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Editor's Choice – Thirty day Outcomes and Costs of Fenestrated and Branched Stent Grafts versus Open Repair for Complex Aortic Aneurysms

  • M. Michel
    Correspondence
    Corresponding author. URC Eco, DRCD, AP-HP, Hôtel Dieu, 1 place du Parvis de Notre Dame, 75004 Paris, France.
    Affiliations
    URC Eco Ile de France, DRCD, AP-HP, Hôtel Dieu, Paris, France
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  • Author Footnotes
    d J.-P. Becquemin and M.-C. Clément contributed equally to this article.
    J.-P. Becquemin
    Footnotes
    d J.-P. Becquemin and M.-C. Clément contributed equally to this article.
    Affiliations
    Department of Vascular Surgery, CHU Henri Mondor, Créteil, France
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  • Author Footnotes
    d J.-P. Becquemin and M.-C. Clément contributed equally to this article.
    M.-C. Clément
    Footnotes
    d J.-P. Becquemin and M.-C. Clément contributed equally to this article.
    Affiliations
    URC Eco Ile de France, DRCD, AP-HP, Hôtel Dieu, Paris, France
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  • J. Marzelle
    Affiliations
    Department of Vascular Surgery, CHU Henri Mondor, Créteil, France
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  • C. Quelen
    Affiliations
    URC Eco Ile de France, DRCD, AP-HP, Hôtel Dieu, Paris, France
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  • I. Durand-Zaleski
    Affiliations
    URC Eco Ile de France, DRCD, AP-HP, Hôtel Dieu, Paris, France

    UPEC, CHU Henri Mondor, Créteil, France
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  • on behalf of theWINDOW Trial Participants
    Author Footnotes
    e The members are listed in Appendix 1, Supplementary Material.
  • Author Footnotes
    d J.-P. Becquemin and M.-C. Clément contributed equally to this article.
    e The members are listed in Appendix 1, Supplementary Material.
Open ArchivePublished:June 19, 2015DOI:https://doi.org/10.1016/j.ejvs.2015.04.012

      Objective

      To compare 30 day outcomes and costs of fenestrated and branched stent grafts (f/b EVAR) and open surgery (OSR) for the treatment of complex abdominal aortic aneurysms (AAA) and thoraco-abdominal aortic aneurysms (TAAA).

      Methods

      The multicenter prospective registry WINDOW was set up to evaluate f/b EVAR in high risk patients with para/juxtarenal AAA, and infradiaphragmatic and supradiaphragmatic TAAA. A control group of patients treated by OSR was extracted from the national hospital discharge database. The primary endpoint was 30 day mortality. Secondary endpoints included severe complications, length of stay, and costs. Mortality was assessed by survival analysis and uni/multivariate Cox regression analyses using pre- and post-operative characteristics. Bootstrap methods were used to estimate the cost-effectiveness of f/b EVAR versus OSR.

      Results

      Two hundred and sixty eight cases and 1,678 controls were included. There was no difference in 30 day mortality (6.7% vs. 5.4%, p = 0.40), but costs were higher with f/b EVAR (€38,212 vs. €16,497, p < .001). After group stratification, mortality was similar with both treatments for para/juxtarenal AAA (4.3% vs. 5.8%, p = .26) and supradiaphragmatic TAAA (11.9% vs. 19.7%, p = .70), and higher with f/b EVAR for infradiaphragmatic TAAA (11.9% vs. 4.0%, p = .010). Costs were higher with f/b EVAR for para/juxtarenal AAA (€34,425 vs. €14,907, p < .0001) and infradiaphragmatic TAAA (€37,927 vs. €17,530, p < .0001), but not different for supradiaphragmatic TAAA (€54,710 vs. €44,163, p = .18).

      Conclusion

      f/b EVAR does not appear justified for patients with para/juxtarenal AAA and infradiaphragmatic TAAA fit for OSR but may be an attractive option for patients with para/juxtarenal AAA not eligible for surgery and patients with supradiaphragmatic TAAA. Clinical Trial Registration: http://www.clinicaltrials.gov/ct2/show/NCT01168037; identifier: NCT01168037 (WINDOW registry).

      Keywords

      The use of fenestrated and branched endovascular repair for complex aortic aneurysms is currently limited by the high unit cost of the custom made devices and the lack of head to head trial evidence of a better outcome compared with open surgical repair. In addition, there has been no economic evaluation of f/b EVAR in the treatment of complex aortic aneurysms. The results of this study are a first step towards helping clinicians decide which patients should benefit from these expensive and innovative devices.

