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Editor's Choice – Endovascular Aneurysm Repair Versus Open Repair for Patients with a Ruptured Abdominal Aortic Aneurysm: A Systematic Review and Meta-analysis of Short-term Survival

  • Author Footnotes
    a Both authors equally contributed to current manuscript.
    S.C. van Beek
    Footnotes
    a Both authors equally contributed to current manuscript.
    Affiliations
    Department of Vascular Surgery, Academic Medical Centre, Amsterdam, The Netherlands
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  • Author Footnotes
    a Both authors equally contributed to current manuscript.
    A.P. Conijn
    Footnotes
    a Both authors equally contributed to current manuscript.
    Affiliations
    Department of Vascular Surgery, Academic Medical Centre, Amsterdam, The Netherlands
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  • M.J. Koelemay
    Affiliations
    Department of Vascular Surgery, Academic Medical Centre, Amsterdam, The Netherlands
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  • R. Balm
    Correspondence
    Corresponding author. R. Balm, Department of Vascular Surgery, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
    Affiliations
    Department of Vascular Surgery, Academic Medical Centre, Amsterdam, The Netherlands
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  • Author Footnotes
    a Both authors equally contributed to current manuscript.
Open AccessPublished:April 18, 2014DOI:https://doi.org/10.1016/j.ejvs.2014.03.003

      Background

      There is clinical equipoise between open (OR) and endovascular aneurysm repair (EVAR) for the best treatment of ruptured abdominal aortic aneurysm (RAAA).

      Objective

      The aim of the study was to perform a systematic review and meta-analysis to estimate the short-term (combined 30-day or in-hospital) survival after EVAR and OR for patients with RAAA. Data sources included Medline, Embase, and the World Health Organization International Clinical Trials Registry until 13 January 2014. All randomised controlled trials (RCTs), observational cohort studies, and administrative registries comparing OR and EVAR of at least 50 patients were included. Articles were full-length and in English.

      Methods

      Standard PRISMA guidelines were followed. The methodological quality of RCTs was assessed with the Cochrane Collaboration's tool for assessing risk of bias. The quality of observational studies was assessed with a modified Cochrane Collaboration's tool for assessing risk of bias, the Newcastle–Ottawa Scale, and the Methodological Index for Non-Randomized Studies. The results of the RCTs, of the obersvational studies, and of the administrative registries were pooled separately and analysed with the use of a random effects model.

      Results

      From a total of 3,769 articles, three RCTs, 21 observational studies, and eight administrative registries met the inclusion criteria. In the RCTs, the risk of bias was lowest and the pooled odds ratio for death after EVAR versus OR was 0.90 (95% CI 0.65–1.24). The majority of the observational studies had a high risk of bias and the pooled odds ratio for death was 0.44 (95% CI 0.37–0.53). The majority of the administrative registries had a high risk of bias and the pooled odds ratio for death was 0.54 (95% CI 0.47–0.62).

      Conclusion

      Endovascular aneurysm repair is not inferior to open repair in patients with a ruptured abdominal aortic aneurysm. This supports the use of EVAR in suitable patients and OR as a reasonable alternative.

      Keywords

      MeSH keywords

      There is a clinical equipoise about the best treatment for a patient with a ruptured abdominal aortic aneurysm: endovascular (EVAR) or open repair (OR). The results of the present systematic review indicate that endovascular aneurysm repair is not inferior to open repair with regard to short-term survival. This supports the use of EVAR in suitable patients and OR as a reasonable alternative. Possible future directions are centralisation of care in high-volume hospitals, ‘EVAR-first’/hybrid repair, or an ‘EVAR-only’ approach.

      Introduction

      The death rate in all patients with a ruptured abdominal aortic aneurysm (RAAA) is around 80%.
      • Reimerink J.J.
      • van der Laan M.J.
      • Koelemay M.J.
      • Balm R.
      • Legemate D.A.
      Systematic review and meta-analysis of population-based mortality from ruptured abdominal aortic aneurysm.
      One-third of all patients with RAAA do not reach the hospital alive, and one-third do not have an intervention. Of the patients having an intervention, only half survive intervention and admission. The traditional intervention is open surgical repair (OR) with exclusion of the aneurysm with a synthetic tube or bifurcated graft. Endovascular aneurysm repair (EVAR) was developed in the 1990s. The experience with elective EVAR has led to its increasing use in the emergency setting. Between 46% and 64% of patients with RAAA have suitable aortic anatomy for EVAR.
      • Powell J.T.
      • Sweeting M.J.
      • Thompson M.M.
      • Ashleigh R.
      • Bell R.
      • Gomes M.
      • et al.
      Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial.
      • Reimerink J.J.
      • Hoornweg L.L.
      • Vahl A.C.
      • Wisselink W.
      • van den Broek T.A.
      • Legemate D.A.
      • et al.
      Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial.
      Observational studies have reported improved short-term survival after EVAR compared with OR. Observational studies however have methodological limitations, leading to biased estimates of outcome. Randomised controlled trials are regarded as providing the best evidence for the relative efficacy of interventions. An early trial from the UK did not show any benefit of EVAR in patients with RAAA.
      • Hinchliffe R.J.
      • Bruijstens L.
      • MacSweeney S.T.R.
      • Braithwaite B.D.
      A randomised trial of endovascular and open surgery for ruptured abdominal aortic aneurysm – results of a pilot study and lessons learned for future studies.
      Recently, the results of two larger RCTs have been published.
      • Powell J.T.
      • Sweeting M.J.
      • Thompson M.M.
      • Ashleigh R.
      • Bell R.
      • Gomes M.
      • et al.
      Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial.
      • Reimerink J.J.
      • Hoornweg L.L.
      • Vahl A.C.
      • Wisselink W.
      • van den Broek T.A.
      • Legemate D.A.
      • et al.
      Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial.
      These new studies might help to better determine whether EVAR improves short-term survival when compared with open repair, which in turn might help caregivers to decide on the best treatment strategy.

