Time Dependent Correlation Between Sac Behaviour and Re-intervention after Endovascular Aneurysm Repair.

OBJECTIVE: This study aimed to investigate the correlation between aneurysm sac behaviour and time to re-intervention after endovascular aneurysm repair (EVAR). METHODS: A retrospective observational cohort study of patients who underwent EVAR at a single centre between January 2008 and November 2011 and who were followed up for a mean of 6.6 ± 2.9 years was conducted. Based on sac appearances on pre-operative imaging and imaging at the end of follow up, patients were stratified into two groups: (1) sac regression; and (2) no sac regression. The no sac regression group was further subdivided into stable sac group and sac expansion group. Sac regression and expansion throughout follow up were defined as a decrease or increase in the abdominal aortic aneurysm sac diameter of ≥ 5 mm compared with the pre-operative size. A Cox proportional hazards model using multiple failure per subject data was used to identify sac behaviour as a predictor of re-intervention free time. RESULTS: Patients with sac regression had a higher probability of freedom from re-intervention compared with those with a stable or expanding aneurysm sac (94%, 57%, and 16% at 12 years, respectively; log rank, p < .001). Mean time to re-intervention was 11.3 years for the sac regression group, 8.8 years for the stable sac group, and 5.0 years for the sac expansion group (p < .001). In the stable sac group, the risk of re-intervention increased sharply six years after EVAR, whereas in the sac expansion group a sharp rise in re-intervention was noted 3.5 years after EVAR, reaching a plateau after year 6. CONCLUSION: A time dependent correlation between aneurysm sac behaviour and re-intervention was found. Such findings have implications for surveillance strategies.

Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms.

OBJECTIVE: The European Society for Vascular Surgery (ESVS) has developed clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries in succession to the 2011 and 2019 versions, with the aim of assisting physicians and patients in selecting the best management strategy. METHODS: The guideline is based on scientific evidence completed with expert opinion on the matter. By summarising and evaluating the best available evidence, recommendations for the evaluation and treatment of patients have been formulated. The recommendations are graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C mark the level of evidence. RESULTS: A total of 160 recommendations have been issued on the following topics: Service standards, including surgical volume and training; Epidemiology, diagnosis, and screening; Management of patients with small abdominal aortic aneurysm (AAA), including surveillance, cardiovascular risk reduction, and indication for repair; Elective AAA repair, including operative risk assessment, open and endovascular repair, and early complications; Ruptured and symptomatic AAA, including peri-operative management, such as permissive hypotension and use of aortic occlusion balloon, open and endovascular repair, and early complications, such as abdominal compartment syndrome and colonic ischaemia; Long term outcome and follow up after AAA repair, including graft infection, endoleaks and follow up routines; Management of complex AAA, including open and endovascular repair; Management of iliac artery aneurysm, including indication for repair and open and endovascular repair; and Miscellaneous aortic problems, including mycotic, inflammatory, and saccular aortic aneurysm. In addition, Shared decision making is being addressed, with supporting information for patients, and Unresolved issues are discussed. CONCLUSION: The ESVS Clinical Practice Guidelines provide the most comprehensive, up to date, and unbiased advice to clinicians and patients on the management of abdominal aorto-iliac artery aneurysms.

Systematic Review and Meta-Analysis of the Effect of Anticoagulation on Outcomes After Endovascular Aneurysm Repair.

PURPOSE: Our objective was to investigate whether patients who receive anticoagulation therapy have different outcomes after endovascular aneurysm repair (EVAR) from those who do not. MATERIALS AND METHODS: We conducted a systematic review of studies that compared outcomes of EVAR in patients who were on therapeutic anticoagulation vs those who were not. We developed and reported the review in accordance with the PRISMA guidelines with a registered protocol (CRD42022375894). The Ovid interface was used to search Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database (EMBASE), and Cochrane Central Register of Controlled Trials (CENTRAL) up to November 2022. The quality of studies was assessed with the Newcastle-Ottawa Scale (NOS) (maximum score=9), and the evidence was appraised with the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework. The hazard ratio (HR) and 95% confidence interval (CI) was the effect estimate in time-to-event meta-analyses, calculated using the inverse-variance statistical method and random-effects models. RESULTS: Sixteen studies qualified for inclusion reporting a total of 35 739 individuals. Anticoagulated patients had a statistically significantly higher hazard of death (HR=1.93, 95% CI=1.03-3.63), endoleak (HR=2.13, 95% CI=1.55-2.93), reintervention (HR=1.79, 95% CI=1.27-2.52), and aneurysm sac expansion (HR=2.72, 95% CI=1.57-4.72) than patients not receiving anticoagulation therapy. The median score on the NOS was 7 (range=4-9). The certainty of evidence was very low for mortality and reintervention and low for endoleak and sac expansion. CONCLUSIONS: Anticoagulation is a poor prognostic factor after standard EVAR and should be considered in decision-making, consent processes, and surveillance strategies. CLINICAL IMPACT: The number of individuals who take anticoagulation treatment has been rapidly increasing over the recent years. We aimed to investigate the effect of such treatment on outcomes after endovascular aneurysm repair (EVAR). Anticoagulated patients were found to have increased mortality, endoleak, and reintervention rates after EVAR compared to their non-anticoagulated counterparts. Anticoagulation therapy has a prognostic role in EVAR and should be considered in decision making and EVAR surveillance. Anticoagulated patients need to be informed of the higher failure rates of EVAR, and intensified surveillance strategies may need to be implemented in this patient cohort.

