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Editor's Choice – Fenestrated or Branched Endovascular versus Open Repair for Complex Aortic Aneurysms: Meta-Analysis of Time to Event Propensity Score Matched Data

  • George A. Antoniou
    Correspondence
    Corresponding author. Room G37, Vascular Offices, J Block, The Royal Oldham Hospital, Rochdale Road, Oldham OL1 2JH. UK.
    Affiliations
    Department of Vascular and Endovascular Surgery, The Royal Oldham Hospital, Pennine Acute Hospitals NHS Trust, Northern Care Alliance NHS Group, Manchester, UK

    Division of Cardiovascular Sciences, School of Medical Sciences, The University of Manchester, Manchester, UK
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  • Maciej T. Juszczak
    Affiliations
    Birmingham Aortic Team, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK

    Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK
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  • Stavros A. Antoniou
    Affiliations
    Medical School, European University of Cyprus, Nicosia, Cyprus

    Department of Surgery, Mediterranean Hospital of Cyprus, Limassol, Cyprus
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  • Athanasios Katsargyris
    Affiliations
    Department of Vascular and Endovascular Surgery, Paracelsus Medical University Nuremberg, General Hospital Nuremberg, Nuremberg, Germany
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  • Stephan Haulon
    Affiliations
    Vascular Centre, Hôpital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, INSERM UMR_S999, Université Paris Saclay, Le Plessis-Robinson, France
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Open ArchivePublished:December 04, 2020DOI:https://doi.org/10.1016/j.ejvs.2020.10.010

      Objective

      The aim of this review was to investigate comparative outcomes of fenestrated or branched endovascular aneurysm repair (F/BEVAR) with open repair for juxta/para/suprarenal or thoraco-abdominal aortic aneurysms.

      Methods

      Electronic bibliographic sources (MEDLINE and Embase) were interrogated using the Healthcare Databases Advanced Search interface. Eligible studies compared F/BEVAR with open repair for complex aortic aneurysms using propensity score or Cox regression modelling/multivariable logistic regression analysis. Pooled estimates of peri-operative outcomes were calculated using the odds ratio (OR) and 95% confidence interval (CI). The result of time to event analysis was reported as summary hazard ratio (HR) and 95% CI. Random effects models and the inverse variance method were applied. The quality of evidence was graded using the system developed by the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) working group.

      Results

      Eleven studies published between 2014 and 2019 were selected for inclusion in qualitative and quantitative synthesis reporting a total of at least 7 061 patients. The odds of peri-operative mortality after F/BEVAR were lower, although not significantly, than after open repair (OR 0.56, 95% CI 0.28–1.12), whereas the hazard of overall mortality during follow up was higher following F/BEVAR, but, again, without reaching statistical significance (HR 1.25, 95% CI 0.93–1.67). The hazard of re-intervention was significantly higher after endovascular therapy (HR 2.11, 95% CI 1.39–3.18). The certainty for the body of evidence for peri-operative and overall mortality during follow up was judged to be very low and moderate, respectively, and for re-intervention it was judged to be high.

      Conclusion

      The evidence is uncertain about the effect of F/BEVAR on peri-operative mortality when compared with open repair. There is probably no difference in overall survival, but F/BEVAR results in an increased re-intervention hazard. There is a need for high level evidence to inform decision making and vascular/aortic service provision.

      Keywords

      With constantly evolving endovascular technology, complex aortic aneurysms are increasingly treated by endovascular methods. In the absence of randomised trials, current practices are based on individual specialist preferences and expertise rather than solid scientific evidence. The best available evidence comparing fenestrated/branched endovascular and open surgery for juxta/para/suprarenal and thoraco-abdominal aortic aneurysms is considered. Meta-analysis of data from >7 000 patients showed a lower peri-operative mortality after endovascular repair but a higher hazard of mortality during follow up and a significantly higher risk of re-intervention. This work highlights the need for high level evidence to inform decision making and vascular/aortic service provision.

      Introduction

      An abdominal aortic aneurysm (AAA) commonly affects the infrarenal segment of the aorta. In patients with favourable morphological characteristics of the proximal aortic neck, the AAA can be treated by standard endovascular or open surgical methods. The results of open surgery, which is the traditional approach to treatment for juxta/para/suprarenal and thoraco-abdominal aortic aneurysms (referred to as complex aortic aneurysms), have been dismal, with a reported peri-operative mortality rate of 14.7% in the recently published annual report of the Vascular Services Quality Improvement Programme in the UK.
      • Waton S.
      • Johal A.
      • Heikkila K.
      • Cromwell D.
      • Boyle J.
      • Miller F.
      National vascular registry: 2019 annual report.
      In recent years, concerted efforts of clinical, research, and technology teams have focused on the development and evaluation of complex stent graft designs to accommodate adverse aortic anatomies and provide less invasive interventional treatment options for complex aortic aneurysms. Fenestrated and branched endovascular aneurysm repair (F/BEVAR) aims to exclude the aneurysm sac from the arterial circulation and, at the same time, preserve the perfusion of vital intra-abdominal organs. Although technically demanding, such procedures are better tolerated than open surgery by multimorbid patients with poor physiological reserve; thus, F/BEVAR technology has the potential of expanding the patient population that can be offered treatment.
      In the absence of high level evidence in this setting, considerations regarding the early and late efficacy of F/BEVAR have been largely extrapolated from randomised clinical trial data in standard endovascular aneurysm repair (EVAR).
      • Antoniou G.A.
      • Antoniou S.A.
      • Torella F.
      Endovascular vs. open repair for abdominal aortic aneurysm: systematic review and meta-analysis of updated peri-operative and long term data of randomised controlled trials.
      ,
      • Armstrong N.
      • Burgers L.
      • Deshpande S.
      • Al M.
      • Riemsma R.
      • Vallabhaneni S.R.
      • et al.
      The use of fenestrated and branched endovascular aneurysm repair for juxtarenal and thoracoabdominal aneurysms: a systematic review and cost-effectiveness analysis.
      Clinicians tend preferentially to offer F/BEVAR to older patients who are deemed physiologically unfit for open surgical repair (OSR), resulting in attenuation of the true effect of endovascular therapy. In an attempt to circumvent the limitation of selection bias, over the recent years, a number of studies have applied advanced statistical methods, such as propensity analysis, to investigate the comparative effects of endovascular therapies for complex aortic aneurysms. However, these studies are limited by small patient numbers, resulting in diminished power and uncertain effect estimates. The aim of this review was to collate and synthesise data from such studies in order to demonstrate potential advantages of F/BEVAR over OSR for complex aortic aneurysms.

      Methods

      Review design

      The review objectives and methodology were prespecified in a protocol. The review was developed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRIMSA) guidelines.
      • Liberati A.
      • Altman D.G.
      • Tetzlaff J.
      • Mulrow C.
      • Gøtzsche P.C.
      • Ioannidis J.P.
      • et al.
      The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration.

      Eligibility criteria and study selection

      Two independent review authors (G.A.A. and S.A.A.) conducted the prespecified literature searches and selected studies against the eligibility criteria listed below. When disagreement arose, a third review author acted as an arbitrator (M.T.J.).

      Types of studies

      Eligible studies were observational studies comparing outcomes of F/BEVAR with those of OSR for complex aortic aneurysms (juxta/para/suprarenal and thoraco-abdominal aortic aneurysms). Only studies that used propensity score matched populations of F/BEVAR and OSR and studies that used Cox regression modelling or multivariable logistic regression analysis to adjust for potential confounding factors were considered.

      Types of participants

      Eligible participants were patients of any age or sex that were treated for a complex AAA. Complex aortic aneurysms were defined as those involving the renal and/or visceral branches of the aorta. Eligible participants should have been treated in an elective setting; thus, patients receiving treatment for ruptured or symptomatic aortic aneurysm were not considered.

      Types of interventions

      The intervention of interest was F/BEVAR and the comparator intervention was OSR for complex aortic aneurysm.

      Types of outcomes measures

      Primary outcome measures were peri-operative mortality, defined as death occurring within 30 days from or during the hospital stay for the index aortic procedure; and mortality during follow up.
      Secondary outcomes were secondary intervention; spinal cord ischaemia; renal impairment; and length of Intensive Care Unit (ICU) stay.

      Search methods for identification of studies

      The literature search strategy was developed by the review author team with experience in outreach, knowledge, and evidence search.