      Objective

      The aim of this study was to perform a systematic review and meta-analysis to obtain the best estimates of the short-term (combined 30-day or in-hospital) survival after endovascular repair compared with open repair for patients with a RAAA in randomised controlled trials and observational studies.

      Methods

      The present review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
      • Moher D.
      • Liberati A.
      • Tetzlaff J.
      • Altman D.G.
      Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.
      The objectives, the methodology, and the inclusion criteria were prespecified in a protocol (Appendix 1).

      Search strategy

      A systematic search in Medline through Pubmed and in Embase through Ovid was conducted with the assistance of a clinical librarian. The search strategy was built around the participants, intervention, comparison, outcomes, and study design (PICOS) framework (Appendix 1). Additionally, the World Health Organization International Clinical Trials Registry Platform (WHOICTRP) was searched for relevant RCTs.
      The last search was done on the 13 January 2014. Two authors (SvB, AC) independently screened the titles and abstracts of the identified articles for relevance. Subsequently, the relevant full length articles were assessed by two authors (SvB, AC) to check if they met the inclusion criteria. Disagreements were resolved by discussion with two other authors (MK, RB). The reference list of the included articles was checked for other eligible articles and a cited reference search in the Web of Science was done.

      Eligibility criteria

      All RCTs comparing OR and EVAR, and all observational studies comparing OR and EVAR that included at least 50 patients were included. Observational studies that included patients based on the International Classification of Diseases (ICD) or other forms of coding were analysed separately, and are referred to as administrative registries. Studies were included if they were full length and in English. Studies reporting more than once on the same patient population were included only once, based on relevance and size. Studies were excluded if they did not allow extraction of two-by-two contingency tables for the endpoint 30-day or in-hospital death rate.

      Assessment of study quality

      The methodological quality of the included articles was independently assessed by two authors (SvB, AC). For the RCTs, The Cochrane Collaboration's tool for assessing risk of bias was used (Appendix 1). For the observational studies and administrative registries, a tool based on the Cochrane Collaboration's tool for assessing risk of bias, the Newcastle–Ottawa Scale, and the Methodological Index for Non-Randomized Studies (MINORS) was used (Appendix). Again, disagreements were resolved by discussion with two other authors. The risk of bias within studies was reported as an online supplement (Appendix 1, Figs. 7–9).

      Data collection

      Data were extracted independently by two authors (SvB, AC) with use of a standardised form in Microsoft Office Access 2003 (Microsoft Corporation, Redmond, WA, USA). The following data were collected: study design (RCT, observational study or administrative registry), study period, study size, country, and rejection rate. For the included RCTs, the number of events and the total number of patients per type of intervention were extracted based on intention-to-treat analysis. For the included observational studies, the number of events and the total number of patients per type of intervention were extracted based on as-treated analysis. Authors were contacted to obtain missing data if necessary. When the authors were unable to provide missing data, the study was excluded from the analysis.

      Statistical analysis

      The primary endpoint was the combined 30-day and in-hospital death rate. If not reported, the 30-day or in-hospital death rate was used instead. For the observational studies, a secondary endpoint was the odds ratio of EVAR on death rate after adjustment for age, sex, and hemodynamic stability. The statistical analysis was performed using Review Manager 5.2 (Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration) and Stata/SE 11.0 (StataCorp, College Station, TX, USA). Three meta-analyses were done. The first meta-analysis included all RCTs, the second all observational studies, and the third all administrative registries. Pooled effects of EVAR and OR were presented as odds ratios with 95% CI. Because heterogeneity was expected, the meta-analyses were done a priori with the use of a random effects model. A prespecified sensitivity analysis of observational studies was done by pooling the odds ratios of EVAR versus OR adjusted for at least, age,
      • Acosta S.
      • Lindblad B.
      • Zdanowski Z.
      Predictors for outcome after open and endovascular repair of ruptured abdominal aortic aneurysms.
      sex,
      • Grootenboer N.
      • van Sambeek M.R.
      • Arends L.R.
      • Hendriks J.M.
      • Hunink M.G.
      • Bosch J.L.
      Systematic review and meta-analysis of sex differences in outcome after intervention for abdominal aortic aneurysm.
      and hemodynamic stability.
      • Tambyraja A.
      • Murie J.
      • Chalmers R.
      Predictors of outcome after abdominal aortic aneurysm rupture: Edinburgh Ruptured Aneurysm Score.
      Heterogeneity between studies was determined with the I2 statistic. An I2 between 30% and 50% was considered moderate heterogeneity and between 60% and 90% as substantial heterogeneity. Funnel plots were created and inspected for the presence of publication bias if more then 10 studies were included.

