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European Journal of Vascular and... Sep 2018A systematic review and meta-analysis was performed to determine the incidence of thrombotic events following great saphenous vein (GSV) endovenous thermal ablation... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
A systematic review and meta-analysis was performed to determine the incidence of thrombotic events following great saphenous vein (GSV) endovenous thermal ablation (EVTA).
METHODS
MEDLINE, Embase and conference abstracts were searched. Eligible studies were randomised controlled trials and case series that included at least 100 patients who underwent GSV EVTA (laser ablation or radiofrequency ablation [RFA]) with duplex ultrasound (DUS) within 30 days. The systematic review focused on the complications of endovenous heat induced thrombosis (EHIT), deep venous thrombosis (DVT), and pulmonary embolism (PE). The primary outcome for the meta-analysis was deep venous thrombotic events which were defined as DVT or EHIT Type 2, 3, or 4. Secondary outcomes for the meta-analysis were EHIT Type 2, 3, or 4, DVT and PE. Subgroup analyses were performed for both the RFA and EVLA groups. Pooled proportions were calculated using random effects modelling.
RESULTS
Fifty-two studies (16,398 patients) were included. Thrombotic complications occurred infrequently. Deep venous thrombotic events occurred in 1.7% of cases (95% CI 0.9-2.7%) (25 studies; 10,012 patients; 274 events). EHIT Type 2, 3, or 4 occurred in 1.4% of cases (95% CI 0.8-2.3%) (26 studies; 10,225 patients; 249 events). DVT occurred in 0.3% of cases (95% CI = 0.2%-0.5%) (49 studies; 15,676 patients; 48 events). PE occurred in 0.1% of cases (95% CI = 0.1-0.2%) (29 studies; 8223 patients; 3 events). Similar results were found when the RFA and EVLA groups were analysed separately.
CONCLUSION
Thrombotic events occur infrequently following GSV EVTA. Given the large numbers of procedures worldwide and the potential for serious consequences, further research is needed on the burden of these complications and their management.
Topics: Adult; Catheter Ablation; Endovascular Procedures; Female; Hot Temperature; Humans; Incidence; Laser Therapy; Male; Middle Aged; Risk Factors; Saphenous Vein; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Varicose Veins; Venous Thrombosis
PubMed: 29895399
DOI: 10.1016/j.ejvs.2018.05.008 -
Annals of Vascular Surgery Mar 2022Cyanoacrylate embolization (CAE) is a novel non-thermal non-tumescent venous ablation technique that has shown promising results in treating saphenous vein... (Comparative Study)
Comparative Study Meta-Analysis
INTRODUCTION
Cyanoacrylate embolization (CAE) is a novel non-thermal non-tumescent venous ablation technique that has shown promising results in treating saphenous vein insufficiency. We aimed to assess the efficacy and safety profile of CAE in comparison to endovenous laser ablation (EVLA) in treating saphenous vein insufficiency.
MATERIAL AND METHODS
We conducted a systematic review and meta-analysis in accordance with the PRISMA Statement. A systematic search was performed through online databases including PubMed, ScienceDirect, and Cochrane to find relevant studies. Manual searching was also performed from the references of the selected studies. Specific keywords that we used were "(cyanoacrylate) AND (laser OR laser ablation OR laser therapy) AND (vein OR venous OR saphenous vein OR venous insufficiency OR varicose vein)". Outcomes of interest were efficacy, safety, and intervention time. Efficacy was determined by venous closure rate 1 year post-intervention and Venous Clinical Severity Score (VCSS) 1 year post-intervention. Safety was determined by rates of periprocedural pain, skin pigmentation, nerve damage, phlebitis, deep vein thrombosis (DVT) and ecchymosis. Data extraction and quality assessment of included studies were performed by 2 reviewers, and statistical analysis was conducted using RevMan 5.4.0 software.
RESULTS
Five relevant articles (2 randomized-controlled trials and 3 cohort studies) were selected for this study, consisting a total of 1432 venous ablation procedures (710 CAE and 722 EVLA). From the efficacy point of view, venous closure rates and VCSS did not differ significantly between CAE group and EVLA group. From the safety point of view, pooled data showed that CAE group was associated with less periprocedural pain score (P < 0.001), lower skin pigmentation rates (0.60% vs. 4.46%; P = 0.008), and lower nerve damage rates (0% vs. 3.94%; P = 0.007). Rates of phlebitis, deep vein thrombosis, and ecchymosis did not differ significantly between the 2 groups. In addition, intervention time was significantly faster in CAE group compared to EVLA group (P < 0.001).
CONCLUSION
Cyanoacrylate embolization yields similar efficacy compared to EVLA. However, CAE is associated with less periprocedural pain, lower occurrence rates of skin pigmentation and nerve damage, and faster intervention time.
