Endovascular Repair of Juxtarenal and Pararenal Abdominal Aortic Aneurysms Using a Novel Low-Profile Fenestrated Custom-Made Endograft: Technical Details and Short-Term Outcomes.

INTRODUCTION: The aim of this study is to share preliminary experiences and outcomes with a novel custom-made fenestrated TREO® Abdominal Stent-Graft System to treat juxtarenal and pararenal abdominal aortic aneurysms (AAAs). METHODS: Juxtarenal and pararenal AAA patients treated with the custom-made fenestrated TREO® Abdominal Stent-Graft System were included from 4 high-volume European academic medical centers from June 2021 to September 2023. Technical success and 30-day/in-hospital mortality and complications were analyzed. Technical success was defined as successful endovascular implantation of the stent graft with preservation of antegrade flow to the target vessels, and absence of type 1 or 2 endoleak (EL) at the first postoperative computed tomography angiography (CTA). RESULTS: Forty-two consecutive patients were included. The majority of the devices were constructed with 2 (N=4; 9.5%), 3 (N=9; 21.4%), or 4 (N=27; 64%) fenestrations. In 1 case, the device was constructed with a single fenestration (2.4%) and 1 device contained 5 fenestrations (2.4%); 17% had previous AAA repair. Target vessel cannulation with placement of a bridging stent was successful in all but 1 vessel (99, 3%). One aneurysm-related death occurred in the direct postoperative period and 2 limb occlusions necessitated reintervention during admission. In the median follow-up period of 101 (2-620) days, 3 more patients died due to non-aneurysm-related causes. Technical success was achieved in 90% of the cases. Nineteen ELs were seen on the first postoperative CT scan: 1 type 1b EL (N=1; 2%), 15 type 2 ELs (N=15; 36%), and 3 type 3 ELs (N=3%). Eleven patients received more than 1 CT scan during a median follow-up of 361 days (82-620): 3 type 2 ELs resolved and 1 type 3 EL was treated in this period. In the follow-up, 1 patient had a coagulation disorder that caused occlusions of the branches. CONCLUSION: The results of the first experiences using the custom-made fenestrated TREO® Abdominal Stent-Graft System in Europe are promising. There was a low short-term mortality and morbidity rate in these patients of which 17% had previous AAA repair. Mid-term and long-term follow-up data are needed to evaluate endograft durability and performance. CLINICAL IMPACT: This study shows the first experiences and short-term results of a novel low-profile custom-made device: the custom-made fenestrated TREO® Abdominal Stent-Graft System. Showing these results and experiences can help the physicians in clinical decision-making for their patients.

Exploring the expression and potential function of follicle stimulating hormone receptor in extragonadal cells related to abdominal aortic aneurysm.

INTRODUCTION: Follicle stimulating hormone (FSH) is identified to play a role in postmenopausal disease and hypothesized to affect abdominal aortic aneurysm (AAA) onset/progression in postmenopausal women. We aimed to detect FSHR gene expression in AAA tissue and cell types involved in AAA formation. METHODS: FSH stimulation of human umbilical cord endothelial cells (HUVECs), smooth muscle cells (HUCs) and PMA-differentiated macrophages to assess gene expression of FSHR and various markers. Human macrophages activated with various stimuli were assessed for FSHR gene expression. AAA dataset, AAA tissue samples and AAA-derived smooth muscle cells (SMC) obtained from elderly female donors were assessed for FSHR gene expression. AAA-SMCs were stimulated with FSH to assess its effect on gene expression. Lastly, oxidized low-density-lipoprotein (ox-LDL) uptake and abundance of cell surface protein markers were assessed by flow cytometry after FSH stimulation of human monocytes. RESULTS: FSH stimulation showed similar levels of gene expression in HUVECs and HUCs. Only ACTA2 was downregulated in HUCs. In PMA-differentiated macrophages, gene expression of inflammation markers was unchanged after FSH stimulation. FSHR gene expression was found to be low in the AAA datasets. Female AAA-SMCs show occasional FSHR gene expression at a very low level, yet stimulation with FSH did not affect gene expression of SMC- or inflammation markers. FSH stimulation did not impact ox-LDL uptake or alter cell surface protein expression in monocytes. While FSHR gene expression was detected in human testis tissue, it was below quantification level in all other investigated cell types, even upon activation of macrophages with various stimuli. CONCLUSION: Despite previous reports, we did not detect FSHR gene expression in various extragonadal cell types, except in occasional female AAA-SMCs. No clear effect on cell activation was observed upon FSH stimulation in any cell type. Our data suggest that a direct effect of FSH in AAA-related extragonadal cells is unlikely to influence AAA.

