visceral vessels is technically challenging and the procedure takes longer than standard EVAR. Subsequent morbidity and mortality rates are therefore higher after FEVAR than standard EVAR 8 . Grafts are custom-made and significantly more expen- sive than standard grafts. Thus the benefits of FEVAR over open surgical repair may be less than those seen 2012 British Journal of Surgery Society Ltd British Journal of Surgery 2012; 99: 217–224 Published by John Wiley & Sons Ltd

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Original article

Indications for fenestrated endovascular aneurysm repair

J. Cross1, R. Raine2, P. Harris1 and T. Richards1, on behalf of the FEVAR Consensus WorkingGroup of the British Society of Endovascular Therapy*1Multidisciplinary Endovascular Team, University College London Hospitals, and 2Epidemiology & Public Health, 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: Endovascular technology has advanced rapidly in the development of fenestrated endovas-cular aneurysm repair (FEVAR). Current evidence for endovascular aneurysm repair is limited to infra-renal aortic aneurysms. With increased costs and complexity of FEVAR, its current role is unclear.A national multicentre, cross-disciplinary consensus model was developed to propose indications forFEVAR.Methods: All UK FEVAR centres and a wide selection of high-volume aneurysm treatment centres wereinvited to participate. The RAND appropriateness methodology was used. Five key steps were under-taken: meta-analysis of current literature; survey of current UK practice; nominal group establishmentand definition of key clinical attributes; round 1 – online survey of case vignettes; and round 2 – nominalgroup consensus meeting.Results: More than 90 per cent of UK FEVAR centres participated. Literature review showed hetero-geneous case series with no clear indications for use of FEVAR. Survey of current practice showedwide variations in aneurysm management. Consensus agreement on the role of FEVAR was achieved in68·8 per cent of cases. Consensus for FEVAR was agreed in areas of moderate risk from open repair andneed for suprarenal clamping, but it was less likely to be indicated in patients aged 85 years or more with5·5–6-cm aneurysms, or short-necked infrarenal aortic aneurysms.Conclusion: These data record areas of agreement and define the grey area of equipoise. Consequently,guidelines and recommendations can be developed on the indications for FEVAR to inform clinicians,commissioners and health economists.*A full list of contributors can be found under the heading Contributors

Paper accepted 17 October 2011Published online in Wiley Online Library (www.bjs.co.uk). DOI: 10.1002/bjs.7811

Introduction

The management of infrarenal abdominal aortic aneurysm(AAA) is well established with level 1 evidence to guidepractice. Over the past decade endovascular aneurysmrepair (EVAR) has emerged as a viable alternative toopen repair1. Use of EVAR has increased rapidly and theNational Vascular Database 2009 audit showed EVAR tobe the management choice for approximately 44 per centof all aneurysms2. EVAR confers reduced periproceduralmortality, postoperative complications, blood transfusionrequirement, and intensive care unit and hospital stay3.

Commercially available devices are limited in applicationby the anatomical morphology of the AAA, in particularthe infrarenal landing zone. Although instructions for usevary according to graft model, recent guidelines4 of min-imum requirements for standard commercially availableendografts are an infrarenal neck length of 10 mm, neck

diameter of less than 32 mm and angulation of less than60–90°. Approximately 25–75 per cent of all AAAs remainunsuitable for standard EVAR5,6 and in these patientsoptions include open repair, conservative management orcomplex endograft repair. Fenestrated endografts are themost commonly used complex endovascular technique inthe UK.

Fenestrated endovascular repair (FEVAR), first des-cribed in 19967, allows the graft sealing zone to be extendedto an adequate, more proximal landing zone incorporatingthe visceral vessels. Cannulation of the visceral vessels istechnically challenging and the procedure takes longer thanstandard EVAR. Subsequent morbidity and mortality ratesare therefore higher after FEVAR than standard EVAR8.Grafts are custom-made and significantly more expen-sive than standard grafts. Thus the benefits of FEVARover open surgical repair may be less than those seen

2012 British Journal of Surgery Society Ltd British Journal of Surgery 2012; 99: 217–224Published by John Wiley & Sons Ltd

218 FEVAR Consensus Working Group

with standard infrarenal EVAR, questioning the validity ofFEVAR for juxtarenal aneurysms.

