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Methods: This was an open, multicentre, randomized controlled trial. Patients with intermittent claudication attending vascular surgery outpatient clinics were randomized (1:1) to receive either neuromuscular electrical stimulation (NMES) or not in addition to local standard care available at study centres (best medical therapy alone or plus supervised exercise therapy (SET)). The objective of this trial was to investigate the clinical efficacy of an NMES device in addition to local standard care in improving walking distances in patients with claudication. The primary outcome was change in absolute walking distance, measured by a standardized treadmill test at 3 months. Secondary outcomes included intermittent claudication (IC) distance, adherence, quality of life, and haemodynamic changes., Results: Of 200 participants randomized, 160 were included in the primary analysis (intention to treat, Tobit regression model). The square root of absolute walking distance was analysed (due to a right-skewed distribution) and, although adjunctive NMES improved it at 3 months, no statistically significant effect was observed. SET as local standard care seemed to improve distance compared to best medical therapy at 3 months (3.29 units; 95 per cent c.i., 1.77 to 4.82; P < 0.001). Adjunctive NMES improved distance in mild claudication (2.88 units; 95 per cent c.i., 0.51 to 5.25; P = 0.02) compared to local standard care at 3 months. No serious adverse events relating to the device were reported., Conclusion: Supervised exercise therapy is effective and NMES may provide further benefit in mild IC.This trial was supported by a grant from the Efficacy and Mechanism Evaluation Program, a Medical Research Council and National Institute for Health and Care Research partnership. Trial registration: ISRCTN18242823., (© The Author(s) 2023. Published by Oxford University Press on behalf of BJS Society Ltd.)

Objective: The aim of this study was to identify potential biomarkers predictive of healing or failure to heal in a population with venous leg ulceration., Summary Background Data: Venous leg ulceration presents important physical, psychological, social and financial burdens. Compression therapy is the main treatment, but it can be painful and time-consuming, with significant recurrence rates. The identification of a reliable biochemical signature with the ability to identify nonhealing ulcers has important translational applications for disease prognostication, personalized health care and the development of novel therapies., Methods: Twenty-eight patients were assessed at baseline and at 20 weeks. Untargeted metabolic profiling was performed on urine, serum, and ulcer fluid, using mass spectrometry and nuclear magnetic resonance spectroscopy., Results: A differential metabolic phenotype was identified in healing (n = 15) compared to nonhealing (n = 13) venous leg ulcer patients. Analysis of the assigned metabolites found ceramide and carnitine metabolism to be relevant pathways. In this pilot study, only serum biofluids could differentiate between healing and nonhealing patients. The ratio of carnitine to ceramide was able to differentiate between healing phenotypes with 100% sensitivity, 79% specificity, and 91% accuracy., Conclusions: This study reports a metabolic signature predictive of healing in venous leg ulceration and presents potential translational applications for disease prognostication and development of targeted therapies., Competing Interests: Conflicts of Interest and Source of Funding: M.S.G., E.H., and A.H.D. were recipients of a research grant from Laboratories Urgo (P37702), which supported consumable, assay, and salary costs for this study. M.B. and S.B. are Laboratoires URGO employees. Infrastructure support for this work was provided by the NIHR Imperial Biomedical Research Center. The authors report no conflicts of interests., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Adequate tissue perfusion is an important prognostic and diagnostic factor during the management of lower limb peripheral arterial disease. Convenient and real-time tissue perfusion monitoring remains an elusive challenge., Methods: Tissue perfusion on the dorsal and plantar surfaces of both feet of 20 participants was measured during and after cuff-induced ischemia using a novel 4-channel, laser-based perfusion monitoring device based on diffuse speckle contrast analysis technology (Pedra sensors). Participants were free of significant peripheral arterial disease. Transcutaneous partial pressure of oxygen (TcPO2) measurements were recorded concurrently for comparison., Results: Pedra sensors detected perfusion changes significantly more quickly than TcPO2 sensors. One minute after induced ischemia, the mean percent changes from baseline values (before ischemia) were -22.7±32.0% and -3.1±8.8% (P<0.001) for Pedra and TcPO2 sensors, respectively. One minute into induced ischemia, Pedra sensors had reached 50.5% of the 5-minute ischemia reading whereas TcPO2 sensors had reached only 18.6% of the 5-minute reading (P=0.046). Pedra sensors reported hyperemia immediately after cuff release with a mean percent change from baseline of 143.8±122.3%/173.4±121.8% on the dorsal/plantar surfaces while TcPO2 measurements were still recording negative changes at that time (-26.7±19.4%/-18.6±24.4% dorsal/plantar). Pedra sensors exhibited markedly lower interobserver and intraobserver variability than TcPO2 sensors., Conclusions: A device based on diffuse speckle contrast analysis reported tissue perfusion in real time. Cuff-induced ischemia and hyperemia following cuff release were rapidly and consistently detected on both the dorsal and plantar surfaces of the foot. Diffuse speckle contrast analysis may have value for real-time perfusion monitoring during angiography procedures.

