Evaluating pharmacological THRomboprophylaxis in Individuals undergoing superficial endoVEnous treatment across NHS and private clinics in the UK: a multi-centre, assessor-blind, randomised controlled trial-THRIVE trial.

INTRODUCTION: Endovenous therapy is the first choice management for symptomatic varicose veins in NICE guidelines, with 56-70 000 procedures performed annually in the UK. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a known complication of endovenous therapy, occurring at a rate of up to 3.4%. Despite 73% of UK practitioners administering pharmacological thromboprophylaxis to reduce VTE, no high-quality evidence supporting this practice exists. Pharmacological thromboprophylaxis may have clinical and cost benefit in preventing VTE; however, further evidence is needed. This study aims to establish whether when endovenous therapy is undertaken: a single dose or course of pharmacological thromboprophylaxis alters the risk of VTE; pharmacological thromboprophylaxis is associated with an increased rate of bleeding events; pharmacological prophylaxis is cost effective. METHODS AND ANALYSIS: A multi-centre, assessor-blind, randomised controlled trial (RCT) will recruit 6660 participants from 40 NHS and private sites across the UK. Participants will be randomised to intervention (single dose or extended course of pharmacological thromboprophylaxis plus compression) or control (compression alone). Participants will undergo a lower limb venous duplex ultrasound scan at 21-28 days post-procedure to identify asymptomatic DVT. The duplex scan will be conducted locally by blinded assessors. Participants will be contacted remotely for follow-up at 7 days and 90 days post-procedure. The primary outcome is imaging-confirmed lower limb DVT with or without symptoms or PE with symptoms within 90 days of treatment. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, using a repeated measures analysis of variance, adjusting for any pre-specified strongly prognostic baseline covariates using a mixed effects logistic regression. ETHICS AND DISSEMINATION: Ethical approval was granted by Brent Research Ethics Committee (22/LO/0261). Results will be disseminated in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN18501431.

Study protocol for neuromuscular stimulation for rehabilitation after general and vascular surgery: a pilot randomised clinical study.

OBJECTIVES: To investigate the acceptability and safety of neuromuscular stimulation (NMES) as an adjunct for rehabilitation after vascular and general surgery. METHODS AND ANALYSIS: Prospective, single-centre, single-blind, parallel group, randomised controlled study. This study will be conducted in a single-centre, secondary care setting (National Healthcare Service Hospital) in the UK. All patients aged over 18 years undergoing vascular or general surgery with Rockwood Frailty Score of 3 or above on admission. Exclusion is inability or unwillingness to participate in trial, implanted electrical device, pregnancy and acute deep vein thrombosis. Target number of recruitment is 100. Participants will be randomly assigned to active NMES group (group A) or placebo NMES group (group B) prior to surgery. Participants will be blinded and asked to use the NMES device, 1-6 sessions daily (30 min per session) after surgery in addition to standard National Health Service rehabilitation care until discharge. The primary study outcomes are acceptability and safety of NMES assessed by the device satisfaction questionnaire on discharge and adverse events recorded during hospital stay. The secondary outcomes are the postoperative recovery and cost-effectiveness compared between two groups, assessed by various activity tests, mobility and independence measures and questionnaires. ETHICS AND DISSEMINATION: Ethical approvals were provided by London-Harrow Research Ethics Committee (REC) and the Health Research Authority (HRA), Ref: 21/PR/0250. Findings will be published in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: NCT04784962.

Abdominal aortic aneurysm clinical practice guidelines: a methodological assessment using the AGREE II instrument.