Topics: Cyanoacrylates; Embolization, Therapeutic; Humans; Laser Therapy; Operative Time; Postoperative Complications; Saphenous Vein; Severity of Illness Index; Skin Pigmentation; Venous Insufficiency
PubMed: 34780939
DOI: 10.1016/j.avsg.2021.09.041 -
Phlebology Jul 2020Catheter-directed foam sclerotherapy is a new addition to the treatment modalities available for varicose veins. As a modification of ultrasound-guided foam... (Meta-Analysis)
Meta-Analysis
PURPOSE
Catheter-directed foam sclerotherapy is a new addition to the treatment modalities available for varicose veins. As a modification of ultrasound-guided foam sclerotherapy, catheter-directed foam sclerotherapy has been purported to offer higher complete ablation rates and an improved safety profile. The aim of this study is to appraise the current literature on the outcomes of catheter-directed foam sclerotherapy compared to ultrasound-guided foam sclerotherapy in chronic venous insufficiency.
METHODS
The review of the literature was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Data from studies that reported the outcomes of catheter-directed foam sclerotherapy and ultrasound-guided foam sclerotherapy were extracted, to determine the pooled proportion of complete ablation rates, using a random effect meta-analysis model.
RESULTS
A total of 62 studies, involving 3689 patients, were included in the systematic review. Higher rates of complete ablation were reported in catheter-directed foam sclerotherapy compared to ultrasound-guided foam sclerotherapy during the short- and medium-term follow-ups (Relative Risk = 1.06, Relative Risk = 1.15, Relative Risk = 1.19, p < 0.05). Fewer major and minor complications were also reported in patients who underwent catheter-directed foam sclerotherapy (Relative Risk = 0.23, Relative Risk= 0.43-0.76, p < 0.05).
CONCLUSION
Catheter-directed foam sclerotherapy has been demonstrated to have many advantages over ultrasound-guided foam sclerotherapy, offering superior complete ablation rates in the short-, medium- and long-term follow-ups. It also has a better safety profile, conferring a lower risk of major and minor complications. The conclusions should however be viewed in the context of significant limitations imposed by limited study data.
Topics: Catheter Ablation; Catheterization; Chronic Disease; Endovascular Procedures; Humans; Laser Therapy; Patient Safety; Risk; Saphenous Vein; Sclerotherapy; Ultrasonics; Ultrasonography, Interventional; Varicose Veins; Venous Insufficiency
PubMed: 31918640
DOI: 10.1177/0268355519898309 -
European Journal of Vascular and... Jun 2019The aim was to summarise the evidence for the relationship between vein diameters and clinical severity, and elucidate the relationship between diameters and health...
OBJECTIVE/BACKGROUND
The aim was to summarise the evidence for the relationship between vein diameters and clinical severity, and elucidate the relationship between diameters and health related quality of life (HRQoL) METHODS: A systematic review was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines. The MEDLINE and Embase databases were searched from 1946 to 31 August 2018. Reference lists of included studies were searched for further relevant papers. Full text studies in English reporting the relationship between great and small saphenous vein diameters and clinical severity and/or HRQoL scores measured using validated instruments were included. All study designs were included. Studies that did not include relationships between these parameters, non-English studies, and studies focusing on non-truncal veins were excluded. Two reviewers independently performed the study selection, data extraction, and risk of bias assessment.
RESULTS
Eleven eligible studies were identified, reporting on 2,732 limbs (range 22-681). Four studies correlated truncal vein diameter with both clinical severity and HRQoL, while seven reported only on clinical severity measures. Multiple instruments were used to quantify HRQoL and clinical severity. Seven studies assessed the relationship with CEAP class, with the majority observing a positive correlation between vein diameter and disease severity. Four studies found weak correlations with VCSS, with one showing correlations with VCSS components. No significant relationship between diameters and HRQoL scores was reported. One study also revealed no correlation with Aberdeen Varicose Vein Questionnaire improvements post-treatment. The majority of studies failed to include C and C participants.
CONCLUSIONS
While further studies are required to improve the level of evidence, the existing literature suggests that truncal vein diameters correlate with clinical severity. Diameters are a poor predictor of HRQoL, with no relationship to patients' perceived impact of chronic venous disease. As such, vein diameter should not be used as a measure to decide who needs venous intervention.
