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Phlebology Apr 2013The objective of the study was to review the literature reporting visual disturbance (VD)following sclerotherapy for varicose veins. Underlying mechanisms will be... (Review)
Review
The objective of the study was to review the literature reporting visual disturbance (VD)following sclerotherapy for varicose veins. Underlying mechanisms will be discussed. A literature search of the databases Medline and Google Scholar was performed. Original articles including randomized trials, case series and case reports reporting VD in humans following sclerotherapy for varicose veins were included. Additional references were also obtained if they had been referenced in related publications. The search yielded 4948 results of which 25 reports were found to meet the inclusion criteria. In larger series with at least 500 included patients the prevalence of VD following sclerotherapy ranges from 0.09% to 2%. In most reports foam sclerotherapy was associated with VD (19); exclusive use of liquid sclerosant was reported in two cases, some reports included foam and liquid sclerosant (4). There were no persistent visual disorders reported. VD occurred with polidocanol and sodium tetradecyl sulphate in different concentrations (0.25–3%). Various forms of foam preparation including various ways of foam production and the liquid –air ratio (1 or 2 parts of liquid mixed with 3, 4 or 5 parts of air) were reported in association with the occurrence of VD. VDs following sclerotherapy for varicose veins are rare and all reported events were transient. Bubble embolism or any kind of embolism seems unlikely to be the only underlying mechanism. A systemic inflammatory response following sclerotherapy has been suggested. Further research to clarify the mechanism of action of sclerosants is required.
Topics: Embolism; Female; Humans; MEDLINE; Male; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Telangiectasis; Varicose Veins; Vision Disorders
PubMed: 23761921
DOI: 10.1258/phleb.2012.012051 -
The British Journal of Surgery Aug 2014A Health Technology Assessment was conducted to evaluate the relative clinical effectiveness and cost-effectiveness of minimally invasive techniques (foam sclerotherapy... (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
A Health Technology Assessment was conducted to evaluate the relative clinical effectiveness and cost-effectiveness of minimally invasive techniques (foam sclerotherapy (FS), endovenous laser ablation (EVLA) and radiofrequency ablation (RFA)) for managing varicose veins, in comparison with traditional surgery.
METHODS
A systematic review of randomized clinical trials (RCTs) was undertaken to assess the effectiveness of minimally invasive techniques compared with other treatments, principally surgical stripping, in terms of recurrence of varicose veins, Venous Clinical Severity Score (VCSS), pain and quality of life. Network meta-analysis and exploratory cost-effectiveness modelling were performed.
RESULTS
The literature search conducted in July 2011 identified 1453 unique citations: 31 RCTs (51 papers) satisfied the criteria for effectiveness review. Differences between treatments were negligible in terms of clinical outcomes, so the treatment with the lowest cost appears to be most cost-effective. Total FS costs were estimated to be lowest, and FS was marginally more effective than surgery. However, relative effectiveness was sensitive to the model time horizon. Threshold analysis indicated that EVLA and RFA might be considered cost-effective if their costs were similar to those for surgery. These findings are subject to various uncertainties, including the risk of bias present in the evidence base and variation in reported costs.
CONCLUSION
This assessment of currently available evidence suggests there is little to choose between surgery and the minimally invasive techniques in terms of efficacy or safety, so the relative cost of the treatments becomes one of the deciding factors. High-quality RCT evidence is needed to verify and further inform these findings.
