Search

The morphology of infrarenal abdominal aortic aneurysms (AAAs) directly influences the perioperative outcome and long-term durability of endovascular aneurysm repair. A variety of methods have been proposed for the characterization of AAA morphology using reconstructed three-dimensional (3D) computed tomography (CT) images. At present, there is lack of consensus as to which of these methods is most applicable to clinical practice or research. The purpose of this review was to evaluate existing protocols that used 3D CT images in the assessment of various aspects of AAA morphology. An electronic search was performed, from January 1996 to the end of October 2010, using the Embase and Medline databases. The literature review conformed to PRISMA statement standards. The literature search identified 604 articles, of which 31 studies met inclusion criteria. Only 15 of 31 studies objectively assessed reproducibility. Existing published protocols were insufficient to define a single evidence-based methodology for preoperative assessment of AAA morphology. Further development and expert consensus are required to establish a standardized and validated protocol to determine precisely how morphology relates to outcomes after endovascular aneurysm repair. [ABSTRACT FROM AUTHOR]

Purpose: To examine the feasibility of an 'off-the-shelf' fenestrated endograft repository to broaden the applicability of fenestrated endovascular aneurysm repair (f-EVAR) to a greater number of emergent cases. Methods: Graft dimensions of 438 consecutive customized fenestrated endografts for juxtarenal aneurysms were obtained from the commercial manufacturer, classified into tolerance ranges, and encoded in a database for statistical analysis. Limits of variability for tolerance ranges were set to maintain target vessel patency within acceptable surgical limits at deployment. Key independent structural variables were identified and analyzed for trends. Detailed analysis was performed of 282 (64%) 3-fenestration endografts, representing 232 structurally unique grafts. Results: Seven key individual structural variables were identified, constituting 21,952 possible combinations. Only 8/232 (3.5%) graft configurations were compatible with greater than or equal to 3 patients. Nearly a third of the patients (86/282, 30.5%) were treated by a range of 36 customized endografts. Graft dimensions were not uniformly distributed; there were modal sizes that were likely to recur at a median 39 cases (95% CI 17-121). Deploying endografts incorporating double diameter-reducing tie technology increased the tolerance such that 28 grafts would treat 81% of this population. Conclusion: The current design of fenestrated stent-grafts means that an 'off-the-shelf' option is not practicable. However, there is evidence of recurrent patterns of morphology. Statistical modeling is capable of predicting demand for graft configurations. Innovations in f-EVAR endograft technology may decrease the required variability in graft morphology, paving the way for ready-to-deploy fenestrated stent-grafts. [ABSTRACT FROM AUTHOR]

