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Journal of Vascular Surgery. Venous and... Jul 2023Cyanoacrylate glue closure was first used in humans 10 years ago to treat venous reflux of the axial veins. Studies have since shown its clinical efficacy in vein... (Review)
Review
OBJECTIVE
Cyanoacrylate glue closure was first used in humans 10 years ago to treat venous reflux of the axial veins. Studies have since shown its clinical efficacy in vein closure. However, great need exists to elucidate further the types of specific adverse reactions that cyanoacrylate glue can cause for better patient selection and to minimize these events. In the present study, we systematically reviewed the literature to identify the types of reported reactions. In addition, we explored the pathophysiology contributing to these reactions and proposed the mechanistic pathway with inclusion of actual cases.
METHODS
We searched the literature for reports of reactions following cyanoacrylate glue use in patients with venous diseases between 2012 and 2022. The search was performed using MeSH (medical subject headings) terms. The terms included cyanoacrylate, venous insufficiency, chronic venous disorder, varicose veins, vein varicosities, venous ulcer, venous wound, CEAP (clinical, etiologic, anatomic, pathophysiologic), vein, adverse events, phlebitis, hypersensitivity, foreign body granuloma, giant cell, endovenous glue-induced thrombosis, and allergy. The search was limited to the literature reported in English. These studies were evaluated for the type of product used and the reactions noted. A systematic review, in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) method, was performed. Covidence software (Melbourne, VC, Australia) was used for full-text screening and data extraction. Two reviewers reviewed the data, and the content expert served as the tiebreaker.
RESULTS
We identified 102, of which, 37 reported on cyanoacrylate use other than in the context of chronic venous diseases and were excluded. Fifty-five reports were determined appropriate for data extraction. The adverse reactions to cyanoacrylate glue were phlebitis, hypersensitivity, foreign body granuloma, and endovenous glue-induced thrombosis.
CONCLUSIONS
Although cyanoacrylate glue closure for venous reflux is generally a safe and clinically effective treatment choice for patients with symptomatic chronic venous disease and axial reflux, some adverse events could be specific to the properties of the cyanoacrylate product. We propose mechanisms for how such reactions can occur based on histologic changes, published reports, and case examples; however, further exploration is necessary to confirm these theories.
Topics: Humans; Cyanoacrylates; Granuloma, Foreign-Body; Saphenous Vein; Varicose Veins; Venous Insufficiency; Treatment Outcome; Phlebitis; Hypersensitivity
PubMed: 37054883
DOI: 10.1016/j.jvsv.2023.03.018 -
The Cochrane Database of Systematic... Jan 2023Chronic venous insufficiency (CVI) is a progressive and common disease that affects the superficial and deep venous systems of the lower limbs. CVI is characterised by... (Review)
Review
BACKGROUND
Chronic venous insufficiency (CVI) is a progressive and common disease that affects the superficial and deep venous systems of the lower limbs. CVI is characterised by valvular incompetence, reflux, venous obstruction or a combination of these symptoms, with consequent distal venous hypertension. Clinical manifestations of CVI include oedema, pain, skin changes, ulcerations and dilated skin veins in the lower limbs. It places a large financial burden on health systems. There is a wide variety of treatment options for CVI, ranging from surgery and medication to compression and physiotherapy. Balneotherapy (treatments involving water) may be a relatively cheap and efficient way to deliver physiotherapy to people with CVI. This is an update of a review first published in 2019.
OBJECTIVES
To assess the effectiveness and safety of balneotherapy for the treatment of people with chronic venous insufficiency.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search date was 28 June 2022.
SELECTION CRITERIA
We included randomised and quasi-randomised controlled trials comparing balneotherapy to no treatment or other types of treatment for CVI. We also included studies that used a combination of treatments.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were 1. disease severity, 2. health-related quality of life (HRQoL) and 3.