Technological advances have exceeded the evidence forthe value of FEVAR. Currently, the evidence for the bene-fit of FEVAR is based on case series. Thirty-day mortalityrates from review series are 1·4–1·8 per cent, which com-pares favourably with 3·1–3·6 per cent after open repairof juxtarenal aneurysms9,10. However, there is much het-erogeneity between the case series and the indicationsfor FEVAR vary between studies. In particular, there waspoor concurrence in the classification of aneurysm neckmorphology. There is likely to be bias in reporting ofcases, particularly in open repair, and these results do notnecessarily represent a real world experience.

The IDEAL (innovation, development, exploration,assessment and long-term study) model11 suggests astaged approach for introduction of new clinical prac-tice. Part of this is the development of recommendationsfor use. Guidelines for clinical practice may be developedusing formal consensus methods12,13. The recommenda-tions produced by consensus methods represent the viewsof groups about current research evidence and clinicalopinion14,15. These methods identify where there is con-sensus, or whether individual views diverge to such anextent that no recommendation can be made. Consensusmethodology is a validated technique, in particular forareas lacking in research evidence or where randomizedcontrolled trials may not be possible. Consensus method-ology has been used previously to produce guidelines bynational bodies such as the National Institute for Healthand Clinical Excellence in the UK. An example of previoususe in vascular surgery was in the construct of the Bypassversus Angioplasty in Severe Ischaemia of the Leg (BASIL)trial16 to define areas requiring further focused research.

Current evidence for FEVAR indicates that its role isunclear, yet it is too early to deliver a good randomizedcontrolled trial. Although this may evolve in the future,at present a consensus statement is a suitable alternativefor clarification of the role of FEVAR. The aim of thisstudy was to develop a consensus opinion on the currentindications for FEVAR.

Methods

This consensus statement was performed using a modifiedform of the RAND appropriateness technique17. RAND isa hybrid of the Delphi survey and the nominal group tech-nique. The process involves a series of surveys, the results ofwhich are fed back to all participants. Time is then allowedfor discussion before further surveys are undertaken. Thekey features are feedback and discussion of results in a

non-dominant and independent manner. Participantsshould represent a wide range of experience, opinions,knowledge and enthusiasm of the larger professional body,thereby avoiding bias. The consensus process employsanonymous scoring, thus not allowing domination by indi-vidual enthusiasts. The number of participants on the finaldiscussion panel is limited to allow optimal debate anddiscussion.

There were five key steps in the development of theFEVAR consensus process: review of current literature;survey of current practice; establishment of the nominalgroup and definitions of clinical attributes; RAND – round1; and RAND – round 2.

Literature review of published work

A Meta-analysis Of Observational Studies in Epidemiol-ogy (MOOSE) of the current evidence for FEVAR wasundertaken. Eleven studies were identified that met theinclusion criteria. Results have been reported separately18.

Survey of current practice

The aim of this round was to assess responses from a rangeof UK vascular surgeons and interventional radiologists,representing a breadth of experience and enthusiasmfor all types of AAA management. A questionnaire oncurrent practice was completed (Appendix S1, supportinginformation). This was designed as a scoping strategyto establish areas of opinion using open-ended, non-quantifiable questions. At the time of writing, onlyone company supplied complex endografts in the UK.Interrogation of their database determined a list of centresin the UK that had ordered a fenestrated endograft.These centres and a nationwide spread of other vascularcentres with a high volume of open or endovascularaneurysm surgery were contacted and invited to participate.The questionnaire was undertaken either as a telephoneinterview or in e-mail format.

Establishment of the nominal group and definingthe clinical attributes

All those who participated in the survey were invited toattend a meeting in August 2010, the aim of which was toestablish areas requiring consensus agreement, define theclinical attributes that would make up the clinical scenarios,and form an expert panel for data collection. The expertpanel included a group of professionals representativeof current UK practice with a range of experience andknowledge of the clinical choices in AAA management.

