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Sao Paulo Medical Journal = Revista... 2018Varicose veins affect nearly 30% of the world's population. This condition is a social problem and needs interventions to improve quality of life and reduce risks....
BACKGROUND
Varicose veins affect nearly 30% of the world's population. This condition is a social problem and needs interventions to improve quality of life and reduce risks. Recently, new and less invasive methods for varicose vein treatment have emerged. There is a need to define the best treatment options and to reduce the risks and costs. Since there are cosmetic implications, treatments for which effectiveness remains unproven present risks to consumers and higher costs for stakeholders. These risks and costs justify conducting an overview of systematic reviews to summarize the evidence.
DESIGN AND SETTING
Overview of systematic reviews within the Discipline of Evidence-Based Health, at Universidade Federal de São Paulo (UNIFESP).
METHODS
Systematic reviews on clinical or surgical treatments for varicose veins were included, with no restrictions on language or publication date.
RESULTS
51 reviews fulfilled the inclusion criteria. Outcomes and comparators were described, and a narrative review was conducted. Overall, there was no evidence that compression stockings should be recommended for patients as the initial treatment or after surgical interventions. There was low to moderate evidence that minimally invasive therapies (endovenous laser therapy, radiofrequency ablation or foam sclerotherapy) are as safe and effective as conventional surgery (ligation and stripping). Among these systematic reviews, only 18 were judged to present high quality.
CONCLUSIONS
There was evidence of low to moderate quality that minimally invasive treatments, including foam sclerotherapy, laser and radiofrequency therapy are comparable to conventional surgery, regarding effectiveness and safety for treatment of varicose veins.
Topics: Evidence-Based Medicine; Humans; Laser Therapy; Saphenous Vein; Sclerotherapy; Varicose Veins; Vascular Surgical Procedures
PubMed: 30020324
DOI: 10.1590/1516-3180.2018.0003240418 -
Journal of Vascular Surgery. Venous and... Jan 2022In the present study, we reviewed and analyzed the currently available data on the Flebogrif device (Balton, Warsaw, Poland) to define its role in the global varicose... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
In the present study, we reviewed and analyzed the currently available data on the Flebogrif device (Balton, Warsaw, Poland) to define its role in the global varicose vein treatment devices market.
METHODS
A systematic literature search was performed in MEDLINE, Embase, and the Cochrane Library. Studies were eligible if they had included patients treated using the Flebogrif for saphenous vein incompetence, had been reported in English, and had the full text available. The methodologic quality of the studies was assessed using the methodologic index for nonrandomized studies (MINORS) score. A random effects model was used to estimate the primary outcome of anatomic success, defined as the occlusion rate of the treated vein. The estimates are reported with the 95% confidence intervals (CIs). The secondary outcomes were clinical success, complication rate, pain during and after the procedure, and time to return to work.
RESULTS
Five articles met the inclusion criteria, reporting 348 procedures in 392 patients. Four studies reported the 3-month anatomic success, and three studies reported the 12-month anatomic success. The pooled 3-month anatomic success rate was 95.6% (95% CI, 93.2%-98.0%). The 12-month anatomic success rate was 93.2% (95% CI, 90.3%-96.1%). The only major complication reported within 3 months was deep vein thrombosis, which developed in 0.3% of the patients. The minor complications of thrombophlebitis and hyperpigmentation had occurred in 13.3% to 14.5% and 3.3% to 10.0% of patients, respectively, within 3 months. The methodologic quality of the included studies was moderate.
CONCLUSIONS
Mechanochemical ablation using the Flebogrif device is a safe and well-tolerated procedure for the treatment of saphenous vein insufficiency. However, well-designed studies of sufficient sample size and follow-up are required to compare the effectiveness with other endovenous treatment modalities and define the definitive role of the Flebogrif device.
Topics: Ablation Techniques; Catheters; Combined Modality Therapy; Endovascular Procedures; Humans; Varicose Veins
PubMed: 34091106
DOI: 10.1016/j.jvsv.2021.05.010 -
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... Feb 2015Chronic deep venous incompetence (DVI) is caused by incompetent vein valves and/or blockage of large-calibre leg veins and causes a range of symptoms including recurrent... (Review)
Review
BACKGROUND
Chronic deep venous incompetence (DVI) is caused by incompetent vein valves and/or blockage of large-calibre leg veins 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 patients, 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 incompetence in terms of ulcer healing, ulcer recurrence and alleviation of symptoms.