Systematic Review With Meta-Analysis of Endovascular Versus Open Repair of Abdominal Aortic Aneurysm Repair in the Young.

PURPOSE: The purpose of this study was to investigate which treatment method for abdominal aortic aneurysm (AAA), endovascular or open repair, has better outcomes in young patients. MATERIALS AND METHODS: A systematic review was conducted to identify observational studies or randomized controlled trials (RCTs) that compared endovascular and open repair of intact AAA in young patients. MEDLINE, EMBASE, and CENTRAL were searched up to March 2022 using the Ovid interface. The risk of bias was assessed with the Newcastle-Ottawa scale (NOS), with a maximum score of 9, or version 2 of the Cochrane risk of bias tool. The certainty of evidence was assessed with the GRADE framework. Primary outcomes were perioperative, overall, and aneurysm-related mortality. Secondary outcomes were reintervention, hospital length of stay, and perioperative complications. Effect measures in syntheses were the odds ratio (OR), risk difference (RD), mean difference (MD), or hazard ratio (HR) and were calculated with the Mantel-Haenszel or inverse variance statistical method and random-effects models. RESULTS: Fifteen observational studies and 1 RCT were included, reporting a total of 48 976 young patients. Definitions of young ranged from 60 to 70 years. The median score on the NOS was 8 (range: 4-9), and the RCT was judged to be high risk of bias. The perioperative mortality was lower after EVAR (RD: -0.01, 95% CI: -0.02 to -0.00), but the overall and aneurysm-related mortality was not significantly different between EVAR and open repair (HR: 1.38, 95% CI: 0.81 to 2.33; HR: 4.68, 95% CI: 0.71 to 31.04, respectively), as was the hazard of reintervention (HR: 1.50, 95% CI: 0.88 to 2.56). The hospital length of stay was shorter after EVAR (MD: -4.44 days, 95% CI: -4.79 to -4.09), and the odds of cardiac (OR: 0.22, 95% CI: 0.13 to 0.35), respiratory (OR: 0.17, 95% CI: 0.11 to 0.26), and bleeding complications were lower after EVAR (OR: 0.26, 95% CI: 0.11 to 0.64). The level of evidence was low or very low. CONCLUSION: Patient preferences and perspectives should be considered during shared decision-making process considering the available evidence. EVAR may be considered in young and fit patients with a suitable anatomy. PROTOCOL REGISTRATION: PROSPERO, CRD42022325051. CLINICAL IMPACT: Uncertainty surrounds the optimal treatment strategy for abdominal aortic aneurysm in young patients. Meta-analysis of some 48,976 young patients showed that endovascular aneurysm repair (EVAR) has a lower perioperative mortality and morbidity and a shorter hospital and intensive care unit stay than open surgical repair, but the overall and aneurysm-related mortality in the short to medium term are not significantly different between EVAR and open repair. EVAR can be considered in young patients.

A Statistical Shape Model of Infrarenal Aortic Necks in Patients With and Without Late Type Ia Endoleak After Endovascular Aneurysm Repair.

PURPOSE: Hostile aortic neck characteristics, including short length, severe suprarenal and infrarenal angulation, conicity, and large diameter, have been associated with increased risk for type Ia endoleak (T1aEL) after endovascular aneurysm repair (EVAR). This study investigates the mid-term discriminative ability of a statistical shape model (SSM) of the infrarenal aortic neck morphology compared with or in combination with conventional measurements in patients who developed T1aEL post-EVAR. MATERIALS AND METHODS: The dataset composed of EVAR patients who developed a T1aEL during follow-up and a control group without T1aEL. Principal component (PC) analysis was performed using a parametrization to create an SSM. Three logistic regression models were created. To discriminate between patients with and without T1aEL, sensitivity, specificity, and the area under the receiver operating characteristic (ROC) curve (AUC) were calculated. RESULTS: In total, 126 patients (84% male) were included. Median follow-up time in T1aEl group and control group was 52 (31, 78.5) and 51 (40, 62.5) months, respectively. Median follow-up time was not statistically different between the groups (p=0.72). A statistically significant difference between the median PC scores of the T1aEL and control groups was found for the first, eighth, and ninth PC. Sensitivity, specificity, and AUC values for the SSM-based versus the conventional measurements-based logistic regression models were 79%, 70%, and 0.82 versus 74%, 73%, and 0.85, respectively. The model of the SSM and conventional measurements combined resulted in sensitivity, specificity, and AUC of 81%, 81%, and 0.92. CONCLUSION: An SSM of the infrarenal aortic neck determines its 3-dimensional geometry. The SSM is a potential valuable tool for risk stratification and T1aEL prediction in EVAR. The SSM complements the conventional measurements of the individual preoperative infrarenal aortic neck geometry by increasing the predictive value for late type Ia endoleak after standard EVAR. CLINICAL IMPACT: A statistical shape model (SSM) determines the 3-dimensional geometry of the infrarenal aortic neck. The SSM complements the conventional measurements of the individual pre-operative infrarenal aortic neck geometry by increasing the predictive value for late type Ia endoleaks post-EVAR. The SSM is a potential valuable tool for risk stratification and late T1aEL prediction in EVAR and it is a first step toward implementation of a treatment planning support tool in daily clinical practice.

