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Objective:\ud Chronic limb-threatening ischemia (CLTI) is a growing global problem due to the widespread use of tobacco and increasing prevalence of diabetes. Although the financial consequences are considerable, few studies have compared the relative cost-effectiveness of different CLTI management strategies. The Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial is randomizing patients with CLTI to primary infra-popliteal (IP) vein bypass surgery (BS) or best endovascular treatment (BET) and includes a comprehensive within-trial cost-utility analysis. The aim of this study is to compare over a 12-month time horizon, the costs of primary IP BS, IP best endovascular treatment (BET), and major limb major amputation (MLLA) to inform the BASIL-2 cost-utility analysis.\ud \ud Methods:\ud We compared procedural human resource (HR) costs and total in-hospital costs for the index admission, and over the following 12-months, in 60 consecutive patients undergoing primary IP BS (n = 20), IP BET (n = 20), or MLLA (10 transfemoral and 10 transtibial) for CLTI within the BASIL prospective cohort study.\ud Results\ud \ud Procedural:\ud HR costs were greatest for BS (BS £2551; 95% confidence interval [CI], £1934-£2807 vs MLLA £1130; 95% CI, £1046-£1297 vs BET £329; 95% CI, £242-£390; P < .001, Kruskal-Wallis) due to longer procedure duration and greater staff requirement. With regard to the index admission, MLLA was the most expensive due to longer hospital stay (MLLA £13,320; 95% CI, £8986-£18,616 vs BS £8714; 95% CI, £6097-£11,973 vs BET £4813; 95% CI, £3529-£6097; P < .001, Kruskal-Wallis). The total cost of the index admission and in-hospital care over the following 12 months remained least for BET (MLLA £26,327; 95% CI, £17,653-£30,458 vs BS £20,401; 95% CI, £12,071-£23,926 vs BET £12,298; 95% CI, £6961-£15,439; P < .001, Kruskal-Wallis).\ud \ud Conclusions:\ud Over a 12-month time horizon, MLLA and IP BS are more expensive than IP BET in terms of procedural HR costs and total in-hospital costs. These economic data, together with quality of life data from BASIL-2, will inform the calculation of incremental cost-effectiveness ratios for different CLTI management strategies within the BASIL-2 cost-utility analysis.

Although high quality epidemiological data are lacking, the global increase in chronic limb threatening ischaemia may be disproportionately affecting low and LMICs. All available data for outcomes from bypass for limb salvage are from high income countries, with none from LMIC settings where the challenge is greatest. This study aimed to assess the clinical outcomes following vein lower extremity bypass for chronic limb threatening ischaemia at the University of Colombo, Sri Lanka, and to compare patients and outcomes with those described in the Society for Vascular Surgery (SVS) Objective Performance Goals (OPG) and United States National Surgical Quality Improvement Program (NSQIP).Consecutive patients (n = 367) undergoing SVS-OPG eligible lower extremity bypass between 2015 and 2017 were studied. Thirty day major adverse cardiovascular events (MACE), major adverse limb events (MALE), deaths, and amputations are reported, along with one year overall survival, limb salvage, and amputation free survival.Patients at University of Colombo had more diabetes mellitus (80% vs. SVS 57% vs. NSQIP 50%, p .001) and tissue loss (100% vs. SVS 74% vs. NSQIP 59%, p .001). The 30 day MALE was 7.6%, which is not a statistically significant difference from the SVS (6.1%) or NSQIP (9%). The 30 day MACE was 8.2%, statistically significantly higher than NSQIP (4.2%, p .001) but not SVS (6.2%, p = .20). At 12 months, the overall survival (82%) was within the OPG threshold, but limb salvage (81.8%) and amputation free survival (64.5%) were just outside.Outcomes following vein bypass for ischaemic necrosis at the University of Colombo, Sri Lanka, are acceptable and similar to those reported from high income countries despite greater limb threat severity and resource limitations. Further real world data from similar settings on outcomes following revascularisation are required. These data suggest that a vein bypass first strategy for advanced ischaemic necrosis is feasible and effective even in resource limited settings.

Background Ultrasound guided foam sclerotherapy (UGFS) is a flexible and highly utilised tool in the treatment of varicose veins (VVs), both as a primary treatment and as an adjunct to other treatments. Concern remains regarding the risk of neurological adverse events (AEs) such as migraine, visual disturbance and serious adverse events (SAEs) such as cerebrovascular accident that have been reported after UGFS treatments. Aim To determine the incidence of neurological AEs and SAEs after UGFS. Methods A prospective, multicentre, post-authorisation safety study across Europe (both private and government) was performed between January 2015–2020. Neurological adverse events after UGFS with Fibrovein® (Sodium Tetradecyl Sulfate) 1 and 3% physician generated foam. Results 8056 patients underwent treatment. There were 46 AE (including 5 SAEs), 30 (65%) SAEs were in female patients. Mean age was 55 years with mean body mass index (BMI) of 27. Univariable logistic regression demonstrate that UGFS only treatment (i.e. no adjunctive treatment), liquid-to-gas ratio, gas type and total foam volume (1% sodium tetradecyl sulfate, STS) were significantly associated with the odds of experiencing the outcome. Multivariable logistic regression model exhibits that migraine and total foam volume (1% STS) maintained statistical significance thus associated with the odds of adverse events. Conclusions This study demonstrates that UGFS with Fibrovein is safe with a very low incidence of neurological AEs and SAEs. Past history of migraine, use of physiological gas (O2/CO2) and increasing volumes of 1% foam increase the risk of AEs.

This work was supported by the National Institute for Health Research (NIHR), Health Technology Assessment Programme, project number 17/147/47. The HTA Programme is funded by the NIHR, with contributions from the Chief Scientist Office in Scotland and National Institute for Social Care and Health Research in Wales and the Health and Social Care R&D Division, Public Health Agency in Northern Ireland. Sponsor: Imperial College London., Introduction Up to 50% of patients develop post-thrombotic syndrome (PTS) after an above knee deep vein thrombosis (DVT). The aim of the study was to determine the effect of graduated compression stockings in preventing PTS after DVT. Methods and analysis Pragmatic, UK multicentre randomised trial in adults with first above knee DVT. The standard of care arm is anticoagulation. The intervention arm will receive anticoagulation plus stockings (European class II, 23-32 mm Hg compression) worn for a median of 18 months. The primary endpoint is PTS using the Villalta score. Analysis of this will be through a time to event approach and cumulative incidence at median 6, 12 and 18 months. An ongoing process evaluation will examine factors contributing to adherence to stockings to understand if and how the behavioural interventions were effective. Ethics and dissemination UK research ethics committee approval (reference 19/LO/1585). Dissemination though the charity Thrombosis UK, the Imperial College London website, peer-reviewed publications and international conferences., National Institute for Health Research (NIHR) 17/147/47, National Institute for Health Research (NIHR), Chief Scientist Office in Scotland, National Institute for Social Care and Health Research in Wales, Health and Social Care R&D Division, Public Health Agency in Northern Ireland, Imperial College London

This study is supported by the J P Moulton Charitable Foundation (grant number: N/A). The DCD allograft is provided free of charge by NHSBT., The authors wish to thank the principal investigators, research nurses and their teams at the recruiting sites. The authors also wish to thank the NHS Blood and Transplant (NHSBT) for providing the DCD allograft free of charge and for their support in training clinical staff, and the NIHR Clinical Research Networks (CRNs) for their support in identifying sites. Finally, the authors wish to thank all individuals who participated in the PPI focus groups and extend a special thank you to PPI representative Emanuel Ezeife, whose useful feedback helped to inform the design of the study., Introduction Venous leg ulceration (VLU), the most common type of chronic ulcer, can be difficult to heal and is a major cause of morbidity and reduced quality of life. Although compression bandaging is the principal treatment, it is time-consuming and bandage application requires specific training. There is evidence that intervention on superficial venous incompetence can help ulcer healing and recurrence, but this is not accessible to all patients. Hence, new treatments are required to address these chronic wounds. One possible adjuvant treatment for VLU is human decellularised dermis (DCD), a type of skin graft derived from skin from deceased tissue donors. Although DCD has the potential to promote ulcer healing, there is a paucity of data for its use in patients with VLU. Methods and analysis This is a multicentre, parallel group, pragmatic randomised controlled trial. One hundred and ninety-six patients with VLU will be randomly assigned to receive either the DCD allograft in addition to standard care or standard care alone. The primary outcome is the proportion of participants with a healed index ulcer at 12 weeks post-randomisation in each treatment arm. Secondary outcomes include the time to index ulcer healing and the proportion of participants with a healed index ulcer at 12 months. Changes in quality of life scores and cost-effectiveness will also be assessed. All analyses will be carried out on an intention-to-treat (ITT) basis. A mixed-effects, logistic regression on the outcome of the proportion of those with the index ulcer healed at 12 weeks will be performed. Secondary outcomes will be assessed using various statistical models appropriate to the distribution and nature of these outcomes. Ethics and dissemination Ethical approval was granted by the Bloomsbury Research Ethics Committee (19/LO/1271). Findings will be published in a peer-reviewed journal and presented at national and international conferences., J P Moulton Charitable Foundation

