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Advances in Skin & Wound Care Jan 2024Chronic venous disease is a circulatory system dysfunction that has the potential to lead to venous leg ulceration. Although research on the influence of specific gene...
OBJECTIVE
Chronic venous disease is a circulatory system dysfunction that has the potential to lead to venous leg ulceration. Although research on the influence of specific gene variants on chronic venous disease has been limited, a few studies have reported an association between hemochromatosis and chronic venous disease. However, no studies have looked at the prevalence of lower-limb venous disease and leg ulcers in people with hemochromatosis. This study aimed to review the existing literature for any association between venous disease and hemochromatosis and investigate the prevalence of venous disease and leg ulcers in people with hemochromatosis.
METHODS
Scoping systematic literature review and cross-sectional study surveying people with hemochromatosis.
RESULTS
This scoping systematic literature review included nine articles and indicated a link between hemochromatosis and venous disease/leg ulcers, although further studies are needed to support this link. Analysis of survey results from people with hemochromatosis found a 9.2% prevalence of leg ulcers in those with self-reported hemochromatosis, considerably higher than the 1% to 3% expected, suggesting that hemochromatosis gene variants may be associated with the pathogenesis of chronic venous disease and leg ulcers.
CONCLUSIONS
This is the first known study to complete a review of the literature regarding hemochromatosis and venous leg ulcers and document the association between hemochromatosis and venous disease/leg ulcers. There is a lack of research in this area and hence limited evidence to guide practice.
Topics: Humans; Hemochromatosis; Cross-Sectional Studies; Lower Extremity; Leg Ulcer; Varicose Ulcer; Vascular Diseases
PubMed: 38117169
DOI: 10.1097/ASW.0000000000000080 -
Journal of Tissue Viability Nov 2023To determine the monetary costs identified in economic evaluations of treatment with compression bandages among adults with venous leg ulcers (VLU). (Review)
Review
AIM
To determine the monetary costs identified in economic evaluations of treatment with compression bandages among adults with venous leg ulcers (VLU).
METHOD
A scoping review of existing publications was conducted in February 2023. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used.
RESULTS
Ten studies met the inclusion criteria. To place the costs of treatment into context, these are reported in conjunction with the healing rates. Three comparisons were made: 1.4 layer compression versus no compression (3 studies). One study reported that 4 layer compression was more expensive than usual care (£804.03 vs £681.04, respectively), while the 2 other studies reported the converse (£145 vs £162, respectively) and all costs (£116.87 vs £240.28 respectively). Within the three studies, the odds of healing were statistically significantly greater with 4 layer bandaging (OR: 2.20; 95% CI: 1.54-3.15; p = 0.001).; 2.4 layer compression versus other compression (6 studies). For the three studies reporting the mean costs per patient associated with treatment (bandages alone), over the treatment period, analysis identified a mean difference (MD) in costs for 4 layer vs comparator 1 (2 layer compression, short-stretch compression, 2 layer compression hosiery, 2 layer cohesive compression, 2 layer compression) of -41.60 (95% CI: 91.40 to 8.20; p = 0.10). The OR of healing for 4 layer compression vs comparator 1 (2 layer compression, short-stretch compression, 2 layer compression hosiery, 2 layer cohesive compression, 2 layer compression) is: 0.70 (95% CI: 0.57-0.85; p = 0.004). For 4 layer vs comparator 2 (2 layer compression) the MD is: 14.00 (95% CI: 53.66 to -25.66; p < 0.49). The OR of healing for 4 layer compression vs comparator 2 (2 layer compression) is: 3.26 (95% CI: 2.54-4.18; p < 0.00001). For comparator 1 (2 layer compression, short-stretch compression, 2 layer compression hosiery, 2 layer cohesive compression, 2 layer compression) vs comparator 2 (2 layer compression) the MD in costs is: 55.60 (95% CI: 95.26 to -15.94; p = 0.006). The OR of healing with Comparator 1 (2 layer compression, short-stretch compression, 2 layer compression hosiery, 2 layer cohesive compression, 2 layer compression) is: 5.03 (95% CI:4.10-6.17; p < 0.00001). Three studies presented the mean annual costs per patient associated with treatment (all costs). The MD is 172 (150-194; p = 0.401), indicating no statistically significant difference in costs between the groups. All studies showed faster healing rates in the 4 layer study groups. 3. Compression wrap versus inelastic bandage (one study). Compression wrap was less expensive than inelastic bandage (£201 vs £335, respectively) with more wounds healing in the compression wrap group (78.8%, n = 26/33; 69.7%, n = 23/33).