Editor's Choice - Meta-Analysis of Compliance with Endovascular Aneurysm Repair Surveillance: The EVAR Surveillance Paradox.

OBJECTIVE: To compare the survival of patients who attended surveillance after endovascular aneurysm repair (EVAR) with those who were non-compliant. DATA SOURCES: MEDLINE and Embase were searched using the Ovid interface. REVIEW METHODS: A systematic review was conducted complying with the PRISMA guidelines. Eligible studies compared survival in EVAR surveillance compliant patients with non-compliant patients. Non-compliance was defined as failure to attend at least one post-EVAR follow up. The risk of bias was assessed with the Newcastle-Ottawa scale, and the certainty of evidence using the GRADE framework. Primary outcomes were survival and aneurysm related death. Effect measures were the hazard ratio (HR) or odds ratio (OR) and 95% confidence interval (CI) calculated using the inverse variance or Mantel-Haenszel statistical method and random effects models. RESULTS: Thirteen cohort studies with a total of 22 762 patients were included. Eight studies were deemed high risk of bias. The pooled proportion of patients who were non-compliant with EVAR surveillance was 43% (95% CI 36 - 51). No statistically significant difference was found in the hazard of all cause mortality (HR 1.04, 95% CI 0.61 - 1.77), aneurysm related mortality (HR 1.80, 95% CI 0.85-3.80), or secondary intervention (HR 0.66, 95% CI 0.31 - 1.41) between patients who had incomplete and complete follow up after EVAR. The odds of aneurysm rupture were lower in non-compliant patients (OR 0.63, 95% CI 0.39 - 1.01). The certainty of evidence was very low for all outcomes. Subgroup analysis for patients who had no surveillance vs. those with complete surveillance showed no significant difference in all cause mortality (HR 1.10, 95% CI 0.43 - 2.80). CONCLUSION: Patients who were non-compliant with EVAR surveillance had similar survival to those who were compliant. These findings question the value of intense surveillance in all patients post-EVAR and highlight the need for further research on individualised or risk adjusted surveillance.

Systematic Review of the Effect of Cerebrospinal Fluid Drainage on Outcomes After Endovascular Descending Thoracic/Thoraco-Abdominal Aortic Aneurysm Repair.

OBJECTIVE: This study aimed to investigate whether prophylactic use of cerebrospinal fluid (CSF) drainage in endovascular descending thoracic aortic aneurysm (DTAA) and thoraco-abdominal aortic aneurysm (TAAA) repair contributes to a lower rate of post-operative spinal cord ischaemia (SCI). DATA SOURCES: MEDLINE, Embase, and CINAHL. REVIEW METHODS: A literature review was conducted in accordance with PRISMA guidelines (PROSPERO registration no. CRD42021245893). Risk of bias was assessed through the Newcastle-Ottawa scale (NOS), and the certainty of evidence was graded using the GRADE approach. A proportion meta-analysis was conducted to calculate the pooled rate and 95% confidence interval (CI) of both early and late onset SCI. Pooled outcome estimates were calculated using the odds ratio (OR) and associated 95% CI. The primary outcome was SCI, both early and lateonset. Secondary outcomes were complications of CSF drainage, length of hospital stay, and peri-operative (30 day or in hospital) mortality rates. RESULTS: Twenty-eight observational, retrospective studies were included, reporting 4 814 patients (2 599 patients with and 2 215 without CSF drainage). The NOS showed a moderate risk of bias. The incidence of SCI was similar in patients with CSF drainage (0.05, 95% CI 0.03 ‒ 0.08) and without CSF drainage (0.05, 95% CI 0.00 ‒ 0.14). No significant decrease in SCI was found when using CSF drainage (OR 0.67, 95% CI 0.29 ‒ 1.55, p = .35). The incidence rate of CSF drainage related complication was 0.10 (95% CI 0.04 ‒ 0.19). The 30 day and in hospital mortality rate with CSF drainage was 0.08 (95% CI 0.05 ‒ 0.12). The 30 day and in hospital mortality rate without CSF drainage and comparison with late mortality and length of hospital stay could not be determined due to lack of data. The quality of evidence was considered very low. CONCLUSION: Pre-operative CSF drainage placement was not related to a favourable outcome regarding SCI rate in endovascular TAAA and DTAA repair. Due to the low quality of evidence, no clear recommendation on pre-operative use of CSF drainage placement can be made.

Pre-Emptive Embolization of the Aneurysm Sac or Aortic Side Branches in Endovascular Aneurysm Repair: Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Trials.

