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Journal of Vascular Surgery. Venous and... Mar 2023The Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society collaborated to update the 2011 Society for Vascular Surgery/American... (Meta-Analysis)
Meta-Analysis
The 2022 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part I. Duplex Scanning and Treatment of Superficial Truncal Reflux: Endorsed by the Society for Vascular...
The Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society collaborated to update the 2011 Society for Vascular Surgery/American Venous Forum clinical practice guidelines and provide new evidence-based recommendations on critical issues affecting the care of patients with varicose veins. Each recommendation is based on a recent, independent systematic review and meta-analysis of the diagnostic tests and treatments options for patients with lower extremity varicose veins. Part I of the guidelines includes evidence-based recommendations for the evaluation of patients with CEAP (Clinical Class, Etiology, Anatomy, Pathology) class 2 varicose vein using duplex ultrasound scanning and other diagnostic tests, open surgical treatment (ligation and stripping) vs endovenous ablation techniques, thermal vs nonthermal ablation of the superficial truncal veins, and management of incompetent perforating veins in CEAP class 2 disease. We have also made recommendations on the concomitant vs staged treatment of varicose tributaries using phlebectomy or liquid or foam sclerotherapy (with physician-compounded foam or commercially prepared polidocanol endovenous microfoam) for patients undergoing ablation of incompetent superficial truncal veins.
Topics: Humans; United States; Venous Insufficiency; Treatment Outcome; Saphenous Vein; Varicose Veins; Sclerotherapy; Vascular Surgical Procedures; Lower Extremity; Cardiology
PubMed: 36326210
DOI: 10.1016/j.jvsv.2022.09.004 -
The Cochrane Database of Systematic... Dec 2021Varicose veins are enlarged and tortuous veins, affecting up to one-third of the world's population. They can be a cause of chronic venous insufficiency, which is... (Review)
Review
BACKGROUND
Varicose veins are enlarged and tortuous veins, affecting up to one-third of the world's population. They can be a cause of chronic venous insufficiency, which is characterised by oedema, pigmentation, eczema, lipodermatosclerosis, atrophie blanche, and healed or active venous ulcers. Injection sclerotherapy (liquid or foam) is widely used for treatment of varicose veins aiming to transform the varicose veins into a fibrous cord. However, there is limited evidence regarding its effectiveness and safety, especially in patients with more severe disease. This is the second update of the review first published in 2002.
OBJECTIVES
To assess the effectiveness and safety of injection sclerotherapy for the treatment of varicose veins.
SEARCH METHODS
For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, AMED, CINAHL, and LILACS databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries, on 20 July 2021.
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) (including cluster-randomised trials and first phase cross-over studies) that used injection sclerotherapy for the treatment of varicose veins.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed, selected and extracted data. Disagreements were cross-checked by a third review author. We used Cochrane's Risk of bias tool to assess the risk of bias. The outcomes of interest were cosmetic appearance, complications, residual varicose veins, quality of life (QoL), persistence of symptoms, and recurrent varicose veins. We calculated risk ratios (RRs) or mean difference (MD) with 95% confidence intervals (CIs). We used the worst-case-scenario for dichotomous data imputation for intention-to-treat analyses. For continuous outcomes, we used the 'last-observation-carried-forward' for data imputation if there was balanced loss to follow-up. We assessed the certainty of the evidence using the GRADE approach.