ADVERSE EFFECTS
Our secondary outcomes were 1. pain, 2. oedema, 3. leg ulcer incidence and 4. skin pigmentation changes. We used GRADE to assess the certainty of evidence for each outcome.
MAIN RESULTS
We included nine randomised controlled trials involving 1126 participants with CVI. Seven studies evaluated balneotherapy versus no treatment, one study evaluated balneotherapy versus a phlebotonic drug (melilotus officinalis), and one study evaluated balneotherapy versus dryland exercises. We downgraded our certainty in the evidence due to a lack of blinding of participants and investigators, participant-reported outcomes and imprecision. Balneotherapy versus no treatment Balneotherapy compared to no treatment probably results in slightly improved disease severity signs and symptoms scores as assessed by the Venous Clinical Severity Score (VCSS; mean difference (MD) -1.75, 95% confidence interval (CI) -3.02 to -0.49; 3 studies, 671 participants; moderate-certainty evidence). Balneotherapy compared to no treatment may improve HRQoL as assessed by the Chronic Venous Insufficiency Quality of Life Questionnaire 2 (CIVIQ2) at three months, but we are very uncertain about the results (MD -10.46, 95% CI -19.21 to -1.71; 2 studies, 153 participants; very low-certainty evidence). The intervention may improve HRQoL at 12 months (MD -4.48, 95% CI -8.61 to -0.36; 2 studies, 417 participants; low-certainty evidence). It is unclear if the intervention has an effect at six months (MD -2.99, 95% CI -6.53 to 0.56; 2 studies, 436 participants; low-certainty evidence) or nine months (MD -6.40, 95% CI -13.84 to 1.04; 1 study, 59 participants; very low-certainty evidence). Balneotherapy compared with no treatment may have little or no effect on the occurrence of adverse effects. The main adverse effects were thromboembolic events (odds radio (OR) 0.35, 95% CI 0.09 to 1.42; 3 studies, 584 participants; low-certainty evidence), erysipelas (OR 2.58, 95% CI 0.65 to 10.22; 2 studies, 519 participants; low-certainty evidence) and palpitations (OR 0.33, 95% CI 0.01 to 8.52; 1 study, 59 participants; low-certainty evidence). No studies reported any serious adverse effects. Balneotherapy compared with no treatment may improve pain scores slightly at three months (MD -1.12, 95% CI -1.35 to -0.88; 2 studies, 354 participants; low-certainty evidence); and six months (MD -1.02, 95% CI -1.25 to -0.78; 2 studies, 352 participants; low-certainty evidence). Balneotherapy compared with no treatment may have little or no effect on oedema (measured by leg circumference) at 24 days to three months, but we are very uncertain about the results (standardised mean difference (SMD) 0.32 cm, 95% CI -0.70 to 1.34; 3 studies, 369 participants; very low-certainty evidence). Balneotherapy compared with no treatment may have little or no effect on the incidence of leg ulcers at 12 months, but we are very uncertain about the results (OR 1.06, 95% CI 0.27 to 4.14; 2 studies, 449 participants; very low-certainty evidence). Balneotherapy compared with no treatment may slightly reduce skin pigmentation changes as measured by the pigmentation index at 12 months (MD -3.60, 95% CI -5.95 to -1.25; 1 study, 59 participants; low-certainty evidence). Balneotherapy versus melilotus officinalis For the comparison balneotherapy versus a phlebotonic drug (melilotus officinalis), there was little or no difference in pain symptoms (OR 0.29, 95% CI 0.03 to 2.87; 1 study, 35 participants; very low-certainty evidence) or oedema (OR 0.21, 95% CI 0.02 to 2.27; 1 study, 35 participants; very low-certainty evidence), but we are very uncertain about the results. The study reported no other outcomes of interest. Balneotherapy versus dryland exercise For the comparison balneotherapy versus dryland exercise, evidence from one study showed that balneotherapy may improve HRQoL as assessed by the Varicose Vein Symptom Questionnaire (VVSymQ), but we are very uncertain about the results (MD -3.00, 95% CI -3.80 to -2.20; 34 participants, very low-certainty evidence). Balneotherapy compared with dryland exercises may reduce oedema (leg volume) after five sessions of treatment (right leg: MD -840.70, 95% CI -1053.26 to -628.14; left leg: MD -767.50, 95% CI -910.07 to -624.93; 1 study, 34 participants, low-certainty evidence). The study reported no other outcomes of interest.