BACKGROUND: To investigate outcomes of pre-emptive embolization of the aneurysm sac or aortic side branches in endovascular aneurysm repair (EVAR). METHODS: The review was reported as per Preferred Reporting Items for Systematic reviews and Meta-Analyses 2020 with a preregistered protocol. Bibliographic sources (MEDLINE, Embase, and CENTRAL) were searched using subject headings and free text terms. Randomized controlled trials comparing EVAR with versus without embolization were included. Pooled estimates of dichotomous outcomes were calculated using odds ratio (OR) or risk difference (RD) and 95% confidence interval (CI) applying the Mantel-Haenszel method. Continuous outcomes were summarized using mean difference (MD) and 95% CI applying the inverse variance method. The certainty of evidence was appraised with the Grading of Recommendations Assessment, Development, and Evaluation framework. Version 2 of the Cochrane tool was used to assess the risk of bias. Trial sequential analysis assumed alpha = 5% and power = 80%. RESULTS: Four randomized controlled trials were included. No significant difference was found in aneurysm-related mortality (RD 0.00, 95% CI -0.03 to 0.03), overall mortality (OR 1.85, 95% CI 0.42-8.13), aneurysm rupture (RD 0.00, 95% CI -0.03 to 0.03), type II endoleak-related reintervention (RD -0.07, 95% CI -0.21 to 0.06), procedure time (MD 20.12, 95% CI -11.54 to 51.77), or fluoroscopy time (MD 11.17, 95% CI -11.22 to 33.56). Patients with pre-emptive embolization had significantly lower odds of type II endoleak (OR 0.45, 95% CI 0.26-0.78) and sac expansion (OR 0.19, 95% CI 0.07-0.52). The risk of bias was high for all outcomes. The certainty of evidence was very low for all outcomes, except for type II endoleak, for which it was low. Trial sequential analysis showed an inconclusive result for overall mortality and type II endoleak-related reintervention but confirmed the advantage of embolization in reducing type II endoleak and sac expansion. CONCLUSIONS: Limited, low certainty data suggest pre-emptive embolization confers no clinical benefits in EVAR.

Echocardiographic Changes in Cardiac Function After Thoracic Endovascular Aortic Repair: A Systematic Review and Meta-Analysis.

BACKGROUND: Evidence suggests thoracic stent grafts increase the aortic stiffness postimplantation. Our objective was to examine the effect of thoracic aortic stenting on heart function, as demonstrated with echocardiography. METHODS: We considered nonrandomized studies examining echocardiographic parameters (left ventricle ejection fraction (LVEF), left ventricle end-diastolic (LVED) and end-systolic diameter (LVESD), posterior wall thickness (LVPWT), interventricular septal thickness (IVST), mass, and mass index) pre and poststent graft implantation in patients with thoracic aortic diseases (aneurysm, dissection, and blunt injury). MEDLINE and CENTRAL were searched (up to March 2021) for eligible studies. The National Institutes of Health Quality Assessment Tool was used for risk of bias assessment. Echocardiographic data pre and postimplantation were compared using the pooled standardized mean difference (SMD) and 95% confidence interval (CI). RESULTS: Four studies were included in the meta-analysis. Three of the studies were judged to be "good" quality and one "fair". Nonsignificant differences pre and postimplantation were found for ejection fraction (SMD = -0.53, 95% CI = -1.8 to 0.728, P = 0.406), IVST (SMD = -0.79, 95%, CI = -3.25 to 1.66, P = 0.52), EDD (SMD = -0.10, 95% CI = -0.48 to 0.28, P = 0.60), ESD (SMD = -0.66, 95% CI = -2.35 to 1.02, P = 0.44), and PWT (SMD = -2.20, 95% CI = -5.89 to 1.47, P = 0.24). A trend toward an increase in mass postimplantation was found (SMD = 0.28, 95%, CI = -0.03 to 0.60, P = 0.08), but there was no significant difference in mass index (SMD = 0, 95%, CI = -0.195 to 0.195, P = 1). CONCLUSIONS: Thoracic aortic stenting does not appear to significantly impact cardiac physiology as indicated by echocardiographic parameters.

Updated guideline for closure of abdominal wall incisions from the European and American Hernia Societies.

BACKGROUND: Incisional hernia is a frequent complication of abdominal wall incision. Surgical technique is an important risk factor for the development of incisional hernia. The aim of these updated guidelines was to provide recommendations to decrease the incidence of incisional hernia. METHODS: A systematic literature search of MEDLINE, Embase, and Cochrane CENTRAL was performed on 22 January 2022. The Scottish Intercollegiate Guidelines Network instrument was used to evaluate systematic reviews and meta-analyses, RCTs, and cohort studies. The GRADE approach (Grading of Recommendations, Assessment, Development and Evaluation) was used to appraise the certainty of the evidence. The guidelines group consisted of surgical specialists, a biomedical information specialist, certified guideline methodologist, and patient representative. RESULTS: Thirty-nine papers were included covering seven key questions, and weak recommendations were made for all of these. Laparoscopic surgery and non-midline incisions are suggested to be preferred when safe and feasible. In laparoscopic surgery, suturing the fascial defect of trocar sites of 10 mm and larger is advised, especially after single-incision laparoscopic surgery and at the umbilicus. For closure of an elective midline laparotomy, a continuous small-bites suturing technique with a slowly absorbable suture is suggested. Prophylactic mesh augmentation after elective midline laparotomy can be considered to reduce the risk of incisional hernia; a permanent synthetic mesh in either the onlay or retromuscular position is advised. CONCLUSION: These updated guidelines may help surgeons in selecting the optimal approach and location of abdominal wall incisions.