CONCLUSION
The results for the analysis of costs varied across the included studies. As with the primary outcome, the results indicated that the costs of compression therapy are inconsistent. Given the methodological heterogeneity among studies, future studies in this area are needed and these should use specific methodological guidelines to generate high-quality health economic studies.
Topics: Adult; Humans; Compression Bandages; Varicose Ulcer; Health Care Costs; Pressure; Cost-Benefit Analysis; Leg Ulcer
PubMed: 37423836
DOI: 10.1016/j.jtv.2023.06.009 -
Journal of Vascular Surgery. Venous and... May 2024The objective of this study is to systemically review the literature on Anterior Saphenous Vein (ASV) reflux treatment and insurance impediments to treatment coverage.
The anterior saphenous vein. Part 3. Systematic review of the literature and payor coverage policies. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology.
OBJECTIVE
The objective of this study is to systemically review the literature on Anterior Saphenous Vein (ASV) reflux treatment and insurance impediments to treatment coverage.
METHODS
A literature search was performed using a PRISMA framework. In addition, a cross-sectional analysis of insurance policies for ASV treatment was evaluated.
RESULTS
Published evidence and treatment considerations in the literature for ASV treatment are discussed. In 155 of 226 (68.6%) insurance policies reviewed coverage of ASV ablation was allowed while 62/226 (27.4%) did not specify coverage and 9/226 (4.0%) specified ASV treatment was not covered. Of the 155 that provide ASV coverage, 98 (62.2%) provide coverage with criteria such as requiring prior treatment of the great saphenous vein.
CONCLUSIONS
Vein treatment experts should continue to advocate to insurance carriers to update their varicose vein treatment policies to reflect the substantial clinical evidence so that patients with ASV reflux can be appropriately treated.
Topics: Humans; United States; Saphenous Vein; Cross-Sectional Studies; Varicose Veins; Femoral Vein; Sclerotherapy; Venous Insufficiency; Treatment Outcome
PubMed: 38551528
DOI: 10.1016/j.jvsv.2024.101856 -
Journal of Vascular Surgery. Venous and... Sep 2023The benefit of using electric stimulation therapy (EST) to heal venous leg ulcers (VLUs) is not well established. The main aim of this systematic review was to evaluate... (Review)
Review
OBJECTIVE
The benefit of using electric stimulation therapy (EST) to heal venous leg ulcers (VLUs) is not well established. The main aim of this systematic review was to evaluate the effects of ulcer EST in VLU healing.
METHODS
A systematic search of the literature was conducted using the databases PubMed, Scopus, and Web of Science and included original studies that reported VLU healing after EST. The inclusion criteria were at least two surface electrodes placed on or near the wound or a planar probe covering the ulcer area to be treated. The Cochrane risk of bias tool for randomized control trials (RCTs) and Joanna Briggs Institute critical appraisal checklist for case series were used to evaluate the risk of bias.
RESULTS
This review included eight RCTs and three case series involving a total of 724 limbs in 716 patients with VLUs. The mean patient age was 64.2 years (95% confidence interval, 62.3-66.2), and 46.2% (95% confidence interval, 41.2%-50.4%) were men. The active electrode was placed on the wound with the passive electrode placed on healthy skin (n = 6), the two electrodes were placed on either side of the wound edges (n = 4), or a planar probe was used (n = 1). The pulsed current was the most used waveform (n = 9). The change in the ulcer size was the main method used to determine ulcer healing (n = 8), followed by the ulcer healing rate (n = 6), exudate levels (n = 4), and the time to healing (n = 3). Five RCTs detected a statistically significant improvement in at least one VLU healing outcome, after EST compared with the control group. In two of these, EST was better than the control but only for patients who had not undergone surgical treatment of VLU.
CONCLUSIONS
The findings from the present systematic review support the use of EST to accelerate wound healing of VLUs, especially for patients who are not surgical candidates. However, the significant variation in electric stimulation protocols represents an important limitation to its use and should be addressed in future studies.