SEARCH METHODS
For this update, the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched October 2014) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 9).
SELECTION CRITERIA
Randomised controlled trials of surgical treatment for patients with DVI.
DATA COLLECTION AND ANALYSIS
For this update, two review authors (RRG and SCH) extracted data independently. All included studies required full risk of bias assessment in line with current procedures of The Cochrane Collaboration. Two review authors (RRG and SCH) independently assessed risk of bias and consulted with a third review author (AA) when necessary.
MAIN RESULTS
Four studies with 273 participants were included. All included studies reported clinical outcomes following valvuloplasty. We found no studies investigating other surgical procedures for the treatment of patients with DVI. All included studies investigated primary valve incompetence. We found no trials that investigated the results of surgery for secondary valvular incompetence or the obstructive form of DVI. Because different outcome measures were used, it was not possible to pool the results of included studies. The methodological quality of the included studies was low, mainly because information regarding randomisation and blinding was missing, or because data were incomplete or were presented poorly. Ulcer healing and ulcer recurrence were not reported in one study, and the remaining three studies did not include participants with ulcers or with active ulceration. Three studies reported no significant complications of surgery and no incidence of DVT during follow-up. One study did not report on the occurrence of complications. Clinical changes were assessed by subjective and objective measurements, as specified in the clinical, aetiological, anatomical, and pathophysiological (CEAP) classification score. This requires vascular laboratory measurements of lower limb haemodynamics before and after surgery. Tests include an overall evaluation of venous function with venous refilling time (VRT) or ambulatory venous pressure (AVP). Two small trials comparing external valvuloplasty using limited anterior plication in combination with ligation of incompetent superficial veins against ligation alone (L) showed that ligation plus limited anterior plication produced significant improvement in AVP: The mean difference was -15 mm Hg (95% confidence interval (CI) -20.9 to -9.0) at one year and -15 mm Hg (95% CI -21 to -8.9) at two years. Sustainable statistically significant improvement in AVP and VRT was achieved by ligation and limited anterior plication at 10 years in one study. However, AVP values after surgery remained relatively high, causing its benefit to be questioned. Similarly, another study including participants who were deteriorating preoperatively showed sustained mild clinical improvement for seven years in those subjected to valvuloplasty compared with participants undergoing superficial venous surgery alone. However, this benefit was lost when the condition of participants was stable preoperatively. One small study (n = 40) with grade 3 reflux and no participants with ulcers reported that external valvuloplasty of the femoral vein combined with surgical repair of the superficial venous system improved the haemodynamic status of the lower limbs, restored valvular function more effectively and achieved better outcomes than surgical repair of the superficial venous system alone.
AUTHORS' CONCLUSIONS
No evidence was found for benefit or harm of valvuloplasty in the treatment of patients with DVI secondary to primary valvular incompetence. The individual trials included in this review were small; they used different methods of assessment and overall were of poor quality. They did not include participants with severe DVI. Trials investigating the effects of other surgical procedures on deep veins are needed. Until the findings of such trials become available, the benefit of valvuloplasty remains uncertain.
Topics: Humans; Leg; Peripheral Vascular Diseases; Randomized Controlled Trials as Topic; Venous Insufficiency; Venous Valves
PubMed: 25702915
DOI: 10.1002/14651858.CD001097.pub3 -
The Cochrane Database of Systematic... Aug 2015Venous leg ulcers are a common and recurring type of chronic, complex wound associated with considerable cost to patients and healthcare providers. To aid healing,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Venous leg ulcers are a common and recurring type of chronic, complex wound associated with considerable cost to patients and healthcare providers. To aid healing, primary wound contact dressings are usually applied to ulcers beneath compression devices. Alginate dressings are used frequently and there is a variety of alginate products on the market, however, the evidence base to guide dressing choice is sparse.
OBJECTIVES
To determine the effects of alginate dressings compared with alternative dressings, non-dressing treatments or no dressing, with or without concurrent compression therapy, on the healing of venous leg ulcers.
SEARCH METHODS
For this first update, in March 2015, we searched the following databases: The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. There were no restrictions based on language or date of publication.
SELECTION CRITERIA
Published or unpublished randomised controlled trials (RCTs) that evaluated the effects of any type of alginate dressing in the treatment of venous ulcers were included.