AUTHORS' CONCLUSIONS
For the comparison balneotherapy versus no treatment, we identified moderate-certainty evidence that the intervention improves disease severity signs and symptoms scores slightly, low-certainty evidence that it improves pain and skin pigmentation changes, and very low-certainty evidence that it improves HRQoL. Balneotherapy compared with no treatment made little or no difference to adverse effects, oedema or incidence of leg ulcers. Evidence comparing balneotherapy with other interventions was very limited. To ensure adequate comparison between trials, future trials should standardise measurements of outcomes (e.g. disease severity signs and symptoms score, HRQoL, pain and oedema) and follow-up time points.
Topics: Humans; Balneology; Edema; Leg Ulcer; Pain; Quality of Life; Venous Insufficiency; Randomized Controlled Trials as Topic
PubMed: 36622745
DOI: 10.1002/14651858.CD013085.pub3 -
Journal of Vascular Surgery. Venous and... May 2023Incompetent perforator veins are encountered frequently during ultrasound assessment of the venous system in chronic venous disease. Some studies have shown that... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Incompetent perforator veins are encountered frequently during ultrasound assessment of the venous system in chronic venous disease. Some studies have shown that concomitant treatment of truncal and perforator incompetence improves ulcer healing, yet a Cochrane review was unable to determine the potential benefits of perforator surgery in venous ulcer management due to poor quality evidence. This study aims to establish the exact role of concomitant treatment in patients with chronic venous disease.
METHODS
A search of online databases including MEDLINE, Embase, and Cochrane was performed in March 2022. All studies comparing the outcomes of concomitant superficial venous plus perforator surgery with standard therapy were included. Variables assessed included ulcer healing, time to healing, and ulcer recurrence. Disease severity and quality of life, vein occlusion rates, number of incompetent perforator veins on duplex ultrasound post treatment, and reintervention and complication rates were also analyzed. Data were pooled using a random effects model.
RESULTS
Seven studies (872 limbs) were included for analysis. Included studies were of reasonable methodological quality. Ulcer healing rates were similar in each group (relative risk [RR], 1.07; 95% confidence interval [CI] 0.96-1.19; P = .23). Two studies reported no difference in mean time (days) to ulcer healing between groups (mean difference, -14.60; 95% CI, -34.57 to 5.38; P = .15; I = 0%; P = .56). Ulcer recurrence was significantly lower in the concomitant group (3.7% vs 44%) (RR, 0.21; 95% CI, 0.07- 0.65; P = .007; I = 43%; P = .17). Overall, there was no difference in disease severity measured at 12-month follow-up, with a weighted mean difference between groups of -0.88 (95% CI, -2.05 to 0.29; P = .14; I = 84%; P = .002). Quality of life was reported in only one study. The total number of perforator veins identified at follow-up duplex ultrasound was significantly lower in the concomitant group (22.4% vs 89%) compared with standard therapy (RR, 0.31; 95% CI, 0.19-0.53; P < .0001; I = 88%; P = .0002). There was no difference between groups for occlusion rates of treated great saphenous vein or incompetent perforators (RR, 2.22; 95% CI, 0.10-49.74; P = .61). Reported minor (RR, 0.98; 95% CI, 0.63-1.52; P = .92) and thrombotic complications (RR, 2.04; 95% CI, 0.59-6.99; P = .26) were similar between groups.
