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Introduction: Chronic venous disease (CVD) can lead to considerable morbidity and impact health-related quality of life (HRQoL). The aim of this review was twofold: (i) to provide a deeper understanding of how CVD affects HRQoL (physical, psychological and social functioning), and (ii) to review the impact of evidence-based veno-active drugs (VADs) on HRQoL., Evidence Acquisition: For the effect of CVD on HRQoL, information was gathered during an Expert Consensus Meeting, during which data were presented from both the patient and physician perspective assessed with validated quality-of-life measures. For the impact of VADs on HRQoL, a systematic literature review was performed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Electronic databases were searched for real world evidence or randomized-controlled trials (RCT) vs. placebo, reporting data on the influence of VADs on HRQoL in patients with CVD., Evidence Synthesis: CVD can negatively affect daily life in a number of areas related to pain, physical function and social activities. The impact of CVD on HRQoL begins early in the disease and for patients the emotional burden of the disease is as high as the physical burden. In contrast, physicians tend to overestimate the physical impact. The database search yielded 184 unique records, of which 19 studies reporting on VADs and HRQoL in patients with CVD met the inclusion criteria (13 observational and 6 RCTs). Micronized purified flavonoid fraction (MPFF) was the most represented agent, associated with 12/19 studies (2 RCTs and 10 observational). Of the 6 RCTs, only MPFF, aminaphthone and low-dose diosmin provided statistically significant evidence for improvement on HRQoL compared with placebo; for the other VADs improvements in HRQoL were not statistically different from placebo. MPFF was also associated with improvements in HRQoL in the observational studies, across all CEAP clinical classes, as monotherapy or in combination with other conservative therapy, and for all aspects of HRQoL: physical, psychological, and social. Real-world data for the other VADs were scarce. Ruscus extract, sulodexide and a semi-synthetic diosmin were each represented by a single observational study and these limited data were associated with statistically significant improvements compared with baseline in overall and subdomain scores across the range of CEAP clinical classes., Conclusions: CVD can impair patients' HRQoL significantly at all stages of the disease. MPFF has the greatest evidence base of clinical use in both RCT and real-world observational studies for effectiveness on HRQoL and is recognized by international guidelines. The complete video presentation of the work is available online at www.minervamedica.it (Supplementary Digital Material 1: Supplementary Video 1, 5 min, 194 MB).

Introduction: The use of a venoactive drug is considered an important component of medical treatment of chronic venous disease (CVD), although the efficacy of certain venoactive drugs (VADs) on one or more individual leg symptoms or signs may have not been extensively studied to justify a strong recommendation in guidelines on CVD. The aim of this systematic review and meta-analysis was to study the effectiveness of the micronized purified flavonoid fraction (MPFF, Daflon®) across the spectrum of defined venous symptoms, signs, quality of life (QoL) and treatment assessment by the physician., Evidence Acquisition: On September 9, 2017, a systematic review of the databases MEDLINE, Scopus and Cochrane Central was performed, supplemented by hand searching, to identify randomized double-blind placebo-controlled trials on MPFF in patients with CVD., Evidence Synthesis: The main outcome measures were the individual and global symptoms, leg edema and redness, skin changes, QoL and evaluation of the overall effectiveness of the treatment by the physician. The effectiveness of MPFF compared with placebo was expressed as risk ratio (RR) or standardized mean difference (SMD) with 95% confidence interval (CI). Trial quality of evidence was graded using the GRADE system., Results: We identified 7 trials, mostly with low risk of bias, involving 1,692 patients. On qualitative analysis, MPFF significantly improved nine defined leg symptoms, including pain, heaviness, feeling of swelling, cramps, paresthesia, burning sensation, and pruritus (itching), but also functional discomfort compared with placebo, leg redness, skin changes and QoL. On quantitative analysis, MPFF compared with placebo, assessed as a categorical variable, reduced leg pain (RR 0.53, P=0.0001, NNT=4.2), heaviness (RR 0.35, P<0.00001, NNT=2.0), feeling of swelling (RR 0.39, P<0.00001, NNT=3.1), cramps (RR 0.51, P=0.02, NNT=4.8), paresthesia (RR 0.45, P=0.03, NNT=3.5), and functional discomfort (RR 0.41, P=0.0004, NNT=3.0). Similarly, MPFF compared with placebo, assessed as a continuous variable reduced pain (SMD -0.25, 95% CI -0.38 to -0.11), heaviness (SMD -0.80, 95% CI -1.05 to -0.54), feeling of swelling (SMD -0.99, 95% CI -1.25 to -0.73), burning sensation (SMD -0.46, 95% CI -0.78 to -0.14), cramps (SMD -0.46, 95% CI -0.78 to -0.14), and functional discomfort (SMD -0.87, 95% CI -1.13 to -0.61). Regarding objective assessments of leg edema, the use of MPFF compared with placebo reduced ankle circumference (SMD -0.59, 95% CI -1.15 to -0.02), and leg redness (SMD -0.32, 95% CI -0.56 to -0.07, RR 0.50, P=0.03, NNT=3.6), improved skin changes (RR 0.18, P=0.0003, NNT=1.6) and quality of life (SMD -0.21, 95% CI -0.37 to -0.04) and was associated with clinical improvement as assessed by the physician (RR 0.28, P<0.00001, NNT=2.5). Heterogeneity was mostly minimal. The existing evidence where sufficient was mostly of high quality., Conclusions: Based on high quality evidence, MPFF is highly effective in improving leg symptoms, edema and quality of life in patients with CVD.