      Introduction

      The benefits of standard endovascular (EVAR) over open repair (OSR) for infrarenal abdominal aortic aneurysms (AAA) have been documented both in terms of 30 day mortality and length of stay (LOS) by randomized controlled trials (RCT) and meta-analyses.
      • Lederle F.A.
      • Freischlag J.A.
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      • Padberg Jr., F.T.
      • Matsumura J.S.
      • Kohler T.R.
      • et al.
      Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial.
      • Hayes P.D.
      • Sadat U.
      • Walsh S.R.
      • Noorani A.
      • Tang T.Y.
      • Bowden D.J.
      • et al.
      Cost-effectiveness analysis of endovascular versus open surgical repair of acute abdominal aortic aneurysms based on worldwide experience.
      • Greenhalgh R.M.
      • Brown L.C.
      • Kwong G.P.S.
      • Powell J.T.
      • Thompson S.G.
      EVAR trial participants
      Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30 day operative mortality results: randomised controlled trial.
      • United Kingdom EVAR Trial Investigators
      • Greenhalgh R.M.
      • Brown L.C.
      • Powell J.T.
      • Thompson S.G.
      • Epstein D.
      • et al.
      Endovascular versus open repair of abdominal aortic aneurysm.
      • Becquemin J.-P.
      • Pillet J.-C.
      • Lescalie F.
      • Sapoval M.
      • Goueffic Y.
      • Lermusiaux P.
      • et al.
      A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients.
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      • Sidloff D.
      • Dattani N.
      • Choke E.
      • Bown M.J.
      • Sayers R.D.
      Systematic review and meta-analysis of the early and late outcomes of open and endovascular repair of abdominal aortic aneurysm.
      • Lederle F.A.
      • Stroupe K.T.
      Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group
      Cost-effectiveness at two years in the VA Open versus Endovascular Repair Trial.
      • Sultan S.
      • Hynes N.
      Clinical efficacy and cost per quality-adjusted life years of pararenal endovascular aortic aneurysm repair compared with open surgical repair.
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      • Blackhouse G.
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      • Bowen J.M.
      • Hopkins R.
      • et al.
      Cost-effectiveness analysis of elective endovascular repair compared with open surgical repair of abdominal aortic aneurysms for patients at a high surgical risk: a 1-year patient-level analysis conducted in Ontario, Canada.
      However, standard stent grafts are not adapted to complex aortic aneurysms, including AAAs with short or absent neck and/or involving visceral arteries, and thoraco-abdominal aneurysms (TAAA). Fenestrated and branched stent grafts (f/b EVAR), which allow revascularization of thoracic, visceral, and renal arteries, have been developed to fill that gap. Initial reports have demonstrated feasibility and efficacy of this technique;
      • Semmens J.B.
      • Lawrence-Brown M.M.D.
      • Hartley D.E.
      • Allen Y.B.
      • Green R.
      • Nadkarni S.
      Outcomes of fenestrated endografts in the treatment of abdominal aortic aneurysm in Western Australia (1997–2004).
      • Verhoeven E.L.G.
      • Vourliotakis G.
      • Bos W.T.G.J.
      • Tielliu I.F.J.
      • Zeebregts C.J.
      • Prins T.R.
      • et al.
      Fenestrated stent grafting for short-necked and juxtarenal abdominal aortic aneurysm: an 8-year single centre experience.
      • British Society for Endovascular Therapy and the Global Collaborators on Advanced Stent-Graft Techniques for Aneurysm Repair (GLOBALSTAR) Registry
      Early results of fenestrated endovascular repair of juxtarenal aortic aneurysms in the United Kingdom.
      however, no head to head trial has ever been carried out to compare f/b EVAR with OSR. The very high unit cost of the custom made f/b stent graft also needs to be considered. While several in trial analyses and models have compared the cost-effectiveness of EVAR and OSR in AAA,
      • Hayes P.D.
      • Sadat U.
      • Walsh S.R.
      • Noorani A.
      • Tang T.Y.
      • Bowden D.J.
      • et al.
      Cost-effectiveness analysis of endovascular versus open surgical repair of acute abdominal aortic aneurysms based on worldwide experience.
      • United Kingdom EVAR Trial Investigators
      • Greenhalgh R.M.
      • Brown L.C.
      • Powell J.T.
      • Thompson S.G.
      • Epstein D.
      • et al.
      Endovascular versus open repair of abdominal aortic aneurysm.
      • Lederle F.A.
      • Stroupe K.T.
      Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group
      Cost-effectiveness at two years in the VA Open versus Endovascular Repair Trial.
      • Sultan S.
      • Hynes N.
      Clinical efficacy and cost per quality-adjusted life years of pararenal endovascular aortic aneurysm repair compared with open surgical repair.
      • Tarride J.-E.
      • Blackhouse G.
      • De Rose G.
      • Novick T.
      • Bowen J.M.
      • Hopkins R.
      • et al.
      Cost-effectiveness analysis of elective endovascular repair compared with open surgical repair of abdominal aortic aneurysms for patients at a high surgical risk: a 1-year patient-level analysis conducted in Ontario, Canada.
      there has not, to the authors' knowledge, been an economic evaluation of f/b EVAR in the treatment of complex aortic aneurysms. The objective of the present study was to compare outcomes and costs of f/b EVAR with those of OSR for complex AAA or TAAA.

      Materials and Methods

      Study design

      WINDOW is a multicenter prospective registry for patients treated with f/b EVAR, which has been described previously.
      • Marzelle J.
      • Presles E.
      • Becquemin J.P.
      WINDOWS trial participants
      Results and factors affecting early outcome of fenestrated and/or branched stent grafts for aortic aneurysms: a multicenter prospective study.
      Only 30 day data are available at this stage. A control group of patients treated with OSR was extracted from the national hospital discharge database (Programme de médicalisation des systèmes d'information) for the years 2010–2012. This database records all acute care hospital admissions using diagnostic related groups (DRG), along with other variables such as diagnoses (primary and secondary, using the 10th edition of the International Classification of Diseases [ICD-10]), surgical procedures, and LOS. Record linkage is performed at national level. In addition, a probabilistic analysis of the national hospital discharge database was performed to consolidate the information available in cases' case report forms (CRF) and for comparison purposes.
      The protocol was approved by the institutional review board of Hôtel Dieu Hospital (Paris), and all cases signed a written consent to participate in the registry. The French Data Protection Authority granted access to control data.