2012 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2012; 99: 217–224Published by John Wiley & Sons Ltd

Indications for fenestrated endovascular aneurysm repair 219

The results of the meta-analysis of the current evidencefor FEVAR were first presented to the experts, togetherwith the results from the current practice survey. A struc-tured group discussion followed, the minutes of whichwere fully transcribed, and clear definitions of the clinicalattributes were established. Four main clinical attributegroups were identified and each group was further subcat-egorized; from these, the clinical scenarios that formed thebasis of the consensus process were developed (Table 1).

Round 1

Round 1 of the consensus development was performed asan online survey to all participants. Every combination ofthe clinical attribute groups was used in a factorial design,providing 192 case vignettes (4 age groups, 3 aneurysm sizegroups, 4 co-morbidity groups, 4 aneurysm morphologygroups (A–E) = 192). For each case vignette, participantswere given four management options (open aneurysmrepair, standard EVAR, conservative management orFEVAR) reflecting normal clinical situations, and wereasked which option they felt was most appropriate. Theresults were presented as percentage agreement for eachoption. Consensus was defined where there was more than90 per cent agreement for one option and these vignetteswere then excluded from further discussions at round 2.On completion, results from round 1 were e-mailed backto all participants (Fig. 1).

Agreement >90%Agreement >90%Agreement >90%

Standard EVAR

Open aneurysm repair

Fenestrated EVAR

Conservative management

Standard EVAR

Open aneurysm repair

Fenestrated EVAR

Conservative management

Total # of respondents 21. Statistics based on 21 respondents; 0 filtered; 0 skipped.

Total # of respondents 21. Statistics based on 21 respondents; 0 filtered; 0 skipped.

0%

ResponsePercent

A man (age range 66-74 years) presents with a >8.0 cm type E aneurysm. Heis a moderate risk category patient.

A man (85 years or over) presents with a 5.5-6.0 cm type E aneurysm. He is ahigh risk category patient.

ResponseTotal

ResponsePercent

ResponseTotal

9.5%

90.5%

0%

0

0

2

19

0%

0%

0%

100%

0

21

0

0

Fig. 1 Example of return from round 1 fed back to all participants

Round 2

Round 2 consisted of a meeting, attended by selectedmembers of the expert panel. The results from round 1were shown for each case vignette in which consensus hadnot been reached. The results were discussed, reasons fordivergence analysed, and any ambiguities clarified and, ifnecessary, reworded before rescoring. To avoid the effectof a dominant personality, each participant was given a 60-suninterrupted opportunity to present their opinion. Thepanel was then asked to rescore each scenario’s suitabilityfor FEVAR using a Likert scale of 1–9, where 1 was

Table 1 Main clinical attributes relating to indications for fenestrated endovascular aneurysm repair

Age (years) < 6565–7475–84≥ 85

Aneurysm size (cm) < 5·55·5–6·06·1–7·9≥ 8

Co-morbidities/risk of surgery (after Low risk: no significant past medical history, < 5% mortality risk at surgerypreop. assessment andoptimization)

Mild risk: some mild co-morbidities or reduced exercise tolerance, or 5–10% mortality risk at open surgeryModerate risk: some significant co-morbidities, etc., or > 10% mortality risk at open surgeryHigh Risk: housebound, etc.; unfit for open surgery

AAA morphology Type A aneurysm: AAA with long infrarenal neck that is suitable for EVAR by manufacturer’s guidelines forthe graft of surgeon’s choice

Type B aneurysm: AAA that lies outside manufacturer’s guidelines but in the surgeon’s opinion EVAR isfeasible (may be conical, thrombus-lined, short neck angulated, etc.); technically suitable for standardopen repair involving an infrarenal clamp

Type C aneurysm: standard EVAR not feasible but infrarenal clamp possible, abutting but below renals, orsuitable for a fenestrated graft

Type D aneurysm: AAA where, if open surgery, suprarenal clamp necessary or double fenestrated EVARType E aneurysm: suprarenal/type IV AAA or AAA that requires supracoeliac clamp/medial visceral rotation

± reconstruction of renal/visceral arteries or 4 fenestrations/branches

AAA, abdominal aortic aneurysm; EVAR, endovascular aneurysm repair.

