Venous leg symptoms, ecchymosis, and coldness in patients with peripheral varicose vein: A multicenter assessment and validation study (VEIN-VIOLET study).

OBJECTIVES: We aimed to evaluate peripheral varicose vein symptoms including ecchymosis and coldness by using the Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms (VEINES-QoL/Sym) questionnaire. METHODS: A total of 1120 patients were enrolled to the analysis after the exclusion of 199 patients who did not match the inclusion criteria. Patients were asked to answer the VEINES-Sym questionnaire and questions about ecchymosis and coldness. Scores of ecchymosis and coldness were calculated similar to VEINES-Sym questionnaire. Classifications of peripheral varicose vein were made according to the clinical part of clinical, etiological, anatomical, and pathophysiological classification system and patients with grade 2 or higher were considered as positive for peripheral varicose vein. RESULTS: Frequency of symptoms present in the VEINES-Sym instrument, ecchymosis and coldness were significantly higher in patients with peripheral varicose vein. Mean score of each symptom was significantly lower in peripheral varicose vein patients including scores of ecchymosis and coldness. Logistic regression analysis revealed that presence of hemorrhoids and all symptoms in VEINES-Sym questionnaire except restless leg were significantly and independently associated with peripheral varicose vein. Besides, ecchymosis (odds ratio: 2.04, 95% confidence interval: 1.34-3.08, p = 0.008) but not coldness was significantly and independently associated with peripheral varicose vein. There was also significant correlation of VEINES-Sym score with ecchymosis (r = 0.43, p < 0.001) and coldness (r = 0.47, p < 0.001). CONCLUSIONS: Venous leg symptoms present in VEINES-Sym questionnaire except restless legs, presence of hemorrhoids and ecchymosis are significantly and independently associated with peripheral varicose vein. Not only ecchymosis but also coldness has shown an independent association with total VEINES-Sym score.

Effect of endovenous ablation assessment stratified by great saphenous vein size, gender, clinical severity, and patient-reported outcomes.

OBJECTIVE: The policies of insurance carriers have used the truncal vein size as a criterion for coverage. The objective of the present study was to compare the effect of great saphenous vein (GSV) size ≥5 mm vs <5 mm on patient presentation and clinical outcomes. METHODS: Patients in a national cohort were prospectively captured in the Vascular Quality Initiative Varicose Vein Registry. From January 2015 to October 2017, the Vascular Quality Initiative Varicose Vein Registry database was queried for all patients who had undergone varicose vein procedures. The CEAP (clinical, etiologic, anatomic, pathophysiologic) classification, Venous Clinical Severity Score, and patient-reported outcomes were compared by GSV size (<5 mm, group 1; ≥5 mm, group 2) before and after the procedures. A 2-sample Wilcoxon test was performed to assess the differences between the 2 groups stratified by GSV size. To assess for postoperative improvement, a matched-pairs Wilcoxon signed rank test was performed for each group separately. RESULTS: During the study period, 5757 vein ablation procedures had been performed for GSV: 770 for GSV size <5 mm and 4987 for GSV size ≥5 mm. Patients in group 1 were more likely to be women (81.7% vs 68.4%; P = .001) and older (56.8 vs 55.6 years; P = .012). The CEAP clinical class was more advanced in group 2 than in group 1 (P = .001). The maximal GSV diameter in group 2 was significantly greater than in group 1 (8.32 vs 3.86 mm; P = .001); 64% of group 2 and 59.2% of group 1 had undergone radiofrequency thermal ablation (P = .001). No mortalities occurred in either group. Group 2 had more complications postoperatively (0.6% vs 0%; P = .027), required postoperative anticoagulation (8.8% vs 5%, P = .001), developed partial recanalization (0.8% vs 0.3%; P = .001), and missed more work days (2.32 vs 1.6 days) compared with group 1. A similar rate of hematoma developed in both groups, but group 1 had a higher rate of paresthesia. Both groups had improvement in the Venous Clinical Severity Score and HASTI (heaviness, achiness, swelling, throbbing, itching) score. The degree of symptomatic improvement between the 2 groups was similar. CONCLUSIONS: All patients demonstrated improvement in both clinical outcomes and patient-reported outcomes after endovenous ablation, regardless of GSV size. Patients with a preoperative GSV size ≥5 mm experienced similar improvement in symptoms but an increased complication rate. Patients with a smaller vein size should not be denied intervention or coverage by vein size.