Objective: Determine standards of referral and management of patients with venous leg ulceration in primary care after the release of the EVRA (A Randomized Trial of Early Endovenous Ablation in Venous Ulceration) study results., Methods: An online questionnaire was disseminated over four months to professionals working within primary care., Results: The survey received 643 responses. Of respondents, 90 (14%) had heard of the EVRA trial and 51 (8%) were familiar with the results. Of those who answered the following questions, 410 (69.1%) stated that referral to a vascular specialist must be made by the General Practitioner and 13 (2.2%) reported that they would always refer patients for secondary care assessment before the publication of EVRA. Considering the EVRA results, 128 (29%) reported that they would change practice regarding referral and would experience no barriers and 198 (45%) reported that they would like to refer earlier but is not their decision. Barriers to changing practice included local referral policies, training and time restrictions, 266 (59%) had heard of the NICE guideline (CG168) and 194 (43%) were aware of the recommendations for referral to a vascular service within two weeks for patients with an open or healed ulcer., Conclusion: There is a considerable variation in local referral pathways for venous leg ulceration, and despite clinicians wanting to refer promptly, many primary care professionals are unable to. Unfortunately, the EVRA study alone may not change the overall practice, and work is needed to overcome barriers faced by primary care professionals.

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.

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  < 0.001 for non-inferiority), the results indicate that non-inferiority of low-molecular-weight heparin alone was shown., 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.

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  < 0.001), EuroQol-5 Dimensions index values ( 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., Competing Interests: Manjit S Gohel has received personal fees from Medtronic pLc (Minneapolis, MN, USA) and Cook Medical LLC (Bloomington, IN, USA), plus a grant from Laboratoires Urgo S.A. (Chenôve, France). Andrew Bradbury had committee membership for the National Institute for Health Research Health Technology Assessment (HTA) Prioritisation Group and HTA Surgery Themed Call Board 2012–13, HTA Efficient Study Designs Board 2014–16, HTA Interventional Procedures Methods Group 2015–19 and HTA IP Panel 2015–19. In addition, Andrew Bradbury has received funding from STD Pharmaceutical Products Ltd (Hereford, UK) to travel to a foam sclerotherapy workshop in Tehran, Iran, in October 2016 and a grant to cover costs of undertaking a post-authorisation safety study in the UK and Europe. He also sat on the National Institute for Health and Care Excellence (NICE) committee for a clinical guideline (CG168) for the diagnosis and management of varicose veins. Nicky Cullum had committee membership on the HTA Commissioning Board from 2003 to 2008. David M Epstein has received grant funding from Vascular Insights LLC (Quincy, MA, USA) which was administered by the University of Granada. Alun H Davies has received grant funding from Medtronic, Vascular Insights, Laboratoires Urgo, Vascutek (Inchinnan, UK) and Actegy Health Ltd (Bracknell, UK), which are administered by Imperial College London. In addition, Alun H Davies has chaired the NICE clinical guideline (CG168) for the diagnosis and management of varicose veins.

Background: Treatment of superficial venous reflux in addition to compression therapy accelerates venous leg ulcer healing and reduces ulcer recurrence. The aim of this study was to evaluate the costs and cost-effectiveness of early versus delayed endovenous treatment of patients with venous leg ulcers., Methods: This was a within-trial cost-utility analysis with a 1-year time horizon using data from the EVRA (Early Venous Reflux Ablation) trial. The study compared early versus deferred endovenous ablation for superficial venous truncal reflux in patients with a venous leg ulcer. The outcome measure was the cost per quality-adjusted life-year (QALY) over 1 year. Sensitivity analyses were conducted with alternative methods of handling missing data, alternative preference weights for health-related quality of life, and per protocol., Results: After early intervention, the mean(s.e.m.) cost was higher (difference in cost per patient £163(318) (€184(358))) and early intervention was associated with more QALYs at 1 year (mean(s.e.m.) difference 0·041(0·017)). The incremental cost-effectiveness ratio (ICER) was £3976 (€4482) per QALY. There was an 89 per cent probability that early venous intervention is cost-effective at a threshold of £20 000 (€22 546)/QALY. Sensitivity analyses produced similar results, confirming that early treatment of superficial reflux is highly likely to be cost-effective., Conclusion: Early treatment of superficial reflux is highly likely to be cost-effective in patients with venous leg ulcers over 1 year. Registration number: ISRCTN02335796 (http://www.isrctn.com)., (© 2019 BJS Society Ltd Published by John Wiley & Sons Ltd.)

Introduction: While traditional ambulatory phlebectomy (AP) is a safe and effective procedure, few adverse effects such as hematoma, bleeding, bruising and nerve injury have been reported. To improve AP and to reduce some of these adverse events, herein we report a novel technique - Foam Sclerotherapy Assisted Phlebectomy (SAP)., Report: The details of the above technique, along with the potential advantages and limitations will be discussed., Discussion: Foam sclerotherapy and DUS act as valuable adjuncts to traditional AP. SAP increases precision and creates additional venospasm leading to reduced bruising, reduced nerve injury and sclerosis of residual vein segments.

