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Background: Preventing lower-extremity amputations (LEAs) is pivotal. In the present study, we aimed to examine the recent trends in nontraumatic LEAs seen in the Northern Danish Region., Methods: Using data from the regional Business Intelligence unit, we identified all nontraumatic LEAs (n = 689) performed in people above 50 years of age in the Northern Danish Region between January 2016 and December 2021 (approximately 600,000 inhabitants). Persons with diabetes (n = 26,025) were identified based on International Classification of Diseases-10 codes and data from the National Health Insurance Service Registry, while preventive vascular procedures (n = 1,097) were identified using surgical codes. Major LEA was defined as any amputation above the ankle. Incidence rates were expressed as events per 1,000 person-years. Trends were described as differences between the periods 2016-2018 and 2019-2021., Results: A total of 249 (36%) major LEAs were performed in people with diabetes. People with diabetes were younger (71 vs 77 years, P < 0.001) and more frequently male (70% versus 54%, P < 0.001). Between 2016-2018 and 2019-2021, the incidence of major LEA declined from 1.76 (95% CI: 1.75-1.76) to 1.39 (1.39-1.39) in people with diabetes and from 0.47 (0.47-0.47) to 0.20 (0.20-0.20) in people without diabetes (all P < 0.001). Simultaneously, the incidence of preventive vascular surgery increased from 2.26 (2.26-2.26) to 3.48 (3.48-3.48) in people with diabetes and declined slightly in people without 0.49 (0.49-0.49) to 0.47 (0.47-0.47) (all P < 0.001)., Conclusions: Despite significant declines in major LEA in both people with and without diabetes, most of the decline was driven by a large reduction in major LEAs in people without diabetes., (Copyright © 2024 Elsevier Inc. All rights reserved.)

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.)

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.)

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis, and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this updated guideline, the IWGDF, the European Society for Vascular Surgery, and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications., (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.)

Objective: To identify implantable devices currently used for vascular and endovascular procedures, to ascertain how many have randomised controlled trial (RCT) evidence available, and to assess the quality of that evidence., Data Sources: MEDLINE, Embase, DARE, PROSPERO, clinical trial registries, and Cochrane databases., Review Methods: A list of current devices used in both vascular and endovascular procedures was generated by searching conference proceedings, manufacturer catalogues, and websites. MEDLINE, Embase, DARE, PROSPERO, clinical trial registries, and Cochrane databases were searched from inception up to June 2020. The primary outcome was the availability of RCTs to support the use of a vascular implantable device. RCTs were then quality assessed using the Cochrane risk of bias tool., Results: A total of 116 current vascular implantable devices were identified. The systematic literature review identified 165 RCTs. Eighty-three of the RCTs (50.3%) applied to 33 of the 116 (28.4%) current implantable devices. When grouped by device type, eight of the 13 types (62%) had at least one RCT performed. There was a high risk of bias across the majority of the RCTs, with only nine (5.4%) deemed to be at low risk of bias. Only 22 (13.3%) RCTs had a clear safety outcome., Conclusion: Sixty-two per cent of implantable device types for use in vascular and endovascular interventions had at least one RCT available to show equivalence to previous devices or safety. RCTs were generally of low quality and are decreasing in frequency with time. With medical implantable device failure being increasingly recognised as causing significant harm to patients worldwide, there is a clear need for a more robust implantable device regulation and approval systems., (Copyright © 2022 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: The optimal timing and modality of surveillance after endovascular intervention for peripheral arterial disease is controversial, and no randomized trial to assess the value of peripheral endovascular intervention has ever been performed. The aim of this systematic review was to examine the practice of surveillance after peripheral endovascular intervention in randomized trials., Methods: We used the Medline, Embase, Cochrane Library, and WHO trial registry databases in this systematic review of the literature to capture surveillance strategies used in randomized trials comparing endovascular interventions. Surveillance protocols were assessed for completeness, modalities used, duration, and intensity., Results: Ninety-six different surveillance protocols were reported in 103 trials comparing endovascular interventions. Protocol specification was incomplete in 32% of trials. The majority of trials used multiple surveillance modalities (mean of 3.46 modalities), most commonly clinical examination (96%), ankle-brachial index (80%), duplex ultrasound examination (75%), and