Validation of a Swedish version of a short patient-reported outcome measure for superficial venous insufficiency.

OBJECTIVE: Patient-reported outcome measures (PROMs) are increasingly used to measure symptoms and treatment effects, and a short PROM is more user friendly. The aim of this study was to test whether a Swedish seven-item version of the PROM used in the Vascular Quality Initiative Varicose Vein Registry can be used to measure quality of life in a Swedish cohort of patients with superficial venous insufficiency (SVI) equally well as the 26-item Swedish version of the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym-S) and measure treatment effect. METHODS: Consecutive patients with SVI and Clinical-Etiology-Anatomy-Pathophysiology (CEAP) clinical class ≥C2 were recruited at three private clinics and one county hospital between January 2018 and October 2019. The patients were asked to answer both the VEINES-QOL/Sym-S and the Swedish seven-item version, called VARIShort, at two assessment points, baseline (cohort 1, 252 patients) and 1 week later (cohort 2, 138 patients), and the VARIShort at baseline and 8 weeks after an endovenous procedure (cohort 3, 106 patients). The mean age was 58.3 years (range, 20-93 years), 61.4 years (range, 20-93 years), and 57.2 years (range, 20-89 years) in cohorts 1, 2, and 3, respectively; the majority were female (59%, 55%, and 64%), and most were CEAP C4 (39%, 46%, and 38%). The VARIShort was evaluated with regard to its validity, test-retest reliability, internal consistency reliability, sensitivity, and responsiveness. RESULTS: There was a strong correlation between the VEINES-QOL-S and the VARIShort (rs = -0.819; P < .001). The VARIShort showed both excellent internal consistency with Cronbach's α of 0.93 and a high response to clinical change as measured with Cohen's d, overall score of 1.17. CONCLUSIONS: The Swedish seven-item PROM, the VARIShort, may be used for assessment of symptoms of SVI and outcome after treatment in Swedish SVI patients. The short PROM shows degree of SVI symptom impact on quality of life in the same manner as the 26-item VEINES-QOL/Sym-S.

Economic benefit of a novel dual-mode ambulatory compression device for treatment of chronic venous leg ulcers in a randomized clinical trial.

BACKGROUND: Limb compression is a key component of protocols used to heal venous leg ulcers (VLUs). A novel ambulatory pneumatic compression device was tested in comparison with multilayered bandage (MLB) compression systems for the treatment of VLUs in a prospective randomized clinical trial. METHODS: Patients with VLUs measuring 1.5 to 50 cm2 with duration of 1 to 24 months were randomized to treatment with a pneumatic compression device, the ACTitouch adaptive compression therapy (ACT) system (Tactile Medical, Minneapolis, Minn), or MLB. The ACT group patients were seen in the clinic at weeks 1, 2, 4, 6, 9, 12, and 16 or until wounds healed; the MLB group was seen weekly for bandage and dressing changes for 16 weeks or until wounds healed. All other aspects of VLU care were standardized between the two groups. The primary study objective was to compare the VLU percentage area reduction at 16 weeks in the ACT group compared with the MLB group. RESULTS: There were 56 patients randomized to treatment with ACT (n = 26) or MLB (n = 30). In the ACT group, five patients exited because of skin or wound problems related to the ACT device and five withdrew because of the inconvenience of using the device. Therefore, the trial was halted before full randomization so improvements to the ACT device could be made. Data collected on 42 patients who were able to tolerate treatment for the 16-week study period (per protocol group) showed that both groups experienced similar rates of wound healing. In the per protocol population, the percentage area size reduction was greater for the ACT group compared with the MLB group (83.8% vs 70.5%, respectively), whereas no significant differences were noted in the percentage of wounds that healed by 16 weeks (60.0% vs 63.0%, respectively). CONCLUSIONS: In this truncated clinical trial, a novel dual-mode ambulatory compression device, when tolerated, achieved wound healing results similar to those with MLB for chronic VLUs. The device requires modifications to improve the patient's comfort and ease of use. However, this mode of therapy appears to have promise for improving the cost-effectiveness of treatment for chronic VLUs.

