A comparison of patient-reported outcome measures following technical success and technical failure in the treatment of great saphenous vein incompetence using ClariVein: A subanalysis of a multicenter randomized controlled trial comparing 2% and 3% polidocanol.

OBJECTIVE: This study aimed to compare patient-reported outcomes after technical success (TS) and technical failure (TF) in treating great saphenous vein incompetence (GSV) with ClariVein. METHODS: A subanalysis of a previous trial was conducted on symptomatic GSV incompetence patients who received ClariVein treatment with 2% or 3% polidocanol (POL) and were followed for 6 months. Blinding was implemented for observers and patients, and data from both POL groups were combined. TS was defined as at least 85% occlusion of the treated vein, while TF indicated failure to meet TS criteria. Secondary outcomes included Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and Short-Form 36 Health Survey Questionnaire (SF-36). RESULTS: Among the 364 patients included, the TS rate was 64.5%. Comparison of VCSS, AVVQ, and SF-36 scores between TS and TF groups did not yield significant differences. CONCLUSION: This study indicates no significant variation in VCSS, AVVQ, and SF-36 scores between patients experiencing TS and TF following ClariVein treatment for GSV insufficiency.

The relationship between psychological distress and impairment of disease-specific quality-of-life compared between liquid sclerocompression therapy and invasive treatments in patients with superficial venous disease during a one-year follow-up.

INTRODUCTION: Superficial venous disease (SVD) is a very common disease and much research has been done towards finding the ideal treatment and discovering the pathophysiology of SVD. Not much is known about the psychological burden of SVD. Current guidelines and scientific publications tend to focus on clinical and physiological aspects of SVD. The aim of this study was to relate the changes in Quality-of-Life (QoL) after SVD treatment to possible changes in psychological distress (PD). METHODS: A prospective cohort was set up with the assistance of 5 specialized vein clinics in the Netherlands. Inclusion criteria were: 18 years of age or older, fluent in Dutch language, C1 to C6 (CEAP) class intended to be primary treated with either endovenous laser(LA), radiofrequency ablation (RFA) and phlebectomy(PHL) or sclerocompression therapy alone (SCT). Patients were divided in two groups:1. C1-C3 patients treated by SCT2. C1-C6 patients treated invasively (LA, RFA and PHL)Outcomes were a disease specific QoL questionnaire (CIVIQ-20) and a questionnaire to assess PD (Hospital Anxiety and Depression Scales (HADS)). This study was approved by the local institutional review board, following the principles outlines in the Declaration to Helsinki. This trial was registered in the ISRCTN registry with study ID ISRCTN12085308. RESULTS: 442 patients were included in the study and completed the T0 measurements. Mean age of these patients is 54.4 years (s.d. 12.9, 17-90). Number of females: 349 (79.0%), of males: 93 (21.0%). The mean baseline (T-0) HADS depression (0-3) scale scores is 2.54 (s.d. 0.51, n = 412). The mean one-year difference between T-12 HADS depression (0-3) scale scores and baseline T-0 scores is +0.06. The mean baseline (T-0) HADS anxiety (0-3) scale scores is 2.19 (s.d. 0.5, n = 283). The mean one-year difference between T-12 HADS anxiety (0-3) scale scores and baseline T-0 scores is +0.06. Controlled for baseline scores, gender, age, weight and length(BMI), patients in group 2 (receiving invasive treatment) show significantly higher one-year improvement in the QoL of their psychological state of mind than patients in group 1 (receiving SCT and having C1,2,3) (beta 0.158 p = 0.002). CONCLUSIONS: The significant improvement in psychological, QoL and clinical scores that we observe after successful invasive treatment compared to no significant improvement after SCT and the lack of psychological distress in patients with "simple" SVD indicates that SCT is mainly performed for cosmetic reasons. One could thus argue that reimbursement of SCT as a stand-alone medical treatment is debatable.

Triage of patients with venous and lymphatic diseases during the COVID-19 pandemic - The Venous and Lymphatic Triage and Acuity Scale (VELTAS) : A consensus document of the International Union of Phlebology (UIP), Australasian College of Phlebology (ACP), American Vein and Lymphatic Society (AVLS), American Venous Forum (AVF), European College of Phlebology (ECoP), European Venous Forum (EVF), Interventional Radiology Society of Australasia (IRSA), Latin American Venous Forum, Pan-American Society of Phlebology and Lymphology and the Venous Association of India (VAI) This consensus document has been co-published in Phlebology [DOI: 10.1177/0268355520930884] and Journal of Vascular Surgery: Venous and Lymphatic Disorders [DOI: 10.1016/j.jvsv.2020.05.002]. The publications are identical except for minor stylistic and spelling differences in keeping with each journal's style. The contribution has been published under a Attribution-Non Commercial-No Derivatives 4.0 International (CC BY-NC-ND 4.0), (https://creativecommons.org/licenses/by-nc-nd/4.0/).