      Electronic searches

      The Healthcare Databases Advanced Search interface developed by the National Institute for Health and Care Excellence was used to interrogate electronic bibliographic sources. MEDLINE and Embase were searched. Relevant terms were selected to identify eligible reports. Thesaurus headings, search operators, and limits in each of the databases were adapted accordingly. The MEDLINE search was run in December 2019 and that of EMBASE in March 2020. No language constraints were applied. The literature search strategy is presented in Appendix S1 (see Supplementary Material).

      Searches of other sources

      The reference lists of the selected studies were screened for additional studies.

      Data extraction and management

      One review author extracted data from the selected studies (G.A.A.) and a second review author crosschecked the extracted data (S.A.A). The following information was collected:
      • study related data (first author, journal and year of publication, country of the corresponding author, retrospective or prospective study design, single centre or multicentre study, type of complex aortic aneurysm [juxtarenal, pararenal, suprarenal, thoraco-abdominal], treatment period, inclusion and exclusion criteria for patient recruitment in the individual studies, length of follow up, information on propensity or Cox regression analysis and confounding factors);
      • baseline demographics (sex and age);
      • data pertaining to study quality assessment, as outlined in the “Methods of study and evidence appraisal” section;
      • outcome data, as outlined in the “Eligibility criteria and study selection” section;
      The method of hazard ratio (HR) calculation was also recorded.

      Methods of Study and Evidence Appraisal

      The methodological quality of observational studies was assessed with a modified Newcastle–Ottawa scale.
      • Wells G.A.
      • Shea B.
      • O'Connell D.
      • Peterson J.
      • Welch V.
      • Losos M.
      • et al.
      The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses.
      Using the tool, each study was judged on eight items, categorised into three groups: the selection of the study groups; the comparability of the groups; and the assessment of outcome. In the assessment of outcome domain, an acceptable follow up time was a priori defined as a minimum of five years. Stars awarded for each quality item served as a quick visual assessment. Stars were awarded such that the highest quality studies were awarded up to nine stars. Two independent review authors (G.A.A. and M.T.J.) assessed the quality of the selected studies.
      A summary of findings table was also generated. The quality of evidence was graded by two review authors (G.A.A and S.A.A.) independently using the system developed by the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) working group applying an online platform (https://gdt.gradepro.org/app/).
      • Antoniou S.A.
      • Antoniou G.A.
      The GRADE approach to appraising the evidence or how to increase the credibility of your research.

      Methods of quantitative synthesis

      Measures of effect estimates

      A pooled estimate of peri-operative mortality was calculated using the odds ratio (OR) and 95% confidence interval (CI). As a number of studies reported the OR and associated 95% CI (instead of raw data on death occurring in the peri-operative period), the inverse variance statistical method was applied to calculate the summary OR. If the HR for peri-operative mortality was reported instead, it was used as an approximation to OR.
      A meta-analysis of time to event data was conducted using the inverse variance method and the result was reported as summary HR and 95% CI. A mixture of direct (e.g., reported HRs with CI from inverse probability weighted propensity analysis) and indirect methods were applied (e.g., from survival curves with numbers at risk) to calculate the individual study logHR and standard error (SE) for specific outcome measures.
      • Tierney J.F.
      • Stewart L.A.
      • Ghersi D.
      • Burdett S.
      • Sydes M.R.
      Practical methods for incorporating summary time-to-event data into meta-analysis.
      ,
      • Antoniou G.A.
      • Antoniou S.A.
      • Smith C.T.
      A guide on meta-analysis of time-to-event outcomes using aggregate data in vascular and endovascular surgery.
      When HR estimates from both propensity and Cox regression analysis were provided, data derived from propensity analysis were used for the purposes of meta-analysis. Data extracted from published Kaplan–Meier curves were digitalised using the open source software Plot Digitizer (http://plotdigitizer.sourceforge.net).

      Unit of analysis

      The unit of analysis was the individual patient.

      Dealing with missing data

      No attempt was made to contact included study authors to enquire about missing or incomplete data for meta-analysis.

      Assessment of heterogeneity

      In between study heterogeneity was examined with the Cochrane's Q (χ2) test. Inconsistency was quantified by calculating I2 and interpreted using the following guide: 0%–40% might not be important; 30%–60% may represent moderate heterogeneity; 50%–90% may represent substantial heterogeneity; and 75%–100% may represent considerable heterogeneity.

      Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, et al (editors). Cochrane handbook for systematic reviews of interventions version 6.0 (updated July 2019). Available at: www.training.cochrane.org/handbook [Accessed 1 July 2020].

      Data synthesis

      In view of the anticipated clinical and methodological diversity among the selected studies, the summary outcome estimates were calculated using the random effects models of DerSimonian and Laird.
      • DerSimonian R.
      • Laird N.
      Meta-analysis in clinical trials.
      A forest plot was created for each treatment effect.

      Sensitivity analysis

      The following sensitivity analyses were performed to discern differences in calculated summary effect estimates: meta-analysis of studies that applied a propensity methodology; and meta-analysis of studies that included only patients treated for juxtarenal aneurysm.

      Statistical software

      The following software were used for statistical analysis: Review Manager (RevMan) version 5.3 and https://static-content.springer.com/esm/art%3A10.1186%2F1745-6215-8-16/MediaObjects/13063_2006_188_MOESM1_ESM.xls

      Results

      Results of the literature search

      Formal literature searches following the strategy outlined in the “Search methods for identification of studies” section identified 41 relevant studies, the full texts of which were retrieved for review. Following exclusions, 11 studies were selected for inclusion in the qualitative and quantitative synthesis.
      • Arnaoutakis D.J.
      • Scali S.T.
      • Beck A.W.
      • Kubilis P.
      • Huber T.S.
      • Martin A.J.
      • et al.
      Comparative outcomes of open, hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms.
      • O'Donnell T.F.X.
      • Boitano L.T.
      • Deery S.E.
      • Schermerhorn M.L.
      • Schanzer A.
      • Beck A.W.
      • et al.
      Open versus fenestrated endovascular repair of complex abdominal aortic aneurysms.
      • Fiorucci B.
      • Speziale F.
      • Kölbel T.
      • Tsilimparis N.
      • Sirignano P.
      • Capoccia L.
      • et al.
      Short- and midterm outcomes of open repair and fenestrated endografting of pararenal aortic aneurysms in a concurrent propensity-adjusted comparison.
      • Chinsakchai K.
      • Prapassaro T.
      • Salisatkorn W.
      • Hongku K.
      • Moll F.L.
      • Ruangsetakit C.
      • et al.
      Outcomes of open repair, fenestrated stent grafting, and chimney grafting in juxtarenal abdominal aortic aneurysm: is it time for a randomized trial?.
      • Bizos A.
      • Chaufour X.
      • Segal J.
      • Senemaud J.
      • Desgranges P.
      • Canoui-Poitrine F.
      • et al.
      Comparison of fenestrated stentgrafts and open repair for juxtarenal aortic aneurysms using a propensity score matching.
      • Tinelli G.
      • Crea M.A.
      • de Waure C.
      • Di Tanna G.L.
      • Becquemin J.P.
      • Sobocinski J.
      • et al.
      A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms.
      • Deery S.E.
      • Lancaster R.T.
      • Gubala A.M.
      • O'Donnell T.F.X.
      • Kwolek C.J.
      • Conrad M.F.
      • et al.
      Early experience with fenestrated endovascular compared to open repair of complex abdominal aortic aneurysms in a high-volume open aortic center.
      • Michel M.
      • Becquemin J.P.
      • Marzelle J.
      • Quelen C.
      • Durand-Zaleski I.
      WINDOW Trial participants. Editor's Choice – a study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.
      • Locham S.S.
      • Nejim B.
      • Aridi H.D.
      • Srouji R.
      • Faateh M.
      • Malas M.
      Perioperative outcomes of patients undergoing fenestrated endovascular repair vs open repair of intact abdominal aortic aneurysms involving the visceral vessels: 10-year national study.
      • Ferrer C.
      • Cao P.
      • De Rango P.
      • Tshomba Y.
      • Verzini F.
      • Melissano G.
      • et al.
      A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
      • Raux M.
      • Patel V.I.
      • Cochennec F.
      • Mukhopadhyay S.
      • Desgranges P.
      • Cambria R.P.
      • et al.
      A propensity-matched comparison of outcomes for fenestrated endovascular aneurysm repair and open surgical repair of complex abdominal aortic aneurysms.
      Two of the studies were published in abstract form.
      • Bizos A.
      • Chaufour X.
      • Segal J.
      • Senemaud J.
      • Desgranges P.
      • Canoui-Poitrine F.
      • et al.
      Comparison of fenestrated stentgrafts and open repair for juxtarenal aortic aneurysms using a propensity score matching.
      ,
      • Locham S.S.
      • Nejim B.
      • Aridi H.D.
      • Srouji R.
      • Faateh M.
      • Malas M.
      Perioperative outcomes of patients undergoing fenestrated endovascular repair vs open repair of intact abdominal aortic aneurysms involving the visceral vessels: 10-year national study.
      The PRISMA study selection flow diagram is presented in Fig. 1. Bibliographic information on excluded studies along with reasons for exclusion are presented in Appendix S2 (see Supplementary Material).
      Figure 1
      Figure 1The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) flow diagram of the systematic literature review of studies reporting comparative outcomes of fenestrated/branched endovascular aneurysm repair (F/BEVAR) and open repair for complex aortic aneurysms. EVAR = endovascular aneurysm repair; FEVAR = fenestrated endovascular aneurysm repair. Duplicates were not removed using the Healthcare Databases Advanced Search interface as database specific thesaurus terms were used.