Comparison of hand-held acoustic Doppler with point-of-care portable color Doppler ultrasound in the assessment of venous reflux disease.

OBJECTIVE: Diagnostic-quality portable color Doppler ultrasound (PCD) offers convenient point-of-care venous reflux disease (VRD) diagnosis. Philips Lumify (Philips N.V., Best, The Netherlands), a high-fidelity broadband linear array transducer (4-12 MHz frequency), connects through a web-enabled smartphone or tablet to cloud software and offers B-mode and color Doppler imaging without pulsed wave Doppler capability. The aims of the study were to compare hand-held acoustic Doppler (HHD) vs PCD diagnostic performance using conventional duplex ultrasound (DUP) as the "gold standard" for VRD assessment, to assess effects of body mass index (BMI) and disease severity on diagnostic performance of HHD and PCD, and to determine whether PCD offers any diagnostic improvement over HHD in VRD assessment. METHODS: There were 241 patients (65 male, 176 female; mean age, 55.5 ± 15.5 years; mean BMI, 32.2 ± 7.9 kg/m2). DUP (447 legs), PCD (262 legs), and HHD (217 legs) studied the great saphenous vein at above-knee (AK) and below-knee (BK) levels. A phlebologist performed HHD, whereas PCD and DUP were performed sequentially (PCD first) by an experienced technologist and interpreted independently. PCD was done blinded to DUP results. DUP findings were analyzed blinded to HHD and PCD results. Venous reflux was dichotomously assessed as <2 seconds and >2 seconds. RESULTS: HHD improves from moderate to good sensitivity from AK level (68%) to BK level (94%) but suffers poor specificity that declines significantly from AK level (50%) to BK level (12%; P < .05). HHD positive predictive value exceeds its negative predictive value (NPV) and remains unchanged from AK level (71%) to BK level (72%). HHD NPV remains consistently poor at AK (48%) and BK (42%) levels. PCD has similar sensitivity from AK level (69%) to BK level (74%), better AK level (79%) vs BK level (58%) specificity (P < .05), similar positive predictive value for AK (76%) and BK levels (78%), and better NPV for AK level (72%) vs BK level (53%; P < .05). BMI range (<30 kg/m2 vs ≥ 30 kg/m2) did not influence diagnostic performance of HHD and PCD significantly. HHD and PCD specificity was higher for Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) class <4 compared with CEAP class ≥4 (P < .05). CONCLUSIONS: The relative diagnostic performance of HHD and PCD is highly dependent on insonation level. PCD advantages compared with HHD are marginally greater specificity at AK and BK levels and better NPV at AK level. Compared with HHD, PCD's disadvantage is lower sensitivity at BK level. Both HHD and PCD have higher specificity at AK level than at BK level. Overall, PCD offers only moderate sensitivity and specificity, making it inadequate for exclusion of significant venous reflux. Neither obesity nor CEAP class significantly influenced the general diagnostic performance of PCD or HHD.

Assessment and grading of pigmentation in chronic venous insufficiency.

INTRODUCTION: Chronic venous insufficiency causes skin pigmentation of the leg ranging from small patches of mild dyschromia to extensive areas of severe skin pigmentation. It is thought that the pigmentation is mainly due to haemosiderin or melanin deposition. Erythrodiapedesis which occurs as a result of venular hypertension causes erythrocytes to migrate across the microvascular network into the dermis. METHODS: We categorized the grading of pigmentation into four grades: +, few spots; ++, pigmentation over gaiter area; +++, pigmentation involving leg and ankle; ++++, heavily pigmented (dark). Skin biopsies were taken from the patient while undergoing surgery; two biopsies were taken from each patient, one from apparently normal skin and other from the site of pigmentation. A total of 45 patients diagnosed as chronic venous insufficiency with pigmentation were included in the study and five patients included in control. The biopsy specimens were sent to pathology department for H&E, Perls stain and IHC for S100. RESULTS: Majority of cases, i.e. 62% of limbs fall under (++) grade of pigmentation, followed by (+) grade of pigmentation in 20%, while (+++) and (++++) constitute 9% of the cases each. Increased melanin deposition was seen in 40 pigmented skin biopsies and 3 normal skin biopsies from the case group, and normal melanin deposition was seen in all the non-varicose controls. CONCLUSION: We have tried to categorize pigmentation in chronic venous insufficiency into four grades. As the grade of pigmentation increases the per cent of cases with ulceration is increasing. It was observed that presence of melanin deposition irrespective of the grade of pigmentation was distributed more towards the advanced clinical classification (C5 and C6).