Aim: Several studies have demonstrated the effective antithrombotic action of mesoglycan to treat chronic venous disease (CVD). The study aimed to assess clinical and quality of life (QoL) (CIVIQ 20 questionnaire) improvements in mesoglycan-treated patients with clinical, etiological, anatomical and pathophysiological (CEAP) stages 2 and 3., Methods: The open, multicentre, uncontrolled, observational, prospective study involved treating patients with 50 mg x 2/day mesoglycan for 2 months and measuring improvement to lower-limb edema and QoL in the Global, Physical, Pain, Psychological, and Social Dimensions of the Chronic Venous Disease Quality-of-Life Questionnaire (CIVIQ 20) at the first, baseline visit (V1), at the end of treatment (V2) and 2 (V3) and 4 months after treatment completion (V4). At the last visit (V4), patient disease status was assessed objectively (by the treating physician) and subjectively (by the patient). The study population was divided into three groups: 1) patients with only varicose veins; 2) patients with only lower-limb edema; 3) patients with varicose veins and edema (ITT population)., Results: Seventy-five centers enrolled 1066 patients (ITT population); 914 patients completed the study. Mesoglycan treatment produced significant improvement of edema and lower-limb circumference at every visit, in both patients with edema alone and those with edema and varicose veins (paired sample t-test P<0.001). QoL improved significantly in all questionnaire dimensions in all three patient groups even after treatment was concluded (V2). Improvement continued up to the end of the study observation period (V4) (paired sample t-test P<0.001). Objective clinical improvement of the underlying CVD was found in 76.82% of patients with varicose veins alone, in 82.83% of patients with edema alone, and in 76.7% of patients with varicose veins and edema. Patients' own subjective assessment of improvement was 82.0%, 79.39% and 79.39% respectively for the three groups., Conclusion: Results showed mesoglycan treatment to improve QoL significantly in patients with CVD as measured by a specific questionnaire like the CIVIQ 20. The extent of average edema reduction observed at the last visit (4 months after the end of drug treatment), suggests mesoglycan might have an etiological role, modifying the physiological factors underlying CVD and not just affording temporary improvement of symptoms.

Aim: The rates of pregnant women with functional symptoms of venous insufficiency who accepted or refused to wear therapeutic compression stockings were evaluated and compared in relation to their clinical evolution and their compliance levels., Methods: The observational study was conducted in pregnant women between 4 and 28 weeks of amenorrhea presenting a CEAP C0S to C3S venous disease. Therapeutic compression stockings (BSN medical, UltraSheer Maternity stockings, 15-20 mmHg) were offered to pregnant women satisfying the inclusion criteria during routine check visits, and both groups of patients (those who accepted as well as those who refused) were followed up until the end of the pregnancy. The clinical profiles of both groups and the evolution of the venous insufficiency were monitored and compared. The women were requested to indicate pain and further quality of life parameter by means of a specific questionnaire (CIVIQ)., Results: Ninety-eight women were included in the study and followed up; 30.6% (N.=30) of the women refused to wear compression stockings (Wr), 69.4% accepted 10.6% were not compliant to a daily wear (Wanc) and 58.8% wore them every day (Wac). Leg pain was more prominent in case of the Wac group (49.5 ± 21.3) than in case of the Wanc (42.1 ± 20.4) and Wr groups (36.6 ± 18). Their global quality also decreased (48.8 ± 15.7 vs. 43.6 ± 16.1 and 36.6 ± 15.6). Regular use of compression stockings led to decrease of pain (Wac -17 ± 10.1 vs. Wanc -10.3 ± 10.5 vs. Wr -4.2 ± 9.8 [P < 0.0001]) and enhanced total quality of life (Wac 13.5 ± 9.6 vs. Wanc 10.7 ± 11.3 vs. Wr -3.3 ± 9.4 [P < 0.0001). Similar results were observed on the CIVIQ subscale (pain, psychological, social, physical impact of legs' pain on women quality of life)., Conclusion: In daily practice, more than two third of the pregnant women accepted to wear compression stockings. The use of compression stockings reduced the legs pain and increased the quality of life of pregnant women.

