Cross-sectional study on heredity and venous disorders: the end of the dominant maternal heredity dogma?

OBJECTIVE: To evaluate the heredity factor of the chronic venous disorders and odds ratio linked to maternal or paternal heredity. METHODS: Cross-sectional epidemiological study conducted in daily practice of medical practitioners on all patients consulting them. The practitioners described the venous status of all patients consulting them and recorded the familial past history of venous disease. RESULTS: Among 21319 patients, 60.4% have a familial history of chronic venous disorder: unilateral paternal 7.5%, unilateral maternal 40.9% and bilateral: 12.0%. Chronic venous disorder prevalence is 58.8% in the global population, 38.2% in the absence of parental history, 67.0% for unilateral paternal, 71.3% for unilateral maternal and 79.2% for bilateral (p < 0.0001). After adjustment on age and sex, results show significant (p < 0.0001) odds ratio of 3.2 for unilateral paternal, of 3.4 for unilateral maternal and of 5.6 for a history in both parents. In the context of a history in both parents, the odds ratio increased to 5.6 for women and 8.4 for men. CONCLUSION: This large cross-sectional study confirms the association between heredity and venous disease, but its results could call into question the maternal predominant character of the chronic venous disorder heredity.

European guidelines for sclerotherapy in chronic venous disorders.

AIM: Sclerotherapy is the targeted chemical ablation of varicose veins by intravenous injection of a liquid or foamed sclerosing drug. The treated veins may be intradermal, subcutaneous, and/or transfascial as well as superficial and deep in venous malformations. The aim of this guideline is to give evidence-based recommendations for liquid and foam sclerotherapy. METHODS: This guideline was drafted on behalf of 23 European Phlebological Societies during a Guideline Conference on 7-10 May 2012 in Mainz. The conference was organized by the German Society of Phlebology. These guidelines review the present state of knowledge as reflected in published medical literature. The regulatory situation of sclerosant drugs differs from country to country but this has not been considered in this document. The recommendations of this guideline 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: This guideline focuses on the two sclerosing drugs which are licensed in the majority of the European countries, polidocanol and sodium tetradecyl sulphate. Other sclerosants are not discussed in detail. The guideline gives recommendations concerning indications, contraindications, side-effects, concentrations, volumes, technique and efficacy of liquid and foam sclerotherapy of varicose veins and venous malformations.

Treatment of chronic venous disease with flavonoids: recommendations for treatment and further studies.

OBJECTIVES: A variety of studies have suggested that flavonoids are effective for the treatment of CVD. However, many questions remain about their mechanism of action and when, how, and for what signs and symptoms they should be used. METHOD: A panel of experts in CVD met in Budapest, Hungary in December 2011 to discuss the current state of knowledge of CVD and the role of flavonoids in its treatment. The discussion was based on a literature search in the current databases. The goals of this paper are recommendations for further studies on the use of flavonoids in the treatment of CVD. RESULTS: There is good evidence to recommend the use of flavonoids in the treatment of CVD. However, because of the poor quality of some older clinical trials, inadequate reporting, and insufficient information, much work is still needed to firmly establish their clinical efficacy and to determine when and how they should be employed. In particular, long-term randomized, placebo-controlled, double-blind studies are needed to establish the efficacy and safety of flavonoids. Additional studies are also needed to establish their mechanism of action, pharmacokinetics, toxicity, and cost-effectiveness. CONCLUSIONS: Aside from good evidence for the use of flavonoids in CVD further studies are indicated to establish long term treatment in this indication.

Epidemiology of chronic venous disorders in geographically diverse populations: results from the Vein Consult Program.