MAIN RESULTS
We included 23 new RCTs for this update, bringing the total to 28 studies involving 4278 participants. The studies differed in their design, and in which sclerotherapy method, agent or concentration was used. None of the included RCTs compared sclerotherapy to no intervention or to any pharmacological therapy. The certainty of the evidence was downgraded for risk of bias, low number of studies providing information for each outcome, low number of participants, clinical differences between the study participants, and wide CIs. Sclerotherapy versus placebo Foam sclerotherapy may improve cosmetic appearance as measured by IPR-V (independent photography review - visible varicose veins scores) compared to placebo (polidocanol 1%: mean difference (MD) -0.76, 95% CI -0.91 to -0.60; 2 studies, 223 participants; very low-certainty evidence); however, deep vein thrombosis (DVT) rates may be slightly increased in this intervention group (RR 5.10, 95% CI 1.30 to 20.01; 3 studies, 302 participants; very low-certainty evidence). Residual varicose vein rates may be decreased following polidocanol 1% compared to placebo (RR 0.19, 95% CI 0.13 to 0.29; 2 studies, 225 participants; very low-certainty evidence). Following polidocanol 1% use, there may be a possible improvement in QoL as assessed using the VEINES-QOL/Sym questionnaire (MD 12.41, 95% CI 9.56 to 15.26; 3 studies, 299 participants; very low-certainty evidence), and possible improvement in varicose vein symptoms as assessed using the Venous Clinical Severity Score (VCSS) (MD -3.25, 95% CI -3.90 to -2.60; 2 studies, 223 participants; low-certainty evidence). Recurrent varicose veins were not reported for this comparison. Foam sclerotherapy versus foam sclerotherapy with different concentrations Three individual RCTs reported no evidence of a difference in cosmetic appearance after comparing different concentrations of the intervention; data could not be pooled for two of the three studies (RR 1.11, 95% CI 0.84 to 1.47; 1 study, 80 participants; very low-certainty evidence). Similarly, there was no clear difference in rates of thromboembolic complications when comparing one foam concentration with another (RR 1.47, 95% CI 0.41 to 5.33; 3 studies, 371 participants; very low-certainty evidence). Three RCTs investigating higher concentrations of polidocanol foam indicated the rate of residual varicose veins may be slightly decreased in the polidocanol 3% foam group compared to 1% (RR 0.67, 95% CI 0.43 to 1.04; 3 studies, 371 participants; moderate-certainty evidence). No clear improvement in QoL was detected. Two RCTs reported improved VCSS scores with increasing concentrations of foam. Persistence of symptoms were not reported for this comparison. There was no clear difference in recurrent varicose vein rates (RR 0.91, 95% CI 0.62 to 1.32; 1 study, 148 participants; low-certainty evidence). Foam sclerotherapy versus liquid sclerotherapy One RCT reported on cosmetic appearance with no evidence of a difference between foam or liquid sclerotherapy (patient satisfaction scale MD 0.2, 95% CI -0.27 to 0.67; 1 study, 126 participants; very low-certainty evidence). None of the RCTs investigated thromboembolic complications, QoL or persistence of symptoms. Six studies individually showed there may be a benefit to polidocanol 3% foam over liquid sclerotherapy in reducing residual varicose vein rate; pooling data from two studies showed a RR of 0.51, with 95% CI 0.41 to 0.65; 203 participants; very low-certainty evidence. One study reported no clear difference in recurrent varicose vein rates when comparing sodium tetradecyl sulphate (STS) foam or liquid (RR 1.10, 95% CI 0.86 to 1.42; 1 study, 286 participants; very low-certainty evidence). Sclerotherapy versus sclerotherapy with different substances Four RCTs compared sclerotherapy versus sclerotherapy with any other substance. We were unable to combine the data due to heterogeneity or assess the certainty of the evidence due to insufficient data.
AUTHORS' CONCLUSIONS
There is a very low to low-certainty evidence that, compared to placebo, sclerotherapy is an effective and safe treatment for varicose veins concerning cosmetic appearance, residual varicose veins, QoL, and persistence of symptoms. Rates of DVT may be slightly increased and there were no data concerning recurrent varicose veins. There was limited or no evidence for one concentration of foam compared to another; foam compared to liquid sclerotherapy; foam compared to any other substance; or one technique compared to another. There is a need for high-quality trials using standardised sclerosant doses, with clearly defined core outcome sets, and measurement time points to increase the certainty of the evidence.
Topics: Humans; Sclerotherapy; Varicose Ulcer; Varicose Veins; Veins; Venous Insufficiency
PubMed: 34883526
DOI: 10.1002/14651858.CD001732.pub3 -
Cell Stem Cell Sep 2023Life-long reconstitution of a tissue's resident stem cell compartment with engrafted cells has the potential to durably replenish organ function. Here, we demonstrate...
Life-long reconstitution of a tissue's resident stem cell compartment with engrafted cells has the potential to durably replenish organ function. Here, we demonstrate the engraftment of the airway epithelial stem cell compartment via intra-airway transplantation of mouse or human primary and pluripotent stem cell (PSC)-derived airway basal cells (BCs). Murine primary or PSC-derived BCs transplanted into polidocanol-injured syngeneic recipients give rise for at least two years to progeny that stably display the morphologic, molecular, and functional phenotypes of airway epithelia. The engrafted basal-like cells retain extensive self-renewal potential, evident by the capacity to reconstitute the tracheal epithelium through seven generations of secondary transplantation. Using the same approach, human primary or PSC-derived BCs transplanted into NOD scid gamma (NSG) recipient mice similarly display multilineage airway epithelial differentiation in vivo. Our results may provide a step toward potential future syngeneic cell-based therapy for patients with diseases resulting from airway epithelial cell damage or dysfunction.