Objectives: Compression stockings are commonly prescribed for patients with a range of venous disorders, but are difficult to don and uncomfortable to wear. This study aimed to investigate compliance and complications of compression stockings in patients with chronic venous disease (CVD) and post-thrombotic syndrome (PTS)., Methods: A literature search of the following databases was carried out: MEDLINE (via PubMed), EMBASE (via OvidSP, 1974 to present), and CINAHL (via EBSCOhost). Studies evaluating the use of compression stockings in patients with CVD (CEAP C2-C5) or for the prevention or treatment of PTS were included. After scrutinising full text articles, compliance with compression and associated complications were assessed. Compliance rates were compared based on study type and degree of compression. Good compliance was defined as patients wearing compression stockings for >50% of the time., Results: From an initial search result of 4303 articles, 58 clinical studies (37 randomised trials and 21 prospective studies) were selected. A total of 10,245 limbs were included, with compression ranging from 15 to 40 mmHg (not stated in 12 studies) and a median follow-up of 12 months (range 1-60 months). In 19 cohorts, compliance was not assessed and in a further nine, compliance was poorly specified. Overall, good compliance with compression was reported for 5371 out of 8104 (66.2%) patients. The mean compliance, weighted by study size, appeared to be greater for compression ≤25 mmHg (77%) versus > 25 mmHg (65%) and greater in the randomised studies (74%) than in prospective observational studies (64%). Complications of stockings were not mentioned in 43 out of 62 cohorts reviewed. Where complications were considered, skin irritation was a common event., Conclusions: In published trials, good compliance with compression is reported in around two thirds of patients, with inferior compliance in those given higher degrees of compression. Further studies are required to identify predictors of non-compliance, to help inform the clinical management of these patients. Complications of compression are not documented in many studies and should be given more consideration in the future., (Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Background: Varicose veins and chronic venous disease are common, and some funding bodies ration treatment based on a minimum diameter of the incompetent truncal vein. This study assessed the effect of maximum vein diameter on clinical status and patient symptoms., Methods: A prospective observational cohort study of patients presenting with symptomatic varicose veins to a tertiary referral public hospital vascular clinic between January 2011 and July 2012. Patients underwent standardized assessment with venous duplex ultrasonography, and completed questionnaires assessing quality of life (QoL) and symptoms (Aberdeen Varicose Vein Questionnaire, EuroQol Five Domain QoL assessment and EuroQol visual analogue scale). Clinical scores (Venous Clinical Severity Score (VCSS) and Clinical Etiologic Anatomic Pathophysiologic (CEAP) class) were also calculated. Regression analysis was used to investigate the relationship between QoL, symptoms and vein diameter., Results: Some 330 patients were assessed before surgery. The median maximum vein diameter was 7·0 (i.q.r. 5·3-9·2) mm overall, 7·9 (6·0-9·8) mm for great saphenous vein and 6·0 (5·2-8·9) mm for small saphenous vein. In linear regression analysis, vein diameter was shown to have a significant association with VCSS (P = 0·041). For every 1-mm increase in vein diameter, there was a 2·75-fold increase in risk of being in CEAP class C4 compared with C2. No other QoL or symptom measures were related to vein diameter., Conclusion: Incompetent truncal vein diameter was associated with increasing VCSS, but not a variety of other varicose vein disease-specific and generic patient-reported outcome measures., (© 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.)

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)., (Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Introduction: Acute kidney injury (AKI) following ruptured abdominal aortic aneurysm (rAAA) repair is common and multifactorial. A standard definition of AKI after endovascular repair (EVAR), the Aneurysm Renal Injury Score (ARISe), has been proposed to facilitate standardised reporting and thus improve understanding of this issue., Methods: Data were collected retrospectively on AKI in a prospectively maintained database of all patients treated for rAAA in a single tertiary referral centre since the availability of routine out of hours emergency EVAR. The ARISe score was used to describe the degree of AKI and factors which correlated with poor renal outcomes were assessed., Results: Two-hundred and five patients were treated between January 2006 and April 2014. Of these, 125 were treated with open repair (OSR) and 80 were treated with EVAR. Severe AKI (defined as ARISe score ≥3) occurred in 36% of patients. After correction for confounders, patients treated with OSR were significantly more likely to develop severe AKI (43% vs. 26%, p = .02). There was no significant difference in preoperative serum creatinine between groups, but increased preoperative serum creatinine was strongly associated with severe AKI postoperatively (p < .001). Age, sex, endograft type, and preoperative CT scanning were not associated with differences in renal outcomes. Clamp position above renal arteries was predictive of severe AKI in patients treated with OSR (p < .01). Patients suffering severe AKI had significantly higher mortality at 30 days and 12 months (28% vs. 5% and 44% vs. 13%, p < .001 for both comparisons)., Conclusion: Severe AKI is common following successful repair of rAAA. In this large case series of high-risk patients, OSR was associated with significantly higher rates of severe AKI compared with EVAR, despite the increased dose of contrast involved in EVAR and the older age of these patients. In turn, severe AKI was associated with higher mortality rates., (Copyright © 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Background: With the advent of endovenous truncal ablation under local anaesthetic for the treatment of varicose veins, the fate of varicosed tributaries has become controversial, with centres offering different timings of treatment, if offered at all. This study aims to review the literature assessing delayed and simultaneous varicosity treatment during truncal ablation., Methods: Randomised trials and cohort studies concerning varicosity treatment timing were identified through a systematic literature search. Requirements for further treatment, quality of life and rate of venous thrombotic events were assessed for meta-analysis., Results: Four studies were identified assessing need for further varicosity procedure, with no significant difference seen between simultaneous or delayed treatment (p = 0.339). Two studies assessed quality of life, with simultaneous treatment providing significantly improved outcomes at six weeks (p = 0.029) but not at 12 weeks (p = 0.283). Studies examining venous thrombotic events showed no difference in venous thromboembolism rate between simultaneous or delayed treatment approaches (p = 0.078)., Conclusion: The evidence base regarding timing of varicosity treatment is sparse; however, it does show that simultaneous treatment of varicosities leads to early gains in quality of life, with a non-significant trend for fewer further procedures but more venous thrombotic events., (© The Author(s) 2014.)