      Results

      Literature search

      3,769 unique articles were identified from Medline and Embase, of which 123 were retrieved for more detailed evaluation and 30 met the inclusion criteria (Fig. 1). Two additional RCTs
      • Powell J.T.
      • Sweeting M.J.
      • Thompson M.M.
      • Ashleigh R.
      • Bell R.
      • Gomes M.
      • et al.
      Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial.
      • Desgranges P.
      • Kobeiter H.
      • Castier Y.
      • Senechal M.
      • Majewski M.
      • Krimi A.
      The Endovasculaire vs Chirurgie dans les Anevrysmes Rompus PROTOCOL trial update.
      were identified from the WHO ICTRP, of which one was published
      • Powell J.T.
      • Sweeting M.J.
      • Thompson M.M.
      • Ashleigh R.
      • Bell R.
      • Gomes M.
      • et al.
      Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial.
      and included. One additional administrative registry
      • Chen C.K.
      • Chang H.T.
      • Chen Y.C.
      • Chen T.J.
      • Chen I.M.
      • Shih C.C.
      Surgeon elective abdominal aortic aneurysm repair volume and outcomes of ruptured abdominal aortic aneurysm repair: a 12-year nationwide study.
      was identified from the cited reference search. Of 32 included studies, three articles were RCTs,
      • Powell J.T.
      • Sweeting M.J.
      • Thompson M.M.
      • Ashleigh R.
      • Bell R.
      • Gomes M.
      • et al.
      Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial.
      • Reimerink J.J.
      • Hoornweg L.L.
      • Vahl A.C.
      • Wisselink W.
      • van den Broek T.A.
      • Legemate D.A.
      • et al.
      Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial.
      • Hinchliffe R.J.
      • Bruijstens L.
      • MacSweeney S.T.R.
      • Braithwaite B.D.
      A randomised trial of endovascular and open surgery for ruptured abdominal aortic aneurysm – results of a pilot study and lessons learned for future studies.
      21 were observational studies,
      • Acosta S.
      • Lindblad B.
      • Zdanowski Z.
      Predictors for outcome after open and endovascular repair of ruptured abdominal aortic aneurysms.
      • Bosch J.A.T.
      • Willigendael E.M.
      • Kruidenier L.M.
      • De Loos E.R.
      • Prins M.H.
      • Teijink J.A.W.
      Early and mid-term results of a prospective observational study comparing emergency endovascular aneurysm repair with open surgery in both ruptured and unruptured acute abdominal aortic aneurysms.
      • Chagpar R.B.
      • Harris J.R.
      • Lawlor D.K.
      • DeRose G.
      • Forbes T.L.
      Early mortality following endovascular versus open repair of ruptured abdominal aortic aneurysms.
      • Cho J.-S.
      • Park T.
      • Kim J.Y.
      • Chaer R.A.
      • Rhee R.Y.
      • Makaroun M.S.
      Prior endovascular abdominal aortic aneurysm repair provides no survival benefits when the aneurysm ruptures.
      • Coppi G.
      • Silingardi R.
      • Gennai S.
      • Saitta G.
      • Ciardullo A.V.
      A single-center experience in open and endovascular treatment of hemodynamically unstable and stable patients with ruptured abdominal aortic aneurysms.
      • Eefting D.
      • Ultee K.H.
      • Von Meijenfeldt G.C.
      • Hoeks S.E.
      • Ten R.S.
      • Hendriks J.M.
      • et al.
      Ruptured AAA: state of the art management.
      • Lee R.W.
      • Rhodes J.M.
      • Singh M.J.
      • Davies M.G.
      • Wolford H.Y.
      • Diachun C.
      • et al.
      Is there a selection bias in applying endovascular aneurysm repair for rupture?.
      • Mayer D.
      • Aeschbacher S.
      • Pfammatter T.
      • Veith F.J.
      • Norgren L.
      • Magnuson A.
      • et al.
      Complete replacement of open repair for ruptured abdominal aortic aneurysms by endovascular aneurysm repair: a two-center 14-year experience.
      • Mehta M.
      • Byrne J.
      • Darling III, R.C.
      • Paty P.S.K.
      • Roddy S.P.
      • Kreienberg P.B.
      • et al.
      Endovascular repair of ruptured infrarenal abdominal aortic aneurysm is associated with lower 30-day mortality and better 5-year survival rates than open surgical repair.
      • Moore R.
      • Nutley M.
      • Cina C.S.
      • Motamedi M.
      • Faris P.
      • Abuznadah W.
      Improved survival after introduction of an emergency endovascular therapy protocol for ruptured abdominal aortic aneurysms.
      • Mukherjee D.
      • Kfoury E.
      • Schmidt K.
      • Waked T.
      • Hashemi H.
      Improved results in the management of ruptured abdominal aortic aneurysm may not be on the basis of endovascular aneurysm repair alone.
      • Noorani A.
      • Page A.
      • Walsh S.R.
      • Varty K.
      • Hayes P.D.
      • Boyle J.R.
      Mid-term outcomes following emergency endovascular aortic aneurysm repair for ruptured abdominal aortic aneurysms.
      • Ockert S.
      • Schumacher H.
      • Bockler D.
      • Megges I.
      • Allenberg J.-R.
      Early and midterm results after open and endovascular repair of ruptured abdominal aortic aneurysms in a comparative analysis.
      • Peppelenbosch N.
      • Geelkerken R.H.
      • Soong C.
      • Cao P.
      • Steinmetz O.K.
      • Teijink J.A.
      • et al.
      Endograft treatment of ruptured abdominal aortic aneurysms using the Talent aortouniiliac system: an international multicenter study.
      • Rodel S.G.
      • Meerwaldt R.
      • Beuk R.J.
      • Huisman A.B.
      • Zeebregts C.J.
      • Geelkerken R.H.
      Endovascular treatment of ruptured abdominal aortic aneurysm: is there a long-term benefit at follow-up?.
      • Saqib N.
      • Park S.C.
      • Park T.
      • Rhee R.Y.
      • Chaer R.A.
      • Makaroun M.S.
      • et al.
      Endovascular repair of ruptured abdominal aortic aneurysm does not confer survival benefits over open repair.
      • Sarac T.P.
      • Bannazadeh M.
      • Rowan A.F.
      • Bena J.
      • Srivastava S.
      • Eagleton M.
      • et al.
      Comparative predictors of mortality for endovascular and open repair of ruptured infrarenal abdominal aortic aneurysms.
      • Sharif M.A.
      • Lee B.
      • Makar R.R.
      • Loan W.
      • Chee V.S.
      Role of the Hardman index in predicting mortality for open and endovascular repair of ruptured abdominal aortic aneurysm.
      • Van Schaik D.E.L.
      • Dolmans D.E.J.G.
      • Ho G.H.
      • Geenen G.P.J.
      • Vos L.D.