Topics: Adult; Catheter Ablation; Cost-Benefit Analysis; Humans; Laser Therapy; Middle Aged; Pain; Pain Measurement; Quality-Adjusted Life Years; Randomized Controlled Trials as Topic; Recurrence; Sclerotherapy; Technology Assessment, Biomedical; Varicose Veins
PubMed: 24964976
DOI: 10.1002/bjs.9566 -
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 -
Wound Repair and Regeneration :... May 2021The wound microbiome may play an important role in the wound healing process. We conducted the first systematic prognosis review investigating whether aspects of the... (Review)
Review
The wound microbiome may play an important role in the wound healing process. We conducted the first systematic prognosis review investigating whether aspects of the wound microbiome are independent prognostic factors for the healing of complex wounds. We searched Medline, Embase, CINAHL and the Cochrane Library to February 2019. We included longitudinal studies which assessed the independent association of aspects of wound microbiome with healing of complex wounds while controlling for confounding factors. Two reviewers extracted data and assessed risk of bias and certainty of evidence using the GRADE approach. We synthesised studies narratively due to the clinical and methodological heterogeneity of included studies and sparse data. We identified 28 cohorts from 21 studies with a total of 38,604 participants, including people with diabetes and foot ulcers, open surgical wounds, venous leg ulcers and pressure ulcers. Risk of bias varied from low (2 cohorts) to high (17 cohorts); the great majority of participants were in cohorts at high risk of bias. Most evidence related to the association of baseline clinical wound infection with healing. Clinical infection at baseline may be associated with less likelihood of wound healing in foot ulcers in diabetes (HR from cohort with moderate risk of bias 0.53, 95% CI 0.33 to 0.83) or slower healing in open surgical wounds (HR 0.65, 95% CI 0.51 to 0.83); evidence in other wounds is more limited. Most other associations assessed showed no clear relationship with wound healing; evidence was limited and often sparse; and we documented gaps in the evidence. There is low certainty evidence that a diagnosis of wound infection may be prognostic of poorer healing in foot ulcers in diabetes, and some moderate certainty evidence for this in open surgical wounds. Low certainty evidence means that more research could change these findings.
Topics: Bacteria; Humans; Prognosis; Surgical Wound; Varicose Ulcer; Wound Healing
PubMed: 33591630
DOI: 10.1111/wrr.12898 -
Vascular Jun 2015The purpose of this systematic review and meta-analysis is to synthesise the available evidence of randomised controlled trials comparing endovenous laser therapy to... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
The purpose of this systematic review and meta-analysis is to synthesise the available evidence of randomised controlled trials comparing endovenous laser therapy to traditional open surgery, high ligation and stripping, for the treatment of great saphenous vein varicose veins in terms of clinical effectiveness, patient satisfaction and peri-operative complications.
METHODS
MEDLINE, CINAHL, EMBASE and the Cochrane library were searched to identify eligible studies. All randomised controlled trials comparing endovenous laser therapy to high ligation and stripping that used ultrasound examination as an outcome measure and had follow up of one year or more were included. The Cochrane Collaboration's tool for assessing risk of bias was also used to assess the methodological quality of the included studies. Pooled risk ratios with 95% confidence intervals were used as the measure of effect for each dichotomous outcome.
FINDINGS
Nine eligible publications relating to six randomised controlled trials were identified. The total enrolment of the studies was 1289 limbs. The clinical efficacy of endovenous laser therapy is comparable to that of surgery in the relatively short follow up period described in the studies. Meta-analysis revealed a trend towards a higher risk of ultrasound recurrence after endovenous laser therapy at 12 months. Quality of life questionnaires reveal similar outcomes for endovenous laser therapy and surgery. There is low quality evidence to suggest surgery is associated with more pain, sensory complications and infection.
CONCLUSION
Endovenous laser therapy is a safe alternative to traditional open surgery. There is some weak evidence to suggest that endovenous laser therapy has a higher risk of ultrasound-detected recurrence at 12 months following treatment compared to open surgery. However, it may be associated with less sensory complications, pigmentation and infection.
Topics: Adolescent; Adult; Aged; Femoral Vein; Humans; Laser Therapy; Middle Aged; Quality of Life; Saphenous Vein; Surveys and Questionnaires; Varicose Veins; Young Adult
PubMed: 25026892
DOI: 10.1177/1708538114542633 -
The British Journal of Surgery Oct 2017Varicose veins can affect quality of life. Patient-reported outcome measures (PROMs) provide a direct report from the patient about the impact of the disease without... (Review)
Review
BACKGROUND
Varicose veins can affect quality of life. Patient-reported outcome measures (PROMs) provide a direct report from the patient about the impact of the disease without interpretation from clinicians or anyone else. The aim of this study was to examine the quality of the psychometric evidence for PROMs used in patients with varicose veins.