Topics: Humans; Animals; Mice; Pluripotent Stem Cells; Cell- and Tissue-Based Therapy; Epithelial Cells; Epithelium; Mice, Inbred NOD; Mice, SCID
PubMed: 37625411
DOI: 10.1016/j.stem.2023.07.014 -
Frontiers in Medicine 2022Achalasia is a primary esophageal dysmotility disorder. Despite the high volume of studies addressing the conventional treatments for achalasia, few are debated... (Review)
Review
INTRODUCTION
Achalasia is a primary esophageal dysmotility disorder. Despite the high volume of studies addressing the conventional treatments for achalasia, few are debated regarding the non-conventional treatments, such as cardiectomy, cardioplasty, endoluminal substances injection (ethanolamine oleate, polidocanol, botulinum toxin), stents, and certain drugs (beta-agonists, anticholinergic, nitrates, calcium channel blockers, and phosphodiesterase inhibitors).
METHODS
A critical review was performed.
RESULTS
Endoscopic, surgical, and pharmacological treatments were included. A qualitative synthesis was presented.
CONCLUSION
Non-conventional therapeutic options for treating achalasia encompass medical, endoscopic, and surgical procedures. Clinicians and patients need to know all the tools for the management of achalasia. However, several currently available studies of non-conventional treatments lack high-quality evidence, and future randomized trials are still needed.
PubMed: 35814742
DOI: 10.3389/fmed.2022.941464 -
Orthopadie (Heidelberg, Germany) May 2023The therapy of the lateral epicondylopathy (tennis elbow) includes drug injection into the extensor tendon insertion in chronic cases. The choice of medication and the... (Review)
Review
The therapy of the lateral epicondylopathy (tennis elbow) includes drug injection into the extensor tendon insertion in chronic cases. The choice of medication and the type of injection is decisive for the success of therapy. Furthermore, accurate application is indispensable for therapy success (e.g. peppering injection technique, ultrasound-supported injection technique). Corticosteroid injection is often associated with short-term success, so that other options have found their way into everyday practice. Objectification of treatment success is usually defined by Patient-Reported Outcome Measurements (PROM). With the introduction of Minimal Clinically Important Differences (MCID), statistically significant results are put into perspective in terms of clinical significance. Therapy for lateral epicondylopathy was considered effective if the mean difference in score results between baseline and follow-up exceeded 1.5 points for the Visual Analogue Scale (VAS), 16 points for Disabilities of Arm, Shoulder and Hand Score (DASH), 11 points for Patient-Rated Tennis Elbow Evaluation (PRTEE), and 15 points for Mayo Elbow Performance Score (MEPS). However, the effectiveness must still be critically questioned according to meta-analytical evaluations, in which healing within 12 months was found in 90% of the cases of untreated chronic tennis elbow in the placebo groups. The use of substances, such as Traumeel (Biologische Heilmittel Heel GmbH, Baden-Baden, Germany), hyaluronic acid, botulinum toxin, platelet rich plasma (PRP), autologous blood or polidocanol, are based on various mechanisms. In particular, the use of PRP or autologous blood for the treatment of musculotendinous and degenerative articular pathologies has become popular, although the studies regarding effectiveness are inconsistent. PRP can be divided into leukocyte-rich (LR-PRP) and leukocyte-poor plasma (LP-PRP) according to its preparation. In contrast to LP-PRP, LR-PRP incorporates the middle and intermediate layers, but there is no standardized preparation described in the literature. Conclusive data regarding effective efficacy are still pending.
Topics: Humans; Tennis Elbow; Adrenal Cortex Hormones; Treatment Outcome; Injections; Pain Measurement
PubMed: 37074369
DOI: 10.1007/s00132-023-04371-9 -
Annals of Vascular Surgery Aug 2024This review article provides an updated review of a relatively common pathology with various manifestations. Superficial venous diseases (SVDs) are a broad spectrum of... (Review)
Review
BACKGROUND
This review article provides an updated review of a relatively common pathology with various manifestations. Superficial venous diseases (SVDs) are a broad spectrum of venous vascular disease that predominantly affects the body's lower extremities. The most serious manifestation of this disease includes varicose veins, chronic venous insufficiency, stasis dermatitis, venous ulcers, superficial venous thrombosis, reticular veins, and spider telangiectasias.
METHODS
The anatomy, pathophysiology, and risk factors of SVD were discussed during this review. The risk factors for developing SVD were related to race, age, sex, lifestyle, and certain genetic conditions as well as comorbid deep vein thrombosis. Various classification systems were listed, focusing on the most common one-the revised Clinical-Etiology-Anatomy-Pathophysiology classification. The clinical features including history and physical examination findings elicited in SVD were outlined.