      • Van Der Waal J.C.H.
      • et al.
      Ruptured abdominal aortic aneurysm: endovascular or open approach in a Dutch general hospital.
      • Verhoeven E.L.G.
      • Kapma M.R.
      • Bos W.T.G.J.
      • Vourliotakis G.
      • Bracale U.M.
      • Bekkema F.
      • et al.
      Mortality of ruptured abdominal aortic aneurysm with selective use of endovascular repair.
      • Wallace G.A.
      • Starnes B.W.
      • Hatsukami T.S.
      • Quiroga E.
      • Tang G.L.
      • Kohler T.R.
      • et al.
      Favorable discharge disposition and survival after successful endovascular repair of ruptured abdominal aortic aneurysm.
      and eight were administrative registries.
      • Chen C.K.
      • Chang H.T.
      • Chen Y.C.
      • Chen T.J.
      • Chen I.M.
      • Shih C.C.
      Surgeon elective abdominal aortic aneurysm repair volume and outcomes of ruptured abdominal aortic aneurysm repair: a 12-year nationwide study.
      • Edwards S.T.
      • Schermerhorn M.L.
      • O'Malley A.J.
      • Bensley R.P.
      • Hurks R.
      • Cotterill P.
      • et al.
      Comparative effectiveness of endovascular versus open repair of ruptured abdominal aortic aneurysm in the Medicare population.
      • Giles K.A.
      • Pomposelli F.B.
      • Hamdan A.D.
      • Wyers M.C.
      • Schermerhorn M.L.
      Comparison of open and endovascular repair of ruptured abdominal aortic aneurysms from the ACS-NSQIP 2005–07.
      • Greco G.
      • Egorova N.
      • Anderson P.L.
      • Gelijns A.
      • Moskowitz A.
      • Nowygrod R.
      • et al.
      Outcomes of endovascular treatment of ruptured abdominal aortic aneurysms.
      • Holt P.J.E.
      • Karthikesalingam A.
      • Poloniecki J.D.
      • Hinchliffe R.J.
      • Loftus I.M.
      • Thompson M.M.
      Propensity scored analysis of outcomes after ruptured abdominal aortic aneurysm.
      • Mani K.
      • Lees T.
      • Beiles B.
      • Jensen L.P.
      • Venermo M.
      • Simo G.
      • et al.
      Treatment of abdominal aortic aneurysm in nine countries 2005–2009: a vascunet report.
      • Mohan P.P.
      • Hamblin M.H.
      Comparison of endovascular and open repair of ruptured abdominal aortic aneurysm in the United States in the past decade.
      • Trenner M.
      • Haller B.
      • Söllner H.
      • Storck M.
      • Umscheid T.
      • Niedermeier H.
      • et al.
      Twelve years of the quality assurance registry abdominal aortic aneurysm of the German Vascular Society (DGG).
      • Wanhainen A.
      • Bylund N.
      • Bjorck M.
      Outcome after abdominal aortic aneurysm repair in Sweden 1994–2005.
      Table 1 summarises their main characteristics.
      Table 1Characteristics of studies included in the meta-analyses evaluating the outcome after endovascular and open repair of a ruptured abdominal aortic aneurysm.
      StudyCountryStudy designStudy periodNumber of patientsRejection rateType death rateDeath rate EVAR (CI)Death rate OR (CI)
      Nottingham 2006United KingdomRCT2002–20043254% (55/103)30-day53% (30–75)53% (31–74)
      AJAX 2013The NetherlandsRCT2004–20111169% (46/520)30-day or IH28% (18–41)29% (19–41)
      IMPROVE 2014United KingdomRCT2009–201361323% (299/1275)30-day32% (27–37)35% (30–40)
      Coppi 2006ItalyOS1999–2006124Not reported30-day30% (17–47)46% (36–56)
      Peppelenbosch 2006Multiple
      Belgium, Canada, Finland, Italy, Netherlands and Northern Ireland.
      OS2003–2004100Not reported30-day or IH35% (23–49)39% (27–53)
      Acosta 2007SwedenOS2000–200416224% (51/213)IH34% (23–47)45% (36–55)
      Ockert 2007GermanyOS2000–200558Not reported30-day31% (17–49)31% (17–49)
      Moore 2007CanadaOS2004–200656Not reported30-day5% (1–24)25% (14–41)
      Sharif 2007United KingdomOS2001–200612610% (14/140)30-day or IH33% (22–46)51% (40–62)
      Lee 2008USAOS2002–200652Not reported30-day or IH35% (17–59)63% (46–77)
      Verhoeven 2009The NetherlandsOS2002–20091599% (16/175)30-day or IH20% (11–34)35% (27–44)
      Chagpar 2010CanadaOS2003–2008167Not reported30-day16% (7–32)44% (36–52)
      Cho 2010USAOS2001–2008233Not reported30-day or IH20% (7–45)38% (32–45)
      Sarac 2011USAOS1990–2008160Not reported30-day or IH31% (18–49)32% (25–41)
      Van Schaik 2011The NetherlandsOS2006–2008563% (2/58)30-day27% (11–52)46% (32–61)
      Bosch 2012The NetherlandsOS2002–20081294% (6/135)30-day20% (9–39)45% (36–55)
      Mayer 2012Multiple
      Sweden, Switzerland.
      OS1998–201143110% (42/473)30-day18% (14–23)37% (30–45)
      Noorani 2012United KingdomOS2006–20101028% (9/111)IH12% (5–23)28% (17–42)
      Rödel 2012The NetherlandsOS2006–201010510% (12/117)30-day17% (8–33)31% (22–43)
      Saqib 2012USAOS2001–2011148Not reported30-day or IH22% (11–37)32% (24–41)
      Eefting 2013The NetherlandsOS2002–2012195Not reported30-day24% (16–35)52% (43–61)
      Mehta 2013USAOS2002–2011283Not reported30-day24% (17–33)44% (37–52)
      Mukherjee 2013
      Patients treated with hybrid repair included in open repair group.
      USAOS2007–201150Not reported30-day27% (15–43)15% (4–42)
      Wallace 2013USAOS2007–201210015% (18/118)
      10 patients died during unknown intervention.
      IH16% (9–28)46% (32–61)
      Greco 2006USAAR2000–20035,798Not reportedIH39% (34–45)48% (46–49)
      Wanhainen 2008SwedenAR1994–20053,516Not reported30-day15% (9–24)36% (35–38)
      Giles 2009USAAR2005–2007567Not reported30-day24% (17–32)36% (32–41)
      Holt 2010United KingdomAR2003–20084,414Not reportedIH32% (27–37)47% (46–49)
      Mani 2011Multiple
      Australia, Denmark, Finland, Hungary, Italy, Norway, Sweden, Switzerland, United Kingdom.
      AR2005–20097,040Not reported30-day or IH20% (17–23)33% (31–34)
      Chen 2013TaiwanAR1998–2009537Not reportedIH44% (29–59)38% (34–43)
      Mohan 2013USAAR2001–201042,126Not reportedIH26% (25–27)39% (38–40)
      Trenner 2013GermanyAR1999–20104,859Not reportedIH23% (20–26)41% (40–43)
      USA = United States of America; OS = observational study; RCT = randomised controlled trial; AR = administrative registry; EVAR = endovascular aneurysm repair; IH = in-hospital; OR = open repair; CI = 95% confidence interval.
      a Patients treated with hybrid repair included in open repair group.
      b 10 patients died during unknown intervention.
      c Belgium, Canada, Finland, Italy, Netherlands and Northern Ireland.
      d Sweden, Switzerland.
      e Australia, Denmark, Finland, Hungary, Italy, Norway, Sweden, Switzerland, United Kingdom.

