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.

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.

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.

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.

Nonthermal Endovenous Procedures for Varicose Veins: A Health Technology Assessment.

BACKGROUND: Varicose veins are part of the spectrum of chronic venous disease and are a sign of underlying chronic venous insufficiency. Treatments to address varicose veins include surgical vein removal under general anesthesia, or endovenous laser (EVLA) or radiofrequency ablation (RFA) under tumescent anesthesia. Two newer nonthermal endovenous procedures can close veins without any tumescent anesthesia, using either mechanochemical ablation (MOCA, a combination of mechanical and chemical techniques) or cyanoacrylate adhesive closure (CAC). We conducted a health technology assessment of these nonthermal endovenous procedures for people with symptomatic varicose veins, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding MOCA and CAC, and patient preferences and values. METHODS: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane Risk of Bias or RoBANS tool, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. Meta-analysis was conducted using Review Manager 5.2, where appropriate.We performed a systematic economic literature search and conducted a cost-utility analysis with a 5-year time horizon from the perspective of Ontario Ministry of Health. In our primary economic evaluation, we assessed the cost-effectiveness of nonthermal endovenous procedures (CAC and MOCA) compared with surgical vein stripping and thermal endovenous therapies (EVLA and RFA). We also analyzed the budget impact of publicly funding nonthermal and thermal endovenous therapies for adults with symptomatic varicose veins in Ontario over the next 5 years. Costs are expressed in 2020 Canadian dollars.To contextualize the potential value of nonthermal endovenous treatments, we spoke with 13 people with varicose veins who had sought various treatment options. We conducted phone interviews and qualitatively analyzed their responses regarding their care journey and the impact of different treatment options; the only nonthermal treatment that participants had experience with was CAC. RESULTS: We included 19 primary studies reported in 25 publications comparing either MOCA or CAC with at least one other invasive treatment for symptomatic varicose veins. No studies compared MOCA with CAC. Based on evidence of low to moderate quality, MOCA resulted in slightly poorer technical outcomes (vein closure and recanalization) than thermal endovenous ablation procedures. However, clinical outcomes, quality of life improvement, and patient satisfaction were similar compared with RFA (GRADE: Very low to Moderate) and EVLA (GRADE: High). Cyanoacrylate adhesive closure resulted in little to no difference in technical outcomes, clinical outcomes, and quality of life improvement compared with RFA and EVLA (GRADE: Moderate). Patient satisfaction may also be similar (GRADE: Low). Recovery time was slightly reduced with nonthermal endovenous procedures compared with thermal ablation (GRADE: Moderate). The effect of CAC compared with surgical vein stripping is very uncertain (GRADE: Very low). Major complications of any procedure were rare, with minor complications occurring as expected and resolving.We included two European studies in the economic evidence review that were partially applicable to the Ontario context. Both studies found that thermal ablation procedures (RFA, EVLA, or steam vein sclerosis) were the most cost-effective treatments, compared with surgical vein stripping and nonthermal therapies. Our cost-utility analysis showed that surgical vein stripping is the least effective and most costly treatment among five treatments for varicose veins. Differences in quality-adjusted life-years (QALYs) between endovenous treatments (CAC, MOCA, RFA, and EVLA) were small. When the willingness-to-pay (WTP) value was $50,000 per QALY gained, the probabilities of being cost-effective were 55.6%, 18.8%, 15.6%, 10.0%, and 0%, for EVLA, CAC, MOCA, RFA, and surgical vein stripping, respectively. When the WTP was $100,000 per QALY gained, the probabilities of being cost-effective were 40.2%, 30.0%, 17.7%, 12.1%, and 0%, for EVLA, CAC, RFA, MOCA, and surgical vein stripping, respectively. Publicly funding endovenous procedures (both nonthermal and thermal) would increase the total volume of treatments, resulting in a total 5-year budget impact of around $17 million.People with varicose veins with whom we spoke reported positively on their experiences with the CAC procedure and its outcomes. They also described geographic and financial barriers to accessing the range of available treatment options. CONCLUSIONS: Cyanoacrylate adhesive closure and MOCA produced similar patient-important outcomes, and slightly shorter recovery compared with thermal ablation. Cyanoacrylate adhesive closure yielded similar anatomical outcomes as thermal endovenous ablation, but the technical outcomes of MOCA were slightly poorer.Compared with surgical vein stripping, all endovenous treatments were more effective and less expensive. If we were to look at the most cost-effective strategy (at WTP less than $100,000 per QALY), EVLA is most likely to be cost-effective. Assuming an 80% increase in the number of eligible people over the next 5 years, we estimate that publicly funding nonthermal and thermal endovenous treatments for varicose veins in Ontario would range from $2.59 million in year 1 to $4.35 million in year 5, and that the total 5-year budget impact would be around $17 million.For people with varicose veins, the CAC procedure was seen as a positive treatment method that reduced their symptoms and improved their quality of life.