Systematic review and meta-analysis comparing the autogenous vein bypass versus a prosthetic graft for above-the-knee femoropopliteal bypass surgery in patients with intermittent claudication.

OBJECTIVES: According to guidelines, the autogenous saphenous vein (ASV) is the preferred conduit for femoropopliteal bypass surgery in all patients with peripheral artery disease. However, in contrast to patients with critical limb ischemia (CLI), patients with intermittent claudication (IC) only, tend to have milder disease, and thus a prosthetic graft may be as good as a vein conduit. The objective of this study was to compare patency rates of the ASV and a prosthetic graft in femoropopliteal bypass surgery in patients with IC. METHODS: A systematic literature search was performed in the PubMed, Embase, and Cochrane databases to identify randomized controlled trials comparing prosthetic graft versus ASV in patients with IC. Articles with a mixed IC and CLI study population were included if more than 50% of the study cohort was treated for IC. Primary analysis was performed on IC patients only. Secondary analysis was performed on the mixed group. The primary endpoint was short- and long-term patency and secondary endpoints were complications, limb salvage, and mortality. RESULTS: In total, six studies with 524 patients were included. Only two studies reported solely on patients with IC. All these patients underwent above-the-knee bypasses and average patency rates at one and 5 years were 88% and 76% vs 81% and 68% in the ASV and the PTFE groups, respectively. One and five-year patency was not statistically different between the groups (OR 5.21; 95% CI 0.60-45.36 and OR 2.10; 95% CI 0.88-5.01). In a mixed population of patients with IC and CLI (84% IC patients), 1 year patency was comparable (OR 1.40; 95% CI 0.87-2.25). However, after a follow-up of over 3 years, this mixed group had significantly higher patency rates in favour of the ASV (OR 2.06; 95 % CI 1.30-3.26). Complication and amputation rates were comparable in both groups. CONCLUSIONS: Limited data are available for patients receiving above-the-knee femoropopliteal bypass for intermittent claudication. The ASV remains the conduit of choice for femoropopliteal bypass surgery. However, the prosthetic conduit seems a feasible alternative for patients with intermittent claudication in whom the ASV is not present or unsuitable.

Mortality following elective abdominal aortic aneurysm repair in women.

BACKGROUND: Previous studies have focused on patient-related risk factors to explain the higher mortality risk in women undergoing elective abdominal aortic aneurysm (AAA) repair. The aim of this study was to evaluate whether hospital-related factors influence outcomes following AAA repair in women. METHODS: Patients undergoing elective AAA repair in 61 hospitals in the Netherlands were identified from the Dutch Surgical Aneurysm Audit registry (2013-2018). A mixed-effects logistic regression analysis was conducted to assess the effect of sex on in-hospital and/or 30-day mortality. This analysis accounted for possible correlation of outcomes among patients who were treated in the same hospital, by adding a hospital-specific random effect to the statistical model. The analysis adjusted for patient-related risk factors and hospital volume of open surgical repair (OSR) and endovascular aneurysm repair (EVAR). RESULTS: Some 12 034 patients were included in the analysis. The mortality rate was higher in women than among men: 53 of 1780 (3.0 per cent) versus 152 of 10 254 (1.5 per cent) respectively. Female sex was significantly associated with mortality after correction for patient- and hospital-related factors (odds ratio 1.68, 95 per cent c.i. 1.20 to 2.37). OSR volume was associated with lower mortality (OR 0.91 (0.85 to 0.95) per 10-procedure increase) whereas no such relationship was identified with EVAR volume (OR 1.03 (1.01 to 1.05) per 10-procedure increase). CONCLUSION: Women are at higher risk of death after abdominal aortic aneurysm repair irrespective of patient- and hospital-related factors.