Health and economic benefits of advanced pneumatic compression devices in patients with phlebolymphedema.

OBJECTIVE: Phlebolymphedema (chronic venous insufficiency-related lymphedema) is a common and costly condition. Nevertheless, there is a dearth of evidence comparing phlebolymphedema therapeutic interventions. This study sought to examine the medical resource utilization and phlebolymphedema-related cost associated with Flexitouch (FLX; Tactile Medical, Minneapolis, Minn) advanced pneumatic compression devices (APCDs) relative to conservative therapy (CONS) alone, simple pneumatic compression devices (SPCDs), and other APCDs in a representative U.S. population of phlebolymphedema patients. METHODS: This was a longitudinal matched case-control analysis of deidentified private insurance claims. The study used administrative claims data from Blue Health Intelligence for the complete years 2012 through 2016. Patients were continuously enrolled for at least 18 months, diagnosed with phlebolymphedema, and received at least one claim for CONS either alone or in addition to pneumatic compression (SPCDs or APCDs). The main outcomes included direct phlebolymphedema- and sequelae-related medical resource utilization and costs. RESULTS: After case matching, the study included 86 patients on CONS (87 on FLX), 34 on SPCDs (23 on FLX), and 69 on other APCDs (67 on FLX). Compared with CONS, FLX was associated with 69% lower per patient per year total phlebolymphedema- and sequelae-related costs net of any pneumatic compression device-related costs ($3839 vs $12,253; P = .001). This was driven by 59% fewer mean annual hospitalizations (0.13 vs 0.32; P < .001) corresponding to 82% lower inpatient costs and 55% lower outpatient hospital costs. FLX was also associated with 52% lower outpatient physical therapy and occupational therapy costs and 56% lower other outpatient-related costs. Compared with SPCDs, FLX was associated with 85% lower total costs ($1153 vs $7449; P = .008) driven by 93% lower inpatient costs ($297 vs $4215; P = .002), 84% lower outpatient hospital costs ($368 vs $2347; P = .020), and 85% lower other outpatient-related costs ($353 vs $2313; P = .023). Compared with APCDs, FLX was associated with 53% lower total costs ($3973 vs $8436; P = .032) because of lower outpatient costs and lower rates of cellulitis (22.4% vs 44.9% of patients; P = .02). CONCLUSIONS: This analysis indicates significant benefits attributable to FLX compared with alternative compression therapies that can help reduce the notable economic burden of phlebolymphedema.

Central Venous Pathologies: Treatments and Economic Impact.

Chronic venous insufficiency (CVI) is responsible for significant costs to society in the form of medical and surgical treatment and, importantly, unmeasurable lost work productivity due to pain and disability. Symptomatic chronic central vein obstruction, a cause of CVI, is potentially treatable using open surgical and endovascular techniques to restore vessel patency. Although upper extremity central vein obstruction often requires an open surgical procedure for durable relief, endovascular stents have proven remarkably useful for iliofemoral disease. Containment of healthcare resources requires accurate diagnosis, durable treatment modalities, and appropriate patient selection so that therapy is targeted to those individuals most likely to benefit. In this regard, identification of appropriate lesions should be based on intravascular ultrasound and 3-dimensional imaging studies. Treatment with dedicated venous stents offers the potential for long-term symptomatic improvement and increased work productivity when used in a well-defined, anatomically appropriate population with significant, symptomatic CVI.

[Functional assessment of primary lesion of the great saphenous vein when deciding upon stripping]. / Funktsional'naia otsenka pervichnogo porazheniia bol'shoi podkozhnoi veny pri reshenii voprosa o stripinge.