Background Anaemia affects 30–50% of patients before they undergo major surgery. Preoperative anaemia is associated with increased need for blood transfusion, postoperative complications and worse patient outcomes after surgery. International guidelines support the use of intravenous iron to correct anaemia in patients before surgery. However, the use of preoperative intravenous iron for patient benefit has not been assessed in the setting of a formal clinical trial. Objectives To assess if intravenous iron given to patients with anaemia before major abdominal surgery is beneficial by reducing transfusion rates, postoperative complications, hospital stay and re-admission to hospital, and improving quality of life outcomes. Design A multicentre, double-blinded, randomised, controlled, Phase III clinical trial, with 1 : 1 randomisation comparing placebo (normal saline) with intravenous iron (intravenous ferric carboxymaltose 1000 mg). Randomisation and treatment allocation were by a secure web-based service. Setting The study was conducted across 46 hospitals in England, Scotland and Wales between September 2013 and September 2018. Participants Patients aged > 18 years, undergoing elective major open abdominal surgery, with anaemia [Hb level of > 90 g/l and Intervention Double-blinded study comparing placebo of normal saline with 1000 mg of ferric carboxymaltose administered 10–42 days prior to surgery. Main outcome measures Co-primary end points were risk of blood transfusion or death at 30 days postoperatively, and rate of blood transfusions at 30 days post operation. Results A total of 487 patients were randomised (243 given placebo and 244 given intravenous iron), of whom 474 completed the trial and provided data for the analysis of the co-primary end points. The use of intravenous iron increased preoperative Hb levels (mean difference 4.7 g/l, 95% confidence interval 2.7 to 6.8 g/l; p p = 0.84; absolute risk difference +0.8%, 95% confidence interval –7.3% to 9.0%), or rates of blood transfusion (rate ratio 0.98, 95% confidence interval 0.68 to 1.43; p = 0.93; absolute rate difference 0.00, 95% confidence interval –0.14 to 0.15). There was no difference in postoperative complications or hospital stay. The intravenous iron group had higher Hb levels at the 8-week follow-up (difference in mean 10.7 g/l, 95% confidence interval 7.8 to 13.7 g/l; p p = 0.009). There were no differences between the groups in terms of mortality (two per group at 30 days post operation) or in any of the prespecified safety end points or serious adverse events. Conclusions In patients with anaemia prior to elective major abdominal surgery, there was no benefit from giving intravenous iron before the operation. Future work The impact of iron repletion on recovery from postoperative anaemia, and the association with reduced re-admission to hospital for complications, should be investigated. Limitations In the preoperative intravenous iron to treat anaemia in major surgery (PREVENTT) trial, all patients included had anaemia and only 20% had their anaemia corrected before surgery. The definition and causality of iron deficiency in this setting is not clear. Trial registration Current Controlled Trials ISRCTN67322816 and ClinicalTrials.gov NCT01692418. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25 No. 11. See the NIHR Journals Library website for further project information.

Background Patients admitted to hospital for surgery are at an increased risk of venous thromboembolism. Pharmaco-thromboprophylaxis and mechanical prophylaxis (usually graduated compression stockings or intermittent pneumatic compression) have been shown to reduce the incidence of venous thromboembolism. The evidence base supporting the National Institute for Health and Care Excellence’s recommendation for the use of graduated compression stockings for venous thromboembolism prevention in the UK has recently been challenged. It is unclear if the risks and costs associated with graduated compression stockings are justified for deep-vein thrombosis prevention in moderate- and high-risk elective surgical inpatients receiving low-dose low-molecular-weight heparin pharmaco-thromboprophylaxis. Objectives The primary objective was to compare the venous thromboembolism rate in elective surgical inpatients at moderate or high risk of venous thromboembolism who were receiving either graduated compression stockings and low-dose low-molecular-weight heparin (standard care) or low-dose low-molecular-weight heparin alone (intervention). Design This was a pragmatic, multicentre, prospective, non-inferiority, randomised controlled trial. Setting This took place in secondary care NHS hospitals in the UK. Participants Patients aged ≥ 18 years who were assessed to be at moderate or high risk of venous thromboembolism according to the NHS England venous thromboembolism risk assessment tool (or the trust equivalent based on this form) and who were not contraindicated to low-molecular-weight heparin or graduated compression stockings were deemed eligible to take part. Interventions Participants were randomised 1 : 1 to either low-molecular-weight heparin or low-molecular-weight heparin and graduated compression stockings. Main outcome measures The primary outcome measure was venous thromboembolism up to 90 days after surgery. A combined end point of duplex ultrasound-proven new lower-limb deep-vein thrombosis (symptomatic or asymptomatic) plus imaging-confirmed symptomatic pulmonary embolism. Secondary outcomes included quality of life, compliance with graduated compression stockings and low-molecular-weight heparin during admission, and all-cause mortality. Results A total of 1905 participants were randomised and 1858 were included in the intention-to-treat analysis. A primary outcome event occurred in 16 out of 937 (1.7%) patients in the low-molecular-weight heparin-alone arm compared with 13 out of 921 (1.4%) patients in the low-molecular-weight heparin plus graduated compression stockings arm. The risk difference between low-molecular-weight heparin and low-molecular-weight heparin plus graduated compression stockings was 0.30% (95% confidence interval –0.65% to 1.26%). As the 95% confidence interval did not cross the non-inferiority margin of 3.5% (p Limitations In total, 13% of patients did not receive a duplex ultrasound scan that could have detected further asymptomatic deep-vein thrombosis. However, missing scans were balanced between both trial arms. The subpopulation of those aged ≥ 65 years assessed as being at a moderate risk of venous thromboembolism was under-represented in the study; however, this reflects that this group is under-represented in the general population. Conclusions For elective surgical patients at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and graduated compression stockings. These findings indicate that graduated compression stockings may be unnecessary for most elective surgical patients. Future work Further studies are required to evaluate whether or not adjuvant graduated compression stockings have a role in patients receiving extended thromboprophylaxis, beyond the period of hospital admission, following elective surgery or in patients undergoing emergency surgical procedures. Trial registration Current Controlled Trials ISRCTN13911492. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 69. See the NIHR Journals Library website for further project information.

Disclaimer Due to the evolving field of medicine, new research may, in due course, modify the recommendations presented in this document. At the time of publication, every attempt has been made to ensure that the information provided is up to date and accurate. It is the responsibility of the treating physician to determine the best treatment for the patient. The authors, committee members, editors, and publishers cannot be held responsible for any legal issues that may arise from the citation of this statement. Rules of evidence Management of patients with chronic venous disorders has been traditionally undertaken subjectively among physicians, often resulting in less than optimal strategies. In this document, a systematic approach has been developed with recommendations based upon cumulative evidence from the literature. Levels of evidence and grades of recommendation range from Level I and Grade A to Level III and Grade C. Level I evidence and Grade A recommendations derive from scientifically sound randomized clinical trials in which the results are clear-cut. Level II evidence and Grade B recommendations derive from clinical studies in which the results among trials often point to inconsistencies. Level III evidence and Grade C recommendations result from poorly designed trials or from small case series.1, 2 Meta-analysis Meta-analyses are included in the present document but there should be caution as to their possible abuse. Certain studies may be included in a meta-analysis carelessly without sufficiently understanding of substantive issues, ignoring relevant variables, using heterogenous findings or interpreting results with a bias.3 It has been demonstrated that the outcomes of 12 large randomized controlled trials were not predicted accurately 35% of the time by the meta-analyses published previously on the same topics.4

BACKGROUND Since the turn of the millennium, there has been a worldwide trend towards an endovascular-first strategy where possible revascularization strategy for chronic limb-threatening ischemia. There is concern that this may be inappropriate and can result in net patient harm. The aim of this study, therefore, is to compare important clinical outcomes following femoropopliteal plain balloon angioplasty (FP-PBA), with selective use of bare metal stents (BMSs), in a contemporary series (CS) of patients treated in our unit between 2009 and 2014 with those observed following FP-PBA ± BMS in the United Kingdom National Institute of Health Research Health Technology Assessment-funded Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL-1 [B1]) trial (treated 1999-2004). METHODS Baseline and clinical outcome data (amputation-free survival [AFS], overall survival [OS], limb salvage, freedom from reintervention, and freedom from major adverse limb events) were obtained from prospectively gathered hospital data and B1 trial case record forms. RESULTS There were 237 CS and 218 B1 patients. CS patients were older (77 vs 73 years; P = .0002). B1 patients were more likely to be current smokers, less likely to be on best medical therapy, and underwent more extensive endovascular interventions. CS had more hospital admissions (4 vs 2; P < .0001) before they reached their primary endpoint (AFS). Immediate technical success was nonsignificantly higher in the CS patients (87% vs 83%; P = .2). BMS were used in 20 CS (8%) and 2 B1 (1%) patients (P = .0002). AFS (hazard ratio, 0.64; 95% confidence interval, 0.49-0.82; P = .0005) and OS (hazard ratio, 0.58; 95% confidence interval, 0.44-0.76; P = .0001) were significantly worse in the CS cohort. There was no significant difference in limb salvage, freedom from reintervention, or freedom from major adverse limb events. CONCLUSIONS Patients with chronic limb-threatening ischemia managed in our unit (2009-2014) by means of a FP-PBA ± BMS first (where possible) revascularization strategy experienced significantly worse AFS and OS than patients treated with FP-PBA ± BMS in the B1 trial 10 years earlier (1999-2004).

ObjectivesTo investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery.DesignOpen, multicentre, randomised, controlled, non-inferiority trial.SettingSeven National Health Service tertiary hospitals in the United Kingdom.Participants1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate.InterventionParticipants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS.Outcome measuresThe primary outcome was imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality.ResultsBetween May 2016 and January 2019, 1905 participants were randomised. 1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery). A primary outcome event occurred in 16 of 937 (1.7%) patients in the LMWH alone group compared with 13 of 921 (1.4%) in the LMWH and GCS group. The risk difference between the two groups was 0.30% (95% confidence interval −0.65% to 1.26%). Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (PConclusionsFor patients who have elective surgery and are at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and GCS. These findings indicate that GCS might be unnecessary in most patients undergoing elective surgery.Trial registrationISRCTN13911492.