Patient-Reported Outcomes of Yearly Imaging Surveillance in Patients Following Endovascular Aortic Aneurysm Repair.

Little is known about the impact of standardized imaging surveillance on anxiety levels and well-being of patients after endovascular aortic aneurysm repair (EVAR). We hypothesize that patient anxiety levels increase just before receiving the imaging results compared with standard anxiety levels. METHODS: Prospective cohort study from November 2018 to May 2020 including post-EVAR patients visiting the outpatient clinics of 4 Dutch hospitals for imaging follow-up. The Patient-Reported Outcomes Measurement Information System (PROMIS) was used. Patients completed the PROMIS Anxiety v1.0 Short Form (SF) 4a, PROMIS-Global Health Scale v1.2, and PROMIS-Physical Function v1.2 SF8b at 2 time points: prior to the result of the imaging study (T1: pre-visit) and 6-8 months later (T2: reference measurement). Mean T-scores at T1 were compared to T2, and T2 to the general 65+ Dutch population. RESULTS: Altogether 342 invited patients were eligible, 214 completed the first questionnaire, 189 returned 2 completed questionnaires and 128 patients did not participate. Out of 214 respondents, 195 were male (91.1%) and the mean (standard deviation) age was 75.2 (7.0) years. There were no significant differences between T1 and T2 in anxiety levels (0.48; 95% confidence interval[CI] -0.42-1.38), global mental health (0.27; 95% CI -0.79-0.84), global physical health (0.10; 95% CI -0.38-1.18) and physical function (0.53; 95% CI -0.26-1.32). Compared with the 65+ Dutch population, at T2 patients experienced more anxiety (3.8; 95% CI 2.96-5.54), had worse global physical health (-3.2; 95% CI -4.38 - -2.02) and physical function (-2.4; 95% CI -4.00 - -0.80). Global mental health was similar (-1.0; 95% CI -2.21 - 0.21). CONCLUSIONS: Post-EVAR patients do not experience more anxiety just before receiving surveillance imaging results than outside this period, but do suffer from more anxiety and worse physical outcomes than the 65+ Dutch population.

Short-term outcomes of open surgical abdominal aortic aneurysm repair from the Dutch Surgical Aneurysm Audit.

BACKGROUND: The sharp decrease in open surgical repair (OSR) for abdominal aortic aneurysm (AAA) has raised concerns about contemporary postoperative outcomes. The study was designed to analyse the impact of complications on clinical outcomes within 30 days following OSR. METHODS: Patients who underwent OSR for intact AAA registered prospectively between 2016 and 2019 in the Dutch Surgical Aneurysm Audit were included. Complications and outcomes (death, secondary interventions, prolonged hospitalization) were evaluated. The adjusted relative risk (aRr) and 95 per cent confidence intervals were computed using Poisson regression. Subsequently, the population-attributable fraction (PAF) was calculated. The PAF reflects the expected percentage reduction of an outcome if a complication were to be completely prevented. RESULTS: A total of 1657 patients were analysed. Bowel ischaemia and renal complications had the largest impact on death (aRr 12·44 (95 per cent c.i. 7·95 to 19·84) at PAF 20 (95 per cent c.i. 8·4 to 31·5) per cent and aRr 5·07 (95 per cent c.i. 3·18 to 8.07) at PAF 14 (95 per cent c.i. 0·7 to 27·0) per cent, respectively). Arterial occlusion had the greatest impact on secondary interventions (aRr 11·28 (95 per cent c.i. 8·90 to 14·30) at PAF 21 (95 per cent c.i. 14·7 to 28·1) per cent), and pneumonia (aRr 2·52 (95 per cent c.i. 2·04 to 3·10) at PAF 13 (95 per cent c.i. 8·3 to 17·8) per cent) on prolonged hospitalization. Small effects were observed on outcomes for other complications. CONCLUSION: The greatest clinical impact following OSR can be made by focusing on measures to reduce the occurrence of bowel ischaemia, arterial occlusion and pneumonia.

Differences in Comorbidities Between Women and Men Treated with Elective Repair for Abdominal Aortic Aneurysms: A Systematic Review and Meta-Analysis.

