-
Wound Repair and Regeneration :... Sep 2019Use of complementary and alternative medicine for wound healing is influencing mainstream medical practice. This systematic review evaluates the role of Calendula...
Use of complementary and alternative medicine for wound healing is influencing mainstream medical practice. This systematic review evaluates the role of Calendula officinalis flower extract as monotherapy compared to control for wound healing in vivo. Searches were conducted in PubMed, EMBASE, Cochrane Central Register of Controlled Trials, CINAHL, and Scopus (up to April 2018) with 14 studies meeting the inclusion criteria, comprising 7 animal experiments and 7 clinical trials. Findings from the review on acute wound healing showed faster resolution of the inflammation phase with increased production of granulation tissue in the test groups treated with extract. These findings were consistent in five animal studies and one randomized clinical trial. Chronic wound healing studies were varied. Two clinical control studies on venous ulcers demonstrated decreased ulcer surface area compared to controls. Another randomized clinical trial demonstrated no improvement for the calendula group in diabetic leg ulcer healing. Burn healing similarly showed mixed results. Two animal studies demonstrated a prophylactic effect for the administration of calendula extract prior to burn injury. A randomized clinical trial of patients suffering from partial to full thickness burns demonstrated no benefit for topical application of calendula extract compared to controls. Two randomized clinical trials assessed the potential for extract to prevent acute post radiation dermatitis, with one study showing improvements compared to trolamine, while the other found no improvement compared to aqua gel cream. Animal studies provide moderate evidence for improved recovery from the inflammation phase and increased production of granulation tissue in calendula extract treatment groups. This review identified some evidence for the beneficial effects of C. officinalis extract for wound healing, consistent with its role in traditional medicine. There is a need for larger, well-designed randomized control trials to assess the effect of calendula on wound healing including complications.
Topics: Administration, Topical; Animals; Calendula; Clinical Trials as Topic; Granulation Tissue; Humans; Models, Animal; Ointments; Phytotherapy; Plant Extracts; Treatment Outcome; Varicose Ulcer; Wound Healing
PubMed: 31145533
DOI: 10.1111/wrr.12737 -
International Wound Journal Nov 2023Venous leg ulcers (VLU) represent a major public health challenge. Little is known about the prevalence and incidence of VLU internationally. Published studies are... (Meta-Analysis)
Meta-Analysis Review
Venous leg ulcers (VLU) represent a major public health challenge. Little is known about the prevalence and incidence of VLU internationally. Published studies are usually reporting different estimates because of disparities in study designs and measurement methods. Therefore, we conducted a systematic literature review and meta-analysis to identify the prevalence and incidence of VLU internationally and to characterise the population as reported in these studies. Studies were identified from searches in Medline (PubMed), CINAHL Complete (EBSCOhost), Embase, Scopus, Web of Science, LiSSa (Littérature Scientifique en Santé), Google Scholar and Cochrane Database of Systematic Reviews up to November 2022. Studies were included if their primary outcomes were reported as a period prevalence or point prevalence or cumulative incidence or incidence VLU rate. Fourteen studies met the inclusion criteria, 10 reporting estimates of prevalence, three reporting both prevalence and incidence estimates and one incidence. All were included in meta-analyses. The results show a pooled prevalence of 0.32% and a pooled incidence of 0.17%. Our results highlighted an extreme heterogeneity across effect sizes for both prevalence and incidence, which prevent a meaningful interpretation of pooled indexes and argue for further studies with specific prevalence-type reported and target population under study.
Topics: Humans; Prevalence; Incidence; Varicose Ulcer
PubMed: 37293810
DOI: 10.1111/iwj.14272 -
The Cochrane Database of Systematic... Jan 2021Standard treatment for deep vein thrombosis (DVT) aims to reduce immediate complications. Use of thrombolytic clot removal strategies (i.e. thrombolysis (clot dissolving... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Standard treatment for deep vein thrombosis (DVT) aims to reduce immediate complications. Use of thrombolytic clot removal strategies (i.e. thrombolysis (clot dissolving drugs), with or without additional endovascular techniques), could reduce the long-term complications of post-thrombotic syndrome (PTS) including pain, swelling, skin discolouration, or venous ulceration in the affected leg. This is the fourth update of a Cochrane Review first published in 2004.
OBJECTIVES
To assess the effects of thrombolytic clot removal strategies and anticoagulation compared to anticoagulation alone for the management of people with acute deep vein thrombosis (DVT) of the lower limb.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries to 21 April 2020. We also checked the references of relevant articles to identify additional studies.