Aim: Chronic venous disease (CVD) is a well-defined and known disorder which impact on related-health quality of life (QoL). However, individuals factors which determinate quality of life on CVD are not well defined. The purposes of this study were to describe the QoL in patients with CVD and examine socio-demographical and clinical factors which influence QoL METHODS: One thousand five hundred sixty patients with CVD were evaluated. We calculated for each patient two disease-specific severity scores: The "C" grade (clinical) of the CEAP classification and the Venous Clinical Severity Score (VCSS). Additionally, two QoL questionnaires were recorded: Short-Form Health Survey (SF-12) and Chronic Lower Limb Venous Insufficiency Questionnaire (CIVIQ-20). Two multivariate logistic regression analyses (SF-12 and CIVIQ-20 model) were conducted to determine whether demographic and clinical variables were independently associated with QoL., Results: Both QoL questionnaires indicated that the QoL decreased significantly (P<0.05) as the C grade of CEAP increased. Each increase of 0.10 in VCSS score represented 2% worsening in QoL as measured by CIVIQ-20. Three factors were strongly associated with poor QoL on SF-12: increasing age, prior superficial venous thrombosis (SVT) or prior deep venous thrombosis. In the specific disease CIVIQ-20 questionnaire three factors (higher age, prior SVT and higher weight) were strongly associated with decrease QoL., Conclusion: Increasing disease severity by VCSS is associated with reductions in QoL. Subgroup analysis indicates that there are several significant individual determinants of worsening QoL.

Aim: The present study assessed the effect of Ruscus aculeatus, hesperidin methyl-chalcone and ascorbic acid (HMC-AA), in the treatment of chronic venous disorders (CVD) in Latin American patients., Methods: This study is an observational, single arm, multicentric and prospective trial. Patients suffering from CVD and belonging to C0s-C3 Clinical Etiological Anatomical and Physiopathological (CEAP) classes were included. Patient profiles, risk factors, clinical symptomatology and quality of life (QoL) assessed by SF-12 and CIVIQ questionnaires were evaluated at inclusion and after 12-week treatment., Results: The main factors influencing the previous management of patients were age, gender, body mass index (BMI), familial history, physical activity, exposure to heat, heavy loads lifting, profession and clinical characteristics. All clinical symptoms significantly improved with treatment and, as BMI and CEAP classes increased. Ankle circumferences decreased over time, correlating with BMI and CEAP classes. The physical and psychological dimensions of the SF-12 score significantly increased over time and improved within each CEAP class. The CIVIQ score significantly improved over time, correlating with age and CEAP classes., Conclusion: A 12-week treatment with Ruscus aculeatus HMC-AA showed a significant decrease in the clinical symptoms and a significant improvement in the QoL of patients with CVD.

Aim: Although compression therapy is the corner stone of phlebological therapy, less is known about the patients' view of compression. The aim of the study was to answer the following questions: Are there differences in the use of compression and the quality of life during compression therapy depending on the device (bandages, stocking [medical compression stockings, MCS], length, compression class) or indication of compression?, Methods: Questioning of 200 consecutive phlebological patients (C2-C6) with a compression therapy time of >2 weeks. Analysis of 110 returned questionnaires (rate of return 55%)., Results: Twenty-nine point one percent voted the therapy as "comfortable". About 37% of the patients had an improvement of their leg symptoms by using compression therapy. Most patients (105/110) wore their compression therapy for more than 6 hours/day. The main side effects were dryness of the skin (58.5%), itching (32.7%), slipping (29.1%) or constriction of the compression device (24.5%). There were no significant differences in the side effect spectrum or the usage according to the type of compression device or the indication for the treatment (varicose surgery/ sclerotherapy). Patients with a leg ulcer and longer duration of compression therapy experienced a worse quality of life., Conclusions: Patients accept the recommended compression therapy (alone or in combination with other phlebological therapies) as a necessary therapy. Compression devices are really used by the patients. According to the main side effect (dryness of the skin), improvement is essential (skin care, caring MCS). Especially patients with indication for a long-term or even life-long compression therapy should be advised in detail.