Background: Frailty is a multidimensional vulnerability resulting from age-associated decline. The impact of frailty on outcomes was assessed in a cohort of vascular surgical patients., Methods: The study included patients aged over 65 years with length of hospital stay (LOS) greater than 2 days, who were admitted to a tertiary vascular unit over a single calendar year. Demographics, mode of admission, diagnosis, mortality, LOS and discharge destination were recorded, as well as a variety of frailty-specific characteristics. The impact of frailty on LOS, discharge destination, survival and readmission rate was assessed using multivariable regression techniques. The ability of the models to predict these outcomes was also assessed., Results: In total, 413 patients of median age 77 years were followed for a median of 18 (range 12-24) months. The in-hospital, 3- and 12-month mortality rates were 3·6, 8·5 and 13·8 per cent respectively. Receiver operating characteristic (ROC) curve analysis revealed that frailty-based regression models were excellent predictors of 12-month mortality (area under the ROC curve (AUC) = 0·81), prolonged LOS (AUC = 0·79) and discharge to a care institution (AUC = 0·84). A simple additive frailty score using six key features retained strong predictive power for 12-month mortality (AUC = 0·83), discharge to a care institution (AUC = 0·78) and prolonged LOS (AUC = 0·74). This frailty score was also strongly associated with readmission rates (P < 0·001)., Conclusion: Frailty in vascular surgery patients predicts a multiplicity of poorer outcomes. Optimal management should include identification of at-risk patients and treatment of modifiable risk factors., (© 2015 BJS Society Ltd Published by John Wiley & Sons Ltd.)

Background: Accurate adjustment of surgical outcome data for risk is vital in an era of surgeon-level reporting. Current risk prediction models for abdominal aortic aneurysm (AAA) repair are suboptimal. We aimed to develop a reliable risk model for in-hospital mortality after intervention for AAA, using rigorous contemporary statistical techniques to handle missing data., Methods: Using data collected during a 15-month period in the United Kingdom National Vascular Database, we applied multiple imputation methodology together with stepwise model selection to generate preoperative and perioperative models of in-hospital mortality after AAA repair, using two thirds of the available data. Model performance was then assessed on the remaining third of the data by receiver operating characteristic curve analysis and compared with existing risk prediction models. Model calibration was assessed by Hosmer-Lemeshow analysis., Results: A total of 8088 AAA repair operations were recorded in the National Vascular Database during the study period, of which 5870 (72.6%) were elective procedures. Both preoperative and perioperative models showed excellent discrimination, with areas under the receiver operating characteristic curve of .89 and .92, respectively. This was significantly better than any of the existing models (area under the receiver operating characteristic curve for best comparator model, .84 and .88; P < .001 and P = .001, respectively). Discrimination remained excellent when only elective procedures were considered. There was no evidence of miscalibration by Hosmer-Lemeshow analysis., Conclusions: We have developed accurate models to assess risk of in-hospital mortality after AAA repair. These models were carefully developed with rigorous statistical methodology and significantly outperform existing methods for both elective cases and overall AAA mortality. These models will be invaluable for both preoperative patient counseling and accurate risk adjustment of published outcome data., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Although the clinical benefits of endovenous thermal ablation are widely recognized, few studies have evaluated the health economic implications of different treatments. This study compares 6-month clinical outcomes and cost-effectiveness of endovenous laser ablation (EVLA) compared with radiofrequency ablation (RFA) in the setting of a randomized clinical trial., Methods: Patients with symptomatic primary varicose veins were randomized to EVLA or RFA and followed up for 6 months to evaluate clinical improvements, health related quality of life (HRQOL) and cost-effectiveness., Results: A total of 131 patients were randomized, of which 110 attended 6-month follow-up (EVLA n = 54; RFA n = 56). Improvements in quality of life (AVVQ and SF-12v2) and Venous Clinical Severity Scores (VCSS) achieved at 6 weeks were maintained at 6 months, with no significant difference detected between treatment groups. There were no differences in treatment failure rates. There were small differences in favor of EVLA in terms of costs and 6-month HRQOL but these were not statistically significant. However, RFA is associated with less pain at up to 10 days., Conclusions: EVLA and RFA result in comparable and significant gains in quality of life and clinical improvements at 6 months, compared with baseline values. EVLA is more likely to be cost-effective than RFA but absolute differences in costs and HRQOL are small.

