Contemporary management of incompetence of the small saphenous vein in the light of the recent results of the FOVELASS study.

The FOVELASS study, a randomised multicentre trial published this year by the French Society of Phlebology, confirms the technical superiority of endovenous laser over sclerosing foam in the treatment of small saphenous vein incompetence, over a 3-year follow-up. However, this study also validates the good clinical results of foam, equivalent to those of endovenous laser, already observed in other clinical studies on the great saphenous vein. Thermal ablation has therefore consolidated its leading position in the treatment of saphenous veins but depending on the anatomical configuration of the veins and the economic context, sclerosing foam, which is widely applicable, highly versatile, and cost-effective, may be an interesting alternative.

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.

FOVELASS: A Randomised Trial of Endovenous Laser Ablation Versus Polidocanol Foam for Small Saphenous Vein Incompetence.

OBJECTIVE: To compare the outcomes of ultrasound guided foam sclerotherapy (UGFS) and endovenous laser ablation (EVLA) to treat isolated small saphenous vein (SSV) incompetence in a multicentre randomised controlled study (RCT; ClinicalTrials.gov identifier: NCT05468450). METHODS: Patients aged ≥ 18 years undergoing isolated SSV treatment (reflux > 0.5 seconds) were randomised to UGFS or EVLA. Patients treated with UGFS were allowed one additional truncal treatment at six weeks. Tributary treatments (phlebectomy or sclerotherapy) were permitted after six months. Participants were assessed at eight days, six months, and one, two, and three years. The primary endpoint was the absence of SSV reflux (> 0.5 seconds). Secondary outcomes included clinical scores and quality of life (QoL) scores. All analyses were done by intention to treat. RESULTS: Of 1 522 screened patients, 161 were randomised to UGFS (n = 82) and EVLA (n = 79). Only 3% of patients who received UGFS had the second (allowed) treatment and 86% of patients completed the three year study. Forty-one and 19 tributary treatments (by sclerotherapy) were performed in 27 UGFS patients (33%) and 15 EVLA patients (19%), respectively. The complete absence of reflux at three years was significantly better after EVLA (86%) than after UGFS (56%) (odds ratio [OR] 5.36, 95% confidence interval [CI] 2.31 - 12.44; risk ratio 1.59, 95% CI 1.26 - 2.01). Two deep vein thromboses (DVTs; one femoropopliteal and one gastrocnemius) and one endovenous heat induced thrombosis occurred in the EVLA group. Seven DVTs were seen in the UGFS group, including two partial popliteal DVTs and five gastrocnemius vein thromboses (four asymptomatic and incidental on day 8 screening). At three years, there was no difference between groups for the following: rate of visible varices (p = .87), revised Venous Clinical Severity Score (p = .28), and QoL (p = .59). Patient satisfaction scores were high in both groups (median score: EVLA 97/100 and UGFS 93/100; p = .080). Symptoms were significantly improved in both groups. (p < .001) CONCLUSION: Technical success was better for EVLA than for UGFS three years after SSV treatment. This agrees with studies that have reported on these treatments in the great saphenous vein. However, improvements in clinical outcome were similar for both groups.

Design and evaluation of the psychometric properties of a self-questionnaire on patient adherence to wearing elastic compression stockings.

BACKGROUND: Patients' adherence to elastic compression stockings is difficult to evaluate, and therefore we create a short self-questionnaire and validate its psychometric properties. METHODS: We reduce the questions with Varimed rotation analysis, evaluate its internal consistency using Cronbach's alpha test and its external validity by comparison to electronic thermic captors. Receiver operating characteristic (ROC) analysis was used to determine a threshold and determine its sensitivity and specificity. RESULTS: The initial questionnaire was reduced from 22 to 5 questions rated from 0 to 4. The internal consistency and its external validity are good, and the ROC analysis shows that values > 3 correspond to poor compliance with a sensitivity of 88.1% and a specificity of 63.1%. CONCLUSION: The adherence score is valid for the detection of patients poorly compliant to the wearing of elastic compression. Its small number of questions makes it a suitable for a screening in everyday practice.

Great Saphenous Vein Diameters in Phlebological Practice in France: A Report of the DIAGRAVES Study by the French Society of Phlebology.

OBJECTIVE: The aim was to evaluate the distribution of the diameter of the great saphenous vein (GSV) at mid-thigh level and to investigate its association with clinical class, symptoms, and proximal extent of reflux. METHODS: Vascular physicians, members of the French Society of Phlebology, were invited to participate in a consecutive observational study in patients presenting with symptoms and/or signs of uni- or bilateral chronic venous disorders (CVDs) in previously untreated limbs (clinical class of the CEAP classification C0s - C6). Patients were included between January and March 2015. They completed a specially designed venous symptoms questionnaire. Duplex ultrasound of the included limbs was performed with the patient standing to detect reflux in the GSV and to measure the GSV inner diameter at mid-thigh. RESULTS: Between January and March 2015, 35 physicians examined 1245 patients (2450 limbs after excluding 40 limbs): 77% were female, mean age 52 ± 14; 69% of the patients had venous symptoms in one or both legs. The most frequent symptoms were feeling of heaviness, feeling of swelling and aching. Predominant CEAP clinical classes were C2 (38% of limbs) and C1 (35%). In case of GSV reflux (40% of limbs), the average diameter was 5.6 ± 2 mm and the distribution was 62% < 6 mm, 30% between 6 and 8 mm, and 8% > 8 mm. The study showed a clear association between clinical class and GSV diameter (the higher the clinical class, the larger the diameter; p < .0001), between venous symptoms and diameter (the larger the diameter, the higher the intensity of symptoms, p < .0001 for overall discomfort) and between proximal extent of reflux and diameter (the more proximal the extent of reflux, the larger the diameter, p < .0001). CONCLUSION: The DIAGRAVES study demonstrated that in France for patients consulting with CVDs, more than half of the incompetent GSVs had a diameter < 6 mm, while large diameters were relatively infrequent. This should be kept in mind when considering management strategies in patients with CVDs.

Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: The efficacy and safety of anticoagulant treatment is not established for patients with acute symptomatic deep vein thrombosis (DVT) of the calf. We aimed to assess whether therapeutic anticoagulation is superior to placebo in patients with symptomatic calf DVT. METHODS: In this randomised, double-blind, placebo-controlled trial, we enrolled low-risk outpatients (without active cancer or previous venous thromboembolic disease) with a first acute symptomatic DVT in the calf from 23 university medical centres or community medical clinics in Canada, France, and Switzerland. We randomly assigned (1:1) patients to receive either the low-molecular-weight heparin nadroparin (171 UI/kg, subcutaneously, once a day) or placebo (saline 0·9%, subcutaneously, once a day) for 6 weeks (42 days). Central randomisation was done using a computer-generated randomisation list, stratified by study centre. Random allocation sequences of variable block size were centrally determined by an independent research clinical centre. Study staff, patients, and outcome assessors (central adjudication committee) were masked to group assignment. Numbered boxes of active drug or placebo were provided to pharmacies in identical packaging. All patients were prescribed compression stockings and followed up for 90 days. The primary efficacy outcome was a composite measure of extension of calf DVT to proximal veins, contralateral proximal DVT, and symptomatic pulmonary embolism at day 42 in the modified intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding at day 42. The trial was registered with ClinicalTrials.gov, number NCT00421538. FINDINGS: Between Feb 1, 2008, and Nov 30, 2014, we screened 746 patients, enrolling 259 patients (50% of the prespecified sample size), before the trial steering committee terminated the trial because of expiry of study drug and slow recruitment. The intention-to-treat analysis population comprised 122 patients in the nadroparin group and 130 in the placebo group. There was no significant difference between the groups in the composite primary outcome, which occurred in four patients (3%) in the nadroparin group and in seven (5%) in the placebo group (risk difference -2·1%, 95% CI -7·8 to 3·5; p=0·54). Bleeding occurred in five patients (4%) in the nadroparin group and no patients in the placebo group (risk difference 4·1, 95% CI 0·4 to 9·2; p=0·0255). In the nadroparin group one patient died from metastatic pancreatic cancer and one patient was diagnosed with heparin-induced thrombocytopenia type 2. INTERPRETATION: Nadroparin was not superior to placebo in reducing the risk of proximal extension or venous thromboembolic events in low-risk outpatients with symptomatic calf DVT, but did increase the risk of bleeding. Avoidance of systematic anticoagulation for calf DVT could have a substantial impact on individual patients and from a public health perspective. FUNDING: Swiss National Science Foundation, the Programme Hospitalier de Recherche Clinique in France, and the Canadian Institutes of Health Research.

Evaluation of the efficacy of polidocanol in the form of foam compared with liquid form in sclerotherapy of the greater saphenous vein: initial results.

BACKGROUND: Foamed sclerosing agents have been used with enthusiasm by phlebologists for more than 5 decades. Any type of varicose veins can and has been treated with this technique. Numerous publications have stressed the advantages of foamed sclerosing agents on the basis of empiric and experimental criteria and have described various individual techniques to prepare foams. Until now, however, no comparative study for the treatment of large varicose veins with foam or liquid exists. OBJECTIVE: The purpose of this first randomized, prospective, multicenter trial was to study the elimination of reflux, the rate of recanalization, and possible side effects of foam sclerotherapy (FS) compared with conventional liquid sclerotherapy for the greater saphenous vein (GSV). METHODS: Eighty-eight patients were randomized into two groups: One group was treated with sclerosing foam (45 patients) and the other with sclerosing liquid (43 cases). Sclerotherapy was performed with direct puncture of the vessel under duplex guidance. The reference sclerosing agent was polidocanol in a 3% solution. The foam was prepared using the Double Syringe System (DSS) method. Only one injection of 2.0 or 2.5 mL liquid or foam was allowed, depending on the diameter of the GSV. Results were assessed according to the protocol. RESULTS: Follow-up after 3 weeks showed 84% elimination of reflux in the GSV with DSS foam versus 40% with liquid sclerosant (P < 0.01). At 6 months, six recanalizations were found in the liquid group versus two in the foam group. After 1 year, no additional recanalization was observed with either foam or liquid. Longer term studies are underway. Side effects did not differ between both groups. CONCLUSION: The efficacy of sclerosing foam (DSS) compared with sclerosing liquid in therapy of the GSV is superior, a finding that had already gained empirical recognition but for which there has not been any clinical evidence to date.