2012 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2012; 99: 217–224Published by John Wiley & Sons Ltd

220 FEVAR Consensus Working Group

FEVAR is a good treatment option:-

Q5. A female aged less than 65 years presentswith a 5·5–6·0 cm type B aneurysm. She is

categorised mild risk for surgery

Strongly disagree...................................................................Strongly agree

0 = don't know; 5 = ambivalent36%

27%

9% 9%18%

10987654321

3·18

1 2 3 4 5 6 7 8 9

Fig. 2 Example of return from round 2 fed back to small expertpanel

considered very unsuitable and 9 very suitable. Rating wasdone using a simultaneous electronic voting system to avoidpeer influence. Anonymized results were immediately fedback to the panel (Fig. 2).

The results from the consensus were then sent back tothe entire cohort of participants. Any comments and dis-agreements were incorporated into the final analysis withthe aim of producing results representative of the group asa whole.

Analysis

A median rating for each of the 192 vignettes was calcu-lated. The median score reflected the strength of supportfor each vignette. These were then categorized into one

100

1st round

2nd round90

80

70

60

50

% a

gree

men

t

40

30

20

10

0< 65 66–74

Age (years)

a Age

75–84 ≥ 85

100

90

80

70

60

50

% a

gree

men

t

40

30

20

10

0Low Mild

Operative risk category

c Operative risk

Moderate High

100

90

80

70

60

50

% a

gree

men

t

40

30

20

10

0Type B Type C

Aneurysm morphology

d Aneurysm morphology

Type D Type E

100

90

80

70

60

50

% a

gree

men

t

40

30

20

10

05·5–6·0

Aneurysm diameter (cm)

b Aneurysm diameter

6·1–7·9 ≥ 8

Fig. 3 Summary of agreement on management after expert panel review, based on clinical attributes: a age, b aneurysm diameter,c operative risk, d aneurysm morphology

2012 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2012; 99: 217–224Published by John Wiley & Sons Ltd

Indications for fenestrated endovascular aneurysm repair 221

of three groups. Group medians of 1–3·5 were consideredgood agreement for ‘not suitable for FEVAR’, 3·6–6·5indicated no agreement on suitability for FEVAR, and6·6–9 was considered good agreement for ‘suitable forFEVAR’. For transparency of results, the group’s meanabsolute deviation from the median (MADM; the averagedistance (on the 9-point Likert scale) of the participants’ratings from the group’s median rating) was also calculated.The MADM defines the extent of support of the group.Consensus was considered to have been achieved for those

vignettes with a median rating of 6·6–9 or 1–3·5 and a highextent of support reflected by a MADM of less than 1·41.

Results

Survey of current practice

Twenty-two centres in the UK were identified thatundertook FEVAR; 26 of the 45 UK consultants invitedto participate took part. This expert panel consisted of

< 65Risk

Aneurysmdiameter

(cm) 65–74

Age (years)

RiskAneurysmdiameter

(cm)

Age (years)Risk

Aneurysmdiameter

(cm)

Age (years)

RiskAneurysmdiameter

(cm)

Age (years)75–84 ≥ 85

Low

5·5–6·0 Mild

Moderate

High

Low

6·1–7·9 Mild

Moderate

High

Low

≥ 8 Mild

Moderate

High

< 65

FEVAR

No FEVAR

No consensus

65–74 75–84 ≥ 85

Low

5·5–6·0 Mild

Moderate

High

Low

6·1–7·9 Mild

Moderate

High

Low

≥ 8 Mild

Moderate

High

< 65 65–74 75–84 ≥ 85

Low

5·5–6·0 Mild

Moderate

High

Low

6·1–7·9 Mild

Moderate

High

Low

≥ 8 Mild

Moderate

High

< 65 65–74 75–84 ≥ 85

Low

5·5–6·0 Mild

Moderate

High

Low

6·1–7·9 Mild

Moderate

High

Low

≥ 8 Mild

Moderate

High

a Type B aneurysms

c Type D aneurysms d Type E aneurysms

b Type C aneurysms

Fig. 4 Final consensus on indications for fenestrated endovascular aneurysm repair (FEVAR) for each type of aneurysm: a type B, b typeC, c type D, d type E (for details of morphology see Table 1)

2012 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2012; 99: 217–224Published by John Wiley & Sons Ltd

222 FEVAR Consensus Working Group

four consultant radiologists and 22 vascular surgeons.Representation was obtained from more than 90 per cent ofcurrent UK FEVAR centres. All consultants cited fitnessfor surgery as a key factor in aneurysm management;however, the definition of fitness varied considerably.It was universally agreed that an aneurysm diameter of5·5 cm was the cut-off value for treatment in a fit man.There was much variation in defining an acceptable necklength for standard infrarenal EVAR, and more than halfthe consultants would be prepared to insert a standardinfrarenal graft outside instructions for use. There was noclear agreement on the definition of a juxtarenal aneurysm,and poor concordance on the indications for FEVAR.

