A randomized clinical trial of isolated ambulatory phlebectomy versus saphenous thermal ablation with concomitant phlebectomy (SAPTAP Trial).

BACKGROUND: Current treatment of patients with saphenous trunk and tributary incompetence consists of truncal ablation with concomitant, delayed or no treatment of the tributary. However, reflux of the saphenous trunk may be reversible after treatment of the incompetent tributary. The aim of this study was to determine whether single ambulatory phlebectomy with or without delayed endovenous truncal ablation (SAP) is non-inferior to thermal endovenous ablation with concomitant phlebectomy (TAP), and whether SAP is a cost-effective alternative to TAP. METHODS: A multicentre, non-inferiority RCT was conducted in patients with an incompetent great saphenous vein or anterior accessory saphenous vein with one or more incompetent tributaries. Participants were randomized to receive SAP or TAP. After 9 months, additional truncal treatment was considered for SAP patients with remaining symptoms. The primary outcome was VEnous INsufficiency Epidemiological and Economic Study Quality of Life/Symptoms (VEINES-QOL/Sym score) after 12 months. Secondary outcomes were, among others, cost-effectiveness, perceived improvement of symptoms, and anatomical success. RESULTS: Some 464 patients received the allocated treatment (SAP 227, TAP 237). VEINES-QOL scores were 52.7 (95 per cent c.i. 51.9 to 53.9) for SAP and 53.8 (53.3 to 55.1) for TAP; VEINES-Sym scores were 53.5 (52.6 to 54.4) and 54.2 (54.0 to 55.6) respectively. Fifty-eight patients (25.6 per cent) in the SAP group received additional truncal ablation. Treatment with SAP was less costly than treatment with TAP. CONCLUSION: One year after treatment, participants who underwent SAP had non-inferior health-related quality of life compared with those who had TAP. Treatment with SAP was a cost-effective alternative to TAP at 12 months. REGISTRATION NUMBER: NTR 4821 (www.trialregister.nl).

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.

Safety and Effectiveness of Endovenous Thermal Ablation for Incompetent Saphenous Veins with an Aneurysm Close to the Junction.

OBJECTIVE: The aim was to evaluate the safety and effectiveness of endovenous thermal ablation (EVTA) with or without adding high ligation (HL) for the treatment of incompetent saphenous veins with an aneurysm (>20 mm for the great saphenous vein, >15 mm for the small saphenous vein) close to the junction. METHODS: This was a prospective observational cohort study in a single centre. All patients presenting with saphenous aneurysms close to the junction were included. Those with a venous aneurysm more distally, at >2 cm from the junction, or with associated deep venous aneurysms were excluded. Patients were treated with EVTA alone or combined with HL in cases of an aneurysm with a diameter >30 mm. Phlebectomies were performed during the same treatment session. Patients were followed up one and six weeks, and one year after treatment. Duplex ultrasound (DUS) was performed to evaluate occlusion of the vein and aneurysm as well as possible complications such as endovenous heat induced thrombosis (EHIT) or deep vein thrombosis (DVT). Venous clinical severity scores (VCSS) were registered before and one year after treatment. RESULTS: Thirteen patients (15 limbs) were included between February 2012 and January 2015. Eleven limbs were treated with EVTA alone, the remaining four limbs with EVTA and HL. No severe adverse events occurred (no EHIT, no DVT). After one year none of the aneurysms was still visible on DUS and the truncal obliteration rate was 80% (two partial, one segmental recanalisation). Both treatment strategies showed significant improvement of the VCSS at the one year follow up, from a median score of 6 (interquartile range [IQR] 5-7) to 2 (IQR 1-3) (p = .001). CONCLUSION: EVTA with or without HL appeared to be a safe and effective treatment for patients presenting with incompetent saphenous veins with an aneurysm close to the junction.

Editor's Choice - Five Year Results of Great Saphenous Vein Treatment: A Meta-analysis.

