Editor's Choice - Short Term Cost Effectiveness of Radiofrequency Ablation and High Ligation and Stripping for Great Saphenous Vein Incompetence.

OBJECTIVE: Superficial venous incompetence (SVI) is a common disease that causes significant quality of life (QoL) impairment. There is a need for more health economic evaluations of SVI treatment. The aim of this study was to perform a cost effectiveness analysis in patients with great saphenous vein (GSV) incompetence comparing radiofrequency ablation (RFA), high ligation and stripping (HL/S), and no treatment or conservative treatment with one year follow up. METHODS: Randomised controlled trial economic analysis from an ongoing trial; 143 patients (156 limbs) with GSV incompetence (CEAP clinical class 2 - 6) were included. Treatment was performed with RFA or HL/S. Follow up was performed up to one year using duplex ultrasound, revised venous clinical severity score (r-VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and EuroQol-5D-3L (EQ-5D-3L). RESULTS: Seventy-eight limbs were treated with RFA and HL/S respectively. No treatment or conservative treatment was assumed to have zero in treatment cost and no treatment benefit. In the RFA group, one limb had reflux in the GSV after one month and three limbs after one year. In HL/S, two limbs had remaining reflux in the treated area at one month and one year. Both disease severity (r-VCSS, p = .004) and QoL (AVVQ, p = .021 and EQ-5D-3L, p = .028) were significantly improved over time. The QALY gain was 0.21 for RFA and 0.17 for HL/S. The cost per patient was calculated as €1 292 for RFA and €2 303 for HL/S. The cost per QALY (compared with no treatment or conservative treatment) was €6 155 for RFA and €13 549 for HL/S. With added cost for days absent from work the cost per QALY was €7 358 for RFA and €24 197 for HL/S. The cost per QALY for both methods was well below the threshold suggested by Swedish National Board of Health. CONCLUSION: RFA is more cost effective than HL/S and no treatment or conservative treatment at one year follow up.

A Comparison of Venaseal Versus Radiofrequency Ablation Outcomes Within a Managed Care Organization.

BACKGROUND: Chronic venous insufficiency is a common medical condition that afflicts over 30 million adults in the United States. Treatment and management have changed dramatically over the past 20 years with the introduction of various endovenous therapies, including radiofrequency ablation (RFA) and cyanoacrylate closure using the Venaseal system. In this study, we explore a direct comparison of outcomes between RFA and VenaSeal conducted by a single surgeon within a managed care organization. METHODS: Between May 2020 and December 2021, there were 87 patients undergoing 97 total procedures who were treated with either VenaSeal (n = 55) or RFA (n = 42), conducted by a single surgeon within a managed care organization. Primary outcomes included successful greater saphenous vein (GSV) closure, postoperative deep vein thrombosis (DVT), embolization, saphenofemoral junction (SFJ) thrombosis, skin reaction (allergic or thrombophlebitis), or procedure-related emergency room (ER) and urgent care (UC) visits. Retrospective chart review was conducted to describe patient demographics, indications for treatment, treatment details (number of access sites and indication for treatment), as well as follow-up adjunctive vein procedures (sclerotherapy and stab phlebectomy). RESULTS: All patients had postprocedural ultrasound (US) performed within 7 days by the operating surgeon and mean overall patient follow-up from index procedure was 12 months; 2 patients were lost to follow-up due to death. All operations utilized intraoperative US, and SFJ thrombosis was not observed in any patient postprocedure. The average age of VenaSeal and RFA groups was 59.05 and 59.51 years, respectively. The average number of access sites during the procedure for VenaSeal and RFA was 1.56 and 1.20, respectively. Of the 55 VenaSeal treatments, 9.1% of patients reported postoperative skin reactions, and 9.1% of patients underwent subsequent stab phlebectomy (22 stabs on average). Of the 42 RFA treatments, 7.1% of RFA patients reported postoperative skin reactions, and 9.5% underwent subsequent stab phlebectomy (36 stabs on average). The percentage of patients who had postoperative UC or emergency department visits related to the procedure in the VenaSeal and RFA groups was 3.6% and 0%, respectively. CONCLUSIONS: Both VenaSeal and RFA demonstrated effective vein closure of the GSV at 12-month follow-up, with VenaSeal demonstrating continued noninferiority to RFA. Based on our data, postoperative skin reactions do not appear to be significantly higher with VenaSeal treatment, as previously reported.

Ultrasound assessment is linked to histological vein wall thickness in chronic venous disease.