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.

Avaliação do coto residual após 12 meses de safenectomia sem ligadura alta da junção safeno-femoral / Assessment of residual stumps 12 months after saphenectomy without high ligation of the saphenofemoral junction

Resumo Contexto Atualmente, recomenda-se como primeira opção cirúrgica de varizes a termoablação da veia safena; porém, esse procedimento não é realizado pelo Sistema Único de Saúde do Brasil. Como forma de incluir melhores resultados, técnicas cirúrgicas esforçam-se para mimetizar as novas tecnologias sem seus custos, sendo a principal delas a realização da safenectomia convencional sem ligadura das suas tributárias. Objetivos Avaliar a evolução do coto residual após safenectomia sem ligadura alta da junção safeno-femoral associada à invaginação do mesmo, assim como avaliar o comportamento das veias acessórias anterior/posterior. Métodos Estudo prospectivo e intervencionista. Foram operados 52 membros pela técnica de safenectomia sem ligadura alta da junção safeno-femoral seguida da invaginação do coto residual. Os pacientes foram avaliados no pré e pós-operatório (7 dias, 3, 6 e 12 meses) através de ultrassonografia vascular com Doppler para análise de diâmetro e extensão do coto residual, diâmetro e refluxo na veia acessória anterior/posterior e presença de neovascularização. A análise estatística foi realizada por média, desvio padrão, mediana, valor mínimo e máximo, frequências e percentuais, teste de Fisher e bimodal. Resultados Evidenciou-se um efeito significativo do tempo sobre a medida de diâmetro (p < 0,001) e da extensão (p = 0,002) do coto residual, porém o mesmo não foi observado quanto ao diâmetro (p = 0,355) ou refluxo na veia acessória anterior. Foi identificada neovascularização em 7 (14,3%) membros. Conclusões Após a utilização da técnica descrita, o coto residual apresentou retração e diminuição do seu diâmetro no período de 1 ano e não transmitiu refluxo para veia acessória. As taxas de neovascularização foram condizentes com a literatura.

Abstract Background Currently, the first-choice option recommended for varicose vein surgery is thermal ablation of the saphenous vein, but this procedure is not available on the Brazilian National Health Service (SUS - Sistema Único de Saúde). In an effort to improve results, surgical techniques have been developed to mimic the new technologies, without their high costs. The most prominent such method involves conventional saphenectomy, without ligation of tributaries. Objectives To assess progression of the residual stump after saphenectomy without high ligation of the saphenofemoral junction but with stump invagination and to assess the behavior of anterior/posterior accessory veins. Methods Prospective intervention study. A total of 52 limbs were treated with saphenectomy without high ligation of the saphenofemoral junction followed by invagination of the residual stump. Patients were assessed preoperatively and at 7 days, and 3, 6, and 12 months postoperatively using vascular ultrasonography with Doppler to analyze the length of the residual stump, the diameters of the residual stump and the anterior/posterior accessory vein, reflux in the accessory vein, and presence of neovascularization. Statistical analysis involved calculation of means, standard deviations, medians, minimum and maximum values, frequencies, and percentages, and Fisher's test and the binomial test. Results There was evidence of a significant time effect on residual stump diameter (p < 0.001) and length (p = 0.002), but the same was not observed with relation to diameter (p = 0.355) or reflux of the anterior accessory vein. Neovascularization was found in 7 (14.3%) limbs. Conclusions After use of the technique described, the residual stump retracted, its diameter reduced over the 1 year postoperative period, and it did not transfer reflux to the accessory vein. Neovascularization rates were in line with the literature.

Validation of the 3D SYM VEIN Symptom Assessment Tool.