      Description of included studies

      One of the studies did not report the number of patients included in the propensity analysis.
      • Michel M.
      • Becquemin J.P.
      • Marzelle J.
      • Quelen C.
      • Durand-Zaleski I.
      WINDOW Trial participants. Editor's Choice – a study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.
      The remaining 10 studies reported a total of 7 061 patients (2 356 patients treated byF/BEVAR and 4705 patients treated by open repair). All studies were published recently (five studies were published in 2019,
      • Arnaoutakis D.J.
      • Scali S.T.
      • Beck A.W.
      • Kubilis P.
      • Huber T.S.
      • Martin A.J.
      • et al.
      Comparative outcomes of open, hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms.
      • O'Donnell T.F.X.
      • Boitano L.T.
      • Deery S.E.
      • Schermerhorn M.L.
      • Schanzer A.
      • Beck A.W.
      • et al.
      Open versus fenestrated endovascular repair of complex abdominal aortic aneurysms.
      • Fiorucci B.
      • Speziale F.
      • Kölbel T.
      • Tsilimparis N.
      • Sirignano P.
      • Capoccia L.
      • et al.
      Short- and midterm outcomes of open repair and fenestrated endografting of pararenal aortic aneurysms in a concurrent propensity-adjusted comparison.
      • Chinsakchai K.
      • Prapassaro T.
      • Salisatkorn W.
      • Hongku K.
      • Moll F.L.
      • Ruangsetakit C.
      • et al.
      Outcomes of open repair, fenestrated stent grafting, and chimney grafting in juxtarenal abdominal aortic aneurysm: is it time for a randomized trial?.
      • Bizos A.
      • Chaufour X.
      • Segal J.
      • Senemaud J.
      • Desgranges P.
      • Canoui-Poitrine F.
      • et al.
      Comparison of fenestrated stentgrafts and open repair for juxtarenal aortic aneurysms using a propensity score matching.
      three in 2018,
      • Tinelli G.
      • Crea M.A.
      • de Waure C.
      • Di Tanna G.L.
      • Becquemin J.P.
      • Sobocinski J.
      • et al.
      A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms.
      • Deery S.E.
      • Lancaster R.T.
      • Gubala A.M.
      • O'Donnell T.F.X.
      • Kwolek C.J.
      • Conrad M.F.
      • et al.
      Early experience with fenestrated endovascular compared to open repair of complex abdominal aortic aneurysms in a high-volume open aortic center.
      • Michel M.
      • Becquemin J.P.
      • Marzelle J.
      • Quelen C.
      • Durand-Zaleski I.
      WINDOW Trial participants. Editor's Choice – a study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.
      and the remaining three in 2017, 2016, and 2014, respectively
      • Locham S.S.
      • Nejim B.
      • Aridi H.D.
      • Srouji R.
      • Faateh M.
      • Malas M.
      Perioperative outcomes of patients undergoing fenestrated endovascular repair vs open repair of intact abdominal aortic aneurysms involving the visceral vessels: 10-year national study.
      • Ferrer C.
      • Cao P.
      • De Rango P.
      • Tshomba Y.
      • Verzini F.
      • Melissano G.
      • et al.
      A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
      • Raux M.
      • Patel V.I.
      • Cochennec F.
      • Mukhopadhyay S.
      • Desgranges P.
      • Cambria R.P.
      • et al.
      A propensity-matched comparison of outcomes for fenestrated endovascular aneurysm repair and open surgical repair of complex abdominal aortic aneurysms.
      ). The patient recruitment period in the individual studies spanned from 1998 to 2018. Nearly all studies had a retrospective design and most (eight studies
      • O'Donnell T.F.X.
      • Boitano L.T.
      • Deery S.E.
      • Schermerhorn M.L.
      • Schanzer A.
      • Beck A.W.
      • et al.
      Open versus fenestrated endovascular repair of complex abdominal aortic aneurysms.
      ,
      • Fiorucci B.
      • Speziale F.
      • Kölbel T.
      • Tsilimparis N.
      • Sirignano P.
      • Capoccia L.
      • et al.
      Short- and midterm outcomes of open repair and fenestrated endografting of pararenal aortic aneurysms in a concurrent propensity-adjusted comparison.
      ,
      • Bizos A.
      • Chaufour X.
      • Segal J.
      • Senemaud J.
      • Desgranges P.
      • Canoui-Poitrine F.
      • et al.
      Comparison of fenestrated stentgrafts and open repair for juxtarenal aortic aneurysms using a propensity score matching.
      ,
      • Tinelli G.
      • Crea M.A.
      • de Waure C.
      • Di Tanna G.L.
      • Becquemin J.P.
      • Sobocinski J.
      • et al.
      A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms.
      ,
      • Michel M.
      • Becquemin J.P.
      • Marzelle J.
      • Quelen C.
      • Durand-Zaleski I.
      WINDOW Trial participants. Editor's Choice – a study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.
      • Locham S.S.
      • Nejim B.
      • Aridi H.D.
      • Srouji R.
      • Faateh M.
      • Malas M.
      Perioperative outcomes of patients undergoing fenestrated endovascular repair vs open repair of intact abdominal aortic aneurysms involving the visceral vessels: 10-year national study.
      • Ferrer C.
      • Cao P.
      • De Rango P.
      • Tshomba Y.
      • Verzini F.
      • Melissano G.
      • et al.
      A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
      • Raux M.
      • Patel V.I.
      • Cochennec F.
      • Mukhopadhyay S.
      • Desgranges P.
      • Cambria R.P.
      • et al.
      A propensity-matched comparison of outcomes for fenestrated endovascular aneurysm repair and open surgical repair of complex abdominal aortic aneurysms.
      ) were multicentre. Five studies were conducted in the USA,
      • Arnaoutakis D.J.
      • Scali S.T.
      • Beck A.W.
      • Kubilis P.
      • Huber T.S.
      • Martin A.J.
      • et al.
      Comparative outcomes of open, hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms.
      ,
      • O'Donnell T.F.X.
      • Boitano L.T.
      • Deery S.E.
      • Schermerhorn M.L.
      • Schanzer A.
      • Beck A.W.
      • et al.
      Open versus fenestrated endovascular repair of complex abdominal aortic aneurysms.
      ,
      • Deery S.E.
      • Lancaster R.T.
      • Gubala A.M.
      • O'Donnell T.F.X.
      • Kwolek C.J.
      • Conrad M.F.
      • et al.
      Early experience with fenestrated endovascular compared to open repair of complex abdominal aortic aneurysms in a high-volume open aortic center.
      ,
      • Locham S.S.
      • Nejim B.
      • Aridi H.D.
      • Srouji R.
      • Faateh M.
      • Malas M.
      Perioperative outcomes of patients undergoing fenestrated endovascular repair vs open repair of intact abdominal aortic aneurysms involving the visceral vessels: 10-year national study.
      ,
      • Raux M.
      • Patel V.I.
      • Cochennec F.
      • Mukhopadhyay S.
      • Desgranges P.
      • Cambria R.P.
      • et al.
      A propensity-matched comparison of outcomes for fenestrated endovascular aneurysm repair and open surgical repair of complex abdominal aortic aneurysms.
      two in Italy,
      • Tinelli G.
      • Crea M.A.
      • de Waure C.
      • Di Tanna G.L.
      • Becquemin J.P.
      • Sobocinski J.
      • et al.
      A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms.
      ,
      • Ferrer C.
      • Cao P.
      • De Rango P.
      • Tshomba Y.
      • Verzini F.
      • Melissano G.
      • et al.
      A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
      two in France,
      • Bizos A.
      • Chaufour X.
      • Segal J.
      • Senemaud J.
      • Desgranges P.
      • Canoui-Poitrine F.
      • et al.
      Comparison of fenestrated stentgrafts and open repair for juxtarenal aortic aneurysms using a propensity score matching.
      ,
      • Michel M.
      • Becquemin J.P.
      • Marzelle J.
      • Quelen C.
      • Durand-Zaleski I.
      WINDOW Trial participants. Editor's Choice – a study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.
      and the remaining two in Germany
      • Fiorucci B.
      • Speziale F.
      • Kölbel T.
      • Tsilimparis N.
      • Sirignano P.
      • Capoccia L.
      • et al.
      Short- and midterm outcomes of open repair and fenestrated endografting of pararenal aortic aneurysms in a concurrent propensity-adjusted comparison.
      and Thailand.
      • Chinsakchai K.
      • Prapassaro T.
      • Salisatkorn W.
      • Hongku K.