Objective: Inconsistencies in outcome data of therapeutic strategies for acute lower limb ischaemia (ALI) have hindered the synthesis of findings. A core outcome set (COS) may offer a solution to this problem by defining a minimum set of outcomes that are considered essential to all stakeholders involved. The first step in developing a COS is to review the previously reported outcomes on various treatment strategies for ALI., Data Sources: PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science databases were searched from inception to August 2023., Review Methods: This systematic review was conducted in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) initiative framework, adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and was pre-registered with PROSPERO (CRD42022320073). Abstracts were independently screened by two authors for full text review. All outcomes and their definitions were extracted from selected papers. Outcomes with different terminologies were then categorised into an agreed outcome term. The list of agreed outcomes was given a standardised outcome domain and core area using a 38 item standardised taxonomy., Results: Of 6 184 articles identified, 176 relevant studies were included, yielding 1 325 verbatim outcomes. After deduplication, 72 unique verbatim outcomes were categorised into five broad outcome domains. Outcomes considered key to the evaluation of treatment of ALI were further categorised as delivery of care (19.4%), vascular outcomes (13.8%), and adverse events (12.5%). The three most frequently reported agreed outcomes were amputation (14.1%), death (12.3%), and general bleeding (11.6%)., Conclusion: This systematic review provides an overview of currently reported outcomes in the literature of interventions for ALI. After categorisation into agreed outcome terms, 72 outcomes were identified that can be used in the development of a COS., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: The contemporary burden of smoking in patients undergoing elective abdominal aortic aneurysm (AAA) repair in the UK is unknown. This study aimed to quantify the prevalence of smoking in patients undergoing AAA repair in the UK and determine the association between smoking and peri-operative outcomes., Methods: This was an observational cohort study. The National Vascular Registry was interrogated for adults undergoing elective infrarenal AAA repair from 2014 to 2021 for prevalence of current smokers, former smokers, and non-smokers over time. The primary outcomes were post-operative complications by smoking status. Secondary outcomes were variation in smoking rates over time and by hospital, in hospital mortality, and length of stay by smoking status. All analyses were adjusted using the validated British Aneurysm Repair score., Results: Overall, 26 916 patients undergoing elective AAA repair were included (21.9% smokers, 62.2% former smokers, 15.9% non-smokers). The prevalence of smoking did not change over time, with a 2.4 fold variation between UK hospitals (range 13.0 - 31.8% excluding outliers). In hospital mortality was not significantly different between smokers, former smokers, and non-smokers (p > .050 for all comparisons). Compared with non-smokers, smoking was associated with increased overall (odds ratio [OR] 1.40, 95% confidence interval [CI] 1.24 - 1.57) and respiratory complications (OR 1.98, 95% CI 1.63 - 2.39), limb ischaemia (OR 1.63, 95% CI 1.19 - 2.23), bowel ischaemia (OR 1.64, 95% CI 1.06 - 2.54), return to theatre (OR 1.38, 95% CI 1.11 - 1.71), and intensive care admission (OR 1.43, 95% CI 1.31 - 1.56). Compared with former smokers, smoking was associated with increased overall (OR 1.24, 95% CI 1.14 - 1.36), respiratory (OR 1.44, 95% CI 1.27 - 1.63) and limb ischaemia complications (OR 1.48, 95% CI 1.19 - 1.84), and intensive care admission (OR 1.37, 95% CI 1.28 - 1.46). On analysis of the endovascular aneurysm repair subgroup, active smoking was associated with significantly higher rates of limb ischaemia compared with former and non-smokers (OR 2.12, 95% CI 1.49 - 3.01 and OR 1.94, 95% CI 1.19 - 3.16 respectively)., Conclusion: The prevalence of smoking remains high in patients undergoing elective AAA repair with no evidence of a decline in active smokers from 2014 to 2021 compared with the general UK population. Smoking is associated with increased peri-operative complication rates., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Multiple disciplines are involved in the management of diabetes-related foot disease and a common vocabulary is essential for clear communication. Based on the systematic reviews of the literature that form the basis of the International Working Group on the Diabetic Foot (IWGDF) Guidelines, the IWGDF has developed a set of definitions and criteria for diabetes-related foot disease. This document describes the 2023 update of these definitions and criteria. We suggest these definitions be used consistently in both clinical practice and research, to facilitate clear communication with people with diabetes-related foot disease and between professionals around the world., (© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.)