Topics: Chronic Disease; Clinical Decision-Making; Humans; Patient Selection; Peripheral Vascular Diseases; Predictive Value of Tests; Prognosis; Quality of Life; Risk Factors; Saphenous Vein; Severity of Illness Index; Surveys and Questionnaires
PubMed: 30850282
DOI: 10.1016/j.ejvs.2019.01.024 -
Phlebology Sep 2015With the advent of endovenous truncal ablation under local anaesthetic for the treatment of varicose veins, the fate of varicosed tributaries has become controversial,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
With the advent of endovenous truncal ablation under local anaesthetic for the treatment of varicose veins, the fate of varicosed tributaries has become controversial, with centres offering different timings of treatment, if offered at all. This study aims to review the literature assessing delayed and simultaneous varicosity treatment during truncal ablation.
METHODS
Randomised trials and cohort studies concerning varicosity treatment timing were identified through a systematic literature search. Requirements for further treatment, quality of life and rate of venous thrombotic events were assessed for meta-analysis.
RESULTS
Four studies were identified assessing need for further varicosity procedure, with no significant difference seen between simultaneous or delayed treatment (p = 0.339). Two studies assessed quality of life, with simultaneous treatment providing significantly improved outcomes at six weeks (p = 0.029) but not at 12 weeks (p = 0.283). Studies examining venous thrombotic events showed no difference in venous thromboembolism rate between simultaneous or delayed treatment approaches (p = 0.078).
CONCLUSION
The evidence base regarding timing of varicosity treatment is sparse; however, it does show that simultaneous treatment of varicosities leads to early gains in quality of life, with a non-significant trend for fewer further procedures but more venous thrombotic events.
Topics: Catheter Ablation; Female; Humans; Male; Quality of Life; Randomized Controlled Trials as Topic; Varicose Veins; Venous Thromboembolism; Venous Thrombosis
PubMed: 25135826
DOI: 10.1177/0268355514548473 -
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 -
BMJ Clinical Evidence Sep 2008Leg ulcers usually occur secondary to venous reflux or obstruction, but 20% of people with leg ulcers have arterial disease, with or without venous disorders. Between... (Review)
Review
INTRODUCTION
Leg ulcers usually occur secondary to venous reflux or obstruction, but 20% of people with leg ulcers have arterial disease, with or without venous disorders. Between 1.5 and 3.0/1000 people have active leg ulcers. Prevalence increases with age to about 20/1000 in people aged over 80 years.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of standard treatments, adjuvant treatments, and organisational interventions for venous leg ulcers? What are the effects of interventions to prevent recurrence of venous leg ulcers? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2007 (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 80 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: compression bandages and stockings, cultured allogenic (single or bilayer) skin replacement, debriding agents, dressings (cellulose, collagen, film, foam, hyaluronic acid-derived, semi-occlusive alginate), hydrocolloid (occlusive) dressings in the presence of compression, intermittent pneumatic compression, intravenous prostaglandin E1, larval therapy, laser treatment (low-level), leg ulcer clinics, multilayer elastic system, multilayer elastomeric (or non-elastomeric) high-compression regimens or bandages, oral treatments (aspirin, flavonoids, pentoxifylline, rutosides, stanozolol, sulodexide, thromboxane alpha(2) antagonists, zinc), peri-ulcer injection of granulocyte-macrophage colony-stimulating factor, short-stretch bandages, single-layer non-elastic system, skin grafting, superficial vein surgery, systemic mesoglycan, therapeutic ultrasound, self-help (advice to elevate leg, advice to keep leg active, advice to modify diet, advice to stop smoking, advice to reduce weight), and topical treatments (antimicrobial agents, autologous platelet lysate, calcitonin gene-related peptide plus vasoactive intestinal polypeptide, freeze-dried keratinocyte lysate, mesoglycan, negative-pressure recombinant keratinocyte growth factor, platelet-derived growth factor).
Topics: Bandages; Debridement; Humans; Leg Ulcer; Occlusive Dressings; Ultrasonic Therapy; Varicose Ulcer; Wound Healing
PubMed: 19445798
DOI: No ID Found -
Health Technology Assessment... Oct 2013Varicose veins are enlarged, visibly lumpy knotted veins, usually in the legs. Uncomplicated varicose veins can cause major discomfort and some complications. They are... (Review)
Review
BACKGROUND
Varicose veins are enlarged, visibly lumpy knotted veins, usually in the legs. Uncomplicated varicose veins can cause major discomfort and some complications. They are part of chronic venous disease (CVD), which is reported to have a substantial negative impact on health-related quality of life (HRQoL). Traditional treatments for varicose veins involve surgical stripping and ligation and liquid sclerotherapy (LS), but can be invasive and painful. New minimally invasive treatments offer an alternative. These treatments typically involve use of laser, radiofrequency or foam sclerosant. They are increasingly widely used and offer potential benefits such as reduced complications, faster recovery, fewer physical limitations and improved quality of life.
OBJECTIVE
The aim of this report is to evaluate the clinical effectiveness, safety and cost-effectiveness of the minimally invasive techniques of foam sclerotherapy (FS), endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) in comparison with other techniques, including traditional surgical techniques, LS and conservative management, in the management of varicose veins.