SELECTION CRITERIA
We considered randomised controlled trials (RCTs) examining thrombolysis (with or without adjunctive clot removal strategies) and anticoagulation versus anticoagulation alone for acute DVT.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures as recommended by Cochrane. We assessed the risk of bias in included trials with the Cochrane 'Risk of bias' tool. Certainty of the evidence was evaluated using GRADE. For dichotomous outcomes, we calculated the risk ratio (RR) with the corresponding 95% confidence interval (CI). We pooled data using a fixed-effect model, unless we identified heterogeneity, in which case we used a random-effects model. The primary outcomes of interest were clot lysis, bleeding and post thrombotic syndrome.
MAIN RESULTS
Two new studies were added for this update. Therefore, the review now includes a total of 19 RCTs, with 1943 participants. These studies differed with respect to the thrombolytic agent, the doses of the agent and the techniques used to deliver the agent. Systemic, loco-regional and catheter-directed thrombolysis (CDT) strategies were all included. For this update, CDT interventions also included those involving pharmacomechanical thrombolysis. Three of the 19 included studies reported one or more domain at high risk of bias. We combined the results as any (all) thrombolysis interventions compared to standard anticoagulation. Complete clot lysis occurred more frequently in the thrombolysis group at early follow-up (RR 4.75; 95% CI 1.83 to 12.33; 592 participants; eight studies) and at intermediate follow-up (RR 2.42; 95% CI 1.42 to 4.12; 654 participants; seven studies; moderate-certainty evidence). Two studies reported on clot lysis at late follow-up with no clear benefit from thrombolysis seen at this time point (RR 3.25, 95% CI 0.17 to 62.63; two studies). No differences between strategies (e.g. systemic, loco-regional and CDT) were detected by subgroup analysis at any of these time points (tests for subgroup differences: P = 0.41, P = 0.37 and P = 0.06 respectively). Those receiving thrombolysis had increased bleeding complications (6.7% versus 2.2%) (RR 2.45, 95% CI 1.58 to 3.78; 1943 participants, 19 studies; moderate-certainty evidence). No differences between strategies were detected by subgroup analysis (P = 0.25). Up to five years after treatment, slightly fewer cases of PTS occurred in those receiving thrombolysis; 50% compared with 53% in the standard anticoagulation (RR 0.78, 95% CI 0.66 to 0.93; 1393 participants, six studies; moderate-certainty evidence). This was still observed at late follow-up (beyond five years) in two studies (RR 0.56, 95% CI 0.43 to 0.73; 211 participants; moderate-certainty evidence). We used subgroup analysis to investigate if the level of DVT (iliofemoral, femoropopliteal or non-specified) had an effect on the incidence of PTS. No benefit of thrombolysis was seen for either iliofemoral or femoropopliteal DVT (six studies; test for subgroup differences: P = 0.29). Systemic thrombolysis and CDT had similar levels of effectiveness. Studies of CDT included four trials in femoral and iliofemoral DVT, and results from these are consistent with those from trials of systemic thrombolysis in DVT at other levels of occlusion.
AUTHORS' CONCLUSIONS
Complete clot lysis occurred more frequently after thrombolysis (with or without additional clot removal strategies) and PTS incidence was slightly reduced. Bleeding complications also increased with thrombolysis, but this risk has decreased over time with the use of stricter exclusion criteria of studies. Evidence suggests that systemic administration of thrombolytics and CDT have similar effectiveness. Using GRADE, we judged the evidence to be of moderate-certainty, due to many trials having small numbers of participants or events, or both. Future studies are needed to investigate treatment regimes in terms of agent, dose and adjunctive clot removal methods; prioritising patient-important outcomes, including PTS and quality of life, to aid clinical decision making.
Topics: Acute Disease; Anticoagulants; Hemorrhage; Humans; Lower Extremity; Postthrombotic Syndrome; Randomized Controlled Trials as Topic; Thrombolytic Therapy; Time Factors; Treatment Outcome; Varicose Ulcer; Venous Thrombosis
PubMed: 33464575
DOI: 10.1002/14651858.CD002783.pub5 -
International Angiology : a Journal of... Aug 2022Venous thromboembolism (VTE) is a possible complication after varicose vein surgery, reported after both open and endovascular interventions. Nonetheless, there are no...
INTRODUCTION
Venous thromboembolism (VTE) is a possible complication after varicose vein surgery, reported after both open and endovascular interventions. Nonetheless, there are no internationally accepted recommendations regarding postoperative VTE prevention strategies, with some authors advocating for its use, while others recommend against it. This study aims to systematically review current evidence on the efficacy and safety of chemothromboprophylactic strategies after varicose vein surgery.