Summary Background Preoperative anaemia affects a high proportion of patients undergoing major elective surgery and is associated with poor outcomes. We aimed to test the hypothesis that intravenous iron given to anaemic patients before major open elective abdominal surgery would correct anaemia, reduce the need for blood transfusions, and improve patient outcomes. Methods In a double-blind, parallel-group randomised trial, we recruited adult participants identified with anaemia at preoperative hospital visits before elective major open abdominal surgery at 46 UK tertiary care centres. Anaemia was defined as haemoglobin less than 130 g/L for men and 120 g/L for women. We randomly allocated participants (1:1) via a secure web-based service to receive intravenous iron or placebo 10–42 days before surgery. Intravenous iron was administered as a single 1000 mg dose of ferric carboxymaltose in 100 mL normal saline, and placebo was 100 mL normal saline, both given as an infusion over 15 min. Unblinded study personnel prepared and administered the study drug; participants and other clinical and research staff were blinded to treatment allocation. Coprimary endpoints were risk of the composite outcome of blood transfusion or death, and number of blood transfusions from randomisation to 30 days postoperatively. The primary analysis included all randomly assigned patients with data available for the primary endpoints; safety analysis included all randomly assigned patients according to the treatment received. This study is registered, ISRCTN67322816, and is closed to new participants. Findings Of 487 participants randomly assigned to placebo (n=243) or intravenous iron (n=244) between Jan 6, 2014, and Sept 28, 2018, complete data for the primary endpoints were available for 474 (97%) individuals. Death or blood transfusion occurred in 67 (28%) of the 237 patients in the placebo group and 69 (29%) of the 237 patients in the intravenous iron group (risk ratio 1·03, 95% CI 0·78–1·37; p=0·84). There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68–1·43; p=0·93). There were no significant differences between the two groups for any of the prespecified safety endpoints. Interpretation Preoperative intravenous iron was not superior to placebo to reduce need for blood transfusion when administered to patients with anaemia 10–42 days before elective major abdominal surgery. Funding UK National Institute of Health Research Health Technology Assessment Program.

Background NICE Clinical Guidelines (CG) 168, published in July 2013, recommend specialist vascular referral for all leg ulcers, defined as a break in the skin below the knee that has not healed within two weeks. Aim To examine the impact of CG168 on the primary care management of leg ulcers using The Health Improvement Network database. Methods An eligible population of approximately two million adult patients was analysed over two 18-month periods before and after publication of CG168. Those with a new diagnosis of leg ulcers in each time period were analysed in terms of demographics, specialist referral and superficial venous ablation. Results We identified 7532 and 7462 new diagnoses of leg ulcers in the pre- and post-CG168 cohorts, respectively. Patients with a new diagnosis of leg ulcers were elderly (median age: 77 years both cohorts) and less likely to be male (47% both cohorts). There were 2259 (30.0%) and 2329 (31.2%) vascular service referrals in the pre- and post-CG168 cohorts, respectively (hazard ratio, 1.05, 95% CI: 0.99, 1.11, p = 0.096). The median interval between general practitioner diagnosis and referral was 1.5 days in both cohorts. Patients from both cohorts who were referred for a new diagnosis of leg ulcers were equally likely to receive superficial venous ablation. Conclusions Disappointingly, we have been unable to demonstrate that publication of NICE CG168 has been associated with a meaningful change in leg ulcer management in primary care in line with guideline recommendations.

Background The optimal strategy for revascularization in infrainguinal chronic limb-threatening ischemia (CLTI) remains debatable. Comparative trials are scarce, and daily decisions are often made using anecdotal or low-quality evidence. Methods We searched multiple databases through May 7, 2017, for prospective studies with at least 1-year follow-up that evaluated patient-relevant outcomes of infrainguinal revascularization procedures in adults with CLTI. Independent pairs of reviewers selected articles and extracted data. Random-effects meta-analysis was used to pool outcomes across studies. Results We included 44 studies that enrolled 8602 patients. Periprocedural outcomes (mortality, amputation, major adverse cardiac events) were similar across treatment modalities. Overall, patients with infrapopliteal disease had higher patency rates of great saphenous vein graft at 1 and 2 years (primary: 87%, 78%; secondary: 94%, 87%, respectively) compared with all other interventions. Prosthetic bypass outcomes were notably inferior to vein bypass in terms of amputation and patency outcomes, especially for below knee targets at 2 years and beyond. Drug-eluting stents demonstrated improved patency over bare-metal stents in infrapopliteal arteries (primary patency: 73% vs 50% at 1 year), and was at least comparable to balloon angioplasty (66% primary patency). Survival, major amputation, and amputation-free survival at 2 years were broadly similar between endovascular interventions and vein bypass, with prosthetic bypass having higher rates of limb loss. Overall, the included studies were at moderate to high risk of bias and the quality of evidence was low. Conclusions There are major limitations in the current state of evidence guiding treatment decisions in CLTI, particularly for severe anatomic patterns of disease treated via endovascular means. Periprocedural (30-day) mortality, amputation, and major adverse cardiac events are broadly similar across modalities. Patency rates are highest for saphenous vein bypass, whereas both patency and limb salvage are markedly inferior for prosthetic grafting to below the knee targets. Among endovascular interventions, percutaneous transluminal angioplasty and drug-eluting stents appear comparable for focal infrapopliteal disease, although no studies included long segment tibial lesions. Heterogeneity in patient risk, severity of limb threat, and anatomy treated renders direct comparison of outcomes from the current literature challenging. Future studies should incorporate both limb severity and anatomic staging to best guide clinical decision making in CLTI.

OBJECTIVE/BACKGROUND In a pilot study, a relationship between abdominal aortic aneurysm (AAA) diameter and serum interleukin (IL)-1α levels was reported, and that endothelial cell (EC) activation in vitro in response to serum from patients with AAA was blocked by anti-IL-1α antibodies. The aim of the present study was to further investigate the relationship between serum IL-1α and asymptomatic infrarenal AAA size, morphology, and growth rates. METHODS Serum IL-1α was measured using enzyme linked immunosorbent assay in 101 patients with asymptomatic, infrarenal AAA and related to aneurysm size, morphology, and growth rates. RESULTS IL-1α was measured in 101 patients. There was no statistically significant difference in mean age between men and women. IL-1α was detectable in 62.4% of patients; median IL-1α titre was 3.26 pg/mL. There was no statistically significant relationship between IL-1α and maximum AAA antero-posterior diameter as measured by ultrasound (p = .649), AAA morphology (aortic length [p = .394], sac [p = .369], and thrombus volume [p = .629]) as measured on computed tomography, absolute increase in AAA diameter (p = .214), or AAA growth rate (p = .230). CONCLUSION IL-1α is detectable in the majority of patients with infrarenal AAA, but the cause and clinical significance of this novel observation remains unknown.

Background For a cytokine to have a role as a clinically useful biomarker, it must be measureable in a practical, reliable, and reproducible manner. Furthermore, assays from different manufacturers should produce comparable results. The aim of this paper was to examine the effect of 2 sample processing methodologies and compare 9 commercially available immunoassays for their measurement of serum interleukin (IL)-1α in patients with abdominal aortic aneurysm. Methods Two sample processing methodologies and 9 manufacturers' immunoassays were compared. Each immunoassay was also tested for detection of both IL-1α isoforms. Results A positive signal for IL-1α was found in all serum samples, in all immunoassays, using both processing methods. In the majority, titer concentrations were unquantifiable with values below manufacturers' detectable range. Variability in titer concentrations was seen across all immunoassays. With the exception of 1 immunoassay, all were able to detect both IL-1α isoforms. Conclusions Researchers wishing to measure serum cytokines levels should be aware that differences in sample processing methods and manufacturers' immunoassays can affect the results. This may result in misleading conclusions being drawn about biological processes underpinning a wide range of inflammatory diseases.

The aim was to compare outcomes in a subgroup of patients with infrapopliteal (IP) disease randomised to infrapopliteal vein bypass (VB) or plain balloon angioplasty (PBA) in the original BASIL trial.A comparison of outcomes from patients randomised to VB or PBA undergoing revascularisation for severe limb ischaemia (SLI) because of IP disease with or without femoropopliteal disease. Data were extracted from case report forms from the BASIL trial. The primary outcome was amputation free survival (AFS); secondary outcomes included overall survival (OS), 30 day mortality and morbidity, freedom from arterial re-intervention, immediate technical success, repeat and crossover interventions, length of hospital stay, and quality of revascularisation.A total of 104 patients were identified in the BASIL study with IP disease, 56 randomised to IP VB, and 48 to IP PBA. Groups were similar at baseline except for more chronic kidney disease and non-steroidal anti-inflammatory drug use in the VB group, and more previous surgical arterial intervention and antihypertensive use in the PBA group. There were no statistically significant differences in AFS or OS; however, clinically important trends were apparent in favour of a VB first strategy. Patients allocated to VB demonstrated significantly quicker relief of rest pain when compared with PBA (p = .005), but no significant differences in improved tissue healing. Median length of index hospital admission was significantly greater in the VB than in the PBA group (18 vs. 10 days, p .0001) but there was no difference between the two groups in median total hospital stay between randomisation and the primary endpoint (VB 43.5 vs. PBA 42 days).Further randomised trials, like BASIL-2 and BEST-CLI, are required to determine whether patients with severe limb ischaemia who require IP revascularisation and who are suitable for VB should have bypass or endovascular intervention as their primary revascularisation procedure.