An incisional hernia results from a weakness of the abdominal wall muscles that allows fat from the inside or organs to bulge out. These hernias are quite common after abdominal surgery at the site of a previous incision. There is research that discusses different ways to close an incision and this may relate to the chance of hernia formation. The aim of this study was to review the latest research and to provide a guide for surgeons on how best to close incisions to decrease hernia rates. When possible, surgery through small incisions may decrease the risk of hernia formation. If small incisions are used, it may be better if they are placed away from areas that are already weak (such as the belly button). If the incision is larger than 1 cm, it should be closed with a deep muscle-fascia suture in addition to skin sutures. If there is a large incision in the middle of the abdomen, the muscle should be sutured using small stitches that are close together and a slowly absorbable suture should be used. For patients who are at higher risk of developing hernias, when closing the incision, the muscle layer can be strengthened by using a piece of (synthetic) mesh. There is no good research available on recovery after surgery and no clear guides on activity level or whether a binder will help prevent hernia formation.

Treatment Strategies for Proximal Deep Vein Thrombosis: A Network Meta-analysis of Randomised Controlled Trials.

OBJECTIVE: To investigate the outcomes of treatment strategies for proximal and iliofemoral deep vein thrombosis (DVT). METHODS: Randomised controlled trials (RCTs) investigating outcomes of catheter directed thrombolysis (CDT), ultrasound assisted CDT (USCDT), percutaneous aspiration thrombectomy (PAT), and best medical therapy (BMT) for proximal DVT from 2000 onwards were considered. MEDLINE, EMBASE, and CINAHL were searched using the Healthcare Databases Advanced Search interface developed by the National Institute for Health and Care Excellence. The primary outcome was the rate of post-thrombotic syndrome (PTS), which was defined using the Villalta scoring system (score of ≥5). Secondary outcomes included vessel patency, recurrence, bleeding, and mortality. The network of evidence was summarised using network plots, and random effects network meta-analyses were performed. The certainty of evidence was assessed using the Certainty In Network Meta-Analysis (CINeMA) approach. RESULTS: Seven RCTs meeting the inclusion criteria were identified. There were direct comparisons between medical therapy, CDT, and USCDT across outcomes, except for patency. There were no direct comparisons between medical therapy and PAT (except for patency), and USCDT and PAT. There was no significant difference observed in PTS between the treatment modalities for proximal and iliofemoral DVT (low certainty). There was a significant difference in patency rates between medical therapy and USCDT (odds ratio [OR] 9.46, 95% confidence interval [CI] 3.05 - 29.35; low certainty) and CDT (OR 2.03, 95% CI 1.46 - 2.80; low certainty) in favour of USCDT and CDT, respectively, for proximal DVT. USCDT significantly improved patency rates compared with CDT (OR 4.67, 95% CI 1.58 - 13.81; very low certainty) for proximal DVT. There was no significant difference in DVT recurrence, bleeding, or mortality between treatment groups for proximal and iliofemoral DVT (low to moderate certainty for most comparisons). CONCLUSION: USCDT may improve patency rates compared with BMT and the other interventional treatment modalities used for the management of proximal DVT. However, no treatment modality showed superiority with regard to a reduction in PTS, and overall, the quality of available evidence is poor.

Editor's Choice - Endovascular Aneurysm Repair in High Risk Patients: A Systematic Review and Meta-Analysis.

OBJECTIVE: To investigate outcomes of endovascular aneurysm repair (EVAR) in high risk patients. METHODS: Bibliographic sources (MEDLINE, EMBASE, CINAHL, and CENTRAL) were searched using combinations of thesaurus and free text terms. The review protocol was registered in PROSPERO (CRD42021287207) and reported according to PRISMA 2020. Pooled estimates were calculated using odds ratio (OR) or hazard ratio (HR) and 95% confidence interval (CI) applying the Mantel-Haenszel or inverse variance method. EVAR peri-operative mortality in high risk patients over time was examined with mixed effects meta-regression. The GRADE framework was used to rate the certainty of evidence. RESULTS: The pooled peri-operative mortality in 18 416 high risk patients who underwent EVAR was 3% (95% CI 2.3 - 4%) and has significantly reduced over time (year of publication p = .003; median study point p = .023). The peri-operative mortality was significantly lower in high risk patients treated with EVAR compared with open repair (OR 0.64; 95% CI 0.45 - 0.92), but no significant difference was found in overall (HR 1.06; 95% CI 0.76 - 1.49) or aneurysm related mortality (HR 0.57; 95% CI 0.21 - 1.55). No significant difference was found in overall mortality between high risk patients treated with EVAR vs. no intervention (HR 0.42; 95% CI 0.14 - 1.26), but the aneurysm related mortality was significantly lower in the former (HR 0.30; 95% CI 0.14 - 0.63). The peri-operative mortality was higher in high risk than normal risk patients treated with EVAR (OR 2.33; 95% CI 1.75 - 3.10), as was the overall mortality (HR 3.50; 95% CI 2.55 - 4.80). The certainty of evidence was very low for EVAR vs. open surgery or no intervention and low for high vs. normal risk patients. CONCLUSION: The EVAR peri-operative mortality in high risk patients has improved over time. Even though the aneurysm related mortality of EVAR is lower compared with no intervention, EVAR may confer no overall survival benefit.

Editor's Choice - European Society for Vascular Surgery Clinical Practice Guideline Development Scheme: An Overview of Evidence Quality Assessment Methods, Evidence to Decision Frameworks, and Reporting Standards in Guideline Development.

