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A propensity-matched comparison of earlyoutcomes for fenestrated endovascular aneurysmrepair and open surgical repair of complexabdominal aortic aneurysmsMaxime Raux, MD,a,b Virendra I. Patel, MD, MPH,b Frédéric Cochennec, MD,a

Shankha Mukhopadhyay, MS,b Pascal Desgranges, MD, PhD,a Richard P. Cambria, MD,b

Jean-Pierre Becquemin, MD,a and Glenn M. LaMuraglia, MD,b Créteil, France; and Boston, Mass

Objective: The benefit of fenestrated endovascular aortic aneurysm repair (FEVAR) compared with open surgical repair(OSR) of complex abdominal aortic aneurysms (CAAAs) is unknown. This study compares 30-day outcomes of theseprocedures from two high-volume centers where FEVAR was undertaken for high-risk patients.Methods: Patients undergoing FEVAR with commercially available devices and OSR of CAAAs (total suprarenal/supra-visceral clamp position) were propensity matched by demographic, clinical, and anatomic criteria to identify similar pa-tient cohorts. Perioperative outcomes were evaluated using univariate and multivariate methods.Results: From July 2001 to August 2012, 59 FEVAR and 324 OSR patients were identified. After 1:4 propensitymatching for age, gender, hypertension, congestive heart failure, coronary disease, chronic obstructive pulmonary disease,stroke, diabetes, preoperative creatinine, and anticipated/actual aortic clamp site, the study cohort consisted of 42FEVARs and 147 OSRs. The most frequent FEVAR construct was two renal fenestrations, with or without a singlemesenteric scallop, in 50% of cases. An average of 2.9 vessels were treated per patient. Univariate analysis demonstratedFEVAR had higher rates of 30-day mortality (9.5% vs 2%; P [ .05), any complication (41% vs 23%; P [ .01), proceduralcomplications (24% vs 7%; P < .01), and graft complications (30% vs 2%; P < .01). Multivariable analysis showed FEVARwas associated with an increased risk of 30-day mortality (odds ratio [OR], 5.1; 95% confidence interval [CI], 1.1-24;P [ .04), any complication (OR, 2.3; 95% CI, 1.1-4.9; P [ .01), and graft complications (OR, 24; 95% CI, 4.8-66;P < .01).Conclusions: FEVAR, in this two-center study, was associated with a significantly higher risk of perioperative mortalityand morbidity compared with OSR for management of CAAAs. These data suggest that extension of the paradigm shiftcomparing EVAR with OSR for routine AAAs to patients with CAAAs is not appropriate. Further study to establishproper patient selection for FEVAR instead of OSR is warranted before widespread use should be considered. (J VascSurg 2014;-:1-7.)

During the last 10 years, endovascular aneurysm repair(EVAR) has been replacing open surgical repair (OSR) tobecome the predominant modality of treatment for stan-dard infrarenal aortic aneurysms.1,2 The benefits ofEVAR of abdominal aortic aneurysm (AAA) rather thanOSR are clearly established by large multicenter random-ized trials.3-5 Nevertheless, for complex aneurysmsinvolving visceral arteries and those unsuitable for EVAR,

the Department of Vascular and Endovascular Surgery, Henri Mon-r Hospital, University of Paris XII, Créteila; and the Division ofascular and Endovascular Surgery, Massachusetts General Hospital,arvard Medical School, Boston.b

or conflict of interest: none.ented at the 2013 Vascular Annual Meeting of the Society for Vascularrgery, San Francisco, Calif, May 30-June 1, 2013.rint requests: Virendra I. Patel, MD, MPH, Massachusetts Generalospital, 15 Parkman SteWang ACC 440, Boston, MA 02114-mail: vpate14@partners.org).editors and reviewers of this article have no relevant financial relationshipsdisclose per the JVS policy that requires reviewers to decline review of anyanuscript for which they may have a conflict of interest.-5214/$36.00yright � 2014 by the Society for Vascular Surgery.://dx.doi.org/10.1016/j.jvs.2014.04.011

OSR has remained the standard of care. Early outcomesof OSR of complex abdominal aortic aneurysms (CAAAs)in large centers have been excellent, with comparable 30-day mortality to infrarenal disease.6 Early outcomes ofEVAR with fenestrated grafts (FEVAR) for CAAAs arealso very encouraging, with very low mortality rates andexcellent technical success.7

Notwithstanding, studies comparing open and endo-vascular repair are sparse, and this lack of data preventsour ability to determine if the relatively straightforwardparadigm shift that occurred from OSR to EVAR, willalso be possible when applying it to EVAR of complexaortic disease. Therefore, the aim of this study was tocompare 30-day outcomes of FEVAR procedures andOSR for the treatment of CAAAs.

