23 research outputs found

    Long-term Clinical and Cost-effectiveness of Early Endovenous Ablation in Venous Ulceration: A Randomized Clinical Trial

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    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 (26283)perqualityadjustedlifeyearand90.826 283) 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

    A multi-centre randomised controlled trial comparing radiofrequency and mechanical occlusion chemically assisted ablation of varicose veins - final results of the Venefit versus Clarivein for varicose veins trial

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    BACKGROUND: Endovenous thermal ablation has revolutionised varicose vein treatment. New non-thermal techniques such as mechanical occlusion chemically assisted endovenous ablation (MOCA) allow treatment of entire trunks with single anaesthetic injections. Previous non-randomised work has shown reduced pain post-operatively with MOCA. This study presents a multi-centre randomised controlled trial assessing the difference in pain during truncal ablation using MOCA and radiofrequency endovenous ablation (RFA) with six months' follow-up. METHODS: Patients undergoing local anaesthetic endovenous ablation for primary varicose veins were randomised to either MOCA or RFA. Pain scores using Visual Analogue Scale and number scale (0-10) during truncal ablation were recorded. Adjunctive procedures were completed subsequently. Pain after phlebectomy was not assessed. Patients were reviewed at one and six months with clinical scores, quality of life scores and duplex ultrasound assessment of the treated leg. RESULTS: A total of 170 patients were recruited over a 21-month period from 240 screened. Patients in the MOCA group experienced significantly less maximum pain during the procedure by Visual Analogue Scale (MOCA median 15 mm (interquartile range 7-36 mm) versus RFA 34 mm (interquartile range 16-53 mm), p = 0.003) and number scale (MOCA median 3 (interquartile range 1-5) versus RFA 4 mm (interquartile range 3-6.5), p = 0.002). 'Average' pain scores were also significantly less in the MOCA group; 74% underwent simultaneous phlebectomy. Occlusion rates, clinical severity scores, disease specific and generic quality of life scores were similar between groups at one and six months. There were two deep vein thromboses, one in each group. CONCLUSION: Pain secondary to truncal ablation is less painful with MOCA than RFA with similar short-term technical, quality of life and safety outcomes

    Temporal artery biopsies: Are we taking long enough specimens?

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    Mesura 4,40 x 1,10 x 1,10 metres.Arnau Mascort, EusebiPla general de l'escultura a plaça Catalunya .Elogi a la navegació, fou realitzada amb pedra de Montjuïc, la figura mesura 2,90 x 1,08 x 0,90 metres

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    Leg Ulcer Outcomes

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    Background Venous disease is the most common cause of leg ulceration. Treatment of superficial venous reflux has been shown to reduce the rate of ulcer recurrence but the effect of early endovenous ablation of superficial venous reflux on ulcer healing remains unclear. It is generally accepted that there is considerable global variation in the management of leg ulcers. Objectives To determine: the clinical and cost-effectiveness of early endovenous treatment of superficialvenous reflux in addition to standard care compared to standard care alone in patients with venous ulceration; the current standards of global management of venous leg management and the impact on these following the results of the randomised controlled trial. Methods i. The Early Venous Reflux Ablation Trial (EVRA) multi-centre randomised clinical trial of 450 participants compared early versus deferred intervention at 12 months and at 3.5 years. ii. Health professionals treating patients with leg ulcers globally were surveyed before and after the publication of the RCT results to gain insight on the management of venous leg ulceration, and subsequent impact on practice. Results i. EVRA: i. time to ulcer healing was shorter in the early group at 12 months; no clear difference in time to first ulcer recurrence at 3.5 years; early intervention at 3 years is 91% likely to be cost-effective at £20,000/QALY. ii. Surveys: ⁃ Pre/post-EVRA UK primary care: 90/643 responses received; Pre/post-EVRA global clinicians: 799/644 responses were received. Conclusions The EVRA RCT showed that early intervention reduces the time to healing of venous leg ulcers, does not affect the time to recurrent ulceration but is highly likely to be cost-effective and therefore is beneficial for both patients and healthcare providers. The surveys demonstrated that the management of venous ulceration is disparate globally. It is likely that the EVRA RCT results influenced the timing of intervention worldwide.Open Acces

    Comparing methods for handling missing cost and quality of life data in the Early Endovenous Ablation in Venous Ulceration trial

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    This study was funded by the National Institute for Health Research (NIHR HTA) Programme (EVRA, project number 11/129/197) and European Union's Horizon 2020 research under Grant agreement 733203.Objectives: This study compares methods for handling missing data to conduct cost-effectiveness analysis in the context of a clinical study. Methods: Patients in the Early Endovenous Ablation in Venous Ulceration (EVRA) trial had between 1 year and 5.5 years (median 3 years) of follow-up under early or deferred endovenous ablation. This study compares completecase- analysis (CCA), multiple imputation using linear regression (MILR) and using predictive mean matching (MIPMM), Bayesian parametric approach using the R package missingHE (BPA), repeated measures fixed effect (RMFE) and repeated measures mixed model (RMM). The outcomes were total mean costs and total mean quality-adjusted life years (QALYs) at different time horizons (1 year, 3 years and 5 years). Results: All methods found no statistically significant difference in cost at the 5% level in all time horizons, and all methods found statistically significantly greater mean QALY at year 1. By year 3, only BPA showed a statistically significant difference in QALY between treatments. Standard errors differed substantially between the methods employed. Conclusion: CCA can be biased if data are MAR and is wasteful of the data. Hence the results for CCA are likely to be inaccurate. Other methods coincide in suggesting that early intervention is cost-effective at a threshold of £30,000 per QALY 1, 3 and 5 years. However, the variation in the results across the methods does generate some additional methodological uncertainty, underlining the importance of conducting sensitivity analyses using alternative approaches.National Institute for Health Research (NIHR HTA) Programme (EVRA) 11/129/197European Commission 73320
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