DATA COLLECTION AND ANALYSIS
Two review authors independently performed study selection, data extraction and risk of bias assessment. Meta-analysis was undertaken when deemed feasible and appropriate.
MAIN RESULTS
Five RCTs (295 participants) were included in this review. All were identified during the original review. The overall risk of bias was high for two RCTs and unclear for three. One RCT compared different proprietary alginate dressings (20 participants), three compared alginate and hydrocolloid dressings (215 participants), and one compared alginate and plain non-adherent dressings (60 participants). Follow-up periods were six weeks in three RCTs and 12 weeks in two. No statistically significant between-group differences were detected for any comparison, for any healing outcome. Meta-analysis was feasible for one comparison (alginate and hydrocolloid dressings), with data from two RCTs (84 participants) pooled for complete healing at six weeks: risk ratio 0.42 (95% confidence interval 0.14 to 1.21). Adverse event profiles were generally similar between groups (not assessed for alginate versus plain non-adherent dressings).
AUTHORS' CONCLUSIONS
The current evidence base does not suggest that alginate dressings are more or less effective in the healing of venous leg ulcers than hydrocolloid or plain non-adherent dressings, and there is no evidence to indicate a difference between different proprietary alginate dressings. However, the RCTs in this area are considered to be of low or unclear methodological quality. Further, good quality evidence is required from well designed and rigorously conducted RCTs that employ - and clearly report on - methods to minimise bias, prior to any definitive conclusions being made regarding the efficacy of alginate dressings in the management of venous leg ulcers.
Topics: Aged; Alginates; Bandages, Hydrocolloid; Compression Bandages; Female; Humans; Male; Pain Measurement; Randomized Controlled Trials as Topic; Varicose Ulcer
PubMed: 26286189
DOI: 10.1002/14651858.CD010182.pub3 -
The Cochrane Database of Systematic... Jul 2015Leg ulceration is a common, chronic, recurring condition. The estimated prevalence of leg ulcers in the UK population is 1.5 to 3 per 1000. Venous ulcers (also called... (Review)
Review
BACKGROUND
Leg ulceration is a common, chronic, recurring condition. The estimated prevalence of leg ulcers in the UK population is 1.5 to 3 per 1000. Venous ulcers (also called stasis or varicose ulcers) comprise 80% to 85% of all leg ulcers. Electromagnetic therapy (EMT) is sometimes used as a treatment to assist the healing of chronic wounds such as venous leg ulcers.
OBJECTIVES
To assess the effects of EMT on the healing of venous leg ulcers.
SEARCH METHODS
For this fourth update, we searched The Cochrane Wounds Group Specialised Register (searched 30 January 2015); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 12).
SELECTION CRITERIA
Randomised controlled trials comparing EMT with sham-EMT or other treatments.
DATA COLLECTION AND ANALYSIS
Standard Cochrane Collaboration methods were employed. At least two review authors independently scrutinised search results and obtained full reports of potentially eligible studies for further assessment. We extracted and summarised details of eligible studies using a data extraction sheet, and made attempts to obtain missing data by contacting study authors. A second review author checked data extraction, and we resolved disagreements after discussion between review authors.
MAIN RESULTS
Three randomised controlled trials (RCTs) of low or unclear risk of bias, involving 94 people, were included in the original review; subsequent updates have identified no new trials. All the trials compared the use of EMT with sham-EMT. Meta-analysis of these trials was not possible due to heterogeneity. In the two trials that reported healing rates; one small trial (44 participants) reported that significantly more ulcers healed in the EMT group than the sham-EMT group however this result was not robust to different assumptions about the outcomes of participants who were lost to follow up. The second trial that reported numbers of ulcers healed found no significant difference in healing. The third trial was also small (31 participants) and reported significantly greater reductions in ulcer size in the EMT group however this result may have been influenced by differences in the prognostic profiles of the treatment groups.
AUTHORS' CONCLUSIONS
It is not clear whether electromagnetic therapy influences the rate of healing of venous leg ulcers. Further research would be needed to answer this question.
