The anterior saphenous vein. Part 3. Systematic review of the literature and payor coverage policies. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum and the International Union of Phlebology.

OBJECTIVE: The objective of this study is to systemically review the literature on Anterior Saphenous Vein (ASV) reflux treatment and insurance impediments to treatment coverage. METHODS: A literature search was performed using a PRISMA framework. In addition, a cross-sectional analysis of insurance policies for ASV treatment was evaluated. RESULTS: Published evidence and treatment considerations in the literature for ASV treatment are discussed. In 155 of 226 (68.6%) insurance policies reviewed coverage of ASV ablation was allowed while 62/226 (27.4%) did not specify coverage and 9/226 (4.0%) specified ASV treatment was not covered. Of the 155 that provide ASV coverage, 98 (62.2%) provide coverage with criteria such as requiring prior treatment of the great saphenous vein. CONCLUSIONS: Vein treatment experts should continue to advocate to insurance carriers to update their varicose vein treatment policies to reflect the substantial clinical evidence so that patients with ASV reflux can be appropriately treated.

Disparities in access to endovenous treatment options in chronic lower extremity superficial venous insufficiency: A national 7-year analysis.

OBJECTIVE: The goal of this study was to analyze trends in treatment access for chronic superficial venous disease and to identify disparities in care. METHODS: This retrospective study was exempt from institutional review board approval. The American College of Surgeon National Surgical Quality Improvement Program database was used to identify patients who underwent vein stripping (VS) and endovenous procedures for treatment of chronic superficial venous disease. Endovenous options included radiofrequency ablation (RFA) and laser ablation. Data was available from 2011 to 2018 and demographic information was extracted for each patient identified by Current Procedural Terminology codes. For all racial and ethnic groups, trend lines were plotted, and the relative rate of change was determined within each specified demographic. RESULTS: There were 21,025 patients included in the analysis. The overall mean age was 54.2 years, and the majority of patients were female (64.8%). In total, 27.9%, 55.2%, and 16.9% patients underwent VS, RFA, and laser ablation, respectively. Patients who received laser ablation were older (P < .001). Hispanic ethnicity was associated with significantly lower odds of receiving endovascular thermal ablation (EVTA) over VS (odds ratio [OR], 0.71; 95% confidence interval [CI], 0.64-0.78; P < .001). American Indian/Alaska Native patients were more likely to receive EVTA over VS (OR, 4.02; 95% CI, 2.48-6.86); similarly, Native Hawaiian/Pacific Islander patients were more likely to receive EVTA over VS, although this difference was not statistically significant (OR, 1.44; 95% CI, 0.93-2.27). On multinomial regression, Hispanic patients were less likely to receive RFA over VS, whereas American Indian/Alaskan Native patients were more likely to receive RFA over VS. In all racial and ethnic groups, the percentage of endovenous procedures increased, whereas vein stripping decreased. CONCLUSIONS: Based on a hospital-based dataset, demographic indicators, including age, sex, race, and ethnicity, are associated with differences in endovenous treatments for chronic superficial venous insufficiency suggesting disparities in obtaining minimally invasive treatment options among certain patient groups.

Indications, contraindications, side effects, general assessment, and outlook for the future: An International Compression Club survey.

BACKGROUND: The effectiveness of compression therapy (CT) and the best compression modality choice are questioned in many clinical stages of chronic venous disease (CVD). This work aims to obtain information on indications, contraindications, and the best treatment option for CT in different clinical scenarios of CVD. METHOD: An online survey was made among members of the International Compression Club, experts in CT. RESULTS: The experts apply CT in all clinical stages of CVD, even when evidence is missing. Regarding compression materials, experts use inelastic materials in the advanced stages of CVD and compression stockings in the early or chronic stages of CVD. CONCLUSION: The authors highlight the gap between experts' practical use of CT and evidence-based medicine results. They also suggested that, given the cost of randomized clinical trials aimed at specifying specific indications for different devices, artificial intelligence could be used for large-scale practice surveys in the future.

The clinical and economic impact of chronic venous insufficiency-associated lymphedema and the prevalence of persistent edema after venous intervention.