The coronavirus disease 2019 (COVID-19) global pandemic has resulted in diversion of healthcare resources to the management of patients infected with SARS-CoV-2 virus. Elective interventions and surgical procedures in most countries have been postponed and operating room resources have been diverted to manage the pandemic. The Venous and Lymphatic Triage and Acuity Scale was developed to provide an international standard to rationalise and harmonise the management of patients with venous and lymphatic disorders or vascular anomalies. Triage urgency was determined based on clinical assessment of urgency with which a patient would require medical treatment or surgical intervention. Clinical conditions were classified into six categories of: (1) venous thromboembolism (VTE), (2) chronic venous disease, (3) vascular anomalies, (4) venous trauma, (5) venous compression and (6) lymphatic disease. Triage urgency was categorised into four groups and individual conditions were allocated to each class of triage. These included (1) medical emergencies (requiring immediate attendance), example massive pulmonary embolism; (2) urgent (to be seen as soon as possible), example deep vein thrombosis; (3) semi-urgent (to be attended to within 30-90 days), example highly symptomatic chronic venous disease, and (4) discretionary/non-urgent- (to be seen within 6-12 months), example chronic lymphoedema. Venous and Lymphatic Triage and Acuity Scale aims to standardise the triage of patients with venous and lymphatic disease or vascular anomalies by providing an international consensus-based classification of clinical categories and triage urgency. The scale may be used during pandemics such as the current COVID-19 crisis but may also be used as a general framework to classify urgency of the listed conditions.

Detecting stent geometry changes after venous recanalization using duplex ultrasound.

BACKGROUND: Patients with post-thrombotic syndrome due to chronic venous obstruction and resistant to conservative management can benefit from endovenous revascularization. The current study investigated the usefulness of duplex ultrasound in monitoring the stent changes over the time. METHOD: All duplex ultrasound images of treated patients were reviewed retrospectively. The stent diameter and area during the follow-up visits have been analyzed. RESULT: A total of 210 stents were placed in 137 limbs. Duplex ultrasound findings showed a decrease in area of stent in all patients (mean: 0.69 cm2). Reduction of stent area over the time was a predictor of stent patency (odds ratio: 0.910; confidence interval: 0.832-0.997). CONCLUSION: Duplex ultrasound has sufficient accuracy in detection of stent changes and its patency. There is a discrepancy between diameter of the stent lumen in vitro and after deployment in all patients. Stent occlusion is related to reduction of stent lumen over the time rather than the percent of the stenosis.

Venous stent patency may be affected by collateral vein lumen size.

PURPOSE: Deep venous thrombosis causes blood flow deviation. It is hypothesized that with stent placement, developed collateral veins become redundant. This article evaluates the relation between the surface area of the collaterals and stent patency. METHODS: The azygos and hemiazygos veins were identified and the largest surface area was measured at thoracic level. Patency rates of stented tracts were evaluated and related to collateral vein lumen size. RESULTS: The vena cava occlusion and the azygos and hemiazygos vein surface area measurements were positive and statistically significant related (OR 1.01, 95% CI 1.003-1.019, p = 0.004) respectively (and OR 1.007, 95% CI 1.001-1.013, p = 0.004). An azygos surface area measurement of 23 (p<0.001) and hemiazygos surface area measurement of 40 (p = 0.008) was shown as cut-off point related to higher occlusion rates. CONCLUSIONS: The surface area of major venous collateral pathways seems to be related to stent occlusion in deep venous interventions.

The inability of venous occlusion air plethysmography to identify patients who will benefit from stenting of deep venous obstruction.

Background The aim of this study was to assess whether venous occlusion plethysmography can be used to identify venous obstruction and predict clinical success of stenting. Method Receiver operated characteristic curves were used to determine the ability of venous occlusion plethysmography to discriminate between the presence and absence of obstruction, measured by duplex ultrasound and magnetic resonance venography, and to discriminate between successful and non-successful stenting, measured by VEINES-QOL/Sym. Result Two hundred thirty-seven limbs in 196 patients were included. Areas under the curve for post-thrombotic obstruction were one-second outflow volume 0.71, total venous volume 0.69 and outflow fraction 0.59. Stenting was performed in 45 limbs of 39 patients. Areas under the curve for identifying patients with successful treatment at one year after stenting were 0.57, 0.54 and 0.63, respectively. Conclusion Venous occlusion plethysmography cannot be used to identify venous obstruction proximal to the femoral confluence or to distinguish which patients will benefit from treatment.