OBJECTIVE: A structured and transparent approach is instrumental in translating research evidence to health recommendations and evidence informed clinical decisions. The aim was to conduct an overview and analysis of principles and methodologies for health guideline development. METHODS: A literature review on methodologies, strategies, and fundamental steps in the process of guideline development was performed. The clinical practice guideline development process and methodology adopted by the European Society for Vascular Surgery are also presented. RESULTS: Sophisticated methodologies for health guideline development are being applied increasingly by national and international organisations. Their overarching principle is a systematic, structured, transparent, and iterative process that is aimed at making well informed healthcare choices. Critical steps in guideline development include the assessment of the certainty of the body of evidence; evidence to decision frameworks; and guideline reporting. The goal of strength of evidence assessments is to provide well reasoned judgements about the guideline developers' confidence in study findings, and several evidence hierarchy schemes and evidence rating systems have been described for this purpose. Evidence to decision frameworks help guideline developers and users conceptualise and interpret the construct of the quality of the body of evidence. The most widely used evidence to decision frameworks are those developed by the GRADE Working Group and the WHO-INTEGRATE, and are structured into three distinct components: background; assessment; and conclusions. Health guideline reporting tools are employed to ensure methodological rigour and transparency in guideline development. Such reporting instruments include the AGREE II and RIGHT, with the former being used for guideline development and appraisal, as well as reporting. CONCLUSION: This guide will help guideline developers/expert panels enhance their methodology, and patients/clinicians/policymakers interpret guideline recommendations and put them in context. This document may be a useful methodological summary for health guideline development by other societies and organisations.

AGREE-S: AGREE II extension for surgical interventions: appraisal instrument.

BACKGROUND: The Appraisal of Guidelines Research and Evaluation (AGREE) II instrument was developed to evaluate the quality of clinical practice guidelines. Evidence suggests that development, reporting, and appraisal of guidelines on surgical interventions may be better informed by modification of the instrument. OBJECTIVE: We aimed to develop an AGREE II extension specifically designed for appraisal of guidelines of surgical interventions. METHODS: In a three-part project funded by the United European Gastroenterology and the European Association for Endoscopic Surgery, (i) we identified factors that were associated with higher quality of surgical guidelines, (ii) we statistically calibrated the AGREE II instrument in the context of surgical guidelines using correlation, reliability, and factor analysis, and (iii) we undertook a Delphi consensus process of stakeholders to inform the development of an AGREE II extension instrument for surgical interventions. RESULTS: Several features were prioritized by stakeholders as of particular importance for guidelines of surgical interventions, including development of a guideline protocol, consideration of practice variability and surgical expertise in different settings, and specification of infrastructures required to implement the recommendations. The AGREE-S-AGREE II extension instrument for surgical interventions has 25 items, compared to the 23 items of the original AGREE II instrument, organized into the following 6 domains: Scope and purpose, Stakeholders, Evidence synthesis, Development of recommendations, Editorial independence, and Implementation and update. As the original instrument, it concludes with an overall appraisal of the quality of the guideline and a judgement on whether the guideline is recommended for use. Several items were amended and rearranged among domains, and an item was deleted. The Rigor of Development domain of the original AGREE II was divided into Evidence Synthesis and Development of Recommendations. Items of the AGREE II domain Clarity of Presentation were incorporated in the new domain Development of Recommendations. Three new items were introduced, addressing the development of a guideline protocol, support by a guideline methodologist, and consideration of surgical experience/expertise. CONCLUSION: The AGREE-S appraisal instrument has been developed to be used for assessment of the methodological and reporting quality of guidelines on surgical interventions.

Meta-Analysis of the Crossed Versus Standard Limb Configuration in Endovascular Aneurysm Repair.

OBJECTIVE: To investigate whether the crossed-limb technique confers better or worse clinical outcomes compared to the standard straight limb configuration in standard endovascular aneurysm repair (EVAR). METHODS: We conducted a systematic review to identify studies comparing outcomes of EVAR with the crossed versus standard limb configuration. MEDLINE, EMBASE, CINAHL, and CENTRAL were searched in March 2021 using the Healthcare Databases Advanced Search interface developed by the National Institute for Heath and Care Excellence. The risk of bias was assessed with the Newcastle-Ottawa scale (NOS) and the Risk Of Bias In Non-randomized Studies - of Interventions (ROBINS-I) tool. Summary estimates were calculated using the odds ratio (OR), risk difference (RD), or mean difference (MD) and 95% confidence interval (CI), applying the Mantel-Haenszel or inverse variance statistical method. Random-effects models were employed. RESULTS: Four observational studies qualified for inclusion, reporting a total of 1132 patients. All presented contemporary experiences. Baseline clinical characteristics were largely similar between patients with and without the crossed-limb configuration, but the anatomy tended to be less favourable in patients treated with the crossed-limb technique. No statistically significant difference was found in the primary outcomes: limb occlusion (OR 1.44, 95% CI 0.65 - 3.19), type Ib endoleak (RD 0.01, 95% CI -0.03 - 0.04), type III endoleak (RD 0.01, 95% CI -0.01 - 0.03); or secondary outcomes: perioperative mortality (RD 0.00, 95% CI -0.03 - 0.03), type Ia endoleak (RD 0.00, 95% CI -0.03 - 0.02), type II endoleak (OR 1.38, 95% CI 0.51 - 3.74), procedure duration (MD 18.07 min, 95% CI -1.14-37.29). Inconsistency across studies was low for all outcomes. The studies were judged to be of high quality on the NOS. The main bias identified using the ROBINS-I tool was due to confounding. CONCLUSIONS: The crossed-limb technique was not found to confer inferior clinical outcomes in the medium term compared to the standard limb configuration in patients who undergo standard EVAR.