The purpose of the study was to examine a possibility of functional assessment of the great saphenous vein (GSV) with the help of a day orthostatic loading test for prognosis of restoration of the function of the GSV afterremoving its varicose tributaries in patients with primary varicose veins. Our prospective study included a total of sixty-five 29-to-53-year-old patients (15 men and 50 women, mean age - 36.7 years). The total number of the lower limb examined amounted to 87. All patients underwent ultrasonographic examination (duplex scanning) prior to operation, 1 and 12 months thereafter. The study was carried out using a day orthostatic loading test consisting in duplex scanning performed twice during 24 hours: in the evening after 18:00 hours and in the morning before 10:00 hours after a good night's rest. It was demonstrated that the day orthostatic loading test characterized the degree of preservation of the muscular-tonic properties of the GSV, making it possible to predict reversibility of reflux along it after removing the varicose tributaries, hence it may be used as a criterion for individualization of the choice of the scope of surgical intervention. A high orthostatic gradient prior to operation suggests preservation of the potential of the muscular-tonic function of the GSV; its decrease after surgery demonstrates reduction of the volemic loading on the GSV.

The value of near-infrared spectroscopy for the assessment of calf muscle function in venous patients.

OBJECTIVE: Near-infrared spectroscopy (NIRS) is a noninvasive technique with the potential to determine the degree of tissue oxygenation. The aim of the current study was to investigate the use of NIRS as a reliable method of detecting calf muscle pump dysfunction in groups of patients with venous disease. METHODS: Patients with superficial venous insufficiency (SVI) or history of deep venous thrombosis (DVT) were classified according to the comprehensive classification system for chronic venous disorders (clinical class, etiology, anatomy, and pathophysiology) and compared with controls (GROUP variable). A 10-stage evaluation of ambulatory venous function was performed, and corresponding values of calf regional oxygen saturation (crSaO2, %) at each phase were recorded (TIME variable). Thereafter, the percentage changes of crSaO2 values (Δ scores, %) between a given phase and the reference phase were estimated. Differences among groups and phases were evaluated using analysis of variance. Subgroup analysis between C0-C2 and C3-C6 patients was performed. The receiver operating characteristic curve analysis was used to detect the best predictive capability for SVI and DVT. RESULTS: A total of 30 patients with SVI, 31 patients with DVT, and 34 controls were included in the study. A statistically significant effect of TIME (F = 382.4; P < .001) and TIME × GROUP interaction (F = 6.3; P < .001) was recorded. Concerning prediction, we found a statistically significant area under the curve (AUC) for SVI (AUC = 0.72; 95% confidence interval, 0.58-0.83; P = .003) and for DVT (AUC = 0.83; 95% confidence interval, 0.71-0.92; P < .0001) patients. CONCLUSIONS: The measurement of crSaO2 using NIRS detected alterations in calf muscle pump oxygenation during exercise and differences in tissue oxygenation among SVI patients, DVT patients, and controls. NIRS may represent a reliable noninvasive tool for the study of calf muscle dysfunction in venous disease and a useful vehicle for generating testable hypotheses in the laboratory setting.

Four-dimensional flow magnetic resonance imaging and ultrasound assessment of cerebrospinal venous flow in multiple sclerosis patients and controls.

A possibly causal relationship between multiple sclerosis and chronic cerebrospinal venous insufficiency has recently been hypothesized. Studies investigating chronic cerebrospinal venous insufficiency have reported conflicting results and few have employed multiple diagnostic imaging modalities across a large patient and control population. In this study, three complementary imaging modalities were used to investigate the chronic cerebrospinal venous insufficiency hypothesis in patients with multiple sclerosis and two age- and sex-matched control groups: healthy volunteers and patients with other neurological diseases. Strictly blinded Doppler ultrasound according to the original chronic cerebrospinal venous insufficiency hypothesis; four-dimensional flow magnetic resonance imaging of venous flow in the head, neck, and chest; and contrast-enhanced magnetic resonance venography for neck and chest venous luminography were acquired. An internal jugular vein stenosis evaluation was also performed across modalities. Percentage of subjects meeting ultrasound-based chronic cerebrospinal venous insufficiency criteria was small and similar between groups. In group-wise and pairwise testing, no four-dimensional flow magnetic resonance imaging variables were statistically significantly different, for any measurement location. In contrast-enhanced magnetic resonance venography of the internal jugular and azygos veins, no statistically significant differences were observed in stenosis scores between groups. These results represent compelling evidence against the chronic cerebrospinal venous insufficiency hypothesis in multiple sclerosis.