      Study quality

      The quality assessment of the included studies is summarised in Figure 2, Figure 3, Figure 4 and in Figure 6,
      • Grootenboer N.
      • van Sambeek M.R.
      • Arends L.R.
      • Hendriks J.M.
      • Hunink M.G.
      • Bosch J.L.
      Systematic review and meta-analysis of sex differences in outcome after intervention for abdominal aortic aneurysm.
      ,
      • Tambyraja A.
      • Murie J.
      • Chalmers R.
      Predictors of outcome after abdominal aortic aneurysm rupture: Edinburgh Ruptured Aneurysm Score.
      ,
      • Desgranges P.
      • Kobeiter H.
      • Castier Y.
      • Senechal M.
      • Majewski M.
      • Krimi A.
      The Endovasculaire vs Chirurgie dans les Anevrysmes Rompus PROTOCOL trial update.
      of the appendix. The risk of bias was lowest in the RCTs, whereas the observational studies suffered from all forms of bias. In >75% of observational studies the representativeness of the cohort, the blinding of outcome assessment and the baseline equivalence of groups was considered to have a high risk of bias. In all observational studies, patient selection for EVAR and OR was considered to have a high risk of bias because treatment was based on the preference of caregivers or a clinical algorithm. The administrative registries also suffered from all forms of bias. In more than 50% of the registries the representativeness of the cohort was considered to have a high risk of bias, mostly because of lack of information about the type of hospitals (secondary, tertiary) included.
      Figure thumbnail gr2
      Figure 2Risk of bias randomised controlled trials.
      Figure thumbnail gr3
      Figure 3Risk of bias observational studies.
      Figure thumbnail gr4
      Figure 4Risk of bias administrative registries.

      Pooled outcomes

      In the RCTs, the reported death rates ranged between 28% and 53% after EVAR and between 29% and 53% after OR. The pooled odds ratio for death after EVAR versus OR was 0.90 (95% CI 0.65–1.24) (Fig. 5). No funnel plot was created because of the low number of included RCTs.
      Figure thumbnail gr5
      Figure 5Forest plot showing the pooled odds ratios of the randomised controlled trials, observational studies, and administrative registries comparing endovascular versus open repair in patients with a ruptured abdominal aortic aneurysm. SVR = Swedish Vascular Registry; NSQIP = American College of Surgeons National Surgical Quality Improvement Program; HES = Hospital Episode Statistics; NHIRD = National Health Insurance Research Database; NIS = Nationwide Inpatient Sample; DGG = German Vascular Society.
      In the observational studies, the death rates after EVAR ranged between 5% and 35% and between 15% and 63% after OR. The pooled odds ratio for death after EVAR versus OR was 0.44 (0.37–0.53) (Fig. 5). There were no signs of asymmetry in the funnel plot (Appendix 1, Fig. 10). In the sensitivity analysis of observational studies adjusting for age, sex, and haemodynamic stability, the pooled adjusted odds ratio of EVAR versus OR was 0.53 (95% CI 0.29–0.98) with moderate heterogeneity among the studies (I2 = 34%) (Fig. 6).
      Figure thumbnail gr6
      Figure 6Sensitivity analysis of observational studies comparing endovascular vs. open repair after adjustment for at least age, sex, and hemodynamic stability.
      In the administrative registries, the death rates after EVAR ranged between 15% and 39% and between 33% and 48% after OR. The pooled odds ratio for death after EVAR versus OR was 0.54 (95% CI 0.47–0.62) (Fig. 5). There was moderate heterogeneity in outcomes among the administrative registries (I2 = 67%). No funnel plots were created because of the low number of included administrative registries.