OBJECTIVES: Elective abdominal aortic aneurysm (AAA) repair is performed to prevent rupture. For reasons as yet unknown, the 30-day mortality risk after elective AAA repair is higher in women than in men. We hypothesised that this higher risk might be related to differences in comorbidity. METHODS: Systematic review (PROSPERO CRD42019133314) according to PRISMA guidelines. A search in the EMBASE/MEDLINE/CENTRAL databases identified 1870 studies that included patients who underwent elective AAA repair (final search February 17th, 2021). Ultimately, 28 studies were included and all reported comorbidities were categorised into 17 comorbidity groups. Additionally, 15 groups of clearly defined comorbidities were used for sensitivity analysis. For both groups, meta-analyses of each comorbidity were performed to estimate the difference in pooled prevalence between women and men with a random effects model. RESULTS: When analysing data of all reported comorbidities (17 groups), smoking [risk difference (RD) 11%, 95% confidence interval (CI) 4-18], diabetes (RD 3%, 95% CI 2-4), ischaemic heart disease (RD 12%, 95% CI 8-16), arrhythmia (RD 3%, 95% CI 0.4-5), liver disease (RD 0.1%, 95% CI 0.01-0.2), and cancer (RD 3%, 95% CI 2-4)) were less prevalent in women, whereas, hypertension (RD 4%, 95% CI 3-6) and pulmonary disease (RD 4%, 95% CI 3-5) were more prevalent in women. At the time of surgery women were significantly older than men (74.9 years versus 72.4; mean difference 2.4 years (95% CI 2.1-2.7)). In the sensitivity analysis of 15 comorbidity groups, the same comorbidities remained significantly different between women and men, except smoking and arrhythmia. Women had a higher mortality risk than men (RD 1%, 95% CI 1-2). CONCLUSIONS: Although women undergoing elective AAA repair have fewer baseline comorbidities than men, their 30-day mortality risk is higher. In-depth studies on the cause of death in women after elective AAA repair are needed to explain this discrepancy in mortality.

Context-Relative Norms Determine the Appropriate Type of Consent in Clinical Biobanks: Towards a Potential Solution for the Discrepancy between the General Data Protection Regulation and the European Data Protection Board on Requirements for Consent.

Clinical biobanks processing data of participants in the European Union (EU) fall under the scope of the General Data Protection Regulation (GDPR), which among others includes requirements for consent. These requirements are further specified by the Article 29 Working Party (WP29)-an EU advisory body currently known as the European Data Protection Board (EDPB). Unfortunately, their guidance is cause for some confusion. While the GDPR allows participants to give broad consent for research when specific research purposes are still unknown, the WP29 guidelines suggest that additional consent for specific uses should be obtained in addition to broad consent when this becomes applicable. This discrepancy elicits the question whether clinical biobanks can fail the requirement of consent if they obtain broad consent, but not a specific consent for each biomedical study. We analysed this discrepancy within the framework of contextual integrity, in order to describe the context-relative informational norms that govern information flows in clinical biobanks. However, our analysis demonstrates that there is no uniform set of norms that can be applied to all clinical biobanks. As such, neither the GDPR nor the WP29 guidance can act as a "one size fits all" approach to all clinical biobanks. Rather, differences between clinical biobanks-especially regarding the scientific aims and patient populations-make the case for context-relative norms that determine the appropriate type of consent.

Improving shared decision-making in vascular surgery by implementing decision support tools: study protocol for the stepped-wedge cluster-randomised OVIDIUS trial.