OBJECTIVES: Abdominal aortic aneurysm (AAA) clinical practice guidelines (CPGs) provide evidence-based information on patient management; however, methodological differences exist in the development of CPGs. This study examines the methodological quality of AAA CPGs using a validated assessment tool. METHODS: Medline, EMBASE and online CPG databases were searched from 1946 to 31 October 2021. Full-text, English language, evidence-based AAA CPGs were included. Consensus-based CPGs, summaries of CPGs or CPGs which were only available on purchase were excluded. Five reviewers assessed their quality using the Appraisal of Guidelines for Research and Evaluation II instrument. An overall guideline assessment scaled score of ≥80% was considered as the threshold to recommend CPG use in clinical practice. RESULTS: Seven CPGs were identified. Scores showed good inter-reviewer reliability (intraclass correlation coefficient 0.943, 95% CI 0.915 to 0.964). On average, CPGs performed adequately with mean scaled scores of over 50% in all domains. However, between CPGs, significant methodological heterogeneity was observed in all domains. Four CPGs scored ≥80% (European Society of Cardiology, the Society of Vascular Surgery, the European Society of Vascular Surgery and the National Institute of Health and Care Excellence), supporting their use in clinical practice. CONCLUSIONS: Four CPGs were considered of adequate methodological quality to recommend their use in clinical practice; nonetheless, these still showed areas for improvement, potentially through performing economic analysis and trial application of recommendations. A structured approach employing validated CPG creation tools should be used to improve rigour of AAA CPGs. Future work should also evaluate recommendation accuracy using validated appraisal tools.

Systematic review of inframalleolar endovascular interventions and rates of limb salvage, wound healing, restenosis, rest pain, reintervention and complications.

OBJECTIVES: Peripheral artery disease is estimated to affect 237 million individuals worldwide. Critical limb ischaemia, also known as chronic limb threatening ischaemia is a consequence of the progression of peripheral artery disease which occurs in ∼21% of patients over a five-year period. The aim of this systematic review is to assess the use of additional below-the-ankle angioplasty in comparison to the use of above-the-ankle angioplasty alone, and the subsequent rates of amputation, wound healing, restenosis, rest pain, reintervention and complications. METHODS: This systematic review was undertaken in accordance with PRISMA guidelines following a registered protocol (CRD42019154893). Online databases were searched using a search strategy of 20 keywords. Included articles reported the outcome for inframalleolar (pedal artery, pedal arch, plantar arteries) angioplasty with additional proximal angioplasty in comparison to proximal angioplasty alone. GRADE assessment was applied to assess the quality of the evidence. RESULTS: After screening 1089 articles, 10 articles met the inclusion criteria. Comparative performance assessment of below-the-ankle with above-the-ankle versus above-the-ankle angioplasty alone was undertaken in 3 articles, with the remaining 7 articles reporting outcomes of below-the-ankle with above-the-ankle angioplasty with no distinct comparator group. Significant decrease in major lower limb amputation at the last follow-up in the below-the-ankle group when compared with the above-the-ankle angioplasty alone group was observed in a single study (3.45% vs. 14.9%, p < 0.05). Improved wound healing rate at follow-up in the below-the-ankle group versus above-the-ankle angioplasty alone group was also reported in a single study (59.3% vs. 38.1%, p < 0.05). Subsequent rate of amputation after below-the-ankle angioplasty has been estimated as 23.5%. CONCLUSION: To date, there is a lack of studies assessing inframalleolar interventions and their use in improving limb salvage, wound healing and symptomatology. Prospective RCTs should be undertaken with adequate participant numbers to be sufficiently powered and report clinically important end-points.

Are venous thromboembolism risk assessment tools reliable in the stratification of microvascular risk following lower extremity reconstruction?

INTRODUCTION: The incidence of flap failure is significantly higher in the lower extremity compared to free tissue transfer in the head, neck and breast. The most common cause of flap failure is venous thrombosis. The aim of this study was to assess the reliability of venous thromboembolism (VTE) risk assessment tools in this high-risk cohort and to assess the ability of such tools to identify patients at risk of developing microvascular venous thrombosis and venous thromboembolism following lower extremity free flap reconstruction. METHODS: A single centre retrospective cohort study was conducted between August 2012-August 2019. Adult patients who had undergone free tissue transfer following open lower extremity fractures were eligible for inclusion. All patients were retrospectively risk assessed using the Department of Health (DoH), Modified Caprini and Padua VTE risk assessment tools. RESULTS: Fifty-eight patients were included; all were at high risk of DVT according to the DoH (mean score ± SD, 3.7 ± 0.93), Caprini (10.2 ± 1.64) and Padua (5.4 ± 0.86) risk assessment tools. All patients received appropriate thromboprophylaxis; the incidence of symptomatic hospital acquired VTE was 3.5%. Micro-anastomotic venous thrombosis occurred in 4 patients resulting in one amputation. Partial flap necrosis occurred in 7 patients. There were no significant differences in scaled Caprini (median score, 10 vs 9, z = 1.289, p = 0.09), DoH (3 vs 3, z = 0.344, p = 0.36), and Padua (5 vs 5.5, z= -0.944, p = 0.17) scores between those with and without microvascular venous thrombosis. CONCLUSION: This data suggests that current VTE risk assessment tools do not predict risk of microvascular venous thrombosis following lower extremity reconstruction. Further prospective studies are required to optimise risk prediction models and thromboprophylaxis use in this cohort.

Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168).

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. TRIAL REGISTRATION NUMBER: ISRCTN registration number 73041168.

Lower extremity arterial interventions in England.

INTRODUCTION: The increasing prevalence of diabetes mellitus and advances in endovascular therapies continue to have an impact on the epidemiology and management of lower extremity arterial disease. This study describes trends in lower extremity revascularisation and major lower limb amputation in NHS England over the past two decades (2000-2019). METHODS: Numbers of lower extremity endovascular interventions, open surgical procedures and major lower limb amputations performed in NHS England between 2000 and 2019 were extracted from publicly available hospital admitted patient care activity reports. Trends in intervention were assessed with linear regression models and chi-square tests for trend. RESULTS: Over this period, 527,131 revascularisations and 92,053 amputations were performed. The mean age of patients was 67.5 years (standard deviation 1.6 years) and 65.3% were male. The number of lower limb revascularisation procedures increased by 402.4 units/year (95% confidence interval, CI, 290.1-514.6, p < 0.001). The number of endovascular interventions rose by 43.5% (10,912 in 2000 vs 15,657 in 2019; ß = 359.5.0, 95% CI 279.3-439.8, p < 0.001) compared with no significant increase in the number of open surgical procedures (8,483 in 2000 vs 7,872 in 2019; ß = 42.8, 95% CI -8.3 to 94.0, p = 0.095). The number of major lower limb amputations has decreased by 9.4% (5,418 in 2000 vs 4,907 in 2019; ß = -31.0; 95% CI -49.6 to -12.5, R2 = 0.42, p = 0.003). CONCLUSIONS: There has been a significant increase in the rate of lower limb revascularisation procedures associated with decreased numbers of major lower limb amputations over the past two decades. These changes in overall trends may affect both service provision and vascular surgery training planning.

Study protocol for a multicentre, randomised controlled trial to compare the use of the decellularised dermis allograft in addition to standard care versus standard care alone for the treatment of venous leg ulceration: DAVE trial.

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. TRIAL REGISTRATION NUMBER: ISRCTN21541209.

Surgical and non-surgical approaches in the management of lower limb post-thrombotic syndrome.

Introduction: Post-thrombotic syndrome (PTS) is a common lifelong condition affecting up to 50% of those suffering from deep vein thrombosis (DVT). PTS compromises function and quality of life with subsequent venous ulceration in up to 29% of those affected.Areas covered: A literature review of surgical and non-surgical approaches in the prevention and treatment of PTS was undertaken. Notable areas include the use of percutaneous endovenous interventions and the use of graduated compression stockings (GCS) after acute proximal DVT.Expert opinion: In patients with acute iliofemoral DVT, we think it is important to have a frank conversation with the patient about catheter-directed thrombolysis, aiming to reduce the severity of PTS experienced. We advocate ultrasound-accelerated thrombolysis with adjunctive procedures, such as deep venous stenting for proximal iliofemoral DVT. For patients with isolated femoral DVT, we believe that anticoagulation and GCS should be recommended. In patients with established PTS, we recommend GCS for symptomatic relief. We recommend that patients engage in regular exercise where possible with the prospect of gaining symptomatic relief. For those with severe PTS that has a significant effect on quality of life, we discuss the patient's case at a multi-disciplinary team meeting to plan for endovenous intervention.

Systematic review on the benefit of graduated compression stockings in the prevention of venous thromboembolism in low-risk surgical patients.