Aim: The aim of this paper was to evaluate the efficacy of the concomitant use of endovenous laser treatment (ELT) and ultrasound-guided foam sclerotherapy (USGFS) in the management of chronic venous disorder and to objectively analyze the influence of the combination therapy on the Health Related Quality of Life (HRQL) of the treated patients., Methods: In this prospective series, 1 114 varicose veins in 924 consecutive subjects were treated either with a 980 nm (7-15W) or a 1320 nm (3-10W) endovenous laser., Inclusion Criteria: informed consent, clinical, etiologic, anatomical, and pathophysiological (CEAP) clinical class >or=2, and an accessible vein., Exclusion Criteria: coagulation disorder, pregnancy, lactation, current thrombosis, systemic disease, poor general health, or allergy to sodium tetradecyl sulfate (STS). ELT was performed on refluxing saphenous truncal and non-saphenous veins, including incompetent perforators. USGFS was utilized to treat selective refluxing, symptomatic varicose tributaries that were not amenable to ELT alone. The Venous Dysfunction Score (VDS) and Health Related Quality of Life (HRQL) were assessed. All of the patients were strictly monitored and had Duplex ultrasound scanning to evaluate for deep vein thrombosis (DVT) at 24-72 hours. Thorough Duplex scanning was done at 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months., Results: At 1 month, there was continued reflux (> 0.5 seconds) in 26 SFJs (3.0%, N=824) and 4 SPJ s (2.5%, N=155) and at 3 months in 15 SFJs (1.8%), 5 SPJ s (3.7%). At 6 months, reflux was present in 10 SFJs (1.2%) and 4 SPJs (2.5%). At a mean of 12+/-10 months of post-treatment follow-up, 4 SFJ (1.9%, N=207) and 1 SPJ (1.9%, N=52) had reflux. Overall, there was elimination of reflux in 98% of junctions. The posterior accessory saphenous veins (PAV: N=117) had 100 % elimination of reflux at 1 month, a result that remained unchanged for more than a year (P<0.001). Similarly, anterior accessory saphenous veins (AAV: N=56), cranial, caudal, or thigh, extensions of the small saphenous vein (CESSV: N=31), and non-saphenous veins and incompetent perforators (NSV, IP: N=31) all had sustained and statistically significant response (P<0.001). Sequentially assessed VDS showed significant improvement (P<0.001). The Aberdeen Varicose Vein Questionnaire (AVVQ) revealed significant improvement in HRQL at 1-2 year (P<0.001). Failed ELT attempts occurred in six cases due to vein spasm (N=4, 0.36%) or fiber/laser machine malfunction (N=2, 0.18%). These veins were successfully treated with ultrasound-guided foam sclerotherapy. Thirty-two patients (2.9%) complained of a small area of numbness at one month. There was complete resolution in 6 (18.8%) of the patients by 6 months. There were four cases of a localized cellulitis at laser venous access sites. These resolved uneventfully with oral antibiotics. There were also two skin reactions, with localized urticaria, due to dressing tape. These required no additional treatment. There were two cases of superficial phlebitis that resolved with continued compression and NSAIDs. There was one asymptomatic popliteal DVT and one uncomplicated superficial skin burn that both resolved uneventfully with no treatment other than observation. No pulmonary embolism (PE), thrombophlebitis, or visual disturbance occurred., Conclusions: Ultrasound-guided foam sclerotherapy given concomitantly with ELT is safe and highly efficacious in the management of GSV, SSV reflux and in their tributaries or in non-saphenous veins. CVD patients treated with combination therapy given in this manner demonstrated significant improvement in their HRQL.

Aim: Manual Lymphatic Drainage (MLD) may increase the quality of life (QoL) of patients with chronic venous disorder (CVD). The aim of the study was to determine the effect of MLD in patients with CVD who were candidates for venous surgery., Methods: Patients with CVD selected for elective venous surgery were randomly divided into 2 groups (N.=20). In the preoperative period, patients in the MLD group underwent MLD 3 times a week for 5 weeks. Patients in the control group did not undergo MLD. Both groups were evaluated for CVD staging on the day of selection for surgery and again 25 days after surgery. CVD staging was evaluated by: HADs (Hospital Anxiety and Depression scale), CEAP classification and Venous Reflux Index (VRI)., Results: Mean parameter values in the MLD group (before treatment/after MLD/after surgery): Anxiety 12.85/8.85/4.95, Depression 9.40/6.30/3.00, VRI 0.39/0.25/0.17, CEAP 3.60/2.95/1.55. Parameter values in the control group (before treatment/after surgery): Anxiety 10.95/3.45, Depression 7.55/2.20, VRI 0.30/0.10, CEAP 3.55/1.80. In the MLD group there was improvement of QoL (P<0.05) and clinical stage according to the CEAP scale (P<0.05), and VRI (P<0.03)., Conclusions: After surgery, the MLD group had significantly better results than the control group in CEAP score (P<0.05) and had comparable results for QoL. MLD improved (P<0.05) VRI, CEAP score, anxiety and depression states. MLD can be an alternative or a supplementary procedure for patients surgically treated.

