“We found deficiencies in current indications for intervention, which may explain some of the overutilisation we have been encountering,” explained Elna Masuda (Straub Medical Center, Hawaii Pacific Health, Honolulu, USA), during an overview of the new 2020 appropriate use criteria for chronic lower extremity venous disease.
Presented at the annual meeting of the American Venous Forum (VENOUS 2020; 3–6 March, Amelia Island, USA), the new guidelines are described by former AVF president Brajesh K Lal (University of Maryland, Baltimore, USA) as “the first appropriate use criteria in venous and lymphatic disease that has ever been produced”, and were developed by the AVF, in collaboration with the Society for Vascular Surgery (SVS), American Vein and Lymphatic Society (AVLS), and Society of Interventional Radiology (SIR).
According to the authors and AVF ethics taskforce, this project was stimulated by published reports regarding the potentially inappropriate application of venous procedures. Commenting on misuse, Masuda acknowledged in her presentation that “this type of predatory behaviour is certainly alarming, and adds to much of what we are already aware of in our community”. She continued, noting that what began as a list of “don’ts” soon led to the creation of the Appropriate Use Multi-society project.
The aim of the criteria, published online ahead of print in the Journal of Vascular Surgery: Venous and Lymphatic Disorders, is to provide clarity to the application of venous procedures, duplex ultrasound imaging, timing, and reimbursements, in the treatment of chronic lower extremity venous disease.
Detailing how the criteria were established, Masuda et al write: “The appropriate use criteria were developed using the RAND/UCLA Appropriateness Method, a validated method of developing appropriateness criteria in healthcare. By conducting a modified Delphi exercise and incorporating the best available evidence and expert opinion, criteria were developed and scored.” At VENOUS 2020, Masuda expanded, emphasising that the criteria “underwent two complete rounds of discussions and ratings by 16 panellists from several distinguished societies”.
Overall, 119 scenarios that may be encountered—in relation to venous disease—were rated on a scale of 1 to 9 by an expert panel, with 1 being never appropriate and 9 being appropriate. Although most scenarios consisting of symptomatic indications were deemed appropriate for venous intervention, scenarios characterised by anatomically short segments of reflux and/or a lack of symptoms were considered less appropriate.
“Overall we were not surprised that ratings were appropriate for saphenous vein ablation when encountering long segments of (axial) reflux, in patients with symptoms,” stated Masuda. For CEAP clinical class C2–C6 there was agreement that treatment in symptomatic patients was appropriate.
“When we came to the indication of ablation for oedema,” Masuda said, turning her attention to more specific examples featured in the criteria, “we found that this is a category where there is still some uncertainty.” She stated that there are clearly examples of how treatment effectively benefits those with oedema, but the panellists felt this was not always predictable and is an area that deserves more research.
These thoughts are reflected by the online publication, which states that for the indication of oedema, a wide dispersion of ratings was observed, especially for short segments of saphenous reflux or stenting for iliac and inferior vena cava disease. Furthermore, it was noted by the authors that there are multifactorial causes of oedema, “some of which could coexist with venous disease and possibly impact treatment outcomes”.
Iliac vein stenting was regarded as another area where clinical evidence is lacking, yet clinicians are encountering iliac stenosis as diagnostic testing extends to the pelvis. Members of the expert panel were asked to rate the appropriateness of this intervention as a first-line treatment for iliac obstruction of greater than 50%. “The group rated this appropriate for symptomatic C4–C6 patients, which was not surprising given current knowledge,” though Masuda stated that there is very little quality evidence supporting its effectiveness, especially for C4 cases.
There are several scenarios that have been deemed “never appropriate”, which were not surprising to investigators and included: treatment of saphenous veins without reflux; iliac vein or inferior vena cava stenting for iliac vein compression as an incidental finding by imaging with minimal or no symptoms; and incentivising sonographers to find reflux.
In the online publication of the criteria, it is concluded by the authors that appropriate use criteria 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”. Masuda et al go on, underlining that “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”.
Commenting herself at VENOUS 2020, on the intentions of authors for assembling these criteria, Masuda said: “The appropriate use criteria provides a guide for addressing commonly encountered scenarios, a potential framework for future research, and the opportunity to achieve advanced practice standards.”
“We would like to thank the leaders of all four societies that participated. Marc Passman, one of our past presidents, was the individual who created our ethics taskforce, and Brajesh K Lal helped process the entire manuscript. I would also like to add that this project really gave us a chance to identify areas where we lack quality scientific evidence to clarify indications for some of our venous procedures. We should all work together to create those definitions, preferably through quality evidence, and move this field forward.”