DATA SOURCES
A systematic search was made of 11 bibliographic databases of published and unpublished literature from their inception to July 2011: MEDLINE; EMBASE; Cumulative Index to Nursing and Allied Health Literature; The Cochrane Library; Biological Abstracts; Science Citation Index (SCI); Social Sciences Citation Index; Conference Proceedings Citation Index-Science; UK Clinical Research Network; Current Controlled Trials; and ClinicalTrials.gov.
REVIEW METHODS
A systematic review of randomised controlled trials (RCTs) to assess the clinical effectiveness of minimally invasive techniques compared with other treatments, principally surgical stripping, in terms of recurrence of varicose veins, retreatment and clinical symptoms, as measured by the Venous Clinical Severity Score (VCSS), pain and quality of life. Network meta-analysis and exploratory cost-effectiveness modelling were performed.
RESULTS
The literature search identified 1453 unique citations, of which 34 RCTs (54 papers) satisfied the criteria for the clinical effectiveness review. The minimally invasive techniques reported clinical outcomes similar to surgery. Rates of recurrence were slightly lower for EVLA, RFA and FS, especially for longer follow-up periods; VCSS score was lower for EVLA and FS than for stripping, but slightly higher for RFA; short-term pain was less for FS and RFA but higher for EVLA; higher quality-of-life scores were reported for all evaluated interventions than for stripping. Differences between treatments were therefore negligible in terms of clinical outcomes, so the treatment with the lowest cost appears to be most cost-effective. Our central estimate is that total FS costs were lowest and FS is marginally more effective than stripping. However, this result was sensitive to the model time horizon. Threshold analysis indicated that EVLA and RFA might be considered cost-effective if their costs are equivalent to stripping. These findings are subject to uncertainty on account of the risk of bias present in the evidence base and the variation in costs.
LIMITATIONS
The relative clinical effectiveness and cost-effectiveness of the techniques are principally based on rates of post-operative technical recurrence rather than symptomatic recurrence, as this was the reported outcome in all trials. The true proportion of treated individuals who are likely to present with symptoms of recurrence requiring retreatment is therefore not certain. A figure reflecting the likely proportion of treated individuals who would experience symptomatic recurrence requiring retreatment (with its associated costs), therefore, had to be calculated by the authors based on a small number of studies. The findings of this report also need to be verified by data from future trials with longer follow-up and using more standardised outcome measures.
CONCLUSIONS
This assessment of the currently available evidence suggests there is little to choose between the minimally invasive techniques in terms of efficacy or cost, and each offers a viable, clinically effective alternative to stripping. FS might offer the most cost-effective alternative to stripping, within certain time parameters. High-quality RCT evidence is needed. Future trials should aim to measure and report outcomes in a standardised manner, which would permit more efficient pooling of their results.
STUDY REGISTRATION
PROSPERO number CRD42011001355.
FUNDING
The National Institute for Health Research Health Technology Assessment programme.
Topics: Catheter Ablation; Cost-Benefit Analysis; Health Expenditures; Humans; Laser Therapy; Quality-Adjusted Life Years; Randomized Controlled Trials as Topic; Recurrence; Sclerotherapy; Varicose Veins
PubMed: 24176098
DOI: 10.3310/hta17480 -
Angiology Aug 2023This systematic review and network meta-analysis investigated the clinical efficacy and safety of chemical agent injections in patients with varicose veins. PubMed,...
This systematic review and network meta-analysis investigated the clinical efficacy and safety of chemical agent injections in patients with varicose veins. PubMed, Embase, and Cochrane databases were searched for eligible studies where patients administered endovascular agents comprised an intervention group, and patients administered other interventions comprised the comparison group. The endovascular agents included foam and liquid form sclerotherapy or cyanoacrylate glue. The other interventions in this study included surgery, endovenous laser ablation (EVLA), radiofrequency ablation (RFA), and placebo. A network meta-analysis for treatment effectiveness was performed. In addition, we illustrated the P-score lines of success rate and complication rate sorted by the P-score. Our results showed that at all postprocedural time intervals, cyanoacrylate glue therapy exhibited a significantly higher success rate compared with foam and liquid sclerotherapy. According to the plot of P-score lines, cyanoacrylate glue had an overall tendency of higher success rate and lower complication rate compared with foam and liquid sclerotherapy. Comparing with the other invasive treatments, cyanoacrylate glue may be non-inferior and could be considered as an option for treating varicose veins. However, the clinical benefits and safety of endovascular agents for the treatment of varicose veins require further corroboration through randomized control trials.
PubMed: 37649310
DOI: 10.1177/00033197231199027 -
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