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.

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.

Defining the human and health care costs of chronic venous insufficiency.

Chronic venous insufficiency (CVI) affects more than 25 million adults in the United States alone, and more 6 million with advanced stages of venous disease. The high incidence of CVI and the increasing costs of care, place a heavy financial burden on the US health care system. Recent studies estimate the total cost of care at more than $3 billion per year. These staggering numbers highlight the importance of timely diagnosis, treatment, and prevention of CVI. In this article, we review the epidemiology and prevalence of CVI, and its financial impact on national health care budget. Racial disparities in CVI and the impact of socioeconomic status on access to care are also discussed. Finally, we discuss CVI-related screening programs and the importance of preventative measures in venous disease.

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.

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

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

Central Venous Pathologies: Treatments and Economic Impact.

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

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.

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.

[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.

The Impact of Race on Advanced Chronic Venous Insufficiency.

BACKGROUND: The study aimed to determine the association between race and patient variables, hospital covariates, and outcomes in patients presenting with advanced chronic venous insufficiency. METHODS: The National Inpatient Sample was queried to identify all Caucasian and African-American patients with a primary International Classification of Diseases, Ninth Revision (ICD-9) diagnosis code for venous stasis with ulceration (454.0), inflammation (454.1), or complications (454.2) from 1998 to 2011. CEAP scores were correlated with ICD-9 diagnosis. Demographics, CEAP classification, management, cost of care, length of stay (LOS), and inpatient mortality were compared between races. Statistical analysis was via descriptive statistics, Student's t-test, and the Fisher's exact test. Trend analysis was completed using the Mann-Kendall test. RESULTS: A total of 20,648 patients were identified of which 85% were Caucasian and 15% were African-American. Debridement procedures had the highest costs at $6,096 followed by skin grafting at $4,089. There was an overall decrease in the number of ulcer debridements, vein stripping, and sclerotherapy procedures between 1998 and 2011 (P < 0.05) for both groups. However, African-American patients had significantly more ulcer debridements than their Caucasian counterparts. CONCLUSIONS: African-American patients with a primary diagnosis of venous stasis present with more advanced venous disease at a younger age compared with their Caucasian counterparts. This is associated with increased ulcer debridement, deep vein thrombosis rates and hospital charges in the African-American cohort. There are no differences in sclerotherapy or skin grafting procedures, LOS or inpatient mortality between races.

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.

CVD: a condition of underestimated severity.

Chronic venous disease (CVD) affects approximately a quarter of the adult population and causes a considerable burden on the health of these patients. The true extent of the severity of the disease is hampered because of reduced public awareness, operational difficulties in diagnosis, and the perception that varicose veins are mainly a cosmetic inconvenience. Consequently the disease receives little attention in public health care systems which focus on life threatening conditions and those which cause obvious morbidity like cancer, cardiac disease and stroke. This review aims to correct these misconceptions by addressing the full scope of CVD, including the post-thrombotic syndrome and venous ulceration. The severity of conditions like telangectasiae and edema and the symptoms they cause are frequently underestimated, especially if varicose veins are not present to alert the patient or doctor. The definition, diagnosis, scope, epidemiology, progression and cost of CVD are discussed with evidence to explain how these underestimate the severity of the disease. It is anticipated that once CVD achieves greater recognition this will open up greater opportunities for treatment. These include surgery, endovenous ablation, stenting, compression, venoactive drugs like micronized purified flavonoid fraction and other drugs such as sulodexide and pentoxifylline.

Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial.

BACKGROUND: Radiofrequency ablation (RFA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. The use of thermal energy as a treatment source requires the instillation of tumescence anesthesia. Mechanochemical endovenous ablation (MOCA) combines mechanical endothelial damage, using a rotating wire, with the infusion of a liquid sclerosant. Tumescence anesthesia is not required. Preliminary experiences with MOCA showed good results and low post-procedural pain. METHODS/DESIGN: The MARADONA (Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation) trial is a multicenter randomized controlled trial in which 460 patients will be randomly allocated to MOCA or RFA. All patients with primary GSV incompetence who meet the eligibility criteria will be invited to participate in this trial. The primary endpoints are anatomic and clinical success at a one-year follow-up, and post-procedural pain. The secondary endpoints are technical success, complications, operation time, procedural pain, disease-specific quality of life, time taken to return to daily activities and/or work, and cost-efficiency analyses after RFA or MOCA. Both groups will be evaluated on an intention to treat base. DISCUSSION: The MARADONA trial is designed to show equal results in anatomic and clinical success after one year, comparing MOCA with RFA. In our hypothesis MOCA has an equal anatomic and clinical success compared with RFA, with less post-procedural pain. TRIAL REGISTRATION: Clinicaltrials NCT01936168.

Superficial venous insufficiency from the infernal to the endothermal.

