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Towards a Core Outcome Set for Abdominal Aortic Aneurysm: Systematic Review of Outcomes Reported Following Intact and Ruptured Abdominal Aortic Aneurysm Repair

Open ArchivePublished:March 16, 2021DOI:https://doi.org/10.1016/j.ejvs.2021.02.009

      Objective

      To encompass the needs of all stakeholders and allow effective data synthesis from trials, registries, and other studies; a core outcome set for infrarenal abdominal aortic aneurysm (AAA) repair is needed. In this first stage, the aim was to report the range, frequency, and time of pre-specified outcomes reported following AAA repair.

      Data Sources

      Medline, Embase, and CENTRAL databases 2010 – 2019 were searched using ProQuest Dialog™.

      Review Methods

      The systematic review was reported to Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines (PRISMA), PROSPERO registration CRD42019130119. Outcomes were coded using Core Outcome Measures in Effectiveness Trials (COMET) taxonomy and presented separately for intact and rupture repairs, endovascular aneurysm repair (EVAR) and open repair, and time from repair (acute < 90 days vs. ≥ 1 year) (COMET Initiative 1582).

      Results

      For intact AAA and rupture repair, a total of 231 and 70 reports with 589 255 and 177 465 patients respectively were included: only 98 and 19 respectively provided ≥ 1 year outcomes. Most studies were retrospective, with 13 randomised trials of intact AAA repair and five randomised trials of ruptured AAA repair. For intact AAA, the most common pre-specified COMET taxonomy outcomes were mortality (181), vascular complications (137), and re-intervention (52). EVAR studies dominated the vascular outcomes in acute and later time periods: excluding 47 reports from device registries, reduced vascular outcomes to 83. For ruptured AAA, the three most common outcomes were mortality (64), vascular (11), and hospital stay (10). The range of outcomes reported was wide with functioning outcomes reported from most randomised trials but few retrospective studies.

      Conclusion

      This review identifies the paucity of long term data and the disproportionate attention paid to vascular complications vs. patient functioning outcomes, this skew being accentuated by reporting from EVAR device registries. These data will inform focus groups, prior to a pan-European Delphi consensus, involving clinicians, patients, carers and providers, for developing core outcomes for repair of intact and ruptured AAA.

      Keywords

      The recent published literature for intact infrarenal AAA repair focuses on the reporting of mortality and vascular complications in the acute and mid term periods. The prominence of outcomes relating to vascular complication is partly attributable to endograft device registries. There are few reports of outcomes after five years for this prophylactic procedure. Patient functioning and quality of life outcomes, likely to be important in shared patient–surgeon decision making have been largely neglected. For ruptured AAA repair, the published literature has an even stronger focus on the acute period, with mortality, and general medical complications dominating the outcomes.