OBJECTIVES: The aim of this systematic review is to assess the performance of graduated compression stockings (GCS) in comparison to no venous thromboembolism (VTE) prophylaxis in the prevention of hospital-acquired thrombosis in low-risk surgical patients undergoing short-stay procedures. METHODS: Aligning with PRISMA guidelines, online databases MEDLINE and EMBASE, Cochrane Library® and trial registries were searched. Eligible articles reported the VTE rate in low-risk surgical patients either receiving GCS or no VTE prophylaxis. RESULTS: Narrative synthesis was performed on a single eligible article. The included study arm consisted of participants undergoing knee arthroscopy with the use of GCS alone reporting a total of 29 VTE events (4.4%), 16 of which were asymptomatic DVTs (2.4%). CONCLUSION: There is a complete lack of evidence to support the use of GCS in the prevention of HAT for low-risk surgical patients. An adequately powered trial is required to provide level-IA evidence to support this practice.

Effect of footplate neuromuscular electrical stimulation on functional and quality-of-life parameters in patients with peripheral artery disease: pilot, and subsequent randomized clinical trial.

BACKGROUND: Supervised exercise programmes for intermittent claudication have poor access and limited compliance. Neuromuscular electrical stimulation (NMES) may be an effective alternative. A proof-of-concept study and RCT were conducted. METHODS: In study 1, eligible patients underwent baseline assessment; treadmill testing for initial (ICD) and maximum (MCD) claudication distance; EuroQoL Five Dimensions five-level instrument (EQ-5D-5L™) and Intermittent Claudication Questionnaire (ICQ) assessment; and measurement of ultrasound haemodynamics of the superficial femoral artery. After familiarization with the NMES device, participants underwent a 30-min session of stimulation with concomitant recording of haemodynamic measures at 15 min, and after device cessation. Measurements were repeated after 6 weeks of daily use of NMES. In study 2, consecutive patients underwent baseline assessment before online randomization to a supervised exercise programme only, or adjunctive NMES treatment for 6 weeks, followed by repeat measurements. RESULTS: Study 1 (20 patients) showed a significant improvement in MCD (46 per cent; P < 0·001) and ICD (71 per cent; P < 0·001). The RCT (42 patients) showed a significant adjunctive benefit of NMES in ICD (46 per cent; P = 0·014). Improvements were seen in the ICQ (9 points; P = 0·009) and EQ-5D-5L™ (P = 0·007) in study 1, and there was a significant adjunctive benefit of NMES on the ICQ score in patients who did supervised exercise (11·2 points; P = 0·031). Blood volume flow and time-adjusted mean velocity increased significantly with the device on (P < 0·050). Overall, NMES compliance exceeded 95 per cent. CONCLUSION: Footplate NMES significantly improved walking distance in patients with intermittent claudication when used independently and also as an adjunct to supervised exercise. Registration number: trial 1, NCT02436200; trial 2, NCT02429310 (http://www.clinicaltrials.gov).

ANTECEDENTES: Los programas de ejercicio supervisado (supervised exercise programmes, SEP) para la claudicación intermitente (intermittent claudication, IC) tienen un acceso y un cumplimiento deficientes. La estimulación eléctrica neuromuscular (neuromuscular electrical stimulation, NMES) puede ser una alternativa clínicamente efectiva. Se realizó un estudio de prueba de concepto y un ensayo controlado aleatorizado. MÉTODOS: Estudio 1: Veinte pacientes elegibles se sometieron a una evaluación inicial que incluía una prueba en la cinta de correr para la distancia inicial de claudicación (initial claudication distance, ICD) y la distancia máxima de claudicación (maximum claudication distance, MCD), EuroQoL-5D (EQ-5D), valoración mediante el cuestionario de claudicación intermitente (intermittent claudication questionnaire, ICQ), y hemodinámica por ecografía de la arteria femoral superficial. Después de familiarizarse con el dispositivo NMES, los participantes se sometieron a una sesión de estimulación de 30 minutos con el registro concomitante de medidas hemodinámicas a los 15 minutos y después del cese del dispositivo. Se realizaron mediciones repetidas después de 6 semanas de uso diario de NMES. Estudio 2: Se reclutaron 42 pacientes que tras una evaluación inicial y posterior aleatorización al azar en línea, se asignaron al Grupo A, utilizando SEP solamente; o al el Grupo B, con tratamiento NMES complementario durante 6 semanas seguido de medidas repetidas. RESULTADOS: El estudio 1 mostró una mejoría significativa de la MCD (46%, P < 0,0001) y de la ICD (71%, P < 0.004). El ensayo clínico mostró un beneficio coadyuvante significativo de NMES en la ICD (46%, P = 0,014). Se observaron mejorías en la puntuación del ICQ (9 puntos, P < 0,01) y del EQ-5D (P < 0,05) en el estudio 1, con un beneficio coadyuvante significativo de NMES en la puntuación del ICQ (11 puntos, P < 0,05). El flujo de volumen de sangre (CC/min) y TAMV (cm/s) aumentaron significativamente con el dispositivo en funcionamiento (P < 0,05). El cumplimiento global de la NMES superó el 95%. CONCLUSIÓN: La plataforma de NMES para el pie mejora significativamente las distancias de caminar en la claudicación intermitente cuando se usa de forma independiente y también proporciona un beneficio complementario al ejercicio supervisado en la distancia caminada sin dolor. La mejora del flujo sanguíneo puede ser un mecanismo para explicar estos resultados.

Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration.

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).

Cost-effectiveness of treatments for superficial venous reflux in patients with chronic venous ulceration.

BACKGROUND: Venous leg ulcers impair quality of life significantly, with substantial costs to health services. The aim of this study was to estimate the cost-effectiveness of interventional procedures alongside compression therapy versus compression therapy alone for the treatment of chronic venous leg ulceration. METHODS: A Markov decision analytical model was developed. The main outcome measures were quality-adjusted life-years (QALYs) and lifetime costs per patient, from the perspective of the UK National Health Service at 2015 prices. Resource use included the initial procedures, compression therapy, primary care and outpatient consultations. The interventional procedures included superficial venous surgery, endothermal ablation and ultrasound-guided foam sclerotherapy (UGFS). The study population was patients with a chronic venous ulcer who were eligible for either compression therapy or an interventional procedure. Data were obtained from systematic review and meta-analysis of RCTs. RESULTS: Surgery gained 0·112 (95 per cent c.i. -0·011 to 0·213) QALYs compared with compression therapy alone, with a difference in lifetime costs of €-1330 (-3570 to 1262). Given the expected savings in community care, the procedure would pay for itself within 4 years. There was insufficient evidence regarding endothermal ablation and UGFS to draw conclusions. DISCUSSION: This modelling study found surgery to be more effective and less costly than compression therapy alone. Further RCT evidence is required for both endothermal ablation and UGFS.

Deep Venous Procedures Performed in the National Health Service in England between 2005 and 2015.

OBJECTIVES: Recent advances in imaging technology and endovenous interventions have revolutionised the management of specific groups of patients with deep venous pathology. This study aimed to examine data published by Hospital Episode Statistics (HES) to assess trends in the number of endovascular and open surgical deep venous procedures performed in National Health Service (NHS) hospitals in England between 2005 and 2015. MATERIALS AND METHODS: The main diagnosis of deep venous thrombosis (DVT), and total number of primary open and percutaneous procedures for deep venous pathology for patients admitted to the NHS hospitals in England from 2005 to 2015 were retrieved from the HES database and analysed. RESULTS: An overall declining trend in the annual number of admissions for a primary diagnosis of DVT was observed (linear regression r2 = 0.9, p < .0001). The number of open surgical procedures for removal of thrombus remained largely unchanged (range 26-70); the frequency of percutaneous procedures increased steadily over the study period (range 0-311). The number of open surgical procedures relating to the vena cava fell between 2005 and 2009, and remained around 50 per year thereafter. Annual numbers of cases of deep venous bypass (range 17-33) and venous valve surgery (range 8-47) remained similar in trend over this period. The number of vena cava stent (range 0-405), other venous stent (range 0-316), and percutaneous venoplasty (range 0-972) procedures increased over the first 5 years of the study period. CONCLUSIONS: There is an increasing trend in relation to endovenous procedures but not open surgery, being carried out for deep venous pathology in the last decade in NHS hospitals in England. Despite a number of limitations with HES, the increase in the number of endovenous procedures shown is likely to have significant implications for the provision of care and healthcare resources for patients with deep venous pathology.

Truncal varicose vein diameter and patient-reported outcome measures.

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.

Graduated Compression Stockings as an Adjunct to Low Dose Low Molecular Weight Heparin in Venous Thromboembolism Prevention in Surgery: A Multicentre Randomised Controlled Trial.

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).