Differences in risk profile associated with varicose veins and chronic venous insufficiency - results from the Bonn Vein Study 1.

Background: The aim of this publication is to demonstrate similarities and differences in the association of risk factors with the prevalence of different manifestations of chronic venous disease (CVD), like varicose veins (VV), venous oedema (C3) and severe chronic venous insufficiency (CVI) in the population-based cross-sectional Bonn Vein Study 1 (BVS). Patients and methods: In the BVS 1 between 13.11.2000 and 15.3.2002, 3.072 participants, 1350 men and 1722 women, from a simple random sample of the general population of the city of Bonn and two rural townships aged 18-79 years were included. The overall response proportion was 59%. All participants answered a standardized questionnaire including information about socio-economic data, lifestyle, physical activity, medical history, and quality of life. Venous investigations were performed clinically and by a standardized duplex examination by trained investigators. The CEAP classification in the version of 1996 was used to classify the findings. Logistic regression models were performed for the association of possible risk factors with VV, venous edema (C3) and severe CVI (C4-C6). The predictive risk (PR) describes the association of the diseases and the possible influencing factors. Results: VV, venous oedema (C3) and severe CVI (C4-C6) have common risk factors like higher age, number of pregnancies, family history of VV and overweight or obesity. Female gender is significantly associated with VV and C3 but not with severe CVI (C4-C6). High blood pressure and urban living are only associated with C3 and C4-C6 disease whereas prolonged sitting is associated with C3 and lower social class with C4-C6 exclusively. Discussion: In many epidemiological studies risk factors were associated with chronic venous disorders in general. Our data show that VV, venous edema and severe CVI may have different risk profiles. Venous edema is more often associated with arterial hypertension and sedentary lifestyle whereas lower social class seems to be a risk factor for severe CVI including venous ulcers. Conclusions: The differences in the association of risk factors to VV, venous edema and severe CVI should be considered if prevention and treatment of chronic venous diseases are planned. As examples, compression stockings could be proposed in sitting profession to prevent oedema, VV patients with risk factors like obesity might benefit from early treatment for VV and obesity. More longitudinal evaluation of risk factors is necessary to evaluate the true risk profile of CVD.

Diagnosis and treatment of venous leg ulcers: S2k Guideline of the German Society of Phlebology and Lymphology (DGPL) e.V.

This S2k guideline on venous leg ulcers was created on the initiative and under the leadership of the German Society of Phlebology and Lymphology (DGPL). The guideline group also consisted of representatives from the German Society for Phlebology and Lymphology, German Dermatological Society, German Society for General Medicine, German Society for Angiology, German Society for Vascular Surgery and Vascular Medicine, German Society for Surgery, German Society for Dermatosurgery, German Society for Wound Healing and Wound Treatment, Professional Association of Phlebologists and Lymphologists and Initiative Chronische Wunden. The aim of this guideline is to combine the different approaches and levels of knowledge of the respective professional groups on the basis of consensus, so that a basic concept for the best possible treatment of patients with venous leg ulcers can be provided. A total of 70 specific recommendations were formulated and agreed upon, divided into the subject areas of diagnostics, therapy, prevention of recurrences, and everyday challenges. The guideline thus reflects the current state of scientific knowledge and is intended to be widely used as the best available document for the treatment of patients with venous leg ulcers in everyday clinical practice.

[What is evidence-based in the treatment of chronic venous insufficiency?] / Was ist gesichert in der Therapie der chronischen Veneninsuffizienz?

Chronic venous diseases belong to the most frequent diseases. They can be asymptomatic, cause subjective symptoms or lead to objectif alterations, such as edema, cutaneous alterations and venous leg ulcers. This ultimately results in chronic venous insufficiency (CVI). Varicose veins are a progressive degenerative disease of the venous walls in the superficial venous system of the legs, which can decisively impair the quality of life of those affected. The classification of chronic venous diseases is carried out with the CEAP classification according to clinical, etiological, anatomical and pathophysiological criteria. Instruments, such as the venous clinical severity score, are used for assessment of the severity. The treatment of chronic venous diseases targets the improvement of the subjective complaints and objectifiable alterations. In addition, complications, such as phlebitis and formation of ulcers should be avoided. Invasive procedures, compression treatment and pharmaceutical treatment are complementary and a combination of these procedures can be meaningful. General physical measures, such as propping up the legs and frequent walking, are part of the basic measures for every patient with venous diseases. Compression therapy with medical compression stockings is the gold standard in the noninvasive treatment of symptomatic venous diseases, possibly supplemented by anti-inflammatory drugs. A varicose vein should be eliminated whenever possible. Stripping operations and the less invasive endovenous thermal ablation show comparable results for saphenous vein varicosis. Foam sclerotherapy and percutaneous phlebectomy are the methods of choice for elimination of side branch varicosis; however, recurrences of varicose veins are frequent.