      • Moll F.L.
      • Ruangsetakit C.
      • et al.
      Outcomes of open repair, fenestrated stent grafting, and chimney grafting in juxtarenal abdominal aortic aneurysm: is it time for a randomized trial?.
      The study characteristics are summarised in Table 1, and the individual study inclusion and exclusion criteria for patient selection and length of follow up are presented in Table S1 (see Supplementary Material).
      Table 1Characteristics of the 11 studies reporting comparative outcomes of fenestrated/branched endovascular aneurysm repair (F/BEVAR) and open surgical repair (OSR) for complex aortic aneurysms
      First author (country)Journal (year)Prospective/retrospectiveSingle/multicentreType of aneurysmRecruitment periodFEVAR/OSR – n
      Arnaoutakis (USA)
      • Arnaoutakis D.J.
      • Scali S.T.
      • Beck A.W.
      • Kubilis P.
      • Huber T.S.
      • Martin A.J.
      • et al.
      Comparative outcomes of open, hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms.
      J Vasc Surg (2020)RetrospectiveSingleCrawford II and III2002–1892/66
      O'Donnell (USA)
      • O'Donnell T.F.X.
      • Boitano L.T.
      • Deery S.E.
      • Schermerhorn M.L.
      • Schanzer A.
      • Beck A.W.
      • et al.
      Open versus fenestrated endovascular repair of complex abdominal aortic aneurysms.
      Ann Surg (2020)Not mentioned, but most probably retrospectiveMulti
      Data collected by the Society for Vascular Surgery Quality Initiative.
      NR2012–181 128/2 125
      Fiorucci (Germany)
      • Fiorucci B.
      • Speziale F.
      • Kölbel T.
      • Tsilimparis N.
      • Sirignano P.
      • Capoccia L.
      • et al.
      Short- and midterm outcomes of open repair and fenestrated endografting of pararenal aortic aneurysms in a concurrent propensity-adjusted comparison.
      J Endovasc Ther (2019)RetrospectiveMultiPararenal AAA1998–201541/102
      Chinsakchai (Thailand)
      • Chinsakchai K.
      • Prapassaro T.
      • Salisatkorn W.
      • Hongku K.
      • Moll F.L.
      • Ruangsetakit C.
      • et al.
      Outcomes of open repair, fenestrated stent grafting, and chimney grafting in juxtarenal abdominal aortic aneurysm: is it time for a randomized trial?.
      Ann Vasc Surg (2019)RetrospectiveSingleJuxtarenal2011–1620/32
      Bizos (France)
      • Bizos A.
      • Chaufour X.
      • Segal J.
      • Senemaud J.
      • Desgranges P.
      • Canoui-Poitrine F.
      • et al.
      Comparison of fenestrated stentgrafts and open repair for juxtarenal aortic aneurysms using a propensity score matching.
      Eur J Vasc Endovasc Surg (2019)Not mentioned, but most probably retrospectiveMultiJuxtarenal2005–17102/51
      Tinelli (Italy)
      • Tinelli G.
      • Crea M.A.
      • de Waure C.
      • Di Tanna G.L.
      • Becquemin J.P.
      • Sobocinski J.
      • et al.
      A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms.
      J Vasc Surg (2018)RetrospectiveMultiPararenal AAA2010–16102/102
      Deery (USA)
      • Deery S.E.
      • Lancaster R.T.
      • Gubala A.M.
      • O'Donnell T.F.X.
      • Kwolek C.J.
      • Conrad M.F.
      • et al.
      Early experience with fenestrated endovascular compared to open repair of complex abdominal aortic aneurysms in a high-volume open aortic center.
      Ann Vasc Surg (2018)RetrospectiveSingleJuxtarenal/suprarenal/supravisceral AAA excluding TAAA extent IV2010–1518/98
      Michel (France)
      • Michel M.
      • Becquemin J.P.
      • Marzelle J.
      • Quelen C.
      • Durand-Zaleski I.
      WINDOW Trial participants. Editor's Choice – a study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.
      Eur J Vasc Endovasc Surg (2018)RetrospectiveMulti
      WINDOW registry (a French multicentre prospective registry) for fenestrated/branched endovascular aneurysm repair and French national hospital discharge database for open surgical repair.
      TAAA or complex AAA2010–12NR
      Locham (USA)
      • Locham S.S.
      • Nejim B.
      • Aridi H.D.
      • Srouji R.
      • Faateh M.
      • Malas M.
      Perioperative outcomes of patients undergoing fenestrated endovascular repair vs open repair of intact abdominal aortic aneurysms involving the visceral vessels: 10-year national study.
      J Am Coll Surg (2017)Not mentioned, but most probably retrospectiveMulti
      American College of Surgeons' National Surgical Quality Improvement Program (NSQIP) database.
      NR2006–15746/1 917
      Ferrer (Italy)
      • Ferrer C.
      • Cao P.
      • De Rango P.
      • Tshomba Y.
      • Verzini F.
      • Melissano G.
      • et al.
      A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
      J Vasc Surg (2016)RetrospectiveMultiTAAA2007–1465/65
      Raux (USA)
      • Raux M.
      • Patel V.I.
      • Cochennec F.
      • Mukhopadhyay S.
      • Desgranges P.
      • Cambria R.P.
      • et al.
      A propensity-matched comparison of outcomes for fenestrated endovascular aneurysm repair and open surgical repair of complex abdominal aortic aneurysms.
      J Vasc Surg (2014)RetrospectiveMultiNR2001–1242/147
      NR = not reported; AAA = abdominal aortic aneurysm; F/BEVAR = fenestrated/branched endovascular aneurysm repair; OSR = open surgical repair; TAAA = thoraco-abdominal aortic aneurysm.
      Data collected by the Society for Vascular Surgery Quality Initiative.
      WINDOW registry (a French multicentre prospective registry) for fenestrated/branched endovascular aneurysm repair and French national hospital discharge database for open surgical repair.
      American College of Surgeons' National Surgical Quality Improvement Program (NSQIP) database.
      The baseline demographics of the study populations are presented in Table S2 (see Supplementary Material). Most studies reported medium term follow up, whereas two studies reported peri-operative data only.
      • Locham S.S.
      • Nejim B.
      • Aridi H.D.
      • Srouji R.
      • Faateh M.
      • Malas M.
      Perioperative outcomes of patients undergoing fenestrated endovascular repair vs open repair of intact abdominal aortic aneurysms involving the visceral vessels: 10-year national study.
      ,
      • Raux M.
      • Patel V.I.
      • Cochennec F.
      • Mukhopadhyay S.
      • Desgranges P.
      • Cambria R.P.
      • et al.
      A propensity-matched comparison of outcomes for fenestrated endovascular aneurysm repair and open surgical repair of complex abdominal aortic aneurysms.
      Seven studies compared outcomes in propensity score matched patients.
      • Arnaoutakis D.J.
      • Scali S.T.
      • Beck A.W.
      • Kubilis P.
      • Huber T.S.
      • Martin A.J.
      • et al.
      Comparative outcomes of open, hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms.
      ,
      • Fiorucci B.
      • Speziale F.
      • Kölbel T.
      • Tsilimparis N.
      • Sirignano P.
      • Capoccia L.
      • et al.
      Short- and midterm outcomes of open repair and fenestrated endografting of pararenal aortic aneurysms in a concurrent propensity-adjusted comparison.
      ,
      • Bizos A.
      • Chaufour X.
      • Segal J.
      • Senemaud J.
      • Desgranges P.
      • Canoui-Poitrine F.
      • et al.
      Comparison of fenestrated stentgrafts and open repair for juxtarenal aortic aneurysms using a propensity score matching.
      ,
      • Tinelli G.
      • Crea M.A.
      • de Waure C.
      • Di Tanna G.L.
      • Becquemin J.P.
      • Sobocinski J.
      • et al.
      A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms.
      ,
      • Michel M.
      • Becquemin J.P.
      • Marzelle J.
      • Quelen C.
      • Durand-Zaleski I.
      WINDOW Trial participants. Editor's Choice – a study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.
      ,
      • Ferrer C.
      • Cao P.
      • De Rango P.
      • Tshomba Y.
      • Verzini F.
      • Melissano G.
      • et al.
      A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
      ,
      • Raux M.
      • Patel V.I.
      • Cochennec F.
      • Mukhopadhyay S.
      • Desgranges P.
      • Cambria R.P.
      • et al.
      A propensity-matched comparison of outcomes for fenestrated endovascular aneurysm repair and open surgical repair of complex abdominal aortic aneurysms.
      The remaining four used multiple Cox regression or multivariable models to adjust for confounding factors (Table S3; see Supplementary Material).