METHODS

Study population. This retrospective cohort studycompared 30-day outcomes of OSR and FEVAR repairof CAAAs by using prospectively collected data from twohigh-volume centers: Henri Mondor Hospital (Créteil,France) and the Massachusetts General Hospital (MGH)

1

JOURNAL OF VASCULAR SURGERY2 Raux et al --- 2014

(Boston, Mass). A large number of EVAR and OSR pro-cedures have been performed at both centers,8-11 includingcomplex aneurysms12 and thoracoabdominal aneurysms.13

Data collected represent the clinical experience from July2001 to August 2012. All OSRs were performed at theMGH and all FEVARs at Henri Mondor. Each in-stitution’s Institutional Review Board approved the studyand waived patient consent for this retrospective medicalrecord review.

All FEVAR patients were considered high-risk patientsaccording to criteria defined by the Agence Française deSécurité Sanitaire des Produits de Santé (AFSSAPS).FEVAR patients were deemed unsuitable for OSR by theoperating surgeon. Because of anatomic involvement withthe aneurysm of renal or visceral arteries, or both, these pa-tients were not candidates for conventional EVAR. Onlypatients who would have required an actual or anticipatedcompletely suprarenal or more proximal clamp positionwere included in the study. For the FEVAR group, theoperating surgeon defined the anticipated clamp site afterreviewing a preoperative computed tomography (CT)scan. For OSR, the actual clamp site was determined dur-ing surgery.

Data included demographic, anatomic informationwith aneurysm morphology, surgical procedural details,postoperative events, and radiographic follow-up. Renalfunction was monitored preoperatively and postoperatively.Renal insufficiency was defined by a creatinine level$1.5 mg/dL.

The study excluded patients referred for extent I-IVthoracoabdominal aneurysms, ruptured or symptomaticaneurysms, patients with a redo aortic surgery or a historyof aortic intervention, and patients with actual or antici-pated infrarenal clamp position.

End points. The primary end point was 30-day mor-tality. Secondary outcomes included any complication(including procedural and graft complications, cardiac,renal, and respiratory complications), procedural, and graftcomplications #30 days postoperatively. Cardiac compli-cations were defined as acute myocardial infarction oremergent arrhythmia. Pulmonary complications consistedof ventilation >48 hours postoperatively, reintubation,pneumonia, and pulmonary embolism. Renal failure wasdefined when the patient required transient or definitivehemodialysis postoperatively. New-onset renal insufficiencywas defined by an increase of creatinine of 0.5 mg/dL overbaseline, and with a creatinine increase to >1.5 mg/dL.Procedural complications encompassed postoperativebleeding and a return to the operating room. Graft com-plications included any graft-related event during surgeryor in the postoperative period.

Statistical analysis. To obtain comparable cohorts, apropensity score (PS) was generated using multivariableregression modeling to assess each patient’s propensityfor undergoing FEVAR repair. Statistically significant(P < .05) determinants of the PS for FEVAR repairincluded gender, age, chronic obstructive pulmonary dis-ease (COPD), coronary artery disease (CAD), congestive

heart failure (CHF), history of coronary intervention, dia-betes, and actual or anticipated clamp location. PS match-ing was then performed using the caliper method,matching each case (FEVAR) with four controls (OSR)#0.2 standard deviations of the PS. This resulted in well-matched cases and controls for analysis.

Clinical features, demographic, and outcomes data arepresented as the number in each category and the percent-age this number represents. Data for continuous variablesare presented as the mean 6 standard deviation. Univari-ate analysis was performed using the c2 or the Fisher exacttest for discrete variables, the t-test with equal variancesfor normal continuous variables, and the Wilcoxon ranksum test for non-normally distributed continuous orordinal variables. Multivariate regression analysis was per-formed to identify independent predictors of primary andsecondary outcomes. Odds ratios (ORs) and 95% confi-dence intervals (CIs) are presented. A two-sided P valueof <.05 was considered statistically significant. Statisticalanalysis was performed using SAS 9.2 software (SAS Insti-tute, Cary, NC).