OBJECTIVES: To determine the demographics, outcomes, and healthcare utilization of patients with chronic venous insufficiency-associated lymphedema (CVI-LED) and the prevalence of lymphedema-specific therapy use after venous intervention. METHODS: The IBM MarketScan Commercial and Medicare Claims Databases were examined for patients with CVI-LED. Patient demographics and the use of lymphedema-specific therapy before and after venous intervention were collected. RESULTS: Of 85,601 LED patients identified, 8,406 also had a diagnosis of CVI. In the CVI-LED group, 1051 underwent endovenous ablation or venous stent placement. The use of lymphedema-specific therapy before and after venous intervention was 52% and 39%, respectively (p < .05). The mean time of initiation of LED-specific therapy following venous intervention was 265 days after ablation and 347 days after stent placement. CONCLUSION: Treating venous hypertension improves certain venous-related signs and symptoms of CVI. However, a significant proportion of patients have persistent edema which may reflect underlying, sub-optimally treated LED.

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.

Arterial and venous peripheral vascular assessment using wearable electro-resistive morphic sensors.

Peripheral vascular diseases (PVDs) represent a significant burden on global human health and healthcare systems. With continued growth in obesity and diabetes, it is likely that the incidence of these conditions will increase. As many PVDs remain undiagnosed, low-cost and easy to use diagnostic methods are required. This work uses newly developed wearable electro-resistive morphic sensors to assess venous and arterial competence in the lower limbs of 36 healthy subjects. Comparison of this HeMo device was made to currently available benchtop light reflection rheography and photoplethymography devices. Results indicate that HeMo can detect the physiological signals of interest for both chronic venous insufficiency and peripheral arterial disease and all subjects were interpreted as healthy by each system. However, measurement repeatability of HeMo was highlighted as an issue that requires further system development. Furthermore, as HeMo captures changes in a section of limb circumference due to changes in underlying blood movement, rather than at a single point, the recorded signal is typically damped by comparison. This factor should be considered in any future developments.

A comparison of tablet-based and paper-based venous insufficiency epidemiologic and economic study quality of life/symptom questionnaire for assessment of chronic venous disease.

OBJECTIVE: To comparatively evaluate performances of tablet-based versus paper-based Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptom (VEINES-QOL/Sym) questionnaire. METHODS: We prospectively evaluated 78 consecutive patients who completed tablet-based and paper-based VEINES-QOL/Sym questionnaires and compared their scores, completion time, data entry time, and ease of use. We used Student's t-test and Wilcoxon test for quantitative variables, Bland-Altman test and kappa coefficient for agreement between questionnaires and patients, respectively. Spearman's correlation coefficient was used to assess correlations. RESULTS: Most participants (83.3%) found it easier to use the tablet device. Less time was needed to complete the tablet-based (median, 4.75; IQR, 3-7 min) than the paper-based (median, 8.3; IQR, 6.3-11.3 min) questionnaire (p < .001). Better educated patients took less time to complete paper-based (p = .003) and tablet-based (p = .001) questionnaires and considered the latter easier to use (p = .010). CONCLUSIONS: The tablet-based VEINES-QOL/Sym proved to be an easy-to-use and time-saving tool.

Assessment of lower extremity venous insufficiency and lipedema and their association with knee symptoms, functions, and quality of life in patients with knee osteoarthritis.

OBJECTIVE: To evaluate the effects of the venous insufficiency (VI) or lipedema on the symptoms, functions, and quality of life (QoL) of patients with knee osteoarthritis (OA). METHODS: 96 patients with stage 3/4 knee OA were included in the study. Patients were grouped as OA (n = 35), VI + OA (n = 35), and lipedema + OA (n = 26). Range of motion (ROM), Visual Analogue Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), short-form (SF-36), and 6-minute walking test (6MWT) were evaluated. RESULTS: WOMAC stiffness score was significantly higher in the VI group than the other groups (p < .05). VAS resting, WOMAC pain, function, and total scores were significantly higher in the lipedema + OA and VI + OA groups than the OA group (p < .05). SF-36-physical role limitation was significantly lower in the lipedema and VI groups (p < .05). CONCLUSION: VI or lipedema accompanying knee OA increases the existing disability due to OA by negatively affecting patients regarding pain, QoL, and physical functioning.

Assessment of skin and associated soft tissue changes with ultrasonography in chronic venous disease.

