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European Journal of Vascular and... Nov 2023The objective was to compare technical success, complications, and quality of life after thermal vs. non-thermal endovenous ablation for the treatment of superficial... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The objective was to compare technical success, complications, and quality of life after thermal vs. non-thermal endovenous ablation for the treatment of superficial venous incompetence.
DATA SOURCES
Electronic bibliographic sources (Google Scholar, Pubmed, Cochrane Database, Scopus, Web of Science, and Embase).
REVIEW METHODS
A systematic review and meta-analysis of randomised controlled trials was conducted using terms to identify relevant studies to be included. The primary outcome was vein occlusion rate at up to four weeks and one to two years from procedure. Secondary outcome measures included peri-procedural pain, nerve injury, endothermal heat induced thrombosis, and quality of life.
RESULTS
Eight randomised controlled trials met the selection criteria. These comprised a total of 1 956 patients, of whom 1 042 underwent endovenous thermal ablation and 915 underwent endovenous non-thermal ablation. There was no statistically significant difference in occlusion rate at all time points. Relative risk at four weeks and one to two years was 0.99 (95% CI 0.96 - 1.02) and 0.95 (95% CI 0.88 - 1.01), respectively. Non-thermal ablation was tolerated better and had less risk of nerve injury. There was no statistically significant difference in risk of endothermal heat induced thrombosis (EHIT). There was improvement in quality of life scores post-procedure but there was no statistically significant difference in thermal vs. non-thermal ablation. The quality of evidence assessed using GRADE methodology showed high quality for occlusion rate at four weeks and one to two years, moderate quality for nerve injury and peri-procedural pain, and low quality for EHIT.
CONCLUSION
Vein occlusion rates after thermal vs. non-thermal endovenous ablation are similar. In the early post-operative period, non-thermal endovenous ablation demonstrated the advantages of less pain and less risk of nerve injury. Improvement in quality of life after both thermal and non-thermal endovenous ablation is similar.
Topics: Humans; Pain, Procedural; Quality of Life; Varicose Veins; Saphenous Vein; Thrombosis; Venous Insufficiency; Treatment Outcome; Laser Therapy; Randomized Controlled Trials as Topic
PubMed: 37295602
DOI: 10.1016/j.ejvs.2023.06.002 -
Contraception Sep 2016Superficial venous disease, which includes superficial venous thrombosis (SVT) and varicose veins, may be associated with a higher risk of venous thromboembolism (VTE).... (Review)
Review
BACKGROUND
Superficial venous disease, which includes superficial venous thrombosis (SVT) and varicose veins, may be associated with a higher risk of venous thromboembolism (VTE). Use of combined hormonal contraceptives (CHCs) has been associated with an increased risk of VTE compared with nonuse. Little is known about whether use of CHCs by women with superficial venous disease may further elevate the risk of VTE.
OBJECTIVES
To investigate evidence regarding risk of VTE in women with SVT or varicose veins who use CHCs compared with non-CHC users.
METHODS
We searched the PubMed database for all English-language articles published from database inception through September 2014. We included primary research studies that examined women with SVT or varicose veins who used CHCs compared to women with these conditions who did not use CHCs. Outcomes of interest included VTE (among women with SVT or varicose veins) and SVT (for those with varicose veins).
RESULTS
Two studies were identified that met inclusion criteria. One fair-quality case-control study reported an odds ratio (OR) for VTE of 43.0 (95% confidence interval [CI] 15.5-119.3) among women with SVT using oral contraceptives (OCs) compared with nonusers without SVT. The OR for VTE was also increased for women with SVT not using OCs (OR 5.1; 95% CI 2.8-9.5) and for women without SVT using OCs (OR 4.0; 95% CI 3.3-4.7), compared with nonusers without SVT. One fair-quality cohort study demonstrated that women with varicose veins had an increased rate of VTE with use of OCs (1.85 per 1000 women-years [WY]), compared with users without varicose veins (0.84 per 1000 WY), nonusers with varicose veins (0.31 per 1000 WY) and nonusers without varicose veins (0.19 per 1000 WY). This study also demonstrated that women with varicose veins had an increased rate of SVT with use of OCs (10.63 per 1000 WY), compared with nonusers with varicose veins (7.59 per 1000 WY), users without varicose veins (1.89 per 1000 WY) and nonusers without varicose veins (0.77 per 1000 WY).