CONCLUSIONS
Concomitant truncal and perforator surgery is comparable to standard therapy in terms of ulcer healing, safety, and efficacy. Meta-analysis suggests that concomitant treatment could significantly reduce ulcer recurrence rates, but included studies were subject to some biases and short follow-up. Concomitant treatment may be considered to prevent recurrence rather than improve ulcer healing.
Topics: Humans; Venous Insufficiency; Ulcer; Quality of Life; Varicose Ulcer; Saphenous Vein; Treatment Outcome
PubMed: 36736858
DOI: 10.1016/j.jvsv.2022.12.068 -
The Cochrane Database of Systematic... Sep 2021Chronic deep venous insufficiency is caused by incompetent vein valves, blockage of large-calibre leg veins, or both; and causes a range of symptoms including recurrent... (Review)
Review
BACKGROUND
Chronic deep venous insufficiency is caused by incompetent vein valves, blockage of large-calibre leg veins, or both; and causes a range of symptoms including recurrent ulcers, pain and swelling. Most surgeons accept that well-fitted graduated compression stockings (GCS) and local care of wounds serve as adequate treatment for most people, but sometimes symptoms are not controlled and ulcers recur frequently, or they do not heal despite compliance with conservative measures. In these situations, in the presence of severe venous dysfunction, surgery has been advocated by some vascular surgeons. This is an update of the review first published in 2000.
OBJECTIVES
To assess the effects of surgical management of deep venous insufficiency on ulcer healing and recurrence, complications of surgery, clinical outcomes, quality of life (QoL) and pain.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases, and the WHO ICTRP and ClinicalTrials.gov trials registries to 23 June 2020.
SELECTION CRITERIA
We considered randomised controlled trials (RCTs) of surgical treatment versus another surgical procedure, usual care or no treatment, for people with deep venous insufficiency.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion, extracted data and assessed the risk of bias with the Cochrane risk of bias tool. We evaluated the certainty of the evidence using GRADE. We were unable to pool data due to differences in outcomes reported and how these were measured. Outcomes of interest were ulcer healing and recurrence, complications of surgery, clinical changes, QoL and pain.
MAIN RESULTS
We included four RCTs (273 participants) comparing valvuloplasty plus surgery of the superficial venous system with surgery of the superficial venous system for primary valvular incompetence. Follow-up was two to 10 years. All included studies investigated primary valve incompetence. No studies investigated other surgical procedures for the treatment of people with deep venous insufficiency or surgery for secondary valvular incompetence or venous obstruction. The certainty of the evidence was downgraded for risk of bias concerns and imprecision due to small numbers of included trials, participants and events. None of the studies reported ulcer healing or ulcer recurrence. One study included 27 participants with active venous ulceration at the time of surgery; the other three studies did not include people with ulcers. There were no major complications of surgery, no incidence of deep vein thrombosis and no deaths reported (very low-certainty evidence). All four studies reported clinical changes but the data could not be pooled due to different outcome measures and reporting of the data. Two studies assessed clinical changes using subjective and objective measurements, as specified in the clinical, aetiological, anatomical and pathophysiological (CEAP) classification score (low-certainty evidence). One study reported mean CEAP severity scores and one study reported change in clinical class using CEAP. At baseline, the mean CEAP severity score was 18.1 (standard deviation (SD) 4.4) for limbs undergoing external valvuloplasty with surgery to the superficial venous system and 17.8 (SD 3.4) for limbs undergoing surgery to the superficial venous system only. At three years post-surgery, the mean CEAP severity score was 5.2 (SD 1.6) for limbs that had undergone external valvuloplasty with surgery to the superficial venous system and 9.2 (SD 2.6) for limbs that had undergone surgery to the superficial venous system only (low-certainty evidence). In another study, participants with progressive clinical dynamics over the five years preceding