digital subtraction angiography (51%). Trials involving infrapopliteal lesions used more angiographic surveillance than trials with femoropopliteal lesions (P = .006). The median number of surveillance visits in the first 12 months after intervention was three and the mean surveillance duration was 21 months. Trials treating infrapopliteal vessels had a higher surveillance intensity compared with those treating femoropopliteal lesions in the first 12 months after endovascular intervention (mean 5 vs 3 surveillance visits; P = .017). Trials with drug-eluting devices had longer surveillance duration compared with those without (mean 26 vs 19 months; P = .020)., Conclusions: There is a high level of variation in the modality, duration, and intensity of surveillance protocols used in randomized trials comparing different types of peripheral endovascular arterial intervention. Further research is required to determine the value and impact of postprocedural surveillance on patient outcomes., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To perform a scoping review of how patients with COVID-19 are affected by acute limb ischaemia (ALI) and evaluate the recommendations of the 2020 ESVS ALI Guidelines for these patients., Methods: Research questions were defined, and a systematic literature search was performed following the PRISMA guidelines. Abstracts and unpublished literature were not included. The definition of ALI in this review is in accordance with the ESVS guidelines., Results: Most identified papers were case reports or case series, although population based data and data from randomised controlled trials were also identified. In total, 114 unique and relevant papers were retrieved. Data were conflicting concerning whether the incidence of ALI increased, or remained unchanged, during the pandemic. Case reports and series reported ALI in patients who were younger and healthier than usual, with a greater proportion affecting the upper limb. Whether or not this is coincidental remains uncertain. The proportion of men/women affected seems unchanged. Most reported cases were in hospitalised patients with severe COVID-19. Patients with ALI as their first manifestation of COVID-19 were reported. Patients with ALI have a worse outcome if they have a simultaneous COVID-19 infection. High levels of D-dimer may predict the occurrence of arterial thromboembolic events in patients with COVID-19. Heparin resistance was observed. Anticoagulation should be given to hospitalised COVID-19 patients in prophylactic dosage. Most of the treatment recommendations from the ESVS Guidelines remained relevant, but the following were modified regarding patients with COVID-19 and ALI: 1) CTA imaging before revascularisation should include the entire aorta and iliac arteries; 2) there should be a high index of suspicion, early testing for COVID-19 infection and protective measures are advised; and 3) there should be preferential use of local or locoregional anaesthesia during revascularisation., Conclusion: Although the epidemiology of ALI has changed during the pandemic, the recommendations of the ESVS ALI Guidelines remain valid. The above mentioned minor modifications should be considered in patients with COVID-19 and ALI., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: Most major lower limb amputations are related to peripheral artery disease (PAD) or diabetes. Just 40% of patients who undergo major lower limb amputation will use a prosthesis yet measures of surgical success commonly focus on prosthesis use. Patient reported outcome measures (PROMs) are valuable to comprehensively evaluate health related quality of life (HRQL) after surgery. This systematic review aimed to identify and describe PROMs available to assess HRQL in patients after amputation for PAD or diabetes., Methods: A search was conducted based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) for systematic reviews of PROMs. Ovid MEDLINE, Ovid EMBASE, PsycINFO, CINAHL, and Cochrane CENTRAL were also searched from inception until August 2019. Included were articles describing the development, measurement properties, or evaluation of HRQL via a PROM in adult patients after amputation for PAD or diabetes. Studies of amputation exclusively for trauma or malignancy were excluded. Data were collected on study characteristics, PROM characteristics (generic/disease specific), and properties of amputation specific PROMs., Results: Of 3 317 abstracts screened, 111 full text articles were assessed for eligibility and 64 included. Fifty-six studies evaluated HRQL, with 23 (46%) of these using an amputation specific PROM to do so. Eleven different amputation specific PROMs were identified, 10 (91%) of which were developed only for prosthesis users. One measure was suitable for use in all patients after amputation. This "Amputee single item mobility measure" includes a single item evaluating mobility. Nine studies reported some psychometric testing of an amputation specific PROM., Conclusion: A well tested, multidimensional PROM applicable to wheelchair and prosthetic users after amputation is lacking and urgently needed for studies in this field. Future work to develop an appropriate measure is