RESULTS

Demographics. During the study period, 324 pa-tients underwent OSR at the MGH and 59 underwentFEVAR at Henri Mondor Hospital. Five patients fromthe OSR group and four from the FEVAR cohort wereexcluded due to an actual/anticipated partial suprarenalclamping site, based on operative records or CT scan re-view. Demographic and anatomic data are presented inTable I. Before propensity matching, patients in theFEVAR group had a higher incidence of CHF, CAD,COPD, and diabetes than those in the OSR group. TheFEVAR patients also had a higher proportion of antici-pated supravisceral clamp position, which includedclamping above the superior mesenteric artery (SMA) orceliac artery. After propensity matching, there were 42patients in the FEVAR group and 147 in the OSR group.Propensity matching resulted in correction of all differ-ences in baseline clinical characteristics, including clamplocation (Table I).

All of the fenestrated grafts used were commerciallyapproved devices, with 95% being Cook Z-FEN (CookAustralia, Brisbane, Queensland, Australia). The distribu-tion of visceral vessel involvement in FEVAR includedthe following: 30% of the EVAR patients had two vesselstreated, 50% had three fenestrations/scallops, and 20%had four vessels treated for the implanted device, resultingin an average number of 2.9 vessels treated per patient.Grafts configurations are presented in Table II. The proce-dure for implantation of fenestrated grafts has been previ-ously described.14,15

For the OSR patients, 91% were treated through a leftflank thoracoabdominal incision. Surgical reconstructionmethods for CAAAs have also been previously detailed.12

Univariate analysis of 30-day outcomes. In thepropensity-matched cohorts, 30-day mortality was 2% forOSR vs 9.5% for FEVAR (P ¼ .04). Two patients in the

Table II. Stent graft configurations in fenestratedendovascular aneurysm repair (FEVAR) group

Graft configuration Patients, No.

1 fenestration, 1 scallop 11 fenestration, 2 scallops 32 fenestrations 122 fenestrations, 1 scallop 93 fenestrations 93 fenestrations, 1 scallop 74 fenestrations 1

Table I. Clinical and demographic features

Variable

Unmatched cohort Propensity-matched cohort

FEVAR (n ¼ 55) OSR (n ¼ 319) P FEVAR (n ¼ 42) OSR (n ¼ 147) P

Age, mean 6 SD, years 73 6 9.3 74 6 8.0 .8 73 6 10 73 6 7.8 .8Male sex, % 91 70 .001 88 82 .4History of aneurysm, % 7.3 5.3 .2 4.8 5.4 .3Hypertension, % 65 90 <.0001 74 80 .4MI, % 35 34 .9 26 36 .2CHF, % 24 7.5 .0002 14 12 .6CAD, % 56 23 <.0001 43 34 .3COPD, % 44 24 .003 36 25 .2CVA, % 11 7.9 .1 7.1 7.5 .3Diabetes, % 22 11 .02 19 14 .5Smoking, % 60 78 .005 67 71 .6CRI, % 24 19 .5 26 20 .4Clamp, %

Suprarenal 53 76 .0003 57 63 .5Supravisceral 47 24 .0003 43 37 .5

CAD, Coronary artery disease; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; CRI, chronic renal insufficiency; CVA, cere-brovascular accident; FEVAR, fenestrated endovascular aneurysm repair; MI, myocardial infarction; OSR, open surgical repair; SD, standard deviation.

Table III. Univariate analysis of perioperative outcomes

OutcomeFEVAR

(n ¼ 42) (%)OSR

(n ¼ 147) (%) P

30-day mortality 9.5 2 .04ComplicationAny 43 23 .01Cardiac 4.8 9.5 .2Pulmonary 12 10 .2Renal 7.1 2.7 .1Procedural 24 8 .004Graft 33 2 <.0001

FEVAR, Fenestrated endovascular aneurysm repair; OSR, open surgicalrepair.

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FEVAR group died of mesenteric infarction, one died ofmultiple organ failure and mesenteric ischemia, and onedied of respiratory failure due to pneumonia.

The proportion of any complication was higher in theFEVAR group, with complications in 43% of FEVARcompared with 23% for OSR (P ¼ .01). Procedural compli-cations were more frequent in the FEVAR group (24%)than in OSR group (7.5%) (P ¼ .004). Graft complications,excluding all endoleaks, were also significantly higher in theFEVAR group than in the OSR group (33% vs 2%; P <.0001). The occurrence of organ system specific, cardiac,pulmonary, or renal complications was not significantlydifferent between the groups. These results are summa-rized in Table III. Procedural complications are detailedin Table IV.

