Current practice of cyanoacrylate endovenous ablation: American vein and lymphatic society position statement.

BACKGROUND: Cyanoacrylate endovenous ablation and closure of incompetent saphenous veins have become increasingly utilized since its approval for use in the United States in 2015. This increase in usage necessitates a societal update to guide treatment and ensure optimal and consistent patient outcomes. METHOD: The American Vein and Lymphatic Society convened an expert panel to write an updated Position Statement with explanations and recommendations for the appropriate use of cyanoacrylate endovenous ablation for patients with venous insufficiency. RESULT: A Position Statement was produced by the expert panel with recommendations for appropriate use, treatment technique, outcomes review, and potential adverse events. Their recommendations were reviewed, edited, and approved by the Guidelines Committee of the Society. CONCLUSION: This societal Position Statement provides a useful document for reference for physicians and venous specialists to assist in the appropriate use of cyanoacrylate endovenous ablation in the treatment of patients with venous insufficiency.

Proposal for a national coverage determination for the treatment of varicose veins and venous disease due to disparate Centers for Medicare and Medicaid Services local coverage determination policies.

Varicose veins and chronic venous disease are common problems in the United States. Persons with these conditions often have an adversely affected quality of life. There are a number of proven interventions to treat varicose veins and to improve patients' life quality, but these interventions are often restricted by the Centers for Medicare and Medicaid Services and private third-party payers. The Centers for Medicare and Medicaid Services have private contractors that administer Medicare policies in 10 jurisdictions across the United States. There is no national policy or coverage for the treatment of varicose veins; rather, there are multiple, disparate regional policies written by the contractors that cover the same Medicare beneficiary population. These disparate policies are not evidence based and provide unfair coverage of the same disease to the Medicare population, depending on where they live. Our proposal is for a national coverage determination policy for the treatment of varicose veins.

Multicenter assessment of the repeatability and reproducibility of the revised Venous Clinical Severity Score (rVCSS).

BACKGROUND: The Venous Clinical Severity Score (VCSS) was designed and validated as an objective measure of disease severity in patients with chronic venous disease (CVD). Recently, a revision of the VCSS (rVCSS) was performed to resolve ambiguity in the clinical descriptors and improve clarity and ease of use. This new revised VCSS requires validation to determine its repeatability and reproducibility in clinical evaluation of patients with varying levels of CVD. METHODS: A prospective multicenter protocol was designed to enroll patients undergoing evaluation for CVD at venous practices with experience using the original VCSS. At the time of initial evaluation, two clinicians independently assessed both lower extremities to determine the rVCSS and the CEAP clinical score. Between 1 and 6 weeks, patients returned and received repeat assessment of the rVCSS by the same two clinicians independently. Patients were excluded if any venous intervention occurred between the two separate evaluation visits. Scores were compared to determine inter- and intra-observer variability overall and within each CEAP clinical class. RESULTS: Seven centers enrolled a total of 136 limbs yielding 248 paired evaluations for interobserver variability and 258 paired evaluations for intraobserver variability. The mean interobserver rVCSS difference was 1.4 ± 1.7 and the mean intraobserver variability was 1.3 ± 1.6. Statistical assessment with weighted kappa yielded good repeatability (κ = 0.68; P < .0001) and good reproducibility (κ = 0.72; P < .000001) for the rVCSS. The rVCSS correlated well with the CEAP clinical class with significant differences between rVCSS in increasing classes. (P < .0001). CONCLUSIONS: In this multicenter evaluation, the rVCSS was demonstrated to be a reliable and reproducible instrument for documentation of the severity of symptoms in patients with lower extremity venous insufficiency.

The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum.

The Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) have developed clinical practice guidelines for the care of patients with varicose veins of the lower limbs and pelvis. The document also includes recommendations on the management of superficial and perforating vein incompetence in patients with associated, more advanced chronic venous diseases (CVDs), including edema, skin changes, or venous ulcers. Recommendations of the Venous Guideline Committee are based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system as strong (GRADE 1) if the benefits clearly outweigh the risks, burden, and costs. The suggestions are weak (GRADE 2) if the benefits are closely balanced with risks and burden. The level of available evidence to support the evaluation or treatment can be of high (A), medium (B), or low or very low (C) quality. The key recommendations of these guidelines are: We recommend that in patients with varicose veins or more severe CVD, a complete history and detailed physical examination are complemented by duplex ultrasound scanning of the deep and superficial veins (GRADE 1A). We recommend that the CEAP classification is used for patients with CVD (GRADE 1A) and that the revised Venous Clinical Severity Score is used to assess treatment outcome (GRADE 1B). We suggest compression therapy for patients with symptomatic varicose veins (GRADE 2C) but recommend against compression therapy as the primary treatment if the patient is a candidate for saphenous vein ablation (GRADE 1B). We recommend compression therapy as the primary treatment to aid healing of venous ulceration (GRADE 1B). To decrease the recurrence of venous ulcers, we recommend ablation of the incompetent superficial veins in addition to compression therapy (GRADE 1A). For treatment of the incompetent great saphenous vein (GSV), we recommend endovenous thermal ablation (radiofrequency or laser) rather than high ligation and inversion stripping of the saphenous vein to the level of the knee (GRADE 1B). We recommend phlebectomy or sclerotherapy to treat varicose tributaries (GRADE 1B) and suggest foam sclerotherapy as an option for the treatment of the incompetent saphenous vein (GRADE 2C). We recommend against selective treatment of perforating vein incompetence in patients with simple varicose veins (CEAP class C(2); GRADE 1B), but we suggest treatment of pathologic perforating veins (outward flow duration ≥500 ms, vein diameter ≥3.5 mm) located underneath healed or active ulcers (CEAP class C(5)-C(6); GRADE 2B). We suggest treatment of pelvic congestion syndrome and pelvic varices with coil embolization, plugs, or transcatheter sclerotherapy, used alone or together (GRADE 2B).

Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group.

In response to the need for a disease severity measurement, the American Venous Forum committee on outcomes assessment developed the Venous Severity Scoring system in 2000. There are three components of this scoring system, the Venous Disability Score, the Venous Segmental Disease Score, and the Venous Clinical Severity Score (VCSS). The VCSS was developed from elements of the CEAP classification (clinical grade, etiology, anatomy, pathophysiology), which is the worldwide standard for describing the clinical features of chronic venous disease. However, as a descriptive instrument, the CEAP classification responds poorly to change. The VCSS was subsequently developed as an evaluative instrument that would be responsive to changes in disease severity over time and in response to treatment. Based on initial experiences with the VCSS, an international ad hoc working group of the American Venous Forum was charged with updating the instrument. This revision of the VCSS is focused on clarifying ambiguities, updating terminology, and simplifying application. The specific language of proven quality-of-life instruments was used to better address the issues of patients at the lower end of the venous disease spectrum. Periodic review and revision are necessary for generating more universal applicability and for comparing treatment outcomes in a meaningful way.

The importance of uniform venous terminology in reports on varicose veins.

There is a need for a standardized consistent language in vascular surgery that allows easy flow of information and comparison of results among clinicians. Beginning with current nomenclature, a common language serves as a framework for more detailed efforts. Understanding the outcomes assessment tools available provides the opportunity for universal outcomes reporting. Data collected at widespread points can then be fairly compared, and common goals of therapy can be determined. Common outcomes that have demonstrated verifiable trends and reproducibility should be subjected to the rigors of evidence-based questioning. The resultant standards of care and expectations of therapy are then confidently presented for everyday practice and ongoing research.

The utility of the Venous Clinical Severity Score in 682 limbs treated by radiofrequency saphenous vein ablation.

OBJECTIVES: The goal of endovenous ablation is to reduce the symptoms associated with chronic venous insufficiency. This prospective study was designed to apply the venous clinical severity score to limbs before and after endovenous saphenous vein radiofrequency ablation and to identify risk factors associated with treatment failure. METHODS: Between September 2003 and March 2005, 499 patients underwent 682 saphenous vein radiofrequency ablation procedures. Preoperative venous clinical severity scores were documented. Follow-up clinical and duplex examinations were performed at 4 days, 4 weeks, and 4 months after saphenous vein radiofrequency ablation and at > or=6 months thereafter. Venous clinical severity scoring was repeated at follow-up visits, and patients were asked to evaluate their level of satisfaction with the procedure. RESULTS: The mean +/- standard deviation age of the patients was 53.5 +/- 13.3 years (range, 28 to 86 years), and 68% were women. Pretreatment CEAP clinical class C3/C4 comprised 80% of limbs (520/682). Preoperative, 4-day, 4-week, and 4-month venous clinical severity scores were, respectively, 8.8 +/- 3.7 in 648 limbs, 5.2 +/- 3.0 in 629, 4.1 +/- 2.4 in 530, and 3.3 +/- 1.6 in 479 limbs. Saphenous vein radiofrequency ablation significantly reduced pain related to lower extremity venous disease from 95.7% to 15.2% (P < .0001) and edema from 92.4% to 17.0% (P < .0001). Before treatment, venous stasis ulcers were present in 52 limbs and healed at a rate of 86%. Complications in 633 limbs at last follow-up included superficial thrombophlebitis in 12.0%, paresthesia in 0.3%, and nonocclusive thrombus extension in 0.2%. No skin thermal injury was observed. Fewer than 2% of patients reported dissatisfaction with their procedural outcome. Age (relative risk, 0.98; P = .06), female sex (relative risk, 0.19; P < .0001), and tumescent volume >250 mL (relative risk, 0.59; P = .06) were associated with higher rates of occlusion. The overall occlusion rate was 87.1%. CONCLUSIONS: As determined by the venous clinical severity score, treatment of saphenous vein reflux with endovenous radiofrequency ablation results in the clinical improvement of symptoms and aids in the healing of venous ulcers. Age, female sex, and tumescent volume are associated with high success rates of occlusion. We found the venous clinical severity score to be an excellent stand-alone tool for assessing outcomes after saphenous vein radiofrequency ablation.