BACKGROUND: The evidence base upon which current global venous thromboembolism (VTE) prevention recommendations have been made is not optimal. The cost of purchasing and applying graduated compression stockings (GCS) in surgical patients is considerable and has been estimated at £63.1 million per year in England alone.OBJECTIVE: The aim was to determine whether low dose low molecular weight heparin (LMWH) alone is non-inferior to a combination of GCS and low dose LMWH for the prevention of VTE.METHODS: The randomised controlled Graduated compression as an Adjunct to Pharmacoprophylaxis in Surgery (GAPS) Trial (ISRCTN 13911492) will randomise adult elective surgical patients identified as being at moderate and high risk of VTE to receive either the current "standard" combined thromboprophylactic LMWH with GCS mechanical thromboprophylaxis, or thromboprophylactic LMWH pharmacoprophylaxis alone. To show non-inferiority (3.5% non-inferiority margin) for the primary endpoint of all VTE within 90 days, 2236 patients are required. Recruitment will be from seven UK centres. Secondary outcomes include quality of life, compliance with stockings and LMWH, overall mortality, and GCS or LMWH related complications (including bleeding). Recruitment commenced in April 2016 with the seven UK centres coming "on-line" in a staggered fashion. Recruitment will be over a total of 18 months. The GAPS trial is funded by the National Institute for Health Research Health Technology Assessment in the UK (14/140/61).

Background Leg ulcers are a common cause of morbidity and disability and result in significant health and social care expenditure. The UK National Institute for Health and Care Excellence (NICE) Clinical Guideline (CG)168, published in July 2013, sought to improve care of patients with leg ulcers, recommending that patients with a break in the skin below the knee that had not healed within two weeks be referred to a specialist vascular service for diagnosis and management. Aim Determine the impact of CG168 on referrals to a leg ulcer service. Methods Patients referred with leg ulceration during an 18-month period prior to CG168 (January 2012–June 2013) and an 18-month period commencing six months after (January 2014–June 2015) publication of CG168 were compared. Results There was a two-fold increase in referrals (181 patients, 220 legs vs. 385 patients, 453 legs) but no change in mean age, gender or median-duration of ulcer at referral (16.6 vs. 16.2 weeks). Mean-time from referral to specialist appointment increased (4.8 vs. 6 weeks, p = 0.0001), as did legs with superficial venous insufficiency (SVI) (36% vs. 44%, p = 0.05). There was a trend towards more SVI endovenous interventions (32% vs. 39%, p = 0.271) with an increase in endothermal (2 vs. 32 legs, p = 0.001) but no change in sclerotherapy (24 vs. 51 legs) treatments. In both groups, 62% legs had compression. There was a reduction in legs treated conservatively with simple dressings (26% vs. 15%, p = 0.0006). Conclusions Since CG168, there has been a considerable increase in leg ulcer referrals. However, patients are still not referred until ulceration has been present for many months. Although many ulcers are multi-factorial and the mainstay of treatment remains compression, there has been an increase in SVI endovenous intervention. Further efforts are required to persuade community practitioners to refer patients earlier, to educate patients and encourage further investment in chronically underfunded leg ulcer services.

Background UK National Institute for Health and Care Excellence (NICE) clinical guidelines (CG) 168, published in July 2013, aimed to improve the management of lower limb venous disease by newly recommending interventional treatment for all people affected by symptomatic varicose veins (VV) and specialist vascular referral for all people suffering from a leg ulcer (LU) that had been present for ≥2 weeks. This study aims to determine if CG168 has increased access to vascular services, particularly for the socially deprived, who might be expected to have greater need for such services. Methods The study was performed in a highly multi-cultural, socio-economically diverse, mixed urban/suburban population of approximately 1.2 million people living in and around East Birmingham, UK. Index of multiple deprivation quintile (IMD-Q) was used as a measure of social deprivation to compare levels of social deprivation of people undergoing interventions for symptomatic VV or referred with an LU during 18-month periods before and after the publication of CG168. The referring general practitioner practices (GPPs) were also recorded. Results There was no change in overall IMD-Q distribution before and after CG168 in terms of VV interventions. However, there was a non-significant increase in proportions of people classified as IMD-Q5 (the most deprived quintile). After CG168, fewer IMD-Q5 people with LU were referred, with a shift in referrals towards those from less socially deprived areas. More GPP referred people with both VV and LU after CG168, and those that referred patients before and after CG168 tended to refer more after CG168. Conclusions CG168 has increased VV interventions as well as the number referred with LU. However, this improvement in access to treatment and referral may have disproportionately favoured the more socio-economic privileged. Professional and public education is required to ensure that the beneficial impact of the CG168 recommendations are maximised and that those with the greatest health needs have equal access to evidence-based management of their venous disease.

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.

This randomized clinical trial uses data from the Early Venous Reflux Ablation trial to evaluate the long-term clinical and cost benefits of combined early endovenous ablation and compression compared with compression therapy alone and deferred ablation for treating superficial venous reflux of the leg., Key Points Question In patients with venous leg ulceration and superficial reflux, what is the clinical and cost-effectiveness of early endovenous ablation of reflux? Findings In this 450-patient, multicenter, randomized clinical trial, early endovenous ablation with compression accelerated venous ulcer healing, reduced the overall incidence of ulcer recurrence, and was highly cost-effective compared with compression with deferred intervention. Meaning To deliver clinical and cost benefits, leg ulcer care pathways should be revised to include early assessment and treatment of superficial venous reflux., Importance One-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux. Objective To evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration. Design, Setting, and Participants Between October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months’ duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019. Interventions Patients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n = 224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n = 226). Endovenous modality and strategy were left to the preference of the treating clinical team. Main Outcomes and Measures The primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness. Results The early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57-1.17; P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480-0.898; P = .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12-1.64; P = .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year. Conclusions and Relevance Early endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence. Trial Registration ClinicalTrials.gov identifier: ISRCTN02335796

Objective The aim was to investigate the cost-effectiveness of interventional treatment for varicose veins (VV) in the UK NHS, and to inform the national clinical guideline on VV, published by the National Institute of Health and Care Excellence. Design An economic analysis was constructed to compare the cost-effectiveness of surgery, endothermal ablation (ETA), ultrasound-guided foam sclerotherapy (UGFS), and compression stockings (CS). The analysis was based on a Markov decision model, which was developed in consultation with members of the NICE guideline development group (GDG). Methods The model had a 5-year time horizon, and took the perspective of the UK National Health Service. Clinical inputs were based on a network meta-analysis (NMA), informed by a systematic review of the clinical literature. Outcomes were expressed as costs and quality-adjusted life years (QALYs). Results All interventional treatments were found to be cost-effective compared with CS at a cost-effectiveness threshold of £20,000 per QALY gained. ETA was found to be the most cost-effective strategy overall, with an incremental cost-effectiveness ratio of £3,161 per QALY gained compared with UGFS. Surgery and CS were dominated by ETA. Conclusions Interventional treatment for VV is cost-effective in the UK NHS. Specifically, based on current data, ETA is the most cost-effective treatment in people for whom it is suitable. The results of this research were used to inform recommendations within the NICE guideline on VV.

The reports from cohort studies comparing outcomes after revascularisation for chronic limb threatening ischaemia (CLTI) between men and women remain controversial. Anatomical and clinical disease severity is often heterogeneous, and treatment choice influenced by a variety of clinician and patient factors. The aim was to compare outcomes in men and women entered into the only randomised study comparing bypass and angioplasty for infra-inguinal disease causing severe limb ischaemia.Data were obtained from BASIL-1 trial case record forms. Baseline demographics were compared, and Cox proportional hazard models were used to examine the relationship between sex and amputation free survival (AFS), overall survival (OS), and freedom from major adverse limb events (FF-MALE) using a per-protocol analysis. Data were analysed using a per-protocol analysis.A total of 452 patients were randomised into the BASIL-1 trial from 1999 to 2004. At randomisation, women were older and less likely to be smokers, to have diabetes, or to be on recommended best medical therapy. Men were more likely to present with gangrene. Ankle brachial pressure index (ABPI), post-revascularisation length of hospital stay, and 30 day morbidity and mortality were similar for men and women. At three years, female sex was associated with significantly better AFS (HR 0.65, 95% CI 0.47-0.89, p .01), OS (HR 0.66 95% CI 0.46-0.95, p = .02) and FF-MALE (HR 0.74, 95% CI 0.57-0.96, p = .02).In the BASIL-1 trial, women had similar short term but better long term outcomes after revascularisation. Sex is an important consideration when developing early, evidence based treatment pathway and revascularisation strategies for CLTI, and is an independent risk factor for outcomes following revascularisation as well as development of symptomatic PAD.