[Epidemiology of chronic venous diseases]. / Epidemiologie der chronischen Venenkrankheiten.

AIM: Overview of the recent knowledge in epidemiology of chronic venous diseases. METHODS: Systematic search and discussion of recent studies concerning epidemiology of chronic venous diseases. RESULTS: The more recent epidemiologic studies of venous diseases in which the CEAP classification was used showed a prevalence of 60-70 % CEAP clinical class C0 and C1, app. 25 % for C2 and C3 and up to 5 % for C4 to C6 with skin changes or venous ulcers. The incidence of varicose veins is app. 2 % per year. CONCLUSIONS: Chronic venous diseases like varicose veins and chronic venous insufficiency belong to the most frequent diseases in our adult population.

Compression therapy after endovenous laser ablation: Patient compliance and impact on clinical outcome.

OBJECTIVES: This study aimed to investigate the impact of post-interventional compression therapy on clinical outcomes after endovenous laser ablation (EVLA) of incompetent saphenous veins. METHODS: This prospective, controlled, multicenter study in Germany involved 493 varicose vein patients followed-up for 6 months. RESULTS: Compression therapy significantly reduced symptoms compared to no compression (VCSS: 1.4 ± 1.6 vs 2.2 ± 2.2; p = .007). Post-interventional therapy duration of up to 14 days was found to be most effective for improving patient-reported disease severity (p < .001) and higher quality of life (p = .001). Patient compliance was high (82%), and non-compliance was linked to worse disease severity (VCSS 1.4 ± 1.5 vs 2.1 ± 2.3, p = .009). CONCLUSION: In conclusion, post-interventional compression therapy is beneficial by reducing symptoms and improving quality of life. High patient compliance with the therapy is observed, and non-compliance is associated with worse disease severity.

Safety of synchronous prophylactic ablation of the anterior saphenous vein in patients undergoing great saphenous vein thermal ablation- 6 months follow-up data of the SYNCHRONOUS study.

BACKGROUND: The SYNCHRONOUS-study investigates simultaneous ASV-ablation with great saphenous vein (GSV) treatment in endovenous laser ablation (EVLA) for preventing varicose vein recurrence. This sub-study examines complication rates associated with prophylactic ASV-ablation. METHODS: Among 1173 patients with refluxing GSV, 604 underwent GSV-ablation only, and 569 received additional ASV-ablation. Complication rates were compared over 6 months. RESULTS: Approximately 80% of patients were complication-free with minor bruising and dysesthesia being most common complications. After 6 months, additional prophylactic ASV-ablation did not increase the rate of complications compared to GSV-only treatment. CONCLUSION: The 6-months follow-up data suggests that prophylactic ASV-closure, alongside GSV-treatment, is safe, with similar complication rates to GSV-only EVLA.

Therapy with compression stockings in Germany - results from the Bonn Vein Studies.

BACKGROUND: Despite the frequent use of medical compression stockings (MCS), reliable data are lacking on the frequency of MCS use and experience of patients with the treatment. PATIENTS AND METHODS: The Bonn Vein Study included 3,072 participants from the general population aged 18 to 79 years (1,350 men/1,722 women). Between 2007 and 2008 (Bonn Vein Study 2) 1,978 participants from the Bonn Vein Study 1 were reinvestigated. This paper combines the results of both investigations. RESULTS: 14.6% (7.5% men, 20.3% women) reported having previously undergone treatment with compression stockings. A mean of 71.3% reported an improvement in their venous disease as a result of MCS treatment. During the 6.6 years of follow-up (Bonn Vein Study 2), significantly more prescriptions of MCS were given to patients in higher CEAP clinical stages. 12.2% of the population in C2 was treated with MCS as were 19.1% in C3 and 27.0% in C4-C6. Among participants with chronic venous insufficiency (CVI) (skin changes up to venous ulcers), about 60% were not treated by MCS or bandages in the past years. CONCLUSIONS: These results show that MCS is the most common treatment of venous disorders in the German population. At the same time, these figures also demonstrate severely lacking treatment with MCS in CVI.

