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The Cochrane Database of Systematic... Jul 2023Venous leg ulcers (VLUs) are a serious manifestation of chronic venous disease affecting up to 3% of the adult population. This typically recalcitrant and recurring... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Venous leg ulcers (VLUs) are a serious manifestation of chronic venous disease affecting up to 3% of the adult population. This typically recalcitrant and recurring condition significantly impairs quality of life, and its treatment places a heavy financial burden upon healthcare systems. The longstanding mainstay treatment for VLUs is compression therapy. Surgical removal of incompetent veins reduces the risk of ulcer recurrence. However, open surgery is an unpopular option amongst people with VLU, and many people are unsuitable for it. The efficacy of the newer, minimally-invasive endovenous techniques has been established in uncomplicated superficial venous disease, and these techniques can also be used in the management of VLU. When used with compression, endovenous ablation aims to further reduce pressure in the veins of the leg, which may impact ulcer healing.
OBJECTIVES
To determine the effects of superficial endovenous ablation on the healing and recurrence of venous leg ulcers and the quality of life of people with venous ulcer disease.
SEARCH METHODS
In April 2022 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scrutinised reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions on the language of publication, but there was a restriction on publication year from 1998 to April 2022 as superficial endovenous ablation is a comparatively new technology.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing endovenous ablative techniques with compression versus compression therapy alone for the treatment of VLU were eligible for inclusion. Studies needed to have assessed at least one of the following primary review outcomes related to objective measures of ulcer healing such as: proportion of ulcers healed at a given time point; time to complete healing; change in ulcer size; proportion of ulcers recurring over a given time period or at a specific point; or ulcer-free days. Secondary outcomes of interest were patient-reported quality of life, economic data and adverse events.
DATA COLLECTION AND ANALYSIS
Two reviewers independently assessed studies for eligibility, extracted data, carried out risk of bias assessment using the Cochrane RoB 1 tool, and assessed GRADE certainty of evidence.
MAIN RESULTS
The previous version of this review found no RCTs meeting the inclusion criteria. In this update, we identified two eligible RCTs and included them in a meta-analysis. There was a total of 506 participants with an active VLU, with mean durations of 3.1 months ± 1.1 months in the EVRA trial and 60.5 months ± 96.4 months in the VUERT trial. Both trials randomised participants to endovenous treatment and compression or compression alone, however the compression alone group in the EVRA trial received deferred endovenous treatment (after ulcer healing or from six months). There is high-certainty evidence that combined endovenous ablation and compression compared with compression therapy alone, or compression with deferred endovenous treatment, improves time to complete ulcer healing (pooled hazard ratio (HR) 1.41, 95% CI 1.36 to 1.47; I = 0%; 2 studies, 466 participants). There is moderate-certainty evidence that the proportion of ulcers healed at 90 days is probably higher with combined endovenous ablation and compression compared with compression therapy alone or compression with deferred endovenous treatment (risk ratio (RR) 1.14, 95% CI 1.00 to 1.30; I = 0%; 2 studies, 466 participants). There is low-certainty evidence showing an unclear effect on ulcer recurrence at one year in people with healed ulcers with combined endovenous treatment and compression when compared with compression alone or compression with deferred endovenous treatment (RR 0.29, 95% CI 0.03 to 2.48; I = 78%; 2 studies, 460 participants). There is also low-certainty evidence that the median number of ulcer-free days at one year may not differ (306 (interquartile range (IQR) 240 to 328) days versus 278 (IQR 175 to 324) days) following combined endovenous treatment and compression when compared with compression and deferred endovenous treatment; (1 study, 450 participants). There is low-certainty evidence of an unclear effect in rates of thromboembolism between groups (RR 2.02, 95% CI 0.51 to 7.97; I = 78%, 2 studies, 506 participants). The addition of endovenous ablation to compression is probably cost-effective at one year (99% probability at GBP 20,000/QALY; 1 study; moderate-certainty evidence).