Stent extension into a single inflow vessel is a valuable option after endophlebectomy.

Background Venous stenting with an endophlebectomy and arteriovenous fistula can be performed in patients with extensive post-thrombotic changes. However, these hybrid procedures can induce restenosis, sometimes requiring stent extension, into a single inflow vessel. This study investigates the effectiveness of stenting into a single inflow vessel. Methods All evaluated patients had temporary balloon occlusion of the arteriovenous fistula to evaluate venous flow into the stents. When stent inflow was deemed insufficient, AVF closure was postponed and additional stenting was performed. Patency rates and clinical outcomes were evaluated. Results Twenty-four (38%) of 64 patients had additional stenting. The primary, assisted primary and secondary patency were 60 %, 70% and 70% respectively. Villalta score reduced by 6.1 points ( p < 0.001), and venous clinical severity score by 2.7 points ( p = 0.034). Conclusion Stenting through the femoral confluence into a single inflow vessel is a feasible bailout option if primary hybrid intervention fails with relative high patency rates and clinical improvement.

Wound complications after common femoral vein endophlebectomy: Influence on outcome.

Introduction Venous recanalization of obstructed femoral and iliac veins is associated with good results regarding the feasibility and patency rate. If the common femoral vein with its inflow vessels is involved, open surgical desobliteration or endophlebectomy has been described as a crucial part of the intervention. However, when performing the hybrid procedure, a number of specific complications have been described. We present our results after venous recanalization including an endophlebectomy, focussing on wound complications and its impact on outcome. Material and methods A retrospective analysis of prospective recorded data of all patients who underwent a hybrid procedure for chronic obstruction of iliofemoral veins between 2010 and 2015 was performed. The patients were treated by recanalization of the affected veins combined with endophlebectomy of the common femoral vein and arteriovenous fistula implantation. Data assessment focussed on complications and patency rates. Results This study includes 96 patients, thereof 58 females with a mean age of 44.1 years. The mean procedure time was 344 ± 140 min (range 124-663). Median follow-up time was 12.5 months (2-33 months). Primary patency was 62.5% and secondary patency was 90%. Re-intervention due to early occlusion within the first 30 post-intervention days was necessary in 37.5% of all cases. Besides bleeding complications, wound complications, mainly classified as Szilagyi I, occurred in 33% of all patients. A multivariate analysis showed a significant impact of wound complications on primary as well as secondary patency rate ( p = 0.032, respectively 0.015). Conclusion Recanalization of obstructed iliac veins and/or the inferior vena cava combined with endophlebectomy of the common femoral vein and arteriovenous fistula implantation is a safe and feasible treatment option in the post-thrombotic syndrome. As wound complications are a common and associated with a significant impact on patency rate, further attempts to improve the procedure are crucial.

Prediction of venous wound healing with laser speckle imaging.

Introduction Laser speckle imaging is used for noninvasive assessment of blood flow of cutaneous wounds. The aim of this study was to assess if laser speckle imaging can be used as a predictor of venous ulcer healing. Methods After generating the flux speckle images, three regions of interest (ROI) were identified to measure the flow. Sensitivity, specificity, negative predictive value, and positive predictive value for ulcer healing were calculated. Results In total, 17 limbs were included. A sensitivity of 92.3%, specificity of 75.0%, PPV of 80.0%, and NPV 75.0% were found in predicting wound healing based on laser speckle images. Mean flux values were lowest in the center (ROI I) and showed an increase at the wound edge (ROI II, p = 0.03). Conclusion Laser speckle imaging shows acceptable sensitivity and specificity rates in predicting venous ulcer healing. The wound edge proved to be the best probability for the prediction of wound healing.

Risk factors of postthrombotic syndrome before and after deep venous thrombosis treatment.

Postthrombotic syndrome is the most common complication after deep venous thrombosis. Postthrombotic syndrome is a debilitating disease and associated with decreased quality of life and high healthcare costs. Postthrombotic syndrome is a chronic disease, and causative treatment options are limited. Prevention of postthrombotic syndrome is therefore very important. Not all patients develop postthrombotic syndrome. Risk factors have been identified to try to predict the risk of developing postthrombotic syndrome. Age, gender, and recurrent deep venous thrombosis are factors that cannot be changed. Deep venous thrombosis location and extent seem to predict severity of postthrombotic syndrome and are potentially suitable as patient selection criteria. Residual thrombosis and reflux are known to increase the incidence of postthrombotic syndrome, but are of limited use. More recently developed treatment options for deep venous thrombosis, such as new oral factor X inhibitors and catheter-directed thrombolysis, are available at the moment. Catheter-directed thrombolysis shows promising results in reducing the incidence of postthrombotic syndrome after deep venous thrombosis. The role of new oral factor X inhibitors in preventing postthrombotic syndrome is still to be determined.