Topics: Humans; Magnetic Field Therapy; Randomized Controlled Trials as Topic; Varicose Ulcer; Wound Healing
PubMed: 26134172
DOI: 10.1002/14651858.CD002933.pub6 -
Journal of Vascular Surgery. Venous and... Nov 2017Endothermal treatment of the great saphenous vein (GSV) has become the first-line treatment for superficial venous reflux. Nonthermal ablation has potential benefits for... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Endothermal treatment of the great saphenous vein (GSV) has become the first-line treatment for superficial venous reflux. Nonthermal ablation has potential benefits for acceptability by patients and decreased risk of nerve injury. We performed a systematic review and meta-analysis to evaluate the efficacy of mechanochemical endovenous ablation (MOCA) and cyanoacrylate vein ablation (CAVA) for GSV incompetence.
METHODS
MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, and Cochrane databases were searched for papers published between January 1966 and December 2016. Eligible articles were prospective studies that included patients treated for GSV incompetence and described the primary outcome. Exclusion criteria were full text not available, case reports, retrospective studies, small series (n < 10), reviews, abstracts, animal studies, studies of small saphenous vein incompetence, and recurrent GSV incompetence. Primary outcome was anatomic success. Secondary outcomes were initial technical success, Venous Clinical Severity Score, Aberdeen Varicose Vein Questionnaire score, and complications.
RESULTS
Fifteen articles met the inclusion criteria. Pooled anatomic success for MOCA and CAVA was 94.7% and 94.8% at 6 months and 94.1% and 89.0% at 1 year, respectively. Venous Clinical Severity Score and Aberdeen Varicose Vein Questionnaire score significantly improved after treatment with MOCA and CAVA.
CONCLUSIONS
These results are promising for these novel techniques that could serve as alternatives for thermal ablation techniques. However, to determine their exact role in clinical practice, high-quality randomized controlled trials comparing these novel modalities with well-established techniques are required.
Topics: Ablation Techniques; Aged; Cyanoacrylates; Endovascular Procedures; Epidemiologic Methods; Female; Humans; Male; Saphenous Vein; Tissue Adhesives; Venous Insufficiency
PubMed: 29037363
DOI: 10.1016/j.jvsv.2017.05.022 -
The Cochrane Database of Systematic... Jun 2015Chronic wounds are common and present a health problem with significant effect on quality of life. Various pathologies may cause tissue breakdown, including poor blood... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Chronic wounds are common and present a health problem with significant effect on quality of life. Various pathologies may cause tissue breakdown, including poor blood supply resulting in inadequate oxygenation of the wound bed. Hyperbaric oxygen therapy (HBOT) has been suggested to improve oxygen supply to wounds and therefore improve their healing.
OBJECTIVES
To assess the benefits and harms of adjunctive HBOT for treating chronic ulcers of the lower limb.
SEARCH METHODS
For this second update we searched the Cochrane Wounds Group Specialised Register (searched 18 February 2015); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015, Issue 1); Ovid MEDLINE (1946 to 17 February 2015); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, 17 February 2015); Ovid EMBASE (1974 to 17 February 2015); and EBSCO CINAHL (1982 to 17 February 2015).
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing the effect on chronic wound healing of therapeutic regimens which include HBOT with those that exclude HBOT (with or without sham therapy).
DATA COLLECTION AND ANALYSIS
Three review authors independently evaluated the risk of bias of the relevant trials using the Cochrane methodology and extracted the data from the included trials. We resolved any disagreement by discussion.
MAIN RESULTS
We included twelve trials (577 participants). Ten trials (531 participants) enrolled people with a diabetic foot ulcer: pooled data of five trials with 205 participants showed an increase in the rate of ulcer healing (risk ratio (RR) 2.35, 95% confidence interval (CI) 1.19 to 4.62; P = 0.01) with HBOT at six weeks but this benefit was not evident at longer-term follow-up at one year. There was no statistically significant difference in major amputation rate (pooled data of five trials with 312 participants, RR 0.36, 95% CI 0.11 to 1.18). One trial (16 participants) considered venous ulcers and reported data at six weeks (wound size reduction) and 18 weeks (wound size reduction and number of ulcers healed) and suggested a significant benefit of HBOT in terms of reduction in ulcer area only at six weeks (mean difference (MD) 33.00%, 95% CI 18.97 to 47.03, P < 0.00001). We identified one trial (30 participants) which enrolled patients with non-healing diabetic ulcers as well as venous ulcers ("mixed ulcers types") and patients were treated for 30 days. For this "mixed ulcers" there was a significant benefit of HBOT in terms of reduction in ulcer area at the end of treatment (30 days) (MD 61.88%, 95% CI 41.91 to 81.85, P < 0.00001). We did not identify any trials that considered arterial and pressure ulcers.