EVIDENCE ACQUISITION
A literature search was performed on the MEDLINE, Scopus, SciELO and Web of Science databases, which returned 532 studies. Ten studies were included. Data were extracted using piloted forms.
EVIDENCE SYNTHESIS
A total of 6929 patients were included for analysis, out of which 70.4% were treated by open surgery (N.=4878) and 29.6% by endovenous procedures (N.=2051; 79.1% EVLA; 20.9% RFA). VTE chemothromboprophylaxis was performed in 76.3% of the patients (N.=5284), from which 62.5% were treated by open surgery (N.=3301) and 37.5% by endovenous interventions (N.=1983). Among those treated by open surgery, reported deep venous thrombosis (DVT) rates ranged between 0-6.25%, while pulmonary embolism (PE) was reported in 0-0.07% of the cases. Regarding endovenous interventions, EHIT and DVT rates ranged between 0-2.5% and 0-0.9%, respectively, with no cases of PE described. The remaining 23.7% of the patients did not underwent VTE chemothromboprophylaxis (N.=1645), with DVT and PE rates after open surgery ranging between 0-5.17% and 0-1.48%, respectively. Only one study reported thrombotic complications after endovenous interventions in this subgroup of patients, with postoperative EHIT rates of 7.3%, and no information regarding PE or DVT. Bleeding complications were higher in patients undergoing chemothromboprophylaxis (0-10.2%) when compared to those who did not (0-0.18%), and were more frequent after endovenous interventions (0-10.2% versus 0-0.75% after open surgery).
CONCLUSIONS
VTE is a possible complication after both open and endovascular varicose vein procedures, although overall VTE complications occur less frequently after endovascular interventions. There's a clear heterogeneity regarding peri and postoperative chemoprophylaxis regimens used. Further studies are required to stratify risk factors and indications for chemothromboprophylaxis after varicose vein surgery.
Topics: Endovascular Procedures; Humans; Pulmonary Embolism; Risk Factors; Varicose Veins; Venous Thromboembolism
PubMed: 35583457
DOI: 10.23736/S0392-9590.22.04908-2 -
Journal of Vascular Surgery. Venous and... Jul 2023Cyanoacrylate glue closure was first used in humans 10 years ago to treat venous reflux of the axial veins. Studies have since shown its clinical efficacy in vein... (Review)
Review
OBJECTIVE
Cyanoacrylate glue closure was first used in humans 10 years ago to treat venous reflux of the axial veins. Studies have since shown its clinical efficacy in vein closure. However, great need exists to elucidate further the types of specific adverse reactions that cyanoacrylate glue can cause for better patient selection and to minimize these events. In the present study, we systematically reviewed the literature to identify the types of reported reactions. In addition, we explored the pathophysiology contributing to these reactions and proposed the mechanistic pathway with inclusion of actual cases.
METHODS
We searched the literature for reports of reactions following cyanoacrylate glue use in patients with venous diseases between 2012 and 2022. The search was performed using MeSH (medical subject headings) terms. The terms included cyanoacrylate, venous insufficiency, chronic venous disorder, varicose veins, vein varicosities, venous ulcer, venous wound, CEAP (clinical, etiologic, anatomic, pathophysiologic), vein, adverse events, phlebitis, hypersensitivity, foreign body granuloma, giant cell, endovenous glue-induced thrombosis, and allergy. The search was limited to the literature reported in English. These studies were evaluated for the type of product used and the reactions noted. A systematic review, in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) method, was performed. Covidence software (Melbourne, VC, Australia) was used for full-text screening and data extraction. Two reviewers reviewed the data, and the content expert served as the tiebreaker.
RESULTS
We identified 102, of which, 37 reported on cyanoacrylate use other than in the context of chronic venous diseases and were excluded. Fifty-five reports were determined appropriate for data extraction. The adverse reactions to cyanoacrylate glue were phlebitis, hypersensitivity, foreign body granuloma, and endovenous glue-induced thrombosis.
CONCLUSIONS
Although cyanoacrylate glue closure for venous reflux is generally a safe and clinically effective treatment choice for patients with symptomatic chronic venous disease and axial reflux, some adverse events could be specific to the properties of the cyanoacrylate product. We propose mechanisms for how such reactions can occur based on histologic changes, published reports, and case examples; however, further exploration is necessary to confirm these theories.