OBJECTIVES: Few studies compared both ultrasound and histological approaches for the same series of patients with chronic venous disease (CVD). We aimed to assess the diagnostic performances of duplex ultrasound assessment (US) of Vein Wall Thickness (VWT) among patients with CVD. METHODS: 38 adults with primary varicose veins having undergone Great Saphenous Vein thermal ablation with phlebectomy, and agreeing to biopsy of the Posterior Accessory Great Saphenous Vein (PASV) were consecutively included in a two-center prospective study. VWT assessment of the PASV was performed using both US, and microscope examination. High values for microscope-assessed VWT were defined at > 0.5 mm. RESULTS: The mean age was 53.0 ± 13.1 years, 71% were women. Maximization of US performances was obtained with a threshold of 0.6 mm: Sensitivity (Se) = 92.9%, Specificity (Sp) = 91.7%, positive (86.7%) and negative predictive value (NPV) (95.7%), positive (11.1) and negative likelihood ratio (NLR) (0.07). CONCLUSIONS: US assessment of VWT could be a non-invasive tool for diagnosis and follow-up in CVD, and an interesting in vivo parameter complementing diameter and reflux measures, with a view to optimizing treatment. It could help to determine i) the energy level necessary in case of endovenous laser ablation, and ii) the sclerosing agent concentration in case of chemical ablation.

The use of strain-gauge plethysmography in the functional assessment of chronic venous disease: five-year experience at a single centre.

OBJECTIVE: Plethysmography can be used in the diagnosis and evaluation of chronic venous disease in the lower extremities. This study aimed to evaluate the applicability and reliability of strain-gauge plethysmography (SDP) in the functional assessment of chronic venous disease. METHODS: This descriptive study was conducted between 2016 and 2021 at a single centre. Four hundred and thirty-two patients with symptomatic chronic venous disease were included in the study. All participants were diagnosed initially with Doppler ultrasonography. SGP was then performed to evaluate venous outflow capacity, venous reflux and muscle pump function. RESULTS: The average age was 45.16 ± 12.54 years (median age 46 years; range 20-78 years), and 239 (55.3%) women and 193 (44.7%) men were included in the study. The age groups, diagnosis, pathological distribution and risk factors were quantitatively determined according to gender. Localisation and lateralisation statistics of the pathologies are given. SGP measurements, including venous volume (V), venous emptying (VE), expelled volume ratio in four seconds (EV4/V), half refilling time (t½) and refilling volume (RV) of each lower extremity, were done individually to compare the involved extremity with the normal contralateral side. SGP measurements of each affected lower limb were also compared separately by gender, age group and disease onset. The correlation between t½ values and skin discolouration or oedema of the affected limb was examined. Finally, receiver operating characteristic curve analyses of the V, VE, EV4/V, t½ and RV values were done, and the cut-off values of each parameter were defined accordingly. CONCLUSION: High reliability and consistent results indicate that SGP is a practical and sensitive test for quantitative functional assessment of patients with chronic venous disease. It can be used as an effective method in diagnosing and following up chronic venous disorders. As there are no currently accepted cut-off values, we suggest that ours can be used as new reference values for SGP measurements.

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.

Quantification of Superficial Venous Reflux by Duplex Ultrasound - Role of Peak Reflux Velocity and Reflux Time in the Assessment of Varicose Vein.

BACKGROUND: The study compared the peak reflux velocity and reflux time in cases of varicose veins and non-varicose veins with a focus on quantifying the reflux parameters. METHODS: This is a hospital based observational comparative study. The limbs with CEAP Clinical classification of C2 or more were taken as diseased limbs and contra-lateral limbs with no symptoms or disease were taken as control limbs. RESULTS: Altogether 792 limbs (452 diseased limbs and 340 control limbs) were evaluated with color duplex. Mean Great Saphenous Vein diameter was 5.68 ± 2.07 mm and 4.00 ± 1.34mmin diseased limbs and control limbs respectively (p=0.0001). Mean sapheno-femoral junction diameter was 8.23 ± 2.64 mm and 6.16 ± 1.93 mm in diseased limbs and control limbs respectively (p=0.0001). Mean peak reflux velocity in diseased limbs was significantly higher than control limbs (77.38 cm/sec vs 7.95 cm/sec; p=0.0001).  Similarly mean reflux time was significantly longer in diseased limbs than non-diseased limb (406.58ms and 67.28 ms respectively; p=0.0001). An optimal cut-off point of 27.4 cm/s for peak reflux velocity and 250 ms for the reflux time at Sapheno-Femoral junction had a discriminatory power between the two groups. CONCLUSION: The quantification of peak reflux velocity seems to be more consistent than reflux time in determining the superficial venous reflux. An optimal peak reflux velocity cut off point of 27.4 cm/sec has the discriminatory power between diseased and non-diseased limb.