      Discussion

      The present systematic review expands upon previous reviews
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      Ruptured abdominal aortic aneurysms: endovascular repair versus open surgery – systematic review.
      • Azizzadeh A.
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      • Miller III, C.C.
      • Estrera A.L.
      • Coogan S.M.
      • Safi H.J.
      Endovascular repair of ruptured abdominal aortic aneurysms: systematic literature review.
      • Harkin D.W.
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      Endovascular ruptured abdominal aortic aneurysm repair (EVRAR): a systematic review.
      • Mastracci T.M.
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      • Sutton A.J.
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      A systematic review and meta-analysis of endovascular repair (EVAR) for ruptured abdominal aortic aneurysm.
      • Sadat U.
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      • Tang T.
      • Varty K.
      • Hayes P.D.
      Endovascular vs open repair of acute abdominal aortic aneurysms – a systematic review and meta-analysis.
      • Antoniou G.A.
      • Georgiadis G.S.
      • Antoniou S.A.
      • Pavlidis P.
      • Maras D.
      • Sfyroeras G.S.
      • et al.
      Endovascular repair for ruptured abdominal aortic aneurysm confers an early survival benefit over open repair.
      considering EVAR versus OR for patients with RAAA in two ways. First, this is the first to include three RCTs. Second, only one previous systematic review also included a thorough study quality assessment. The results of the meta-analyses presented here indicate that EVAR is not inferior to OR with regard to short-term survival after RAAA. This supports the use of EVAR in suitable patients and OR as reasonable alternative.

      Study quality

      There was a conspicuous contradiction between the pooled results of the RCTs, the observational cohort studies and the administrative registries. The pooled results of the observational studies and administrative registries show that EVAR improves short-term survival. However, in the pooled results of the RCTs these results were not confirmed. For this reason, we are reluctant to draw the conclusion that short-term survival is lower after EVAR than after OR.
      The disparate results are most likely explained by study quality and selection bias. The study quality assessment clearly showed that the RCTs had the least risk of bias for the comparison of EVAR and OR. Treatment allocation by caregivers and thereby selection of patients for either intervention is the most important risk of bias in observational studies. Treatment algorithms and surgeon's decisions resulted directly in OR in haemodynamically unstable patients and in preoperative computed tomographic angiography and subsequent EVAR in haemodynamically stable patients. By this selection, patients with a low-risk profile for survival were treated with OR and with a high-risk profile for survival with EVAR. In only three
      • Mayer D.
      • Aeschbacher S.
      • Pfammatter T.
      • Veith F.J.
      • Norgren L.
      • Magnuson A.
      • et al.
      Complete replacement of open repair for ruptured abdominal aortic aneurysms by endovascular aneurysm repair: a two-center 14-year experience.
      • Reimerink J.J.
      • Hoornweg L.L.
      • Vahl A.C.
      • Wisselink W.
      • van den Broek T.A.
      • Legemate D.A.
      • et al.
      Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial.
      • Saqib N.
      • Park S.C.
      • Park T.
      • Rhee R.Y.
      • Chaer R.A.
      • Makaroun M.S.
      • et al.
      Endovascular repair of ruptured abdominal aortic aneurysm does not confer survival benefits over open repair.
      of 21 observational studies was the outcome adjusted for the most important confounders age, sex, and haemodynamic stability. The improved short-term survival after EVAR persisted in the sensitivity analysis of the observational studies adjusting for these confounders (odds ratio 0.53, 95% CI 0.29–0.98). Contrary to our expectations, these pooled results did not mimic the outcomes of the RCTs. The multivariate analyses may have been affected by residual confounding, which means that statistical methods could not eliminate all differences in observed and unobserved confounders. On the other hand, the RCTs might have been affected by selection bias before enrolment of patients, thereby hampering comparison with daily practice.
      The administrative registries with a low risk of bias described their data quality checks and represented both secondary and tertiary hospitals. These registries reflect the daily practice of EVAR and OR over a longer time period and are state-, nation-, or continent-wide. An advantage is that referral patterns are automatically incorporated in the results. However, rejection rates and detailed patient characteristics are scarcely available which are essential elements of the direct comparison between EVAR and OR. Moreover, accuracy of patient identification with use of ICD coding can be questioned.