BACKGROUND: Shared decision-making improves the quality of patient care. Unfortunately, shared decision-making is not yet common practice among vascular surgeons. Thus, decision support tools were developed to assist vascular surgeons and their patients in using shared decision-making. This trial aims to evaluate the effectiveness and implementation of decision support tools to improve shared decision-making during vascular surgical consultations in which a treatment decision is to be made. METHODS: The study design is a multicentre stepped-wedge cluster-randomised trial. Eligible patients are adult patients, visiting the outpatient clinic of a participating medical centre for whom several treatment options are feasible and who face a primary treatment decision for their abdominal aortic aneurysm, carotid artery disease, intermittent claudication, or varicose veins. Patients and vascular surgeons in the intervention group receive decision support tools that may help them adopt shared decision-making when making the final treatment decision. These decision support tools are decision aids, consultation cards, decision cards, and a practical training. Decision aids are informative websites that help patients become more aware of the pros and cons of the treatment options and their preferences regarding the treatment choice. Consultation cards with text or decision cards with images are used by vascular surgeons during consultation to determine which aspect of a treatment is most important to their patient. In the training vascular surgeons can practice shared decision-making with a patient actor, guided by a medical psychologist. This trial aims to include 502 vascular surgical patients to achieve a clinically relevant improvement in shared decision-making of 10 out of 100 points, using the 5-item OPTION instrument to score the audio-recordings of consultations. DISCUSSION: In the OVIDIUS trial the available decision support tools for vascular surgical patients are implemented in clinical practice. We will evaluate whether these tools actually improve shared decision-making in the consultation room. The stepped-wedge cluster-randomised study design will ensure that at the end of the study all participating centres have implemented at least some of the decision support tools and thereby a certain level of shared decision-making. TRIAL REGISTRATION: Netherlands Trial Registry, NTR6487 . Registered 7 June 2017. URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6487.

Editor's Choice - Nationwide Analysis of Patients Undergoing Iliac Artery Aneurysm Repair in the Netherlands.

OBJECTIVE: The new 2019 guideline of the European Society for Vascular Surgery (ESVS) recommends consideration for elective iliac artery aneurysm (eIAA) repair when the iliac diameter exceeds 3.5 cm, as opposed to 3.0 cm previously. The current study assessed diameters at time of eIAA repair and ruptured IAA (rIAA) repair and compared clinical outcomes after open surgical repair (OSR) and endovascular aneurysm repair (EVAR). METHODS: This retrospective observational study used the nationwide Dutch Surgical Aneurysm Audit (DSAA) registry that includes all patients who undergo aorto-iliac aneurysm repair in the Netherlands. All patients who underwent primary IAA repair between 1 January 2014 and 1 January 2018 were included. Diameters at time of eIAA and rIAA repair were compared in a descriptive fashion. The anatomical location of the IAA was not registered in the registry. Patient characteristics and outcomes of OSR and EVAR were compared with appropriate statistical tests. RESULTS: The DSAA registry comprised 974 patients who underwent IAA repair. A total of 851 patients were included after exclusion of patients undergoing revision surgery and patients with missing essential variables. eIAA repair was carried out in 713 patients, rIAA repair in 102, and symptomatic IAA repair in 36. OSR was performed in 205, EVAR in 618, and hybrid repairs and conversions in 28. The median maximum IAA diameter at the time of eIAA and rIAA repair was 43 (IQR 38-50) mm and 68 (IQR 58-85) mm, respectively. Mortality was 1.3% (95% CI 0.7-2.4) after eIAA repair and 25.5% (95% CI 18.0-34.7) after rIAA repair. Mortality was not significantly different between the OSR and EVAR subgroups. Elective OSR was associated with significantly more complications than EVAR (intra-operative: 9.8% vs. 3.6%, post-operative: 34.0% vs. 13.8%, respectively). CONCLUSION: In the Netherlands, most eIAA repairs are performed at diameters larger than recommended by the ESVS guideline. These findings appear to support the recent increase in the threshold diameter for eIAA repair.

Delphi Study to Reach International Consensus Among Vascular Surgeons on Major Arterial Vascular Surgical Complications.