      Introduction

      Abdominal aortic aneurysm (AAA) repair is a common operation performed in older populations worldwide. Reports of the outcomes of both endovascular aneurysm repair (EVAR) and open surgery procedures are widespread in the medical literature, usually authored by vascular surgeons. However, there are other important stakeholders, principally the patient and their immediate family or carers, as well as healthcare providers and supporting medical specialities in hospital and the community. For EVAR, the medical device industry is another stakeholder.
      Guidelines for current clinical practice derive largely from assessment of the evidence in the medical literature, with randomised controlled trials (RCTs) usually considered as providing the best quality evidence, particularly the synthesis of data from multiple RCTs. Such data synthesis can be challenging. For instance, a recent Cochrane Review noted that data on quality of life from four RCTs of surveillance vs. early repair for small AAA could not be synthesised because each used a different instrument to assess quality of life.
      • Ulug P.
      • Powell J.T.
      • Martinez M.A.-M.
      • Ballard D.J.
      • Filardo G.
      Surgery for small asymptomatic abdominal aortic aneurysms.
      RCTs require careful planning and can be costly to conduct, so that the “real world” data provided by national vascular registries and administrative databases are increasingly used to provide evidence for updating guidelines. The outcomes provided by these latter data sources are varied, may not have standardised definitions, and rarely include patient reported outcomes related to functioning and quality of life. The recent initiatives to harmonise the outcomes reported by vascular registries is a welcome move to improving evidence synthesis for clinicians.
      • Behrendt C.-A.
      • Venermo M.
      • Cronenwett J.L.
      • Sedrakyan A.
      • Beck A.W.
      • Eldrup-Jorgensen J.
      • et al.
      VASCUNET, VQI, and the International Consortium of Vascular Registries–Unique collaborations for quality improvement in vascular surgery.
      However, it may not address the needs of other stakeholders.
      One approach to including the needs of patients and carers is upheld by the James Lind Alliance, who are developing a generalised approach to diagnosis and management in vascular surgery.
      • Alliance J.L.
      James Lind Alliance Vascular Partnership.
      AAA repair has more specific challenges since commonly it is performed as a prophylactic procedure for an asymptomatic condition, which may have specific side effects such as sexual dysfunction.
      • Regnier P.
      • Lareyre F.
      • Hassen-Khodja R.
      • Durand M.
      • Touma J.
      • Raffort J.
      sexual dysfunction after abdominal aortic aneurysm surgical repair: current knowledge and future directions.
      An alternative approach is the development of Core Outcome Sets, which has been embraced by other surgical specialities, e.g., upper gastrointestinal surgery.
      • Avery K.N.
      • Chalmers K.A.
      • Brookes S.T.
      • Blencowe N.S.
      • Coulman K.
      • Whale K.
      • et al.
      Development of a core outcome set for clinical effectiveness trials in esophageal cancer resection surgery.
      ,
      • Coulman K.D.
      • Hopkins J.
      • Brookes S.T.
      • Chalmers K.
      • Main B.
      • Owen-Smith A.
      • et al.
      A core outcome set for the benefits and adverse events of bariatric and metabolic surgery: the BARIACT project.
      Core Outcome Sets comprise a limited number of core outcomes, representing the needs of all principal stakeholders, and are recommended for use in all prospective studies to facilitate evidence synthesis. Such core outcomes do not preclude the investigation of other important and emerging parameters but should be used in addition. The development of Core Outcome Sets is based on a systematic review to identify the range of outcomes reported, which are discussed by a series of stakeholder focus groups before achieving consensus core outcomes through a series of questionnaires to all stakeholders (Delphi consensus).
      • Kirkham J.J.
      • Davis K.
      • Altman D.G.
      • Blazeby J.M.
      • Clarke M.
      • Tunis S.
      • et al.
      Core outcome Set-STAndards for development: the COS-STAD recommendations.
      ,
      • Ambler G.K.
      • Brookes-Howell L.
      • Jones J.A.R.
      • Verma N.
      • Bosanquet D.C.
      • Thomas-Jones E.
      • et al.
      Development of core outcome sets for people undergoing major lower limb amputation for complications of peripheral vascular disease.
      The development process for those undergoing lower limb amputation provides a recent example of this process.
      • Ambler G.K.
      • Brookes-Howell L.
      • Jones J.A.R.
      • Verma N.
      • Bosanquet D.C.
      • Thomas-Jones E.
      • et al.
      Development of core outcome sets for people undergoing major lower limb amputation for complications of peripheral vascular disease.
      The value of developing a core outcome set for AAA repair has been highlighted previously.
      • Powell J.T.
      • Ambler G.K.
      • Svensjö S.
      • Wanhainen A.
      • Bown M.J.
      Beyond the AAA guidelines: core outcome sets to make life better for patients.
      Here the first stage is reported: a systematic review to provide the range, frequency, and timing of outcomes reported for both intact and ruptured AAA repair.