AUTHORS' CONCLUSIONS
Endovenous ablation of superficial venous incompetence in combination with compression improves leg ulcer healing when compared with compression alone. This conclusion is based on high-certainty evidence. There is moderate-certainty evidence to suggest that it is probably cost-effective at one year and low certainty evidence of unclear effects on recurrence and complications. Further research is needed to explore the additional benefit of endovenous ablation in ulcers of greater than six months duration and the optimal modality of endovenous ablation.
Topics: Adult; Humans; Varicose Ulcer; Neoplasm Recurrence, Local; Wound Healing; Veins; Leg Ulcer
PubMed: 37497816
DOI: 10.1002/14651858.CD009494.pub3 -
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 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 -
European Journal of Vascular and... Nov 2023The objective was to compare technical success, complications, and quality of life after thermal vs. non-thermal endovenous ablation for the treatment of superficial... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The objective was to compare technical success, complications, and quality of life after thermal vs. non-thermal endovenous ablation for the treatment of superficial venous incompetence.
DATA SOURCES
Electronic bibliographic sources (Google Scholar, Pubmed, Cochrane Database, Scopus, Web of Science, and Embase).
REVIEW METHODS
A systematic review and meta-analysis of randomised controlled trials was conducted using terms to identify relevant studies to be included. The primary outcome was vein occlusion rate at up to four weeks and one to two years from procedure. Secondary outcome measures included peri-procedural pain, nerve injury, endothermal heat induced thrombosis, and quality of life.
RESULTS
Eight randomised controlled trials met the selection criteria. These comprised a total of 1 956 patients, of whom 1 042 underwent endovenous thermal ablation and 915 underwent endovenous non-thermal ablation. There was no statistically significant difference in occlusion rate at all time points. Relative risk at four weeks and one to two years was 0.99 (95% CI 0.96 - 1.02) and 0.95 (95% CI 0.88 - 1.01), respectively. Non-thermal ablation was tolerated better and had less risk of nerve injury. There was no statistically significant difference in risk of endothermal heat induced thrombosis (EHIT). There was improvement in quality of life scores post-procedure but there was no statistically significant difference in thermal vs. non-thermal ablation. The quality of evidence assessed using GRADE methodology showed high quality for occlusion rate at four weeks and one to two years, moderate quality for nerve injury and peri-procedural pain, and low quality for EHIT.
CONCLUSION
Vein occlusion rates after thermal vs. non-thermal endovenous ablation are similar. In the early post-operative period, non-thermal endovenous ablation demonstrated the advantages of less pain and less risk of nerve injury. Improvement in quality of life after both thermal and non-thermal endovenous ablation is similar.
Topics: Humans; Pain, Procedural; Quality of Life; Varicose Veins; Saphenous Vein; Thrombosis; Venous Insufficiency; Treatment Outcome; Laser Therapy; Randomized Controlled Trials as Topic
PubMed: 37295602
DOI: 10.1016/j.ejvs.2023.06.002 -
International Wound Journal Nov 2023Venous leg ulcers (VLU) represent a major public health challenge. Little is known about the prevalence and incidence of VLU internationally. Published studies are... (Meta-Analysis)
Meta-Analysis Review
Venous leg ulcers (VLU) represent a major public health challenge. Little is known about the prevalence and incidence of VLU internationally. Published studies are usually reporting different estimates because of disparities in study designs and measurement methods. Therefore, we conducted a systematic literature review and meta-analysis to identify the prevalence and incidence of VLU internationally and to characterise the population as reported in these studies. Studies were identified from searches in Medline (PubMed), CINAHL Complete (EBSCOhost), Embase, Scopus, Web of Science, LiSSa (Littérature Scientifique en Santé), Google Scholar and Cochrane Database of Systematic Reviews up to November 2022. Studies were included if their primary outcomes were reported as a period prevalence or point prevalence or cumulative incidence or incidence VLU rate. Fourteen studies met the inclusion criteria, 10 reporting estimates of prevalence, three reporting both prevalence and incidence estimates and one incidence. All were included in meta-analyses. The results show a pooled prevalence of 0.32% and a pooled incidence of 0.17%. Our results highlighted an extreme heterogeneity across effect sizes for both prevalence and incidence, which prevent a meaningful interpretation of pooled indexes and argue for further studies with specific prevalence-type reported and target population under study.