      Quality of included studies

      The results of the study quality assessment are summarised in Table S4 and Fig. S1, and the supports for judgement are presented in Appendix S3 (see Supplementary Material). The main methodological constraints are in the outcome assessment, with none of the included studies reporting long enough follow up times for the primary and secondary outcomes to occur or providing information on losses to follow up. As expected, cases and controls (patients treated with F/BEVAR and open surgery, respectively) were matched in the design and/or confounders were adjusted for in the analysis. Cases and controls were generally well defined, but issues were identified with representativeness of cases and selection of controls in some studies.
      The results of the GRADE assessment and explanations for downgrading the level of evidence are presented in Table 2. The certainty for the body of evidence for peri-operative mortality and survival during follow up was judged to be very low and moderate, respectively; for re-intervention it was judged to be high, and for the remaining secondary outcomes very low.
      Table 2Summary of findings and Grades of Recommendation, Assessment, Development and Evaluation (GRADE) assessment of the 11 studies reporting comparative outcomes of fenestrated/branched endovascular aneurysm repair and open surgical repair for complex aortic aneurysms
      Outcome and studiesCertainty assessmentSummary of findings
      Risk of biasInconsistencyIndirectnessImprecisionOther considerationsOverall certainty of evidenceRelative effect (95% CI)
      Peri-operative mortality
      Seven observational studiesNot serious
      Selection, comparability, and outcome assessment were judged to be adequate for this outcome.
      Not seriousNot seriousSerious
      The number of participants and number events were relatively small, resulting in fairly wide confidence intervals.
      None⊕◯◯◯

      VERY LOW
      OR 0.56

      (0.28–1.12)
      Survival
      Eight observational studiesSerious
      The follow up time was not long enough for this outcome to occur (an acceptable minimum follow up was set at five years). Furthermore, none of the studies provided data on losses to follow up, and most studies reported no information on ascertainment of the outcome.
      Not seriousNot seriousNot seriousNone⊕⊕⊕◯

      MODERATE
      HR 1.25

      (0.93–1.67)
      Re-intervention
      Four observational studiesSerious
      The follow up time was not long enough for this outcome to occur (an acceptable minimum follow up was set at five years). Furthermore, none of the studies provided data on losses to follow up, and most studies reported no information on ascertainment of the outcome.
      Not seriousNot seriousNot seriousStrong association⊕⊕⊕⊕

      HIGH
      HR 2.11

      (1.39–3.18)
      Kidney damage
      Five observational studiesNot serious
      Selection, comparability, and outcome assessment were judged to be adequate for this outcome.
      Serious
      There is statistical evidence of heterogeneity, which most probably resulted from variability in the definition of kidney damage.
      Not seriousNot seriousNone⊕◯◯◯

      VERY LOW
      OR 0.65

      (0.28–1.52)
      Spinal cord ischaemia
      Two observational studiesNot serious
      Selection, comparability, and outcome assessment were judged to be adequate for this outcome.
      Serious
      Although the confidence intervals overlap, the point estimates differ, which is reflected in the statistical inconsistency.
      Not seriousNot seriousNone⊕◯◯◯

      VERY LOW
      OR 1.32

      (0.23–7.53)
      CI = confidence interval; OR = odds ratio; HR = hazard ratio.
      Selection, comparability, and outcome assessment were judged to be adequate for this outcome.
      The number of participants and number events were relatively small, resulting in fairly wide confidence intervals.
      The follow up time was not long enough for this outcome to occur (an acceptable minimum follow up was set at five years). Furthermore, none of the studies provided data on losses to follow up, and most studies reported no information on ascertainment of the outcome.
      § There is statistical evidence of heterogeneity, which most probably resulted from variability in the definition of kidney damage.
      Although the confidence intervals overlap, the point estimates differ, which is reflected in the statistical inconsistency.

      Effects of interventions

      The methods of HR and SE calculation for the individual outcomes in the individual studies are presented in Table S5 (see Supplementary Material). Outcome data extracted from the included studies are presented in Table S6 (see Supplementary Material), and the forest plots for the primary and secondary outcomes are presented in Fig. 2.
      Figure 2
      Figure 2Forest plots of comparisons of (A) peri-operative mortality (B) survival in follow up (C) re-intervention (D) kidney damage, and (E) spinal cord ischaemia after fenestrated/branched endovascular aneurysm repair (F/BEVAR) vs. open repair of complex aortic aneurysms. The solid squares denote the hazard ratios or odds ratios, the horizontal lines represent the 95% confidence intervals (CI), and the diamonds denote the pooled hazard ratios or odds ratios. IV = inverse variance.