CONCLUSION
Two studies suggest increased risk of VTE among OC users with superficial venous disease; however, no definitive conclusions can be made due to the limited number of studies and limitations in study quality. Theoretical concerns need to be clarified with further research on whether the risk of significant sequelae from superficial venous disease among CHC users is related to clinical severity of disease and underlying factors.
Topics: Contraceptives, Oral, Combined; Female; Humans; Risk Factors; Venous Thromboembolism; Venous Thrombosis
PubMed: 25835269
DOI: 10.1016/j.contraception.2015.03.010 -
Value in Health : the Journal of the... Aug 2018To analyze the cost-effectiveness of current technologies (conservative care [CONS], high-ligation surgery [HL/S], ultrasound-guided foam sclerotherapy [UGFS],... (Review)
Review
OBJECTIVES
To analyze the cost-effectiveness of current technologies (conservative care [CONS], high-ligation surgery [HL/S], ultrasound-guided foam sclerotherapy [UGFS], endovenous laser ablation [EVLA], and radiofrequency ablation [RFA]) and emerging technologies (mechanochemical ablation [MOCA] and cyanoacrylate glue occlusion [CAE]) for treatment of varicose veins over 5 years.
METHODS
A Markov decision model was constructed. Effectiveness was measured by re-intervention on the truncal vein, re-treatment of residual varicosities, and quality-adjusted life-years (QALYs) over 5 years. Model inputs were estimated from systematic review, the UK National Health Service unit costs, and manufacturers' list prices. Univariate and probabilistic sensitivity analyses were undertaken.
RESULTS
CONS has the lowest overall cost and quality of life per person over 5 years; HL/S, EVLA, RFA, and MOCA have on average similar costs and effectiveness; and CAE has the highest overall cost but is no more effective than other therapies. The incremental cost per QALY of RFA versus CONS was £5,148/QALY. Time to return to work or normal activities was significantly longer after HL/S than after other procedures.
CONCLUSIONS
At a threshold of £20,000/QALY, RFA was the treatment with highest median rank for net benefit, with MOCA second, EVLA third, HL/S fourth, CAE fifth, and CONS and UGFS sixth. Further evidence on effectiveness and health-related quality of life for MOCA and CAE is needed. At current prices, CAE is not a cost-effective option because it is costlier but has not been shown to be more effective than other options.
Topics: Ablation Techniques; Conservative Treatment; Cost-Benefit Analysis; Elective Surgical Procedures; Humans; Laser Therapy; Markov Chains; Sclerotherapy; Varicose Veins
PubMed: 30098668
DOI: 10.1016/j.jval.2018.01.012 -
Journal of Vascular Surgery. Venous and... Sep 2021A systematic review and meta-analysis was performed to determine the incidence of endovenous heat-induced thrombosis (EHIT) and evaluate its management after endovenous...
OBJECTIVE
A systematic review and meta-analysis was performed to determine the incidence of endovenous heat-induced thrombosis (EHIT) and evaluate its management after endovenous thermal ablation of the great saphenous vein (GSV).
METHODS
MEDLINE and Embase were searched for studies with at least 100 patients who underwent great saphenous vein endovenous thermal ablation and had duplex ultrasound follow-up within 30 days. Data were gathered on the incidence of thrombotic complications and on the management of cases of EHIT. The primary outcome for the meta-analysis was EHIT types 2 to 4 and secondary outcomes were deep venous thrombotic events (which we defined as types 2-4 EHIT plus deep vein thrombosis [DVT]), DVT, and pulmonary embolism (PE). Pooled proportions were calculated using random effects modelling.
RESULTS
We included 75 studies (23,265 patients). EHIT types 2 to 4 occurred in 1.27% of cases (95% confidence interval [CI], 0.74%-1.93%). Deep venous thrombotic events occurred in 1.59% (95% CI, 0.95%-2.4%). DVT occurred in 0.28% (95% CI, 0.18%-0.4%). Pulmonary embolism occurred in 0.11% (95% CI, 0.06%-0.18%). Of the 75 studies, 24 gave a description of the management strategy and outcomes for EHIT and there was inconsistency regarding its management. Asymmetrical funnel plots of studies that reported incidence of EHIT 2 to 4 and DVT suggest publication bias.