Background: Revascularization is the primary treatment modality for chronic limb-threatening ischaemia (CLTI), but is not feasible in all patients. PLX-PAD is an off-the-shelf, placental-derived, mesenchymal stromal cell-like cell therapy. This study aimed to evaluate whether PLX-PAD would increase amputation-free survival in people with CLTI who were not candidates for revascularization., Methods: People with CLTI and minor tissue loss (Rutherford 5) who were unsuitable for revascularization were entered into a randomized, parallel-group, placebo-controlled, multinational, blinded, trial, in which PLX-PAD was compared with placebo (2 : 1 randomization), with 30 intramuscular injections (0.5 ml each) into the index leg on days 0 and 60. Planned follow-up was 12-36 months, and included vital status, amputations, lesion size, pain and quality-of-life assessments, haemodynamic parameters, and adverse events., Results: Of 213 patients enrolled, 143 were randomized to PLX-PAD and 70 to placebo. Demographics and baseline characteristics were balanced. Most patients were Caucasian (96.2%), male (76.1%), and ambulatory (85.9%). Most patients (76.6%) reported at least one adverse event, which were mostly expected events in CLTI, such as skin ulcer or gangrene. The probability of major amputation or death was similar for placebo and PLX-PAD (33 and 28.6% respectively; HR 0.93, 95% c.i. 0.53 to 1.63; P = 0.788). Revascularization and complete wound healing rates were similar in the two groups. A post hoc analysis of a subpopulation of 121 patients with a baseline haemoglobin A1c level below 6.5% showed improved 12-month amputation-free survival (HR 0.46, 0.21 to 0.99; P = 0.048)., Conclusion: Although there was no evidence that PLX-PAD reduced amputation-free survival in the entire study population, benefit was observed in patients without diabetes mellitus or whose diabetes was well controlled; this requires confirmation in further studies. Trial registration: NCT03006770 (http://www.clinicaltrials.gov); 2015-005532-18 (EudraCT Clinical Trials register - Search for 2015-005532-18)., (© The Author(s) 2024. Published by Oxford University Press on behalf of BJS Foundation Ltd.)

Objective: Endovascular technology innovation requires rigorous evaluation in high quality randomised controlled trials (RCTs). However, due to numerous methodological challenges, RCTs evaluating endovascular interventions are complex and potentially difficult to design, conduct, and report. This systematic review aimed to assess the quality of reporting of RCTs for endovascular interventions for lower limb peripheral arterial disease (PAD)., Data Sources and Review Methods: A systematic review of Medline, Embase, and the Cochrane Library databases from inception to December 2021 was performed to identify RCTs including participants with PAD undergoing any infrainguinal lower limb endovascular intervention. Study data were extracted and assessed against the Consolidating Standards of Reporting Trials extension for Non-Pharmacological Treatments (CONSORT-NPT) and the Template for Intervention Description and Replication (TIDieR) checklists. Descriptive statistics were used to summarise general study details and reporting standards of the trials., Results: After screening 6 567 abstracts and 526 full text articles, 112 eligible studies were identified, reporting on 228 different endovascular devices and techniques. Details judged sufficient to replicate the investigated intervention were provided for 47 (21%) interventions. It was unclear whether the description was reported with sufficient details in a further 56 (24%), and the description was judged inadequate in 125 (55%). Any intervention descriptions were provided for 184 (81%), with variable levels of detail (some in 134 [59%] and precise in 50 [22%]). Standardisation of intervention or some aspect of this was reported in 25 (22%) trials, but only one specified that adherence to the study protocol would be monitored., Conclusion: The quality of the reporting standards of RCTs investigating lower limb endovascular treatments is severely limited because the interventions are poorly described, standardised, and reported. PROSPERO registration number: CRD42022288214., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Objective: An increasing number of clinical practice guidelines (CPGs) have emerged over recent years. To have clinical utility, they need to be rigorously developed and scientifically robust. Instruments have been developed to assess the quality of clinical guideline development and reporting. The aim of this study was to evaluate CPGs from the European Society for Vascular Surgery (ESVS) using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument., Methods: CPGs published by the ESVS during the period January 2011 to January 2023 were included. Two independent reviewers assessed the guidelines after receiving training in the use and application of the AGREE II instrument. Inter-reviewer reliability was assessed with the intraclass correlation coefficient. Maximum scaled scores were 100. Statistical analysis was performed using SPSS Statistics v.26., Results: Sixteen guidelines were included in the study. Good inter-reviewer score reliability was found on statistical analysis (> 0.9). The mean ± standard deviation domain scores were 68.1 ± 20.3% for scope and purpose, 57.1 ± 21.1% for stakeholder involvement, 67.8 ± 19.5% for rigour of development, 78.1 ± 20.6% for clarity of presentation, 50.3 ± 15.4% for applicability, 77.6 ± 17.6% for editorial independence, and 69.8 ± 20.1% for overall quality. Stakeholder involvement and applicability have improved in quality over time but are still the lowest scoring domains., Conclusion: Most ESVS clinical guidelines are of high quality and reporting. There is scope for improvement, specifically by addressing the domains of stakeholder involvement and clinical applicability., (Crown Copyright © 2023. Published by Elsevier B.V. All rights reserved.)