      Preferred intervention

      The present review considers short-term survival. Although this is the most important outcome for patients with RAAA, other arguments might support either EVAR or OR. In general, it might be argued that non-inferiority suffices for a minimally invasive surgical technique compared with the open equivalent. In the RCTs there appears to be a benefit for EVAR with regard to secondary outcomes like reduction of intensive care unit and hospital stay, need for mechanical ventilation, and blood loss.
      • Powell J.T.
      • Sweeting M.J.
      • Thompson M.M.
      • Ashleigh R.
      • Bell R.
      • Gomes M.
      • et al.
      Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial.
      • Reimerink J.J.
      • Hoornweg L.L.
      • Vahl A.C.
      • Wisselink W.
      • van den Broek T.A.
      • Legemate D.A.
      • et al.
      Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial.
      The number of in-hospital reinterventions appears to be comparable.
      • Powell J.T.
      • Sweeting M.J.
      • Thompson M.M.
      • Ashleigh R.
      • Bell R.
      • Gomes M.
      • et al.
      Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial.
      • Reimerink J.J.
      • Hoornweg L.L.
      • Vahl A.C.
      • Wisselink W.
      • van den Broek T.A.
      • Legemate D.A.
      • et al.
      Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial.
      In the direct comparison of costs after 30 days between EVAR and OR in the AJAX trial, EVAR was €5,306 more expensive (95% CI 1,854–12,659).
      • Kapma M.R.
      • Dijksman L.M.
      • Reimerink J.J.
      • De Groof A.J.
      • Zeebregts C.J.
      • Wisselink W.
      • et al.
      Cost-effectiveness and cost-utility of endovascular versus open repair of ruptured abdominal aortic aneurysm in the Amsterdam Acute Aneurysm Trial.
      In the comparison of costs after 30 days between the endovascular and open strategy in the IMPROVE trial, the endovascular strategy was €1,435 cheaper (95% CI 3,626–756).
      • Powell J.T.
      • Sweeting M.J.
      • Thompson M.M.
      • Ashleigh R.
      • Bell R.
      • Gomes M.
      • et al.
      Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial.
      These seemingly contradictory outcomes can be explained in the IMPROVE trial by the 112/275 patients treated by open surgery in the endovascular strategy group, by shorter stay in the intensive care unit and hospital, and by a cheaper endograft. Yet, the results are not contradictory if it is argued that EVAR is more expensive than OR but that a treatment strategy offering both EVAR and OR is not more expensive than a treatment strategy including only OR. Although it is of importance in decision-making, few data are available on surgeons and patient preferences. Finally, in elective aortic surgery, the long-term risk of reinterventions and aneurysm rupture is higher after EVAR than after OR.
      • Stather P.W.
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      • 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.
      A recent observational study in patients with RAAA reported a higher late reintervention rate after EVAR (16/62, median follow-up 42 months with an interquartile range 4–76) than after OR (4/85, median follow-up 39 months with an interquartile range 2–75) (p = .008).
      • Rollins K.E.
      • Shak J.
      • Ambler G.K.
      • Tang T.Y.
      • Hayes P.D.
      • Boyle J.R.
      Mid-term cost-effectiveness analysis of open and endovascular repair for ruptured abdominal aortic aneurysm.
      More data are needed before definite conclusions can be drawn with regard to long-term outcomes. However, one might question whether long-term risks should impact decision-making in the acute clinical setting and EVAR for RAAAs could be considered a damage control intervention.

      Future directions

      What are the future directions after the present review? Currently, there is still one RCT underway aiming to compare EVAR versus OR,
      • Desgranges P.
      • Kobeiter H.
      • Castier Y.
      • Senechal M.
      • Majewski M.
      • Krimi A.
      The Endovasculaire vs Chirurgie dans les Anevrysmes Rompus PROTOCOL trial update.
      which might change the pooled results. Based on the results from the currently available RCTs that show small differences in short-term survival, it seems unlikely that a new RCT will show marked differences. To our current knowledge the clinical equipoise on short-term survival will remain and the differences between EVAR and OR should be found in the secondary and long-term outcomes. The aggregated results from the RCTs, the observational studies and administrative registries guide us to the conclusion that EVAR is a good choice in patients that are anatomically and clinically fit for endovascular repair. In other patients OR is a reasonable alternative.
      Specific patient groups could be studied: EVAR might be more beneficial in women
      • Powell J.T.
      • Sweeting M.J.
      • Thompson M.M.
      • Ashleigh R.
      • Bell R.
      • Gomes M.
      • et al.
      Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial.
      and OR might be more beneficial in patients with hostile aortic anatomy. Although a detailed description runs beyond the scope of the present review, several studies gave other future directions of care for patients with RAAA. Centralisation of care in high-volume hospitals was suggested in four of 30 studies.
      • Reimerink J.J.
      • Hoornweg L.L.
      • Vahl A.C.
      • Wisselink W.
      • van den Broek T.A.
      • Legemate D.A.
      • et al.
      Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial.
      • Moore R.
      • Nutley M.
      • Cina C.S.
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      • Faris P.
      • Abuznadah W.
      Improved survival after introduction of an emergency endovascular therapy protocol for ruptured abdominal aortic aneurysms.
      • Greco G.
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      • Anderson P.L.
      • Gelijns A.
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      • Nowygrod R.
      • et al.
      Outcomes of endovascular treatment of ruptured abdominal aortic aneurysms.
      • Holt P.J.E.
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      Propensity scored analysis of outcomes after ruptured abdominal aortic aneurysm.
      Two studies proposed ‘EVAR-first’ or hybrid repair comprising rapid proximal aortic balloon occlusion in all patients and subsequently EVAR or OR.
      • Mukherjee D.
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      • Schmidt K.
      • Waked T.
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      Improved results in the management of ruptured abdominal aortic aneurysm may not be on the basis of endovascular aneurysm repair alone.
      • Wallace G.A.
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      • Tang G.L.
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      • et al.
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      Another study suggested an ‘EVAR-only’ approach and treated 70 of 73 consecutive RAAA patients with EVAR.
      • Mayer D.
      • Aeschbacher S.
      • Pfammatter T.
      • Veith F.J.
      • Norgren L.
      • Magnuson A.
      • et al.
      Complete replacement of open repair for ruptured abdominal aortic aneurysms by endovascular aneurysm repair: a two-center 14-year experience.
      These suggestions are promising, but much research needs to be done before definite conclusions can be drawn.
      Finally, the most important benefit of EVAR might be that patients who were considered unfit for open surgical repair earlier might be considered eligible for endovascular intervention nowadays. This leads to an increase in the number of treated patients, which might explain the improved population-based survival that was found in a recent systematic review.
      • Reimerink J.J.
      • van der Laan M.J.
      • Koelemay M.J.
      • Balm R.
      • Legemate D.A.
      Systematic review and meta-analysis of population-based mortality from ruptured abdominal aortic aneurysm.
      Another indication of a reduction of rejection rates is a trend towards older patients being treated for RAAAs in administrative registries
      • Mani K.
      • Lees T.
      • Beiles B.
      • Jensen L.P.
      • Venermo M.
      • Simo G.
      • et al.
      Treatment of abdominal aortic aneurysm in nine countries 2005–2009: a vascunet report.
      • Trenner M.
      • Haller B.
      • Söllner H.
      • Storck M.
      • Umscheid T.
      • Niedermeier H.
      • et al.
      Twelve years of the quality assurance registry abdominal aortic aneurysm of the German Vascular Society (DGG).
      However, meta-regression of the study midpoint dates and rejection rates showed no significant trend over time (data not shown). Therefore, more high-quality data are needed before definite conclusions can be drawn and the present systematic review cannot answer the question of a reduction in rejection rates. Moreover, a reduction in rejection rates might be caused by EVAR but also by permissive hypotension during transport, massive transfusion protocols, specialised cardiovascular anaesthetic care, and improvements in the intensive care unit.

