Oral Pentoxifylline in the Treatment of Venous Leg Ulcers: a Meta-Analysis

<p>Compression bandaging improves rates of healing in people with venous ulceration. Some ulcers appear resistant to compression therapy and may benefit from adjunctive therapy. Pentoxifylline is known to improve circulation, but individual trials have failed to conclusively demonstrate its effectiveness in venous ulceration. The objective of this meta-analysis was to assess the effectiveness of pentoxifylline as an adjunct to compression bandaging in the treatment of venous leg ulcers. The CENTRAL registers of the Cochrane Peripheral Vascular Diseases and Wounds Groups were searched - each register is routinely updated by extensive searches of electronic databases, handsearching of relevant journals and conference proceedings, and contact with product companies and experts in the field. The drug's manufacturer was contacted and the references of review articles and all obtained trials were scrutinised for further citations. Randomised controlled trials published in any language comparing pentoxifylline and compression with placebo in adult participants with venous ulceration were included. Trials must have reported a meaningful objective outcome (rates of healing, proportions healed, time to healing). Details from eligible trials (independently selected by two reviewers) were extracted and summarised by one reviewer. A second reviewer independently verified extracted data. Eleven clinical trials were identified. Five trials compared pentoxifylline with placebo (compression standard therapy). Six trials were excluded. Pentoxifylline and compression was more effective than placebo and compression (RR 1.30, 95% C1 1.10-1.54) and was robust to sensitivity analyses. The greater number of adverse effects (46 reports) occurred in the pentoxifylline group, although this was not significant (RR 1.12, 95% C1 0.77-1.62); 34 percent of adverse effects were gastro-intestinal. Seven of 21 reported withdrawals were for adverse effects. In conclusion, pentoxifylline appears an effective adjunct to compression bandaging in the treatment of venous ulcers. The absence of cost-effectiveness data suggests it not be employed as a routine adjunct, but it could be considered as for those patients not responding to compression therapy alone. The majority of adverse effects are likely to be tolerated by patients.</p>

Oral Pentoxifylline in the Treatment of Venous Leg Ulcers: a Meta-Analysis

<p>Compression bandaging improves rates of healing in people with venous ulceration. Some ulcers appear resistant to compression therapy and may benefit from adjunctive therapy. Pentoxifylline is known to improve circulation, but individual trials have failed to conclusively demonstrate its effectiveness in venous ulceration. The objective of this meta-analysis was to assess the effectiveness of pentoxifylline as an adjunct to compression bandaging in the treatment of venous leg ulcers. The CENTRAL registers of the Cochrane Peripheral Vascular Diseases and Wounds Groups were searched - each register is routinely updated by extensive searches of electronic databases, handsearching of relevant journals and conference proceedings, and contact with product companies and experts in the field. The drug's manufacturer was contacted and the references of review articles and all obtained trials were scrutinised for further citations. Randomised controlled trials published in any language comparing pentoxifylline and compression with placebo in adult participants with venous ulceration were included. Trials must have reported a meaningful objective outcome (rates of healing, proportions healed, time to healing). Details from eligible trials (independently selected by two reviewers) were extracted and summarised by one reviewer. A second reviewer independently verified extracted data. Eleven clinical trials were identified. Five trials compared pentoxifylline with placebo (compression standard therapy). Six trials were excluded. Pentoxifylline and compression was more effective than placebo and compression (RR 1.30, 95% C1 1.10-1.54) and was robust to sensitivity analyses. The greater number of adverse effects (46 reports) occurred in the pentoxifylline group, although this was not significant (RR 1.12, 95% C1 0.77-1.62); 34 percent of adverse effects were gastro-intestinal. Seven of 21 reported withdrawals were for adverse effects. In conclusion, pentoxifylline appears an effective adjunct to compression bandaging in the treatment of venous ulcers. The absence of cost-effectiveness data suggests it not be employed as a routine adjunct, but it could be considered as for those patients not responding to compression therapy alone. The majority of adverse effects are likely to be tolerated by patients.</p>

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.

O15 Venous Leg Ulceration: an assessment of associated lifestyle, sociodemographic and clinical factors using UK Biobank

Introduction A number of factors have reportedly been associated with venous leg ulceration (VLU) however many of these remain disputed. UK Biobank (UKB) is an electronic dataset that provides in-depth detail on the lives of its participants. The aim of this research is to utilise UKB to understand factors associated with VLU. Methods Participants in the UKB with historical or active venous ulceration were identified and an age, sex and comorbidity matched control group was formed. A multivariate logistic regression was used to explore factors associated with VLU with significant factors expressed through odds ratios (OR). Mortality was investigated using a Kaplan Meier plot and log-rank test. Data analysis was preformed using R Studio Version 1.2.5033 and Python 3.8.10. Results Factors associated with VLU included; male gender, older age, deprivation (OR 1.27), obesity (OR 1.40), current smoking (OR 1.21), immoderate alcohol intake (OR 1.32), previous deep vein thrombosis (OR 3.07), depression and loneliness (OR 1.21). Biochemical factors associated with VLU included low haemoglobin concentrations (OR 1.50), low circulating lymphocyte percentages (OR 1.57), raised glycated haemoglobin (HbA1c) (OR 2.92), raised c-reactive protein (OR 1.41), raised cystatin C (OR 1.11) and low Vitamin D levels (OR 1.52). At a median follow up of 11.5 years, the mortality in VLU participants was 28%; significantly higher than in controls (P &lt; 0.001). Conclusion Participants with VLU are comorbid with poorer physical, social and psychological wellbeing.