CONCLUSIONS
The recently published guidelines on EHIT from the Society for Vascular Surgery/American Venous Forum provide a framework to direct clinical decision-making. EHIT and other thrombotic complications occur infrequently and have a benign course.
Topics: Ablation Techniques; Humans; Incidence; Pulmonary Embolism; Saphenous Vein; Venous Thrombosis
PubMed: 33618065
DOI: 10.1016/j.jvsv.2021.02.006 -
Journal of Vascular Surgery. Venous and... Mar 2024The aim of this study was to determine the association between the duration of systemic anticoagulation therapy (ACT) and the risk of further venous thromboembolism... (Meta-Analysis)
Meta-Analysis Review
A systematic review and meta-analysis for the association between duration of anticoagulation therapy and the risk of venous thromboembolism in patients with lower limb superficial venous thrombosis.
OBJECTIVE
The aim of this study was to determine the association between the duration of systemic anticoagulation therapy (ACT) and the risk of further venous thromboembolism (VTE) in patients with superficial venous thrombosis (SVT).
METHODS
A systematic review and meta-analysis were performed using searches of Medline and Cochrane Library databases in September 2023. Papers that provided VTE incidence within mid-term follow-up of ≥45 days in patients who received any ACT were included. Patients were categorized into subgroups according to the course of treatment: (1) no ACT (0 days); (2) ACT of ≤14 days; (3) ACT of 15 to 30 days; (4) ACT of 31 to 45 days; and (5) ACT of >45 days. Reported events were transformed to events per 100 patient-years, and a random-effects model was used to calculate pooled rates for proportions. The primary outcome (VTE) was a combination of SVT progression or recurrence with the occurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE). Secondary outcomes included major and clinically relevant non-major or minor bleeding.
RESULTS
Twenty-four studies (10 randomized controlled trials and 14 cohort studies) combining outcomes in 12,341 patients were included in the quantitative synthesis. Minimum VTE and SVT recurrence or progression rates were observed with the ACT duration of 31 to 45 days of 16.2 (95% confidence interval [CI], 10.4-23.3) and 8.2 (95% CI, 3.1-15.8) events per 100 patient-years, respectively. Minimum DVT and PE rates observed with the treatment duration of 15 to 30 days were 5.5 (95% CI, 2.8-9.1) and 0.9 (95% CI, 0.5-1.3) events per 100 patient-years, respectively. Short-term treatment of ≤14 days was associated with the highest rates of VTE of 59.7 (95% CI, 37.7-86.4), DVT of 13.7 (95% CI, 9.6-18.4), and PE of 3.1 (95% CI, 1.4-5.6) events per 100 patient-years. Major bleeding rates were unrelated to the duration of ACT and did not exceed 0.5 events per 100 patient-years. The highest rate of clinically relevant non-major or minor bleeding was observed with ACT duration of 31 to 45 days of 14.2 (95% CI, 5.5-26.8) events per 100 patient-years. The most common risk factors for VTE included male sex, cancer, personal history of DVT, PE, or SVT, and thrombosis of non-varicose veins.
CONCLUSIONS
Prolonged systemic anticoagulation is associated with the tendency to decrease VTE rates in patients with lower limb SVT.
Topics: Humans; Male; Venous Thromboembolism; Anticoagulants; Venous Thrombosis; Pulmonary Embolism; Lower Extremity; Hemorrhage; Randomized Controlled Trials as Topic
PubMed: 38008180
DOI: 10.1016/j.jvsv.2023.101726 -
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 -
Systematic review and meta-analysis of exercise therapy for venous leg ulcer healing and recurrence.Journal of Vascular Surgery. Venous and... Jan 2023National guidelines in the United Kingdom have recommended regular exercise for individuals with venous leg ulceration. However, data on the effects of exercise on ulcer... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
National guidelines in the United Kingdom have recommended regular exercise for individuals with venous leg ulceration. However, data on the effects of exercise on ulcer healing and recurrence are sparse. In the present study, we aimed to quantify the evidence for exercise regarding venous ulcer healing with respect to the primary outcomes of the proportion of healed ulcers and rate of ulcer recurrence. The secondary outcomes were improvement in ulcer symptoms, ulcer healing time, quality of life, compliance, and adverse events reported.