Effect of socio-demographic characteristics and clinical findings on the quality of life of patients with chronic venous insufficiency.

Objective This study was planned and implemented to evaluate the effect of socio-demographic characteristics and clinical findings on the quality of life of patients with chronic venous insufficiency. Methods The sample of this cross-sectional study consisted of 163 patients that presented with the diagnosis of chronic venous insufficiency to the cardiovascular surgery clinic of an education and research hospital in the west of Turkey. The data were collected during face-to-face interviews using a personal information form, clinical, etiology, anatomy, pathophysiology classification, venous insufficiency epidemiological and economic study-quality of life/symptoms scales and the Short Form-36. Descriptive statistics as well as univariate and multivariate analyses were used to analyze the data. Results The chronic venous insufficiency patients were found to have a low quality of life. Advanced age, higher body mass index, longer working times, being on regular medication, hypertension and presence of pigmentation according to the clinical, etiology, anatomy, pathophysiology classification were found to be associated with a reduced physical score in SF-36. Furthermore, longer weekly working hours and presence of pigmentation reduced the Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms scores. Undertaking physical exercise at twice and more than twice a week increased the overall physical scores in SF-36. Conclusions The results of the study showed that the quality of life of chronic venous insufficiency patients are affected by not only physical characteristics, working hours and physical activity but also presence of edema and pigmentation.

Value of delayed duplex ultrasound assessment after endothermal ablation of the great saphenous vein.

OBJECTIVE: Endothermal ablation (ETA) of the great saphenous vein (GSV) is associated with a small but definite risk of endothermal heat-induced thrombosis (EHIT) extending into the common femoral vein. Follow-up duplex ultrasound imaging to detect EHIT after ETA is considered standard of care, although the exact timing of duplex ultrasound imaging to detect EHIT after ETA remains unclear. We hypothesized that an additional duplex ultrasound assessment 1 week after ETA would not identify a significant number of patients with EHIT and would significantly increase health care costs. METHODS: This was a retrospective review of consecutive ETA GSV procedures from 2007 to 2014. All patients were evaluated with duplex ultrasound imaging on postprocedure day 1, and 79% of patients underwent a second ultrasound assessment 1 week postprocedure. EHIT was considered present when proximal GSV closure progressed to level ≥4, based on a six-tier classification system. RESULTS: From January 1, 2007, until December 31, 2014, 842 patients underwent GSV ETA. Patients with EHIT were more likely to have had a prior deep venous thrombosis (DVT; P = .002) and a larger GSV (P = .006). Forty-three procedures (5.1%) were classified as having EHIT requiring anticoagulation, based on a level ≥4 proximal closure level. Of the 43 patients with EHIT, 20 (47%) were found on the initial ultrasound assessment performed 24 hours postprocedure, but 19 patients (44%) with EHIT would not have been identified with a single postoperative ultrasound scan performed 24 hours after intervention. These 19 patients had a level ≤3 closure level at the duplex ultrasound scan performed 24 hours postprocedure and progressed to EHIT on the delayed duplex ultrasound scan. Lastly, thrombotic complications in four patients (9%), representing three late DVT and one DVT/pulmonary embolism presenting to another hospital, would not have been identified regardless of the postoperative surveillance strategy. Maximum GSV diameter was the only significant predictor of progression to EHIT on multivariate analysis (P = .007). Based on 2014 United States dollars, the two-ultrasound surveillance paradigm is associated with health care charges of $31,109 per identified delayed venous thromboembolism event. CONCLUSIONS: Delayed duplex ultrasound assessment after ETA of the GSV comes with associated health care costs but does yield a significant number of patients with progression to EHIT. Better understanding of the timing, risk factors, and significance of EHIT is needed to cost-effectively care for patients after ETA for varicose veins.

Psychometric Validation of the 14 items ChronIc Venous Insufficiency Quality of Life Questionnaire (CIVIQ-14): Confirmatory Factor Analysis.