European Society for Vascular Surgery (ESVS) Certification of Theoretical and Practical Competences in Basic Vascular Ultrasound: Validity Investigation of the Assessment Tools.

OBJECTIVE: The aim of this study was to gather validity evidence for the Assessment of basic Vascular Ultrasound Expertise (AVAUSE) tool, and to establish a pass/fail score for each component, to support decisions for certification. METHODS: A cross sectional validation study performed during the European Society for Vascular Surgery's annual meeting. Validity evidence was sought for the theoretical test and two practical tests based on Messick's framework. The participants were vascular surgeons, vascular surgical trainees, sonographers, and nurses with varying experience levels. Five vascular ultrasound experts developed the theoretical and two practical test components of the AVAUSE tool for each test component. Two stations were set up for carotid examinations and two for superficial venous incompetence (SVI) examinations. Eight raters were assigned in pairs to each station. Three methods were used to set pass/fail scores: contrasting groups' method; rater consensus; and extended Angoff. RESULTS: Nineteen participants were enrolled. Acceptable internal consistency reliability (Cronbach's alpha) for the AVAUSE theoretical (0.93), carotid (0.84), and SVI (0.65) practical test were shown. In the carotid examination, inter-rater reliability (IRR) for the two rater pairs was good: 0.68 and 0.78, respectively. The carotid scores correlated significantly with years of experience (Pearson's r = 0.56, p = .013) but not with number of examinations in the last five years. For SVI, IRR was excellent at 0.81 and 0.87. SVI performance scores did not correlate with years of experience and number of examinations. The pass/fail score set by the contrasting groups' method was 29 points out of 50. The rater set pass/fail scores were 3.0 points for both carotid and SVI examinations and were used to determine successful participants. Ten of 19 participants passed the tests and were certified. CONCLUSION: Validity evidence was sought and established for the AVAUSE comprehensive tool, including pass/fail standards. AVAUSE can be used to assess competences in basic vascular ultrasound, allowing operators to progress towards independent practice.

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.

Treatment of chronic venous insufficiency in Latin America.

OBJECTIVE: Venous disease is common in Latin America, with an estimated 68.11% prevalence of chronic venous disease. The diverse social, political, and economic characteristics of the many nations that make up Latin America mean that different conditions affect how these diseases are diagnosed and treated, which may differ markedly from the way they are treated by the health care systems of the United States and Europe. Our goal was to review the current state of treatment of chronic venous insufficiency (CVI) in Latin America. METHODS: This is a narrative review of the medical literature on the subject and synthesizes sometimes fragmentary information on CVI across a large and diverse region. RESULTS: CVI represents an unmet medical need in Latin America. Conservative treatments, such as compression stockings, may be used at first, and there are nonpharmacologic and complementary and alternative medicine approaches in use. Endovenous approaches, such as endovenous thermal ablation, have largely replaced surgical interventions. In Europe and the United States, such procedures are mainly carried out in ambulatory facilities, whereas they are mainly performed in the hospital in Latin America. CONCLUSIONS: Recent strong economic growth in Latin America and improvements in social security and health care suggest that innovative approaches to chronic venous disease and CVI will be implemented.

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.

Impact of provider characteristics on use of endovenous ablation procedures in Medicare beneficiaries.

OBJECTIVE: The objective of this study was to assess the association between provider characteristics and intensity of endovenous therapy (EVT) utilization in the Medicare population. METHODS: The Medicare Provider Utilization and Payment Data Public Use Files (2012-2014) were queried to construct a database of providers performing EVT using laser or radiofrequency ablation techniques for treatment of lower extremity venous reflux. A utilization index (UI; EVT procedure per patient treated per year) was calculated for each provider, and median services per county were determined. Provider specialty, geographic region, and site of service (facility vs outpatient) were determined for each patient. Multivariate regression analysis was used to identify provider characteristics associated with a UI above the 75th percentile. RESULTS: There were 6599 providers who performed EVT in 405,232 Medicare beneficiaries during the study period. Intensity of EVT use by providers was assessed by the calculated UI, the average number of EVT procedures performed in treated patients per year (range, 1-4). Vascular surgeons had the lowest UI among all provider specialties (1.32). By multivariate analysis, the likelihood of a provider's UI being >1.8 (top 25%) was associated with provider training in a field other than surgery, cardiology, or radiology (odds ratio [OR], 3.35; 2.74-4.09); services performed in an outpatient setting (OR, 2.62; 1.97-3.47); and providers who perform high annual volume of EVT (OR, 8.68; 7.59-9.91). A high annual volume provider was defined as one whose EVT volume was ≥75th percentile nationally. CONCLUSIONS: There is great variation in intensity of vein ablation procedures performed on Medicare beneficiaries by geographic location and provider specialty. High-volume providers and those with a specialty not traditionally associated with the management of lower extremity chronic venous disease are more likely to perform more EVT procedures per patient.

