Sclerotherapy of lower limb veins: Indications, contraindications and treatment strategies to prevent complications - A consensus document of the International Union of Phlebology-2023.

BACKGROUND: Sclerotherapy is a non-invasive procedure commonly used to treat superficial venous disease, vascular malformations and other ectatic vascular lesions. While extremely rare, sclerotherapy may be complicated by serious adverse events. OBJECTIVES: To categorise contraindications to sclerotherapy based on the available scientific evidence. METHODS: An international, multi-disciplinary panel of phlebologists reviewed the available scientific evidence and developed consensus where evidence was lacking or limited. RESULTS: Absolute Contraindications to sclerotherapy where the risk of harm would outweigh any benefits include known hypersensitivity to sclerosing agents; acute venous thromboembolism (VTE); severe neurological or cardiac adverse events complicating a previous sclerotherapy treatment; severe acute systemic illness or infection; and critical limb ischaemia. Relative Contraindications to sclerotherapy where the potential benefits of the proposed treatment would outweigh the risk of harm or the risks may be mitigated by other measures include pregnancy, postpartum and breastfeeding; hypercoagulable states with risk of VTE; risk of neurological adverse events; risk of cardiac adverse events and poorly controlled chronic systemic illness. Conditions and circumstances where Warnings and Precautions should be considered before proceeding with sclerotherapy include risk of cutaneous necrosis or cosmetic complications such as pigmentation and telangiectatic matting; intake of medications such as the oral contraceptive and other exogenous oestrogens, disulfiram and minocycline; and psychosocial factors and psychiatric comorbidities that may increase the risk of adverse events or compromise optimal treatment outcomes. CONCLUSIONS: Sclerotherapy can achieve safe clinical outcomes provided that (1) patient-related risk factors and in particular all material risks are (1a) adequately identified and the risk benefit ratio is clearly and openly discussed with treatment candidates within a reasonable timeframe prior to the actual procedure; (1b) when an individual is not a suitable candidate for the proposed intervention, conservative treatment options including the option of 'no intervention as a treatment option' are discussed; (1c) complex cases are referred for treatment in controlled and standardised settings and by practitioners with more expertise in the field; (1d) only suitable individuals with no absolute contraindications or those with relative contraindications where the benefits outweigh the risks are offered intervention; (1e) if proceeding with intervention, appropriate prophylactic measures and other risk-mitigating strategies are adopted and appropriate follow-up is organised; and (2) procedure-related risk factors are minimised by ensuring the treating physicians (2a) have adequate training in general phlebology with additional training in duplex ultrasound, procedural phlebology and in particular sclerotherapy; (2b) maintain their knowledge and competency over time and (2c) review and optimise their treatment strategies and techniques on a regular basis to keep up with the ongoing progress in medical technology and contemporary scientific evidence.

Clinical Perspectives and Management of Edema in Chronic Venous Disease-What about Ruscus?

Background: Edema is highly prevalent in patients with cardiovascular disease and is associated with various underlying pathologic conditions, making it challenging for physicians to diagnose and manage. Methods: We report on presentations from a virtual symposium at the Annual Meeting of the European Venous Forum (25 June 2021), which examined edema classification within clinical practice, provided guidance on making differential diagnoses and reviewed evidence for the use of the treatment combination of Ruscus extract, hesperidin methyl chalcone and vitamin C. Results: The understanding of the pathophysiologic mechanisms underlying fluid build-up in chronic venous disease (CVD) is limited. Despite amendments to the classic Starling Principle, discrepancies exist between the theories proposed and real-world evidence. Given the varied disease presentations seen in edema patients, thorough clinical examinations are recommended in order to make a differential diagnosis. The recent CEAP classification update states that edema should be considered a sign of CVD. The combination of Ruscus extract, hesperidin methyl chalcone and vitamin C improves venous tone and lymph contractility and reduces macromolecule permeability and inflammation. Conclusions: Data from randomized controlled trials support guideline recommendations for the use of Ruscus extract, hesperidin methyl chalcone and vitamin C to relieve major CVD-related symptoms and edema.

Sclerotherapy is a safe method of treatment of chronic venous disorders in older patients: A prospective and comparative study of consecutive patients.