BACKGROUND: The complications discussed with patients by surgeons prior to surgery vary, because no consensus on major complications exists. Such consensus may improve informed consent and shared decision-making. This study aimed to achieve consensus among vascular surgeons on which complications are considered 'major' and which 'minor,' following surgery for abdominal aortic aneurysm (AAA), carotid artery disease (CAD) and peripheral artery disease (PAD). METHODS: Complications following vascular surgery were extracted from Cochrane reviews, national guidelines, and reporting standards. Vascular surgeons from Europe and North America rated complications as major or minor on five-point Likert scales via an electronic Delphi method. Consensus was reached if ≥ 80% of participants scored 1 or 2 (minor) or 4 or 5 (major). RESULTS: Participants reached consensus on 9-12 major and 6-10 minor complications per disease. Myocardial infarction, stroke, renal failure and allergic reactions were considered to be major complications of all three diseases. All other major complications were treatment specific or dependent on disease severity, e.g., spinal cord ischemia, rupture following AAA repair, stroke for CAD or deep wound infection for PAD. CONCLUSION: Vascular surgeons reached international consensus on major and minor complications following AAA, CAD and PAD treatment. This consensus may be helpful in harmonizing the information patients receive and improving standardization of the informed consent procedure. Since major complications differed between diseases, consensus on disease-specific complications to be discussed with patients is necessary.

Value of risk scores in the decision to palliate patients with ruptured abdominal aortic aneurysm.

BACKGROUND: The aim of this study was to develop a 48-h mortality risk score, which included morphology data, for patients with ruptured abdominal aortic aneurysm presenting to an emergency department, and to assess its predictive accuracy and clinical effectiveness in triaging patients to immediate aneurysm repair, transfer or palliative care. METHODS: Data from patients in the IMPROVE (Immediate Management of the Patient With Ruptured Aneurysm: Open Versus Endovascular Repair) randomized trial were used to develop the risk score. Variables considered included age, sex, haemodynamic markers and aortic morphology. Backwards selection was used to identify relevant predictors. Predictive performance was assessed using calibration plots and the C-statistic. Validation of the newly developed and other previously published scores was conducted in four external populations. The net benefit of treating patients based on a risk threshold compared with treating none was quantified. RESULTS: Data from 536 patients in the IMPROVE trial were included. The final variables retained were age, sex, haemoglobin level, serum creatinine level, systolic BP, aortic neck length and angle, and acute myocardial ischaemia. The discrimination of the score for 48-h mortality in the IMPROVE data was reasonable (C-statistic 0·710, 95 per cent c.i. 0·659 to 0·760), but varied in external populations (from 0·652 to 0·761). The new score outperformed other published risk scores in some, but not all, populations. An 8 (95 per cent c.i. 5 to 11) per cent improvement in the C-statistic was estimated compared with using age alone. CONCLUSION: The assessed risk scores did not have sufficient accuracy to enable potentially life-saving decisions to be made regarding intervention. Focus should therefore shift to offering repair to more patients and reducing non-intervention rates, while respecting the wishes of the patient and family.

Systematic review of shared decision-making in surgery.

BACKGROUND: Multiple treatment options are generally available for most diseases. Shared decision-making (SDM) helps patients and physicians choose the treatment option that best fits a patient's preferences. This review aimed to assess the extent to which SDM is applied during surgical consultations, and the metrics used to measure SDM and SDM-related outcomes. METHODS: This was a systematic review of observational studies and clinical trials that measured SDM during consultations in which surgery was a treatment option. Embase, MEDLINE and CENTRAL were searched. Study selection, quality assessment and data extraction were conducted by two investigators independently. RESULTS: Thirty-two articles were included. SDM was measured using nine different metrics. Thirty-six per cent of 13 176 patients and surgeons perceived their consultation as SDM, as opposed to patient- or surgeon-driven. Surgeons more often perceived the decision-making process as SDM than patients (43·6 versus 29·3 per cent respectively). SDM levels scored objectively using the OPTION and Decision Analysis System for Oncology instruments ranged from 7 to 39 per cent. Subjective SDM levels as perceived by surgeons and patients ranged from 54 to 93 per cent. Patients experienced a higher level of SDM during consultations than surgeons (93 versus 84 per cent). Twenty-five different SDM-related outcomes were reported. CONCLUSION: At present, SDM in surgery is still in its infancy, although surgeons and patients both think of it favourably. Future studies should evaluate the effect of new interventions to improve SDM during surgical consultations, and its assessment using available standardized and validated metrics.

Development and External Validation of a Model Predicting Death After Surgery in Patients With a Ruptured Abdominal Aortic Aneurysm: The Dutch Aneurysm Score.