Topics: Humans; Prevalence; Incidence; Varicose Ulcer
PubMed: 37293810
DOI: 10.1111/iwj.14272 -
International Urogynecology Journal Sep 2023The literature is scarce regarding the effects of comorbidities, clinical parameters, and lifestyle as risk factors for pelvic organ prolapse (POP). This study was... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION AND HYPOTHESIS
The literature is scarce regarding the effects of comorbidities, clinical parameters, and lifestyle as risk factors for pelvic organ prolapse (POP). This study was performed to systematically review the literature related to body mass index (BMI), waist circumference, diabetes mellitus (DM), hypertension (HT), dyslipidemia, chronic constipation, smoking, chronic cough, occupation, and striae and varicose veins as determinants for POP.
METHODS
Search terms in accordance with Medical Subject Headings were used in PubMed, Embase, LILACS, and the Cochrane Library. Clinical comparative studies between women with and without POP and containing demographic and/or clinical raw data related to lifestyle and/or comorbidities were included. The ROBINS-I (risk of bias in non-randomized studies of interventions) instrument was used. Fixed-effects and random-effects models were used for homogeneous and heterogeneous studies, respectively.
RESULTS
Forty-three studies were included in the meta-analysis. BMI < 25 kg/m was found to be a protective factor for POP [OR 0.71 (0.51, 0.99); p = 0.04], and BMI > 30 kg/m was a risk factor for POP [OR 1.44 (1.37, 1.52); p < 0.00001]. Waist circumference (≥ 88 cm) was reported as a risk factor for POP [OR 1.80 (1.37, 2.38); p < 0.00001], along with HT [OR 1.18 (1.09, 1.27); p = 0.04], constipation [OR 1.77 (1.23, 2.54); p < 0.00001], occupation [OR 1.86 (1.21, 2.86); p < 0.00001], persistent cough [OR 1.52 (1.18, 1.94); p < 0.0001]), and varicose veins [OR 2.01 (1.50, 2.70); p = 0.12].
CONCLUSIONS
BMI < 25 kg/m is protective while BMI > 30 kg/m is a risk factor for POP. Large waist circumference, dyslipidemia, HT, constipation, occupation, persistent cough, and varicose veins are also determinants for POP.
Topics: Female; Humans; Cough; Risk Factors; Life Style; Hypertension; Pelvic Organ Prolapse; Constipation; Varicose Veins
PubMed: 37256322
DOI: 10.1007/s00192-023-05569-3 -
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 Nov 2023Chronic venous disease (CVD) occurs because of structural or functional disturbances to the venous system of the lower limbs. Signs and symptoms include leg pain,... (Review)
Review
Chronic venous disease (CVD) occurs because of structural or functional disturbances to the venous system of the lower limbs. Signs and symptoms include leg pain, swelling, varicose veins, and skin changes, with venous ulceration ultimately occurring in severe disease. To assess the prevalence of CVD among health care workers, a scoping review of existing publications exploring the prevalence of CVD among health care workers was conducted in July 2022. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used. A total of 15 papers met the inclusion criteria and these formed the basis of the review. Among health care workers, the mean prevalence of CVD was 58.5% and the mean prevalence for varicose veins was 22.1%. There is an increased prevalence of CVD in health care workers when compared with the general population. Therefore, there is a need for early diagnosis and the use of preventative measures to protect health care workers from CVD and varicose vein development.