AIM: The Vein Consult Program is an international, observational, prospective survey aiming to collect global epidemiological data on chronic venous disorders (CVD) based on the CEAP classification, and to identify CVD management worldwide. The survey was organized within the framework of ordinary consultations, with general practitioners (GPs) properly trained on the use of the CEAP classification. METHODS: Screening for CVD was to be performed by enrolling in the survey all consecutive outpatients >18 years whatever the reason for consultation, to record patient's data and classify them according to the CEAP, from the stage C0s to C6. The program enrolled 6232 GPs 91545 subjects were analysed. Their mean age was 50.6±16.9 years, younger patients being in the Middle East and older ones in Europe, and the proportion of women was higher than that of men. RESULTS: The worldwide prevalence of CVD was 83.6%: 63.9% of the subjects ranging C1 to C6, and 19.7% being C0s subjects. C0s patients were more frequently men whatever the age and the geographical zone. C1-C3 appeared to be more frequent among women whatever the country but the rate of severe stages (C4-C6) did not differ between men and women. GPs consider CVD subjects as patients eligible to specialist referral beginning from C2 but some geographical disparities were observed. CONCLUSION: The VCP survey provides reliable results on CVD global epidemiology and shows that CVD affects a significant part of the populations worldwide, underlining the importance of adequate screening for CVD and training of both GPs and specialist physicians.

Importance of patient-reported outcomes in chronic venous disorders.

The assessment of outcomes following treatment for chronic venous disease has been greatly improved over the last three decades. The personal opinion of the physician based on assessment of his own results has been replaced by more objective assessment based on well-defined criteria. The author describes and compares a number of different methods currently in use for this purpose.

Quality of life improvement in Latin American patients suffering from chronic venous disorder using a combination of Ruscus aculeatus and hesperidin methyl-chalcone and ascorbic acid (quality study).

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.

The patient's burden of chronic venous disorders: construction of a questionnaire.

AIMS: On the one hand, the survey aims at the development and validation of an auto-administered questionnaire designed to measure the everyday burden caused by chronic venous disorders (CVDs). On the other hand, it aims at reporting initial epidemiological and demographic data in CVD patients and their correlations. MATERIALS AND METHODS: After identification of 66 possible items, the elimination of redundant and less relevant questions left a questionnaire of 36 simple items, the Assessment of Burden in Chronic-Venous Disease (ABC-V) that has been applied prospectively and consecutively to a population of 328 actual chronic venous disorder (CVD) patients in eight vein-specialized centres in France. Questionnaires were completed by patients at home and returned by mail (free return envelopes). RESULTS: Significant correlation has been found between ABC-V, the Specific Quality of life & Outcomes Response - Venous (SQOR-V) and the Centre for Epidemiologic Studies Depression Scale (CES-D), demonstrating the validity of the concept. ABC-V has been found increased by age (P = 0.0127) and body mass index (P < 0.001), not by gender (P = 0.8758). CONCLUSION: ABC-V is a first tool to assess the burden of CVDs, it provides with individual data and will help, for instance, determining the weight of the coefficient used in the disability-adjusted life year and quality-adjusted life year formulas, thus ensuring an accurate evaluation of the Global Burden of Chronic Venous Disorders.

Pathophysiology of visual disturbances occurring after foam sclerotherapy.

BACKGROUND: Visual disturbances (VDs) are reported with an average rate of 1.4% after foam sclerotherapy (FS). Some clinical clues indicate that they could correspond to migraine with aura (MA). AIMS: To validate the hypothesis that VDs occurring after FS correspond to MA and are not transient ischaemic cerebro-vascular events. METHOD: A prospective multicentre study was carried out by the French Society of Phlebology in collaboration with the Neurology Department of the Marseille University Hospital (France). We included prospectively and consecutively all patients who experienced VDs after FS using air to make the foam. The patients were assessed (1) clinically with a specific form describing procedures of FS and recording neurological symptoms, later analysed by a neurologist specialized in migraine; and (2) by a brain diffusion-weighted magnetic resonance imaging (MRI) (T1, T2, T2*, diffusion) carried out within two weeks and analysed by a neuroradiologist. RESULTS: Twenty patients, 16 women and four men, were included in 11 phlebology clinics. All kinds of veins were treated. VDs occurred in average seven minutes after FS. Clinical assessment showed that VDs presented characteristics of MA in all patients, with headache in 10 and without in 10. Paresthesia was observed in five patients and dysphasic speech disturbance in one. Fifteen patients (75%) had a personal history of migraine. Fifteen MRIs were performed within two weeks (mean: 8 days) and three were late (26 days). All of them were normal. MRI was not performed in two patients. CONCLUSION: These results show that VDs occurring after FS correspond to MA and are not transient ischaemic cerebro-vascular events. We suggest a pathophysiological hypothesis resting on the release of endothelin that would reach the cerebral cortex through a paten foramen ovale.