required., Competing Interests: Conflict of interest None., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: Randomised trials of new devices for peripheral arterial endovascular intervention are published regularly. The evidence for which antiplatelet and/or anticoagulant (antithrombotic) therapy to use after an intervention is lacking. The aim of this systematic review was to examine the antithrombotic regimens in randomised trials for peripheral arterial endovascular intervention to understand choices made and trends with time or type of device., Methods: Data sources were the Medline, Embase, and Cochrane Library databases. Randomised trials including participants with peripheral arterial disease undergoing any endovascular arterial intervention were included. Trial methods were assessed to determine whether an antithrombotic protocol had been specified, its completeness, and the agent(s) prescribed. Antithrombotic therapy protocols were classed as peri-procedural (preceding and during intervention), immediate post-procedural (up to 30 days following intervention), and maintenance post-procedural (therapy continuing beyond 30 days)., Results: Ninety-four trials were included in narrative synthesis. Study quality was low. None of the trials justified their antithrombotic therapy protocol. Only 29% of trials had complete peri-procedural antithrombotic protocols, and 34% had complete post-procedural protocols. In total, 64 different peri-procedural protocols, and 51 separate post-procedural protocols were specified. Antiplatelet monotherapy and unfractionated heparin were the most common regimen choices in the peri-procedural setting, and dual antiplatelet therapy (55%) was most commonly utilised post procedure. Over time there has been an increasing tendency to use dual therapy (p < .001). This corresponds with the introduction of newer technologies and trials focussed on below knee intervention., Conclusion: Randomised trials comparing different types of peripheral endovascular arterial intervention have a high level of heterogeneity in their antithrombotic regimens. Antiplatelet therapy needs to be standardised in trials comparing endovascular technologies to reduce potential confounding. To do this, an independent randomised trial specifically examining antiplatelet therapy following peripheral arterial endovascular intervention is needed., (Crown Copyright © 2020. Published by Elsevier B.V. All rights reserved.)

Objective: Endovascular aneurysm repair (EVAR) is the most commonly used method to repair abdominal aortic aneurysms. EVAR can be performed using a variety of anaesthetic techniques, including general anaesthetic (GA), regional anaesthetic (RA), and local anaesthetic (LA), but little is known about the effects that each of these anaesthetic modes have on patient outcome. The aim of this study was to assess the effect of anaesthetic technique on early outcomes after elective EVAR., Methods: Data from the UK's National Vascular Registry were analysed. All patients undergoing elective standard infrarenal EVAR between 1 January 2014 and 31 December 2016 were included. Patients with a symptomatic aneurysm treated semi-electively were excluded. The primary outcome was in hospital death within 30 days of surgery. Secondary outcomes included post-operative complications and length of hospital stay. Time to event outcomes were compared using Cox proportional hazards regression adjusted for confounders, including British Aneurysm Repair score (a validated aneurysm risk prediction score that is calculated using age, sex, creatinine, cardiac disease, electrocardiogram, previous aortic surgery, white blood cell count, serum sodium, abdominal aortic aneurysm diameter, and American Society of Anaesthesiologists grade) and chronic lung disease., Results: A total of 9783 patients received an elective, standard infrarenal EVAR (GA, n = 7069; RA, n = 2347; and LA, n = 367) across 89 hospitals. RA and/or LA was used in 82 hospitals. There were 64 in hospital deaths within 30 days, 50 (0.9% mortality at 30 days, 95% confidence interval [CI] 0.7-1.2) in the GA group, 11 (0.6%, 95% CI 0.3-1.1) in the RA group, and three (1.5%, 95% CI 0.5-4.7) in the LA group. The mortality rate differed between groups (p = .03) and was significantly lower in the RA group compared with the GA group (adjusted hazard ratio [aHR] RA/GA 0.37 [95% CI 0.17-0.81]; LA/GA 0.63 [95% CI 0.15-2.69]). The median length of stay was two days for all modes of anaesthesia, but patients were discharged from hospital more quickly in the RA and LA groups than the GA group (aHR RA/GA 1.10 [95% CI 1.03-1.17]; LA/GA 1.15 [95% CI 1.02-1.29]). Overall, 20.7% of patients experienced one or more complications (GA group, 22.1%; RA group, 16.8%; LA group, 17.7%) and pulmonary complications occurred with similar frequency in the three groups (overall 2.4%, adjusted odds ratio RA/GA 0.93 [95% CI 0.66-1.32]; LA/GA 0.82 [95% CI 0.41-1.63])., Conclusion: Thirty day mortality was lower with RA than with GA, but mode of anaesthesia was not associated with increased complications for patients undergoing elective standard infrarenal EVAR., (Crown Copyright © 2020. Published by Elsevier B.V. All rights reserved.)