OBJECTIVE: The aim was to validate the SYM VEIN consensus 3D scoring tool in chronic venous disease (CVD). METHODS: This was a prospective cohort study with a total of 35 consecutive patients with CVD. Patients with CVD undergoing saphenectomy were assessed with the revised Venous Clinical Severity Score (r-VCSS), the CIVIQ-20 quality of life score questionnaire, and the SYM VEIN consensus statement 3D system, pre-operatively and four weeks post-operatively. The total 3D score was tested for reliability, construct validity, and responsiveness. RESULTS: The total 3D score demonstrated good reliability and internal consistency (Cronbach's alpha 0.85). Principal component analysis identified three groups of symptoms (paraesthesia, burning pain, and pruritus, vs. heaviness, sensation of swelling and aching/pain, vs. restless leg and throbbing pain) demonstrating a high intragroup correlation and likely to share similar pathophysiology, indicative of adequate construct validity. The total 3D score showed a significant correlation with r-VCSS and CIVIQ-20 score (rho .46, p = .005 and rho .65, p < .001, respectively) indicative of adequate convergent validity. After saphenectomy, significant reductions (p < .001) of the total 3D, and 3D scores for all but two individual venous symptoms were observed, indicative of excellent responsiveness. Median total 3D score was reduced from 31 to 6 (83.8% decrease, p < .001), median r-VCSS was reduced from 6 to 0 (100% decrease, p < .001), and median CIVIQ-20 score was reduced from 24 to 14 (40% decrease, p < .001). The difference of median percentage change between r-VCSS and CIVIQ-20 score vs. total 3D score was significant (p = .005 and p < .001, respectively). CONCLUSION: The total SYM VEIN 3D score has good reliability, construct validity and excellent responsiveness, although less prone to change after saphenectomy compared with r-VCSS.

ASSESSMENT OF QUALITY OF LIFE IN PATIENTS AFTER THE TREATMENT OF ACUTE ASCENDING THROMBOPHLEBITIS OF THE GREAT SAPHENOUS VEIN WITH OF HIGH-FREQUENCY ENDOVENOUS WELDING.

Acute thrombophlebitis of the superficial veins is an urgent problem as it can spread to the deep veins with the subsequent development of pulmonary embolism. The social implications of varicotrombophlebitis are the long-term disability of most patients up to complete disability, so finding the least invasive methods of correction of the discussed disease is a pressing issue of modern phlebology. The research objective is to carry out a comparative analysis of the quality of life of patients with acute ascending thrombophlebitis of the great sapheneous vein after treatment with high-frequency endovenous welding and standard phlebectomy. The results of treatment of 63 patients with acute ascending thrombophlebitis of great saphenous vein (GSV) with III and IV class of thrombophlebitis, who were hospitalized in the surgical wards of the Municipal Clinical Hospital No. 8 of Kyiv from 2017 to 2018, were analyzed. Welding of the thrombotic vein segment was performed using an endovenous welding catheter (WC). Quality of life (QOL) results were assessed using CIVIQ2 (Chronic Venous Insufficiency Questionnaire). According to ultrasound duplex scanning, complete vein ablation occurred in 97.22% of patients after endovenous welding (EW) of thrombotic GSV. In all patients of Group I already on day 2, the total rate of QOL by all factors (pain, physical, social, psychological) significantly (p<0.05) exceeded the presurgery values and was 79.3%, when before treatment this indicator was 4.3% higher. At follow-up, QOL values continued to improve over all observation periods compared to the previous term (p <0.05). Quality of life restriction in connection with pain, social and psychological factors after EW decreased 2.1 times(p<0.05), when in control group patients - only 1.2 times. The revealed advantages of the method of high-frequency endovenous welding by all indicators of quality of life over standard phlebectomy allow recommending this method for wide practical application.

Avaliação da qualidade de vida em pacientes portadores de varizes de membros inferiores submetidos a tratamento cirúrgico / Quality of life assessment before and after surgery for lower limb varicose veins

Resumo Contexto As varizes dos membros inferiores representam uma das doenças mais prevalentes na população mundial e resultam em grande impacto na qualidade de vida dos pacientes devido às limitações nas atividades diárias e no desempenho funcional. Vários autores têm ressaltado a importância da avaliação da qualidade de vida na abordagem de pacientes portadores de doença venosa crônica. Objetivos Avaliar a qualidade de vida antes e após o tratamento cirúrgico de pacientes portadores de varizes dos membros inferiores. Métodos Através de estudo de antes e depois, foram avaliados 92 portadores de varizes dos membros inferiores submetidos a tratamento cirúrgico. Os pacientes foram divididos em grupos de acordo com a faixa etária e a classificação clínica CEAP. A qualidade de vida foi avaliada através do questionário VEINES QOL/SYM, aplicado no pré-operatório e 60 dias após a operação. Resultados Do total de 92 indivíduos analisados, 82,6% (76) eram mulheres. Com relação à idade, a média foi de 45,7±12,11. A classe CEAP 2 foi a mais encontrada, em 57,6% dos pacientes. Foi encontrada diferença significativa entre os escores antes e após a cirurgia para os pacientes na faixa etária entre 30 e 40 anos. Não houve diferença entre os escores nos momentos pré e pós-operatório entre os grupos CEAP. Conclusões Não foi encontrada diferença na qualidade de vida antes e após a cirurgia na maioria dos pacientes do estudo.

