Ulcus cruris venosum: Was bringt die frühzeitige endovenöse Ablation bei venösen Ulzerationen?

<b>Importance:</b> 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. <b>Objective:</b> To evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration. <b>Design, Setting, and Participants:</b> 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. <b>Interventions:</b> 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. <b>Main Outcomes and Measures:</b> The primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness. <b>Results:</b> 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. <b>Conclusions and Relevance:</b> 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. <b>Trial Registration:</b> ClinicalTrials.gov identifier: ISRCTN02335796.

THERMAL AND NON-THERMAL METHODS OF TREATMENT OF PATIENTS WITH PRIMARY VARICOSЕ DISEASES OF THE LOWER LIMBS OF STAGE C2

Treatment results of primary varicose disorders has been shown. The experience of using of thermal (endovenous laser ablation) and non-thermal methods (endovenous mechanochemical ablation, echo-controlled introduction of bioglue) in treatment of stage C2 chronic venous is shown. The purpose of this work is to evaluate the efficiency of endovenous ablation techniques. The treatment of 58 patients was analyzed. In the group of patients who underwent endovenous laser obliteration, reflux was not detected. In the group of patients with mechanochemical obliteration, reflux was determined in 3 patients (27.2%) at follow-up after 3 months required supplementation with foam sclerobliteration. In the group of patients with the introduction of bio glue, reflux was determined in 1 patient (20%) at the examination after 3 months. The received results lead to conclusion, that endovenous laser coagulation of affected veins is a reliable method of threatment, the gold standard. The advantage of non-thermal methods is the absence of thermal effects on the paravenous structures, respectively, patients have no pain during the procedure, increases comfort, and there is no risk of damage to the paravenous nerves. Another advantage of non-thermal techniques is no need to use of tumescent anesthesia, since only one puncture is required for the operation, which is comfortable for patients. The use of adhesive vein obliteration is justified in patients with signs of a short reflux duration and has an advantage for the patient due to the absence of the need for compression in the postoperative period. Non-thermal methods require further research and widespread implementation in practice.

A Systematic Review of Elective Laser Therapy during Pregnancy

Introduction: Currently, lasers are used to treat many diseases and their complications. However, the use of lasers in pregnant patients is still controversial. Methods: In this review, the application of lasers in the fields of urology, surgery, obstetrics, dermatology, and musculoskeletal disorders is evaluated. The following keywords were used to search through PubMed, Google Scholar, and Scopus: pregnancy, laser, urolithiasis, endovenous laser ablation (EVLA) or treatment, leg edema, varicose vein, venous insufficiencies, hair removal, pigmentation, telangiectasia, vascular lesions, Q switch laser, diode laser, holmium, holmium-YAG laser, erbium laser and Pulsed dye laser, low-level laser therapy, high-intensity laser therapy, pain, musculoskeletal disorders, twin to twin transfusion syndrome (TTTS), amnioreduction, and safety. Results: Totally, 147 articles were found, and their abstracts were evaluated; out of 53 articles extracted, 14 articles were about dermatology, 24 articles were about urology, 12 articles were about obstetrics and gynecology, 10 articles were about musculoskeletal disorders and three articles were related to surgery. Conclusion: Laser therapy can be used as a safe treatment for urolithiasis, skin diseases, TTTS and varicose veins of the lower extremities. However, the use of laser therapy for musculoskeletal disorders during pregnancy is not recommended due to lack of evidence, and also we cannot recommend endovenous ablation.

Comparing Methods for Handling Missing Cost and Outcome Data in Clinical Trial-based Cost-effectiveness Analysis

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 Complete-Case-Analysis (CCA), multiple imputation using linear regression (MILR) and using predictive mean matching (MIPMM), Bayesian parametric approach using the R package missingHE (BPA) 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. 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 £20,000 per QALY over all time horizons. 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.