Disclaimer Due to the evolving field of medicine, new research may, in due course, modify the recommendations presented in this document. At the time of publication, every attempt has been made to ensure that the information provided is up to date and accurate. It is the responsibility of the treating physician to determine the best treatment for the patient. The authors, committee members, editors, and publishers cannot be held responsible for any legal issues that may arise from the citation of this statement. Rules of evidence Management of patients with chronic venous disorders has been traditionally undertaken subjectively among physicians, often resulting in less than optimal strategies. In this document, a systematic approach has been developed with recommendations based upon cumulative evidence from the literature. Levels of evidence and grades of recommendation range from Level I and Grade A to Level III and Grade C. Level I evidence and Grade A recommendations derive from scientifically sound randomized clinical trials in which the results are clear-cut. Level II evidence and Grade B recommendations derive from clinical studies in which the results among trials often point to inconsistencies. Level III evidence and Grade C recommendations result from poorly designed trials or from small case series.1, 2 Meta-analysis Meta-analyses are included in the present document but there should be caution as to their possible abuse. Certain studies may be included in a meta-analysis carelessly without sufficiently understanding of substantive issues, ignoring relevant variables, using heterogenous findings or interpreting results with a bias.3 It has been demonstrated that the outcomes of 12 large randomized controlled trials were not predicted accurately 35% of the time by the meta-analyses published previously on the same topics.4

Management of chronic venous disorders of the lower limbs: guidelines according to scientific evidence.

http://www.ejves.com/article/S1078588421009795/pdf

European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs.

Objective The Venogram vs IVUS for Diagnosing Iliac vein Obstruction (VIDIO) trial was designed to compare the diagnostic efficacy of intravascular ultrasound (IVUS) with multiplanar venography for iliofemoral vein obstruction. Methods During a 14-month period beginning July 2014, 100 patients with chronic Clinical, Etiologic, Anatomic, and Pathophysiologic clinical class C4 to C6 venous disease and suspected iliofemoral vein obstruction were enrolled at 11 U.S. and 3 European sites. The inferior vena cava and common iliac, external iliac, and common femoral veins were imaged. Venograms were measured for vein diameter; IVUS provided diameter and area measurements. Multiplanar venograms included three views: anteroposterior and 30-degree right and left anterior oblique views. A core laboratory evaluated the deidentified images, determining stenosis severity as the ratio between minimum luminal diameter and reference vessel diameter, minimal luminal area, and reference vessel area. A 50% diameter stenosis by venography and a 50% cross-sectional area reduction by IVUS were considered significant. Analyses assessed change in procedures performed on the basis of imaging method and concordance of measurements between each imaging method. Results Venography identified stenotic lesions in 51 of 100 subjects, whereas IVUS identified lesions in 81 of 100 subjects. Compared with IVUS, the diameter reduction was on average 11% less for venography ( P Conclusions IVUS is more sensitive for assessing treatable iliofemoral vein stenosis compared with multiplanar venography and frequently leads to revised treatment plans and the potential for improved clinical outcome.

Venography versus intravascular ultrasound for diagnosing and treating iliofemoral vein obstruction

Chronic venous disease (CVD) is a prevalent condition that tends to worsen with age. Patients initially seek treatment to relieve symptoms of leg pain, discomfort, heaviness and swelling, all of which impact their quality of life. As the disease increases in severity to include varicose veins, skin changes, and venous ulcer, the demand for treatment increases while the quality of life further diminishes. The prevalence of CVD is highest in Western countries where it already consumes up to 2% of healthcare budgets. With the aging of the global population, the prevalences of CVD and severe CVD are projected to increase substantially, foretelling unsustainably large increases in the healthcare resources and costs needed to treat CVD patients in the coming decades. Effective venoactive drug treatments and ablation procedures are available that provide symptom relief, improve quality of life, slow disease progression, and promote ulcer healing. In addition, venoactive drug treatments may be highly cost-effective. However, there is evidence that physician awareness of CVD is suboptimal and that many patients with CVD are not being treated or referred to specialists according to established guidelines. To decrease this treatment gap and prevent unnecessary disease progression, international guidelines are available to help physicians consider CVD treatment options and refer patients when warranted. Improved disease awareness and appropriate early treatment may help reduce the coming burden of CVD.Funding: Servier.