      Primary outcomes

      Seven studies reported data on peri-operative mortality.
      • Arnaoutakis D.J.
      • Scali S.T.
      • Beck A.W.
      • Kubilis P.
      • Huber T.S.
      • Martin A.J.
      • et al.
      Comparative outcomes of open, hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms.
      ,
      • Fiorucci B.
      • Speziale F.
      • Kölbel T.
      • Tsilimparis N.
      • Sirignano P.
      • Capoccia L.
      • et al.
      Short- and midterm outcomes of open repair and fenestrated endografting of pararenal aortic aneurysms in a concurrent propensity-adjusted comparison.
      ,
      • Bizos A.
      • Chaufour X.
      • Segal J.
      • Senemaud J.
      • Desgranges P.
      • Canoui-Poitrine F.
      • et al.
      Comparison of fenestrated stentgrafts and open repair for juxtarenal aortic aneurysms using a propensity score matching.
      ,
      • Tinelli G.
      • Crea M.A.
      • de Waure C.
      • Di Tanna G.L.
      • Becquemin J.P.
      • Sobocinski J.
      • et al.
      A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms.
      ,
      • Locham S.S.
      • Nejim B.
      • Aridi H.D.
      • Srouji R.
      • Faateh M.
      • Malas M.
      Perioperative outcomes of patients undergoing fenestrated endovascular repair vs open repair of intact abdominal aortic aneurysms involving the visceral vessels: 10-year national study.
      • Ferrer C.
      • Cao P.
      • De Rango P.
      • Tshomba Y.
      • Verzini F.
      • Melissano G.
      • et al.
      A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
      • Raux M.
      • Patel V.I.
      • Cochennec F.
      • Mukhopadhyay S.
      • Desgranges P.
      • Cambria R.P.
      • et al.
      A propensity-matched comparison of outcomes for fenestrated endovascular aneurysm repair and open surgical repair of complex abdominal aortic aneurysms.
      F/BEVAR was found to have a lower peri-operative mortality than OSR, but the difference did not reach statistical significance (OR 0.56, 95% CI 0.28–1.12; p = .10). The statistical between study heterogeneity was not significant (p = .16, I2 = 35%).
      Eight studies reported data on overall survival during follow up suitable for meta-analysis.
      • Arnaoutakis D.J.
      • Scali S.T.
      • Beck A.W.
      • Kubilis P.
      • Huber T.S.
      • Martin A.J.
      • et al.
      Comparative outcomes of open, hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms.
      • O'Donnell T.F.X.
      • Boitano L.T.
      • Deery S.E.
      • Schermerhorn M.L.
      • Schanzer A.
      • Beck A.W.
      • et al.
      Open versus fenestrated endovascular repair of complex abdominal aortic aneurysms.
      • Fiorucci B.
      • Speziale F.
      • Kölbel T.
      • Tsilimparis N.
      • Sirignano P.
      • Capoccia L.
      • et al.
      Short- and midterm outcomes of open repair and fenestrated endografting of pararenal aortic aneurysms in a concurrent propensity-adjusted comparison.
      • Chinsakchai K.
      • Prapassaro T.
      • Salisatkorn W.
      • Hongku K.
      • Moll F.L.
      • Ruangsetakit C.
      • et al.
      Outcomes of open repair, fenestrated stent grafting, and chimney grafting in juxtarenal abdominal aortic aneurysm: is it time for a randomized trial?.
      ,
      • Tinelli G.
      • Crea M.A.
      • de Waure C.
      • Di Tanna G.L.
      • Becquemin J.P.
      • Sobocinski J.
      • et al.
      A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms.
      • Deery S.E.
      • Lancaster R.T.
      • Gubala A.M.
      • O'Donnell T.F.X.
      • Kwolek C.J.
      • Conrad M.F.
      • et al.
      Early experience with fenestrated endovascular compared to open repair of complex abdominal aortic aneurysms in a high-volume open aortic center.
      • Michel M.
      • Becquemin J.P.
      • Marzelle J.
      • Quelen C.
      • Durand-Zaleski I.
      WINDOW Trial participants. Editor's Choice – a study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.
      ,
      • Ferrer C.
      • Cao P.
      • De Rango P.
      • Tshomba Y.
      • Verzini F.
      • Melissano G.
      • et al.
      A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
      The hazard of death during follow up was not significantly different between F/BEVAR and OSR (HR 1.25, 95% CI 0.93–1.67; p = .14). Statistical heterogeneity was low (p = .18; I2 = 31%).

      Secondary outcomes

      Four studies reported time to event data on re-intervention during follow up suitable for meta-analysis.
      • Tinelli G.
      • Crea M.A.
      • de Waure C.
      • Di Tanna G.L.
      • Becquemin J.P.
      • Sobocinski J.
      • et al.
      A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms.
      • Deery S.E.
      • Lancaster R.T.
      • Gubala A.M.
      • O'Donnell T.F.X.
      • Kwolek C.J.
      • Conrad M.F.
      • et al.
      Early experience with fenestrated endovascular compared to open repair of complex abdominal aortic aneurysms in a high-volume open aortic center.
      • Michel M.
      • Becquemin J.P.
      • Marzelle J.
      • Quelen C.
      • Durand-Zaleski I.
      WINDOW Trial participants. Editor's Choice – a study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.
      ,
      • Ferrer C.
      • Cao P.
      • De Rango P.
      • Tshomba Y.
      • Verzini F.
      • Melissano G.
      • et al.
      A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
      The hazard of re-intervention was significantly higher in patients who underwent endovascular therapy (HR 2.11, 95% CI 1.39–3.18; p < .001), with negligible statistical heterogeneity (p = .42, I2 = 0%). The types of re-intervention are detailed in Table S7 (see Supplementary Material).
      Five studies reported data on kidney damage following surgery.
      • Fiorucci B.
      • Speziale F.
      • Kölbel T.
      • Tsilimparis N.
      • Sirignano P.
      • Capoccia L.
      • et al.
      Short- and midterm outcomes of open repair and fenestrated endografting of pararenal aortic aneurysms in a concurrent propensity-adjusted comparison.
      ,
      • Bizos A.
      • Chaufour X.
      • Segal J.
      • Senemaud J.
      • Desgranges P.
      • Canoui-Poitrine F.
      • et al.
      Comparison of fenestrated stentgrafts and open repair for juxtarenal aortic aneurysms using a propensity score matching.
      ,
      • Tinelli G.
      • Crea M.A.
      • de Waure C.
      • Di Tanna G.L.
      • Becquemin J.P.
      • Sobocinski J.
      • et al.
      A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms.
      ,
      • Ferrer C.
      • Cao P.
      • De Rango P.
      • Tshomba Y.
      • Verzini F.
      • Melissano G.
      • et al.
      A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
      ,
      • Raux M.
      • Patel V.I.
      • Cochennec F.
      • Mukhopadhyay S.
      • Desgranges P.
      • Cambria R.P.
      • et al.
      A propensity-matched comparison of outcomes for fenestrated endovascular aneurysm repair and open surgical repair of complex abdominal aortic aneurysms.
      Three did not define kidney damage; one defined it according to the “Risk, Injury, and Failure; and Loss; and End-stage kidney disease” (RIFLE) criteria, and another defined it as requiring dialysis. The odds of kidney damage were not significantly different between F/BEVAR and OSR (OR 0.65, 95% CI 0.28–1.52; p = .32). The statistical heterogeneity was considerable (p = .01, I2 = 69%).
      Two studies reported information on spinal cord ischaemia suitable for meta-analysis.
      • Arnaoutakis D.J.
      • Scali S.T.
      • Beck A.W.
      • Kubilis P.
      • Huber T.S.
      • Martin A.J.
      • et al.
      Comparative outcomes of open, hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms.
      ,
      • Ferrer C.
      • Cao P.
      • De Rango P.
      • Tshomba Y.
      • Verzini F.
      • Melissano G.
      • et al.
      A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
      The odds of developing any spinal cord ischaemia was not significantly different between F/BEVAR and OSR (OR 1.32, 95% CI 0.23–7.53; p = .76) with a significant statistical heterogeneity (p = .02, I2 = 81%).
      No data suitable for meta-analysis were reported for ICU length of stay.

      Sensitivity analysis

      The results of sensitivity analyses are given in Table S8 (see Supplementary Material). Meta-analysis of propensity score matched studies did not change the effect estimates for any of the clinical outcomes. Meta-analysis of studies that reported juxta/para/suprarenal AAAs (i.e., excluding those reporting thoraco-abdominal aortic aneurysms) showed a higher mortality during follow up in patients who underwent F/BEVAR.

      Discussion

      Summary of main results

      The systematic review identified 11 comparative studies assessing the outcomes of F/BEVAR and OSR for complex aortic aneurysms.
      • Arnaoutakis D.J.
      • Scali S.T.
      • Beck A.W.
      • Kubilis P.
      • Huber T.S.
      • Martin A.J.
      • et al.
      Comparative outcomes of open, hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms.
      • O'Donnell T.F.X.
      • Boitano L.T.
      • Deery S.E.
      • Schermerhorn M.L.
      • Schanzer A.
      • Beck A.W.
      • et al.
      Open versus fenestrated endovascular repair of complex abdominal aortic aneurysms.
      • Fiorucci B.
      • Speziale F.
      • Kölbel T.
      • Tsilimparis N.
      • Sirignano P.
      • Capoccia L.
      • et al.
      Short- and midterm outcomes of open repair and fenestrated endografting of pararenal aortic aneurysms in a concurrent propensity-adjusted comparison.
      • Chinsakchai K.
      • Prapassaro T.
      • Salisatkorn W.
      • Hongku K.
      • Moll F.L.
      • Ruangsetakit C.
      • et al.
      Outcomes of open repair, fenestrated stent grafting, and chimney grafting in juxtarenal abdominal aortic aneurysm: is it time for a randomized trial?.
      • Bizos A.
      • Chaufour X.
      • Segal J.
      • Senemaud J.
      • Desgranges P.
      • Canoui-Poitrine F.
      • et al.
      Comparison of fenestrated stentgrafts and open repair for juxtarenal aortic aneurysms using a propensity score matching.
      • Tinelli G.
      • Crea M.A.
      • de Waure C.
      • Di Tanna G.L.
      • Becquemin J.P.
      • Sobocinski J.
      • et al.
      A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms.
      • Deery S.E.
      • Lancaster R.T.
      • Gubala A.M.
      • O'Donnell T.F.X.
      • Kwolek C.J.
      • Conrad M.F.
      • et al.
      Early experience with fenestrated endovascular compared to open repair of complex abdominal aortic aneurysms in a high-volume open aortic center.
      • Michel M.
      • Becquemin J.P.
      • Marzelle J.
      • Quelen C.
      • Durand-Zaleski I.
      WINDOW Trial participants. Editor's Choice – a study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.
      • Locham S.S.
      • Nejim B.
      • Aridi H.D.
      • Srouji R.
      • Faateh M.
      • Malas M.
      Perioperative outcomes of patients undergoing fenestrated endovascular repair vs open repair of intact abdominal aortic aneurysms involving the visceral vessels: 10-year national study.
      • Ferrer C.
      • Cao P.
      • De Rango P.
      • Tshomba Y.
      • Verzini F.
      • Melissano G.
      • et al.
      A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
      • Raux M.
      • Patel V.I.
      • Cochennec F.
      • Mukhopadhyay S.
      • Desgranges P.
      • Cambria R.P.
      • et al.
      A propensity-matched comparison of outcomes for fenestrated endovascular aneurysm repair and open surgical repair of complex abdominal aortic aneurysms.
      The meta-analysis demonstrated lower, but not statistically significant, peri-operative mortality after endovascular repair. Analysis of renal outcomes favoured F/BEVAR, but this effect was also not statistically significant. No significant association of surgical modality with the incidence of spinal cord ischaemia was demonstrated, and there were no data to support the analysis of length of ICU stay. The time to event analysis showed a statistically insignificant medium and long term survival benefit of open surgery, and a significantly higher hazard of re-intervention after F/BEVAR.