surgery had higher rates of improvement in clinical condition in the treatment group (valvuloplasty plus ligation) compared with the control group (ligation only) (80% versus 51%) after seven years of follow-up. Participants with stable preoperative clinical dynamics demonstrated similar rates of improvement in both groups (95% with valvuloplasty plus ligation versus 90% with ligation only) (low-certainty evidence). One study reported disease-specific QoL using cumulative scores from a 10-item visual analogue scale (VAS) and reported that in the limited anterior plication (LAP) plus superficial venous surgery group the score decreased from 49 to 11 at 10 years, compared to a decrease from 48 to 36 in participants treated with superficial venous surgery only (very low-certainty evidence). Two studies reported pain. Within the QoL VAS scale, one item was 'pain/discomfort' and scores decreased from 4 to 1 at 10 years for participants in the LAP plus superficial venous surgery group and increased from 2 to 3 at 10 years in participants treated with superficial venous surgery only. A second study reported that 'leg heaviness and pain' was resolved completely in 36/40 limbs treated with femoral vein external valvuloplasty plus high ligation and stripping of the great saphenous vein (GSV) and percutaneous continuous circumsuture and 22/40 limbs treated with high ligation and stripping of GSV and percutaneous continuous circumsuture alone, at three years' follow-up (very low-certainty evidence).
AUTHORS' CONCLUSIONS
We only identified evidence from four RCTs for valvuloplasty plus surgery of the superficial venous system for primary valvular incompetence. We found no studies investigating other surgical procedures for the treatment of people with deep venous insufficiency, or that included participants with secondary valvular incompetence or venous obstruction. None of the studies reported ulcer healing or recurrence, and few studies reported complications of surgery, clinical outcomes, QoL and pain (very low- to low-certainty evidence). Conclusions on the effectiveness of valvuloplasty for deep venous insufficiency cannot be made.
Topics: Edema; Humans; Saphenous Vein; Stockings, Compression; Varicose Ulcer; Venous Insufficiency
PubMed: 34591328
DOI: 10.1002/14651858.CD001097.pub4 -
VASA. Zeitschrift Fur Gefasskrankheiten Nov 2023Insufficiency of the small saphenous vein causes 15% of varicose veins in the lower extremities. Endovenous ablation for the treatment of small saphenous vein varices... (Review)
Review
Insufficiency of the small saphenous vein causes 15% of varicose veins in the lower extremities. Endovenous ablation for the treatment of small saphenous vein varices has become a trend, and an increasing number of studies have reported the effects of different types of endovenous ablation in patients with small saphenous varicose veins. The purpose of this systematic review is to summarize the results of existing studies on endovenous ablation for the treatment of small saphenous varicose veins, compare its role and efficacy, and provide insights into the future development of endovenous ablation for treating small saphenous varicose veins. A systematic review of literature published from January 1, 2002 to January 1, 2022 was conducted from PubMed, Embase, and China Academic Journals full-text databases. The pre-determined inclusion criteria were clinical literature of endovenous ablation for treating small saphenous varicose veins. Keywords included "ablation", "small saphenous vein", "lesser saphenous vein", "short saphenous vein", "xiaoyinjingmai" and "xiaorong". Of the 506 articles screened, 33 articles were included in this review: 19 articles were related to endovenous laser ablation, five were related to mechanochemical ablation, seven were related to radiofrequency ablation, and two were related to both endovenous laser ablation and radiofrequency ablation. The anatomical success rate of endovenous laser ablation, radiofrequency ablation, and mechanochemical ablation were 94.3%, 96.0%, and 88.1%, respectively, and the heterogeneities were all moderate. Most of the current studies are of a low-quality level of research. Hence, long-term follow-up studies and large-scale randomized controlled trials are required to obtain high-quality evidence. Although the gold standard for the treatment of small saphenous vein insufficiency remains unclear, endovenous ablation is still the recommended method.