Topics: Humans; Venous Insufficiency; Prevalence; Varicose Veins; Varicose Ulcer; Chronic Disease; Health Personnel
PubMed: 37139850
DOI: 10.1111/iwj.14222 -
Vascular and Endovascular Surgery Aug 2023The use of Hyperbaric Oxygen Therapy (HBOT) in diabetic wounds has been studied extensively. Even though venous insufficiency is the most common cause of lower limb... (Review)
Review
BACKGROUND
The use of Hyperbaric Oxygen Therapy (HBOT) in diabetic wounds has been studied extensively. Even though venous insufficiency is the most common cause of lower limb ulceration, there is comparatively little evidence regarding the use of HBOT for Venous Leg Ulcers (VLU). We performed a systematic-review to evaluate and synthesise available evidence, to evaluate whether patients with VLU, when treated with HBOT, had greater rates of (i) complete VLU healing or (ii) reduction in VLU area, than controls.
METHODS
In keeping with PRISMA guidelines, database searches of PubMed, Scopus and Embase was performed. After removal of duplicates, titles were screened for relevance by two authors, then abstracts, and in turn full text manuscripts. Data were extracted from relevant sources including one published abstract. Included studies were assessed for risk of bias using the Risk of Bias 2 (RoB-2) and Risk Of Bias In Nonrandomized Studies (ROBINS-I) tools.
RESULTS
Six studies were included. There was significant heterogeneity across the studies, with no standard control intervention, method of outcome reporting, or duration of follow up. Two studies reported 12 week follow up results and pooled analysis of complete ulcer healing showed no statistically significant difference between HBOT and controls for the outcome of complete ulcer healing OR 1.54 (95%CI = .50-4.75) P = .4478. A similar non-signifiacnt result was seen in four studies reporting 5-6 week follow up; OR 5.39 (95%CI = .57-259.57) P = .1136. Change in VLU area was reported in all studies, and pooled standardised mean difference was 1.70 (95%CI = .60 to 2.79) P = .0024, indicating a statistically significant benefit of HBOT in reducing ulcer area.
CONCLUSION
Existing evidence suggests that HBOT does not significantly affect complete healing of VLU. There is a statistically significant benefit in terms of reducing ulcer size, though in the absence of ulcer healing the clinical significance of this is not established. Current evidence does not justify widespread use of HBOT for VLU.
Topics: Humans; Varicose Ulcer; Hyperbaric Oxygenation; Ulcer; Treatment Outcome; Wound Healing
PubMed: 36891617
DOI: 10.1177/15385744231162924 -
Asian Journal of Surgery Oct 2023This systematic review and meta-analysis aim to explore the adjuvant effect of hyperbaric oxygen therapy (HBOT) in patients with venous leg ulcer (VLU) undergoing... (Meta-Analysis)
Meta-Analysis Review
This systematic review and meta-analysis aim to explore the adjuvant effect of hyperbaric oxygen therapy (HBOT) in patients with venous leg ulcer (VLU) undergoing surgeries and non-surgeries. Literatures were searched from Web of Science, Cochrane Library, Embase, Pubmed, Wan fang, China National Knowledge Infrastructure (CNKI), and VIP from inception to November 15, 2022. The risk ratio (RR) and weighted mean difference (WMD) were used as effect size for categorical variables and continuous variables, respectively, with 95% confidence interval (95%CI). The heterogeneity was assessed using Q-test and quantified as I. Sensitivity analysis was performed for all outcomes. A total of 11 studies were finally included in this study, with a total of 617 patients (313 in the HBOT group and 304 in the control group). Results showed that HBOT in combination with surgeries was associated with shorter ulcer healing time (WMD: -13.76, 95%CI: -20.42 to -7.10), lower VAS score (WMD: -0.95, 95% CI: -1.83 to -0.07), and smaller ulcer area (WMD: -2.64, 95%CI: -3.86 to -1.42). HBOT in combination with non-surgeries was associated with higher ulcer PAR (WMD: 20.82, 95%CI: 5.86 to 35.79), but no statistical significance was found in the improvement of ulcer area (WMD: 0.79, 95% CI: -1.54 to 3.12). Our results indicating that HBOT had a good adjuvant effect in surgeries to treat VLU, and its effect in non-surgeries needed further studies.
Topics: Humans; Ulcer; Hyperbaric Oxygenation; Varicose Ulcer; China
PubMed: 36740520
DOI: 10.1016/j.asjsur.2023.01.068