Wound Care for Venous Ulceration

Venous leg ulcers (VLUs) affect as many as 20% of patients with advanced chronic venous insufficiency and are associated with significant morbidity and health care costs. VLUs are the most common cause of leg ulcers; however, other etiologies of lower extremity ulcerations should be investigated, most notably arterial insufficiency, to ensure appropriate therapy. Careful clinical examination, standardized documentation, and ultrasound evaluation are needed for diagnosis and treatment success. Reduction of edema and venous hypertension through compression therapy, local wound care, and treatment of venous reflux or obstruction is the foundation of therapy. As key providers in venous disease, interventional radiologists should be aware of current standardized disease classification and scoring systems as well as treatment and wound care guidelines for venous ulcers.

Choosing the Best Treatment Approach for Axial Vein Reflux: Thermal versus Nonthermal Approaches

Chronic venous insufficiency is a common and treatable medical condition which has a high morbidity if left untreated, progressing to lower extremity edema, skin changes of lipodermatosclerosis, and venous ulceration. Treatment options have significantly expanded over the last several decades, shifting away from the traditional surgical approach to more minimally invasive procedures such as endoluminal venous laser ablation or radiofrequency ablation. Even more recently, several techniques using nonthermal methods to ablate varicose veins have been developed, which offer the advantage of not requiring labor-intensive and painful tumescent anesthesia to protect the surrounding tissues. These techniques include mechanochemical ablation, cyanoacrylate closure, or polidocanol microfoam injection and can be offered to a wider range of patients without the need for sedation while offering similar closure rates and improved postprocedure symptom profile. Furthermore, certain patient characteristics which might preclude or complicate the use of thermal ablation methods might not pose a problem with nonthermal nontumescent methods.

Impact of a One-Stop Rapid Access Venous Ulcer Clinic on Inpatient Admissions

Objective To determine whether the introduction of a one-stop see and treat clinic offering early reflux ablation for Venous Leg Ulcer (VLU) patients in July 2016 has affected rates of unplanned inpatient admissions due to venous ulceration. Design Review of inpatient admission data and analysis of related costs. Materials The Hospital Inpatient Enquiry collects data from acute public hospitals in Ireland on admissions and discharges, coded by diagnosis and acuity. This was the primary source of all data relating to admissions and length of stay. Costs were calculated from data published by the Health Service Executive in Ireland on average costs per inpatient stay for given diagnosis codes. Methods Data were collected on admission rates, length of stay, overall bed day usage, and costs across a four-year period; the two years since the introduction of the rapid access clinic, and the two years immediately prior as a control. Results 218 patients admitted with VLUs accounted for a total of 2,529 inpatient bed-days, with 4.5(2-6) unplanned admissions, and a median hospital stay of 7(4-13) days per month. Median unplanned admissions per month decreased from 6(2.5-8.5) in the control period, to 3.5(2-5) after introduction of the clinic p=.040. Bed-day usage was significantly reduced from median 62.5(27-92.5), to 36.5(21-44) bed-days per month (p=.035), though length of stay remained unchanged (p=.57). Cost of unplanned inpatient admissions fell from median \euro33,336.25(\euro14,401.26-\euro49,337.65) per month to \euro19,468.37(\euro11,200.98-\euro22,401.96) (p=.03). Conclusions Admissions for inpatient management of VLUs have fallen after beginning aggressive endovenous treatment of venous reflux in a dedicated one-stop see-and-treat clinic for these patients. As a result, bed-day usage has also fallen, leading to cost savings.

Venography and Selective Ablation for Recurrent Varices after Surgery Using Radiofrequency Ablation Catheter

Recurrent varices after surgery (REVAS) is a common problem with no established treatment. Ultrasonography is a hard method to identify the source of veins that cause REVAS, especially in obese patients with thick thighs. Here, we report the case of a 64-year-old obese patient who previously underwent endothermal venous ablation for her right great saphenous vein. The patient presented with right leg swelling and venous ulceration due to REVAS. Although the source of REVAS was unclear because the patient had thick thighs on ultrasonography assessment, venography revealed that the source of REVAS was the incompetent perforator vein (IPV). Selective ablation for the IPV with radiofrequency ablation catheter was performed. We could ablate the target veins selectively so as not to ablate within the deep vein. The patient remains asymptomatic for 2 years after the procedure, and there has been no recurrence of her varicose veins. Venography allows better visualization of the source of REVAS than ultrasonography. With selective ablation, it is especially effective procedure in obese patients, in whom it is difficult to identify and access the source of REVAS with ultrasonography.