Initial meeting

At the initial meeting, clinical attributes agreed foraneurysm management were patient age, aneurysm size,fitness for surgery and aneurysm morphology (Table 1). Itwas decided that type A aneurysms (long infrarenal neck)and aneurysms smaller than 5·5 cm should be excludedfrom further discussion because it was universally agreedthat type A aneurysms were not suitable for FEVAR andthat aneurysms of less than 5·5 cm should be managedconservatively. No clear agreement could be made ondefinitions for fitness for surgery and it was thereforeestablished that this should be left to the individual. Asimilar strategy was adopted in the EVAR 2 trial19.

Round 1

Some 21 of the 26 members of the expert panel completedsurveys of the case vignettes. In several cases the vignetteswere completed simultaneously by more than one person,reflecting a multidisciplinary team viewpoint.

There was disagreement for 137 (71·4 per cent) of the192 scenarios. The highest level of agreement was seenfor type B (feasible, but outside manufacturer’s guidelines)aneurysms (24 of 48, 50 per cent) and age 85 years or above(19 of 48, 40 per cent). The lowest agreement was seen inthe mild-risk category (7 of 48, 15 per cent).

Round 2

Twelve members of the expert panel convened to discussthe round 1 results. Following peer discussions andfeedback from the first round, agreement was improvedto 132 vignettes (68·8 per cent) (Fig. 3).

The highest level of agreement was again for aneurysmsin people aged 85 years or more (40 of 48, 83 per cent)and in the management of type B aneurysms (39 of 48,81 per cent). The lowest agreement was now seen forthe management of type E (suprarenal) aneurysms (27 of

48, 56 per cent) and management of young patients (ageless than 65 years) (28 of 48, 58 per cent). The categoriesachieving 100 per cent consensus agreement were patientsaged 85 years or over with a type B aneurysm and high-riskpatients aged 85 years or above; it was agreed that theywere not suitable for FEVAR (Fig. 4).

Equipoise was defined as present when the median scorefell in the 3·5–6·5 range or the MADM was above 1·41(the spread of the votes was too large). By the end of thesecond round, the grey area of equipoise had dropped from71·3 to 31·2 per cent.

Discussion

This paper presents the views of UK vascular surgeonsand radiologists on the indications for FEVAR. This studyhighlights clinical scenarios where FEVAR is currentlyregarded as the treatment of choice and where it is notregarded as appropriate. Despite presentation of currentresearch evidence and extensive structured discussions ofan expert panel, agreement regarding best practice was notachieved for almost one-third of case vignettes.

This exercise included vascular experts with differingopinions both for and against EVAR. The RANDmethodology relies on a core group of experts to facilitatepurposeful discussions. However, the final results and paperwere recirculated to the entire group for comments beforepublication. The results are therefore likely to representnational practice. This was a clinically based exercise and,although health economics may limit the availability ofFEVAR, this should not have had an influence on decision-making in these clinical scenarios.

Consensus opinion is that FEVAR is not indicated formore than 80 per cent of type B aneurysms (those feasiblefor EVAR but outside the manufacturer’s guidelines).This may reflect limited availability of FEVAR orcould relate to improvements in standard graft designand durability. Despite evidence that late endoleak andreintervention is more common after EVAR for short orangulated necks20,21, this result indicates that a significantproportion of consultants may be using standard infrarenaldevices outside the manufacturer’s instructions for use.Interestingly, many of the current data are for FEVARin type B aneurysms. As over 90 per cent of currentUK FEVAR centres contributed, the results are likelyto represent national practice.