Multivariate analysis. In the propensity-matched dataset, multivariable analysis identified FEVAR as an inde-pendent predictor of 30-day mortality (OR, 5.1; 95% CI,1.1-24; P ¼ .04). FEVAR was also independently associ-ated with the occurrence of any complication (OR, 2.3;95% CI, 1.1-4.9; P ¼ .03), any procedural complication(OR, 4.3; 95% CI, 1.5-12; P ¼ .006), and was a statisticallysignificant predictor of a graft complication (OR, 24; 95%

CI, 6.5-89; P < .0001). COPD was independently asso-ciated with the occurrence of any complication (OR, 3.3;95% CI, 1.7-6.7; P ¼ .0008) and procedural complications(OR, 4.3; 95% CI, 1.6-11.5; P ¼ .0043). A history ofmyocardial infarction was found to independently predictthe occurrence of procedural complications (OR, 3.9; 95%CI, 1.4-11; P ¼ .0085). These data are presented inTable V.

DISCUSSION

Owing to the paradigm shift from open surgery toendovascular repair for the treatment of standard infrarenalAAA during the last decade, it was consistent to considerthat the same shift might have occurred for the treatmentof complex aneurysms with endovascular repair. FEVAR,however, is a more complex and demanding procedurethan EVAR for infrarenal aortic aneurysms. FEVAR re-quires scrupulous preoperative planning, advanced endo-vascular skills, and an experienced medical team wellversed with the wide endovascular armamentariumrequired to ensure success.

Table IV. Type of complications (matched cohort)

FEVAR group OSR group

1 SMA scallop malposition 1 renal artery injury1 SMA stent migration 1 acute renal artery thrombosis2 renal artery thrombosis 2 retroperitoneal hematoma2 renal stent thrombosis 2 postoperative bleeding1 renal stent disconnection 1 renal bypass thrombosis3 iliac limb grafts thrombosis 1 early wound dehiscence1 iliac limb disconnection3 acute ischemia

on iliac dissection1 acute ischemia

(femoral endarterectomy)1 accidental internal iliac cover

FEVAR, Fenestrated endovascular aneurysm repair; OSR, open surgicalrepair; SMA, superior mesenteric artery.

Table V. Multivariable models for 30-day outcomes inmatched patients

Outcome OR 95% CI P

DeathFEVAR 5.1 1.08-24 .04

Any complicationFEVAR 2.3 1.1-4.9 .03COPD 3.3 1.7-6.7 .0008

Cardiac complicationFEVAR 0.47 0.1-2.2 .34

Pulmonary complicationFEVAR 1.19 0.41-3.5 .75

Renal complicationFEVAR 2.8 0.6-13 .2

Procedural complicationFEVAR 4.3 1.5-12 .006MI 3.9 1.4-11 .009COPD 4.3 1.6-11 .004

Graft complicationFEVAR 24 6.5-89 <.0001

CI, Confidence interval; COPD, chronic obstructive pulmonary disease;FEVAR, fenestrated endovascular aneurysm repair; MI, myocardial infarc-tion; OR, odds ratio.

JOURNAL OF VASCULAR SURGERY4 Raux et al --- 2014

Recent studies and meta-analyses of FEVAR suggestexcellent early and midterm outcomes, with 30-day mortal-ity varying from 2% to 4.1%, with very encouraging tech-nical success rates.7,16-19 Other recent series havehighlighted excellent long-term results in durability,freedom from any reintervention, and branch stentpatency.20,21 However, most of these data represent singlehigh-volume center experiences or trial or registry datawith careful patient selection protocols without controlarms. Studies comparing both techniques are sparse.

In a recent retrospective cohort study, Canavati et al22

reported that FEVAR significantly reduced mortalitycompared with OSR in the treatment of juxtarenal or para-renal aneurysms. In this small series (n ¼ 107), the re-ported perioperative mortality of 9.5% for OSR wassignificantly higher than previously reported in a largemeta-analysis23 of pararenal aneurysms despite including

20 patients (18.6%) who had undergone infrarenal clamp-ing and should not have been included for comparison.

A larger systematic review comparing outcomes ofOSR and FEVAR repair of juxtarenal AAAs pooled resultsfrom eight FEVAR and 12 OSR series and showed favor-able outcomes in patients treated with FEVAR.19 These in-vestigators, however, acknowledged significant limitationsspecifically regarding their inability to compare anatomi-cally similar patients and selection biases inherent to theincluded studies.

Our study is the first report to comparatively evaluateoutcomes of CAAA repair in contemporary practice usingrigorous methods to compare patients both anatomicallyand with similar clinical risk. Contrary to the extant litera-ture, this study’s findings suggest that FEVAR is associatedwith a higher procedural mortality, complications, andgraft-related complications compared with OSR inpropensity-matched patients.