Complications and side-effects of foam sclerotherapy.

AIMS: To describe and report incidence and frequency of side-effects and complications of sclerotherapy with foamed sclerosing agents. To explain, when possible, their pathophysiology and to indicate possible manoeuvres and techniques to limit them. METHODS: Review of current literature and personal research. RESULTS: Complications of foam sclerotherapy include complications of sclerotherapy in general and specific complications of foamed sclerosing agents. Side-effects related to the sclerosing compounds are also taken into account. CONCLUSION: Complications and side-effects of careful foam sclerotherapy remain uncommon. However, more research is needed to understand them better and to further reduce their incidence. Their description to patients in the course of the informed consent is a prerequisite to any sclerosing treatment.

Assessment of quality of life in Mexican patients suffering from chronic venous disorder - impact of oral Ruscus aculeatus-hesperidin-methyl-chalcone-ascorbic acid treatment - 'QUALITY Study'.

OBJECTIVES: The present study assessed the effect of Ruscus aculeatus-hesperidin-methyl-chalcone-ascorbic acid (HMC-AA) on the quality of life (QoL) of patients suffering from chronic venous disorders (CVDs). METHODS: An observational, multicentre and prospective study was performed with 917 Mexican patients suffering from CVD. Patients were treated with R. aculeatus-HMC-AA. After 12 weeks of treatment, the physicians then assessed the patients' symptoms and QoL using Short Form (SF-12) and Chronic Venous Insufficiency (CIVIQ) auto-questionnaires. RESULTS: Patients were mainly women (86.7%), overweight or obese (72.7%) or C2 (39.3%)-C3 (27.6%). All symptoms and ankle circumferences significantly improved over time, with increasing clinical, aetiological, anatomical and pathophysiological (CEAP) classes and body mass index (BMI) (P < 0.001). Concerning QoL, all dimensions of the SF-12 score significantly improved over time (P < 0.001). Moreover, the CIVIQ scores significantly improved (P < 0.001) with increasing BMI (P < 0.002) and CEAP classes (P < 0.05). CONCLUSION: R. aculeatus-HMC-AA significantly improved the symptoms and QoL of CVD patients.

Side-effects and complications of foam sclerotherapy of the great and small saphenous veins: a controlled multicentre prospective study including 1,025 patients.

OBJECTIVES: Increasing interest in foam sclerotherapy (FS) for saphenous insufficiency has highlighted the need to study the side-effects and complications of this treatment. The aim of this study is to better assess their nature and incidence. METHODS: A multicentre, prospective and controlled study was carried out in which patients treated with FS for great (GSV) and small saphenous veins (SSV) trunk incompetence were included. Immediate untoward events were reported. Duplex ultrasound (DUS) examination was carried out to assess all patients between the eighth and 30th day. In addition, 20% of patients were called by an external auditor. RESULTS: In total, 818 GSV and 207 SSV were treated in 1025 patients in 20 phlebology clinics. Ninety-nine percent of patients were controlled with DUS and non-duplex-checked patients were all called. The saphenous trunk was occluded in 90.3% of patients. Twenty-seven (2.6%) side-effects were reported: migraine (n = 8, 4 with visual disturbance); visual disturbance alone (n = 7); chest pressure alone (n = 7); and chest pressure associated with visual disturbance (n = 5). Eleven thrombo-embolic events occurred: 10 deep vein thrombosis (DVT) but only five in symptomatic patients, and one pulmonary embolism that occurred 19 days following the FS without DVT identified by DUS. One transient ischaemic stroke, with complete clinical recovery in 30 minutes, and one septicaemia with satisfactory outcome were reported as well. CONCLUSION: This study demonstrates in a large sample of patients a low rate of adverse reactions after FS of great and small saphenous trunks. However, but the eventuality of exceptional but more serious complications has to be taken into account in the management of patients. A multicentre study like this one takes into account different practices and reports all possible complications, thus demonstrating the need for a common validated protocol.