Abstract Background Lower limb varicose veins are one of the most prevalent diseases in the global population. The disease is chronic and has a great impact on patients' quality of life, limiting daily activities and functional performance. Several authors have emphasized the importance of including quality of life assessment in management of patients with chronic venous disease. Objectives To evaluate quality of life before and after surgical treatment of patients with varicose veins. Methods A before and after study design was employed. Ninety-two people with varicose veins of the lower limbs were treated surgically. Patients were divided into subsets according to age and CEAP clinical classification. Quality of life was assessed using the VEINES QOL/SYM questionnaire, administered during the preoperative period and 60 days after the operation. Results The sample comprised 92 subjects, 82.6% (76) of whom were women and mean age was 45.7±12.11 years. CEAP class 2 was the most frequent clinical classification, in 57.6% of patients. There was a significant difference in scores before and after surgery among patients aged from 30 to 40 years. There was no difference between preoperative and postoperative scores between different CEAP groups. Conclusions No difference in quality of life was observed after surgery in most of the patients in the present study.

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.

Changing Medicare Utilization of Minimally Invasive Procedures for the Treatment of Chronic Venous Insufficiency.

PURPOSE: To examine changes in the utilization of procedures related to treatment of chronic venous insufficiency (CVI) in the Medicare population. MATERIALS AND METHODS: Service-specific claims data for phlebectomy, sclerotherapy, and radiofrequency (RF) and laser ablation were identified by using Medicare Physician Supplier Procedure Summary master files from 2005 through 2014. Longitudinal national utilization rates were calculated by using annual Medicare enrollment data from 2005 through 2013. Procedure volumes by specialty group and site of service were analyzed. RESULTS: Total annual claims for these procedures in the Medicare fee-for-service beneficiaries increased from 95,206 to 332,244 (Compound Annual Growth Rate [CAGR], 15%) between 2005 and 2014. Per 1,000 beneficiaries, overall utilization increased annually from 2.8 in 2005 to 9.4 in 2013. Most procedures were performed in the private office setting (92% in 2014). In 2014, radiologists had a 10% relative market share, compared with vascular surgeons, other surgeons, and cardiologists, who had 26%, 25%, and 14% market shares, respectively. Cardiologists had the fastest relative growth, with a CAGR of 51% compared with 23% for radiology, 12% for vascular surgery, and 13% for other surgery. Total venous RF ablation services grew with a CAGR of 31%, with radiology and cardiology growing most rapidly (40% and 79%, respectively). Total venous laser ablation services grew with a CAGR of 22%, with radiology growing 15% and cardiology growing most rapidly at 44%. CONCLUSIONS: Utilization of CVI procedures in the Medicare population increased markedly from 2005 through 2014. The overwhelming majority are performed in the private office setting by nonradiologists.

Practice patterns of endovenous ablation therapy for the treatment of venous reflux disease.

OBJECTIVE: The purpose of this study was to assess practice patterns of endovenous ablation therapy for the treatment of venous reflux disease among the vein specialist members of the American Venous Forum (AVF). METHODS: An online survey was conducted of AVF members designed to identify demographics, treatment practices, and clinical variables in the selection of vein ablation devices. RESULTS: The survey was distributed to 798 practicing physicians, of whom 129 (16%) responded. The specialty distribution of respondents was as follows: vascular surgeons, 54%; phlebologists, 14%; general surgeons, 11%; interventional radiologists, 9%; and other specialties, 6%. The majority (81%) were from the United States, and 65% were self-employed. Almost half (47%) were in practice for >20 years, with 33% of all respondents performing three to five saphenous vein ablations per week. Three-quarters (79%) of respondents preferred radiofrequency ablation (RFA), with 47% believing that it was more cost-effective and more than half (57%) reporting improved patient satisfaction with this technique. Most of them (63%) responded that previous capital investment played a significant role in their choice of vein ablation device along with the associated cost of disposable equipment. A large majority (77%) of physicians responded that they had a significant role in choosing the treatment device, whereas only 17% thought that patients' choice played a major role in device choice. The capital investment affected choice of modality more significantly in newer practices (P < .0.5). CONCLUSIONS: The majority of AVF vein specialists prefer an RFA technique to laser, believing that RFA is associated with improved patient outcomes and is more cost-effective. Advances in technology, device costs, and reimbursement levels may have an impact on such preferences in the future.