Guideline Summary: Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative., (Copyright © 2019 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: To assess the clinical efficacy of a neuromuscular electrical stimulation (NMES) device to improve the absolute walking distance in patients with intermittent claudication as an adjunct to the local standard care available at the study sites compared with local standard care alone., Methods: This open, multicenter, randomized controlled trial included eight participating centers in England. Sites are equally distributed between those that provide supervised exercise therapy programs and those that do not. Patients with intermittent claudication meeting the eligibility criteria and providing consent will be randomized, depending on the center type, to either NMES and locally available standard care or standard care alone. The primary end point is change in absolute walking distance at 3 months (the end of the intervention period) by treadmill testing. Secondary outcomes include quality of life, compliance with the interventions, economic evaluation of the NMES device, and lower limb hemodynamic measures to further the understanding of underlying mechanisms. Recruitment commenced in March 2018 and will continue for a total of 15 months. The Neuromuscular Electrical Stimulation Improves the Absolute Walking Distance in Patients with Intermittent Claudication trial is funded by the UK Efficacy and Mechanism Evaluation Programme, Medical Research Council, and National Institute for Health Research partnership., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Critical limb ischaemia (CLI) is a life threatening condition with a considerable risk of major amputation and death. Besides revascularisation, no treatment has been proven to reduce the risks. Therapeutic angiogenesis by gene or cell therapy has not demonstrated definitive evidence in randomised controlled trials. PLX-PAD is an "off the shelf" allogeneic placental derived, mesenchymal like cell therapy, which, in preclinical studies, has shown pro-angiogenic, anti-inflammatory, and regenerative properties. Favourable one year amputation free survival (AFS), and trends in reduction of pain scores and increase of tissue perfusion have been shown in two small, open label, phase I trials., Methods: The PACE study is a phase III randomised, double blind, multicentre, multinational placebo controlled, parallel group study to evaluate the efficacy, tolerability, and safety of intramuscular injections of PLX-PAD cells to treat patients with atherosclerotic CLI with minor tissue loss (Rutherford Category 5) up to the ankle level, who are unsuitable for revascularisation or carry an unfavourable risk benefit for that treatment. The study will enroll 246 patients, who after screening are randomised in a ratio of 2:1 to treatment with intramuscular injections of PLX-PAD 300 × 10 6  cells or placebo on two occasions, eight weeks apart. The primary efficacy endpoint is time to major amputation or death (amputation free survival), which will be assessed in follow up of at least 12 months and up to 36 months., Conclusions: Based on favourable pre-clinical and initial clinical study results, the PACE phase III randomised controlled trial will evaluate placenta derived PLX-PAD cell treatment in patients with critical limb ischaemia, with an unfavourable risk benefit for revascularisation. Clinicaltrials.gov: NCT03006770., (Copyright © 2018 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Aims: There is a paucity of robust evidence on prevention and management of diabetic foot ulcers (DFUs) to inform treatment. This study appraises the current quality of the evidence addressing diagnosis, prognosis, and management of peripheral artery disease (PAD) in patients with DFUs using a newly devised 21 point scoring (TOPS) disease specific research appraisal tool published by the International Working Group on the Diabetic Foot (IWGDF) and European Wound Management Association., Methods: The 2015 IWGDF guidance on diagnosis, prognosis, and management of PAD in patients with DFUs was used to identify studies pertaining to prevention and management. Two reviewers assessed these articles against TOPS, which examines study design, conduct, and outcome reporting., Results: The overall median score was 8 (3-12/21). The median design total score was 2 (0-4/11). The median conduct total score was 2 (1-4/6). The median outcomes total score was 3 (1-4/4). There was improvement with time in overall total (Spearman Rho 0.39, p = .0005), design total (0.35, p = .0023), and outcomes total (0.35, p = .0002), but not conduct total (-0.03, p = .8132) scores., Conclusions: Although this analysis revealed an improvement over time in the overall calibre of studies, the present quality remains poor on which to inform the diagnosis, management, and prognosis of patients with PAD and diabetic foot ulceration., (Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.)