      Study population

      Selection criteria of patients with complex AAA or TAAA treated by f/b EVAR have been described previously.
      • Marzelle J.
      • Presles E.
      • Becquemin J.P.
      WINDOWS trial participants
      Results and factors affecting early outcome of fenestrated and/or branched stent grafts for aortic aneurysms: a multicenter prospective study.
      Briefly, patients were included if they were considered at high risk for open surgery and had an AAA >50 mm in men (45 mm in women), with or without thoracic aortic aneurysm >55 mm (50 mm in women), and with an infrarenal neck <10 mm in length or aneurysm extending to the suprarenal aorta. Patients were divided into three groups according to type of aneurysm: para/juxtarenal AAA, infradiaphragmatic TAAA, and supradiaphragmatic TAAA. Control participants were extracted by combining primary diagnosis and procedure codes and were then assigned to their anatomical groups based on those same criteria (see Appendix 2, supplementary material). Emergent and ruptured aneurysms as well as aortic dissections were excluded from both groups.
      Comorbidities at baseline were drawn from the CRF and the discharge database for cases, and from the discharge database for controls. To reduce discrepancies caused by the different recording methods, data from the discharge database were used for both cases and controls when comparing baseline characteristics between treatment groups. The Charlson index
      • Charlson M.E.
      • Pompei P.
      • Ales K.L.
      • MacKenzie C.R.
      A new method of classifying prognostic comorbidity in longitudinal studies: development and validation.
      was calculated to assess patient severity at inclusion. This was preferred to other indexes – including the Medicare score
      • Giles K.A.
      • Schermerhorn M.L.
      • O'Malley A.J.
      • Cotterill P.
      • Jhaveri A.
      • Pomposelli F.B.
      • et al.
      Risk prediction for peri-operative mortality of endovascular vs open repair of abdominal aortic aneurysms using the Medicare population.
      – because it could be scored using hospital discharge data and has been validated for use with a claims database, including the French hospital discharge database.
      • Quan H.
      • Sundararajan V.
      • Halfon P.
      • Fong A.
      • Burnand B.
      • Luthi J.-C.
      • et al.
      Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data.
      • Quan H.
      • Li B.
      • Couris C.M.
      • Fushimi K.
      • Graham P.
      • Hider P.
      • et al.
      Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries.

      Study endpoints

      The primary clinical endpoint was 30 day all cause mortality. Secondary endpoints included major complications (myocardial infarction, stroke, permanent hemodialysis, major amputation, paraplegia, and bowel infarction) as well as vascular repeat interventions, LOS (both in hospital and in the intensive care unit), re-admissions within 30 days (identified using record linkage and each patient's national anonymized identification number), and costs. Endpoints were recorded in the CRF and checked against the discharge database for cases and retrieved from the discharge database for controls.

      Economic evaluation

      Only hospital (acute) resources were considered. Procedure costs for f/b EVAR were obtained with a bottom up micro-costing approach that identified all relevant cost components of the procedure and valued each of those components for all individual patients
      • Drummond M.F.
      • Sculpher M.J.
      • Torrance G.W.
      • O'Brien B.J.
      • Stoddart G.L.
      Methods for the economic evaluation of health care programmes. Édition: 3.
      using the following variables: duration of the procedure, staff present, medical devices used, and type of operating theatre. Graft components and other supplies for each patient were recorded in the CRF or retrieved from the surgical ward databases. The prices of the medical devices used during the procedure were obtained from each center and are in 2012€ (Appendix 3, supplementary material). Hospitalization costs were estimated by adjusting the 2012 average national cost of each patient's DRG with their actual LOS and resources used during their hospitalization (intensive care, blood transfusion, hemodialysis, etc.). This average cost was drawn from the national hospital cost study, which is undertaken yearly by the Ministry of Health and records actual costs for all patients admitted to a sample of hospitals based on a combination of itemized resources and activity based costing. This allowed exclusion of items relative to surgery from patients' hospital costs so as to not count this twice.
      For controls, procedure costs were not estimated with a micro-costing as there was no access to individual patients and therefore this could not be performed. Those costs are included in controls' hospital costs, which – like cases – were taken from the national hospital cost study and adjusted with LOS and other resources used to ensure comparability between the two groups. No tariffs were used at any point in the cost computation as this is not recommended.
      Finally, transfers to another acute care hospital and repeat admissions within 30 days of the initial intervention were also included in cost computations using the same methodology.
      A cost-effectiveness analysis was conducted to assess incremental costs per incremental death averted with f/b EVAR versus OSR.