Background Venous ulceration is a common and costly health-care issue worldwide, with poor healing rates greatly affecting patient quality of life. Compression bandaging has been shown to improve healing rates and reduce recurrence, but does not address the underlying cause, which is often superficial venous reflux. Surgical correction of the reflux reduces ulcer recurrence; however, the effect of early endovenous ablation of superficial venous reflux on ulcer healing is unclear. Objectives To determine the clinical effectiveness and cost-effectiveness of compression therapy with early endovenous ablation of superficial venous reflux compared with compression therapy with deferred endovenous ablation in patients with venous ulceration. Design A pragmatic, two-arm, multicentre, parallel-group, open randomised controlled trial with a health economic evaluation. Setting Secondary care vascular centres in England. Participants Patients aged ≥ 18 years with a venous leg ulcer of between 6 weeks’ and 6 months’ duration and an ankle–brachial pressure index of ≥ 0.8 who could tolerate compression and were deemed suitable for endovenous ablation of superficial venous reflux. Interventions Participants were randomised 1 : 1 to either early ablation (compression therapy and superficial endovenous ablation within 2 weeks of randomisation) or deferred ablation (compression therapy followed by endovenous ablation once the ulcer had healed). Main outcome measures The primary outcome measure was time from randomisation to ulcer healing, confirmed by blinded assessment. Secondary outcomes included 24-week ulcer healing rates, ulcer-free time, clinical success (in addition to quality of life), costs and quality-adjusted life-years (QALYs). All analyses were performed on an intention-to-treat basis. Results A total of 450 participants were recruited (224 to early and 226 to deferred superficial endovenous ablation). Baseline characteristics were similar between the two groups. Time to ulcer healing was shorter in participants randomised to early superficial endovenous ablation than in those randomised to deferred ablation [hazard ratio 1.38, 95% confidence interval (CI) 1.13 to 1.68; p = 0.001]. Median time to ulcer healing was 56 (95% CI 49 to 66) days in the early ablation group and 82 (95% CI 69 to 92) days in the deferred ablation group. The ulcer healing rate at 24 weeks was 85.6% in the early ablation group, compared with 76.3% in the deferred ablation group. Median ulcer-free time was 306 [interquartile range (IQR) 240–328] days in the early ablation group and 278 (IQR 175–324) days in the deferred endovenous ablation group (p = 0.002). The most common complications of superficial endovenous ablation were pain and deep-vein thrombosis. Differences in repeated measures of Aberdeen Varicose Vein Questionnaire scores (p p = 0.03) and Short Form questionnaire-36 items body pain (p = 0.05) over the follow-up period were observed, in favour of early ablation. The mean difference in total costs between the early ablation and deferred ablation groups was £163 [standard error (SE) £318; p = 0.607]; however, there was a substantial and statistically significant gain in QALY over 1 year [mean difference between groups 0.041 (SE 0.017) QALYs; p = 0.017]. The incremental cost-effectiveness ratio of early ablation at 1 year was £3976 per QALY, with a high probability (89%) of being more cost-effective than deferred ablation at conventional UK decision-making thresholds (currently £20,000 per QALY). Sensitivity analyses using alternative statistical models give qualitatively similar results. Limitations Only 7% of screened patients were recruited, treatment regimens varied significantly and technical success was assessed only in the early ablation group. Conclusions Early endovenous ablation of superficial venous reflux, in addition to compression therapy and wound dressings, reduces the time to healing of venous leg ulcers, increases ulcer-free time and is highly likely to be cost-effective. Future work Longer-term follow-up is ongoing and will determine if early ablation will affect recurrence rates in the medium and long term. Trial registration Current Controlled Trials ISRCTN02335796. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 24. See the NIHR Journals Library website for further project information.

BACKGROUND Bypass surgery (BS) remains the gold standard revascularization strategy in patients with chronic limb-threatening ischemia (CLTI) owing to infrainguinal disease. The Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-1 trial showed that, in patients with CLTI who survived for 2 years or more, BS resulted in better clinical outcomes. Despite this finding, there has been an increasing trend toward an endovascular-first approach to infrainguinal CLTI. Our aim was to investigate whether changes in practice have impacted the clinical outcomes of BS in our unit 10 years after BASIL-1. METHODS Data for patients who underwent femoropopliteal (FP) BS in BASIL-1 (1999-2004) were retrieved from trial case record forms. The comparator contemporary series (CS) comprised all patients undergoing FP BS for CLTI in our unit between 2009 and 2014. Demographic and clinical outcome data on patients in the CS were collected from the prospectively collected hospital electronic notes. Anatomic patterns of disease in the BASIL-1 and CS cohorts were scored using the Bollinger and GLASS criteria. Statistical analysis was performed in SAS v9.4. RESULTS There were 128 patients from BASIL-1 and 50 patients in the CS. Baseline age, gender, affected limb, and diabetes prevalence were similar, as were days spent in hospital out to 12 months and length of follow-up. BASIL-1 patients were more likely to be current smokers (P = .000) and had a higher creatinine (P = .04). The 30-day morbidity and mortality were higher in BASIL-1 (45.3% vs 22%; P = .004). There was no significant difference between BASIL-1 and CS with regard to run-off Bollinger (37.7 vs 32.1; P = .167) and IP GLASS (0 vs 0; P = .390) scores, with both groups having a median of two runoff vessels. Amputation-free survival (62% vs 28%; hazard ratio [HR], 1.86; 95% confidence interval [CI], 1.18-2.93; P = .007), limb salvage (85% vs 69%; HR, 2.31; 95% CI, 1.14-4.68; P = .02), overall survival (69% vs 35%; HR, 1.66; 95% CI, 1.00-2.74; P = .05) and major adverse limb events (67% vs 47%; HR, 1.93; 95% CI, 1.15-3.22; P = .01) were all significantly better in BASIL-1. CONCLUSIONS Although 30-day mortality and morbidity were significantly lower, all of the examined longer term clinical outcomes after FP BS were significantly worse in the CS group a decade on from BASIL-1. Further research in the form of prospective cohort studies and randomized controlled trials is urgently required to determine if the CS data reported herein are generalizable to current vascular surgical practice and, if so, to determine the reasons for these unexpected outcomes.

To compare outcomes in patients with chronic limb threatening ischaemia (CLTI) due to femoropopliteal (FP), with or without infrapopliteal (IP), disease who underwent FP (vein or synthetic) open surgical bypass (OSB), or plain balloon angioplasty (PBA), with or without bare metal stenting (BMS), in the Bypass versus Angioplasty in Severe Ischaemia of the Limb (BASIL-1) trial.Data were extracted from BASIL-1 case record forms. Outcomes reported include immediate technical success, freedom from major adverse limb events (FF-MALE) and further re-intervention (FF-R), amputation free survival (AFS), overall survival (OS), and limb salvage (LS).Patients underwent primary OSB (n = 128; 89 vein, 39 synthetic) or primary PBA (n = 183; six had BMS). Mean follow up was 46.2 and 43.6 months respectively. Patients were well matched at baseline except that PBA ± BMS patients were significantly more likely to be current smokers. There was no difference in overall or IP (runoff) Bollinger angiogram scores between groups. Immediate technical success was significantly higher for OSB (98% vs. 81%; p .001). OSB was associated with a longer mean index hospital admission (p = .001), but there was no difference in hospital days at 12 months. FF-MALE (hazard ratio [HR] 1.51; p = .04) and FF-R (HR 1.68; p = .02) but not AFS (HR 1.18; p = .4), OS (HR 1.14; p = .5), and LS (HR 1.09; p = .8) were significantly better after OSB.Although AFS, OS, and LS were similar in the two groups, OSB was associated with significantly fewer MALE and re-interventions. So, while PBA ± BMS may be a less resource intensive (expensive) and morbid option in the short term, this appears unlikely to be the case in the longer term. Present data add further weight to the argument that, where possible, patients presenting with CLTI due to FP disease should be offered OSB as their primary revascularisation procedure.

Objective Chronic limb threatening ischaemia (CLTI) is a growing global health problem. The UK NIHR HTA funded BASIL trial is still the only randomised controlled trial to have compared a “bypass surgery first” with a “plain balloon angioplasty (PBA) first” strategy for the management of CLTI. In patients who were likely to survive for 2 years and had a suitable vein, primary bypass (PB) was associated with better clinical outcomes. Furthermore, PBA was associated with a high technical and clinical failure rate and many went on to have secondary bypass (SB). This study aimed at comparing clinical outcomes following PB and SB in the BASIL trial. Methods Demographic, procedural, and outcome data were obtained from the BASIL case report forms. Outcomes were amputation free survival (AFS), limb salvage (LS), overall survival (OS), and freedom from revascularisation (FFR). The SB cohort comprises patients whose first trial intervention was PBA and who subsequently underwent bypass during follow up. The PB cohort comprises those patients whose first trial intervention was bypass. Results The 190 PB and 49 SB patients were well matched except that the SB patients were more likely to be current smokers. At a median of 7 years, PB was associated with better AFS (PB 60% vs. SB 40%; HR 1.58, p = .04), LS (PB 85% vs. SB 73%, p = .06), and OS (PB 68% vs. 51%, p = .06). FFR was equivalent (PB 53% vs. 53%, p = .3). Conclusion In the BASIL trial, clinical outcomes following PB were significantly better than in patients undergoing SB after failed PBA. Prior to treating patients with CLTI with primary PBA, clinicians should consider that if this should fail, the outcome of attempted subsequent bypass is likely to be significantly worse than if PB were attempted.

Objective The last 10 years have seen the introduction into everyday clinical practice of a wide range of novel non-surgical treatments for varicose veins. In July 2013, the UK National Institute for Health and Care Excellence recommended the following treatment hierarchy for varicose veins: endothermal ablation, ultrasound-guided foam sclerotherapy, surgery and compression hosiery. The aim of this paper is to review the randomised controlled trials that have compared endothermal ablation and ultrasound-guided foam sclerotherapy to determine if the level 1 evidence base still supports an “endothermal ablation first” strategy for the treatment of varicose veins. Methods A PubMed and OVID literature search (until 31 January 2015) was performed and randomised controlled trials comparing endothermal ablation and ultrasound-guided foam sclerotherapy were obtained. Results Although anatomical success appeared higher with endothermal ablation than ultrasound-guided foam sclerotherapy, clinical success and patient-reported outcomes measures were similar. Morbidity and complication rates were very low and not significantly different between endothermal ablation and ultrasound-guided foam sclerotherapy. Ultrasound-guided foam sclerotherapy was consistently less expensive that endothermal ablation. Conclusions All endovenous modalities appear to be successful and have a role in modern day practice. Although further work is required to optimise ultrasound-guided foam sclerotherapy technique to maximise anatomical success and minimise retreatment, the present level 1 evidence base shows there is no significant difference in clinical important outcomes between ultrasound-guided foam sclerotherapy and endothermal ablation. As ultrasound-guided foam sclerotherapy is less expensive, it is likely to be a more cost-effective option in most patients in most healthcare settings. Strict adherence to the treatment hierarchy recommended by National Institute for Health and Care Excellence seems unjustified.