METHODS
The review followed PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines using a registered protocol (CRD42021220925). The MEDLINE and Embase databases and Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, European Union Clinical Trials, and International Standard Randomised Controlled Trial Number registries were searched up to April 6, 2022 and included studies comparing exercise therapy and compression vs compression alone. Data for the proportion of healed ulcers were pooled using a fixed effects meta-analysis.
RESULTS
After screening 1046 reports, 7 were included, with 121 participants allocated to exercise therapy and 125 to compression alone. All the reports were of randomized controlled trials and had reported ulcer healing at 12 weeks, with a pooled relative risk of ulcer healing of 1.38 for exercise vs compression (95% confidence interval, 1.11-1.71). Only one study had reported on recurrence; thus, data pooling was not performed. No differences between exercise and usual care were demonstrated. Compliance with exercise ranged from 33% to 81%. The included studies demonstrated low enrollment and a high risk of bias. Also, most of the trials had failed to demonstrate any differences in activity completed between the intervention and control arms.
CONCLUSIONS
A paucity of studies has examined leg ulcer recurrence after exercise programs, with no evidence to show that exercise is beneficial. Furthermore, the quality of evidence supporting exercise as an adjunct to ulcer healing is very low, and the trials demonstrated serious methodologic flaws, chiefly in recording the activity undertaken by the participants in the intervention arm. Future randomized controlled trials should implement activity monitoring and standardize the reporting of key patient, ulcer, and reflux characteristics to enable future meaningful meta-analyses to determine the role of exercise as an adjunct to venous leg ulceration healing.
Topics: Humans; Varicose Ulcer; Ulcer; Quality of Life; Wound Healing; Exercise Therapy
PubMed: 36202303
DOI: 10.1016/j.jvsv.2022.09.003 -
International Journal of Pediatric... Dec 2023Internal jugular vein phlebectasia (IJVP) is a rare type of vascular abnormality that causes dilatation of internal jugular vein in the neck. There is presently no... (Review)
Review
OBJECTIVES
Internal jugular vein phlebectasia (IJVP) is a rare type of vascular abnormality that causes dilatation of internal jugular vein in the neck. There is presently no consensus on the most effective method of treatment for this condition, that is commonly seen in children. We conducted a systematic review of the literature reported till date to comprehend the key features of IJVP and its most effective therapeutic modalities.
METHODS
Five databases were searched until October 10, 2022 for articles of any design (including case reports) reporting IJVP in pediatric subjects. Individual patient data on demographics, clinical features of this entity and the differential diagnosis, methods of imaging, management, and outcome of illness were recorded. The quality assessment was performed using the Joanna Briggs Institute's Critical Appraisal Checklist for studies.
RESULTS
A total of 51 articles including 169 cases were retrieved and included in the analysis. Of the 169 patients, most of them were male children, and in 77% of cases right internal Juglar vein was involved. All patients had some symptoms suggestive of IJVP with most common ones being neck swelling or tenderness, and difficulty in breathing. In 90% of cases, it was observed that the neck swelling typically increases in size with Valsalva maneuver. Once jugular vein phlebectasia was clinically suspected, ultrasonography, CECT, or color Doppler flow imaging were used to confirm the diagnosis. The management of most of the cases was either conservative or surgical, and in surgery mostly ligation was performed. There have not been any cases of serious complications, therefore, according to included studies, a conservative approach is recommended with continuous monitoring. Out of the 51 studies included, most of them had low risk of bias.
CONCLUSION
Internal jugular vein phlebectasia, a rare benign condition, is most commonly found in children, and affects predominantly the right internal jugular vein. Although most patients did well with merely conservative treatment, still management of this vascular anomaly has to be on a case-by-case basis.
Topics: Child; Humans; Male; Female; Jugular Veins; Varicose Veins; Dilatation, Pathologic; Conservative Treatment; Brachiocephalic Veins; Heart Diseases
PubMed: 37871464
DOI: 10.1016/j.ijporl.2023.111720 -
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 -
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