      Materials and methods

      Search strategy

      This systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines
      • Moher D.
      • Liberati A.
      • Tetzlaff J.
      • Altman D.G.
      • Group P.
      Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.
      and registered in the PROSPERO database (http://www.crd.york.ac.uk/PROSPERO/; registration number CRD42019130119). The aim was systematically to review published articles of the past 10 years (2010 – 2019 inclusive) to identify the range, frequency, and timing of pre-specified outcomes reported after infrarenal AAA repair, both open and EVAR, in an epoch when EVAR was an established treatment for intact AAA repair.
      MEDLINE, Embase, and CENTRAL databases were searched (P.U.) using a combination of controlled vocabulary (medical subject heading [MeSH] or Emtree®) terms and free text terms in ProQuest Dialog™ (Ann Arbor, MI, USA), and limiting the search to data published since 1 January 2010. The outline and full search strategies are given in Table 1 and Table S1 respectively. This search was complemented by scanning reference lists of relevant articles.
      Table 1Search strategy
      The search strategy used the following terms: aortic aneurysm, abdominal; endovascular procedures; stents; blood vessel prosthesis/blood vessel prosthesis implantation/vascular grafting; vascular surgical procedures; aortic aneurysm, abdominal – surgery; aortic aneurysm, abdominal – mortality/aortic aneurysm, abdominal – surgical procedures – mortality/vascular surgical procedures – adverse effects; treatment outcome; patient reported outcome measures; quality of life; randomized controlled trial; registries; population surveillance: 1 640 titles were identified.
      and inclusion and exclusion criteria for studies of infrarenal abdominal aortic aneurysm (AAA) repair
      Inclusion criteriaExclusion criteria
      Operation date year 2000 or later≥26% repairs before 2000
      Minimum of 100 patients for clinical outcome studies
      Patient reported outcome studies, no minimum number of patientsReview articles, editorials, case reports
      Clinical studies of AAA repairs of ≥100 personsStudies of thoracic aortic disease or syndromic pathologies (e.g., Marfan syndrome)
      Studies of open repair and EVARStudies of thoraco-abdominal, suprarenal and isolated iliac aneurysms
      Studies including a minority of patients with juxtarenal or pararenal AAAStudies of experimental technologies including Nellix and flow modulating stents
      Studies including branched, chimney, and fenestrated endograftsBiomarker, pathobiology, epidemiology, AAA screening and risk score studies
      Separate reporting of AAA outcomes (from other vascular or other surgical outcomes)Animal studies
      Separated reporting of outcomes from intact and ruptured AAA cases
      For studies reporting duplicated data, the most recent or most comprehensive publication to be indexedDuplicated data (including abstracts and online ahead of print articles, patient series later updated etc)
      English languageNot in English or French languages
      EVAR = endovascular aneurysm repair.
      The search strategy used the following terms: aortic aneurysm, abdominal; endovascular procedures; stents; blood vessel prosthesis/blood vessel prosthesis implantation/vascular grafting; vascular surgical procedures; aortic aneurysm, abdominal – surgery; aortic aneurysm, abdominal – mortality/aortic aneurysm, abdominal – surgical procedures – mortality/vascular surgical procedures – adverse effects; treatment outcome; patient reported outcome measures; quality of life; randomized controlled trial; registries; population surveillance: 1 640 titles were identified.

      Study selection, data extraction, and quality assessment

      The inclusion and exclusion criteria are shown in Table 1. The initial rejection or inclusion was based on assessment of the study title by two reviewers (J.T.P., P.U.), who retained review articles for examination of their references. Full text versions of the selected studies that met the initial eligibility criteria were obtained. Studies were assessed and extracted (M.M., K.P., P.U., M.J.B., J.T.P.) if the full version was in English. A PRISMA flow diagram showing the selection process of articles is presented (Fig. 1). To estimate patient numbers, studies with multiple reports (including established registries and RCTs) were compiled into single records for intact and ruptured AAA repairs, with the most recent or comprehensive paper as the index report of patient numbers. Individual reports (publications) were the unit of assessment for pre-specified outcomes, their frequency and timing. Pre-specified outcomes were recorded separately from other outcomes provided. The only quality assessment criterion was whether the pre-specified outcome data appeared to be > 90% complete. Full details of data extraction, quality control, and quality assessment are given in the Supplementary material.
      Figure 1
      Figure 1Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) flow diagram for studies of infrarenal abdominal aortic aneurysm (AAA) repair. The search identified 1 640 citations published between 1 January 2010 and 31 December 2019. Screening of titles and/or abstracts eliminated 930 citations as not being relevant. Reasons for the elimination of citations after abstract and/or full text review are listed. The foreign language exclusions were Czech (1), German (4), Hungarian (1), Polish (2) and Portuguese (1).