Objective: Fenestrated and branched endovascular devices are increasingly used for complex aortic diseases, and despite the challenging nature of these procedures, early experiences from pioneering centers have been encouraging. The objectives of this retrospective study were to report our experience of intraoperative adverse events (IOAEs) during fenestrated and branched stent grafting and to analyze the impact on clinical outcomes., Methods: Consecutive patients treated with fenestrated and branched stent grafting in a tertiary vascular center between February 2006 and October 2013 were evaluated. A prospectively maintained computerized database was scrutinized and updated retrospectively. Intraoperative angiograms were reviewed to identify IOAEs, and adverse events were categorized into three types: target vessel cannulation, positioning of graft components, and intraoperative access. Clinical consequences of IOAEs were analyzed to ascertain whether they were responsible for death or moderate to severe postoperative complications., Results: During the study period, 113 consecutive elective patients underwent fenestrated or branched stent grafting. Indications for treatment were asymptomatic complex abdominal aortic aneurysms (CAAAs, n = 89) and thoracoabdominal aortic aneurysms (TAAAs, n = 24). Stent grafts included fenestrated (n = 79) and branched (n = 17) Cook stent grafts (Cook Medical, Bloomington, Ind), Ventana (Endologix, Irvine, Calif) stent grafts (n = 9), and fenestrated Anaconda (Vascutek Terumo, Scotland, UK) stent grafts (n = 8). In-hospital mortality rates for the CAAA and TAAA groups were 6.7% (6 of 89) and 12.5% (3 of 24), respectively. Twenty-eight moderate to severe complications occurred in 21 patients (18.6%). Spinal cord ischemia was recorded in six patients, three of which resolved completely. A total of 37 IOAEs were recorded in 34 (30.1%) patients (22 CAAAs and 12 TAAAs). Of 37 IOAEs, 15 (40.5%) resulted in no clinical consequence in 15 patients; 17 (45.9%) were responsible for moderate to severe complications in 16 patients, and five (13.5%) led to death in four patients. The composite end point death/nonfatal moderate to severe complication occurred more frequently in patients with IOAEs compared with patients without IOAEs (20 of 34 vs 12 of 79; P < .0001)., Conclusions: In this contemporary series, IOAEs were relatively frequent during branched or fenestrated stenting procedures and were often responsible for significant complications., (Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Critical limb ischemia (CLI) is a common condition associated with high levels of morbidity and mortality. Most work to date has focused on surgeon-oriented outcomes such as patency, but there is increasing interest in patient-oriented outcomes such as mobility and independence., Objective: This study was conducted to determine the effect of infrainguinal lower limb bypass surgery (LLBS) on postoperative mobility in a United Kingdom tertiary vascular surgery unit and to investigate causes and consequences of poor postoperative mobility., Methods: We collected data on all patients undergoing LLBS for CLI at our institution during a 3-year period and analyzed potential factors that correlated with poor postoperative mobility., Results: During the study period, 93 index LLBS procedures were performed for patients with CLI. Median length of stay was 11 days (interquartile range, 11 days). The 12-month rates of graft patency, major amputation, and mortality were 75%, 9%, and 6%, respectively. Rates of dependence increased fourfold during the first postoperative year, from 5% preoperatively to 21% at 12 months. Predictors of poor postoperative mobility were female sex (P = .04) and poor postoperative mobility (P < .001), initially and at the 12-month follow-up. Patients with poor postoperative mobility had significantly prolonged hospital length of stay (15 vs 8 days; P < .001)., Conclusions: Patients undergoing LLBS for CLI suffer significantly impaired postoperative mobility, and this is associated with prolonged hospital stay, irrespective of successful revascularization. Further work is needed to better predict patients who will benefit from revascularization and in whom a nonoperative strategy is optimal., (Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: The unique and complex vascular and endovascular theatre environment is associated with significant risks of patient harm and procedural inefficiency. Accurate evaluation is crucial to improve quality. This pilot study attempted to design a valid, reproducible tool for observers and teams to identify and categorise errors., Methods: Relevant published literature and previously collected ethnographic field notes from over 250 h of arterial surgery were analysed. A comprehensive log of vascular procedural errors was compiled and twelve vascular experts graded each error for the potential to disrupt procedural flow and cause harm. Using this multimodal approach, the Imperial College Error CAPture (ICECAP) tool was developed. The tool was validated during 21 consecutive arterial cases (52 h operating-time) as an observer-led error capture record and as a prompt for surgical teams to determine the feasibility of error self-reporting., Results: Six primary categories (communication, equipment, procedure independent pressures, technical, safety awareness and patient related) and 20 error sub-categories were determined as the most frequent and important vascular procedural errors. Using the ICECAP, the number of errors detected correlated well between two observers (Spearman rho = 0.984, p < 0.001). Both observers identified all moderate or severe errors similarly and categorised all but 4/139 (2.9%) of the total errors in an identical fashion. Self-reporting of errors without prompting identified a mean of 24.4% (range 0-50%) of all recorded errors, whereas surgical teams reported a mean of 69.7% (range 50-100%) of errors when ICECAP error-category prompts were used., Conclusion: The ICECAP tool may be useful for capturing and categorising errors that occur during vascular/endovascular procedures. ICECAP may also have a role as an error recall prompt for self-reporting purposes by vascular surgical teams., (Copyright © 2012 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objective: To assess each of the scoring systems used to diagnose and classify post-thrombotic syndrome, a common chronic complication of deep vein thrombosis. The design of the study was a systematic review of the literature pertaining to post-thrombotic syndrome., Methods: A systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines by a search of PubMed (1948 to September 2011) using the search terms "post-thrombotic syndrome," "postthrombotic syndrome," "post-phlebitic syndrome," and "postphlebitic syndrome." A manual reference list search was also carried out to identify further studies that would be appropriate for inclusion. The various scoring systems in use were identified and assessed against a list of criteria to determine their validity for use. For outcome measures, each scoring system was assessed for specific criteria, including interobserver reliability, association with ambulatory venous pressures, ability to assess severity of post-thrombotic syndrome, ability to assess change in condition over time, and association with patient-reported symptom severity., Results: The Villalta, Ginsberg, Brandjes, Widmer, CEAP, and Venous Clinical Severity Score systems all were assessed for the stated outcome measures. From their use in the literature, only the Villalta score was able to fulfill all the criteria described. The main criticism of the Villalta score in the literature appears to be its use of subjective measures. To that end, we propose that use of a venous disease-specific quality-of-life questionnaire in combination with the Villalta score may help standardize the subjective criteria., Conclusions: The Villalta score, combined with a venous disease-specific quality-of-life questionnaire, should be considered the "gold standard" for the diagnosis and classification of post-thrombotic syndrome., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