Topics: Male; Humans; Middle Aged; Female; Ulcer; Varicose Ulcer; Wound Healing; Skin; Electric Stimulation
PubMed: 37196922
DOI: 10.1016/j.jvsv.2023.05.005 -
International Wound Journal Feb 2024Considering the substantial impact of venous ulcers on quality of life and healthcare systems, this study evaluated the efficacy and safety of platelet-rich plasma (PRP)... (Meta-Analysis)
Meta-Analysis Review
Considering the substantial impact of venous ulcers on quality of life and healthcare systems, this study evaluated the efficacy and safety of platelet-rich plasma (PRP) in comparison to conventional therapy. A systematic review of four databases identified 16 randomized clinical trials, including 20 study groups. PRP significantly enhanced complete ulcer healing, exhibiting an odds ratio (OR) of 5.06 (95% confidence interval [CI]: 2.35-10.89), and increased the percentage of healed ulcer area by a mean difference of 47% (95% CI: 32%-62%). Additionally, PRP shortened the time required for complete healing by an average of 3.25 months (95% CI: -4.06 to -2.43). Although pain reduction was similar in both groups, PRP considerably decreased ulcer recurrence rates (OR = 0.16, 95% CI: 0.05-0.50) without increasing the risks of infection or irritative dermatitis. These results suggest PRP as a viable, safe alternative for venous ulcer treatment, providing significant improvements in healing outcomes.
Topics: Humans; Varicose Ulcer; Ulcer; Quality of Life; Randomized Controlled Trials as Topic; Platelet-Rich Plasma
PubMed: 38361238
DOI: 10.1111/iwj.14736 -
Vascular Medicine (London, England) Oct 2023We sought to assess the safety and efficacy of endovenous thermal ablation (EVTA) in treating large great saphenous veins (GSV) > 12 mm in diameter. (Meta-Analysis)
Meta-Analysis
BACKGROUND
We sought to assess the safety and efficacy of endovenous thermal ablation (EVTA) in treating large great saphenous veins (GSV) > 12 mm in diameter.
METHODS
We performed a systematic review according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 for comparative and noncomparative studies depicting EVTA in the treatment of GSV > 12 mm. Primary endpoints included GSV occlusion, technical success, deep vein thrombosis (DVT), and endovenous heat-induced thrombosis (EHIT). We conducted a comparative analysis between GSV > 12 mm and < 12 mm and a meta-regression analysis for two sets of studies, one including the whole dataset, containing treatment arms of comparative studies with GSV < 12 mm and one exclusively for GSV > 12 mm.
RESULTS
Seven studies, including 2564 GSV, depicting radiofrequency (RFA) and endovenous laser ablation (EVLA) were included. GSV > 12 mm occlusion, technical success, DVT, and EHIT estimates were 95.9% (95% CI: 93.6-97.8), 99.9% (95% CI: 98.9-100.0), 0.04% (95% CI: 0.0-3.4), and 1.6% (95% CI: 0.3-3.5). Meta-regression revealed a negative association between GSV diameter and occlusion for both the whole dataset ( < 0.01) and the > 12 mm groups ( = 0.04), GSV diameter and technical success for both groups ( < 0.01), ( = 0.016), and GSV diameter and EHIT only for the whole dataset ( = 0.02). The comparative analysis between GSV < 12 mm and GSV > 12 mm displayed an occlusion estimate of OR 1.79 (95% CI: 1.25-2.56) favoring small GSV.
CONCLUSION
Whereas we have displayed excellent occlusion and technical success results for the EVTA of GSV > 12 mm, our analysis has illustrated the unfavorable impact of GSV diameter on occlusion, technical success, and EHIT outcomes regardless of the 12 mm threshold. Potential parameter or device adjustments in a diameter-oriented fashion could further enhance outcomes.
Topics: Humans; Saphenous Vein; Treatment Outcome; Risk Factors; Laser Therapy; Thrombosis; Varicose Veins; Venous Insufficiency
PubMed: 37458188
DOI: 10.1177/1358863X231183997 -
Journal of Vascular Surgery. Venous and... Apr 2024We compared the effectiveness and safety of polidocanol 1% endovenous microfoam ablation vs endovenous thermal ablation with radiofrequency or laser energy for treatment... (Review)
Review
Comparative effectiveness of non-compounded polidocanol 1% endovenous microfoam (Varithena) ablation versus endovenous thermal ablation utilizing a systematic review and network meta-analysis.