A comparison of endovascular versus open repair for ruptured abdominal aortic aneurysm - Meta-analysis of propensity score-matched data.

BACKGROUND: Optimal management of ruptured abdominal aortic aneurysms (rAAA) has been heavily debated in the literature. The aim of this review is to assess comparative outcomes from propensity-matched studies of endovascular versus open for rAAA. METHODS: Electronic databases (MEDLINE and Embase) were searched in January 2021 using the Healthcare Databases Advanced Search interface. Eligible studies compared endovascular versus open repair for rAAA using propensity-matched cohorts. Pooled estimates of perioperative outcomes were calculated using odds ratio (OR) or mean difference (MD) and 95% confidence interval (CI) using the random-effects model. Time-to-event data meta-analysis was conducted using the inverse-variance method and reported as summary hazard ratio (HR) and associated 95% CI. The quality of evidence was graded using a system developed by the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) working group. RESULTS: Six studies published between 2010 and 2020 were selected for qualitative and quantitative synthesis, reporting a total of 6731 patients. The odds of perioperative mortality after endovascular aneurysm repair (EVAR) were significantly lower than after open surgical repair (OSR) (OR 0.52, 95% CI 0.41-0.65). The hazard of overall mortality during follow-up was lower, although not significantly, after EVAR than after OSR (HR 0.79, 95% CI 0.62-1.01). The odds of acute kidney injury and early aneurysm-related reintervention were both significantly lower after EVAR than after OSR (OR 0.34, 95% CI 0.14-0.78 and OR 0.57, 95% CI 0.33-0.98, respectively). Patients treated with EVAR stayed in hospital for significantly less time than those treated with OSR (MD -5.13, 95% CI -7.94 to -2.32). The certainty of the body of evidence for perioperative mortality was low and for overall mortality was very low. CONCLUSION: The evidence suggests that EVAR confers a significant benefit on perioperative mortality.

Time-to-event data meta-analysis of late outcomes of endovascular versus open repair for ruptured abdominal aortic aneurysms.

OBJECTIVE: We investigated whether the well-documented perioperative survival advantage of emergency endovascular aneurysm repair (EVAR) compared with open repair would be sustained during follow-up. METHODS: A systematic review conforming to the PRISMA (preferred reporting items for systematic reviews and meta-analyses) statement standards was conducted to identify studies that had reported the follow-up outcomes of endovascular vs open repair for ruptured abdominal aortic aneurysms. Electronic bibliographic sources (MEDLINE [medical literature analysis and retrieval system online], Embase [Excerpta Medica database], CINAHL [cumulative index to nursing and allied health literature], and CENTRAL [Cochrane central register of controlled trials]) were interrogated using the Healthcare Databases Advanced Search interface (National Institute for Health and Care Excellence, London, United Kingdom). A time-to-event data meta-analysis was performed using the inverse variance method, and the results were reported as summary hazard ratios (HRs) and associated 95% confidence intervals (CIs). Mixed effects regression was applied to investigate the outcome changes over time. The quality of the body of evidence was appraised using the GRADE (grades of recommendation, assessment, development, and evaluation) system. RESULTS: Three randomized controlled trials and 22 observational studies reporting a total of 31,383 patients were included in the quantitative synthesis. The mean follow-up duration across the studies ranged from 232 days to 4.9 years. The overall all-cause mortality was significantly lower after EVAR than after open repair (HR, 0.79; 95% CI, 0.73-0.86). However, the postdischarge all-cause mortality was not significantly different (HR, 1.10; 95% CI, 0.85-1.43). The aneurysm-related mortality, which was reported by one randomized controlled trial, was not significantly different between EVAR and open repair (HR, 0.89; 95% CI, 0.69-1.15). Meta-regression showed the mortality difference in favor of EVAR was more pronounced in more recent studies (P = .069) and recently treated patients (P = .062). The certainty for the body of evidence for overall and postdischarge all-cause mortality was judged to be low and that for aneurysm-related mortality to be high. CONCLUSIONS: EVAR showed a sustained mortality benefit during follow-up compared with open repair. A wider adoption of an endovascular-first strategy is justified.

Prognostic Role of Severe Infrarenal Aortic Neck Angulation in Endovascular Aneurysm Repair.