OBJECTIVE: The decision whether or not to proceed with surgical intervention of a patient with a ruptured abdominal aortic aneurysm (rAAA) is very difficult in daily practice. The primary objective of the present study was to develop and to externally validate a new prediction model: the Dutch Aneurysm Score (DAS). METHODS: With a prospective cohort of 10 hospitals (n = 508) the DAS was developed using a multivariate logistic regression model. Two retrospective cohorts with rAAA patients from two hospitals (n = 373) were used for external validation. The primary outcome was the combined 30 day and in-hospital death rate. Discrimination (AUC), calibration plots, and the ability to identify high risk patients were compared with the more commonly used Glasgow Aneurysm Score (GAS). RESULTS: After multivariate logistic regression, four pre-operative variables were identified: age, lowest in hospital systolic blood pressure, cardiopulmonary resuscitation, and haemoglobin level. The area under the receiver operating curve (AUC) for the DAS was 0.77 (95% CI 0.72-0.82) compared with the GAS with an AUC of 0.72 (95% CI 0.67-0.77). The DAS showed a death rate in patients with a predicted death rate ≥80% of 83%. CONCLUSIONS: The present study shows that the DAS has a higher discriminative performance (AUC) compared with the GAS. All clinical variables used for the DAS are easy to obtain. Identification of low risk patients with the DAS can potentially reduce turndown rates. The DAS can reliably be used by clinicians to make a more informed decision in dialogue with the patient and their family whether or not to proceed with surgical intervention.

Biomechanical Imaging Markers as Predictors of Abdominal Aortic Aneurysm Growth or Rupture: A Systematic Review.

OBJECTIVES: Biomechanical characteristics, such as wall stress, are important in the pathogenesis of abdominal aortic aneurysms (AAA) and can be visualised and quantified using imaging techniques. This systematic review aims to present an overview of all biomechanical imaging markers that have been studied in relation to AAA growth and rupture. METHODS: This systematic review followed the PRISMA guidelines. A search in Medline, Embase, and the Cochrane Library identified 1503 potentially relevant articles. Studies were included if they assessed biomechanical imaging markers and their potential association with growth or rupture. RESULTS: Twenty-seven articles comprising 1730 patients met the inclusion criteria. Eighteen studies performed wall stress analysis using finite element analysis (FEA), 13 of which used peak wall stress (PWS) to quantify wall stress. Ten of 13 case control FEA studies reported a significantly higher PWS for symptomatic or ruptured AAAs than for intact AAAs. However, in some studies there was confounding bias because of baseline differences in aneurysm diameter between groups. Clinical heterogeneity in methodology obstructed a meaningful meta-analysis of PWS. Three of five FEA studies reported a significant positive association between several wall stress markers, such as PWS and 99th percentile stress, and growth. One study reported a significant negative association and one other study reported no significant association. Studies assessing wall compliance, the augmentation index and wall stress analysis using Laplace's law, computational fluid dynamics and fluid structure interaction were also included in this systematic review. CONCLUSIONS: Although PWS is significantly higher in symptomatic or ruptured AAAs in most FEA studies, confounding bias, clinical heterogeneity, and lack of standardisation limit the interpretation and generalisability of the results. Also, there is conflicting evidence on whether increased wall stress is associated with growth.

Inflammation as a Predictor of Abdominal Aortic Aneurysm Growth and Rupture: A Systematic Review of Imaging Biomarkers.