OBJECTIVES: The most frequently used treatment options for great saphenous vein incompetence are high ligation with stripping (HL+S), endovenous thermal ablation (EVTA), mainly consisting of endovenous laser ablation (EVLA) or radiofrequency ablation, and ultrasound guided foam sclerotherapy (UGFS). The objective of this systematic review and meta-analysis was to compare the long-term efficacy of these different treatment modalities. METHODS: A systematic literature search was performed. Randomised controlled trials (RCTs) with follow-up ≥ 5 years were included. Pooled proportions of anatomical success, which was the primary outcome, rate of recurrent reflux at the saphenofemoral junction (SFJ), and mean difference in venous clinical severity score (VCSS) were compared using a z test or Student t test. Quality of life data were assessed and described. RESULTS: Three RCTs and 10 follow-up studies of RCTs were included of which 12 were pooled in the meta-analysis. In total, 611 legs were treated with EVLA, 549 with HL+S, 121 with UGFS, and 114 with HL+EVLA. UGFS had significantly lower pooled anatomical success rates than HL+S, EVLA, and EVLA with high ligation: 34% (95% CI 26-44) versus 83% (95% CI 72-90), 88% (95% CI 82-92), and 88% (95% CI 17-100) respectively; p ≤ .001. The pooled recurrent reflux rate at the SFJ was significantly lower for HL+S than UGFS (12%, 95% CI 7-20, vs. 29%, 95% CI 21-38; p ≤ .001) and EVLA (12%, 95% CI 7-20, vs. 22%, 95% CI 14-32; p = .038). VCSS scores were pooled for EVLA and HL+S, which showed similar improvements. CONCLUSION: EVLA and HL+S show higher success rates than UGFS 5 years after GSV treatment. Recurrent reflux rates at the SFJ were significantly lower in HL+S than UGFS and EVLA. VCSS scores were similar between EVLA and HL+S.

Guidelines for management of actual or suspected inadvertent intra-arterial injection of sclerosants.

BACKGROUND: Inadvertent intra-arterial injection of sclerosants is an uncommon adverse event of both ultrasound-guided and direct vision sclerotherapy. This complication can result in significant tissue or limb loss and significant long-term morbidity. OBJECTIVES: To provide recommendations for diagnosis and immediate management of an unintentional intra-arterial injection of sclerosing agents. METHODS: An international and multidisciplinary expert panel representing the endorsing societies and relevant specialities reviewed the published biomedical, scientific and legal literature and developed the consensus-based recommendations. RESULTS: Actual and suspected cases of an intra-arterial sclerosant injection should be immediately transferred to a facility with a vascular/interventional unit. Digital Subtraction Angiography (DSA) is the key investigation to confirm the diagnosis and help select the appropriate intra-arterial therapy for tissue ischaemia. Emergency endovascular intervention will be required to manage the risk of major limb ischaemia. This includes intra-arterial administration of vasodilators to reduce vasospasm, and anticoagulants and thrombolytic agents to mitigate thrombosis. Mechanical thrombectomy, other endovascular interventions and even open surgery may be required. Lumbar sympathetic block may be considered but has a high risk of bleeding. Systemic anti-inflammatory agents, anticoagulants, and platelet inhibitors and modifiers would complement the intra-arterial endovascular procedures. For risk of minor ischaemia, systemic oral anti-inflammatory agents, anticoagulants, vasodilators and antiplatelet treatments are recommended. CONCLUSION: Inadvertent intra-arterial injection is an adverse event of both ultrasound-guided and direct vision sclerotherapy. Medical practitioners performing sclerotherapy must ensure completion of a course of formal training (specialty or subspecialty training, or equivalent recognition) in the management of venous and lymphatic disorders (phlebology), and be personally proficient in the use of duplex ultrasound in vascular (both arterial and venous) applications, to diagnose and provide image guidance to venous procedure. Expertise in diagnosis and immediate management of an intra-arterial injection is essential for all practitioners performing sclerotherapy.

Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins.

BACKGROUND: Many case series have been published on treatments of varicose veins, but comparative randomized controlled trials remain sparse. OBJECTIVE: To compare the anatomic success rate, frequency of major complications, and quality-of-life improvement of endovenous laser ablation (EVLA), ultrasound-guided foam sclerotherapy (UGFS), and conventional surgery (CS), after 1-year follow-up. METHODS: A total of 240 consecutive patients with primary symptomatic great saphenous vein reflux were randomized to EVLA, UGFS, or CS, consisting of high ligation and short stripping. Primary outcome was anatomic success defined as obliteration or absence of the treated vein on ultrasound examination after 1 year. Secondary outcomes were complications, improvement of the "C" class of the CEAP classification, and improvement of disease-specific (Chronic Venous Insufficiency Quality-of-Life Questionnaire) and general (EuroQol 5) quality-of-life scores. RESULTS: More than 80% of the study population was classified as C2 or C3 venous disease. After 1 year, the anatomic success rate was highest after EVLA (88.5%), followed by CS (88.2%) and UGFS (72.2%) (P < .001). The complication rate was low and comparable between treatment groups. All groups showed significant (P < .001) improvement of EuroQol 5 and Chronic Venous Insufficiency Quality-of-Life Questionnaire scores after therapy; 84.3% of all treated patients showed an improvement of the "C" of the CEAP classification. CONCLUSIONS: After 1-year follow-up, EVLA is as effective as CS and superior to UGFS according to occlusion on ultrasound duplex. Quality of life improves after treatment in all groups significantly.

