A review of randomised controlled trials comparing ultrasound-guided foam sclerotherapy with endothermal ablation for the treatment of great saphenous varicose veins.

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

Adverse neurological events after sodium tetradecyl sulfate foam sclerotherapy - A prospective, observational study of 8056 treatments.

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

Procedural and 12 month in-hospital costs of primary infra-popliteal bypass surgery, infra-popliteal best endovascular treatment, and major lower limb amputation for Chronic Limb Threatening Ischaemia.

BACKGROUND Chronic limb threatening ischaemia (CLTI) is a growing global problem due to the widespread use of tobacco and increasing prevalence of diabetes. Although the financial consequences are considerable, few studies have compared the relative cost-effectiveness of different CLTI management strategies. The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial is randomising CLTI patients to primary infra-popliteal (IP) vein bypass surgery (BS) or best endovascular treatment (BET) and includes a comprehensive within-trial cost-utility analysis. AIM To compare over a 12-month time horizon, the costs of primary IP BS, IP best endovascular treatment (BET), and major limb major amputation (MLLA) to inform the BASIL-2 cost-utility analysis. METHODS We compared procedural human resource (HR) costs and total in-hospital costs for the index admission, and over the following 12-months, in 60 consecutive patients undergoing primary IP BS (n=20), IP BET (n=20), or MLLA (10 transfemoral and 10 transtibial ) for CLTI within the BASIL prospective cohort study. RESULTS Procedural HR costs were greatest for BS (BS £2,551, 95% CI: £1,934-2,807 vs. MLLA £1,130 95% CI: £1,046-1,297 vs. BET £329, 95% CI: £242-390, p<.001, Kruskal-Wallis) due to longer procedure duration and greater staff requirement. With regard to the index admission, MLLA was the most expensive due to longer hospital stay (MLLA £13,320, 95% CI: £8,986-18,616 vs. BS £8,714, 95% CI: £6,097-11,973 vs. BET £4,813, 95% CI: £3,529-6,097, p<.001, Kruskal-Wallis). The total cost of the index admission and in-hospital care over the following 12-months remained least for BET (MLLA £26,327, 95% CI: £17,653-30,458 vs. BS £20,401, 95% CI: £12,071-23,926 vs. BET £12,298, 95% CI: £6,961-15,439, p<.001, Kruskal-Wallis). CONCLUSION Over a 12-month time horizon, MLLA and IP BS are more expensive than IP BET in terms of procedural HR costs and total in-hospital costs. These economic data together with quality of life data from BASIL-2 will inform the calculation of incremental cost-effectiveness ratios for different CLTI management strategies within the BASIL-2 cost-utility analysis

Publication of UK NICE Clinical Guidelines 168 has not significantly changed the management of leg ulcers in primary care: An analysis of The Health Improvement Network database.

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

The impact of 2013 UK NICE guidelines on the management of varicose veins at the Heart of England NHS Foundation Trust, Birmingham, UK.

OBJECTIVE Although varicose veins are a common cause of morbidity, the UK National Health Service and private medical insurers have previously sought to ration their treatment in a non-evidence based manner in order to limit health-care expenditure and reimbursement. In July 2013, the UK National Institute for Health and Care Excellence published new national Clinical Guidelines (CG168) to promote evidence-based commissioning and management of varicose veins. The aim of this study was to evaluate the impact of CG168 on the referral and management of varicose veins at the Heart of England NHS Foundation Trust, Birmingham, UK. METHODS Interrogation of a prospectively gathered database, provided by the Heart of England NHS Foundation Trust Performance Unit, of patients undergoing interventions for varicose veins since 1 January 2012. Patients treated before (group 1) and after (group 2) publication of CG168 were compared. RESULTS There were 253 patients, 286 legs (48% male, mean (range) age 54 (20-91) years) treated in group 1, and 417 patients, 452 legs, (46% male, mean (range) age 54 (14-90) years) treated in group 2, an increase of 65%. CG168 was associated with a significant reduction in the use of surgery (131 patients (52%) group 1 vs. 127 patients (30%) group 2, p = 0.0003, χ(2)), no change in endothermal ablation (30 patients (12%) group 1 vs. 45 patients (11%) group 2), a significant increase in ultrasound-guided foam sclerotherapy (92 patients (36%) group 1 and 245 patients (59%) group 2, p = 0.0001, χ(2)) and an increase in treatment for C2/3 disease (53% group 1 and 65.2% group 2, p = 0.0022, χ(2)). CONCLUSIONS Publication of National Institute for Health and Care Excellence CG168 has been associated with a significant increase (65%) in the number of patients treated, referral at an earlier (CEAP C) stage and increased use of endovenous treatment. CG 168 has been highly effective in improving access to, and quality of care, for varicose veins at Heart of England NHS Foundation Trust

Impact of UK NICE Clinical Guidelines 168 and social deprivation on access to interventional treatment for symptomatic varicose vein and specialist referral for leg ulceration.

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

Obesity and lower limb venous disease - The epidemic of phlebesity.

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