/pdf/the-seriousness-of-chronic-venous-disease-a-review-of-real-lz28qgnk9d.pdf

The Seriousness of Chronic Venous Disease: A Review of Real-World Evidence

Background Stimulated by published reports of potentially inappropriate application of venous procedures, the American Venous Forum and its Ethics Task Force in collaboration with multiple other professional societies including the Society for Vascular Surgery (SVS), American Vein and Lymphatic Society (AVLS), and the Society of Interventional Radiology (SIR) developed the appropriate use criteria (AUC) for chronic lower extremity venous disease to provide clarity to the application of venous procedures, duplex ultrasound imaging, timing, and reimbursements. Methods The AUC were developed using the RAND/UCLA Appropriateness Method, a validated method of developing appropriateness criteria in health care. By conducting a modified Delphi exercise and incorporating best available evidence and expert opinion, AUC were developed and scored. Results There were 119 scenarios rated on a scale of 1 to 9 by an expert panel, with 1 being never appropriate and 9 being appropriate. The majority of scenarios consisted of symptomatic indications were deemed appropriate for venous intervention. For scenarios with anatomically short segments of reflux and/or no symptoms, the indications were rated less appropriate. For the indication of edema, a wide dispersion of ratings was observed especially for short segments of saphenous reflux or stenting for iliac/ inferior vena cava disease, noting that there are multifactorial causes of edema, some of which could coexist with venous disease and possibly impact effectiveness of treatment. Several scenarios were considered never appropriate, including treatment of saphenous veins with no reflux, iliac vein or inferior vena cava stenting for iliac vein compression as an incidental finding by imaging with minimal or no symptoms or signs, and incentivizing sonographers to find reflux. Conclusions The AUC statements are intended to serve as a guide to patient care, particularly in areas where high-quality evidence is lacking to aid clinicians in making day-to-day decisions for common venous interventions. This may also prove useful when applied on a population level, such as practice patterns, and not necessarily to dictate decision making for individual cases. As a product of a collaborative effort, it is hoped that this could be utilized by physicians and multiple stakeholders committed toward improving patient care and to identify and stimulate future research priorities.

The 2020 appropriate use criteria for chronic lower extremity venous disease of the American Venous Forum, the Society for Vascular Surgery, the American Vein and Lymphatic Society, and the Society of Interventional Radiology.

Background Recurrence of varicose veins after surgery (REVAS) for saphenous incompetence has been well described after ligation and stripping (LS 40 of 125 limbs), followed by the development of anterior accessory saphenous vein incompetence (19%; 23 of 125 limbs). In contrast to other reports, incompetent calf perforating veins were an infrequent cause of REVAS (7%; eight of 125). Conclusions There is no difference in the incidence of REVAS for EVA vs L&S, but the causes of REVAS are different with L&S, which has important implications for treatment.

Recurrence of varicose veins after endovenous ablation of the great saphenous vein in randomized trials.