The diagnosis of peripheral arterial disease (PAD) is not always evident as symptoms and signs may show great variation. As all grades of PAD are linked to both an increased risk for cardiovascular complications and adverse limb events, awareness of the condition and knowledge about diagnostic measures, prevention and treatment is crucial. This article presents in a condensed form information on PAD and its management., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Crown Copyright © 2023. Published by Elsevier Inc. All rights reserved.)

Objective: The prevalence of lower limb chronic venous insufficiency (CVI) of the deep veins is increasing and presents a significant burden to patients and health care services. To improve the evaluation of interventions it is necessary to standardise their reporting. The aim of this study was to perform a systematic review of the outcomes of interventions delivered to people with CVI of the deep veins as part of the development of a novel core outcome set (COS)., Methods: Following the Core Outcome Measures in Effectiveness Trials (COMET) framework for COS development, a systematic review was conducted to PRISMA guidance. The protocol was preregistered on PROSPERO (CRD42021236795). MEDLINE, Embase, Emcare, CINAHL, and the Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews and Clinicaltrials.gov were searched from January 2018 to January 2021. Clinical trials and observational studies involving more than 20 participants, reporting outcomes for patients with CVI of the deep veins were eligible. Outcomes were extracted verbatim, condensed into agreed outcome terms and coded into domains using standard COMET taxonomy. Outcome reporting consistency, where outcomes were fully reported throughout the methods and results of their respective articles was also assessed., Results: Some 103 studies were eligible. There were 1183 verbatim outcomes extracted, spanning 22 domains. No outcome was reported unanimously, with the most widely reported outcome of primary patency featuring in 51 articles (<50%). There was a predominant focus on reporting clinical outcomes (n = 963 [81%]), with treatment durability (n = 278 [23%]) and clinical severity (n = 108 [9%]) reported frequently. Life impact outcomes were relatively under-reported (n = 60 [5%]). Outcome reporting consistency was poor, with just 50% of outcomes reported fully., Conclusions: Outcome reporting in studies of people with CVI of the deep veins is currently heterogeneous. Life impact outcomes, which likely reflect patients' priorities are under-reported. This study provides the first step in the development of a COS for people with lower limb CVI of the deep veins., (Copyright © 2022 Society for Vascular Surgery. All rights reserved.)

Introduction: Techniques and devices for the endovascular treatment of peripheral arterial disease (PAD) are continuously evolving. High-quality clinical trials limit the variation in how endovascular interventions are described, performed and reported. The aim of this systematic review is to assess the quality of reporting standards in randomised controlled trials (RCTs) of endovascular lower limb interventions against the Consolidated Standards of Reporting Trials for Non-Pharmacologic Treatments (CONSORT-NPT) and template for intervention description and replication (TIDieR) framework., Methods: Randomised trials including participants with peripheral arterial disease undergoing any infra-inguinal lower limb endovascular arterial intervention, searched from Medline, Embase and Cochrane Library databases from inception to December 2021, will be included. All study data, including details of the procedure investigated, will be extracted in keeping with the CONSORT-NPT and TIDieR checklist. Descriptive statistics will be used to summarise general study details and reporting standards of the trials., Discussion: The results will be used to inform the design of future RCTs in this area by optimising the way the interventions are described, standardised, and monitored. The systematic review will be disseminated via peer-reviewed manuscripts and presentations at relevant conferences., Systematic Review Registration: PROSPERO CRD42022288214., (© 2023. The Author(s).)