AUTHORS' CONCLUSIONS
In people with foot ulcers due to diabetes, HBOT significantly improved the ulcers healed in the short term but not the long term and the trials had various flaws in design and/or reporting that means we are not confident in the results. More trials are needed to properly evaluate HBOT in people with chronic wounds; these trials must be adequately powered and designed to minimise all kinds of bias.
Topics: Amputation, Surgical; Chronic Disease; Diabetic Foot; Humans; Hyperbaric Oxygenation; Randomized Controlled Trials as Topic; Varicose Ulcer; Wound Healing
PubMed: 26106870
DOI: 10.1002/14651858.CD004123.pub4 -
Blood Aug 2014Chronic venous disease encompasses a spectrum of disorders caused by an abnormal venous system. They include chronic venous insufficiency, varicose veins,... (Review)
Review
Chronic venous disease encompasses a spectrum of disorders caused by an abnormal venous system. They include chronic venous insufficiency, varicose veins, lipodermatosclerosis, postthrombotic syndrome, and venous ulceration. Some evidence suggests a genetic predisposition to chronic venous disease from gene polymorphisms associated mainly with vein wall remodeling. The literature exploring these polymorphisms has not been reviewed and compiled thus far. In this narrative and systematic review, we present the current evidence available on the role of polymorphisms in genes involved in vein wall remodeling and other pathways as contributors to chronic venous disease. We searched the EMBASE, Medline, and PubMed databases from inception to 2013 for basic science or clinical studies relating to genetic associations in chronic venous disease and obtained 38 relevant studies for this review. Important candidate genes/proteins include the matrix metalloproteinases (extracellular matrix degradation), vascular endothelial growth factors (angiogenesis and vessel wall integrity), FOXC2 (vascular development), hemochromatosis (involved in venous ulceration and iron absorption), and various types of collagen (contributors to vein wall strength). The data on associations between these genes/proteins and the postthrombotic syndrome are limited and additional studies are required. These associations might have future prognostic and therapeutic implications.
Topics: Animals; Chronic Disease; Collagenases; Forkhead Transcription Factors; Genetic Predisposition to Disease; Humans; Polymorphism, Genetic; Postthrombotic Syndrome; PubMed; Varicose Ulcer; Vascular Endothelial Growth Factor A
PubMed: 25006132
DOI: 10.1182/blood-2014-03-558478 -
International Journal of Molecular... Jun 2022Venous leg ulcers (VLUs) are the most common type of leg ulcers with a significant socioeconomic burden due to slow healing. Cytokines may be involved in the... (Review)
Review
Venous leg ulcers (VLUs) are the most common type of leg ulcers with a significant socioeconomic burden due to slow healing. Cytokines may be involved in the pathogenesis of VLUs. In this systematic review, our objective was to investigate the association between cytokine levels, including growth factors, with the healing of VLUs. PubMed, Embase, Web of Science and Cochrane Library were searched from their inception to August 2021. We retrieved 28 articles investigating 38 different cytokines in 790 patients. Cytokines were most commonly investigated in wound fluid and less frequently in biopsies and serum. The studies were judged as having a moderate to high risk of bias, and the results were often inconsistent and sometimes conflicting. A meta-analysis was not performed due to clinical and methodological heterogeneities. We found weak evidence for elevated IL-1α, IL-6, IL-8, TNF-α and VEGF levels in non-healing VLUs, an elevation that declined with healing. TGF-β1 levels tended to increase with VLU healing. Other cytokines warranting further investigations include EGF, FGF-2, GM-CSF, IL-1β, IL-1Ra and PDGF-AA/PDGF-BB. We conclude that non-healing VLUs may be associated with an elevation of a palette of pro-inflammatory cytokines, possibly reflecting activated innate immunity in these wounds. There is a paucity of reliable longitudinal studies monitoring the dynamic changes in cytokine levels during wound healing.
Topics: Cytokines; Humans; Leg Ulcer; Varicose Ulcer; Vascular Endothelial Growth Factor A; Wound Healing
PubMed: 35742965
DOI: 10.3390/ijms23126526