Background Duplex ultrasound (DUS) is performed by the majority of physicians after endovenous ablation (EVA) of the great saphenous vein to screen for endovenous heat-induced thrombosis (EHIT) at the saphenofemoral junction extending into the femoral vein. Several factors should be considered in assessing the value and cost of routine DUS after EVA: the natural history of EHIT is poorly defined, the incidence appears low, and the majority are both asymptomatic and Kabnick type 2 (projecting only slightly into the femoral vein). Moreover, routine postoperative DUS screening is not recommended for procedures with higher thromboembolic complication rates, such as joint replacement or bariatric surgery. Methods Data on the incidence of death, EHIT, and deep venous thrombosis (DVT) were derived from a systematic review after either radiofrequency or laser ablation of the saphenous vein from two sources: (1) EVA randomized controlled trials (N = 1482) and a (2) large (>150 patients) EVA case series (N = 12,363). The number of tests required to detect one case of EHIT/DVT was calculated from the incidence in the EVA and case series data bases; the cost to detect a case was estimated using the 2013 Medicare global fee schedule for the cost of a unilateral venous DUS study. Results This analysis included 13,845 EVA-treated limbs. There were no reported deaths. The incidence of DUS-detected venous thromboembolism after EVA is 0.7%. The cost of unilateral DUS according to the Medicare global reimbursement fee for office-based studies is $106.71. The total cost of performing DUS in this study population is estimated to be at least $1,477,399, and the amount of dollars expended per venous thromboembolism detected is $14,667. Conclusions The current Society for Vascular Surgery/American Venous Forum recommendation is to perform screening DUS after EVA within 72 hours postoperatively with a weak level of recommendation (grade 2C). The current analysis demonstrates a low incidence of EHIT/DVT with a corresponding high cost to detect each case with routine DUS screening. These data combined with the unclear clinical significance of EHIT suggest that the policy of universal post-EVA screening should be revised in the near future.

Cost analysis and implications of routine deep venous thrombosis duplex ultrasound scanning after endovenous ablation.

Cost and Benefit Analysis of Stenting Versus Compression Therapy for Patients With Chronic Total Venous Occlusion

Objectives: The Society for Vascular Surgery/American Venous Forum venous leg ulcer guidelines recommended endovenous ablation (EVA) of superficial venous reflux to prevent recurrence with a strong recommendation (grade 1, level of evidence B). Although EVA has not been shown to improve healing rates, when viewed as a continuum of care, recurrence contributes to the more clinically relevant measure of ulcer-free days. The ESCHAR trial reported that on average, during a 3year period, the surgery group had 15 more ulcer-free weeks than the compression group. We have previously shown that EVA increased the cost of care in C6 patients compared with compression alone in the first year. We sought to estimate the midterm costs of EVA and compression, extrapolating our 1-year data using the rates of ulcer healing and recurrence in years 2 and 3 from the ESCHAR trial. Methods: We retrospectively identified all C6 patients (n1⁄4 36) seen in our wound/vein clinic with a minimum of 12 months of follow-up. Of these C6 patients, 15 received EVA and 21 did not, based on standard guidelines. We recorded total cost of care associated with venous leg ulcers during 1 year, including wound center fees, visiting nurse costs, relevant inpatient costs, and EVA global reimbursement. All “costs” are dollars received, not charges. Total costs during 1 year were compared between the two treatment groups. Financial data were then modeled forward using outcome data on healing/ recurrence derived from the 500-patient ESCHAR trial. Results: Ulcer healing and recurrence rates during year 1 were similar in our cohort and ESCHAR (80% healed in the surgery group in both reports; however, compression alone healed 61% in our series vs 82% in ESCHAR. Our actual total costs for the first year of treatment were $9214 for compression and $15,075 for EVA and compression. We applied the healing and recurrence rates in years 2 and 3 in the ESCHAR trial to our data (Table). Conclusions: EVAemployed in the treatment ofC6 patients resulted in increased total cost in the first year. However, our data extrapolated to 3 years, based on ESCHAR healing and recurrence rates, showed that the cost difference disappeared. These data demonstrate that the clinical benefit of EVA in C6 patients does not result in any net increased costs during a 3-year period. EVA treatment of C6 patients appears justified on a cost/benefit basis.

Erica Tangney

Papers

Recurrence of varicose veins after endovenous ablation of the great saphenous vein in randomized trials.

Cost analysis and implications of routine deep venous thrombosis duplex ultrasound scanning after endovenous ablation.

Cost and Benefit Analysis of Stenting Versus Compression Therapy for Patients With Chronic Total Venous Occlusion

Is Superficial Venous Surgery in C6 Patients Justified From a Cost/Benefit Viewpoint?