METHODS
A systematic review was undertaken to identify studies that reported the psychometric properties of generic and disease-specific PROMs in patients with varicose veins. Literature searches were conducted in databases including MEDLINE, up to July 2016. The psychometric criteria used to assess these studies were adapted from published recommendations in accordance with US Food and Drug Administration guidance.
RESULTS
Nine studies were included which reported on aspects of the development and/or validation of one generic (36-Item Short Form Health Survey, SF-36®) and three disease-specific (Aberdeen Varicose Vein Questionnaire, AVVQ; Varicose Veins Symptoms Questionnaire, VVSymQ®; Specific Quality-of-life and Outcome Response - Venous, SQOR-V) PROMs. The evidence from included studies provided data to support the construct validity, test-retest reliability and responsiveness of the AVVQ. However, its content validity, including weighting of the AVVQ questions, was biased and based on the opinion of clinicians, and the instrument had poor acceptability. VVSymQ® displayed good responsiveness and acceptability rates. SF-36® was considered to have satisfactory responsiveness and internal consistency.
CONCLUSION
There is a scarcity of psychometric evidence for PROMs used in patients with varicose veins. These data suggest that AVVQ and SF-36® are the most rigorously evaluated PROMs in patients with varicose veins.
Topics: Humans; Patient Reported Outcome Measures; Psychometrics; Surveys and Questionnaires; Varicose Veins
PubMed: 28771700
DOI: 10.1002/bjs.10639 -
JPMA. the Journal of the Pakistan... Feb 2022To assess the types and effectiveness of simulators present for open varicose vein surgery.
OBJECTIVE
To assess the types and effectiveness of simulators present for open varicose vein surgery.
METHODS
The systematic review was conducted at The Aga Khan University Hospital Karachi and comprised studies published from 1st January 2000 to 30th June 2020 related to open varicose vein surgical procedures done on simulators. Databases searched were PubMed, Medline, Google Scholar, Cochrane and Scopus using appropriate key words. The primary outcome of the review was to assess the effectiveness of different types of simulators used for varicose vein surgery.
RESULTS
Of the 286 articles found, 6(2%) were included. A variety of simulators ranging from animal models, homemade simulators and commercially designed models with high fidelity options had been used. Technical competence was the major domain assessed in most of the studies 5(83.3%), while 1(16.6%) study focussed on self-assessment. Blinding was done in 4(66.6%) studies for assessment purpose, and videorecording of the trainees' performance was done in 5(83.3%) studies. Most studies 4(66.6%) found the use of simulation to be an effective tool in achieving technical competence.
CONCLUSION
The use of simulation in the training of surgical residents for open varicose vein surgery was found to be beneficial, but most studies were heterogeneous in terms of design, simulator types and study participants. This makes it difficult to establish the superiority of any one type of simulator over the rest. Further research is needed to develop and validate simulators in open varicose vein surgery procedures.
Topics: Animals; Clinical Competence; Humans; Pakistan; Simulation Training; Varicose Veins; Vascular Surgical Procedures
PubMed: 35202370
DOI: 10.47391/JPMA.AKU-10 -
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 -
European Journal of Vascular and... Sep 2020This review compares the outcomes of both concomitant and staged superficial varicose tributary (SVT) interventions as an adjunct to endovenous truncal ablation. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This review compares the outcomes of both concomitant and staged superficial varicose tributary (SVT) interventions as an adjunct to endovenous truncal ablation.