Construction and validation of a patient-reported outcome dedicated to chronic venous disorders: SQOR-V (specific quality of life and outcome response - venous).

BACKGROUND: Chronic venous disorders (CVD) have an impact on quality of life (QoL), both physically and psychologically. As of now, several vein specific QoL scales exist, but no patient-reported outcome (PRO) is available which takes into account altogether symptoms, impairment of activities, appearance of the legs and concerns regarding health risk. Since clinical severity and disability are mostly evaluated in severe patients, where the main outcome - namely skin changes - is obvious but rare, the authors considered that a reproducible and clinically relevant survey that could account for specific patients' complaints was needed, particularly for CEAP C0s-C3 patients. OBJECTIVES: The objective of this study was to build a specific autoquestionnaire and to establish its statistical validity and clinical relevance. METHODS: A review of existing questionnaires and an analysis of relevant literature were carried out by a committee of experts. The committee then developed a questionnaire of 46 items, with special attention to relevance for venous disorders and patients' main complaints. After construction, the French version was field-tested and results statistically analyzed. In the specific QoL & Outcome Response - Venous (SQOR-V), each item is given a value by the patient and items are grouped in five dimensions. Each dimension is weighed to a maximum value of 20, yielding an overall maximum score of 100. RESULTS: Two hundred and two questionnaires were analyzed for the initial evaluation and 152 at a second (test-retest). Determination of the Cronbach's alpha coefficient (0.96) and structural analysis demonstrated an excellent internal and structural coherence. Test-retest comparisons confirmed good reproducibility. Comparison with SF-12 and CED-D questionnaires and with CEAP classification groups verified both structural and clinical validity. CONCLUSIONS: This study demonstrates QoL impairment in patients suffering from chronic venous disorders (CVD). It also verifies the statistical validity of the SQOR-V questionnaire. More studies are needed to demonstrate the improvement in specificity and accuracy this questionnaire provides compared to existing vein-specific QoL scales, and to determine its ability to assess efficacy of any kind of treatment at any stage of the disease. Provided adequate acknowledgment of its authors, the use of SQOR-V is free. An English version is available, currently pending validation.

[Contra indications of sclerotherapy, update 2005]. / Les contre-indications de la sclérothérapie, mise à jour 2005.

BACKGROUND: Modern sclerotherapy, using ultrasound guidance and foam sclerosants, is a reference treatment of varices of the lower limbs. Like all other techniques it should be employed in the safest, precisely described and reproducible conditions. Therefore, its contra indications must be clearly known. METHODS: Contra indications of sclerotherapy can be defined in legal notices provided by the manufacturers in compliance with regulatory standards, developed empirically, extrapolated from theoretical mechanisms, or analyzed from controlled studies. RESULTS: Contra indications can be patient-, method-, or sclerosing agent-related. Legal notices (France) are different for the different available sclerosing agents, and often outdated. We can note principally: hypersensitivity, fever, phlebitis, childhood, and pregnancy. Chromated glycerin should be avoided in patients with chronic renal insufficiency. Intra-arterial injections are prohibited (obviously), and the treatment of huge veins as well. Association with disulfirame is contra indicated. We must of course add: bed rest, severe systemic diseases, poor patient understanding, needle phobia, short life expectancy, late stage cancer, known allergy to the sclerosing agent, and treatment with tamoxifen. Previous medical history of deep vein thrombosis and thrombophilia could be theoretical contra indications and are currently under evaluation. Oral anticoagulation is not a contra indication provided the situation is stable and the causal disease is not a contra indication in itself. Pregnancy is not usually a period when sclerotherapy is useful or urgent, according to some authors it can be carried out anyway. In children, sclerotherapy of venous malformation is now a reference treatment. Thanks to progress in ultrasound guided sclerotherapy with foam, the size of the veins is no more an issue, neither is a difficult access to the varix. CONCLUSIONS: Sclerotherapy is now based on seriously documented evidence. It is safe and efficient. Its contra indications are exceptional, usually non-specific. It can be used safely for fragile or elderly patients.