OBJECTIVE
We compared the effectiveness and safety of polidocanol 1% endovenous microfoam ablation vs endovenous thermal ablation with radiofrequency or laser energy for treatment of venous insufficiency caused by lower extremity truncal vein incompetence via network meta-analysis of published comparative evidence.
METHODS
We conducted a systematic literature review following best practices, including a prospective protocol. We screened studies published in English from 2000 to 2023 for randomized and nonrandomized studies reporting direct or indirect comparisons between polidocanol 1% endovenous microfoam and endovenous thermal ablation. Thirteen studies met our eligibility criteria for the network meta-analysis. The co-primary effectiveness outcomes were the closure rate ≥3 months after procedure and the average change in the Venous Clinical Severity Score. For the subgroup of venous ulcer patients, the ulcer healing rate was the primary effectiveness outcome. The secondary outcomes included safety and patient-reported outcomes. Network meta-analyses were conducted on outcomes having sufficient data. Categorical outcomes were summarized using odds ratios (ORs) with 95% confidence intervals (CIs). Sensitivity tests and estimates of network inconsistency were used to investigate the robustness of our meta-analysis.
RESULTS
We found that polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure (OR, 0.65; 95% CI, 0.36-1.18; P = .16). Although not the primary aim of the study, the network meta-analysis also provided evidence to confirm our supposition that polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds for vein closure (OR, 2.91; 95% CI, 1.58-5.37; P < .01). A sensitivity analysis using the longest available time point for closure in each study, with a minimum of 12 months of follow-up (median, 48 months; range, 12-72 months), showed results similar to those of the main analysis. No association was found between the risk of deep vein thrombosis and the treatment received. The available data were insufficient for a network meta-analysis of Venous Clinical Severity Score improvement and ulcer healing rates.
CONCLUSIONS
Polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure and deep vein thrombosis risk for chronic venous insufficiency treatment, based on a network meta-analysis of published evidence. Polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds of vein closure. A sensitivity analysis found venous closure findings were robust at follow-up intervals of 12 months or greater and for up to 6 years. New evidence meeting the inclusion criteria for this review will be incorporated at regular intervals into a living network meta-analysis.
PubMed: 38679141
DOI: 10.1016/j.jvsv.2024.101896 -
The International Journal of Lower... Dec 2023To systematically evaluate the clinical effects of platelet-rich plasma in the treatment of lower limb venous ulcers by applying a meta-analysis method. The Pubmed,... (Meta-Analysis)
Meta-Analysis Review
To systematically evaluate the clinical effects of platelet-rich plasma in the treatment of lower limb venous ulcers by applying a meta-analysis method. The Pubmed, Cochrance Library, Embase, and OVID EBM Reviews databases were searched for the search terms'platelet-rich plasma" or "Plasma, Platelet-Rich" or "Platelet Rich Plasma" and "lower extremity venous ulcers' or "Leg Ulcers' or "Ulcer, Leg", and a meta-analysis was performed on the published research literature on platelet-rich plasma for lower extremity venous ulcers from January 1900 to April 2021. The outcome indicators were: post-treatment trauma area and healing rate. Revman 5.3 statistical software was applied for meta-analysis. A total of 294 patients with lower extremity venous ulcers were included in six publications, including 148 patients in the experimental group treated with PRP versus 146 patients in the control group treated with conventional therapy. There was a statistically significant difference in the Formula of an ellipse at the end of treatment (CM²) between the experimental group and the control group, with a mean difference of -1.19 (95% CI -1.80 to -0.58, = .0001; 6 studies, 294 participants moderate quality of evidence). The difference between the healing rate of the experimental group and the control group was statistically significant, with a risk ratio (RR) of 5.73 (95% CI 3.29 - 9.99, < .00001; 5 studies, 248 participants moderate quality of evidence).There may be publication bias for both Formula of an ellipse at the end of treatment and healing rate. This comprehensive meta-analysis of available evidence suggests that the application of PRP for lower extremity venous ulcers accelerates the wound healing process and improves wound healing rates.