      Data synthesis and analysis

      Pre-specified outcomes were coded by two assessors (M.M., J.T.P.) and all remaining outcomes were coded by a single assessor (M.M.) according to the taxonomy of Dodd et al.,
      • Dodd S.
      • Clarke M.
      • Becker L.
      • Mavergames C.
      • Fish R.
      • Williamson P.R.
      A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery.
      as recommended by COMET (full details and coding dictionary given in Table S2). The vascular outcome category included specific complications reported after endovascular AAA repair and limb ischaemia but did not include re-interventions (within resources), myocardial infarction (in cardiac), stroke (in neurological), bowel ischaemia or incisional hernia (both in gastrointestinal), or wound infection. To simplify the presentation of data, outcomes were reduced from the original 38 categories of the COMET taxonomy to five outcome groups (COMET taxonomy codes in brackets: survival (1), vascular (24), other clinical outcomes (2-23), patient function (25-33), and resource use (34-38) (see Table S2). The data were collated separately for intact and ruptured AAA, with further separation into EVAR and open repair and by time within each category either acute outcomes (0 – 90 days), mid or longer term outcomes (≥ 1 year). For studies that were non-specific about the timing of longer term outcomes, for intact repairs, the time point after which < 50% patients remained at risk was selected, while for ruptures the time point after which < 35% patients remained at risk was selected.

      Results

      Search results

      After database searching, screening and review 231 reports based on 142 studies met the inclusion criteria for intact (elective) AAA repairs, with 111/231 (48%) derived from existing registries and/or administrative databases. Another 70 reports based on 49 studies met the inclusion criteria for ruptured AAA repairs, with 13 of these also included among the intact repair reports: 22/70 (31%) derived from existing registries and/or administrative databases. Thirteen reports provided data for both intact and ruptured AAA repairs. The full details are given in the PRISMA flow chart (Fig. 1) and the full listing of included reports is given in the Supplementary material.

      Study characteristics, quality appraisal, and reporting time

      The outline study characteristics are shown in Table 2. For intact AAA repair there was a total of 589 255 patients, most of these from retrospective studies. However, there is unaccountable duplication of patients likely to be from the different registries and administrative database sources (all assessed as retrospective studies), e.g., the Vascular Quality Initiative, MEDICARE, National Inpatient Sample, the American College of Surgeons National Surgical Quality Improvement Program, Vascular Study Group of New England, and other large studies from the United States and from national registry or administrative data sources (Danish, Dutch, English, German, and Swedish) and VASCUNET within Europe. There were four EVAR only registries with three or more reports (ANCHOR, ENGAGE, GREAT, and PERICLES). RCTs or prospective studies combined, only reported on 30 157 patients (5%) but data completion was better than for retrospective studies, particularly for reports at ≥ 1 year follow up. In total 18 of the studies reported on open repair only, 105 on EVAR only and 108 on both types of repair, with more than half of the reports focusing on acute outcomes (up to 90 days) only (98/231, 42%, reports with outcomes at ≥1 year). The full range of reporting times for each study, to 15 years, is shown in Figure 2.
      Table 2Characteristics of included studies by study design, with separate information provided for intact and ruptured abdominal aortic aneurysms (AAAs)
      AttributeRCTsProspectiveRetrospective
      IntactRuptureIntactRuptureIntactRupture
      Studies13510311941
      Reports281313319054
      Patients per study
       <500104634815
       500–2 0003130369
       >2 00000103517
      Patients5 3111 10024 8461 023559 098175 342
      Geographical region by study
       Americas4030427
       Europe94736025
       Other0000138
       Worldwide010041
      Type of repair by study
       Open repair only1230128
       EVAR only5000552
       Both73735231
      Reporting periods by study
       ≥90 days only13526527
       ≥1 year only3040280
       Both92113614
      Outcome
      Pre-specified outcomes by study. Some studies generated multiple reports, e.g., the ENGAGE registry for Endurant endografts, the DREAM trial of endovascular vs. open repair for intact infrarenal abdominal aortic aneurysms, and a few studies reported on both intact and ruptured AAAs. For the purposes of this table, the few studies (five intact and one rupture) reporting to six months are included in the ≥1 year columns.
      data >90% complete
      24 (86)13 (100)9 (69)3 (100)102 (54)36 (67)
      Data are presented as n except for the bottom line which are n (%). RCT = randomised controlled trial.
      Pre-specified outcomes by study. Some studies generated multiple reports, e.g., the ENGAGE registry for Endurant endografts, the DREAM trial of endovascular vs. open repair for intact infrarenal abdominal aortic aneurysms, and a few studies reported on both intact and ruptured AAAs. For the purposes of this table, the few studies (five intact and one rupture) reporting to six months are included in the ≥1 year columns.
      Figure 2
      Figure 2Frequency of reporting times for pre-specified outcomes after intact and ruptured abdominal aortic aneurysm (AAA) repair. Some reports provided pre-specified outcomes at more than one time point and all are included, with reports as the unit of frequency.
      For ruptured AAA repair there was a total of 177 465 patients included. Retrospective cohort studies contributed 167 682 (94.5%) of the total patients identified. There were five RCTs, 1 100 total patients. No industry sponsored device registries were included. Open repair and EVAR usually were investigated simultaneously, with < 15% of the articles focusing on a single operative approach: eight articles assessed the use of open repair and two articles assessed the use of EVAR alone. Acute outcomes were included in all reports but only 19/70 (27%) publications reported ≥1 year outcomes. The range and frequency of reporting time is shown in Figure 2. Again, the rate of data completion was lower for retrospective studies, especially for reporting times at one year or beyond.

