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).

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.

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.

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.

Influence of reimbursement policies on phlebological surgical practice in Belgium between 2007 and 2017.

BACKGROUND: To date, it is unclear how treatment of patients with chronic venous disease (CVD) is influenced by national reimbursement systems. In Belgium, catheters or fibers used for endovenous thermal ablation (EVTA) are reimbursed only once in a lifetime. The potential impact of the Belgian public health insurance reimbursement policy on surgical practice in phlebology needs to be investigated. METHODS: Billing data available from the Belgian National Institute for Health and Disability Insurance (NIHDI) were used for analyzing the distribution of specific surgical procedures for treating varicose veins and their relative use from 2007 to 2017. The potential influence of age, sex, social status and geographical origin of insured patients on surgical practice in Belgium were studied. RESULTS: The annual intervention rate was 343 per 100,000 insured individuals for 2017 with a slight annual increase over the period 2007-2017 (+ 0.83% per year). Patients with limited resources, benefiting from a preferential reimbursement system, had a significantly lower intervention rate than those having the usual system (P<0.001). There was a large geographical variation in the use of care, ranging from 172 to 549 per 100.000 insured in 2017. The number of classic surgical procedures decreased (-6.17% per year) in the period 2015-2017) while EVTA, newly reimbursed in Belgium since 2012, increased during the same period (+ 3.6% per year). This evolution was more pronounced in the north (Flanders) than in the south (Wallonia) of the country. Bilateral treatment increased considerably from 2012 and stabilized at 33% of all surgical interventions in 2016 and 2017. CONCLUSIONS: Available data of the NIHDI in Belgium highlight remarkable differences in the use of care for CVD, depending on social status and geographical origin of insured patients. The introduction of EVTA techniques has been adopted more rapidly in the north of the country and has led to an increased percentage of bilateral procedures.

Varicose veins due to reflux in a tortuous sartorius muscle vein.

In daily phlebology practice, duplex ultrasound may sometimes reveal unusual pathways of reflux. A 46-year-old woman presented with heaviness and pain at the medial side of the left thigh after exercise. A tortuous intramuscular course of a large refluxing vein was seen in the sartorius muscle in connection with a femoral vein perforator cranially and the below-knee great saphenous vein distally. Magnetic resonance imaging confirmed these findings. Treatment consisted of a combination of foam sclerotherapy, radiofrequency ablation, and phlebectomies.

The effect of single phlebectomies of a large varicose tributary on great saphenous vein reflux.

OBJECTIVE: Phlebectomy of varicose tributaries is usually considered an additional treatment after or during saphenous ablation. As phlebectomies alone affect the hemodynamics of the venous system, this treatment can be effective as primary intervention in selected patients. The objective of this study was to analyze hemodynamic, clinical, and patient-reported outcomes after phlebectomies in a prospective multicenter study to determine predictors for treatment success, that is, restoration of great saphenous vein (GSV) competence. METHODS: Patients with symptomatic GSV and tributary incompetence (reflux > 0.5 second) at the level of the thigh were included. Duplex ultrasound (DUS) was used to assess GSV and tributary characteristics, and a reflux elimination test was performed. Three and 12 months after phlebectomy of the tributary, reflux and GSV diameter were evaluated with DUS. Clinical outcome measures were C class of the Clinical, Etiologic, Anatomic, and Pathologic (CEAP) classification and Venous Clinical Severity Score; patients' reported outcome was determined by the Aberdeen Varicose Vein Questionnaire. To evaluate differences between the success and failure groups, baseline DUS characteristics, Venous Clinical Severity Score, CEAP class, and Aberdeen Varicose Vein Questionnaire score were compared. Multivariable logistic regression including all clinically relevant variables following a backward variable elimination process was used to determine predictors for success. The model was internally validated by 1000 bootstrap samples. RESULTS: The study included 94 patients (65 women, 29 men) with a mean age of 53 years. The majority had C2 or C3 disease. One year after treatment, GSV reflux had disappeared in 50% of patients (P < .01), and GSV diameter had decreased significantly (P < .01). Clinical outcome and Aberdeen Varicose Vein Questionnaire score improved significantly (P < .01) and symptoms had disappeared in 66%. Of 47 patients with persisting GSV incompetence, 15 did not receive additional treatment because they were asymptomatic. Independent predictors for success were low C class of the CEAP classification, low number of refluxing GSV segments, small diameter of the GSV above the tributary, and positive reflux elimination test result (P < .0001). The reflux elimination test appeared to be an important independent predictor, with >65% chance of success when the result was positive. CONCLUSIONS: At 1-year follow-up, treatment with single phlebectomies of a large tributary was effective to abolish GSV reflux in 50% of patients and to free 66% of patients from symptoms. Patients with limited disease progression and mild DUS alterations are most likely to benefit from this approach.