The effect of commercial insurance policies on outcomes of venous ablation.

OBJECTIVE: The use of venous ablation (VA) for treatment of chronic venous insufficiency has exponentially increased. To limit cost and overuse, insurance companies have adopted aleatory policies. The goal of this study was to compare the policies of five major local insurance carriers and to determine whether treatment within the criteria of a certain policy is associated with improved patient outcomes. METHODS: A retrospective single-center review of patients treated with VA was performed. Demographics, comorbidities, symptoms, and clinical class (Clinical, Etiology, Anatomy, and Pathophysiology classification) were recorded. Clinical success was defined on chart review by the patients' reporting of improvement or resolution of symptoms in the leg treated on follow-up, and technical success was defined by vein closure on ultrasound. Patients underwent a telephone survey inquiring about intensity of symptoms on a numeric rating scale of 0 to 10 before and after treatment of each leg as well as effects on quality of life (QOL). The policies of Aetna, Cigna, Anthem Blue Cross Blue Shield, UnitedHealthcare, and Connecticut Care were reviewed. The clinical and technical success rates were compared when veins were treated within the criteria of each policy. A subgroup analysis looking at patients who had clinical success only was performed to determine the potential rate of denial of coverage for each policy. A multivariable analysis was performed to determine independent predictors of clinical success. RESULTS: There were 253 patients with 341 legs treated. The mean age was 58.5 ± 15.2 years (68% women). The most common symptom was pain (89.7%), with 47.8% of patients having C3 disease. The clinical success, technical success, and complication rates were 84.2%, 95.1%, and 5.6%, respectively. On survey, there was improvement of the numeric rating scale score in 84.3% of legs treated after the procedure, and 76.7% continued to experience improvement after a mean follow-up of 26.8 months. There was improvement of QOL in 76.5% of patients. There was no significant difference in procedural success, technical success, complication rate, or improvement in QOL when patients were treated within any of the five insurance policies. On multivariable analysis, there was no single policy significantly associated with clinical success. However, subgroup analysis of procedures with clinical success (n = 287) showed a significant difference between the five policies on analysis of the potential denial of coverage, ranging from 5.6% for Connecticut Care to 64.1% for UnitedHealthcare (P < .0001). CONCLUSIONS: The different insurance policies have no correlation with outcomes of VA. Policies with more stringent criteria typically restrict treatment to larger veins and deny procedures to a significant number of patients with chronic venous insufficiency who can benefit from them.

Clinical presentation of women with pelvic source varicose veins in the perineum as a first step in the development of a disease-specific patient assessment tool.

OBJECTIVE: Pelvic venous incompetence can cause symptomatic varicose veins in the perineum, buttock, and thigh. Presentation, symptom severity, and response to treatment of pelvic source varicose veins are not well defined. Currently available tools to measure the severity of lower extremity venous disease and its effects on quality of life may be inadequate to assess disease severity in these patients. The purpose of this study was to evaluate the histories, demographics, and clinical presentations of women with pelvic source varicose veins and to compare these data to a population of women with nonpelvic source varicose veins. METHODS: A total of 72 female patients with symptomatic pelvic source varicose veins were prospectively followed up. Age, weight, height, parity, and birth weights of offspring were recorded. Both pelvic source varicose veins and saphenous incompetence were identified by duplex ultrasound. Patients were queried as to their primary symptoms, activities that made their symptoms worse, and time when their symptoms were most prominent. Severity of disease was objectively evaluated using the revised Venous Clinical Severity Score (rVCSS) and 10-point numeric pain rating scale (NPRS). RESULTS: Compared with women without a pelvic source of varicose veins (N = 1163), patients with pelvic source varicose veins were younger (mean, 44.6 ± 8.6 vs 52.6 ± 12.9 years; P < .001), had lower body mass index (mean, 21.9 ± 2.8 vs 25.8 ± 6.2; P < .001), and had larger babies than the U.S. population mean (mean, 3656 ± 450 g vs 3389 ± 466 g; P < .001). The most common symptoms were aching (68%), throbbing (47%), and heaviness (35%). In premenopausal patients, 70% noted that symptoms were worst during menses. NPRS score varied from 0 to 8 (mean, 4.9). The correlation between rVCSS (mean 5.6 ± 1.9) and NPRS was small (r = 0.26; P = .03). There was a modest correlation between older age and lower NPRS scores (r = -0.39; P < .001). CONCLUSIONS: Women with pelvic source varicose veins are a unique subset of patients. They are younger and thinner than those with nonpelvic source varicose veins, have larger infants than the general U.S. population, and have an inverse correlation between age and pain. As the majority of premenopausal patients have increased symptoms during menses, this may be due to hormonal influence. As it is poorly associated with patient-reported discomfort, the rVCSS is a poor tool for evaluating pelvic source varicose veins. A disease-specific tool for the evaluation of pelvic source varicose veins is critically needed, and this study is a first step in that endeavor.