BACKGROUND: Methods are required to identify abdominal aortic aneurysms (AAAs) at increased risk of rupture. Inflammatory characteristics of AAA can be visualised using advanced imaging techniques and have been proposed as potential predictors of aneurysm progression. The objective of this review was to determine which inflammatory imaging biomarkers are associated with AAA growth and rupture. METHODS: A systematic review was carried out in accordance with the PRISMA guidelines. The electronic databases of Medline (PubMed), Embase, and the Cochrane Library were searched up to January 1, 2016 for studies to determine the potential association between inflammatory imaging biomarkers and AAA growth or rupture. RESULTS: Seven studies were included, comprising 202 AAA patients. (18)F-fluoro-deoxy-glucose positron emission tomography ((18)F-FDG PET-CT) was evaluated in six studies. Magnetic resonance imaging with ultrasmall superparamagnetic particles of iron oxide (USPIO-MRI) was evaluated in one study. Two of six (18)F-FDG PET-CT studies reported a significant negative correlation (r=.383, p = .015) or a significant negative association (p = .04). Four of six (18)F-FDG PET-CT studies reported no significant association between (18)F-FDG uptake and AAA growth. The single study investigating USPIO-MRI demonstrated that AAA growth was three times higher in patients with focal USPIO uptake in the AAA wall compared to patients with diffuse or no USPIO uptake in the wall (0.66 vs. 0.24 vs. 0.22 cm/y, p = .020). In the single study relating (18)F-FDG uptake results to AAA rupture, the association was not significant. CONCLUSIONS: Current evidence shows contradictory associations between (18)F-FDG uptake and AAA growth. Data on the association with rupture are insufficient. Based on the currently available evidence, neither (18)F-FDG PET-CT nor USPIO-MRI can be implemented as growth or rupture prediction tools in daily practice. The heterogeneous results reflect the complex and partially unclear relationship between inflammatory processes and AAA progression.

Individual-patient meta-analysis of three randomized trials comparing endovascular versus open repair for ruptured abdominal aortic aneurysm.

BACKGROUND: The benefits of endovascular repair of ruptured abdominal aortic aneurysm remain controversial, without any strong evidence about advantages in specific subgroups. METHODS: An individual-patient data meta-analysis of three recent randomized trials of endovascular versus open repair of abdominal aortic aneurysm was conducted according to a prespecified analysis plan, reporting on results to 90 days after the index event. RESULTS: The trials included a total of 836 patients. The mortality rate across the three trials was 31.3 per cent for patients randomized to endovascular repair/strategy and 34.0 per cent for those randomized to open repair at 30 days (pooled odds ratio 0.88, 95 per cent c.i. 0.66 to 1.18), and 34.3 and 38.0 per cent respectively at 90 days (pooled odds ratio 0.85, 0.64 to 1.13). There was no evidence of significant heterogeneity in the odds ratios between trials. Mean(s.d.) aneurysm diameter was 8.2(1.9) cm and the overall in-hospital mortality rate was 34.8 per cent. There was no significant effect modification with age or Hardman index, but there was indication of an early benefit from an endovascular strategy for women. Discharge from the primary hospital was faster after endovascular repair (hazard ratio 1.24, 95 per cent c.i. 1.04 to 1.47). For open repair, 30-day mortality diminished with increasing aneurysm neck length (adjusted odds ratio 0.69 (95 per cent c.i. 0.53 to 0.89) per 15 mm), but aortic diameter was not associated with mortality for either type of repair. CONCLUSION: Survival to 90 days following an endovascular or open repair strategy is similar for all patients and for the restricted population anatomically suitable for endovascular repair. Women may benefit more from an endovascular strategy than men and patients are, on average, discharged sooner after endovascular repair.

Ruptured Aneurysm Trials: The Importance of Longer-term Outcomes and Meta-analysis for 1-year Mortality.

OBJECTIVE: To assess current knowledge for the management of ruptured abdominal aortic aneurysm (AAA), based on the 1-year outcomes of 3 recent randomised trials. METHODS: An individual patient data meta-analysis of three recent randomised trials of endovascular versus open repair, including 817 patients, was conducted according to a pre-specified analysis plan, report all-cause mortality and re-interventions at 1 year after the index event. RESULTS: Mortality across the 3 trials at 1-year was 38.6% for the EVAR or endovascular strategy patient groups and 42.8% for the open repair groups, pooled odds ratio 0.84 (95% CI 0.63-1.11), p = .209. There was no evidence of heterogeneity in the odds ratios between trials. When the patients in the endovascular strategy group of the IMPROVE trial were restricted to those with proven rupture who were anatomically suitable for endovascular repair, the pooled odds ratio reduced slightly to 0.80 (95% CI 0.56-1.16), p = .240. CONCLUSIONS: After 1 year there is a consistent but non-significant trend for lower mortality for EVAR or an endovascular strategy. Taken together with the recent gains in health economic outcomes demonstrated at 1 year in the IMPROVE trial, the evidence suggests that endovascular repair should be used more widely for ruptured aneurysms.