OBJECTIVE: Chronic venous disease (CVD) is accompanied by a spectrum of skin changes. The aim of this study was to assess skin changes in CVD in different classes of the classifications such as the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification using ultrasound (US). METHODS: This study was conducted from July 2020 to July 2021 after obtaining approval from Institutional Ethical Committee. Patients with chronic venous insufficiency were enrolled after taking informed consent. Assessment of cutaneous layer (CL), subcutaneous layer (SCL), dermo-hypodermal junction (D-HJ), and other significant US findings were noted. RESULTS: Ninety-eight limbs were evaluated. Most common skin finding was dermal edema in 59 (60.2%) legs. Other findings included infiltrates, CL thickening, hyper echogenicity and thickening of SCL, anechoic lacunae, disappearance of D-HJ, and epidermal loss or change in thickness of epidermis. Notably, US detected dermal edema in 15 and infiltrates in five C2 legs (normal on inspection). CONCLUSION: US evaluation of skin changes adds insight to clinical assessment and may reveal skin changes in legs affected with CVD that may appear normal on clinical examination.

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.

Cost-effectiveness analysis of intralesional and perilesional recombinant human epidermal growth factor vs hydrocolloid therapy in venous ulcer treatment in the Colombian context.

OBJECTIVE: To perform a comparative analysis of health care expenses and outcomes in response to the question: What is the cost-effectiveness of intralesional and perilesional recombinant human epidermal growth factor (rhEGF) compared with hydrocolloid therapy in patients diagnosed with chronic venous insufficiency without infection in Colombia? METHODS: A Markov model was used to determine cost effectiveness over a 5-year period, considering the perspective of the health system in Colombia. The study included patients aged >18 years diagnosed with chronic venous insufficiency and used clinical studies to calculate the probabilities of epithelialization, infection, recurrence, and mortality. RESULTS: RhEGF is more expensive per unit than hydrocolloids, but it is proven to be effective at healing ulcers in 8 to 12 weeks, even in complex cases. Hydrocolloids, in contrast, typically require 29.5 weeks on average, and ≤46 weeks for complex cases. Despite the cost, rhEGF is more cost effective because it achieves results comparable with hydrocolloid therapy at a lower cost per additional quality-adjusted life-year. CONCLUSIONS: Based on cost-effectiveness analysis, rhEGF is a superior alternative to hydrocolloids for treating venous ulcers in Colombia. Not only is it more affordable, but it also enhances patients' quality of life and streamlines the health care system's resource use.

Treatment patterns and outcomes of Medicare enrolees who developed venous leg ulcers.

OBJECTIVE: To retrospectively evaluate the comorbidities, treatment patterns and outcomes of Medicare enrolees who developed venous leg ulcers (VLUs). METHOD: Medicare Limited Data Standard Analytic Hospital Inpatient and Outpatient Department Files were used to follow patients who received medical care for a VLU between 1 October 2015 and 2 October 2019. Patients diagnosed with chronic venous insufficiency (CVI) and a VLU were propensity matched into four groups based on their treatment regimen. Episode claims were used to document demographics, comorbidities and treatments of Medicare enrolees who developed VLUs, as well as important outcomes, such as time to ulcer closure, rates of complications and hospital utilisation rates. Outcomes were compared across key propensity-matched groups. RESULTS: In total, 42% of Medicare enrolees with CVI (n=1,225,278), developed at least one VLU during the study, and 79% had their episode claim completed within one year. However, 59% of patients developed another VLU during the study period. This analysis shows that only 38.4% of VLU episodes received documented VLU conservative care treatment. Propensity-matched episodes that received an advanced treatment or high-cost skin substitutes for a wound which had not progressed by 30 days demonstrated the best outcomes when their cellular, acellular, matrix-like product (CAMP) treatment was applied weekly or biweekly (following parameters for use). Complications such as rates of infection (33%) and emergency department visits (>50%) decreased among patients who received an advanced treatment (following parameters for use). CONCLUSION: Medicare enrolees with CVI have diverse comorbidities and many do not receive sufficient management, which contributes to high rates of VLUs and subsequent complications. Medicare patients at risk of a VLU who receive early identification and advanced CAMP treatment demonstrated improved quality of life and significantly reduced healthcare resource utilisation.

Varicose Veins: Approach, Assessment, and Management to the Patient with Chronic Venous Disease.

Varicose veins are tortuous and dilated veins commonly seen in chronic venous disease. This article will review chronic venous disease, including its differential diagnosis, workup, and treatment.

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.

Quality-of-life assessment in patients treated with radiofrequency ablation with or without great saphenous vein recanalization.