A 73-year-old man developed type I and III endoleaks from a fractured right renal stent with downward migration of a fenestrated endograft, 6 years after endovascular repair of a juxtarenal aneurysm. Endovascular treatment attempts were unsuccessful. He underwent aortic debranching and antegrade visceral artery revascularization via a left thoracolaparotomy incision and an extraperitoneal approach to the visceral aorta. An antegrade aortic stent covered the endoleak, with technical and clinical success at 9 months. Failure of complex endografts presents particular problems, potentially not amenable to totally endovascular repair. Continued surveillance is mandated as late, asymptomatic sac expansion can occur., (Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Purpose: To assess the incidence of errors before and after implementation of a structured mental rehearsal prior to the endovascular phase of combined open/endovascular arterial procedures., Methods: Over 6 weeks, 15 combined open/endovascular procedures (7 abdominal aorta and 8 thoracic aorta) lasting 58 hours were evaluated by a trained observer. In a blinded fashion, 2 individuals scrutinized event logs for errors, which were categorized by type, by potential to cause patient harm (danger), and by potential to disrupt the procedure (delay). After 9 procedures, a focus group-devised structured mental rehearsal was implemented prior to the endovascular phase for 6 combined procedures. Error patterns were compared before and after implementation. Data are expressed as median (range)., Results: The error rate during the endovascular phase of the combined procedures was higher than the non-endovascular phase [7.64/hour (1.71-9.6) vs. 3.75/hour (1.71-5.54), respectively; p = 0.05]. Error rates during the endovascular phase were lower after the intervention compared to before [2.5/hour (1.4-6.0) vs. 7.6/hour (1.7-9.6), respectively; p = 0.05]. During the endovascular phase, danger and delay scores were also lower after the intervention [1.2/error (1.0-2.0) and 1.3/error (1.0-2.3), respectively] compared to before [1.75/error (1.4-2.5) and 2.0/error (1.3-2.5), respectively] (p = 0.036 and p = 0.036 for danger and delay, respectively)., Conclusion: A structured mental rehearsal before critical stages of procedures may reduce the rate and severity of intraoperative error.

Background: The aim of this paper is to review the potential role of endovascular interventions for young patients with lower-limb ischaemia., Methods: A literature search was performed of PubMed and Medline databases using appropriate search terms and limits. Case reports, retrospective studies, and prospective studies evaluating treatment of lower-limb ischemia in patients aged <50 years were scrutinized. Articles published between 1966 and 2010 were included in this review., Results: Premature atherosclerosis is likely to represent the commonest cause of lower-limb ischemia in patients aged <50 years, although the incidence of nonatherosclerotic causes such as popliteal entrapment syndrome, cystic adventitial disease, and arteritis in these patients is greater than in older patients. As with older patients, endovascular interventions may be beneficial for patients with symptoms secondary to atherosclerosis. At present, the perceived durability of open surgery may be more preferable to patients aged <50 years, but the development of new endovascular technology is challenging this view. Endovascular interventions such as catheter-directed thrombolysis have specific roles in the treatment of lower-limb ischemia due to nonatherosclerotic causes., Conclusion: The use of angioplasty and stenting procedures to treat young patients with lower-limb ischemia is increasing and has specific roles. However, many developmental causes and nonatherosclerotic conditions still require primary surgical correction., (Copyright © 2012 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.)

High blood pressure is responsible for the modulation of blood vessel morphology and function. Arterial hypertension is considered to play a significant role in atherosclerotic ischaemic heart disease, stroke and hypertensive nephropathy, whereas high venous pressure causes varicose vein formation and chronic venous insufficiency and contributes to vein bypass graft failure. Hypertension exerts differing injurious forces on the vessel wall, namely shear stress and circumferential stretch. Morphological and molecular changes in blood vessels ascribed to elevated pressure consist of endothelial damage, neointima formation, activation of inflammatory cascades, hypertrophy, migration and phenotypic changes in vascular smooth muscle cells, as well as extracellular matrix imbalances. Differential expression of genes encoding relevant factors including vascular endothelial growth factor, endothelin-1, interleukin-6, vascular cell adhesion molecule, intercellular adhesion molecule, matrix metalloproteinase-2 and -9 and plasminogen activator inhibitor-1 has been explored using ex vivo cellular or organ stretch models and in vivo experimental animal models. Identification of pertinent genes may unravel new therapeutic strategies to counter the effects of pressure-induced stretch on the vessel wall and hence minimise its notable complications., (Copyright © 2012 S. Karger AG, Basel.)