Abdominal aortic aneurysm (AAA) maximum antero-posterior diameter (MAPD) is the parameter most commonly used to inform the timing of surgical intervention. However, other factors, such as growth rates and patient comorbidities are likely to be important considerations as they may influence AAA related complications including rupture, operative outcomes, and the clinical and cost effectiveness of continued surveillance.This was a retrospective analysis of a 20 year period of a single centre AAA surveillance database. In total, 5363 AAA measurements in 692 patients were analysed for patient demographics, including comorbidity and drug history, growth and rupture rates, and cause of death.A significant proportion of patients (n = 73; 11%) were kept under surveillance despite having a MAPD 30 mm. Overall, mean aneurysm growth rate was 2.3 mm/year. Elective repair was undertaken in 20.1% and those who required surgical intervention had significantly faster growth rates. Only 3.9% of patients in surveillance ruptured, 40.7% of whom had a MAPD55 mm at their last scan. Of the 214 deaths recorded, only 11.7% were related to AAA. The majority of patients who died in surveillance did so from malignancy. Patients with larger AAA (MAPD 40 mm) on entry into surveillance were significantly more likely to receive surgical intervention, as were those whose AAA expanded4 mm/year. Females had significantly higher growth rates, and those with diabetes had significantly smaller growth rates. Other comorbidities and drug history were not associated with AAA growth, or 5 and 10 year surgery free survival.The results highlight several areas for service improvement. Specifically, it is important not to maintain surveillance in patients who are very unlikely to ever grow to a point where AAA surgery would be contemplated on grounds or age and/or comorbidity. Similarly, patients should be discharged from surveillance when this likelihood becomes apparent.

Accurate survival prediction critically influences decision-making in caring for patients with chronic limb-threatening ischemia (CLTI). The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial demonstrated that in patients who survived2 years, there was a significant advantage to infrainguinal bypass compared with endovascular intervention, which increased with time. Validated survival models for patients with CLTI are lacking.The Vascular Quality Initiative was interrogated for patients who underwent infrainguinal bypass or endovascular intervention for CLTI (January 2003-February 2017). Cox survival models were generated using only preoperative variables. Survival at 30 days, 2 years, and 5 years was modeled separately. Patients were defined as low risk (30-day survival97% and 2-year survival70%), medium risk (30-day survival 95%-97% or 2-year survival 50%-70%), and high-risk (30-day survival 95% or 2-year survival 50%).Among 38,470 unique CLTI patients, 63% (n = 24,214) underwent endovascular intervention and 37% (n = 14,256) underwent infrainguinal bypass. Kaplan-Meier estimates of overall survival at 30 days, 2 years, and 5 years were 98%, 81%, and 69%, respectively. The proportion of patients in the low-, medium-, and high-risk groups was 84%, 10%, and 6.5%, respectively. Patients in the low-risk group were significantly less likely to undergo endovascular intervention compared with those in the high-risk group (low risk, 59% endovascular; high risk, 75% endovascular; P .0001). Independent predictors of death were similar in all three models, with greatest magnitude of effect associated with age80 years, oxygen-dependent chronic obstructive pulmonary disease, stage 5 chronic kidney disease, and bedbound status. The C index for the 30-day model, 2-year model, and 5-year model was 0.76, 0.72, and 0.71, respectively. Procedure type (open or endovascular) was not significant in any models and did not have an impact on C indices.These survival prediction models, derived from a large U.S. cohort of patients who underwent revascularization for CLTI, demonstrated good performance and should be validated. Most CLTI patients considered candidates for limb salvage were of average perioperative risk and were predicted to survive beyond 2 years. These models can differentiate patients into low-, medium-, and high-risk groups to facilitate evidence-based revascularization recommendations that are consistent with current treatment guidelines.

In July 2013, new UK guidelines recommended that all patients with symptomatic varicose veins (VV) be referred to a specialist vascular service for consideration of superficial venous intervention (SVI). In the UK, general practitioners (GPs) in primary care control access to publicly funded vascular services provided through the National Health Service. GP awareness and concordance with Clinical Guideline (CG)168 recommendations is vital if patients with VV are to receive evidence-based treatment in line with national recommendations. The aim was to assess the UK-wide impact of new guidelines on GP management of VV using a large database of electronic GP records.An eligible population of patients aged ≥ 18 years was analysed over two 18-month periods, before and after guideline publication. Those with a new diagnosis of VV in each time period were analysed in terms of demographics, specialist referral, compression hosiery prescriptions, and recorded SVI.Analysis included approximately two million patients from 285 GP practices. Before and after CG168 cohorts were well matched. Study populations included 13,014 patients before and 12,466 patients after guideline publication. There was an increase in specialist referrals from 24% (n = 3173) to 28% (n = 3457) (Cox hazard ratio [HR] 1.15, 95% confidence interval [CI] 1.09-1.20; p .001). Median time to referral was 1.5 days. Prescribed compression hosiery declined from 20% (n = 2558) before the new guidelines to 18% (n = 2292) after the new guidelines (HR 0.93, 95% CI 0.88-0.98; p = .008). There were similar increases in proportions recorded as having SVI, from 3.6% (n = 469) before the new guidelines to 4.2% (n = 526) after the new guidelines (HR 1.16, 95% CI 1.02-1.31; p = .023). There was a statistically significant increase in endothermal ablation after CG168. In Cox models, age, sex, Townsend quintile, and body mass index were significantly related to the chance of referral and SVI.Encouragingly, following publication of National Institute for Health and Care Excellence CG168, there has been a statistically significant improvement in the management of VV in primary care in line with the CG recommendations.

Background Supervised exercise (SE) is thought to result in improvements in walking distance and quality of life compared with unsupervised exercise (USE) in people with intermittent claudication. However, the cost-effectiveness of SE is unclear. As a result, many patients are currently unable to access supervised programmes. Methods We searched MEDLINE, Embase, Cochrane, and Cinahl databases to identify randomised controlled trials comparing USE with SE in adults with intermittent claudication. A Markov model was developed to estimate costs and quality adjusted life years (QALYs) from an NHS and personal social services perspective. Quality of life was obtained from the included clinical trials. Resource use was modelled on current programmes and unit costs were based on published sources. Results Depending on estimated rates of compliance, SE was cost-effective in over 75% of model simulations, with an incremental cost-effectiveness ratio of £711 to £1,608 per QALY gained. The model was sensitive to long-term effects of exercise on cardiovascular risk and quality of life. Conclusions SE is more cost-effective than USE for the treatment of people with intermittent claudication. Supervised programmes should be made widely available and offered as a first line treatment to people with intermittent claudication.

BACKGROUND Abdominal aortic aneurysm (AAA) is associated with a prothrombotic diathesis that may increase the risk of cardiovascular events. This diathesis is exacerbated in the short term by open aneurysm repair (OAR) and endovascular aneurysm repair (EVAR). However, the effect of EVAR and OAR on coagulation and fibrinolysis in the medium and long term is poorly understood. The purpose of this study was to investigate the medium-term effects of EVAR and OAR on thrombin generation, neutralization, and fibrinolysis. METHODS Prothrombin fragment (PF)1+2, thrombin antithrombin (TAT) complex, plasminogen activator inhibitor (PAI) activity, and tissue-plasminogen activator (t-PA) antigen were measured in eight age-matched controls (AMCs), 29 patients with AAA immediately before (preoperatively) and 12 months after EVAR (post-EVAR), and in 11 patients at a mean of 16 months after OAR (post-OAR). RESULTS Preoperatively, PF1+2 levels were significantly higher in patients with AAAs than in AMC. PF1+2 levels post-EVAR and post-OAR were significantly lower than preoperative values and similar to AMC. There was no significant difference in TAT, PAI, or t-PA between AMC, AAA preoperatively, and post-EVAR. Post-OAR, PAI activity was significantly higher than in preoperative patients. CONCLUSIONS AAA is associated with increased thrombin generation without upregulation of fibrinolysis. The prothrombotic, hypofibrinolytic diathesis observed in patients with AAA returns toward normal in the medium term after EVAR and OAR, although there is a trend toward decreased fibrinolysis post-OAR.

Introduction Lower limb venous disease affects up to one half, and obesity up to one quarter, of the adult population. Many people are therefore affected by, and present to health services for the treatment of both conditions. This article reviews the available evidence of pathophysiological and clinical relationship between obesity and varicose veins, chronic venous insufficiency and ulceration and deep vein thrombosis. Methods A literature search of PubMed and Cochrane libraries was performed in accordance with PRISMA statement from 1946 to 2015, with further article identification from following cited references for articles examining the relationship between obesity and venous disease. Search terms included obesity, overweight, thrombosis, varicose veins, CEAP, chronic venous insufficiency, treatment, endovenous, endothermal, sclerotherapy, bariatric surgery and deep vein thrombosis. Results The proportion of the population suffering from lower limb venous disease and obesity is increasing. Obesity is an important risk factor for all types of lower limb venous disease, and obese patients with lower limb venous disease are more likely to be symptomatic as a result of their lower limb venous disease. The clinical diagnosis, investigation, imaging and treatment of lower limb venous disease in obese people present a number of challenges. The evidence base underpinning medical, surgical and endovenous management of lower limb venous disease in obese people is limited and such treatment may be associated with worse outcomes and increased risks when compared to patients with a normal body mass index. Conclusion Lower limb venous disease and obesity are both increasingly common. As such, phlebologists will be treating ever greater numbers of obese patients with lower limb venous disease, and clinicians in many other specialties are going to be treating a wide range of obesity-related health problems in people with or at risk of lower limb venous disease. Unfortunately, obese people have been specifically excluded from many, if not most, of the pivotal studies. As such, many basic questions remain unanswered and there is an urgent need for research in this challenging and increasingly prevalent patient group.