Topics: Humans; Cyanoacrylates; Granuloma, Foreign-Body; Saphenous Vein; Varicose Veins; Venous Insufficiency; Treatment Outcome; Phlebitis; Hypersensitivity
PubMed: 37054883
DOI: 10.1016/j.jvsv.2023.03.018 -
Journal of Endovascular Therapy : An... Feb 2016To investigate and compare the anatomical success rates and complications of the treatment modalities for small saphenous vein (SSV) incompetence. (Meta-Analysis)
Meta-Analysis Review
PURPOSE
To investigate and compare the anatomical success rates and complications of the treatment modalities for small saphenous vein (SSV) incompetence.
METHODS
A systematic literature search was performed in PubMed, EMBASE, and the Cochrane Library on the following therapies for incompetence of SSVs: surgery, endovenous laser ablation (EVLA), radiofrequency ablation (RFA), ultrasound-guided foam sclerotherapy (UGFS), steam ablation, and mechanochemical endovenous ablation (MOCA). The search found 49 articles (5 randomized controlled trials, 44 cohort studies) reporting on the different treatment modalities: surgery (n=9), EVLA (n=28), RFA (n=9), UGFS (n=6), and MOCA (n=1). A random-effects model was used to estimate the primary outcome of anatomical success, which was defined as closure of the treated vein on follow-up duplex ultrasound imaging. The estimate is reported with the 95% confidence interval (CI). Secondary outcomes were technical success and major complications [paresthesia and deep vein thrombosis (DVT)], given as the weighted means.
RESULTS
The pooled anatomical success rate was 58.0% (95% CI 40.9% to 75.0%) for surgery in 798 SSVs, 98.5% (95% CI 97.7% to 99.2%) for EVLA in 2950 SSVs, 97.1% (95% CI 94.3% to 99.9%) for RFA in 386 SSVs, and 63.6% (95% CI 47.1% to 80.1%) for UGFS in 494 SSVs. One study reported results of MOCA, with an anatomical success rate of 94%. Neurologic complications were most frequently reported after surgery (mean 19.6%) and thermal ablation (EVLA: mean 4.8%; RFA: mean 9.7%). Deep venous thrombosis was a rare complication (0% to 1.2%).
CONCLUSION
Endovenous thermal ablation (EVLA/RFA) should be preferred to surgery and foam sclerotherapy in the treatment of SSV incompetence. Although data on nonthermal techniques in SSV are still sparse, the potential benefits, especially the reduced risk of nerve injury, might be of considerable clinical importance.
Topics: Catheter Ablation; Humans; Laser Therapy; Patient Selection; Postoperative Complications; Predictive Value of Tests; Risk Assessment; Risk Factors; Saphenous Vein; Sclerotherapy; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Ultrasonography, Interventional; Venous Insufficiency
PubMed: 26564912
DOI: 10.1177/1526602815616375 -
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 -
Journal of Vascular Surgery. Venous and... Oct 2016The association between pregnancy and the development of varicose veins is uncertain. We aimed to determine whether a history of pregnancy is associated with the... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The association between pregnancy and the development of varicose veins is uncertain. We aimed to determine whether a history of pregnancy is associated with the development of varicose veins.
METHODS
We performed a systematic literature search using the databases of PubMed, Embase, Robert Koch-Institut, and Cochrane Central and the references of included papers. Eligible studies were all epidemiologic observational studies in which the outcome "varicose veins" and pregnancy history were assessed. The quality of each study was evaluated on the basis of the Dutch Cochrane review checklist and by the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement. For our meta-analysis, a random effects model was applied to pool odds ratios and 95% confidence intervals across studies.
RESULTS
We found nine eligible studies enrolling 17,109 women. Pregnancy was associated with a significant risk increase in developing varicose veins. The results of our meta-analysis suggest that the odds for women with a history of pregnancy in developing varicose veins significantly increases by 82% (odds ratio, 1.82; 95% CI, 1.43-2.33) compared with women with no history of pregnancy. As expected for epidemiologic observational studies, the heterogeneity was considerably high (I(2) = 81%).
CONCLUSIONS
Our meta-analysis strongly supports the hypothesis that there is a significant and strong association between a history of pregnancy and varicose veins. However, qualitative and quantitative differences among studies were evident and were also reflected in a considerably high heterogeneity.
Topics: Female; Humans; Observational Studies as Topic; Odds Ratio; Pregnancy; Pregnancy Complications; Risk Factors; Varicose Veins
PubMed: 27639009
DOI: 10.1016/j.jvsv.2016.06.003 -
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