The evidence supporting treatment of reflux and obstruction in chronic venous disease.

On July 20, 2016, a Medicare Evidence Development and Coverage Advisory Committee panel convened to assess the evidence supporting treatment of chronic venous disease. Several societies addressed the questions posed to the panel. A multidisciplinary coalition, representing nine societies of venous specialists, reviewed the literature and presented a consensus opinion regarding the panel questions. The purpose of this paper is to present our coalition's consensus review of the literature and recommendations for chronic venous disease.

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.

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.

Assessment of posterior accessory great saphenous vein of the leg using ultrasonography: a preliminary study.

PURPOSE: To assess the frequency and anatomic distributions of the posterior accessory great saphenous vein of the leg (PAGSVL) and its insufficiency rate using ultrasonography (US) in patients who presented with clinical, etiologic, anatomic, and pathophysiologic (CEAP) scores of 1 and above. METHODS: A prospective US study on 200 limbs of 100 consecutive patients with CEAP scores of 1 and above. RESULTS: Right PAGSVL was seen in 45 % (45 cases), whereas left PAGSVL was seen in 54 % (54 cases) of the patients [49.5 % (99 limbs) in total] (p < 0.05). PAGSVL insufficiency was present in 6 % (6 cases) of the patients [6 limbs in total (6.06 %)]. The type of PAGSVL joining to the great saphenous vein (GSV) was above the knee level in 4 % (4 limbs), at the knee level in 14 % (14 limbs), and below the knee level in 74 % of patients (74 limbs). The relationship between posterior tibial perforators and PAGSVL was seen in 3.03 % of cases (3 limbs). There was no statistically significant relationship between PAGSVL insufficiency and the presence of posterior tibial perforators (p = 0.55) or between the presence of PAGSVL and the GSV insufficiency. CONCLUSION: PAGSVL was seen in half of the limbs with CEAP scores of 1 and above. The frequency of PAGSVL was more common in the left limbs than the right limbs. There was no statistically significant relationship between the presence of PAGSVL, GSV insufficiency, and different CEAP scores. The PAGSVL often joined to the GVS below the knee, but could also join above the knee.

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.

C1-C2 X-Ray assessment of misalignment parameters in patients with Chronic Cerebra-spinal Venous Insufficiency and Multiple Sclerosis versus patients with other pathologies.

PURPOSE: The complete compression of the internal jugular veins, in front position, shows a prevalence of 48% and it is equally distributed in the various segments of these veins in patients with Chronic Cerebro-Spinal Venous Insufficiency (CCSVI) and Multiple Sclerosis (MS). The aim of this search is to identify radiological dislocation of C1-C2 as specific markers in patients with CCSVI and Multiple Sclerosis (MS). METHOD: We investigated 386 patients suffering from CCSVI and Multiple Sclerosis and a control group of 156 patients without MS. RESULTS: The assessment of Anterior Intrusion shows the following average values: in the group with CCSVI and MS: 4.29 ±1.48 mm while in the control group: 3.78 ±1.45 mm (p = 0.0008).The evaluation of the Right Laterality shows the following average values: in group with CCSVI and MS: 2.31±1.41 mm, in control group: 1.97 ±1.28 mm (p = 0.0426). We found also that a longer duration of the disease corresponds to a higher severity of the pathological condition (p <0.0001). CONCLUSION: Data analysis of C1-C2 X-Ray parameters shows statistical significance of severe anterior intrusion and right laterality misalignment in the people with CCSVI and MS, that are two to three times more frequent as compared to controls. Considering the novelty of this work and the total absence of scientific similar works able to confirm this data, it is necessary to continue these studies in order to improve the clinical management of these patients and to perform therapeutic strategies based on venous decompressive treatments both surgical that manipulatives.

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.