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.

Fake-news-free evidence-based communication for proper vein-lymphatic disease management.

Published scientific evidence demonstrate the current spread of healthcare misinformation in the most popular social networks and unofficial communication channels. Up to 40% of the medical websites were identified reporting inappropriate information, moreover being shared more than 450,000 times in a 5-year-time frame. The phenomenon is particularly spread in infective diseases medicine, oncology and cardiovascular medicine. The present document is the result of a scientific and educational endeavor by a worldwide group of top experts who selected and analyzed the major issues and related evidence-based facts on vein and lymphatic management. A section of this work is entirely dedicated to the patients and therefore written in layman terms, with the aim of improving public vein-lymphatic awareness. The part dedicated to the medical professionals includes a revision of the current literature, summing up the statements that are fully evidence-based in venous and lymphatic disease management, and suggesting future lines of research to fulfill the still unmet needs. The document has been written following an intense digital interaction among dedicated working groups, leading to an institutional project presentation during the Universal Expo in Dubai, in the occasion of the v-WINter 2022 meeting.

A giant aneurysm of the popliteal vein.

Popliteal vein aneurysm is a rare diagnosis, associated with a 70 % risk of pulmonary embolism, sometimes even with fatal evolution. Surgery dramatically reduces the risk of pulmonary embolism. We report a case of a 66-year-old man with recurrent pulmonary embolism and a giant popliteal venous aneurysm (9.3 × 4 × 4 cm) presenting at our dermatological clinic.

Extended anticoagulation for venous thromboembolism: A survey of the American Venous Forum and the European Venous Forum.

OBJECTIVE: Extended anticoagulation therapy should always be considered after standard treatment of an unprovoked episode of venous thromboembolism (VTE). It can also be considered for selected patients with provoked VTE. However, the evidence-based protocols suggested by some clinical guidelines and risk assessment tools to guide this practice are limited and ambiguous. The goal of the present survey research was to analyze current practices in applying extended anticoagulation therapy for patients with VTE among members of the American Venous Forum (AVF) and European Venous Forum (EVF). METHODS: An online survey was created by the AVF Research Committee. The survey consisted of 16 questions to identify the country of practice, specialty, experience of the participating physicians, and their clinical practice patterns in applying extended anticoagulation therapy for VTE patients. The survey was distributed via e-mail to the members of the AVF and EVF. RESULTS: A total of 144 practitioners, 48 AVF members (33%) and 96 EVF members (66%), participated in the survey. Most of the respondents identified themselves as vascular specialists with primary certification in vascular surgery (70%), vascular medicine or angiology (9%), and venous disease or phlebology (3%). Of the 144 respondents, 72% believed that the risk of VTE recurrence will generally overweigh the risk of bleeding for patients with unprovoked VTE. Extended anticoagulation therapy might be used by 97% of providers. Different patterns in real world clinical practice were identified. More than one half of the practitioners estimated the VTE recurrence and bleeding risk subjectively. The antithrombotic drugs most commonly used for secondary prophylaxis were rivaroxaban, apixaban, warfarin, dabigatran, and aspirin, in decreasing order of frequency. Among the reasons selected for not regularly considering extended anticoagulation therapy were the lack of specific clinical practice guidelines (24%), lack of reported evidence (9%), and absence of valid VTE and/or bleeding risk prediction calculators (8%). Twelve participants (8%) stated that extended anticoagulation therapy would not be beneficial for most patients with VTE. Ten participants (7%) indicated that prescribing extended anticoagulation therapy was outside the scope of their specialty. CONCLUSIONS: Different practice patterns exist regarding extending anticoagulation therapy beyond the standard treatment for patients with VTE. Major gaps in knowledge remain a serious challenge at least partially explaining the inaccuracy and inconsistency in long-term VTE management. Appropriately designed studies are needed to evaluate risk stratification tools when contemporary best medical therapy is used, accurately predict VTE recurrence and its long-term outcomes, and tailor safe and effective secondary prophylaxis.