      Overall completeness, applicability, and quality of evidence

      A recent systematic review collated data from comparative studies of any type of endovascular repair (standard EVAR, F/BEVAR, or EVAR with parallel grafts) vs. open repair for juxtarenal aortic aneurysms in unmatched patient populations, and did not examine follow up outcomes.
      • Doonan R.J.
      • Girsowicz E.
      • Dubois L.
      • Gill H.L.
      A systematic review and meta-analysis of endovascular juxtarenal aortic aneurysm repair demonstrates lower perioperative mortality compared with open repair.
      Another recently published systematic review collated data from studies reporting only endovascular repair and from studies reporting only open repair for thoraco-abdominal aortic aneurysms, and compared pooled outcomes in those sets of studies.
      • Rocha R.V.
      • Friedrich J.O.
      • Elbatarny M.
      • Yanagawa B.
      • Al-Omran M.
      • Forbes T.L.
      • et al.
      A systematic review and meta-analysis of early outcomes after endovascular versus open repair of thoracoabdominal aortic aneurysms.
      As expected, the endovascular and open repair cohorts differed in their baseline clinical characteristics, which may explain the discrepancies between the findings of that study with the results of our meta-analysis. The authors of that review did not examine follow up outcomes.
      The present meta-analysis considered the best available evidence comparing outcomes of endovascular and open surgery for complex aortic aneurysms and is the first to report comparative follow up outcomes using time to event meta-analytical techniques. Although only comparative studies that used propensity or regression analyses to account for baseline differences were included, it is acknowledged that the overall quality of the evidence was poor, and that a very heterogenous group of patients was studied. Potential difficulties in interpreting the results were anticipated; however, in order to mitigate this, unlike previous meta-analyses, comparative studies where the probability of bias was reduced by the use of propensity score analysis or other statistical techniques were concentrated on.
      • Doonan R.J.
      • Girsowicz E.
      • Dubois L.
      • Gill H.L.
      A systematic review and meta-analysis of endovascular juxtarenal aortic aneurysm repair demonstrates lower perioperative mortality compared with open repair.
      • Rocha R.V.
      • Friedrich J.O.
      • Elbatarny M.
      • Yanagawa B.
      • Al-Omran M.
      • Forbes T.L.
      • et al.
      A systematic review and meta-analysis of early outcomes after endovascular versus open repair of thoracoabdominal aortic aneurysms.
      • Jones A.D.
      • Waduud M.A.
      • Walker P.
      • Stocken D.
      • Bailey M.A.
      • Scott D.J.A.
      Meta-analysis of fenestrated endovascular aneurysm repair versus open surgical repair of juxtarenal abdominal aortic aneurysms over the last 10 years.
      As this methodological approach is being used increasingly, a set of reporting standards has been proposed based on Strengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines, which have been endorsed by the EQUATOR network.
      • Yao X.I.
      • Wang X.
      • Speicher P.J.
      • Hwang E.S.
      • Cheng P.
      • Harpole D.H.
      • et al.
      Reporting and guidelines in propensity score analysis: a systematic review of cancer and cancer surgical studies.
      None of the studies included in the present analysis described propensity score analysis methodology in a detailed manner to fulfil all requirements set by Yao et al.
      • Yao X.I.
      • Wang X.
      • Speicher P.J.
      • Hwang E.S.
      • Cheng P.
      • Harpole D.H.
      • et al.
      Reporting and guidelines in propensity score analysis: a systematic review of cancer and cancer surgical studies.

      Data quality

      All papers included in this meta-analysis were based on retrospective studies, and all but two were based on small cohorts. Some of the studies combined data from multiple, variable volume centres, each specialising in different treatment modalities, and even functioning in different healthcare systems. Raux et al.
      • Raux M.
      • Patel V.I.
      • Cochennec F.
      • Mukhopadhyay S.
      • Desgranges P.
      • Cambria R.P.
      • et al.
      A propensity-matched comparison of outcomes for fenestrated endovascular aneurysm repair and open surgical repair of complex abdominal aortic aneurysms.
      compared the experience of FEVAR and open repair from two centres: one in France (FEVAR) and the other in the USA (OSR). The sample size of 55 in the FEVAR group appeared to be very small for a specialist aortic centre, considering the procedures were performed over a 11 year period. This was compared with a cohort of 319 open thoraco-abdominal repairs performed over a similar period. It is therefore not surprising that, for instance, the peri-operative morbidity and mortality were excessive in the FEVAR group, as it is unlikely that the experience of respective teams, resources, and the local set up were comparable between these two institutions.
      Data veracity is the Achilles’ heel of all retrospective analyses. Such nuances were apparent in the study by Michel et al.,
      • Michel M.
      • Becquemin J.P.
      • Marzelle J.
      • Quelen C.
      • Durand-Zaleski I.
      WINDOW Trial participants. Editor's Choice – a study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.
      based on WINDOW registry data, where 268 cases derived from a prospective endovascular registry were compared with a cohort of 1 678 patients in the OSR group from national institution-level data. Inevitably, these two independently collected datasets would have different data granularity and veracity, as they serve different purposes.
      Another cause of concern is that of “learning curve bias”. Raux et al.
      • Raux M.
      • Patel V.I.
      • Cochennec F.
      • Mukhopadhyay S.
      • Desgranges P.
      • Cambria R.P.
      • et al.
      A propensity-matched comparison of outcomes for fenestrated endovascular aneurysm repair and open surgical repair of complex abdominal aortic aneurysms.
      compared outcomes of their first FEVAR cases with those of open repair cases from another institution located in a different healthcare setting, with a long-established practice in open surgery for complex aortic aneurysms. The same holds true for the study of Michel et al.,
      • Michel M.
      • Becquemin J.P.
      • Marzelle J.
      • Quelen C.
      • Durand-Zaleski I.
      WINDOW Trial participants. Editor's Choice – a study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.
      which compared F/BEVAR in French centres with questionable experience in complex endovascular procedures (an experience of only three such cases was required for an institution to participate in that study) with open surgery of which data were derived from national level administrative datasets of uncertain accuracy.
      • Michel M.
      • Becquemin J.P.
      • Marzelle J.
      • Quelen C.
      • Durand-Zaleski I.
      WINDOW Trial participants. Editor's Choice – a study of the cost-effectiveness of fenestrated/branched EVAR compared with open surgery for patients with complex aortic aneurysms at 2 years.