Several of our study findings deserve further consider-ation, the first of which is our primary outcome measureof procedural mortality. We found that patients undergo-ing FEVAR had a significantly higher operative mortalitycompared with previously published single-center re-ports20,22 and with pooled results from several systematicreviews.16,18,19 This difference in mortality may beexplained by patient selection, specifically in regards toaneurysm morphology. Prior FEVAR studies included asignificant proportion of patients who did not qualify forEVAR due to anatomic requirements, particularly shorternecks. Early patients were therefore treated with FEVARto achieve adequate seal zones, primarily using fenestra-tions and scallops to incorporate the renal arteries.16,18,19

Furthermore, each of these reports acknowledged thatmore than half of the included studies did not provideanatomic information about the proximal neck.

Our study took into account this limitation of earliercomparative studies. Therefore, the analysis in this studyincluded all FEVAR patients with respect to the anticipatedclamp location for open reconstruction, thus providinganatomic similarity. The use of such methods made itmore likely that patients in this FEVAR group wouldhave three visceral vessels incorporated into the proximalseal zone, and had they required OSR, almost half wouldrequire a supravisceral aortic cross-clamp. The use ofFEVAR for more complex aneurysm anatomy likelycontributed to the increased mortality for FEVAR weobserved.

Another major determinant for the increased FEVARmortality observed in this study relates to patient selection.Earlier studies, as mentioned above, referred patients withshort necks to FEVAR; however, there was no particularemphasis on patient ineligibility for OSR. In the presentstudy, patients were referred to FEVAR based on the sur-geon’s impression that they were too high risk for OSR.The operative volume and reported outcomes from bothcenters involved in this study suggest excellent discretion,patient selection, and operative management of patientswith CAAA; further qualifying patients as truly high clinical

JOURNAL OF VASCULAR SURGERYVolume -, Number - Raux et al 5

risk. The patients referred to FEVAR in the present studywere therefore more likely to have CAD, CHF, COPD,and chronic renal insufficiency compared with previousstudies. The Endovascular aneurysm repair and outcomein patients unfit for open abdominal aortic aneurysm(EVAR 2) trial4 defined patients as high risk for open repairpredominantly using CAD and COPD. These investigatorsreported that perioperative mortality for EVAR, a muchsimpler technical procedure than FEVAR, was 9%when per-formed in patients deemed too high risk for open infrarenalAAA repair. This study’s results suggest that when patientsare deemed too high risk for open juxtarenal repair, theyare likely to have a high procedural mortality if referred toFEVAR, even at a high-volume endovascular center.

Our study also helps to define patients who may be toohigh risk for FEVAR. In this reported series, four FEVARpatients died. One died of respiratory failure due to pneu-monia after an uncomplicated procedure reflecting patientfactors. Three deaths, however, were related to mesentericinfarction. None of these patients had a prior SMA or celiactrunk stenoses. Two of them had stented SMA fenestrations,and one had an unstented SMA scallop. No particular cathe-terization issue or stent placement was required during theprocedure in the treatment of these patients. Immediatepostoperative imaging and CT scans performed whenpatients clinically deteriorated revealedpatent SMAandceliacvessels. Surgical exploration in these three patients revealedpatent mesenteric pulses with multiple areas of infarctedbowel and pathology consistent with cholesterol emboli. Inthe absences of cholesterol embolization, these patientswould likely have had a favorable outcome resulting in similaroperativemortality in the FEVAR andOSR cohorts. As such,patient selection with a particular focus on anatomic consid-erations, including navigation difficulties and diseased aortasthat have embolic potential, need tobe carefully considered inthe planning of potential candidates for FEVAR. These fac-tors may play a greater role in patient outcomes than patientcomorbidities, as suggested by our experience.

With respect to procedural morbidity, this studyshowed no major effect of OSR or FEVAR on organ-specific complications. FEVAR was not protective for car-diac or pulmonary complications, suggesting that patientsconsidered high risk due to these comorbidities might besafely taken through OSR with good operative techniqueand meticulous anesthesia care.

This study also indicated that FEVAR was indepen-dently associated with increased procedural complications.EVAR for infrarenal AAA has been associated with a higherrate of reintervention than OSR.3 It is not surprising that,owing to the complexity of fenestrated devices and implan-tation procedures, reintervention rates and graft complica-tions were also higher in the FEVAR group. Among the42 patients in the propensity-matched endovascular cohort,14 had graft complications #30 days; of which six were dueto visceral arteries catheterization and 5 to an iliac extensionthrombosis. Five patients had a graft malposition issue.