      Statistical analysis

      The primary goal of the study was to test the null hypothesis that 30 day survival was identical with f/b EVAR and OSR. Proposed sample sizes of 200 (f/b EVAR) and 600 (OSR), with a total number of required events of 20 and a 0.05 level two sided log-rank test for equality of survival curves, had 95% power to detect the difference between the OSR group proportion at time t of 0.900 and the fenestrated stent grafts group proportion at time t of 0.970 (hazard ratio of 3.459).
      Analyses were performed for the entire population and for the three prospectively defined groups. Dichotomous variables were compared using the chi-square test or the Fisher exact test while continuous variables, described by mean and standard deviation (SD), were assessed with a Student t test. Kaplan–Meier survival analyses were carried out and the log-rank test was calculated. Univariate and multivariate analyses were also performed on 30 day mortality using a Cox model. Variables were included in the multivariate model if they were significant in the univariate analysis (p < .2). The final model was identified using a descending stepwise method with a 0.05 significance level. Age, sex, group, and Charlson index were forced. Hazard ratios (HR) and their 95% confidence intervals (95% CI) were calculated. Multiple sensitivity analyses were performed to test the model (presented in Appendix 4, supplementary material, along with their results).
      A concordance analysis using the Kappa test was performed to compare the data present in the CRF and in the national discharge database for cases. Finally, bootstrap methods were used to examine the distribution of the incremental cost and incremental effectiveness across the cost-effectiveness plane for the three subgroups.
      Analyses were performed using Excel (2010, Microsoft) and SAS (9.3, SAS corp. NC) software.

      Results

      Patient characteristics

      Three hundred and twenty five patients were assessed for eligibility for the WINDOW registry. There were 10 deaths before intervention: rupture while waiting for the custom made device in four patients, other causes in five, unknown in one. They were excluded from the final analysis, which included 268 patients effectively treated by f/b EVAR as it was not possible to identify controls who had similarly died before their scheduled surgery. Control participants treated with OSR (1,678) were collected from the national discharge database during the same period of time. Cases were significantly older than controls: 71.6 (8.5) versus 69.2 (8.9) years (p < .001). There was no difference in Charlson index, but all comorbidities were more frequent in cases when comparing CRF with the national discharge database. However, when the national discharge database was used for both cases and controls, only dyslipidemia, hypertension, chronic pulmonary disease, and congestive heart failure were significantly more common in f/b EVAR cases, while peripheral arterial occlusive disease was more common in controls (Table 1). On average 6.2 (2.4) devices were implanted in patients treated by f/b EVAR.
      Table 1Patient characteristics at baseline, using data from the national discharge database for both cases and controls.
      f/b EVAR (n = 268
      n = 262 for comorbidities (six patients could not be found in the discharge database).
      )
      OSR (n = 1,678)p
      Chi-square test for dichotomous variables and Student t test for continuous variables.
      Age, y, mean (SD)71.6 (8.5)69.2 (8.9)<.001
      Men, n (%)250 (93.3)1,539 (91.7).38
      Type of aneurysm, n (%)
       Para/juxtarenal AAA184 (68.6)1,382 (82.4)<.001
       Infradiaphragmatic TAAA42 (15.7)225 (13.4)
       Supradiaphragmatic TAAA42 (15.7)71 (4.2)
      Comorbidities, n (%)
       Hypertension161 (61.5)858 (51.1).002
       Hyperlipidemia111 (42.4)579 (34.5).013
       Diabetes38 (14.5)210 (12.5).37
       Coronary artery occlusive disease24 (9.2)138 (8.2).61
       History of stroke7 (2.7)35 (2.1).54
       Peripheral arterial occlusive disease21 (8.0)243 (14.5).005
       Cardiac insufficiency19 (7.3)53 (3.2).001
       Arrhythmia19 (7.3)139 (8.3).57
       Chronic pulmonary disease61 (23.3)241 (14.4)<.001
       Chronic renal disease23 (8.8)104 (6.2).12
      Charlson index, n (%)
      Charlson index: includes myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, rheumatologic disease, peptic ulcer disease, mild liver disease, diabetes without chronic complications, diabetes with chronic complications, hemiplegia or paraplegia, renal disease, any malignancy, moderate or severe liver disease, metastatic solid tumor, HIV/AIDS.14
       0115 (43.9)751 (44.8).22
       160 (22.9)461 (27.5)
       247 (17.9)249 (14.8)
       321 (8.0)136 (8.1)
       411 (4.2)56 (3.3)
       ≥ 58 (3.1)25 (1.5)
       Missing6 (2.2)0 (0.0)
      y = years.
      a n = 262 for comorbidities (six patients could not be found in the discharge database).
      b Chi-square test for dichotomous variables and Student t test for continuous variables.
      c Charlson index: includes myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, rheumatologic disease, peptic ulcer disease, mild liver disease, diabetes without chronic complications, diabetes with chronic complications, hemiplegia or paraplegia, renal disease, any malignancy, moderate or severe liver disease, metastatic solid tumor, HIV/AIDS.
      • Charlson M.E.
      • Pompei P.
      • Ales K.L.
      • MacKenzie C.R.
      A new method of classifying prognostic comorbidity in longitudinal studies: development and validation.