Background: Duplex ultrasonography (DUS) currently has limited applicability in the diagnosis and surveillance of thoracic aortic pathologies because of associated limitations. This study investigates the feasibility of using an optimised DUS protocol to detect descending thoracic aortic pathology., Methods: This was a prospective, case control cohort study. Patients with computed tomography (CT) confirmed thoracic aortic pathology underwent DUS of the thoracic aorta. A control group known to have no thoracic pathology also underwent DUS. The sonographer performing DUS was blinded to the CT findings, and recorded the presence of pathology or any dilated aortic segment where visualised. Diameter cutoff points of 35 mm and 40 mm were compared., Results: Forty patients were scanned (20 cases and 20 controls). All patients but one had a technically adequate assessment of the thoracic aorta (at least one view of the descending thoracic aorta). Using a size threshold of 40 mm, 16 out of 19 cases and two out of 20 control patients would have been recommended for definitive imaging. Using a cutoff of 35 mm, this became 18 out of 19 cases and six of 20 controls. Sensitivity and specificity were 100% and 70% for a threshold of 35 mm, and 84% and 90% for a threshold of 40 mm., Conclusions: DUS has the potential to be used as a diagnostic modality for thoracic aortic pathology, and may have a role in surveillance for some patients for whom CT scanning is contraindicated. Further validation and refinements to this technique are required. However, this study provides proof of concept., (Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.)

Objective/background: The aim was to describe the re-interventions after endovascular and open repair of rupture, and investigate whether these were associated with aortic morphology., Methods: In total, 502 patients from the IMPROVE randomised trial (ISRCTN48334791) with repair of rupture were followed-up for re-interventions for at least 3 years. Pre-operative aortic morphology was assessed in a core laboratory. Re-interventions were described by time (0-90 days, 3 months-3 years) as arterial or laparotomy related, respectively, and ranked for severity by surgeons and patients separately. Rare re-interventions to 1 year, were summarised across three ruptured abdominal aortic aneurysm trials (IMPROVE, AJAX, and ECAR) and odds ratios (OR) describing differences were pooled via meta-analysis., Results: Re-interventions were most common in the first 90 days. Overall rates were 186 and 226 per 100 person years for the endovascular strategy and open repair groups, respectively (p = .20) but between 3 months and 3 years (mid-term) the rates had slowed to 9.5 and 6.0 re-interventions per 100 person years, respectively (p = .090) and about one third of these were for a life threatening condition. In this latter, mid-term period, 42 of 313 remaining patients (13%) required at least one re-intervention, most commonly for endoleak or other endograft complication after treatment by endovascular aneurysm repair (EVAR) (21 of 38 re-interventions), whereas distal aneurysms were the commonest reason (four of 23) for re-interventions after treatment by open repair. Arterial re-interventions within 3 years were associated with increasing common iliac artery diameter (OR 1.48, 95% confidence interval [CI] 0.13-0.93; p = .004). Amputation, rare but ranked as the worst re-intervention by patients, was less common in the first year after treatment with EVAR (OR 0.2, 95% CI 0.05-0.88) from meta-analysis of three trials., Conclusion: The rate of mid-term re-interventions after rupture is high, more than double that after elective EVAR and open repair, suggesting the need for bespoke surveillance protocols. Amputations are much less common in patients treated by EVAR than in those treated by open repair., (Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective/background: The objective was to summarise the lessons learned, and evolution in local practice over the last 7 years, in the investigation and surgical management of iliac artery endofibrosis., Methods: This was a retrospective case series. A case note review of consecutive patients investigated for suspected iliac artery endofibrosis by a single surgeon, over a 7 year period, was undertaken. Included were cases of first presentation and those who had previously undergone intervention., Results: Some 63 patients were referred with suspected endofibrosis in the period 2011-17, four of whom had previously undergone surgery for the condition. After investigation of both limbs, 50 symptomatic limbs in 46 patients had a confirmed diagnosis; amongst those 46 patients, iliac artery endofibrosis was found in a further six asymptomatic, contralateral limbs. Individuals were diagnosed at a median age of 36 years (range 18-52 years) and typically presented with thigh