The effect of distraction on pain perception during an endovenous thermal ablation procedure.

OBJECTIVES: To determine whether audio and visual distraction can affect the pain perception of a patient undergoing endovenous thermal ablation under tumescent anesthesia. METHODS: Patients underwent an endovenous thermal ablation procedure and were randomized into two groups: non-distraction (AVD-) and with distraction (AVD+). Visual analogue scale pain score and hospital anxiety depression scale scores were used to measure outcome. The recruited patients were asked to submit an anticipated visual analogue scale pain score prior to treatment as well as the actual experienced post-operative visual analogue scale pain score. RESULTS: There was no significant difference between the AVD- and AVD+ groups post-operative pain score 2.85 (SD 1.7) versus 2.60 (SD 2.3), p = 0.68. Pain score in women with distraction (AVD+) decreased from 3.81 to 2.42. The pain score in men with distraction (AVD+) increases from 1.88 to 2.82. In the AVD- group, a significant difference was found between men and women (p = 0.014). Disregarding gender, a significant difference was found between the anticipated pain score and the actual pain score in both the AVD- group (p = 0.009) and AVD+ group (p = 0.021). There was a correlation between depression and the pain score, which was not seen between pain and anxiety score. CONCLUSION: The results suggested that audiovisual distraction has no influence on the visual analogue scale pain score during endovenous thermal ablation under tumescent anesthesia. Despite this, patients appreciate and evaluate audio and visual distraction as pleasant to extremely pleasant when applied.

Cyanoacrylate adhesive perforator embolization (CAPE) of incompetent perforating veins of the leg, a feasibility study.

Consideration of treating incompetent perforating veins remains a conundrum based on scientific evidence available till date. While subfascial endoscopic perforator surgery (SEPS) proved to be a worthy alternative for open surgery, other even less invasive techniques were being introduced by the late nineties of the last century. Percutaneous thermo-ablation techniques are still being used today and seem more effective than non-thermal techniques. However, thermal techniques require anaesthesia and potentially may cause inadvertent damage to surrounding tissues such as nerves. Cyanoacrylate adhesive has a proven record, but not for the treatment of chronic venous disease of the leg. Innovation has led to the development of the VenaSeal® Sapheon Closure System which has been designed to use a modified cyanoacrylate glue as a new therapy for truncal vein incompetence. This paper explores the feasibility of ultrasound guided cyanoacrylate adhesive perforator embolization (CAPE). Results show a 76% occlusion rate of incompetent perforating veins without serious complications leading to the conclusion that further investigation with a dedicated delivery device in a larger patient population is warranted.

Thrombectomy without lysis: the future?

The results of the CaVent-study and the expected results of the ATTRACT and CAVA trials will form the base of evidence to support that rapid cloth removal is beneficial for patients with iliofemoral DVT. Although beneficial, there are still significant risks associated with this therapy. Therefore alternative methods for rapid cloth removal without lysis are a potential valid alternative. In this article we describe the techniques currently available for thrombolysis and discuss the potential improvements to be made to clot removal techniques in the future.

The Future of Phlebology in Europe.

BACKGROUND: Worldwide superficial and deep venous diseases are common and associated with significant individual and socioeconomic morbidity. Increasing burden of venous disease requires Phlebology to define itself as an independent specialty representing not only patients but the multidisciplinary physicians involved in venous care. METHODS & RESULTS: In this article the scope of venous disease in Europe and subsequent future governance for treatment in the region is discussed. Superficial venous disease is common with 26.9-68.6% of European populations reported to have C2-C6 disease according to the CEAP (Clinical severity, Aetiology, Anatomy and Pathophysiology) scoring system. However, a significant disparity is observed in the treatment of superficial venous disease across Europe. Post thrombotic syndrome (PTS) after deep vein thrombosis (DVT) contributes to the increasing burden of deep venous disease. Aggressive thrombus removal for acute ileofemoral DVT provides a cost-effective 14.4% risk reduction in the development of PTS. Additionally, deep venous lesions requiring endovascular intervention are being increasingly performed to prevent recurrent thrombosis. The European College of Phlebology (ECoP) has been formed to provide a responsible body for the care of the European patient with venous disease. The role of the ECoP includes unifying European member states through standardised guideline production, identification of research strategy and provision of training and accreditation of physicians. CONCLUSION: Creation of a European venous disease specific speciality will provide a patient centred approach through understanding of the impact of disease in the region and delivery of high quality diagnostics and treatment from an appropriately certified Phlebologist.