RESULTS
Imaging modalities utilized in SVD were highlighted. Duplex ultrasound is the first line in evaluating SVD but magnetic resonance imaging and computed tomography venography, plethysmography, and conventional venography are feasible options in the event of an ambiguous venous duplex ultrasound study. Treatment options highlighted in this review ranged from conservative treatment with compression stockings, which could be primary or adjunctive to pharmacologic topical and systemic agents such as azelaic acid, diuretics, plant extracts, medical foods, nonsteroidal anti-inflammatory drugs, anticoagulants and skin substitutes for different stages of SVD. Interventional treatment modalities include thermal ablative techniques like radiofrequency ablationss, endovenous laser ablation, endovenous steam ablation, and endovenous microwave ablation as well as nonthermal strategies such as the Varithena (polidocanol microfoam) sclerotherapy, VenaSeal (cyanoacrylate) ablation, and Endovenous mechanochemical ablation. Surgical treatments are also available and include debridement, vein ligation, stripping, and skin grafting.
CONCLUSIONS
SVDs are prevalent and have varied manifestations predominantly in the lower extremities. Several studies highlight the growing clinical and financial burden of these diseases. This review provides an update on the pathophysiology, classification, clinical features, and imaging findings as well as the conservative, pharmacological, and interventional treatment options indicated for different SVD pathologies. It aims to expedite the timely deployment of therapies geared toward reducing the significant morbidity associated with SVD especially varicose veins, venous ulcers, and venous insufficiency, to improve the quality of life of these patients and prevent complications.
Topics: Humans; Risk Factors; Treatment Outcome; Varicose Veins; Venous Insufficiency; Veins; Predictive Value of Tests
PubMed: 38583765
DOI: 10.1016/j.avsg.2024.01.009 -
Dermatologic Surgery : Official... Jan 2022Polidocanol is a safe sclerosing agent with anesthetic properties and minimal skin toxicity. (Clinical Trial)
Clinical Trial
BACKGROUND
Polidocanol is a safe sclerosing agent with anesthetic properties and minimal skin toxicity.
OBJECTIVE
To evaluate the efficacy, safety, and recurrence rates with polidocanol sclerotherapy in the treatment of pyogenic granulomas (PGs).
METHODS AND METHODS
Thirty-nine patients with PG were injected with polidocanol 1% solution. Repeat injections were given weekly in case of incomplete clinical/dermoscopic resolution, until a maximum of 3 sittings. A higher strength (3%) was used for subsequent sessions in those with a minimal response to 1% solution. A final assessment for relapses was performed at 3, 6, and 12 months.
RESULTS
All 39 patients achieved complete resolution (100% clearance rate), with most (n = 26) lesions resolving after the first sitting. Side effects noted were postprocedure pain (22), erythema (2), superficial ulceration (2), paresthesias (1), prominent edema (4), thrombophlebitis (1), cyanotic discoloration (1), purpuric staining around injection site (4), and mild local pruritus (1). The procedure was well tolerated across the age spectrum (4-63 years) included.
CONCLUSION
We report polidocanol to be a highly effective, safe, and cost-effective sclerosant for treatment of PGs with no recurrences or need for special postprocedure care.
Topics: Adolescent; Adult; Child; Child, Preschool; Cost-Benefit Analysis; Drug Costs; Female; Granuloma, Pyogenic; Humans; Injections, Intralesional; Male; Middle Aged; Polidocanol; Recurrence; Sclerosing Solutions; Sclerotherapy; Secondary Prevention; Young Adult
PubMed: 34816819
DOI: 10.1097/DSS.0000000000003308 -
Dermatologic Surgery : Official... Sep 2022Polidocanol is an FDA-approved treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system,... (Review)
Review
BACKGROUND
Polidocanol is an FDA-approved treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system, but numerous other off-label dermatological applications have been reported.
OBJECTIVE
To describe the various off-label dermatological clinical uses of polidocanol, as well as efficacy and adverse effects.
METHODS
The review of studies searchable on PubMed from 2004 to 2021 describing clinical uses of polidocanol to determine efficacy and adverse effects associated with various dermatologic applications.
RESULTS
Polidocanol has shown efficacy in the treatment of mucocele of minor salivary gland, hemangioma, upper extremity veins, reticular veins of the chest, facial veins, pyogenic granuloma, lymphangioma circumscriptum, digital mucous cyst, mixed skin ulcers, cutaneous focal mucinosis, seromas, glomuvenous malformations, acne cysts, lymphocele, and dissecting cellulitis. Commonly reported side effects include pain, erythema, swelling, ecchymosis, and ulceration. Most sources were case reports and small prospective studies, as such the strength of data supporting many uses is limited by small sample sizes and lack of controls.
CONCLUSION
Although polidocanol is currently only FDA approved for incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system, the use of polidocanol has been selected for a variety of off-label clinical applications.
Topics: Humans; Off-Label Use; Polidocanol; Prospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Varicose Veins; Venous Insufficiency
PubMed: 36054050
DOI: 10.1097/DSS.0000000000003520