Topics: Humans; Varicose Ulcer; Wound Healing; Leg Ulcer; Platelet-Rich Plasma; Lower Extremity
PubMed: 34665051
DOI: 10.1177/15347346211046203 -
The International Journal of Lower... Jun 2024The venous leg ulcers are debilitating, painful, and often unresponsive to advanced dressing treatments, so drugs used locally and systematically are essential adjuvant... (Meta-Analysis)
Meta-Analysis
The venous leg ulcers are debilitating, painful, and often unresponsive to advanced dressing treatments, so drugs used locally and systematically are essential adjuvant therapy-pentoxifylline (PTX) whose anti-inflammatory effects may offer a promising avenue to treat venous leg ulcers. However, the current results are controversial. To further evaluate the efficacy and safety of PTX, we performed an updated meta-analysis of randomized placebo-controlled trials of PTX in the treatment of venous leg ulcers. We systematically searched multiple electronic databases PubMed, Web of Science, Embase, the Cochrane Library, the Cochrane Central Register of Controlled Trials, China Science and Technology Journal Database, WanFang Data, China National Knowledge Infrastructure, and the Chinese Biomedical Literature Database to identify eligible studies. Randomized clinical trials of pentoxifylline versus placebo treatment in patients with venous leg ulcers were considered for inclusion. The primary outcomes included ulcer healing rate and the incidence of adverse events after treatment. The secondary outcomes were the ulcer significant improvement (the ulcer size shrank by more than 60% after treatment) rate, mean duration of complete wound healing and changes in mean ulcer size. A meta-analysis and qualitative analysis were conducted to estimate endpoints. A total of 13 randomized clinical trials, including 921 individuals, were finally included. Compared with placebo, pentoxifylline significantly improved the ulcer healing rate (RR = 1.59, 95%CI 1.22 to 2.07, < .001) and significant improvement rate (RR = 2.36, 95%CI 1.31 to 4.24, = .004) while increased the incidence of gastrointestinal disturbances (RR = 2.29, 95%CI 1.04 to 5.03, = .04) at the same time. Moreover, pentoxifylline also shortened mean duration of complete wound healing ( = .007) and shrank ulcer size ( = .02). Currently available evidence suggests that pentoxifylline could help venous leg ulcers heal more quickly and effectively. However, the evidence is insufficient to prove the results due to moderate-certainty evidence. Large-scale, well-designed randomized clinical trials are warranted.
Topics: Humans; Pentoxifylline; Randomized Controlled Trials as Topic; Treatment Outcome; Varicose Ulcer; Wound Healing
PubMed: 34779680
DOI: 10.1177/15347346211050769 -
Journal of Vascular Surgery. Venous and... Jan 2024The purpose of this review was to identify prognostic models for clinical application in patients with venous leg ulcers (VLUs). (Review)
Review
OBJECTIVE
The purpose of this review was to identify prognostic models for clinical application in patients with venous leg ulcers (VLUs).
METHODS
Literature searches were conducted in Embase, Medline, Cochrane, and CINAHL databases from inception to December 22, 2021. Eligible studies reported prognostic models aimed at developing, validating, and adjusting multivariable prognostic models that include multiple prognostic factors combined, and that predicted clinical outcomes. Methodological quality was assessed using the CHARMS checklist and PROBAST short form questionnaire.
RESULTS
Thirteen studies were identified, of which three were validation studies of previously published models, four reported derivation and validation of models, and the remainder reported derivation models only. There was substantial heterogeneity in the model characteristics, including 11 studies focused on wound healing outcomes reporting 91 different predictors. Three studies shared similar predicted outcomes, follow-up timepoint and used a Cox proportional hazards model. However, these models reported different predictor selection methods and different predictors and it was therefore not feasible to summarize performance, such as discriminative ability.
CONCLUSIONS
There are no standout risk prediction models in the literature with promising clinical application for patients with VLUs. Future research should focus on developing and validating high-performing models in wider VLU populations.
Topics: Humans; Prognosis; Varicose Ulcer; Wound Healing
PubMed: 37689364
DOI: 10.1016/j.jvsv.2023.06.017