This study has several limitations. First, it is limited byits retrospective nature, even if the data were collected

prospectively. Patients in this nonrandomized observa-tional series were analyzed from two different internationalcenters, with different clinical practices and referral pat-terns. Although every attempt was made to create anatom-ically and clinically similar cohorts for analysis, comparingpatients that may differ in clinical gravity is difficult. Thepropensity matching was based on observed and recordedfeatures; yet, numerous clinical factors are taken intoconsideration for surgical decision making that are notmeasured and were not available for evaluation in the pro-pensity matching. Such factors that might affect surgicaloutcomes but were not included are patient functional sta-tus, aneurysm growth rate, symptomatic status, and clinicalurgency, to name a few.

Initially, patients from the FEVAR cohort were likelyto have a higher surgical risk than patients from the OSRgroup. This subset of patients likely had a higher propor-tion of CAD, CHF, COPD, and chronic kidney disease.They also had a higher proportion of supravisceral antici-pated clamp position, reflecting the extent of the aneu-rysmal disease. Although the two different patientcohorts were well matched by the PS, there were likely spe-cific anatomic and clinical characteristics that might havebeen important to the FEVAR group but were not consid-ered. It is noteworthy that there was no comparison oftarget vessel anatomy or considerations related to aorticvessel anatomy. There was no comparison of access vesselquality, neck angulation, visceral vessel orientation, ostialvisceral occlusive disease, and aortic morphology forcomparison.

Navigation difficulties and graft placement in visceralvessels are important aspects of FEVAR that might haveadversely affected only that cohort specifically in terms ofgraft and procedural complications; however, this was notcorrected for. Availability of such anatomic and clinicallyrelevant technical differences across the procedure typesand the ability to correct for them in the propensity match-ing would have further strengthened the analysis.

In every surgical procedure, the learning curve remainsa pivotal point that influences results and outcomes. Thisseries compared two different techniques in two differentcenters. OSR is a well-established technique, and the largeskill set needed to procure excellent outcomes has beenwell mastered. FEVAR is a more recent technique that isin evolution and in the same treatment period had <20%the number of cases. Furthermore, FEVAR proceduresrequire not only the implantation of a device as in OSRbut also a significant amount of preoperative planningnecessitating a certain level of expertise, includingadvanced skills in three-dimensional imaging, anticipationof navigation difficulties, salvage maneuvers, and knowl-edge of the graft and material limitations. All this knowl-edge can be only be acquired over time and with anumber of failures to identify those cases that cannot beadequately performed. The learning curve of the endovas-cular technique was likely responsible for part of theadverse outcomes observed in the FEVAR cohort.Although these FEVAR and OSR procedures were

JOURNAL OF VASCULAR SURGERY6 Raux et al --- 2014

performed at high-volume centers, our results may not begeneralizable to other centers with lower surgical volume.

CONCLUSIONS

In this propensity-matched series, FEVAR was associ-ated with a higher mortality and an “any complication”occurrence compared with OSR, highlighting that OSRshould be considered preferable to FEVAR for the low-risk patient with a CAAA. Mesenteric infarction was theprincipal cause of death after FEVAR. Identifying patientswith potential target vessel difficulties or graft complica-tions might identify patients at risk for FEVAR. Thereby,the extension of the infrarenal AAA treatment paradigmshift to EVAR cannot be applied to a similar paradigm shiftof CAAA to FEVAR. Prospective studies will help to deter-mine benefits of FEVAR over OSR.

AUTHOR CONTRIBUTIONS

Conception and design: MR, VP, GLAnalysis and interpretation: MR, VP, FC, SM, PD, RC, JB,

GLData collection: MR, VP, FC, SM, PDWriting the article: MR, VP, GLCritical revision of the article: MR, VP, FC, SM, PD, RC,

JB, GLFinal approval of the article: MR, VP, FC, SM, PD, RC,

JB, GLStatistical analysis: VP, SMObtained funding: MR, RC, JB, GLOverall responsibility: VPMR and VP participated equally and share first authorship.

REFERENCES

1. Giles KA, Pomposelli F, Hamdan A, Wyers M, Jhaveri A,Schermerhorn ML. Decrease in total aneurysm-related deaths in the eraof endovascular aneurysm repair. J Vasc Surg 2009;49:543-51.

2. Schwarze ML, Shen Y, Hemmerich J, Dale W. Age-related trends in uti-lization and outcome of open and endovascular repair for abdominal aorticaneurysm in the United States, 2001-2006. J Vasc Surg 2009;50:722-9.

3. Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG;The EVAR trial participants. Comparison of endovascular aneurysmrepair with open repair in patients with abdominal aortic aneurysm(EVAR trial 1), 30-day operative mortality results: randomizedcontrolled trial. Lancet 2004;364:843-8.

4. EVAR trial participants. Endovascular aneurysm repair and outcome inpatients unfit for open repair of abdominal aortic aneurysm (EVAR trial2). Lancet 2005;365:2187-92.

5. Prinssen M, Verhoeven EL, Buth J, Cuypers PW, van Sambeek MR,Balm R, et al. A randomized trial comparing conventional and endovascularrepair of abdominal aortic aneurysm. N Engl J Med 2004;351:1607-18.

6. Patel VI, Lancaster RT, Conrad MF, LaMuraglia GM, Kwolek CJ,Brewster BC, et al. Comparable mortality with open repair of complexand infrarenal aortic aneurysm. J Vasc Surg 2011;54:952-9.

7. Cross J, Gurasamy K, Gadhvi V, Simring D, Harris P, Ivancev K, et al.Fenestrated endovascular aneurysm repair. Br J Surg 2012;99:152-9.

8. Coscas R, Becquemin JP, Majewski M, Mayer J, Marzelle J, Allaire E,et al. Management of peri-operative endoleaks during endovasculartreatment of juxta-renal aneurysms. Ann Vasc Surg 2012;26:175-84.

9. Cochennec F, Marzelle J, Allaire E, Desgranges P, Becquemin JP.Open vs endovascular repair of abdominal aortic aneurysm involvingthe iliac bifurcation. J Vasc Surg 2010;51:1360-6.

10. Conrad MF, Crawford RS, Pedraza J, Brewster DC, LaMuraglia GL,Corey M, et al. Long-term durability of open abdominal aortic aneu-rysm repair. J Vasc Surg 2007;46:669-75.

11. Brewster DC, Jones JE, Chung TK, LaMuraglia GM, Kwolek CJ,Watkins MT, et al. Long-term outcome after endovascular abdominalaortic aneurysm repair: the first decade. Ann Surg 2006;244:426-38.

12. Tsai S, Conrad MF, Patel VI, Kwolek CK, LaMuraglia GM,Brewster DC, et al. Durability of open repair of juxtarenal abdominalaortic aneurysms. J Vasc Surg 2012;56:2-7.

13. Lancaster RT, Conrad MF, Patel VI, Cambria MR, Ergul EA,Cambria RP. Further experience with distal aortic perfusion and motor-evoked potential monitoring in the management of extent I-III thor-acoabdominal aortic aneurysms. J Vasc Surg 2013;58:283-90.

14. Moore R, Hinojosa CA, O’Neill S, Mastracci TM, Cina CS. Fenes-trated endovascular grafts for juxtarenal aortic aneurysms: a step by steptechnical approach. Catheter Cardiovasc Interv 2007;69:554-71.

15. Browne TF, Hartley D, Purchas S, Rosenberg M, Van Schie G,Lawrence-Brown M. A fenestrated covered suprarenal aortic stent.Eur J Vasc Endovasc Surg 1999;18:445-9.

16. Linsen MA, Jongkind V, Nio D, Hoksbergen AW, Wisselink W. Par-arenal aortic aneurysm repair using fenestrated endografts. J Vasc Surg2012;56:238-46.

17. Greenberg RK, Sternbergh WC, Makaroun M, Ohki T, Chuter T,Bharadwaj P, et al. on behalf of the Fenestrated Investigators. Inter-mediate results of a United States multicenter trial of fenestratedendograft repair for juxtarenal abdominal aortic aneurysms. J Vasc Surg2009;50:730-7.

18. Amiot S, Haulon S, Becquemin JP, Magnan PE, Lermusiax P,Goueffic Y, et al. Association Universitaire de Recherche en ChirurgiVasculaire (AURC). Fenestrated endovascular grafting: the Frenchmulticentre experience. Eur J Vasc Endovasc Surg 2009;39:537-44.

19. Nordon IM, Hinchcliffe RJ, Holt PJ, Loftus IM, Thompson MM.Modern treatment of juxtarenal abdominal aortic aneurysms withfenestrated endografting and open repairea systematic review. Eur JVasc Endovasc Surg 2009;38:35-41.