Background Endovascular aneurysm repair (EVAR) is associated with an improved perioperative mortality compared to open surgical repair. This benefit may reflect reduced incidence of microvascular and macrovascular thrombotic complications after EVAR. Purpose The purpose of this study was to review and compare the effects of abdominal aortic aneurysm (AAA), open surgical repair, and EVAR on coagulation, fibrinolysis, and platelet activation. Methods A MEDLINE (1966-2010) and Cochrane library search for articles relating to the effects of AAA, open surgical repair, and EVAR on hemostasis was performed utilizing and cross-linking terms such as clotting, fibrinolysis, AAA, EVAR, and open surgical repair. Studies with a small cohort of patients (less than 7) or in which values of assessed biomarkers were not included were rejected. Results AAA is associated with increased thrombin generation, activity, and fibrin turnover as evidenced by increased plasma levels of thrombin-antithrombin III-complex (TAT), activated protein C-protein C inhibitor (APC-PCI), fibrin-monomer-fibrinogen (FM-F), F1+2, fibrinogen, and D-dimer. The extent of hemostatic derangement correlates with the volume of intraluminal thrombus. This procoagulant state is exaggerated in the immediate perioperative period after both open surgical repair and EVAR, but is attenuated at medium-term follow-up although not normalized. Conclusion The resultant prothrombotic diathesis after open surgical repair and EVAR may account for the high level of perioperative thrombotic complications.

ObjectiveTo examine serum cytokine/chemokine profiles before and 6 months after endovascular repair (EVAR) of abdominal aortic aneurysm (AAA) and to determine whether they correlate with serum inflammatory activity using an in vitro model of leukocyte recruitment.MethodsSerum IL-1-α, IL-1β, IL-4, IL-6, IL-8, IL-10, IFN-γ, IP-10, MCP-1, TNF-α, and TNF-β were measured using a cytometry-based immunoassay. To test patient serum for direct inflammatory activity, human endothelial cells (EC) were stimulated with 30% patient serum for 24 hours. To test patient serum for the ability to prime EC for inflammatory responses, EC were incubated with 30% patient serum for 24 hours, followed by stimulation with low-dose (5 U/mL) TNF for 4 hours. Under both regimens of stimulation, the degree of EC activation was assessed by assaying neutrophil recruitment in a flow-based model.ResultsOnly IL-1α (67.9 ± 10.4 pg/mL vs 41.9 ± 7.4 pg/mL) and IL-8 (51.5 ± 5.1 vs 32.6 ± 4.7 pg/mL) changed significantly after surgery. Patient serum alone was unable to activate EC. However, serum from both time points could prime EC responses to low-dose TNF. Thus, after priming with preoperative serum, EC stimulated with TNF could recruit 76.7 ± 12.0 neutrophils/mm2 into the subendothelial cell space. Post-EVAR serum was significantly less effective (44.4 ± 10.2 neutrophils/mm2). This reduction in neutrophil recruitment correlated with reduced IL-1α in post-EVAR serum. The addition of a neutralizing antibody against IL-1α to pre-EVAR serum inhibited EC priming and neutrophil recruitment, strongly implying that this cytokine was the priming agent.ConclusionEVAR reduces serum IL-1α and its inflammatory activity in patient serum. IL-1α is, therefore, implicated in the molecular pathology of AAAs and may have potential as a clinically useful biomarker.Clinical RelevanceContinuing uncertainty exists over which patients will benefit from abdominal aortic aneurysm (AAA) repair in addition to medical therapy as well as which repair method, open or endovascular, is the most clinically and cost-effective. Greater understanding of AAA development and progression, and the subsequent identification of biomarkers for rupture risk, are likely to result in better selection of patients for intervention and provide better measures of successful repair. These novel data implicate interleukin (IL)-1α in the molecular pathology of AAA. Further, they suggest that IL-1α may be a predictive biomarker for AAA size as well as outcome after endovascular aneurysm repair.

ObjectivesTo describe duplex ultrasound (DUS) outcomes 12 months following ultrasound-guided foam sclerotherapy (UGFS) of recurrent great saphenous varicose veins (GSVV).MethodsA consecutive series of UK National Health Service patients underwent serial DUS examinations following UGFS with 3% sodium tetradecyl sulphate for symptomatic recurrent GSVV.Results91 treated legs (CEAP C2/3 58, C4 21, C5 8, C6 4) belonging to 73 patients (24 male) of median age 58 (range 32–86) years were enrolled between November 2004 and May 2007. The median volume of foam used was 8 (range 4–14) ml. Above-knee (AK) and below-knee (BK) GSV reflux was present in 88 (97%) and 80 (88%) legs respectively prior to treatment. AK and BK-GSV reflux was completely eradicated by a single session of UGFS in 86 (98%) and 74 (93%) legs respectively; and by two sessions of UGFS in 88 (100%) and 77 (97%) legs respectively. In those legs where GSV reflux had been eradicated, recanalisation occurred in 7/78 (9%) AK and 8/68 (12%) BK-GSV segments after 12 months follow-up. Retreatment, where undertaken, with a single UGFS session effectively eradicated all GSV reflux in all cases of recanalisation.DiscussionA single session of UGFS can eradicate reflux in the AK and BK-GSV in over 93% of patients with symptomatic recurrent GSVV. Re-recurrence at 12 months is superior to that reported after redo GSV surgery, similar to that observed following other minimally-invasive techniques and, when it occurs, is effectively and simply treated by a single further session of UGFS.

Objectives To determine healing and recurrence rates following ultrasound-guided foam sclerotherapy (UGFS) of superficial venous reflux (SVR) in patients with healed (clinical, etiologic, anatomic and pathophysiologic (CEAP) classification, C5) and open (C6) chronic venous ulceration (CVU). Methods Between 1 March 2005 and 31 December 2009, 130 consecutive patients (132 limbs, 49 CEAP C5, 83 C6) of median age 70 (interquartile range (IQR) 56–76) years underwent UGFS as part of their treatment for CVU. Results The median (IQR) follow-up time was 16 (12–32) months. One C6 patient moved abroad 1 week after UGFS and was lost to follow-up. Healing was observed in 67/82 (82%) remaining C6 patients at a median (IQR) of 1 (1–2) month following their first UGFS treatment. In 49 limbs originally treated for C5 disease, and in 67 limbs treated for C6 that healed following UGFS, there were five recurrent ulcers during the follow-up period, giving a 4.9% Kaplan–Meier estimate of recurrence at 2 years. In legs treated for C6 and C5 disease, the median (IQR) ulcer-free periods were 22 (IQR 9–32) and 14 (IQR 8–36) months, respectively. Discussion Healing rates following UGFS for CVU are comparable to those reported after surgery but recurrence may be lower. UGFS is a safe, clinically effective and, thus, highly attractive minimally invasive alternative to surgery in patients with C5 and C6 disease.

IntroductionDigital photoplethysmography (PPG) provides an inexpensive, reproducible, quantitative, non-invasive assessment of lower limb venous function.AimTo examine the relationship between venous refilling time (VRT) and severity of venous disease, and also between changes in VRT and symptomatic improvement after ultrasound guided foam sclerotherapy (UGFS) for symptomatic superficial venous reflux (SVR).MethodsPrior to and 6 months after UGFS, 246 patients (317 limbs) completed a symptom questionnaire, underwent duplex ultrasonography and clinical assessment, and VRT measurement by digital PPG. Health related quality of life (HRQL) questionnaires were also completed.ResultsMedian VRT improved from 11 to 31 s (P

Background:The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that survival in patients with severe lower limb ischemia (rest pain, tissue loss) who survived postintervention for >2 years after initial randomization to bypass surgery (BSX) vs balloon angioplasty (BAP) was associated with an improvement in subsequent amputation-free and overall survival of about 6 and 7 months, respectively. We now compare the effect on hospital costs and health-related quality of life (HRQOL) of the BSX-first and BAP-first revascularization strategies using a within-trial cost-effectiveness analysis.Methods: We measured HRQOL using the Vascular Quality of Life Questionnaire (VascuQol), the Short Form 36 (SF-36), and the EuroQol (EQ-5D) health outcome measure up to 3 years from randomization. Hospital use was measured and valued using United Kingdom National Health Service hospital costs over 3 years. Analysis was by intention-to-treat. Incremental cost-effectiveness ratios were estimated for cost per quality-adjusted life-year (QALY) gained. Uncertainty was assessed using nonparametric bootstrapping of incremental costs and incremental effects.Results: No significant differences in HRQOL emerged when the two treatment strategies were compared. During the first year from randomization, the mean cost of inpatient hospital treatment in patients allocated to BSX ($34,378) was estimated to be about $8469 (95% confidence interval, $2,417-$14,522) greater than that of patients allocated to BAP ($25,909). Owing to increased costs subsequently incurred by the BAP patients, this difference decreased at the end of follow-up to $5521 ($45,322 for BSX vs $39,801 for BAP) and was no longer significant. The incremental cost-effectiveness ratio of a BSX-first strategy was $184,492 per QALY gained. The probability that BSX was more cost-effective than BAP was relatively low given the similar distributions in HRQOL, survival, and hospital costs.Conclusions: Adopting a BSX-first strategy for patients with severe limb ischemia does result in a modest increase in hospital costs, with a small positive but insignificant gain in disease-specific and generic HRQOL. However, the real-world choice between BSX-first and BAP-first revascularization strategies for severe limb ischemia due to infrainguinal disease cannot depend on costs alone and will require a more comprehensive consideration of individual patient preferences conditioned by expectations of survival and other health outcomes. ( J Vase Surg 2010;51:43S-51S.)