      Costs

      The costs of the initial hospitalization were estimated at €37,708 (23,196) on average for a patient treated with f/b EVAR vs. €16,255 (16,660) for a patient treated with OSR (p < .001). The cost of medical devices used in f/b EVAR accounted for the difference, as it amounted to €21,905 (3,337). There was no difference in readmission costs: €5,985 (5,969) for f/b EVAR cases vs. €4,570 (4,886) for controls, p = .248. Total costs at 30 days (or at patient discharge) were €38,212 (23,252) per case and €16,497 (16,695) per control (p < .001).
      While costs were significantly higher for cases in para/juxtarenal AAA and infradiaphragmatic TAAA, there was no significant difference in costs between f/b EVAR and OSR in supradiaphragmatic TAAA (Table 2). Overall, patients with supradiaphragmatic TAAA had higher costs than patients with para/juxtarenal AAA and infradiaphragmatic TAAA in both treatment groups.
      Table 2Hospitalization costs per type of aneurysm (in 2012 €).
      f/b EVAROSRf/b EVAR vs. OSR
      Mean (SD)p
      ANOVA test.
      Mean (SD)p
      ANOVA test.
      p
      Student t test.
      Initial hospitalization
      Para/juxtarenal AAA33,919 (21,906)<.00114,661 (12,822)<.001<.0001
      Infradiaphragmatic TAAA37,517 (11,981)17,239 (12,873)<.0001
      Supradiaphragmatic TAAA54,121 (29,069)44,158 (45,089).2026
      30 day re-admissions
      Para/juxtarenal AAA5,686 (6,856).7944,487 (4,831).566.4064
      Infradiaphragmatic TAAA5,327 (2,943)5,444 (5,416).9723
      Supradiaphragmatic TAAA8,237 (1,968)337 (−).0737
      Total costs at 30 days
      Or at patient's discharge.
      Para/juxtarenal AAA34,425 (22,021)<.00114,907 (12,889)<.001<.0001
      Infradiaphragmatic TAAA37,927 (11,994)17,530 (12,953)<.0001
      Supradiaphragmatic TAAA54,710 (28,919)44,163 (45,090).1771
      a ANOVA test.
      b Student t test.
      c Or at patient's discharge.

      Mortality

      At 30 days, 18 patients treated with f/b EVAR (6.7%) and 90 patients treated with OSR (5.4%) had died (p = .40). Kaplan–Meier survival analysis at 30 days found no difference in survival rates between cases and controls (93.3% vs. 94.6%, p = .48). There was no difference in survival for patients with para/juxtarenal AAA (95.7% vs. 94.2%, p = .26) and supradiaphragmatic TAAA (88.1% vs. 79.6%, p = .70), while cases with infradiaphragmatic TAAA had a worse survival than controls (88.1% vs. 95.0%, p = .010).
      Univariate Cox regression analysis found a significant association between 30 day mortality and age, type of aneurysm, and all complications except amputations. Multivariate analysis confirmed the absence of a significant impact of treatment on 30 day mortality (HR 0.97, 95% CI 0.57–1.66) and a significant association with age, type of aneurysm, and some of the complications (Table 3, sensitivity analyses in Appendix 4, supplementary material).
      Table 3Multivariate Cox regression analysis (final model
      Variables were included in the multivariate model if they were under the 0.2 significance level of the univariate analysis. The variables in the final model were identified using a descending stepwise method with a 0.05 significance level. Age, sex, group (=type of aneurysm), and Charlson index were forced.
      ).
      Hazard ratio95% confidence intervalp
      Mean age at intervention1.061.04–1.09<.001
      Sex
       Male1.61
       Female1.190.61–2.30
      Treatment
       OSR1.92
       f/b EVAR0.970.57–1.66
      Type of aneurysm
       Para/juxtarenal AAA1<.001
       Infradiaphragmatic TAAA0.820.47–1.44
       Supradiaphragmatic TAAA2.801.62–4.84
      Charlson index
       01.60
       10.860.54–1.37
       21.040.60–1.78
       31.130.63–2.04
       40.180.02–1.35
       ≥ 50.910.31–2.64
      Complications
       Myocardial infarction5.522.36–12.9<.001
       Severe ischemic colitis and bowel infarction5.393.16–9.21<.001
       Permanent hemodialysis2.161.40–3.34<.001
       Re-intervention2.281.43–3.64<.001
      a Variables were included in the multivariate model if they were under the 0.2 significance level of the univariate analysis. The variables in the final model were identified using a descending stepwise method with a 0.05 significance level. Age, sex, group (=type of aneurysm), and Charlson index were forced.

      Economic evaluation

      f/b EVAR had a higher cost than OSR for a similar clinical outcome and was therefore dominated. The bootstrap analysis per group (Fig. 1) showed little uncertainty surrounding this result in para/juxtarenal AAA and infradiaphragmatic TAAA, with f/b EVAR being less effective in patients with infradiaphragmatic TAAA. Only supradiaphragmatic TAAA could potentially benefit from f/b EVAR and be cost-effective; however, high uncertainty surrounded this result.
      Figure thumbnail gr1
      Figure 1Bootstrap methods assessing the cost-effectiveness of f/b EVAR versus OSR in each group. Green, para/juxtarenal abdominal aortic aneurysm; red, infradiaphragmatic thoraco-abdominal aortic aneurysm; blue, supradiaphragmatic thoraco-abdominal aortic aneurysm.