OBJECTIVE: To investigate whether patients with severe infrarenal aortic neck angulation have worse outcomes than those without severe angulation after endovascular aneurysm repair (EVAR). DATA SOURCES: The HDAS (Healthcare Database Advanced Search) interface developed by NICE (National Institute for Health and Care Excellence) was used to search electronic bibliographic databases. REVIEW METHODS: Studies comparing outcomes of standard EVAR in patients with and without severe neck angulation were considered. Pooled outcome estimates were calculated using the odds ratio (OR) or hazard ratio (HR) and 95% confidence interval (CI), using the Mantel-Haenszel or inverse variance method, as appropriate. Random effects models of meta-analysis were applied. The GRADE (Grading of Recommendation, Assessment, Development, and Evaluation) methodology was used to assess the certainty of evidence. RESULTS: Ten studies reporting a total of 7 371 patients (1 576 with severe neck angulation and 5 795 without) were included. The studies reported medium term follow up. No statistically significant difference was found for the primary outcomes (overall mortality: HR 1.27, 95% CI 0.88 - 1.85, low certainty; aneurysm related mortality: HR 1.07, 95% CI 0.80 - 1.44, moderate certainty; aneurysm rupture: HR 1.41, 95% CI 0.66 - 2.99, low certainty). The hazard of type Ia endoleak (HR 1.86, 95% CI 1.32 - 2.61) and re-intervention was higher in patient with severe angulation (HR 1.24, 95% CI 1.01 - 1.54), but there was no significant difference in the odds of adjunctive procedures (OR 1.23, 95% CI 0.48 - 3.11), or the hazard of sac expansion (HR 0.83, 95% CI 0.44 - 1.55) or stent migration (HR 1.22, 95% CI 0.78 - 1.92). Meta-analysis of studies that conducted multiple Cox regression analysis showed no significant difference for any of the primary outcomes. CONCLUSION: Severe neck angulation may not be a poor prognostic indicator for overall/aneurysm related mortality and rupture in the medium term after EVAR but may increase the risk of late type 1 endoleaks and re-intervention; therefore, patients require close surveillance.

Editor's Choice - Percutaneous Access Does Not Confer Superior Clinical Outcomes Over Cutdown Access for Endovascular Aneurysm Repair: Meta-Analysis and Trial Sequential Analysis of Randomised Controlled Trials.

OBJECTIVE: To investigate whether a percutaneous approach has better clinical outcomes than surgical access for standard endovascular repair of abdominal aortic aneurysms. DATA SOURCES: MEDLINE and Embase were searched using the Healthcare Databases Advanced Search interface developed by the National Institute for Health and Care Excellence. REVIEW METHODS: Randomised controlled trials (RCTs) that compared percutaneous and cutdown endovascular aneurysm repair (EVAR) were considered. Pooled effect estimates were calculated using the odds ratio (OR), risk difference, or mean difference (MD) and 95% confidence interval (CI). The Mantel-Haenszel or inverse variance statistical method was used as appropriate. Trial sequential analysis was performed to quantify the available evidence and control for the risk of type 1 and type 2 error. Risk of bias was assessed with the revised tool developed by Cochrane and the quality of evidence was graded using the GRADE system (Grades of Recommendation, Assessment, Development and Evaluation). RESULTS: Four RCTs were identified, reporting a total of 368 patients and 530 access sites. Meta-analysis showed no difference in access site complications or infection, post-operative bleeding/haematoma, access related arterial injury, femoral artery occlusion, pseudo-aneurysm, or peri-operative mortality between percutaneous and cutdown EVAR. Seroma/lymphorrhoea was significantly less frequent after percutaneous EVAR (0%) compared with cutdown EVAR (3%; OR 0.18 [95% CI 0.04-0.83]) and the procedure time was significantly shorter (MD -11.53 minutes; 95% CI -15.71-7.34), but hospital length of stay was not different between treatments. Neither the O'Brien-Fleming boundaries nor the futility boundaries were crossed by the cumulative Z curve, and the required information size was not reached for any of the outcomes. All trials were judged to be high risk of bias or have some concerns, and the level of the body of evidence was low or very low for all outcomes. CONCLUSION: The evidence is very uncertain about the effect of percutaneous EVAR on clinically important outcomes.

Editor's Choice - Systematic Review and Meta-Analysis of the Effect of Weekend Admission on Outcomes for Ruptured Abdominal Aortic Aneurysms: A Call for an Equitable Seven Day Vascular Service.

OBJECTIVE: "The weekend effect" of higher patient mortality when presenting at a weekend compared with a weekday has been established for several conditions. The aim of this study was to investigate whether a weekend effect exists for the emergency condition of ruptured abdominal aortic aneurysm. DATA SOURCES: A review of the literature was conducted in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines (PROSPERO registration number CRD42020157484). MEDLINE, EMBASE and CINAHL were searched using the Healthcare Databases Advanced Search interface developed by NICE. REVIEW METHODS: The prognostic factor of interest was weekend admission. The primary outcome of interest was all cause peri-operative mortality, with a secondary outcome of hospital length of stay. A random effects meta-analysis was performed, and the results were reported as summary odds ratio (OR) and 95% confidence interval (CI). RESULTS: Twelve observational cohort studies published between 2001 and 2019 comprising 14 patient cohorts with a total of 95 856 patients were eligible for quantitative synthesis. Patients presenting on a weekend had a significantly higher risk of unadjusted in hospital mortality (OR 1.20, 95% CI 1.10 - 1.31, p < .001). Both the unadjusted 30 day mortality risk (OR 1.16, 95% CI 0.98 - 1.39, p = .090) and unadjusted 90 day mortality risk (OR 1.12, 95% CI 0.90 - 1.40, p = .30) were higher for those presenting at a weekend, but neither reached statistical significance. There was a significantly greater risk of combined unadjusted in hospital, 30 and 90 day mortality for those presenting at a weekend (OR 1.17, 95% CI 1.09 - 1.27, p < .001). Hospital length of stay was not statistically different between groups. CONCLUSION: There is an association between weekend admission and higher mortality in patients presenting with ruptured abdominal aortic aneurysm.