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.

Impact of a synchronous prophylactic treatment of the anterior accessory saphenous vein on the recurrent varicose vein rate in patients undergoing thermal ablation of an insufficient great saphenous vein (SYNCHRONOUS-Study): study protocol for a prospective, multicentre, controlled observational study.

INTRODUCTION: To date, there are no prospective studies evaluating the prevention of recurrent veins by the simultaneous treatment of a sufficient anterior accessory saphenous vein (AASV) in patients undergoing endovenous laser ablation (EVLA) of an insufficient great saphenous vein (GSV). This study will provide important information about the impact of the AASV on the development of recurrent veins after EVLA of the GSV. Additionally, it will be clarified whether patients benefit from a preventive ablation of a sufficient AASV. METHODS AND ANALYSIS: This is a multicentre, prospective, controlled, exploratory clinical study in 1150 patients with a medical indication for EVLA of a refluxing great saphenous vein. Patients will be enrolled into two study groups: in half of the patients EVLA will be performed on the insufficient GSV only. In the other half of the patients EVLA will be performed on the insufficient GSV and additionally on the sufficient AASV. Within seven study visits, patients will be followed-up over a time period of 5 years. Primary study endpoint is the recurrence rate; secondary endpoints include inter alia, complication rate, postoperative pain intensity, quality of life and patient satisfaction. ETHICS AND DISSEMINATION: Before initiation of the study, the protocol was presented and approved by the independent ethics committee of the medical faculty of the University of Heidelberg (Ethics approval number S-596/2018). This study was prospectively registered at the German Clinical Trial Register (https://www.germanctr.de/). Research findings will be disseminated in a peer-reviewed journal and at relevant conferences. TRIAL REGISTRATION NUMBER: German Clinical Trial Registry (DRKS00015486).

Compression treatment in acute symptomatic proximal deep venous thrombosis - Results of a worldwide survey.

OBJECTIVES: The aim of this study was to illustrate how compression is performed worldwide in proximal DVT and if compression management has changed recently. METHODS: A global online survey, consisting of 36 questions, was used. The survey was solicited from membership lists of Union Internationale de Phlébologie (UIP) membership societies. For differences between the continents in comparison to Western Europe odds ratios and 95% Confidence Intervals (95%CI) where calculated. RESULTS: We received 626 answers from 41 countries. Compression is routinely used in proximal DVT in all regions (82.8%). 81.4% start compression immediately after diagnosis. In the acute phase of DVT reduction of pain and swelling (91.7%) and PTS prevention (66.2%) are the main reasons for compression. 33.2% recently changed their compression management with 43.5% starting compression earlier and 7.0% later. CONCLUSIONS: Compression is still used routinely in proximal DVT in addition to anticoagulation. The changes in international guidelines towards the non-routine use of compression in proximal DVT have not caused significant changes in DVT management.

Chronic venous disease and diabetic microangiopathy: pathophysiology and commonalities.

Chronic venous disease and diabetes mellitus are highly prevalent and debilitating conditions affecting millions of individuals globally. Although these conditions are typically considered as separate entities, they often co-exist which may be important in both understanding their pathophysiology and determining the best treatment strategy. Diabetes mellitus is twice as common in patients with chronic venous disease compared with the general population. Notably, a large proportion of patients with diabetes mellitus present with venous disorders, although this is often overlooked. The etiology of chronic venous disease is multifactorial, involving hemodynamic, genetic, and environmental factors which result in changes to the venous endothelium and structural wall as well as inflammation. Inflammation, endothelial dysfunction and hyperfiltration or leakage, are commonly observed in diabetes mellitus and cause various diabetic microvascular complications. Both diseases are also influenced by the increased expression of adhesion molecules, chemokines, and cytokines, and are characterized by the presence of vessel hypertension. Consequently, despite differences in etiology, the pathophysiology of both chronic venous disease and diabetic microangiopathy appears to be driven by endothelial dysfunction and inflammation. Treatment strategies should take the co-existence of chronic venous disease and diabetic microangiopathy into account. Compression therapy is recommended in inflammatory conditions that have an edema component as seen in both chronic venous disease and diabetes mellitus. Lifestyle changes like weight loss and exercise, will improve metabolic state and lower inflammation and should be promoted in these patients. Additionally, both patient populations may benefit from venoactive drugs.