Topics: Humans; Saphenous Vein; Varicose Veins; Sclerotherapy; Laser Therapy; China; Treatment Outcome; Venous Insufficiency
PubMed: 37779391
DOI: 10.1024/0301-1526/a001091 -
The Surgeon : Journal of the Royal... Dec 2022A systematic review and meta-analysis was performed to determine the role of thromboprophylaxis in the prevention of venous thromboembolism in patients undergoing... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
A systematic review and meta-analysis was performed to determine the role of thromboprophylaxis in the prevention of venous thromboembolism in patients undergoing varicose vein interventions.
METHODS
PUBMED, EMBASE and Web of Science were searched for comparative studies of patients undergoing varicose vein interventions and received either thromboprophylaxis or no thromboprophylaxis. Data were collected on the number of thrombotic events including deep vein thrombosis (DVT), pulmonary embolism (PE) and endothermal heat-induced thrombosis (EHIT) as well as bleeding events. The primary outcomes for the meta-analysis were the risk of all thrombotic events, risk of DVT and risk of bleeding. Pooled risk ratios were calculated using random effects modelling.
RESULTS
Eight studies (6479 participants) were included. The use of thromboprophylaxis reduces the risk of all thrombotic events (Pooled risk ratio = 0.63, 95% Confidence interval [CI], 0.04-10.43) and the risk of DVT (Pooled risk ratio = 0.59, 95% CI, 0.08-4.60) with no increased risk of bleeding (Pooled risk ratio = 0.66, 95% CI, 0.06-7.21]. Rivaroxaban has similar efficacy in the prevention of DVT compared to Fondaparinux in patients undergoing endovenous ablation of varicose veins (Pooled risk ratio = 0.68, 95% CI, 0.06-7.41). An extended course of thromboprophylaxis reduces the risk of developing DVT compared to a short course (Pooled risk ratio = 1.40, 95% CI, 0.44-4.46). However, the two studies reporting on the duration of thromboprophylaxis did not stratify patients according to their risk of developing venous thromboembolism.
CONCLUSION
The use of thromboprophylaxis in patients undergoing varicose vein interventions reduces the risk of venous thromboembolism with no significant increase in the risk of bleeding. However, the included studies were underpowered with high to moderate risk of bias. Therefore, more randomised controlled trials with a large sample size are needed in order to provide high quality evidence for clinical practice.
Topics: Humans; Venous Thromboembolism; Varicose Veins; Rivaroxaban; Pulmonary Embolism
PubMed: 35589498
DOI: 10.1016/j.surge.2022.04.002 -
The Surgeon : Journal of the Royal... Oct 2022The objective of this systematic review and meta-analysis was to evaluate rates of ulcer healing following ultrasound-guided foam sclerotherapy (UGFS). (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
The objective of this systematic review and meta-analysis was to evaluate rates of ulcer healing following ultrasound-guided foam sclerotherapy (UGFS).
METHODS
The MEDLINE, CENTRAL and Embase databases were used to search for relevant studies using the terms ' (sclerotherapy AND ulcer) OR (vein AND ulcer) OR (sclerotherapy AND vein)'. Heterogeneity between studies was quantified using the I statistic. A random effects model was used to calculate risk ratios where substantial heterogeneity was found.
RESULTS
The initial search yielded 8266 articles. 8 studies were included in the qualitative synthesis and 3 in the meta-analysis. Superior complete ulcer healing rates were noted in patients treated with foam sclerotherapy versus compression therapy alone (pooled OR 6.41, 95% CI = 0.3-148.2, p = 0.246, random effects method). A marked degree of heterogeneity was observed between studies (I = 81%).
CONCLUSION
A prospective, trial is warranted in order to determine the true merits of UGFS in the setting of venous ulceration.