      Pre-specified outcome range and frequency

      The full range of pre-specified outcomes per report for intact and ruptured AAA are shown in Figure 3, Figure 4 respectively. For intact repairs, the three most common pre-specified outcomes were mortality (n = 181), vascular complications (n = 137), and re-interventions (n = 52), while for ruptured AAA repair they were mortality (n = 64), vascular (n = 11), and length of stay for the index admission (n = 10). Pre-specified outcomes of quality of life and costs were listed in only 15 and 10 reports respectively for intact AAA repair and three and five reports respectively for ruptured AAA repair.
      Figure 3
      Figure 3The full range of pre-specified outcomes following intact abdominal aortic aneurysm repair and their frequency, showing most outcomes as described by the COMET taxonomy, with frequency shown on the horizontal axis. The colour coding in each bar shows the number of times each outcome was reported by randomised controlled trials (RCTs; violet), prospective studies (red) and retrospective studies (blue). Disposal is place of discharge to home, skilled nursing facility, or other care facility. Other outcomes include discharge medications and sexual dysfunction.
      Figure 4
      Figure 4The full range of pre-specified outcomes following ruptured abdominal aortic aneurysm repair and their frequency, showing most outcomes as described by the COMET taxonomy, with frequency shown on the horizontal axis. The colour coding in each bar shows the number of times each outcome was reported by randomised controlled trials (RCTs; violet), prospective studies (red), and retrospective studies (blue). Disposal is place of discharge to home, skilled nursing facility or other care facility; quality of life and Barthel index are the items included in functioning.
      The outcome groups pre-specified in each report varied by type of study. Patient functioning outcomes (including quality of life) were more often reported in RCTs and prospective studies for both intact and ruptured AAA, although reporting time was limited to three years (Table 3). There were differences in the outcome groups reported for EVAR and open repair: for intact AAA repairs, vascular complication outcomes were dominant in reports of EVAR, particularly for the later reporting period, where vascular outcomes were more common than mortality and re-interventions dominated the resource use outcomes (Table 4). Mortality was often the only pre-specified outcome in reports of ruptured AAA repair and vascular outcomes were reported less frequently (Table 4). Detail concerning the frequency of individual pre-specified vascular outcomes by reporting time for both intact and ruptured AAA repairs is shown in Table 5: this includes outcomes of interest to vascular surgeons which were not coded as vascular, such as incisional hernia and bowel ischaemia both coded as gastrointestinal and conversion to open repair coded as a re-intervention. For intact AAA repair, endoleak was the most common reported vascular outcome in both acute and later time periods, limb ischaemia was a common acute vascular outcome, whereas sac expansion/regression and secondary rupture were common later vascular outcomes (Table 5). The management of individual vascular complications was seldom a pre-specified outcome. When vascular re-intervention was a pre-specified outcome, this was included in resource use (code 36). In contrast, for ruptured AAA repair, vascular complication outcomes were seldom reported and there was a stronger focus on general medical complications (Table 4).
      Table 3The frequency of pre-specified outcomes of abdominal aortic aneurysm (AAA) repair, listed by group, according to study design and reporting period of acute (≤90 days) or ≥1 year
      OutcomeIntact AAA repairRuptured AAA repair
      RCT or prospectiveRetrospectiveRCT or prospectiveRetrospective
      ≤90 d≥1 y≤90 d≥1 y≤90 d≥1 y≤90 d≥1 y
      Mortality62311999855111
      Vascular012761026471
      General medical44351441201
      Functioning311210
      Includes loss to surveillance (n = 7).
      1220
      Resource use
      Includes re-intervention. The five studies (six reports) for intact AAA and the one study (two reports) of ruptured AAA reporting six month outcomes have been excluded.
      3133547124142
      Data are presented as n. RCT = randomised controlled trial.
      Includes loss to surveillance (n = 7).
      Includes re-intervention. The five studies (six reports) for intact AAA and the one study (two reports) of ruptured AAA reporting six month outcomes have been excluded.
      Table 4The frequency of pre-specified outcomes of abdominal aortic aneurysm (AAA) repair, by group, according to type of open or endovascular aneurysm repair (EVAR) and reporting period of acute (≤90 days) or ≥1 year
      OutcomeIntact AAA repairRuptured AAA repair
      EVAROpen repairEVAROpen repair
      ≤90 d≥1 y≤90 d≥1 y≤90 d≥1 y≤90 d≥1 y
      Mortality10360822850134215
      Vascular49791717155143
      General medical44214417214212
      Functioning414
      Includes seven for compliance with surveillance.
      6102202
      Resource use
      Figures in brackets show re-intervention. The five studies (six reports) for intact AAA and the one study (two reports) of ruptured AAA reporting six month outcomes have been excluded.
      44 (22)42 (34)41 (14)19 (13)17 (1)7 (5)18 (1)8 (3)
      Data are presented as n.
      Includes seven for compliance with surveillance.
      Figures in brackets show re-intervention. The five studies (six reports) for intact AAA and the one study (two reports) of ruptured AAA reporting six month outcomes have been excluded.
      Table 5The frequency of pre-specified outcomes of particular interest to vascular surgeons after abdominal aortic aneurysm (AAA) repair
      Vascular outcomeCode
      Prespecified outcomes were coded as recommended by COMET (full details and coding dictionary given in Supplementary Table 2).
      Intact AAA repairRuptured AAA repair
      ≤90 d≥1 y≤90 d≥1 y
      Abdominal compartment syndrome821
      Access site/wound infection2351
      Amputation241
      Aortic neck dilatation241
      Bowel ischaemia845
      Conversion to open repair367611
      Endoleak2419582
      Graft infection24151
      Graft thrombosis24352
      Graft migration2412
      Incisional hernia85
      Limb ischaemia2417321
      Sac regression/expansion2429
      Secondary rupture2432
      Data are presented as n unless stated otherwise.
      Prespecified outcomes were coded as recommended by COMET (full details and coding dictionary given in Supplementary Table 2).