Objectives: To investigate failures in patient safety for patients undergoing vascular and endovascular procedures to guide future quality and safety interventions., Design: Single centre prospective observational study., Methods: 66 procedures (17 thoracoabdominal and 23 abdominal aortic aneurysms, 4 carotid and 22 limb procedures) were observed prospectively over a 9-month period (251 h operating time) by two trained observers. Event logs were recorded for each procedure. Two blinded experts identified and independently categorised failures into 22 types (using a validated category tool) and severity (5-point scale). Data are expressed as median (range). Statistical analysis was performed using Mann-Whitney U, Kruskal-Wallis and Spearman's Rank tests., Results: 1145 failures were identified with good inter-assessor reliability (Cronbach's alpha 0.844). The commonest failure types related to equipment (including unavailability, configuration and other failures) (269/1145 [23.5%]) and communication (240/1145 [21.0%]). A comparatively lower number of technical and psychomotor failures were identified (103 [9.0%]). The number of failures correlated with procedure duration (rho = 0.695, p < 0.001) but not anatomical site of the procedure or pathology of the disease process. Failure rate was higher in patients undergoing combined surgical/endovascular procedures compared to open surgery (median 5.7/h [IQR 4.2-8.1] vs 3.0/h [2.5-3.5]; p < 0.001). The severity of failures was similar (1.5/5 [1-2] vs 1/5 [1-2] respectively; p = 0.095). For combined procedures, failure rates were significantly higher during the endovascular phase (9.6/h [7.5-13.7]) compared to the non-endovascular phase (3.0/h [1.0-5.0]; p < 0.001)., Conclusions: Failures in patient safety are common during complex arterial procedures. Few failures were severe, although minor failures during critical stages and accumulation of multiple minor failures may potentially be important. Failures occurred especially during the endovascular phase and were often related to equipment or communication aspects. Interventions to improve procedural safety and quality of care should primarily target these specific areas., (Copyright © 2011. Published by Elsevier Ltd.)

Objective: The wide variety of outcome measures to evaluate patients with varicose veins poses significant difficulties when comparing clinical trials. In addition, the relationship between different outcome measures is poorly understood. The aim of this study was to compare anatomical, hemodynamic, and clinical outcomes with disease-specific quality-of-life tools in patients undergoing treatment for varicose veins., Methods: Patients undergoing treatment for symptomatic veins in a single unit were studied. Assessments included duplex ultrasonography, digital photoplethysmography, evaluation of Venous Clinical Severity Scores and CEAP scores, generic (Short Form 12 [SF12]) and disease-specific (Aberdeen Varicose Vein Questionnaire [AVVQ], and Specific Quality-of-life and Outcome Response-Venous [SQOR-V]) questionnaires. Patients were reviewed at 6 weeks when hemodynamic, clinical, and quality-of-life assessments were repeated. The relationships between these outcomes were assessed., Results: The AVVQ showed a strong positive correlation with the SQOR-V (Spearman coefficient 0.702; P < .001) and weaker, but significant correlations with the SF12 physical and mental component scores and the Venous Clinical Severity Score (VCSS) (P < .001, P = .019, and P < .001, respectively, Spearman correlation). No correlations were observed between the AVVQ and photoplethysmography results (Spearman coefficient -0.042; P = .606), and weak correlations were observed with the AVVQ and anatomical reflux. At 6 weeks, functional, clinical, and hemodynamic measurements were all responsive to changes following interventions; however, correlations observed between changes in disease-specific quality-of-life and generic, clinical, and hemodynamic outcomes were weak., Conclusions: Both the AVVQ and SQOR-V questionnaire are sensitive and responsive disease-specific questionnaires, which correlate with generic and clinical outcomes to some extent. Anatomical and hemodynamic measurements correlated poorly with functional outcomes both preoperatively and following interventions., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Venous hypoxia has long been postulated as a potential cause of varicosity formation. This article aimed to review the development of this hypothesis, including evidence supporting and controversies surrounding it. Vein wall oxygenation is achieved by oxygen diffusing from luminal blood and vasa vasorum. The whole media of varicosities is oxygenated by vasa vasorum as compared to only the outer two-thirds of media of normal veins. There was no evidence that differences exist between oxygen content of blood from varicose and non-varicose veins, although the former demonstrated larger fluctuations with postural changes. Studies using cell culture and ex vivo explants demonstrated that hypoxia activated leucocytes and endothelium which released mediators regulating vein wall remodelling similar to those observed in varicosities. Venoactive drugs may improve venous oxygenation, and inhibit hypoxia activation of leucocytes and endothelium. The evidence for hypoxia as a causative factor in varicosities remains inconclusive, mainly due to heterogeneity and poor design of published in vivostudies. However, molecular studies have shown that hypoxia was able to cause inflammatory changes and vein wall remodelling similar to those observed in varicosities. Further studies are needed to improve our understanding of the role of hypoxia and help identify potential therapeutic targets., (Copyright © 2010 S. Karger AG, Basel.)