Consensus opinion is also that FEVAR is not indicatedfor elderly (aged 85 years or older) high-risk patients.In the initial survey, high surgical risk was commonlycited as an indication for FEVAR. However, the expertpanel stated that FEVAR was appropriate only for patients

2012 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2012; 99: 217–224Published by John Wiley & Sons Ltd

Indications for fenestrated endovascular aneurysm repair 223

with a reasonable life expectancy. EVAR 219 showed highall-cause mortality in unfit patients, and the benefit ofEVAR in someone with limited life expectancy is not clear.

As surgical specialties have evolved, innovations haveled to smaller increments and less striking advances thanthose reported previously. The IDEAL model has beendeveloped as a series of five recommended stages for theimplementation of new surgical innovations. Stage 1 is theproof of concept phase, where the procedure is tried on asmall number of patients for the first time. If early reportssuggest benefit then the innovation may progress to stage2a (innovation stage), where the focus is on the technicaldevelopment of the intervention. Subsequently stage 2b(development stage) investigates the indications for use,understanding the benefits and harm, and optimizingeffectiveness. Stage 3 establishes the clinical efficacy andcost-effectiveness, and stage 4 determines the long-termoutcomes and rare complications.

Currently the development of FEVAR is at stage 2b.An important next step in the development is definingthe indications for FEVAR. Prospective research databasesare often employed at this stage; however, these take timeto accrue meaningful data. A consensus statement is avalidated alternative method to guiding clinical practice,particularly when research evidence is limited.

The use of expert consensus in guideline developmentis based on the assumption that the views of a group havegreater validity and reliability than the judgement of anindividual. Structured methods for developing a consensusshould offer a transparent way of producing judgements,reduce the influence of dominating personalities and peerinfluence on decision-making, and can provide valuableinformation on the extent and reasons for differences ofopinion.

The RAND appropriateness method allows a large, geo-graphically dispersed group to participate in the first round,thus avoiding the effect of a dominant personality. The useof a formal meeting for the second round aims to reducethe risk of misunderstandings and may expose the reasonsfor differences of opinion. Although this is an accepted,validated methodology, outcomes may be biased by thecomposition of the expert group. The level of resourcesavailable in a healthcare system may also influence recom-mendations. Future developments are not always predictedcorrectly by the expert group, particularly when panellistsare misinformed about a topic. Judgements may be unreli-able and unreproducible, particularly in the second roundwhere group discussions can lead to unrepresentative andtherefore unreliable outcomes.

Although the RAND appropriateness method uses aLikert scale for round 1, four management options were

used better to reflect decision-making in clinical practice.A limitation of the study is that not everyone who par-ticipated in round 1 was able to attend round 2, and thattwo people who participated in round 2 had not completedround 1. Given geographical and time restraints, this iswhat was practical and feasible. Recirculation of the resultsand inclusion of comments from the entire group aimed toachieve group representation.

These data provide a baseline professional opinionon potential indications for FEVAR (and when not toundertake FEVAR). They could be developed to provideguidelines and recommendations to clinicians, commis-sioners and health economists. The grey area of equipoiseidentified in this study indicates the need for clarification ofthe indications for FEVAR and these results could be usedto define inclusion criteria for future controlled studies.

Contributors

The following contributed to this study: D. Adam, J.Beard, C. Bicknell, J. Boyle, A. Bradbury, B. Braithwaite,J. Brennan, M. Brooks, T. Carrell, A. Chaudhuri, J. Cross,M. Davis, J. Earnshaw, P. Gaines, G. Geroulakos, R.Gibbs, G. Hamilton, L. Hands, P. Harris, H. Heming-way, R. Hinchliffe, M. Horrocks, K. Ivancev, M. Jenkins,M. Khanbhai, C. Kyriakides, P. Lamont, I. Lapid, K. Maui,F. Meyer, B. Modarai, J. Perkins, R. Raine, T. Richards, C.Rod, J. Rose, F. Serracino-Inglott, C. Shearing, D. Sim-ring, S. Thomas, M. Thompson, J. Tsui, S. Vallabhaneni,K. Varty, N. Wilson, K. Woodburn, M. Wyatt, W. Yusuf.