Objectives An aging population requires evaluation of methods of treatment for older patients. Our objective was to evaluate the indications, practical modalities, safety and tolerability of sclerotherapy in patients 75 years of age and older (group 1) and compare with a control group of patients 18 to74 years of age (group 2). Method This observational, multicentre, prospective and comparative study was conducted by the French Society of Phlebology. Each centre collected in 10 to 20 patients ≥75 years of age and an equal number of patients <75 years of age treated by sclerotherapy, the treatment indication, the patient's personal history, the CEAP clinical class, the type of the veins being treated, the characteristics of sclerotherapy and the complications (immediately after treatment and at one-month follow-up). Results Population: In total, 418 patients were enrolled in 15 centres: 176 patients in group 1 (mean: 79.4 years) and 242 patients in group 2 (mean: 52.7 years).CEAP clinical classes C4, C5 and C6, history of deep vein thrombosis (12.5%) and superficial vein thrombosis (11.9%), long-term anticoagulant therapy (9.1%) and antiplatelet therapy (16.5%) were more frequent in older patients.All types of veins were treated from saphenous veins to telangiectasias. Sclerotherapy features: There was no difference in concentration of the sclerosing agents. When foam sclerotherapy was used (84% of patients), the injected volume was lower in group 1. COMPLICATIONS: One vasovagal syncope occurred in group 1. One asymptomatic distal deep vein thrombosis, confined to the Medial Gastrocnemius Veins, was reported in both groups at one-month follow-up. Conclusions This study shows the feasibility and safety of sclerotherapy in older patients, with no specific complications nor need for special precautions.

Endovenous chemical (and physical) treatments for varices: what's new?

The constant evolution of endo-venous ablative techniques for varicose veins arises from the need for: better patient's comfort, reduced incidence of side effects, better results at short-, mid- and long-term follow-up, as well as reduction of operating time and technical simplicity. All these goals have been aimed at but so far no new technology has been able to achieve them all or to demonstrate it, furthermore the increase of price must be compensated by a considerable improvement of results and a serious reduction of side effects to be incrementally cost effective. We present in this article several recent evolutions of sclerotherapy (chemical ablation). New technologies include: proprietary ready-made foam (Varithena®) foam sclerotherapy with catheter and tumescence, foam + Holmium laser (LAFOS®), liquid sclerosant with rotating wire (clarivein®), liquid sclerosant + endo-venous clip (V-Block®) and endovenous cyano-acrylate glue (Venaseal™).

Complications of sclerotherapy: an update.

OBJECTIVES: To describe, determine the incidence of, and explain the adverse reactions associated with the use of sclerotherapy and sclerosing agents. MATERIAL AND METHODS: Review of current literature and personal research, with special attention to the French registry of 12,173 sclerotherapy sessions. RESULTS: The nature and incidence of side effects of sclerosing agents vary according to the injection form: liquid or foam. They must be differentiated from complications of the method, which are less specific and often related to an inappropriate technique. Severe adverse events are rare, especially in relation to the billions of injections administered. CONCLUSION: Complications and side effects of sclerotherapy are uncommon; the method has demonstrated its safety, with 0.22% of complications per session with liquid sclerosant and 0.58% with foamed sclerosant, but several points remain unclear, and more research is needed. Patient's informed consent can be better obtained thanks to the current knowledge herein summarized.

The French polidocanol study on long-term side effects: a survey covering 3,357 patient years.

BACKGROUND: AIMS Short- and mid-term side effects of sclerotherapy, in particular with polidocanol (lauromacrogol 400), have been previously described in our registry of 12,173 sessions. The objective of this follow-up registry was to evaluate the long-term incidence of adverse events with polidocanol. METHODS: The physicians involved in the initial French registry were contacted and asked to partake in the follow-up survey. Initially included patients were controlled at the latest possible date to determine whether a complication had occurred after the end of the initial survey. RESULTS: Data on 1,605 patients included in the French registry were reviewed with a maximum follow-up of 60 months, covering 3,357 patient years. Five (0.4%) adverse events were observed in patients treated with liquid polidocanol and 46 (1.1%) in patients treated with polidocanol foam. The most frequent side effects were visual disturbances (n=14), and the most severe were muscular vein thrombosis (n=8). The onset of side effects was mostly observed directly after sclerotherapy or in the 6 months after (84% in the first year). One deep vein thrombosis recurrence occurred in a patient with heterozygote Factor V Leiden after stopping anticoagulant treatment (foam sclerotherapy). CONCLUSIONS: Foam sclerotherapy is a recognized reference method in the treatment of varicose veins of all types. This study demonstrates that polidocanol is a safe sclerosing agent in the short and long term.

Correlations between ankle circumference, symptoms, and quality of life demonstrate the clinical relevance of minimal leg swelling reduction: results of a study in 1,036 Argentinean patients.