Chronic venous disease: health status of a population and care impact on this health status through quality of life questionnaires.

AIM: There is growing interest for patient-reported outcomes (PROs) in clinical research. Application of quality of life (QoL) questionnaires to patients suffering from chronic venous disease (CVD) is thought to be an important improvement in the assessment of results in these complex disorders. The aims of the study were to describe the health status of female patients suffering from CVD, and to assess the care impact through QoL questionnaires. METHODS: Symptomatic female patients suffering from CVD (all CEAP clinical classes), aged over 18, newly treated by their general practitioner with a phlebotropic drug were enrolled in the study. Every patient had to complete a self-questionnaire including the SF-12, the CES-D, the Epworth and the CIVIQ scales at day 0 (D0), day 3 (D3) and day 7 (D7). The CIVIQ scale assesses pain and the psychological, physical and social consequences of CVD. The SF-12 is a generic measure of health status. The CES-D scale studies presence of depressive symptoms (DS) in the general population. The Epworth scale measures daytime sleepiness. RESULTS: A total of 765 physicians took part in the survey from April to August 2003. The results of the study concern 1 045 patients. Analyses are realized on the 399 patients who filled out all 3 questionnaires. Mean age was 45 years (SD=11), patients average height was 164.39 cm (SD=5.99) for an average weight of 65.2 kg (SD=12.5). Concerning change in QoL between inclusion and Day 7, the mean CIVIQ total scores at inclusion were 26.7 in the CEAP class 0-2 group and 36.3 in the CEAP class 3-6 group. The mean CIVIQ total scores at D7 were 18.5 in the CEAP class 0-2 group and 27.3 in the CEAP class 3-6 group. The mean CIVIQ total scores demonstrated that QoL is more impaired for patients in the CEAP class 3-6 group. In both groups, an improvement in patients' QoL was observed following patient management (P<0.001). At inclusion time, MCS-12 and PCS-12 were respectively 44.7 (SD=10.6) and 46.4 (SD=8.4): at day 3 and day 7, these dimensions were respectively: D3: 46.5 (SD=10.2) and 46.2 (SD=8) D7: 48 (SD=10.3) and 46.2 (SD=7.8). For the mental dimension, the difference was statistically significant (P=0.0001). In our study a possible DS (score ?17) was reported for 36.3%, 32.3% and 29% respectively at day 0, D3 and D7 (P<0.01, n=328). Concerning daytime sleepiness the Epworth mean total score showed a decrease in daytime sleepiness for patients with severe CVD (C3-C6) between day 0 and D 7 (P=0.02). CONCLUSIONS: Our study demonstrates the high impact of CVD on health status and the validity of QoL questionnaires in this pathology. They show a significant improvement of the QoL after one week of medical management.

Edema and leg volume: methods of assessment.

Various techniques may be used to assess leg edema. The value of these investigations has been discussed in depth in the consensus statement made in Vaux de Cernay in 1997 and supported by Servier Research Group. These techniques can be classified into three groups: The most simple is leg circumference measurement, which can be assessed by a tape measure, or more rigorously with a Leg-O-Meter. This device is a cheap and reproducible method that has been validated and that takes into account the height at which the circumference has been measured. However, circumference measurement is not always correlated with leg (including foot) volume measurement. The second group of techniques assess leg volume. The most simple method is water displacement volumetry, which has been validated in terms of reproducibility. Several other devices have been used: optoelectronic methods, computed tomography, magnetic resonance imaging (high resolution), dual X-ray absorptiometry. These methods are expensive and not all of them have been validated, but these might be the future investigations of choice. Some other investigations assess immediate variations in volume such as water displacement using dynamic foot volumetry, rheoplethysmography, strain gauge plethysmography, and air plethysmography. The assessment made by these methods (using postural, dynamic, or compressive maneuvers) is more an assessment of the venomuscular pump and/or venous outflow than volume assessment. In conclusion, edema, an early and frequent sign of chronic venous insufficiency (CVI), can be precisely measured by several methods. This measurement can be considered one of the most objective ways of assessing treatment efficacy in CVI-associated edema.