This review presents the common diseases associated with superficial venous insufficiency of the leg. These include varicose veins, swelling, skin damage and ulceration. The benefits and rationale behind treatment are discussed, followed by the historical advances from ancient mortality and prayer to the modern endovenous revolution. Finally, an overview of modern treatment options will discuss the evidence supporting the gold standard of endothermal ablation and the cost effectiveness of treatment at this time of challenging resource limitation.

Chronic venous disease cases at the Iasi dermatology clinic.

UNLABELLED: Chronic venous disease (CVD) is defined as a disturbance of blood return to the deep venous system, superficial venous system, and communicating (perforating) veins. Once present, CVD persists throughout life, so like heart failure it is nowadays considered "a condition for life". Severe CVD of the lower limbs is one of the most common medical problems, affecting up to 25% of the general adult population of industrialized countries. AIM: to determine the incidence of CVD among the cases admitted to the Dermatology Clinic of the' "Sf. Spiridon" Emergency Clinical Hospital Iasi, CVD incidence by sex, age, area of residence and the main pathogens incriminated in super infection of ulcerative lesions. MATERIAL AND METHODS: We did a retrospective study of patients admitted to the Dermatology Clinic of the Iasi "Sf. Spiridon" Emergency Hospital over a five years period. RESULTS: Of the total number of patients admitted to our clinic (9375), 57% were diagnosed with CVD and 26.61% of them were with CEAP 6 class chronic venous insufficiency. There was an approximately equal sex distribution and most patients (44%) were older than 65 years. CONCLUSIONS: We did a large epidemiological study of venous disease, based on revised CEAP classification, showing again that it is not only a very important medical problem, with various clinical manifestation and multidisciplinary approach, but also an important issue for health insurance system.

Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein.

BACKGROUND: New minimally invasive treatment modalities, such as ultrasound-guided foam sclerotherapy (UGFS), are becoming more popular. In a multicentre randomized controlled non-inferiority trial, the effectiveness and costs of UGFS and surgery for treatment of the incompetent great saphenous vein (GSV) were compared. METHODS: Patients with primary great saphenous varicose veins were assigned randomly to either UGFS or surgical stripping with high ligation. Recurrence, defined as reflux combined with venous symptoms, was determined on colour duplex scans at baseline, 3 months, 1 year and 2 years after initial treatment. Secondary outcomes were presence of recurrent reflux (irrespective of symptoms), reduction of symptoms, health-related quality of life (EQ-5D(™)), adverse events and direct hospital costs. RESULTS: Two hundred and thirty patients were treated by UGFS and 200 underwent GSV stripping. The 2-year probability of recurrence was similar in the UGFS and surgery groups: 11·3 per cent (24 of 213) and 9·0 per cent (16 of 177) respectively (P = 0·407). At 2 years, reflux irrespective of venous symptoms was significantly more frequent in the UGFS group (35·0 per cent) than in the surgery group (21·0 per cent) (P = 0·003). Mean(s.d.) hospital costs per patient over 2 years were €774(344) per patient for UGFS and €1824(141) for stripping. CONCLUSION: At 2-year follow-up, UGFS was not inferior to surgery when reflux associated with venous symptoms was the clinical outcome of interest. UGFS has the potential to be a cost-effective approach to a common health problem. Registration numbers: NCT01103258 (http://www.clinicaltrials.gov) and NTR654 (http://www.trialregister.nl).

Cost and effectiveness of laser with phlebectomies compared with foam sclerotherapy in superficial venous insufficiency. Early results of a randomised controlled trial.

OBJECTIVES: Quantify endovenous laser ablation (EVLA) with concurrent phlebectomies and ultrasound-guided foam sclerotherapy (UGFS) in cost and effectiveness at 3 weeks and 3 months. DESIGN: Single-centre, prospective, randomised controlled trial. PATIENTS: One hundred patients (100 legs), C(2-6), age 21-78, M:F 42:58, with primary varicose veins received either EVLA under local anaesthetic or UGFS. METHODS: Assessments included duplex, Aberdeen varicose vein questionnaire (AVVQ), venous clinical severity score (VCSS), venous filling index (VFI), visual analogue 7-day pain score and analgesia requirements. Additional treatments with UGFS were performed, if required. Micro-costing, using individually timed treatments, was based on consumables, staff pay and overheads. RESULTS: Changes in AVVQ, VCSS and VFI values (3 months) did not demonstrate any significant difference between groups. At 3 months, the above-knee GSV occlusion rate (without co-existing reflux) was not significantly different between the groups (74% vs 69%; EVLA vs UGFS; P = .596). Of the 9 haemodynamic failures in each group, 7 EVLA patients and 4 UGFS patients had co-existing cross-sectional above-knee GSV occlusion at some point. However, UGFS significantly outperformed EVLA in cost, treatment duration, pain, analgesia requirements and recovery. CONCLUSIONS: UGFS is 3.15 times less expensive than EVLA (£230.24 vs £724.72) with comparable effectiveness but 56% (versus 6%) required additional foam (ISRCTN:03080206).