Advanced Chronic Venous Insufficiency.

INTRODUCTION: Intervention for advanced chronic venous insufficiency is considered an appropriate standard of care. However, outcomes vary among patients who present in advanced clinical stages of disease. The main objectives of this study were to determine whether racial disparity exists at initial presentation and response to intervention. METHODS: A retrospective database was created to include all radiofrequency ablation procedures performed by a single surgeon from January 14, 2009, through May 25, 2011. Demographics, clinical traits, race, procedure, and outcomes were analyzed. Stepwise model selection reduced candidate baseline factors to a final parsimonious model, which was analyzed using analysis of variance. RESULTS: The database consisted of 300 patients with a predominant female (n = 215, 85%) base and 85 (15%) males, with a mean age distribution of 53 years. The mean body mass index was 30.2. Racial distribution revealed Asian (n = 9, 3.3%), Pacific Islander (n = 1, 0.4%), African American (n = 37, 13.6%), and Caucasian (CAU, n = 225, 82.7%). African Americans presented with more advanced clinical stages than the CAU group-C2: African American 21.6%, CAU 36.7%; C4: African American 35%, CAU 24.3%; and C6: African American 35.1%, CAU 7.5%. African Americans demonstrated a higher preoperative venous clinical severity score (VCSS) than their CAU counterparts. Postprocedural decrease in VCSS score was lower in African Americans than their CAU counterparts. CONCLUSION: African American patients present with more advanced venous insufficiency than CAUs. Postprocedural analysis reveals not only slower ulcer healing times but also higher ulcer recurrence rates.

[Surgery of varicose vein insufficiency]. / Operative Therapie der Varikose.

The basis of surgery of great saphenous vein insufficiency is the concept of "privat circulation" coined by Trendelenburg in 1891. It was only logical that the dissection of the insuffcient vein or it's partial or complete resection could bring about healing. Over the years varicose vein stripping was modified to finally result in the highly effectiv concept of crossectomy and stripping. For decades this was the Goldstandard in surgery of varicose vein insufficiency. All the other minimally invasive therapeutic techniques which have been developed in the last decades had to compete with crossectomy and stripping. Thanks to progress in technical development the classic stripping procedure has been replaced by highly effectiv, minimally invasiv procedures, at least in the western industrialisied countries. For a minority of patients with specific anatomical pathologies as well as countries with limited health resources vein stripping remains a surgical standard procedure.

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.

In vivo assessment of two endothelialization approaches on bioprosthetic valves for the treatment of chronic deep venous insufficiency.

Chronic deep venous insufficiency is a debilitating disease with limited therapeutic interventions. A bioprosthetic venous valve could not only replace a diseased valve, but has the potential to fully integrate into the patient with a minimally invasive procedure. Previous work with valves constructed from small intestinal submucosa (SIS) showed improvements in patients' symptoms in clinical studies; however, substantial thickening of the implanted valve leaflets also occurred. As endothelial cells are key regulators of vascular homeostasis, their presence on the SIS valves may reduce the observed thickening. This work tested an off-the-shelf approach to capture circulating endothelial cells in vivo using biotinylated antikinase insert domain receptor antibodies in a suspended leaflet ovine model. The antibodies on SIS were oriented to promote cell capture and showed positive binding to endothelial cells in vitro; however, no differences were observed in leaflet thickness in vivo between antibody-modified and unmodified SIS. In an alternative approach, valves were pre-seeded with autologous endothelial cells and tested in vivo. Nearly all the implanted pre-seeded valves were patent and functioning; however, no statistical difference was observed in valve thickness with cell pre-seeding. Additional cell capture schemes or surface modifications should be examined to find an optimal method for encouraging SIS valve endothelialization to improve long-term valve function in vivo. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 1610-1621, 2016.