METHODS
A systematic search of Medline through Pubmed, Embase, and the Cochrane Central Register of Controlled Trials was last performed in November 2019. All studies comparing the outcomes of both concomitant and staged treatments for SVT as an adjunct to endovenous truncal ablation were included. Each included study was subject to an evaluation of methodological quality using the Downs and Black assessment tool. Outcomes assessed included rates of re-intervention, complications, and thrombotic events. Quality of life (QOL) and disease severity were also analysed. Data were pooled with a random effects model.
RESULTS
Fifteen studies (6 915 limbs) were included for analysis. Included studies were of reasonable methodological quality. Re-intervention rates were significantly lower in the concomitant group (6.3% vs. 36.1%) when compared with staged intervention (relative risk [RR] 0.21 [95% CI 0.07-0.62], p = .004, I = 90%, p ≤ .001). Reported complications (RR 1.14 [95% CI 0.67-1.93], p = .64) and rates of deep venous thrombosis (RR 1.41 [95% CI 0.72-2.77] p = .31) were similar in each group. Overall disease severity (Venous Clinical Severity Score) was lower in the concomitant group (-1.16 [95% CI, -1.97- -0.35] p = .005), while QOL, assessed using the Aberdeen Varicose Vein Questionnaire, favoured concomitant treatment when measured at less than three months (weighted mean difference [WMD] -3.6 [95% CI, -7.17- -0.03] p = .050) and between three and 12 months (WMD -1.61 [95% CI, -2.99- -0.23] p = .020).
CONCLUSION
Concomitant and staged treatments are safe and effective. Improvements in early disease severity and QOL scores were better in the concomitant group. While meta-analysis suggests that concomitant intervention offers significantly lower rates of re-intervention, studies assessing its merits are subject to some biases. This benefit was not reflected by the randomised trial subgroup analysis, which identified no difference in re-intervention.
Topics: Ablation Techniques; Adult; Endovascular Procedures; Female; Humans; Male; Middle Aged; Postoperative Complications; Quality of Life; Risk Factors; Treatment Outcome; Varicose Veins
PubMed: 32771286
DOI: 10.1016/j.ejvs.2020.05.028 -
The Journal of Cardiovascular Surgery Apr 2008Radiofrequency obliteration (RFO), endovenous laser therapy (EVLT) and foam sclerotherapy (FS) are potential treatments for varicose veins. A systematic review was... (Meta-Analysis)
Meta-Analysis Review
AIM
Radiofrequency obliteration (RFO), endovenous laser therapy (EVLT) and foam sclerotherapy (FS) are potential treatments for varicose veins. A systematic review was undertaken to assess their safety and effectiveness and to compare these endoluminal therapeutic options with conventional ligation and vein stripping.
METHODS
An electronic health database search was performed on all studies published between 1970 and 2007 describing RFO, EVLT, and FS for treating varicose veins.
RESULTS
Twenty-nine EVLT studies, 32 RFO studies and 22 FS trials were included. RFO was associated with the worst short and long-term safety and efficacy results compared to EVLT and FS regarding ''complete occlusion at the end of follow-up'', ''phlebitis'', ''deep vein thrombosis'', and ''paraesthesia''. EVLT had the best results concerning the long-term effectiveness parameters for ''occlusion at the end of follow-up'' and ''recanalization, recurrence or development of new veins'', compared to RFO and FS. Foam sclerotherapy of varicose veins is associated with a higher recurrence rate in patients with saphenofemoral incompetence compared to the rates after EVLT or RFO treatment.
CONCLUSION
EVLT, RFO, and FS seem to be safe and effective modalities with good short and mid-term
RESULTS
Acquisition of comparative long-term and very long-term data on clinical efficacy (particularly with regard to the formation of recurrent varicose veins), safety, quality of life outcomes and costs is needed by large high-quality prospective randomized trials of endovenous techniques versus each other and versus surgery before considering endovenous techniques as the standard treatment.
Topics: Catheter Ablation; Humans; Laser Therapy; Sclerotherapy; Treatment Outcome; Varicose Veins
PubMed: 18431342
DOI: No ID Found