BACKGROUND: Clinical classification (C) of patients suffering from chronic venous disorders according to the Clinical, Etiology, Anatomy, and Pathophysiology Classification takes into account signs and symptoms, but the C3 (venous edema) class has been identified as poorly specific. Patients in whom physicians fail to observe significant edema (sign) frequently report a feeling of swelling (symptom). Previous studies of venoactive drugs have demonstrated significant reduction in leg volume, but the correlation with a clinical improvement was lacking. OBJECTIVE: To describe the clinical status of a sample of Argentinean patients presenting with venous symptoms and signs. To demonstrate the relationship between the reduction of leg swelling and the improvement of symptoms of chronic venous disorders (CVDs) and quality of life (QoL) in patients with CVD. MATERIALS AND METHODS: One thousand thirty-six patients were included prospectively and submitted to medical interrogation and examination and specific and generic self-questionnaires. Patients included were reassessed using the same tools after phlebotropic treatment (Ruscus+hesperidin+ascorbic acid), the prescription of which was expected to induce variations in clinical status. RESULTS: Significant correlations were observed between ankle circumference reduction and improvement of all symptoms in C2 to C3 patients: heaviness, pain, paraesthesia, and cramps. Such correlations were found in C0 to C1 patients. There was a correlation between improvement attained in QoL and the physical dimension of the Chronic Venous Insufficiency Questionnaire. CONCLUSIONS: Our results demonstrate the relevance of moderate ankle swelling, which is not usually described clinically as edema and is probably a typical symptom of chronic venous disorders. Future studies should focus on this insufficiently analyzed clinical feature and put to better use more specific QoL questionnaires.

Great saphenous vein stripping with preservation of sapheno-femoral confluence: hemodynamic and clinical results.

BACKGROUND: Radiofrequency and laser vein treatment, which entail preservation of the saphenous confluence, have called into question the dogma of ligation of all tributaries at the sapheno-femoral confluence (SFC), so called "crossectomy". Nevertheless, crossectomy is still done when saphenous vein stripping is chosen for varicose vein treatment. The purpose of this study was to evaluate results after stripping procedures in which the SFC was preserved. METHODS: This was a retrospective cohort study for which limbs treated for varicose veins by surgical stripping of the great saphenous vein and preservation of the SFC were studied. All limbs had a preoperative duplex examination and showed SFC and truncal incompetence of the great saphenous vein. Periodic postoperative standing duplex ultrasound and clinical examinations were carried out, and results were recorded and analyzed retrospectively. RESULTS: A total of 195 lower limbs were operated on in 151 patients (128 women and 25 men) aged from 22 to 88 years (mean age 56.8). The preoperative diameter of the SFC ranged from 4.7 to 17 mm (mean 9.5 mm). The preoperative CEAP class distribution was C1 1.5%, C2 82.1%, C3 6.7%, and C4-C6 9.7%. Preoperative symptoms were present in 61.8% of cases. Postoperative thrombosis of the SFC was observed in one case with an extension to the deep femoral vein and pulmonary embolization at 1 month. Recovery was complete. At a mean of 24.4 months postoperatively (median 27.3 months, range 8 to 34.8), persistent SFC reflux was observed in only two cases (1.8%) and a SFC neovascularization in one case (0.9%). Recurrence of varicose veins appeared in seven cases (6.3%) but in conjunction with SFC reflux in only one case. Post treatment 83.9% of limbs were converted to CEAP clinical class 0 to 1 and significant symptom improvement was observed in 91.3% of cases with an aesthetic benefit in 95.5%. CONCLUSION: Preservation of the SFC during saphenous stripping gave good results with regard to hemodynamics and neovascularization on the SFC, varicose vein recurrence, improvement of symptoms, and aesthetic appearance for legs with a median follow-up of 27.3 months.

Immediate and midterm complications of sclerotherapy: report of a prospective multicenter registry of 12,173 sclerotherapy sessions.

BACKGROUND: Growing interest in sclerotherapy has emphasized the need for complete knowledge of all aspects of this method. OBJECTIVE: To precisely delineate the actual incidence of immediate and delayed untoward events of daily sclerotherapy. METHODS: A multicenter prospective registry was established in 22 phlebology clinics to report their activity and complications. RESULTS: During the study period, 12,173 sessions of sclerotherapy were carried out, 5,434 with liquid, 6,395 with foam, and 344 using both. Four thousand eighty-eight (33.9%) sessions were carried out with ultrasound guidance. Forty-nine incidents or accidents (0.4%) occurred, of which 12 were with liquid and 37 with foam. These were reported during the time of the study and an additional 1-month follow-up. Most numerous were 20 cases of visual disturbances (in 19 cases, foam or air block was used); all resolved shortly, without any after-effects. A femoral vein thrombosis was the only severe adverse event in this study. CONCLUSIONS: This study demonstrates that sclerotherapy is a safe technique.

Foam sclerotherapy: an overview of use for primary venous insufficiency.

Ultrasound-guided sclerotherapy with foam is able to suppress blood flow in almost all types of varicose veins. The technique is efficient, simple, safe, inexpensive, and easily repeatable, although it requires training and skill. It should be considered as the best primary treatment for most varicose patients. Evaluation of long-term results, with regard to comparison with other techniques, should take into account all advantages and drawbacks and evaluate cost-effectiveness from a life-long point of view.