Quality of life (QoL) in patients with chronic venous disorders has a central role to decide the correct treatment approach. In particular, in case of mini-invasive therapy, such as endovenous radiofrequency ablation (RFA), the postoperative QoL improvement remains one of the most important outcome to be reached. Despite this, very few data are published on the long-term QoL modifications after RFA. The aim of this brief report is to describe and analyze the role of QoL scales in a population of patients treated with RFA of the great saphenous vein and phlebectomies, highlighting results in short- and long-term follow-up period, and differences between recanalized and non-recanalized patients.

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.

Clinical assessment of endovenous thermal ablation combined with concomitant phlebectomy for the treatment of lower limb varicose veins with or without poor glycemic control.

BACKGROUND: This study aimed to investigate the clinical results of endovenous thermal ablation combined with stab phlebectomy for unilateral varicose veins based on diabetic management. METHODS: The study reviewed 501 patients who underwent endovenous thermal ablation combined with stab phlebectomy for unilateral varicose veins, including 337 nondiabetics (control group) and 164 diabetics. Diabetics with hemoglobin A1c ≥7% were classified as the poor glycemic control group, and hemoglobin A1c <7% as the good glycemic control group. Surgical outcomes were assessed by Venous Clinical Severity Score. The Chronic Venous disease quality of life Questionnaire was used to assess the quality of life. RESULTS: Lower limb varicose veins can be treated successfully with endovenous thermal ablation combined with stab phlebectomy in patients with or without poor glycemic control, accompanied by a significant improvement in health status. For patients with initial varicose veins (preoperative Venous Clinical Severity Score <10), the results revealed satisfactory improvements in Venous Clinical Severity Score and quality of life among the control, poor glycemic control, and good glycemic control groups. Patients with advanced varicose veins (preoperative Venous Clinical Severity Score ≥10) also showed an obvious amelioration concerning venous symptoms and quality of life. However, the extent of improvement varied among the 3 groups. Patients subjected to advanced varicose veins with the condition of poor glycemic control exhibited a less desirable improvement in postoperative health conditions compared with the control and good glycemic control groups, especially in edema relief and ulcer healing. CONCLUSION: Endovenous thermal ablation combined with stab phlebectomy is safe and effective in the treatment of varicose veins with or without poor glycemic control. Clinical attempts at hemoglobin A1c management may contribute to improved clinical outcomes in patients with advanced varicose veins.

Psychometric properties of the short version of the Freiburg Life Quality Assessment for chronic venous disease.

BACKGROUND: Chronic venous disease is a frequent vascular condition. International societies have recommended the use of health-related quality of life (HRQoL) instruments in the assessment of patients with vascular diseases. Thus, the Freiburg Life Quality Assessment for chronic venous disease, 10-item questionnaire (FLQA-VS-10) was developed. The aim of the present study was to validate the FLQA-VS-10 in a prospective study. METHODS: We recruited 100 patients with recurrent varicosis or incomplete or complete venous insufficiency undergoing interventional vein treatment (high ligation of the great or small saphenous vein or endovenous ablation therapy). These patients completed the FLQA-VS-10 and instruments assessing convergent validation criteria at four points: preoperatively (T1), postoperatively (T2) and twice 3 years later with a 1-week interval (T3 and T4). RESULTS: The mean age was 56.0 ± 13.7 years, and 66.0% were women. The patients had presented with recurrent varicosis of the saphenofemoral junction (28.0%), recurrent varicosis of the saphenopopliteal junction (1.0%), incomplete or complete insufficiency of the great saphenous vein (69.0%), or complete insufficiency of the small saphenous vein (2.0%). The items showed few missing values. The FLQA-VS-10 global score showed no ceiling effect (patients reporting the highest possible impairments in HRQoL) but did show a floor effect (patients reporting the lowest possible impairments in HRQoL), which was highest at the postoperative assessments. The internal consistency of the global score was high at all measurement points. A convergent validity and responsiveness analysis revealed that the FLQA-VS-10 correlated in the expected direction with the convergent instruments, including the Freiburg Life Quality Assessment for venous diseases (venous disease-specific HRQoL) and the five-level EQ-5D (generic HRQoL). Data from T3 and T4 revealed high test-retest reliability (intraclass correlation, 0.92). Overall, the patients stated that the FLQA-VS-10 was comprehensible, comprehensive, and easy to complete. CONCLUSIONS: Our data suggest that the FLQA-VS-10 is a reliable, valid, responsive, and feasible HRQoL questionnaire for patients with chronic venous diseases. This questionnaire can serve as short and easy-to-use instrument to assess patient-reported outcomes in the treatment of these patients.