      Post-market device registries and outcomes of intact AAA repair

      Since vascular outcomes were so prevalent as a pre-specified outcome after EVAR for intact AAA, particularly at later reporting times, it was hypothesised post hoc that this was skewed by the reporting from industry sponsored registries. Apart from the multinational ENGAGE and ANCHOR registries with 18 and nine reports, respectively, there were three additional Endurant (Medtronic) national registry reports. In addition, there were two Zenith (Cook), three Ovation (Endologix), six Excluder (Gore), five Anaconda, and one Treovance (both Terumo) registry reports, making a total of 47/237 (20%) reports from industry sponsored registries. Of the ENGAGE reports, one had no pre-specified outcomes (general five year report), one focused on mortality and length of stay to 30 days, and one focused on quality of life at one year; one Zenith report focused on renal outcomes only. All the remaining 43 reports included one or more pre-specified vascular outcomes. The impact of excluding these reports from the analysis of the five group outcomes after EVAR is shown in Figure 5. After exclusion of these 47 reports, the emphasis on reporting vascular outcomes, particularly for time points at ≥ 1 year, has reduced considerably. More detailed assessment of the individual vascular outcomes investigated showed that for outcomes at ≥ 1 year, the device registries reported over half of endoleaks (32/58), migration outcomes (7/12), and conversions to open repair (4/7), and nearly half of the outcomes for sac regression/expansion (13/29), none of the graft infection outcomes (0/5), and a minority (4/32) of the secondary rupture outcomes.
      Figure 5
      Figure 5The influence of industry sponsored registries on the frequency of outcome group reporting after endovascular aneurysm repair for intact abdominal aortic aneurysm repair. Light coloured bars show all outcome groupings for all reports and the dark coloured bars show outcome groupings with industry sponsored registry data excluded. Although only 47/231 (20%) reports were based on industry sponsored registries, they contributed more than half of the vascular outcomes at the later time point (50/79).