claudication, foot numbness, and limb weakness on exercise. The median delay to diagnosis was 3 years (range 0-14 years). Complete external iliac artery occlusion was a feature in three cases. Overall, 27 limbs in 25 patients underwent operative repair; a further five limbs in four patients underwent operative repair at other centres internationally. There were three post-operative superficial wound infections (11%) and one below knee deep vein thrombosis (4%). Symptoms resolved in 23 cases (85%) with a median follow up of 2.1 years (range 65 days-5.7 years). Of the four limbs developing recurrent symptoms, two had undergone surgery for an occluded external iliac artery., Conclusion: Surgical repair in the medium term appears effective in resolving symptoms in most patients. Further investigation is needed to establish the durability of surgery and to delineate the natural history of the disease., (Copyright © 2018 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Background: Delirium is a common syndrome responsible for a large burden of morbidity and mortality. In surgical settings, research into risk factors for postoperative delirium has largely focused on elective orthopedic patients. We performed a systematic review and meta-analysis to evaluate the evidence surrounding risk factors for delirium in vascular surgical populations., Methods: Two independent reviewers searched five databases (MEDLINE, Web of Science, Embase, Cumulative Index to Nursing and Allied Health Literature, and PsycINFO) from January 1987 to December 2015. We included primary research studies for incident delirium that used validated delirium assessment tools in exclusively vascular surgical populations., Results: We identified 16 studies (3817 patients) that met the inclusion criteria. There was substantial clinical heterogeneity in the populations included under a heading of "vascular surgery." Studies were high quality, with an average Newcastle-Ottawa Scale score of 6.9. Summary incidence of delirium was 23.4% (range, 4.8%-39%). Across all studies, 157 separate risk factors were examined. Ten of the included studies used multivariable models in their analysis of risk factors. Meta-analysis of risk factors with data from more than three studies identified the following factors as conferring an increased risk of delirium: American Society of Anesthesiologists score >2 (odds ratio [OR], 3.44), renal failure (OR, 2.09), previous stroke (OR, 1.87), history of neurologic comorbidity (OR, 1.57), and male sex (OR, 1.30). Delirious patients were older (mean difference [MD], +4.99 years), had lower preoperative hemoglobin levels (MD, -0.66 g/dL), and stayed longer in intensive care units (MD, +1.06 days)., Conclusions: Delirium is common in vascular surgery settings. Meta-analysis has identified significant risk factors relating to the patient, the presentation, and the pathway of care. Better understanding of these risk factors may help in prediction, prevention, and early identification of delirium., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Procedural mortality is of paramount importance for patients undergoing elective abdominal aortic aneurysm (AAA) repair. Previous comparative studies have demonstrated international differences in the care of ruptured AAA. This study compared the use of endovascular aneurysm repair (EVAR) and in-hospital mortality for elective AAA repair in England and the United States., Methods: The English Hospital Episode Statistics and the U.S. Nationwide Inpatient Sample (NIS) were interrogated for elective AAA repair from 2005 to 2010. In-hospital mortality and the use of EVAR were analyzed separately for each health care system, after within-country risk adjustment for age, gender, year, and an accepted national comorbidity index., Results: The study included 21,272 patients with AAA in England, of whom 86.61% were male, with median (interquartile range) age of 74 (69-79) years. There were 196,113 AAA patients in the United States, of whom 76.14% were male, with median (interquartile range) age of 73 (67-78) years. In-hospital mortality was greater in England (4.09% vs 1.96 %; P < .01) and EVAR less common (37.33% vs 64.36%; P < .01). These observations persisted in age- and gender-matched comparison. In both countries, lower mortality and greater use of EVAR were seen in centers performing greater numbers of AAA repairs per annum. In England, lower mortality and greater use of EVAR were seen in teaching hospitals with larger bed capacity., Conclusions: In-hospital survival and the uptake of EVAR are lower in England than in the United States. In both countries, mortality was lowest in high-caseload centers performing a greater proportion of cases with endovascular repair. These common factors suggest strategies for improving outcomes for patients requiring elective AAA repair., (Copyright © 2016. Published by Elsevier Inc.)