Background: The aim of this study was to evaluate the cost-effectiveness of traditional and endovenous treatments for patients with primary great saphenous varicose veins., Methods: A Markov model was constructed to compare costs and quality-adjusted life years (QALYs) for great saphenous vein (GSV) reflux. Eight popular treatment strategies were compared up to 5 years. Estimates for the effectiveness of treatments were obtained from published randomized studies and cost values were obtained from published National Health Service (NHS) healthcare resource group tariffs and device manufacturers. Parameter uncertainty was tested using sensitivity analysis and Monte Carlo simulation., Results: Ultrasound-guided foam sclerotherapy (UGFS) had the lowest initial cost, but a higher requirement for further interventions. Day-case surgery (with concomitant treatment of varicosities), endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) performed in an outpatient or office setting (with staged treatment of varicosities) were likely to be cost-effective treatment strategies. The incremental cost-effectiveness ratio (ICER) for UGFS (versus conservative care), EVLA (versus UGFS) and RFA (versus EVLA) were £1366, £5799 and £17 350 per QALY respectively. The ICER for traditional surgery (performed on a day-case basis) was £19 012 compared with RFA. Other strategies were not cost-effective using the NHS threshold of £20 000 per QALY., Conclusion: Day-case surgery or endovenous ablation using EVLA or RFA performed as an outpatient are likely to be cost-effective treatment strategies for patients with primary unilateral GSV reflux requiring treatment., (Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.)

Background: A range of surgical, endovenous, physical and medical treatments are available for patients with chronic venous disease. The aim of this review was to evaluate the evidence for pharmacological agents used for the treatment of chronic venous disease., Methods: A literature search was performed using Pubmed, Embase, Cochrane and Google Scholar databases. The initial search terms 'varicose vein', 'venous ulcer', 'venous disease' and 'lipodermatosclerosis' were used to identify relevant clinical studies of pharmacotherapy in patients with chronic venous disease (C4-C6)., Results: A huge range of naturally occurring and synthetic drugs have been studied in patients with chronic venous disease. For patients with C4 venous disease, micronized purified flavonoid fraction (MPFF), oxerutin, rutosides and calcium dobesilate may reduce venous symptoms and oedema. MPFF and pentoxifylline have been shown to improve venous ulcer healing when used in addition to multilayer compression bandaging. The clinical benefits of other medications remain unproven. Reliability of meta-analyses was limited by study heterogeneity, small sample sizes and lack of long-term follow-up., Conclusions: In prospective randomized studies, MPFF (Daflon(®)), other flavonoid derivatives and pentoxifylline have demonstrated clinical benefits in patients with C4-C6 venous disease. Pharmacotherapy should be part of a range of treatment options in the modern management of patients with chronic venous disorders.

Aims: The efficacy of endovenous treatments for venous reflux has been demonstrated in numerous randomised clinical trials, although significant heterogeneity may exist between studies. The aim of this study was to assess the heterogeneity in reporting between randomised clinical trials investigating endovenous treatments for patients with varicose veins., Methods: A literature search of the Pubmed, Cochrane and Google Scholar databases was performed using appropriate search terms. Randomised clinical trials published between January 1968 and June 2009 evaluating endovenous interventions for varicose veins were included and relevant abstracts and full text articles were reviewed. Published study reports were evaluated against recommended reporting standards published by the American Venous Forum in 2007., Results: Twenty-eight randomised trials fulfilled the inclusion criteria. Median patient age (reported in 20/28 studies) ranged from 33 to 54 years. The CEAP classification was presented in 17/28 studies and the proportion of patients with C2 disease ranged from 6.3% to 83.5%. A total of 31 different outcome measures were utilised. This included 13 different questionnaires, varicose vein recurrence at 38 time points and 30 categories of complications. Duplex ultrasonography was used in 21/28 trials to assess recurrence. Quality of life was only evaluated in 11 studies and the follow-up period ranged from 3 weeks to 10 years., Conclusions: Meaningful comparison across randomised studies of endovenous treatments is made difficult by considerable variations in study populations and outcome measures between trials. This highlights the need for the use of prospectively agreed population selection, and reporting standards for outcome measures in randomised clinical assessments of new treatments., (Copyright © 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objectives: This study aimed to assess the trends and regional variations in secondary care treatment of patients with varicose veins in National Health Service (NHS) England based on data published by the Hospital Episode Statistics which was freely and readily available to the public and health-care policy-makers., Methods: Hospital Episode Statistics data for patients being treated for varicose veins, and UK Statistics Authority population estimates in all 28 Strategic Health Authorities (SHAs) in England from 2002 to 2006 were retrieved and analysed., Results: Between 2002 and 2006 there was a 20% overall reduction (46,190-37,135) in the total number of varicose vein procedures performed in NHS England per year. The number of varicose vein procedures performed per 100,000 population per year varied significantly across the SHAs (P < 0.0001). Similarly, significant regional variations were also noted in the frequency of primary procedures of greater and small saphenous vein (P < 0.0001). During this time, injection sclerotherapy was only performed in 15 (53.6%) SHAs. The annual proportion of varicose vein procedures performed as daycases had increased from 56% to 64% during the period., Conclusion: From 2002 to 2006 there was an overall reduction in the total number of varicose vein procedures performed in NHS England with major regional variations.