Effect of Compression Stockings after Endovenous Laser Ablation of the Great Saphenous Vein with a 1470 nm Diode Laser Device and a 2ring Fiber.

The aim of this study was to demonstrate the effects of compression following the endovenous laser ablation (EVLA) of incompetent great saphenous veins (GSVs) using a 1470 nm diode laser (Ceralas E 1470 nm, biolitec) and a 2ring radial fiber (ELVeS Radial 2ring™, biolitec). In this single-center prospective study, 150 legs of 150 consecutive patients were randomly allocated to one of three groups (A, B, and C). Group A patients did not undergo postoperative compression. Group B patients wore a thigh-length graduated compression stocking (23-32 mmHg) for 7 days, whereas group C patients wore the same stocking for 28 days. No additional phlebectomies or sclerotherapies were performed. Investigations were performed prior to intervention, at the day of intervention (D0), at day 7 (D7), and at day 28 post intervention (D28). The primary endpoint was post-interventional pain measured on a 10-point scale. A significant but small pain decrease was observed in the first week of compression, by comparing group B's mean pain scores to those of group A (p = 0.009). Wearing a compression stocking after EVLA reduced pain within the first week on a significant, but low level. Taking the very low differences in pain levels into account, the difference may not be clinically relevant and post-treatment compression may not be necessary if no additional phlebectomies or sclerotherapies are performed.

Sclerotherapy of varicose veins with polidocanol based on the guidelines of the German Society of Phlebology.

BACKGROUND: Sclerotherapy involves the injection of a sclerosing agent for the elimination of intracutaneous, subcutaneous, and transfascial varicose veins. OBJECTIVE: To update guidelines for sclerotherapy of varicose veins. METHODS: The guidelines for sclerotherapy of varicose veins of the German Society of Phlebology were updated and modified through a review of the available literature. RESULTS: Published clinical series and controlled clinical trials provide evidence to support the elimination of intracutaneous and subcutaneous varicose veins using sclerotherapy. Allergic skin reactions occur occasionally as allergic dermatitis, contact urticaria, or erythema. Anaphylaxis is rare. Transient migraine headaches present more frequently in patients treated with foam sclerotherapy than liquid sclerotherapy. CONCLUSION: Sclerotherapy is the method of choice for the treatment of small-caliber varicose veins (reticular varicose veins, spider veins). If performed properly, sclerotherapy is an efficient treatment method with a low incidence of complications.

1470 nm diode laser for endovenous ablation (EVLA) of incompetent saphenous veins - a prospective randomized pilot study comparing warm and cold tumescence anaesthesia.

BACKGROUND: Major side effects after endovenous laser ablation (EVLA) are pain and bruising. Low temperature of the tumescence fluid might cause additional venous constriction and a cooling effect around the vein. The aim of this study was to show outcome and side effects after EVLA of incompetent great saphenous veins (GSV) with a 1470 nm Diode laser (Ceralas E, biolitec) using cold or warm tumescence fluid for anaesthesia. PATIENTS AND METHODS: Between August and November 2007, 85 consecutive patients (85 legs) with an incompetent GSV were treated by EVLA. The patients were randomized in two groups. In 42 patients (Group A) a warm (37 degrees C) and in 43 patients (Group B) a cold (5 degrees C) tumescence fluid (TF) was used for local anaesthesia in the track of GSV. All patients were re-examined after 1, 10 and 30 days clinically and by duplex for complications and occlusion in the treated vein segment. Patient's satisfaction was assessed on a 0 to 4 points scale. RESULTS: In each group one patient was lost to follow-up. There was no significant difference concerning gender, age, C of CEAP, BMI or diameter of the treated vein. In Group A a mean of 462 ml TF and in Group B a mean of 428 ml TF were used. In Group A the mean LEED (average linear endovenous energy density) was 114 J / cm and in Group B 115 J / cm. In both groups occlusion of the treated veins was achieved for all patients. The diameter of the GSV at 3 cm below the sapheno-femoral junction shrunk from 1.0 to 0.7 cm in both groups. The modified CEAP clinical score improved in Group A from 2.9 to 0.7 (mean value) and in Group B from 3.0 to 1.1. The mean pain score on a scale from 0 to 4 during day 2 to day 10 was 1.2 in Group A and 1.0 in Group B. At this time patients in Group A took a mean of 3.4 and in Group B 1.7 analgetic tablets. Ecchymoses were rare in both groups (4 in Group A, 7 in Group B). CONCLUSIONS: In this prospective randomized comparative study the temperature of the tumescence fluid did not influence the occlusion rate when a high LEED was used. In both groups pain and ecchymoses are less frequent in this study with a 1470 nm diode laser than reported in studies with 810-980 nm systems. Cold tumescence fluid reduced pain slightly and reduced the intake of analgetics significantly.