Acknowledgements

The authors acknowledge the support of the British Societyof Endovascular Therapy which initiated this project. Nofunding was received to undertake this work. J.C. has aproportion of her salary paid by Cook Medical which hasalso provided funds for the vascular service at UniversityCollege London. T.R. is supported by a Health FoundationSHINE award for innovation. Some of the contributersreceive funding as proctors of Cook Medical.Disclosure: The author declares no other conflict of interest.

References

1 EVAR trial participants. Endovascular aneurysm repair versusopen repair in patients with abdominal aortic aneurysm(EVAR trial 1): randomised controlled trial. Lancet 2005;365: 2179–2186.

2 Vascular Society of Great Britain and Ireland. The NationalVascular Database Report 2009. http://www.vascularsociety.

2012 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2012; 99: 217–224Published by John Wiley & Sons Ltd

224 FEVAR Consensus Working Group

org.uk/news-and-press/2009/1-national-vascular-database-2009-report.html [accessed 8 November 2011].

3 Prinssen M, Verhoeven EL, Buth J, Cuypers PW, vanSambeek MR, Balm R et al.; Dutch RandomizedEndovascular Aneurysm Management (DREAM) TrialGroup. A randomized trial comparing conventional andendovascular repair of abdominal aortic aneurysms. N Engl JMed 2004; 351: 1607–1618.

4 Moll FL, Powell JT, Fraedrich G, Verzini F, Haulon S,Waltham M et al.; European Society for Vascular Surgery.Management of abdominal aortic aneurysms clinical practiceguidelines of the European Society for Vascular Surgery. EurJ Vasc Endovasc Surg 2011; 41(Suppl 1): S1–S58.

5 Keefer A, Hislop S, Singh MJ, Gillespie D, Illig KA. Theinfluence of aneurysm size on anatomic suitability forendovascular repair. J Vasc Surg 2010; 52: 873–877.

6 Elkouri S, Martelli E, Gloviczki P, McKusick MA,Panneton JM, Andrews JC et al. Most patients withabdominal aortic aneurysm are not suitable for endovascularrepair using currently approved bifurcated stent-grafts. VascEndovascular Surg 2004; 38: 401–412.

7 Park JH, Chung JW, Choo IW, Kim SJ, Lee JY, Han MC.Fenestrated stent-grafts for preserving visceral arterialbranches in the treatment of abdominal aortic aneurysms:preliminary experience. J Vasc Interv Radiol 1996; 7:819–823.

8 Haddad F, Greenberg RK, Walker E, Nally J, O’Neill S,Kolin G et al. Fenestrated endovascular grafting: the renalside of the story. J Vasc Surg 2005; 41: 181–190.

9 Nordon IM, Hinchliffe RJ, Holt PJ, Loftus IM,Thompson MM. Modern treatment of juxtarenal abdominalaortic aneurysms with fenestrated endografting and openrepair – a systematic review. Eur J Vasc Endovasc Surg 2009;38: 35–41.

10 Medical Advisory Secretariat, Ministry of Health andLong-term Care. Fenestrated Endovascular Grafts for the Repairof Juxtarenal Aortic Aneurysms: an Evidence-based Analysis.Ontario Health Technology Assessment Series 2008; http://www.health.gov.on.ca/english/providers/program/mas/tech/reviews/pdf/rev_fevar_20090701.pdf [accessed 8November 2011].

11 McCulloch P, Altman DG, Campbell WB, Flum DR,Glasziou P, Marshall JC et al. No surgical innovation withoutevaluation: the IDEAL recommendations. Lancet 2009; 374:1105–1112.

12 Woolf SH, Grol R, Hutchinson A, Eccles M, Grimshaw J.Clinical guidelines: potential benefits, limitations, and harmsof clinical guidelines. BMJ 1999; 318: 527–530.

13 Burgers JS, Grol R, Klazinga NS, Makela M, Zaat J; AGREECollaboration. Towards evidence-based clinical practice: aninternational survey of 18 clinical guideline programs. Int JQual Health Care 2003; 15: 31–45.

14 Savoie I, Kazanjian A, Bassett K. Do clinical practiceguidelines reflect research evidence? J Health Serv Res Policy2000; 5: 76–82.

15 Raine R, Sanderson C, Hutchings A, Carter S, Larkin K,Black N. An experimental study of determinants of groupjudgments in clinical guideline development. Lancet 2004;364: 429–437.