      Peri-operative mortality

      The present results indicate a non-significant advantage of F/BEVAR over OSR regarding peri-operative mortality. It has to be acknowledged that there is only so much that can be explained by patients’ anatomy and physiology. The important factors to consider are surgical and critical care set up, and human factors (reflected, to some extent, by the volume of work).
      • Locham S.
      • Hussain F.
      • Dakour-Aridi H.
      • Barleben A.
      • Lane J.S.
      • Malas M.
      Hospital volume impacts the outcomes of endovascular repair of thoracoabdominal aortic aneurysms.
      Therefore, it would be expected that the gap between the endovascular and open modalities would close when analysing data from highly specialised, well trained, and well equipped teams dealing with more complex aortic disease. Further centralisation of aortic services and formation of Distal Arch, Descending Thoracic and Thoraco-abdominal (DATA) centres with co-location of expertise in endovascular and open surgery could possibly close this gap effectively and allow for a more efficient allocation of resources with great benefit to patients.

      Peri-operative morbidity

      Only five studies reported on changes in post-operative renal function. There was a considerable inconsistency in reporting renal outcomes and a significant heterogeneity among studies, making interpretation of these results difficult. Only two studies reported data on spinal cord ischaemia that were suitable for meta-analysis.
      Ferrer at al.
      • Ferrer C.
      • Cao P.
      • De Rango P.
      • Tshomba Y.
      • Verzini F.
      • Melissano G.
      • et al.
      A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
      reported the incidence of any spinal cord ischaemia to be 12.3% for F/BEVAR and 20% for open repair, high by contemporary standards. It is somewhat difficult to compare the results reported by Ferrer et al.
      • Ferrer C.
      • Cao P.
      • De Rango P.
      • Tshomba Y.
      • Verzini F.
      • Melissano G.
      • et al.
      A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
      with those reported by Arnaoutakis et al.,
      • Arnaoutakis D.J.
      • Scali S.T.
      • Beck A.W.
      • Kubilis P.
      • Huber T.S.
      • Martin A.J.
      • et al.
      Comparative outcomes of open, hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms.
      as they reported only the incidence of permanent spinal cord ischaemia (3% for F/BEVAR and 6% for open repair) and provided only effect size for any spinal cord ischaemia. However, both studies indicated an advantage of the endovascular approach over OSR. This would certainly be consistent with contemporary results from large series of thoraco-abdominal aneurysm repair, which indicated spinal cord ischaemia rates of around 2%.
      • Juszczak M.T.
      • Murray A.
      • Koutsoumpelis A.
      • Vezzosi M.
      • Mascaro J.
      • Claridge M.
      • et al.
      Elective fenestrated and branched endovascular thoraco-abdominal aortic repair with supracoeliac sealing zones and without prophylactic cerebrospinal fluid drainage: early and medium-term outcomes.
      When interpreting such data, one has to consider that BEVAR may be associated with higher rates of spinal cord ischaemia than FEVAR due to the increased length of aortic coverage required for branched stent grafts in thoraco-abdominal aortic aneurysms vs. fenestrated grafts in pararenal aortic aneurysms. Furthermore, the role of physician modified grafts in the elective setting has not been investigated, even though it seems that custom made grafts work better as they have some extra features that not all physician modified grafts have.
      • Sénémaud J.N.
      • Abdallah I.B.
      • Boissieu P.
      • Touma J.
      • Kobeiter H.
      • Desgranges P.
      • et al.
      Intraoperative adverse events and early outcomes of custom-made fenestrated stent grafts and physician-modified stent grafts for complex aortic aneurysms.

      Re-interventions

      A significantly higher risk of re-intervention associated with F/BEVAR was demonstrated using time to event meta-analysis. However, it is important to emphasise that re-intervention in observational studies is the outcome that is very difficult to define and interpret. Unlike protocolised re-interventions with clearly defined indications in clinical trials and rigid prospective observational studies, retrospective studies of routinely collected clinical data do not accurately account for variability in surgeon preferences and departmental policies. There was no data available on the outcome of re-intervention, and whether it affected patient survival.

      Survival

      None of the previous meta-analyses included time to event analysis, which in the current study demonstrated a statistically non-significant medium term survival benefit for open surgery. The higher survival rates of patients who underwent open surgery could be explained by different patient selection (i.e., younger and physiologically fitter patients were offered open aneurysm repair), although parameters such as age were accounted for in propensity or regression analysis in the selected studies, thus minimising selection bias. Interpretation of these results depends on correct reporting of the statistical analyses, which should include verification of outcome (death), median follow up, and number at risk. Comparisons and conclusions regarding survival beyond the median follow up point can be difficult and depend on numbers at risk. This is particularly important if the data were sourced from different cohorts.

      Conclusion

      Implications for practice

      The clinical implications of this analysis are twofold. Firstly, as the source papers comparing treatments for juxta/pararenal and thoraco-abdominal aneurysms inferred early benefits of endovascular repair, it seems logical to suggest that these should be treated using F/BEVAR. However, given that current data suggest that open repair for complex aortic aneurysms may have a survival advantage over F/BEVAR and a reduced risk of secondary intervention, open surgery may be considered in young and fit patients with a long life expectancy.
      • Loftus I.M.
      • Haulon S.
      • Boyle J.R.
      NICE abdominal aortic aneurysm guidelines finally published: how will they influence aortic practice in the UK and beyond?.
      Such practice is consistent with contemporary clinical practice guidelines, which recommend that an endovascular approach should be considered in patients unfit for open repair, acknowledging a low level of evidence.
      • Riambau V.
      • Böckler D.
      • Brunkwall J.
      • Cao P.
      • Chiesa R.
      • Coppi G.
      • et al.
      Editor's Choice – management of descending thoracic aorta diseases: clinical practice guidelines of the European Society for Vascular Surgery (ESVS).
      Secondly, complex open and endovascular procedures should be performed in high volume, specialised aortic centres to further minimise the risk of peri-operative mortality and morbidity, and to achieve the best possible long term outcome.

      Implications for research

      This systematic review demonstrated a paucity of good quality evidence supporting the management of complex aortic aneurysms. The propensity matched studies provide a more robust approach but cannot be treated as a replacement for good quality data in a randomised study. Although the suggestion of a randomised clinical trial seems to be valid, in view of recently reported outcomes of F/BEVAR for thoraco-abdominal aneurysms from specialist aortic centres, the lack of equipoise would render any trial undeliverable.
      • Juszczak M.T.
      • Murray A.
      • Koutsoumpelis A.
      • Vezzosi M.
      • Mascaro J.
      • Claridge M.
      • et al.
      Elective fenestrated and branched endovascular thoraco-abdominal aortic repair with supracoeliac sealing zones and without prophylactic cerebrospinal fluid drainage: early and medium-term outcomes.
      Conversely, there might be a need for a randomised study for juxta- and pararenal aneurysms. The equipoise seems to be there, but trial designs proposed thus far were not met with great support from both the community and the funding bodies, resulting in the observational UK-COMPASS study.

      ISRCTN Registry. A comparison study of open surgery, minimal invasive surgery and medical management for complex aortic aneurysms. Available at: http://www.isrctn.com/ISRCTN85731188?q=&filters=&sort=&offset=7&totalResults=15506&page=1&pageSize=10&searchType=basic-search [Accessed 20 May 2020].

      It is advisable that the PRagmatic-Explanatory Continuum Indicator Summary (PRECIS-2) be applied when designing a randomised clinical trial of F/BEVAR vs. open repair for juxtarenal (and/or pararenal) aortic aneurysms, with a specific focus on the setting, expertise, and resources that are needed to deliver the intervention.
      • Loudon K.
      • Treweek S.
      • Sullivan F.
      • Donnan P.
      • Thorpe K.E.
      • Zwarenstein M.
      The PRECIS-2 tool: designing trials that are fit for purpose.
      Considering that specialist centres may not perform endovascular and open repair equally well, a trial design may need to consider randomisation from different specialist centres with expertise for a specific treatment. External validity is important when designing such a trial, taking into account the continuing development of specialised complex aortic centres.

      Conflicts of Interest

      None.

      Funding

      None.

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      Linked Article

      • Collective Consciousness on Complex Aortic Repair: Time to Focus on Data Capture
        European Journal of Vascular and Endovascular SurgeryVol. 61Issue 2
        • Preview
          In this issue of EJVES, Antoniou et al. synthesise the current literature comparing open treatment of juxta/para/suprarenal and thoraco-abdominal aneurysms (TAAs) with endovascular treatment using branched and fenestrated techniques.1 Their meta-analysis of >7 000 patients should be commended, particularly given the fact that they only include comparative studies that utilise propensity or regression analyses, thereby limiting bias. They also capture follow up data. The take home messages are clear.
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