      Complications

      Based on data recorded in the CRF, permanent hemodialysis was more frequent after OSR (5.6% vs. 20.8%, p < .001) and spinal cord ischemia was more frequent after f/b EVAR (4.1% vs. 1.0%, p < .001). However, 63.6% of patients treated with f/b EVAR recovered, leading to a low rate of permanent paraplegia (1.5%) (Table 4). Using the national discharge database for both f/b EVAR cases and controls, however, led to different results: whereas spinal cord ischemia was still more frequent after f/b EVAR, patients treated with f/b EVAR also presented more myocardial infarctions (3.1% vs. 1.2%, p = .019), strokes (4.2% vs. 0.7%, p < .001), and re-interventions (15.3% vs. 10.3%, p = .017), while there was no difference in the occurrence of renal failure (13.4% vs. 17.2%, p = .120). Appendix 5 (supplementary material) compares the rate of complications per type of aneurysm using both data sources, and Appendix 6 (supplementary material) shows the concordance analysis of the two sources.
      Table 4Post-operative complications, n (%).
      ComplicationsUsing CRF for cases and national discharge database for controlsUsing national discharge database for cases and controls
      f/b EVAR (n = 268)OSR (n = 1,678)p
      Chi-square test (or the Fisher exact test depending on the number of observations).
      f/b EVAR (n = 262)OSR (n = 1,678)p
      Chi-square test (or the Fisher exact test depending on the number of observations).
      Major amputation1 (0.4)4 (0.2).691 (0.4)4 (0.2).67
      Myocardial infarction4 (1.5)20 (1.2).688 (3.1)20 (1.2).019
      Stroke5 (1.9)12 (0.7).06011 (4.2)12 (0.7)<.001
      Paraplegia11 (4.1)16 (1.0)<.0018 (3.1)16 (1.0).004
      Incl. permanent paraplegia4 (1.5)NANANANANA
      Mechanical ventilation ≥ 7 days14 (5.2)124 (7.4).2018 (6.9)124 (7.4).76
      Severe ischemic colitis and bowel infarction6 (2.2)51 (3.0).477 (2.8)51 (3.0).75
      Permanent hemodialysis15 (5.6)289 (17.2)<.00135 (13.4)289 (17.2).120
      Re-intervention34 (12.7)173 (10.3).2440 (15.3)173 (10.3).017
      a Chi-square test (or the Fisher exact test depending on the number of observations).

      Length of stay and 30 day readmissions

      Total initial LOS (including transfers to another acute care hospital) was 13.9 (15.6) days for f/b EVAR patients and 16.2 (14.3) days for OSR patients (p = .020). There was no difference in LOS in ICU: 3.6 (13.5) days after f/b EVAR vs. 4.0 (10.2) after OSR (p = .55). A significant positive association was found between type of aneurysm and LOS (total and in ICU) in both f/b EVAR cases and controls, and a significantly higher total LOS for controls versus f/b EVAR cases in patients with para/juxtarenal AAA and infradiaphragmatic TAAA. More f/b EVAR cases than controls were re-admitted within 30 days of the intervention (9.1% vs. 5.6%, p = .035), although there was no difference in their LOS (total or ICU). After excluding hemodialysis sessions, it was found that there were more re-admissions for a circulatory system disease in the f/b EVAR group (44.0% vs. 15.7%) and more readmissions for a respiratory system disease in the OSR group (13.3% vs. 0%). In addition, more controls than cases were transferred to a long-term care or rehabilitation facility at discharge (5.0% vs. 15.4%, p < .001). This was also true for patients with para/juxtarenal AAA (2.2% vs. 15.8%, p < .001); however, there was no difference for patients with infra- or supradiaphragmatic TAAA.