The prevalence, disease characteristics and treatment of chronic venous disease: an international web-based survey.

Aim: This study assessed the characteristics of individuals with chronic venous disease (CVD) and their treatment pathways. Materials & methods: A web-based survey enrolled representative populations of adults from Brazil, Czech Republic, France, Hungary, Italy, Romania, Russia and Spain, and identified those self-reporting CVD. Results: A total of 22% of respondents had signs/symptoms of CVD. Individuals with CVD were generally older, female and obese, and had more comorbidities than the general population. Common initial symptoms were tiredness, heaviness, pain, swelling in legs and night cramps. Participants waited ∼1 year before seeking treatment but most did not initially consult a physician; those who did tended to have more severe disease. Conclusion: One in five adults had CVD, but most did not seek a physician's help.

Tight junctions and compression therapy in chronic venous insufficiency.

Tight junctions (TJs) provide a barrier function, inhibiting solute and water flow through the paracellular space. There had been no analysis until now as to how tight junction molecules could be involved in the pathology of patients with chronic venous insufficiency. The aim of the study was to analyse the expression pattern of TJ-molecules occludin (OCLN), claudin-1 (CLDN-1), claudin-3 (CLDN-3) and claudin-5 (CLDN-5) on mRNA and protein level in patients with edema, venous leg ulcers and healthy controls. Biopsy specimens were taken in healthy individuals and in patients before, and four weeks after compression therapy. mRNA-expression was determined by using reverse-transcriptase and polymerase chain reaction (RT-PCR) and the protein-expression was determined by Western blotting from tissue specimens. Quantification performed determining the expression for TJ-molecules displayed diminished expression for CLDN-1 (p<0.01) and CLDN-5 (p<0.01) in patients with chronic venous insufficiency in comparison with healthy controls on mRNA as well as protein level. No statistical differences were detected for OCLN and CLDN-3 between the edema group and healthy controls. There was a significantly elevated expression (p<0.01) on mRNA and protein level between the leg ulcer group and healthy controls for OCLN and CLDN-3. Densitometric evaluation revealed a more significantly elevated expression (p<0.01) for CLDN-1 and CLDN-5 on mRNA and protein level after four weeks of compression therapy in comparison with prior to treatment for the edema as well as the leg ulcer group. Compression therapy tightens the paracellular barrier via elevated expression of specific TJs and prevents thereby the progression of chronic venous insufficiency due to inhibited permeability of fluid into the perivascular tissue.

Guidelines of the First International Consensus Conference on Endovenous Thermal Ablation for Varicose Vein Disease--ETAV Consensus Meeting 2012.

AIM: Endovenous thermal ablation (ETA) procedures are catheter-directed, ultrasound (US)-guided thermal methods for treatment in varicose veins disease. Radiofrequency, laser or steam energy thermally denatures vein wall collagen, leading first to vein wall inflammation, then fibrosis and finally to occlusion. The aim of this guideline is to give evidence-based recommendations for ETA procedures. METHODS: These guidelines were drafted during a consensus meeting of a group of experts in the field of ETA in June 2012 (Hvar, Croatia) under the auspices of the International Union of Phlebology (IUP). These guidelines review the present state of knowledge as reflected in peer-reviewed published medical literature. The recommendations of these guidelines are graded according to the American College of Chest Physicians Task Force recommendations on Grading Strength of Recommendations and Quality of Evidence in Clinical Guidelines. RESULTS: Recommendations on the use of ETA procedures were made based on the quality of evidence for efficacy, safety, tolerability, cosmetic outcome, patient satisfaction/preference and, where appropriate, on the experts' opinion. Health economics were not considered, since differences in national health systems and pricing make it difficult to form general conclusions that are relevant at an international level.