20. Verhoeven EL, Vourliotakis G, Bos WT, Tielliu IF, Zeebregts CJ,Prins TR, et al. Fenestrated stent grafting for short-necked and jux-tarenal abdominal aortic aneurysm: an 8-year single-centre experience.Eur J Vasc Endovasc Surg 2010;39:529-36.

21. Mastracci TM, Greenberg RK, Eagleton MJ, Hernandez AV. Dura-bility of branches in branched and fenestrated endografts. J Vasc Surg2013;57:926-33; discussion: 933.

22. Canavati R, Millen A, Brennan J, Fisher R, McWilliams RG, Naik JB,et al. Comparison of fenestrated endovascular and open repair ofabdominal aortic aneurysms not suitable for standard endovascularrepair. J Vasc Surg 2013;57:362-7.

23. Jongkind V, Yeung KK, Akkersdijk GJ, Heidsieck D, Reitsma JB,Tangelder GJ, et al. Juxtarenal aortic aneurysm repair. J Vasc Surg2010;52:760-7.

Submitted Nov 13, 2013; accepted Apr 3, 2014.

DISCUSSION

Dr Gustavo Oderich (Rochester, Minn). I rise here becauseyour results are markedly different than what has been reportedin numerous publications, including meta-analyses, systematic

reviews, prospective studies, and national data sets. Clearly bothoperationsdopen or fenestrated repairdrequire a set of skillsand a learning curve that has to be mastered for one to achieve

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outstanding results. Case selection, planning, and multidisciplinarypostoperative care can have great impact on early outcomes ofboth procedures. Therefore, the obvious question is whether thelearning curve and skill set which has been achieved at the Massa-chusetts General Hospital (MGH) with open repair of hundreds ofpatients with juxtarenal, suprarenal, and thoracoabdominal aneu-rysms over decades, has also been achieved with the first 50 fenes-trated cases done at your center. Clearly, at least in our experience,I think fenestrated repair does require a learning curve, planning,case selection, and mastering a set of skillsdeven for those thatare already skilled and experienced with other types of endovascu-lar procedures.

The other particular question pertain the cause of death,which in most patients was mesenteric ischemia. Do you thinkthis was due to embolization or ischemia from narrow or occludedstents? We now stent all single-diameter scallops. I’ll tell you thatat least in our experience, scallops of 10-mm diameter may be asso-ciated with mesenteric ischemia, and the safest is probably to stentliberally.

Dr Maxime Raux. One of the major causes of death was notmesenteric ischemia but infarction due to multiple embolisms aftercatheterization, but no superior mesenteric artery was thrombosedafter the procedure. And when we made computed tomographyscans for the patients, all superior mesenteric arteries were patent,but it is probably related to multiple emboli.

Dr John Ricotta (Washington, D.C.). That was a very nicepaper. If I interpreted correctly, what it says is if you have a patientthat is suitable for open repair, that fenestrated repair offers nobenefit and may be worse. But it doesn’t address the issue of thepatient who is not suited for open repair. You had about 15 ofyour patients in the fenestrated group who were not propensity

matched, so I assume that they didn’t match with anybody inthe open group. Could you tell us what happened to those pa-tients? Could you tell us whether the mortality rate in the opengroup that was not propensity matched was the same as in the pro-pensity-matched group so that we can get some idea about that?

Dr Raux. The mortality rate in the open group was mostly thesame, but in the fenestrated endovascular repair group (FEVAR)group, on the unmatched patient, the mortality rate was higher,with 10.5% mortality for the unmatched patient. Maybe ProfessorBecquemin would like to comment.

Dr Jean-Pierre Becquemin (Créteil, France). I have somecomments. First, I want to congratulate Maxime for this veryimportant work and also my colleagues from MGH for theoutstanding results. Obviously, we were disappointed by ourown results with FEVAR, which resulted in a higher than expectedmortality rate. As mentioned, this mortality rate was mostly relatedto multiple atherosclerotic embolisms. It was probably a mistake totreat some of these patients with FEVAR.

Lessons can be drawn from this study: (1) surgery can giveexcellent results in expert hands, and (2) FEVAR is not an easyprocedure. It may be very tricky, even if you carefully select pa-tients. Sometimes the target vessels, the aorta, or the access vesselsare not suitable and pushing the limits of indications may end up incatastrophe.

Finally, I think that FEVAR has obviously a future since stentgraft technology will improve as well as the skill of surgeons per-forming these procedures. The key selection criterion, in myopinion, is not patients’ general status (high risk for FEVAR,low risk for open repair), but more the anatomical suitability ofvessels. With a proper selection, results of FEVAR will probablyequal the results of open surgery in the near future.