OBJECTIVES: The study aim was to confirm the factorial structure of the short (14 item) version of the ChronIc Venous Insufficiency quality of life Questionnaire (CIVIQ-14) using the Vein Consult Program (VCP) results. METHODS: The international VCP study sought to evaluate the impact of chronic venous disease (CVD) on health care costs and quality of life (QoL). The factorial structure of the CIVIQ-14 was evaluated using two methods: exploratory factor analysis (EFA) to calculate the probabilities of items and dimensions remaining stable and to study the dimensionality of the scale using explained variance criteria, followed by confirmatory factor analysis (CFA) to confirm the original three dimensional structure and investigate alternative models that may have arisen from the dimensionality analysis. We also used the VCP results to evaluate the psychometric properties of the questionnaire and conducted subgroup analyses on countries with validated translations. RESULTS: A total of 47,149 questionnaires from 17 countries were available in the VCP. EFA revealed both items and dimensions as 100% stable. Dimensionality analysis showed that a two factor approach could be considered. CFA revealed the CIVIQ-14 three dimensional structure to be acceptable while rejecting the two dimensional model. Psychometric analysis confirmed the construct validity, internal consistency, and known groups validity of the CIVIQ-14. The results of subgroup analyses were consistent with those of the primary analysis. CONCLUSIONS: CFA of VCP data supported the factorial structure of the CIVIQ-14. The analysis corroborates the wide use of CIVIQ-14 as a valid instrument for reporting QoL in CVD patients.

Assessment of arterial stiffness in patients with chronic lower extremity venous disease: An observational study.

OBJECTIVES: Arterial stiffness is associated with major adverse cardiovascular events. Chronic venous insufficiency (CVI) is severe form of chronic venous disease (CVD). The aim of this study is to investigate arterial stiffness by cardio-ankle vascular index (CAVI) in patients with CVI. METHODS: This observational and cross-sectional study involved 87 subjects with CVI and 86 healthy subjects. All subjects underwent ultrasonography examination. CAVI was measured by VaSera-1000 CAVI instrument. RESULTS: High density lipoprotein cholesterol (HDL) was significantly lower in patients with CVI than controls (46.83 ± 9.25 mg/dl vs 51.33 ± 11.13 mg/dl, p = 0.004). Body mass index (BMI) was significantly higher in CVI patients than controls (28.53 ± 4.10 kg/m(2) vs 26.37 ± 5.16 kg/m(2), p = 0.003). Ankle brachial index (ABI) was significantly lower in patients with CVI compared to controls (1.08 ± 0.08 vs 1.14 ± 0.11, p < 0.001). CAVI was significantly higher in patients with CVI than controls (7.94 ± 1.37 vs 6.73 ± 1.16, p < 0.001). Mean arterial pressure (MAP) was significantly higher in patients with CVI than control group (105.41 ± 10.77 mmHg vs 99.70 ± 11.17 mmHg, p = 0.001). CAVI (p < 0.001, Odds ratio (OR) = 2.033, 95% Confidence interval (CI) = 1.493-2.768), ABI (p = 0.003, OR = 0.003, 95% CI = 0.001-0.137), female sex (p < 0.001, OR = 3.949, 95% CI = 1.613-9.663), and HDL (p < 0.001, OR = 0.923, 95% CI = 0.883-0.964) were the independent predictors of CVI. A CAVI value > 7.9 had a sensitivity 64.4% and a specificity of 94.7% for predicting the presence of CVI in ROC analysis (area under curve = 0.791, 95% CI = 0.723-0.849, p < 0.001). CONCLUSION: CAVI is independently increased in CVI patients. Therefore CVI may be accepted a form of vascular sclerosis and vascular system should be evaluated in continuum not isolated.

Postoperative Venous Insufficiency in Microsurgical Lower Extremity Reconstruction and Deep Vein Thrombosis Potential as Assessed by a Caprini Risk Assessment Model.