      Limitations

      An important limitation of this systematic review is that it might have been affected by publication bias. No funnel plots of the RCTs or administrative registries could be created because of the low number of studies. Data might have been missed since one eligible study was excluded because of language restrictions and one because data were missing and could not be provided by the corresponding author. The impact of publication bias on the conclusions is difficult to assess. In general, publication bias leads to an overestimation of treatment effect.
      An important limitation of the meta-analysis of the RCTs is that it included only 761 patients. The low number of patients limits the external validity of outcomes for the general RAAA population. It is concluded that EVAR is not inferior to OR. Based on an expected survival rate after EVAR of 68% and after OR of 65% and assuming an α of 5% and a β of 80%, the sample size needed for a hypothetical non-inferiority trial would be 680 patients for a margin of 6% and 860 patients for a margin of 5%. Assuming a survival rate of 65% after OR, the margin of this non-inferiority conclusion includes a survival after EVAR of at least 59% (65 minus 6%). It could be argued that this margin is too wide and more patients are needed to decrease the margin. However, given the pooled results of EVAR from the RCTs, observational studies, and administrative registries it is considered highly unlikely that the survival of EVAR is worse than 59%. The inclusion of the IMPROVE trial troubled our statistical analysis. From this RCT, only the surgically treated RAAA patients were included, and this violated the intention-to-treat principle to reduce bias from patients with no RAAA and patients without treatment. Inclusion of non-surgically treated RAAA patients (n = 36) and patients with other diseases (n = 55) was considered inappropriate. Noteworthy, after including all patients from the IMPROVE trial the pooled odds ratio of the RCTs barely differed (0.93, 95% CI 0.69–1.25).

      Conclusion

      The results of the present systematic review, meta-analyses, and study quality assessment indicate that EVAR is not inferior to OR in patients with a ruptured abdominal aortic aneurysm with regard to short-term survival. This supports the use of EVAR in suitable patients and OR as reasonable alternative.

      Acknowledgements

      The authors wish to thank Anco Vahl for the comparison of the cost-effectiveness between the AJAX and IMPROVE trial and Joost Daams for help with the search strategy. The study was partially funded by the AMC Foundation and Netherlands Organisation for Health Research and Development (AP Conijn, grant 171102025). The sponsors had no involvement in the study design, in the collection, analysis and interpretation of data; in the writing of the manuscript; or in the decision to submit the manuscript for publication.

      Conflict of Interest

      None.

      Funding

      None.

      Appendix A. Supplementary data

      The following are the Supplementary data related to this article:
      Figure thumbnail figs1
      Fig. 7 (online supplemental)Risk of bias within RCTs.
      Figure thumbnail figs2
      Fig. 8 (online supplemental)Risk of bias within observational studies.
      Figure thumbnail figs3
      Fig. 9 (online supplemental)Risk of bias within administrative registries.
      Figure thumbnail figs4
      Fig. 10 (online supplemental)Funnel plot for the meta-analysis in observational studies. Only studies with a sample size of at least 50 patients were included.

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      Linked Article

      • Endovascular Aneurysm Repair of Ruptured Abdominal Aortic Aneurysms
        European Journal of Vascular and Endovascular SurgeryVol. 47Issue 6
        • Preview
          In this edition of the European Journal of Vascular and Endovascular Surgery, Balm et al. have performed an excellent state-of-the-art review of the endovascular treatment of ruptured abdominal aortic aneurysms (rAAA) – so called REVAR.1 This review is based on separate analyses of randomized controlled trials (RCTs), observational studies and administrative registries of rAAA repair, and shows a non-significant relative risk reduction of about 10% in 30 day- and/or in-hospital postoperative mortality in favour of REVAR.
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