Deterioration in renal function has been described after endovascular repair of abdominal aortic aneurysms (EVRs). The etiology is multifactorial and represents an important therapeutic target. A need exists to quantitatively summarize incidence and severity of renal dysfunction after EVR to allow better-informed attempts to preserve renal function and improve life expectancy. Here a systematic search was performed using Medline and Embase for renal function after EVR applying PRISMA statements. Univariate and multivariate random-effects meta-analyses were performed to estimate pooled postoperative changes in serum creatinine and creatinine clearance at four time points after EVR. Clinically relevant deterioration in renal function was also estimated at 1 year or more after EVR. Pooled probability of clinically relevant deterioration in renal function at 1 year or more was 18% (95% confidence interval of 14-23%, I2 of 82.5%). Serum creatinine increased after EVR by 0.05 mg/dl at 30 days/1 month, 0.09 mg/dl at 1 month to 1 year, and 0.11 mg/dl at 1 year or more (all significant). Creatinine clearance decreased after EVR by 5.65 ml/min at 1 month-1 year and by 6.58 ml/min at 1 year or more (both significant). Thus, renal dysfunction after EVR is common and merits attention.

Objective: The purpose of this study was to assess the odds of all-cause mortality in individuals with diabetic foot ulceration (DFU) compared with those with diabetes and no history of DFU. In addition, we sought to determine the strength of association of DFU with cardiovascular and nonvascular mortality., Methods: We obtained data for a cohort of patients who attended a secondary care diabetic foot clinic or a general diabetes clinic between 2009 and 2010. A clinic cohort of patients with diabetes and no history of DFU provided a control group. Cause-specific mortality was recorded during a median follow-up duration of 3.6 years (interquartile range, 3.3-4.2 years). The association between DFU and all-cause mortality was evaluated by Cox regression. The association between DFU and cardiovascular mortality was determined by competing risk modeling., Results: We recorded 145 events of all-cause mortality and 27 events of cardiovascular mortality among 869 patients with diabetes. After adjustment for potential confounders, DFU was associated with both cardiovascular disease (hazard ratio, 2.53; 95% confidence interval, 0.98-6.49; P = .05) and all-cause mortality (hazard ratio, 3.98; 95% confidence interval, 2.55-6.21; P < .001). The proportion of deaths attributable to cardiovascular disease was similar between the groups (18% with diabetes only and 19% with DFU; P = .91)., Conclusions: DFU is associated with premature death from vascular and nonvascular causes., (Copyright © 2014 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The objective of this study was to provide a systematic review and meta-analysis of outcomes of infrainguinal angioplasty with drug-eluting stent (DES) or balloon (DEB)., Methods: The EMBASE, MEDLINE, and Cochrane databases and the Current Controlled Trials register were systematically interrogated for articles reporting results of infrainguinal angioplasty with DESs or DEBs. Clinical and angiographic end points were included., Results: The review included 26 studies that reported on 2407 limbs; 11 were prospective randomized controlled trials. Infrapopliteal angioplasty with DEB was reported in 109 limbs (claudication, 19; critical limb ischemia [CLI], 90) (limb salvage in CLI, 95.6%; target lesion revascularization [TLR], 17.3%; mortality, 16%; mean follow-up, 12.3 months). Infrapopliteal angioplasty with DES was reported in 882 limbs (claudication, 160; CLI, 590; unclear severity, 132) (limb salvage in CLI, 97.4%, TLR, 10.8%; mortality, 17%; mean follow-up, 22.9 months). Femoropopliteal angioplasty with DES was reported in 1174 limbs (claudication, 301; CLI, 58; unclear severity, 815) (limb salvage in CLI, 89.6%; TLR, 17.3%; mortality, 3%; mean follow-up, 10.6 months). Femoropopliteal angioplasty with DEB was reported in 242 limbs (claudication, 182; CLI, 12; unclear severity, 48) (TLR, 10.6%; mortality, 2%; mean follow-up, 11 months). Meta-analysis of studies comparing DEB with standard balloon angioplasty demonstrated a result in favor of DEBs for preventing binary primary restenosis (odds ratio [OR], 0.27; P = .005) and TLR (OR, 0.17; P = .001). The meta-analysis comparing DESs with