BACKGROUND: Individual potential to develop deep vein thrombosis shares a similar pathophysiologic mechanism with intravascular thrombosis formation in the lower extremity venous system, but has not yet been studied in relation to venous insufficiency following free flap procedures. The aim of this study was to investigate the association between potential for deep vein thrombosis as measured by the Caprini Risk Assessment Model and venous insufficiency in microsurgical lower extremity reconstruction. METHODS: The authors conducted a retrospective review of all free flap procedures performed on the lower extremities at their institution between January of 2005 and April of 2014. Patients were divided into two groups consisting of those with or without venous insufficiency, and the association between venous insufficiency and Caprini score was analyzed. Receiver operating characteristic curve analysis was used to estimate the cutoff Caprini point that best discriminated between the two groups. RESULTS: Of a total 170 flaps with 24 cases of venous insufficiency, the difference in median Caprini score between the two groups was statistically significant (p = 0.03). These results were consistent with those of subgroup analysis in the deep vein recipient group. Receiver operating characteristic analysis revealed that patients with Caprini scores of 7 or higher had significantly increased odds ratios for venous insufficiency. History of sepsis (<1 month) and immobilization were significantly associated with venous insufficiency according to a multivariate regression model. CONCLUSION: The authors detected a strong association between individual deep vein thrombosis potential as measured by the Caprini Risk Assessment Model and venous insufficiency following microsurgical lower extremity reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Interobserver variability in the assessment of the clinical severity of superficial venous insufficiency.

BACKGROUND: The clinical class C, of the CEAP classification (Clinical-Etiology-Anatomy-Pathophysiology), is often used when selecting patients for treatment within the national healthcare system. The aim of this study was to test the interobserver reproducibility of C when used in a clinical situation where the decision for reimbursement was made. METHODS: An unselected series of 78 patients (106 limbs) with varicose veins were examined by three independent surgeons with regard to C of CEAP and whether there was a medical indication for treatment. Interobserver reproducibility was calculated with kappa statistic. RESULTS: Total agreement between the three observers for clinical class was obtained in 61% of all cases (κ .55-.68 (95% CI)) and for medical indication in 60% of all cases (κ.35-.57 (95% CI)). CONCLUSION: The reproducibility of C when deciding medical indication for treatment is moderate. This may be due to inherent difficulties in the CEAP, lack of specific training, or the simultaneous assessment of reimbursement that may influence the clinical classification.

[Ultrasound assessment of alterations in venous haemodynamics in patients with post-thrombotic disease permanently taking phlebotonics].

OBJECTIVE: The study was aimed at using ultrasound duplex scanning for determining the sequence and terms of formation of venous haemodynamics impairments in the affected lower extremity in patients after endured acute thrombosis of deep veins and assessing the effect of phlebotonic drugs on the course of these processes. MATERIAL AND METHODS: We examined and treated a total of 66 patients presenting with newly onset acute thrombosis of deep veins of lower limbs without concomitant varicose disease. Group I patients (n = 22) received the standard course of angiotropic and metabolic infusion therapy, direct and indirect anticoagulants, as well as used elastic compression. Group II patients (n = 22) in addition to the similar course of treatment received a phlebotonic drug (Venarus) according to the standard regimen: 1,000 mg daily for two months every half year. Group III patients (n = 22) additionally to the same standard treatment regimen were also given VenarusR at a dose of 1,000 mg daily but taken uninterruptedly and constantly during the whole period of follow up. All patients were subjected to ultrasound duplex scanning of deep veins of lower limbs initially at admission, then 3 weeks, 3, 6, 12 and 18 months after making the diagnosis of acute thrombosis. RESULTS: Group II and III patients additionally taking the phlebotonic were found to have acceleration of processes of recanalization averagely by 15-20% as compared with Group I patients. Group III patients taking the phlebotonic agent permanently demonstrated deceleration of the processes of formation of horizontal and vertical veno-venous refluxes on the background of more adequate recanalization by the end of the follow-up period. CONCLUSION: Permanent taking of phlebotonics increases the rate and scope of recanalization of the thrombosed deep veins of lower limbs, as well as dramatically decreases the development of the horizontal and vertical reflux, decreasing clinical manifestations of chronic venous insufficiency.

Socio-economic impact of endovenous thermal ablation techniques.

Varicose veins are common and cause extensive morbidity; however, the value of treatment is under-appreciated. Many procedures allow the treatment of varicose veins with minimal cost and extensive literature supporting differing minimally invasive approaches. In this article, we investigate the current literature regarding treatment options, clinical outcome and the cost-benefit economics associated with varicose vein treatment. The practice of defining clinical outcome with quality of life (QOL) assessment is explained to provide valid concepts of treatment success beyond occlusion rates.