Aim: Even though compression therapy is the most recommended treatment for chronic venous insufficiency (CVI) in the national and international guidelines, its application, at least in Italy, is lower than the estimated need from the prevalence of CVI in the epidemiological studies. Since we believe that the measurement of the impact of compression therapy on quality of life (QoL) could improve the compliance for this precious treatment, we carried out this study on 50 patients with CVI., Methods: Fifty patients (23 CEAP C2 and 27 C(3-4-5), selected within a larger study on QoL in CVI), received a prescription for compression therapy. Before treatment and 4 months afterwards, the patients received the instrument for QoL assessment (MOS SF-36; CIVIQ-2; Euro-QoL 5D and a visual analogue scale). The score scales have been adjusted to poorest QoL as 0 and best QoL as 100., Results: Baseline QoL of patients in class C2 did not show significant difference with the healthy Italian Population, except for the physical role item. The patients in class C(3-4-5) showed significant reduction of QoL. After 4 months all the items of the utilized instrument showed significant improvement (from P<0.01 to P<0.04 for SF-36; from P<0.099 to P<0.006 for other instruments) in all CEAP classes., Conclusions: The study unquestionably shows that the compression therapy improves the QoL of patients with CVI, and should be included in the CVI treatment covered by the Public National Health Insurance. Finally, the QoL measurement could be utilized as the scientific method to assess the effectiveness and efficacy of different therapeutic devices.

Aim: Chronic venous insufficiency (CVI) is a chronic disease, whose disability has not been appreciated clearly, and several treatment costs are not covered by Public Health Service, probably because its any social impact is not well known. The aim of the study was to assess the impact of CVI on quality of life (QoL), and to compare the sensitivity of more diffused instruments for QoL assessment., Methods: One hundred and four patients with CVI received the Italian version of four QoL assessment instruments (MOS SF-36; CIVIQ-2; Euro-QoL 5D and a visual analogical scale). The poorest QoL was adjusted as 0, the best as 100. After filling the questionnaires, patients underwent a clinical and instrumental examination to assess the diagnosis according to the CEAP classification., Results: The QoL is progressively impaired from CEAP class C1 to class C5-6. The SF-36 showed a normal QoL in patients of CEAP class C1 and C2. Class C3 showed a significant (P<0.0018) reduction of QoL (physical role and bodily pain), and the decline was more significant (P<0.0001) in class C4, involving all physical items and several mental ones. Class C5-6 showed very low scores of physical and social functioning, general health and vitality. Physical and emotional scores were better than C4 patients., Conclusions: QoL is progressively impaired in CVI, involving primarily the physical items and the emotional role, with worsening of mental items only in advanced stages. This early involvement of physical items underlines how CVI is not an esthetic problem, but, a disease. Its impact on the lifestyle and QoL is similar to that of other chronic diseases (diabetes, cancer, chronic pulmonary disease), reaching in the class C5-6 the poorest level, similar to heart failure.

Aim: In order to provide a practical instrument for quality of life measures, for researchers and primary care physicians in Greece, we decided to translate and validate the published postal questionnaire CIVIQ (Chronic Venous Insufficiency Questionnaire) into the Greek language., Methods: The study took place in 2 vascular surgical clinics. Fifty patients with known chronic venous insufficiency (CVI) were asked to complete the questionnaire. A debriefing method was used for the cultural adaptation. To measure test-retest reliability, 50 patients with known CVI disease, were asked to complete the questionnaire., Results: The adaptation of CIVIQ questionnaire in the Greek language demonstrated its good validity (Cronbach's alpha=0.92) and reproducibility (coefficient = 0.98)., Conclusions: CIVIQ seems to be a reliable tool in helping to assess the health status of the Greek general population and could be used to contribute to the identification of the magnitude of the problem of CVI in the Greek setting.