      Discussion

      This systematic review demonstrates that a wide range of outcomes are reported, but their frequency indicates that patients, their families and carers and the wider multidisciplinary care team (including community care) may have been represented inadequately in reports relating to infrarenal AAA repair in the contemporary literature. In particular, there is a paucity of good quality information about the longer term outcomes of intact AAA repair. Many of the reports identified were based on retrospective analysis of established registries or administrative databases, in which available outcomes are limited by database design. However, two examples show that it is possible for these studies to include functioning outcomes: one nationwide registry did collect and report data on patient functioning
      • Yamaguchi T.
      • Nakai M.
      • Sumita Y.
      • Nishimura K.
      • Tazaki J.
      • Kyuragi R.
      • et al.
      Endovascular repair versus surgical repair for Japanese patients with ruptured thoracic and abdominal aortic aneurysms: a nationwide study.
      and quality of life data were reported from a sub-study of the ENGAGE registry.
      • Pol R.A.
      • Zeebregts C.J.
      • Van Sterkenburg S.M.
      • Reijnen M.M.
      • Investigators E.
      Thirty-day outcome and quality of life after endovascular abdominal aortic aneurysm repair in octogenarians based on the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE).
      No reports relating to the influence of AAA repair on community healthcare after discharge were identified. In contrast, industry appears to be well represented through investigational device trials and post-market device registries, with a focus on vascular complications rather than the most injurious events. Hospital healthcare providers are represented, at least in part, since many studies reported on resource use including of intensive care, length of hospital stay and further interventions These data highlight the need for a Core Outcome Set to represent all stakeholders.
      Elective AAA repair is offered to those with reasonable life expectancy to prevent aneurysm rupture in the years ahead. Therefore, it was disappointing to find so few studies reporting on outcomes at more than five years after elective repair (Fig. 2). In contrast, given the high early mortality from AAA rupture, it is less surprising that a high proportion of studies investigated acute events only. In addition, significant patient loss to follow up was observed at the later reporting times. There has been inadequate discussion of the value of specific reporting times. For instance, elective EVAR patients often leave hospital within 48 hours (median length of stay of two days) but can be re-admitted for further intervention within the first few weeks, so that index admission outcomes are likely to be inadequate. Consultation, between clinicians, healthcare providers, and patients, is required to decide the optimal reporting times for specific outcomes.
      Patient involvement is paramount to ensure engagement with healthcare services and ensure patients’ expectations are aligned with that of the provider. From the limited studies available, it is clear that patients fear loss of independence and may prioritise functioning outcomes after AAA repair.
      • Dion D.
      • Power A.
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      • Forbes T.
      • Dubois L.
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      IMPROVE Trial Investigators
      Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: one-year outcomes from the IMPROVE randomized trial.
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      • Mante A.A.
      • Halpern S.D.
      Intuitive vs deliberative approaches to making decisions about life support: a randomized clinical trial.
      Functioning outcomes are important to balancing the benefits and harms of prophylactic AAA repair but appear to be insufficient to fully enable shared patient–clinician decision making. It is a limitation of the work that only medical databases were searched, since it is possible that there is more information about functioning in other sources. Quality of life outcomes are needed for assessing the cost effectiveness of the intervention and subsequent “willingness to pay” analyses.
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      Importantly similar information also is lacking after emergency repair. This is likely to be a fearful and daunting time for patients and quality of life judgements and fitness for surgery decisions are often made around emergency repair in the absence of such information.