Topics: Humans; Prospective Studies; Recurrence; Saphenous Vein; Sclerotherapy; Treatment Outcome; Ulcer; Ultrasonography, Interventional; Varicose Ulcer; Varicose Veins
PubMed: 34629303
DOI: 10.1016/j.surge.2021.08.008 -
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 -
Heliyon Nov 2023This systematic review and meta-analysis aimed to systematically evaluate the prediction models for the risk of post-thrombotic syndrome (PTS) in deep vein thrombosis...
OBJECTIVE
This systematic review and meta-analysis aimed to systematically evaluate the prediction models for the risk of post-thrombotic syndrome (PTS) in deep vein thrombosis (DVT) patients.
METHODS
This systematic review and meta-analysis was guided by the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). A systematic search on the following electronic database: PubMed/MEDLINE, EMBASE, and Cochrane Library, and Chinese databases such as WANFANG and CNKI was conducted to look for relevant articles based on the research question. The risk of bias for each studies included was carried out based on Prediction Model Risk of Bias Assessment Tool (PROBAST).
RESULTS
We identified 10 studies that developed a total of 13 clinical prediction models for PTS risk in DVT patients, 3 models were externally validated, 2 models were temporally validated. The top 5 predictors were: BMI (N = 9), Varicose vein (N = 6), Baseline Villalta Score (N = 6), Iliofemoral thrombosis (N = 5), and Age (N = 4). The high risk of bias was from the analysis domain, which the number of participants and selection of predictors often did not meet the requirements of PROBAST. A random-effects meta-analysis of C-statistics was conducted, the pooled discrimination was C-statistic 0.75, 95%CI (0.69, 0.81).
CONCLUSION
Among the 13 PTS risk prediction models reported in this study, no prediction model has been applied to clinical practice due to the lack of external validation. In the development of prediction models, most models were not standardized in data analysis. It is recommended that future studies on the design and implementation of prediction models refer to Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) and PROBAST.
PubMed: 38045217
DOI: 10.1016/j.heliyon.2023.e22226 -
Occupational and Environmental Medicine Jan 2021The individual peripheral vascular disease risk factors are well documented, but the role of work conditions remains equivocal. This systematic review aims to assess...
OBJECTIVES
The individual peripheral vascular disease risk factors are well documented, but the role of work conditions remains equivocal. This systematic review aims to assess relationships between lower limb peripheral venous diseases (lower limb varicose veins (LLVV), venous thromboembolism (VTE) comprising deep vein thrombosis and pulmonary embolism), peripheral arterial disease (intermittent claudication, aortic dissection, aortic aneurysm) and occupational constraints among working adults.
METHODS
Several databases were systematically searched until February 2019 for observational studies and clinical trials. Preferred Reporting Items for Systematic Reviews and Meta-Analyses method was used for article selection. Quality assessment and risk of bias were evaluated using Strengthening the Reporting of Observational Studies in Epidemiology and Newcastle-Ottawa scales.
RESULTS
Among the 720 screened articles, 37 remained after full-text evaluation. Among the 21 studies on LLVV, prolonged standing was significantly associated to a higher risk of varicose veins with a threshold probably around >3 to 4 hours/day but exposure duration in years was not sufficiently considered. Seated immobility was often observed in workers, with no sufficient evidence to prove that prolonged sitting at work is related to VTE. Carrying heavy loads, stress at work and exposure to high temperatures have emerged more recently notably in relation to varicose veins but need to be better explored. Only three studies discussed the potential role of work on peripheral arterial disease development.
CONCLUSIONS
Although some observational studies showed that prolonged standing can be related to varicose veins and that seated immobility at work could be linked to VTE, very little is known about peripheral arterial disease and occupational constraints. Clinical trials to determine preventive strategies at work are needed.
PROSPERO REGISTRATION NUMBER
CRD42019127652.
Topics: Humans; Occupational Exposure; Peripheral Arterial Disease; Risk Factors; Sitting Position; Standing Position; Varicose Veins; Venous Thromboembolism
PubMed: 32439829
DOI: 10.1136/oemed-2019-106375