16 Bradbury AW, Bell J, Lee AJ, Prescott RJ, Gillespie I,Stansby G et al. Bypass or angioplasty for severe limbischaemia? A Delphi Consensus Study. Eur J Vasc EndovascSurg 2002; 24: 411–416.

17 Raine R, Sanderson C, Black N. Developing clinicalguidelines: a challenge to current methods. BMJ 2005; 331:631–633.

18 Cross J, Gurusamy K, Gadhvi V, Simring D, Harris P,Ivancec K et al. Fenestrated endovascular aneurysm repair. BrJ Surg 2012; 99: 152–159.

19 EVAR trial participants. Endovascular aneurysm repair andoutcome in patients unfit for open repair of abdominal aorticaneurysm (EVAR trial 2): randomised controlled trial. Lancet2005; 365: 2187–2192.

20 Hobo R, Kievit J, Leurs LJ, Buth J; EUROSTARCollaborators. Influence of severe infrarenal aortic neckangulation on complications at the proximal neck followingendovascular AAA repair: a EUROSTAR study. J EndovascTher 2007; 14: 1–11.

21 Leurs LJ, Kievit J, Dagnelie PC, Nelemans PJ, Buth J;EUROSTAR Collaborators. Influence of infrarenal necklength on outcome of endovascular abdominal aorticaneurysm repair. J Endovasc Ther 2006; 13: 640–648.

Supporting information

Additional supporting information may be found in the online version of this article:

Appendix S1 Questionnaire on current practice for management of abdominal aortic aneurysms (Word document)

Please note: John Wiley & Sons Ltd is not responsible for the functionality of any supporting materials suppliedby the authors. Any queries (other than missing material) should be directed to the corresponding author for thearticle.

2012 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2012; 99: 217–224Published by John Wiley & Sons Ltd

Indications for fenestrated endovascular aneurysm repair 225

Commentary

Indications for fenestrated endovascular aneurysm repair (Br J Surg 2012; 99:217–224)

It is apparent that the boundaries for conventional endovascular aneurysm repair for treating abdominal aortic aneurysmhave been pushed to the limit, manifest by increasing 5-year intervention rates. It is therefore imperative that endovascularspecialists examine their indications for fenestrated endovascular aneurysm repair (FEVAR) carefully in the light of currentknowledge and experience of the technique. It could be argued that, in patients with conventional anatomy, we should beperforming more open repairs, provided that mortality rates are less than 4 per cent. For juxtarenal aneurysm, however,the mortality rate associated with suprarenal/coeliac clamping is significant and, if FEVAR can reduce this, it should bewelcomed. There is an initial cost issue for FEVAR, but this should be offset by a reduction in morbidity, mortality andassociated hospital stay. Nevertheless, the positive results of the review of FEVAR by the same authors in this issue1 shouldbe interpreted cautiously as there is great enthusiasm for this expensive technology and as yet we have few long-termefficacy data for FEVAR.

A degree of consensus has been reached by the authors, but I have concerns regarding the overjudicious use of FEVARin patients with type C and D aneurysms, and in younger patients at low risk of death after standard open repair. Inaddition, round 2 of the RAND consensus involved a highly select group of FEVAR enthusiasts, who may not havebeen totally representative of current practice. It is therefore essential that further studies are performed to providedata on the long-term results of FEVAR. In view of these excellent early results, I would agree that the feasibility of arandomized controlled trial is questionable and that data from all future procedures should be submitted to a nationalregistry. Longevity of target vessel/aortic stents and continued freedom from secondary intervention is essential if the useof FEVAR is to be justified for the treatment of patients with juxtarenal aortic aneurysms.

M. G. WyattNorthern Vascular Centre, Freeman Hospital and Newcastle University, Newcastle upon Tyne NE7 7DN, UK

(e-mail: [email protected])DOI: 10.1002/bjs.7806

Disclosure

The author declares no conflict of interest.

Reference

1 Cross J, Gurusamy K, Gadhvi V, Simring D, Harris P, Ivancev K et al. Fenestrated endovascular aneurysm repair. Br J Surg 2012;99: 152–159.

2012 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2012; 99: 225Published by John Wiley & Sons Ltd