      The performance of surgeons is assessed, at least in part, by the metrics of mortality and re-admissions within 30 days of the index procedure. Surgeons also are concerned with the technical success of the procedure and the literature serves them adequately, except for perhaps the under reporting of re-admissions. However, these clinicians also are concerned with the wellbeing of their patients and interactions with non-surgical colleagues and may regret that there are inadequate data for general medical problems and patient functioning but perhaps overemphasis on vascular complications.
      Vascular outcomes dominate the elective EVAR literature, with a focus on the reporting of vascular complications, particularly endoleaks at ≥ 1 year. Interestingly, less attention has been paid to the interventions required to manage the EVAR related complications and the outcome of re-intervention was seldom detailed. Treatment of Type 1 endoleaks requires graft extension which may necessitate a groin incision and re-admission while treatment of Type 3 endoleak requires re-interventions such as deployment of a new bifurcated stent graft over the defective area and can necessitate invasive procedures such as laparotomy and graft explantation.
      • Bradbury A.D.A.
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      • Ribbons T.
      • et al.
      Abdominal aortic aneurysm: diagnosis and management, NICE guideline [NG156]: NHS England.
      ,
      • Chen J.
      • Stavropoulos S.W.
      Management of endoleaks.
      The dominance of vascular complications as a pre-specified outcome was attributable, in large part, to the profusion of reports from industry sponsored EVAR registries, which commonly had specific complications as the a priori outcome of a study: device registries provided more than half of the reports including endoleak as a pre-specified outcome. This creates the impression that most device registries still are concerned only with endograft technical performance rather than either the most serious complications, such as graft infection or with patient wellbeing. Recommendations for post-market device registries include the mandatory reporting of deaths, injuries and device malfunction.
      Stark NJ ClinIcal Device Group Whitepapers
      Registry studies: why and how.
      The definition of injuries (e.g., disabling stroke, impairment of functioning) requires further discussion and better reporting in the future.
      This review sets out the range, timing, and frequency of outcomes reported in the contemporary literature to provide information to focus groups to prioritise outcomes (at specific times) and hence continue the development of a Core Outcome Set. This review was conducted in the UK but the next step, the focus groups to prioritise individual outcomes to enter a Delphi consensus questionnaire, is being conducted mainly in Sweden.
      • Powell J.T.
      • Ambler G.K.
      • Svensjö S.
      • Wanhainen A.
      • Bown M.J.
      Beyond the AAA guidelines: core outcome sets to make life better for patients.
      Pan-European contributions to take the process forward are welcomed: please contact us. The key needs for the future are to improve the quantity, quality, and inclusiveness of the longer term outcomes reported after both intact and emergency AAA repairs to adequately represent all stakeholders. This in turn will improve the evidence base for shared decision making between future patients and clinicians.

      Appendix A. Supplementary data

      The following is the Supplementary data to this article:

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      Linked Article

      • The Life in their Years versus the Years in their Lives
        European Journal of Vascular and Endovascular SurgeryVol. 61Issue 6
        • Preview
          Nearly all infrarenal abdominal aortic aneurysms (AAAs) can be addressed by contemporary open and endovascular therapies for repair. However, the ability to perform a procedure does not always parallel a patient’s capacity to recover. The contrast increases with age, and other socio-economic and psychological factors that come into play. Just because we can do it does not always mean that we should. In this issue of EJVES, Machin et al.1 provide us with a well conducted systematic review showing that, after AAA repair, the majority of studies were focused mainly on surgical outcomes, which was reflected by mortality metrics, while ignoring supposedly minor late complications such as incisional hernias after open surgery or the need for late re-interventions after endovascular treatment.
        • Full-Text
        • PDF
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