Background: An intention-to-treat analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI) due to infrainguinal disease who survived for 2 years after intervention, initial randomization to a bypass surgery (BSX)-first vs balloon angioplasty (BAP)-first revascularization strategy was associated with improvements in subsequent overall survival (OS) and amputation-free survival (AFS) of about 7 and 6 months, respectively. This study explored the value of baseline factors to estimate the likelihood of survival to 2 years for the trial cohort (Cox model) and for individual BASIL trial patients (Weibull model) as an aid to clinical decision making.Methods: Of 452 patients presenting to 27 United Kingdom hospitals, 228 were randomly assigned to a BSX-first and 224 to a BAP-first revascularization strategy. Patients were monitored for at least 3 years. Baseline factors affecting the survival of the entire cohort were examined with a multivariate Cox model. The chances of survival at 1 and 2 years for patients with given baseline characteristics were estimated with a Weibull parametric model.Results: At the end of follow-up, 172 patients (38%) were alive without major limb amputation of the trial leg, and 202 (45%) were alive. Baseline factors that were significant in the Cox model were BASIL randomization stratification group, below knee Bollinger angiogram score, body mass index, age, diabetes, creatinine level, and smoking status. Using these factors to define five equally sized groups, we identified patients with 2-year survival rates of 50% to 90%. The factors that contributed to the Weibull predictive model were age, presence of tissue loss, serum creatinine, number of ankle pressure measurements detectable, maximum ankle pressure measured, a history of myocardial infarction or angina, a history of stroke or transient ischemia attack, below knee Bollinger angiogram score, body mass index, and smoking status.Conclusions: Patients in the BASIL trial were at high risk of amputation and death regardless of revascularization strategy. However, baseline factors can be used to stratify those risks. Furthermore, within a parametric Weibull model, certain of these factors can be used to help predict outcomes for individuals. It may thus be possible to define the clinical and anatomic (angiographic) characteristics of SLI patients who are likely and not likely to live for >2 years after intervention. Used appropriately in the context of the BASIL trial outcomes, this may aid clinical decision making regarding a BSX- or BAP-first revascularization strategy in SLI patients like those randomized in BASIL. ( J Vase Surg 2010;51:52S-68S.)

Identification of patients colonized with methicillin-resistant Staphylococcus aureus (MRSA) and subsequent isolation and decolonization is pivotal to the control of cross infection in hospitals. The aim of this study was to establish if early identification of colonized patients using rapid methods alone reduces transmission. A prospective, cluster, two-period cross-over design was used. Seven surgical wards at a large hospital were allocated to two groups, and for the first 8 months four wards used rapid MRSA screening and three wards used a standard culture method. The groups were reversed for the second 8 months. Regardless of the method of detection, all patients were screened for nasal carriage on admission and then every 4 days. MRSA control measures remained constant. Results were analysed using a log linear Poisson regression model. A total of 12 682/13 952 patient ward episodes (PWE) were included in the study. Admission screening identified 453 (3.6%) MRSA-positive patient ward episodes, with a further 268 (2.2%) acquiring MRSA. After adjusting for other variables, rapid screening was shown to statistically reduce MRSA acquisition, with patients being 1.49 times (p 0.007) more likely to acquire MRSA in wards where they were screened using the culture method. Screening of surgical patients using rapid testing resulted in a statistically significant reduction in MRSA acquisition. This result was achieved in a routine surgical service with high bed occupancy and low availability of isolation rooms, making it applicable to the majority of health-care systems worldwide.

Health-related quality of life (HRQOL) improves after superficial venous surgery for varicose veins, but the effect of ultrasound-guided foam sclerotherapy on HRQOL is unknown. The aim of this study was to determine changes in HRQOL after ultrasound-guided foam sclerotherapy for varicose veins.Consecutive patients undergoing ultrasound-guided foam sclerotherapy for varicose veins were sent the Short Form 12 (SF-12) questionnaire, a generic measure of HRQOL, and the Aberdeen Varicose Vein Symptom Score (AVSS) questionnaire, a disease-specific measure of HRQOL, 1 week before treatment and 1, 6, and 12 months after treatment.The study enrolled 296 patients (34% male; 395 treated legs) with a median age of 57 years (range, 22-89 years). Of these, 24% had had previous superficial venous surgery, and 66% were CEAP C(2-3) (uncomplicated varicose veins). Questionnaire completion rates were 82%, 73%, and 69% at 1, 6, and 12 months after treatment. The median Physical Component Summary score of the SF-12 (higher score indicates better HRQOL) improved from 47.6 pretreatment to 49.4 at 1 month (P.008, Wilcoxon signed rank test), to 51.9 at 6 months (P.0005), and to 52.9 at 12 months (P.0005). The median AVSS (lower score indicates better HRQOL) improved from 19.0 pretreatment to 16.5 at 1 month (P.0005), to 8.7 at 6 months (P.0005), and to 8.6 at 12 months (P.0005).Ultrasound-guided foam sclerotherapy for great and small saphenous varicose veins leads to significant improvements in generic and disease-specific HRQOL for at least 12 months after treatment.

Objectives When compared to compression therapy alone, surgical correction of superficial venous reflux (SVR) reduces recurrence but does not appear to increase healing of chronic venous ulceration (CVU). The role of ultrasound-guided foam sclerotherapy (UGFS) of SVR as part of the treatment of CVU remains uncertain. The aim of this study is to describe CVU healing and recurrence rates after UGFS and to relate these outcomes to patterns of pre- and post-intervention venous reflux. Methods A prospective study of 27 consecutive patients (28 legs) of median age 69 (interquartile range 54–79) years undergoing UGFS for SVR in addition to compression for treatment of CVU of median duration 12 (IQR 6–23) months. Prior to and 1, 6, and 12 months after treatment patients underwent clinical and duplex assessment. Results 8 limbs (29%) had deep and superficial venous reflux, and 20 limbs had SVR alone. There was a history of DVT in 4 limbs, and 4 patients were on warfarin. No limbs had significant arterial disease and all received post-UGFS compression. Median volume of (3% STD) foam used was 8 (range 2–14) ml. 1, 3 and 6 months after UGFS, 22 (79%), 27 (96%) and 27 (96%) CVU had healed. At 12 months, 25 ulcers remained healed, 2 ulcers had recurred; one patient had died from carcinomatosis. Discussion Following UGFS as an adjunct to compression, 96% of CVU healed within 3 months and only 2 healed ulcers (7%) had recurred at 12 months. UGFS appears to be an attractive minimally-invasive alternative to surgery to treat SVR in patients with CVU, especially the elderly and frail.

BackgroundThe advantages of minimally invasive alternatives such as ultrasound-guided foam sclerotherapy (UGFS) over conventional surgery for the treatment of varicose veins include lower morbidity and faster recovery times. The aim was to compare morbidity, analgesia use, and time to return to driving and work following UGFS with those reported after conventional surgery for varicose veins.MethodsPatients who had UGFS or surgery for varicose veins were sent a questionnaire 4 weeks after treatment.ResultsA total of 332 (84·9 per cent) of 391 patients who had UGFS and 53 (56 per cent) of 94 who had surgery returned a questionnaire. The groups were similar in terms of age, sex, and the proportion who had treatment of bilateral or recurrent veins. Patients who had surgery were more likely to have significant bruising (44 versus 7·2 per cent; P < 0·001) and pain (17 versus 5·5 per cent; P = 0·001). After UGFS, 43·2 per cent of patients returned to work within 24 h compared with none who had surgery (P < 0·001). Patients who had UGFS were more likely to return to driving within 4 days (P = 0·014).ConclusionUGFS was associated with less pain and analgesia requirement, time off work and quicker return to driving.

Background The results of surgery for small saphenous varicose vein (SSV) varicosities may be suboptimal in terms of recurrence and complications. The role of minimally invasive alternatives remains incompletely defined. The aim was to review the medium-term outcomes of ultrasound-guided foam sclerotherapy (UGFS) for SSV. Methods Eighty-six patients (92 legs) undergoing UGFS for SSV were assessed before, and 1, 6 and 12 months after treatment. Outcome measures were occlusion of, and abolition of reflux in, the SSV (technical success), absence of visible varicose veins (clinical success) and improvement in disease-specific health-related quality of life (HRQL) following treatment (Aberdeen Varicose Vein Symptom Severity Score (AVSS)). Results The technical and clinical success rates at 12 months were 91 and 93 per cent respectively; only three patients required a second treatment. After treatment of isolated SSV varicosities there was a significant improvement in AVSS, from a median of 19·0 (interquartile range 13·4–26·8) before treatment to 10·2 (4·0–18·3) and 9·7 (3·5–19·1) at 6 and 12 months respectively. The only complication was a popliteal vein thrombosis that required anticoagulation. Conclusion UGFS was an effective treatment for SSV, with abolition of reflux and visible varicose veins, and improvement in HRQL for at least 12 months.