      Discussion

      The results of this study suggest that f/b EVAR is not a cost-effective option for para/juxtarenal AAA or infradiaphragmatic TAAA. Therefore, OSR should be preferred whenever patients are eligible, although f/b EVAR may be a valuable treatment in high risk patients with para/juxtarenal aneurysms, with a mortality rate close to the mortality of OSR in low risk patients. For infradiaphragmatic TAAA, the poorer results of f/b EVAR may be explained by several factors, including a higher risk for surgery, technical issues related to anatomy, and the need for four fenestrations which increases the complexity of the procedure. For supradiaphragmatic TAAA, no difference was found in mortality and costs between f/b EVAR and OSR, suggesting that f/b EVAR may become a preferred option even in low risk patients, but the study was not sufficiently powered to make a stronger case for those patients.
      The efficacy of infrarenal EVAR has been evaluated in several comparative studies, which have found a relatively low mortality – between 1.1% and 1.8%.
      • Greenhalgh R.M.
      • Brown L.C.
      • Kwong G.P.S.
      • Powell J.T.
      • Thompson S.G.
      EVAR trial participants
      Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30 day operative mortality results: randomised controlled trial.
      • United Kingdom EVAR Trial Investigators
      • Greenhalgh R.M.
      • Brown L.C.
      • Powell J.T.
      • Thompson S.G.
      • Epstein D.
      • et al.
      Endovascular versus open repair of abdominal aortic aneurysm.
      • Stather P.W.
      • Sidloff D.
      • Dattani N.
      • Choke E.
      • Bown M.J.
      • Sayers R.D.
      Systematic review and meta-analysis of the early and late outcomes of open and endovascular repair of abdominal aortic aneurysm.
      • Sun Z.
      • Mwipatayi B.P.
      • Semmens J.B.
      • Lawrence-Brown M.M.D.
      Short to midterm outcomes of fenestrated endovascular grafts in the treatment of abdominal aortic aneurysms: a systematic review.
      Repair of complex aortic aneurysms presents a bigger challenge. For such aneurysms, no study has compared f/b EVAR and OSR in a head to head trial, although a recent retrospective comparison of 30 day outcomes suggests that f/b EVAR is associated with reduced 30 day mortality and morbidity compared with OSR.
      • Tsilimparis N.
      • Perez S.
      • Dayama A.
      • Ricotta J.J.
      Endovascular repair with fenestrated-branched stent grafts improves 30 day outcomes for complex aortic aneurysms compared with open repair.
      However, this study concerned only “eligible high volume hospitals,” and the definition of complex aortic aneurysm was limited to involvement of visceral arteries. Moreover, comparison with results of the present study is rendered difficult by the lack of data on morphologic characteristics of the AAA and differences in case mix and comorbid conditions. Cohort studies
      • British Society for Endovascular Therapy and the Global Collaborators on Advanced Stent-Graft Techniques for Aneurysm Repair (GLOBALSTAR) Registry
      Early results of fenestrated endovascular repair of juxtarenal aortic aneurysms in the United Kingdom.
      • Chisci E.
      • Kristmundsson T.
      • de Donato G.
      • Resch T.
      • Setacci F.
      • Sonesson B.
      • et al.
      The AAA with a challenging neck: outcome of open versus endovascular repair with standard and fenestrated stent-grafts.
      also reported a slightly lower mortality than the present study (4.1% and 5.7% 30 day mortality vs. 6.7%), but the present study included a higher proportion of more risky extensive aneurysms.
      LOS was shorter in patients treated by f/b EVAR (13.9 vs. 16.2 days, p = .020), as is also the case in studies comparing EVAR and OSR for infrarenal AAA. The LOS in the present study is higher than that reported in the literature – between 3.7 and 12.0 days after f/b EVAR,
      • Lederle F.A.
      • Stroupe K.T.
      Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group
      Cost-effectiveness at two years in the VA Open versus Endovascular Repair Trial.
      • Haulon S.
      • Greenberg R.K.
      • Pfaff K.
      • Francis C.
      • Koussa M.
      • West K.
      Branched grafting for aortoiliac aneurysms.
      • Roselli E.E.
      • Greenberg R.K.
      • Pfaff K.
      • Francis C.
      • Svensson L.G.
      • Lytle B.W.
      Endovascular treatment of thoracoabdominal aortic aneurysms.
      • Ziegler P.
      • Avgerinos E.D.
      • Umscheid T.
      • Perdikides T.
      • Stelter W.J.
      Fenestrated endografting for aortic aneurysm repair: a 7-year experience.
      • Greenberg R.K.
      • Sternbergh 3rd, W.C.
      • Makaroun M.
      • Ohki T.
      • Chuter T.
      • Bharadwaj P.
      • et al.
      Intermediate results of a United States multicenter trial of fenestrated endograft repair for juxtarenal abdominal aortic aneurysms.
      and between 9.9 and 16.1 days after OSR.
      • Lederle F.A.
      • Stroupe K.T.
      Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group
      Cost-effectiveness at two years in the VA Open versus Endovascular Repair Trial.
      • Tarride J.-E.
      • Blackhouse G.
      • De Rose G.
      • Novick T.
      • Bowen J.M.
      • Hopkins R.
      • et al.
      Cost-effectiveness analysis of elective endovascular repair compared with open surgical repair of abdominal aortic aneurysms for patients at a high surgical risk: a 1-year patient-level analysis conducted in Ontario, Canada.
      • Wilt T.J.
      • Lederle F.A.
      • Macdonald R.
      • Jonk Y.C.
      • Rector T.S.
      • Kane R.L.
      Comparison of endovascular and open surgical repairs for abdominal aortic aneurysm.
      • Chambers D.
      • Epstein D.
      • Walker S.
      • Fayter D.
      • Paton F.
      • Wright K.
      • et al.
      Endovascular stents for abdominal aortic aneurysms: a systematic review and economic model.
      LOS in ICU was also higher (3–4 days vs. only 1 day in the literature). The difference may be because, in this study, transfers to other acute care institutions were included in the LOS calculation. Excluding transfers resulted in a LOS of 12.3 days for f/b EVAR and 15.2 days for OSR, which is within the range reported in the literature, albeit not that of the more recent American College of Surgeons registry.
      • Tsilimparis N.
      • Perez S.
      • Dayama A.
      • Ricotta J.J.
      Endovascular repair with fenestrated-branched stent grafts improves 30 day outcomes for complex aortic aneurysms compared with open repair.
      Finally, f/b EVAR was predictably more costly than EVAR because of the cost of custom made stent grafts. The OSR cost in the present study was lower than previously reported, with the usual costs ranging from €18,242 to €27,930 2,4,9 and up to €39,345,