bare-metal stents demonstrated a result in favor of DES with regard to preventing TLR (OR, 0.15; P = .001) and binary primary restenosis (OR, 0.23; P = .001). Drug-eluting technology did not prevent more deaths or amputations., Conclusions: Early angiographic data suggest that drug-eluting devices prevent restenosis in the short term, but there is as yet no evidence of an increase in limb salvage rates or a reduction in mortality. Further large randomized controlled trials with a focus on clinical outcomes and longer follow-up are needed., (Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: The outcome of patients with ruptured abdominal aortic aneurysm (rAAA) varies by country. Study of practice differences might allow the formulation of pathways to improve care., Methods: We compared data from the Hospital Episode Statistics for England and the Nationwide Inpatient Sample for the USA for patients admitted to hospital with rAAA from 2005 to 2010. Primary outcomes were in-hospital mortality, mortality after intervention, and decision to follow non-corrective treatment. In-hospital mortality and the rate of non-corrective treatment were analysed by binary logistic regression for each health-care system, after adjustment for age, sex, year, and Charlson comorbidity index., Findings: The study included 11,799 patients with rAAA in England and 23,838 patients with rAAA in the USA. In-hospital mortality was lower in the USA than in England (53·05% [95% CI 51·26-54·85] vs 65·90%; p<0·0001). Intervention (open or endovascular repair) was offered to a greater proportion of cases in the USA than in England (19,174 [80·43%] vs 6897 [58·45%]; p<0·0001) and endovascular repair was more common in the USA than in England (4003 [20·88%] vs 589 [8·54%]; p<0·0001). Postintervention mortality was similar in both countries (41·77% for England and 41·65% for USA). These observations persisted in age-matched and sex-matched comparisons. In both countries, reduced mortality was associated with increased use of endovascular repair, increased hospital caseload (volume) for rAAA, high hospital bed capacity, hospitals with teaching status, and admission on a weekday., Interpretation: In-hospital survival from rAAA, intervention rates, and uptake of endovascular repair are lower in England than in the USA. In England and the USA, the lowest mortality for rAAA was seen in teaching hospitals with larger bed capacities and doing a greater proportion of cases with endovascular repair. These common factors suggest strategies for improving outcomes for patients with rAAA., Funding: None., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Background: Endovascular treatments of Stanford type B aortic dissection may help to promote aortic remodeling and reduce the incidence of aortic-related complications. The aim of this study was to review published literature describing aortic remodeling after endovascular treatment of aortic dissection., Methods: A systematic review of the literature was performed which was compliant with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The type of aortic morphology measurements made and the methods used to make them were characterized. The endpoints of interest were the change in these measurements over time., Results: After initial screening, 77 articles were identified; 16 of which met the inclusion criteria. Few studies used three-dimensional reconstruction software and none had validated their measurement protocol. True lumen (TL) and false lumen (FL) diameters, areas, and in some cases volumes were measured. Studies assessed the aorta at a variety of different levels and over different periods of follow-up. Acute dissection patients displayed more consistent degree of remodeling (thoracic FL thrombosis in 80% to 90%) than chronic dissection patients (38% to 91%). Less remodeling was seen below the diaphragm in both groups., Conclusions: Aortic remodeling after treatment for dissection is described in a highly heterogeneous manner. Despite this there appears to be a greater degree of complete FL resolution in patients with acute dissection than chronic. Factors such as length of aortic coverage and timing of treatment may explain the variation seen in the chronic dissection group. Consensus-based reporting standards are required to synthesize evidence and inform clinical decisions regarding patient selection and operative timing., (Copyright © 2014. Published by Elsevier Inc.)