      • Lederle F.A.
      • Stroupe K.T.
      Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group
      Cost-effectiveness at two years in the VA Open versus Endovascular Repair Trial.
      compared with €16,255 in the present study. This may be a result of differences in DRG cost calculations. To the authors' knowledge, the cost of f/b EVAR treatment has been assessed only once, by the Ontario Health Technology Advisory Committee,
      • Ontario Health Technology Advisory Committee
      Fenestrated endovascular grafts for the repair of juxtarenal aortic aneurysms: an evidence based analysis.
      which found a cost of €27,747 for the initial hospitalization (€10,000 less than figures in the present study). This difference may be explained by the shorter LOS (6 days on average after f/b EVAR vs. close to 14 days in the present study), as the cost of the devices was similar in Canada and France (€20,317 vs. €21,905).
      There are some limitations to the present findings. The study is not a traditional head to head RCT; as a result, patients undergoing f/b EVAR were on average 2 years older and sicker than those undergoing OSR. The present risk adjustment used age and Charlson index but other comorbidities may not be accounted for. A RCT was not chosen for several reasons: (1) the relatively low number of patients, even at a nationwide level, that would meet its inclusion criteria; (2) discrepancies between the number of centers currently performing OSR for complex AAA and TAAA and the low number of centers having already fulfilled the learning curve for f/b EVAR; (3) difficulties to convince patients to enter a protocol aimed at comparing a very invasive technique to a lighter one. The weakness of this choice is that clinical outcomes and costs were not measured in an identical way in both arms, the f/b EVAR cases' CRF being more thorough and complete than the controls' data present in the national discharge database. The discrepancies between the two data sources can be observed in the poor results of the concordance analysis, especially where comorbidities are concerned. It also explains the differences between what is reported here vs. what is present in the earlier article by Marzelle et al.,
      • Marzelle J.
      • Presles E.
      • Becquemin J.P.
      WINDOWS trial participants
      Results and factors affecting early outcome of fenestrated and/or branched stent grafts for aortic aneurysms: a multicenter prospective study.
      as the latter reported CRF data while we mainly used the national discharge database. Although researchers are increasingly using discharge databases worldwide, these usually are not designed for research purposes. As such, the data available for a given patient are subject to coding incentives and more likely to contain comorbidities and complications that impact on reimbursement. In addition, using two different data sources meant only variables that were recorded in both could be included. As a result body mass index or aneurysm diameter could not be included in analyses despite potentially influencing mortality. Also, a nationwide database was compared with only eight centers performing f/b EVAR, but while a comparison limited to the same centers may appear more robust, it proved impossible to do because f/b EVAR centers had switched massively to endovascular repair and could not provide a sufficiently large control group. Finally, the discharge database records only hospital deaths, therefore mortality in the control arm may have been underestimated as deaths occurring at home or in another type of institution were not recorded, although the concordance was high and mortality rate for OSR was close to that reported in EVAR vs. OSR trials: 5.4% in the present study vs. 4.3–4.7% in others
      • Greenhalgh R.M.
      • Brown L.C.
      • Kwong G.P.S.
      • Powell J.T.
      • Thompson S.G.
      EVAR trial participants
      Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30 day operative mortality results: randomised controlled trial.
      • United Kingdom EVAR Trial Investigators
      • Greenhalgh R.M.
      • Brown L.C.
      • Powell J.T.
      • Thompson S.G.
      • Epstein D.
      • et al.
      Endovascular versus open repair of abdominal aortic aneurysm.
      • Stather P.W.
      • Sidloff D.
      • Dattani N.
      • Choke E.
      • Bown M.J.
      • Sayers R.D.
      Systematic review and meta-analysis of the early and late outcomes of open and endovascular repair of abdominal aortic aneurysm.
      and up to 10% in TAAA.
      • Bensley R.P.
      • Curran T.
      • Hurks R.
      • Lo R.C.
      • Wyers M.C.
      • Hamdan A.D.
      • et al.
      Open repair of intact thoracoabdominal aortic aneurysms in the American College of Surgeons National Surgical Quality Improvement Program.
      This suggests that using the discharge database had only a limited impact on the 30 day mortality evaluation.
      Endovascular technology is a rapidly evolving field. Since the start of the current study, new devices from different companies have been developed, which will probably decrease the cost of the stent grafts and reduce the waiting time for patients (and thus the risk of rupture).
      • Kitagawa A.
      • Greenberg R.K.
      • Eagleton M.J.
      • Mastracci T.M.
      Zenith p-branch standard fenestrated endovascular graft for juxtarenal abdominal aortic aneurysms.
      Parallel grafts such as chimney grafts using a combination of a standard stent graft with standard covered stents are also being developed, with the advantages of being readily applicable and much cheaper.
      • Coscas R.
      • Kobeiter H.
      • Desgranges P.
      • Becquemin J.-P.
      Technical aspects, current indications, and results of chimney grafts for juxtarenal aortic aneurysms.

      Conclusion

      f/b EVAR does not appear to be justified for patients with para/juxtarenal AAA and infradiaphragmatic TAAA fit for OSR. However, it offers an attractive option for patients with para/juxtarenal AAA at high risk for surgery and for patients with supradiaphragmatic TAAA, including patients fit for open surgery. Durability of these devices needs to be assessed by longer-term follow up.

      Conflict of Interest

      None

      Funding

      A grant obtained from the French Ministry of Health (STIC 2009 – P090209 ; IDRCB 2009- A00743-54 ) covered the cost of the study. Neither the manufacturer nor the sponsor had a role in the design of the study.

      Appendix A. Supplementary data

      The following is the supplementary data related to this article:

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