Big Data Shows More VLU Awareness Needed

New data underscores the need for venous interventions in wound healing

Results of the largest epidemiology study of venous leg ulcers (VLU) and correlated duplex findings are in! Here, American Vein & Lymphatic Society (AVLS) Research Committee Chair, Dr. Marlin Schul shares findings from the recent AVLS PRO Vein Registry study, his personal experience treating VLU patients in his local community, and reflections on the importance of benchmarks.

VLU affects 1−2% of the population, with the prevalence increasing to up to 4% in those over 65 years of age. Both conditions are expensive, together responsible for up to 2% of the annual healthcare budget expenditure of Western societies. The ESCHAR and EVRA trials demonstrated that surgical correction of superficial venous reflux reduced ulcer recurrence, resulted in faster healing times (EVRA), and is proven cost-effective.1-4 Vein Centers are perfectly positioned to work collaboratively with dedicated wound centers. Yet despite level one evidence, such dedicated and early referral programs are rare.

Are you seeing leg ulcer patients? If not, why not? Patients with venous leg ulcers need vein center care—as less than 3% are purely post-thrombotic. It is my opinion that we do not have enough providers to manage the burden of venous leg ulcers and we are not making a dent in the overall incidence. It is true that structural barriers exist, and these are evident in many countries, but doesn’t need to be the rule.

A recent interaction with a referring physician had me seeing and evaluating a patient after hours at their request. We quickly made the diagnosis, applied an Unna boot, and scheduled him for Venaseal and UGFS in the following week. His ulcer was not big and his compliance with compression to decrease edema made substantial improvement before he was treated. His ulcer closed quickly and he is back to work, pain-free and ulcer free wearing compression daily! Yes you can still educate patients with ulcers about the importance of compression too.

My approach with ulcers involved training the primary care physicians to think vein problem at the same time they think wound care. The promise is that we will help triage the ulcer from a vascular standpoint, and work side by side with the wound center and other specialists as indicated. If primary care clinicians don’t know you manage leg ulcers, they won’t think of you when they see a leg ulcer. It truly takes repetition and results to make a difference.

When it came to the wound centers, we found that their biggest concern was a referral may lead to losing the patient. I stopped by and challenged the wound centers to simply send us a patient, and I also had the MiMedix representative sharing our business cards throughout the Wiregrass. I pledged to do the diagnostic studies from a vascular standpoint and assist in managing the patients. Applying skin substitutes and scraping wounds was not my future.

I furthermore shared what we know about these patients, e.g. they are obese, they sleep in recliners, they have many comorbidities and struggle with compliance. When your practice is speaking the same supportive language with the patient, it begins to stick and compliance is far more achievable.

New Venous Leg Ulcer Data

The AVLS PRO Venous Registry is a robust database that collects both physician and patient-reported out- come (PRO) data through the use of AVLS-certified EHR systems.

To identify the prevalence of surgically correctable re- flux disease occurring in VLU patients, the AVLS research committee pulled data for all leg ulcer subjects by CEAP score from the database. The results offer the largest epidemiology study of venous leg ulcers and correlated duplex findings to date.

Investigators, reviewed more than 270,000 unique patient records, resulting in 1,794 unique subjects (1,878 limbs) (0.66%) presenting with a leg wound. Of those, 993 (55.4%) were male, and 799 (44.6%) were female. The subjects were divided into four groups: “Group S” represents patients with isolated superficial pathology (1,291: 68.7%), “Group Mixed” represents patients with mixed superficial and deep pathology (238: 12.7%), “Group D” represents patients with isolated deep vein pathology (58: 3.1%), and “Group N” were patients with leg wounds and no venous pathology (292: 15.5%). rVCSS values in Groups S & Mixed were significantly higher than Group N. In Group S, the dominant patterns involved the GSV above the knee (54.8%), the SSV (30.7%) and the Anterior Accessory GSV (14.4%). Frequencies of single, double, and triple axial vein reflux identified 1.45 vessels eligible for ablation treatment per limb. The Mixed group revealed GSV above the knee (61.7%), the SSV (26.2%), and the Anterior Accessory GSV (12.1%), and a frequency of 1.52 axial segments per limb. Of the 84.4% of venous ulcer patients, duplex analysis reveals that 97% of this large subset have surgically correctable disease.

This study supports early referral to dedicated vein centers and reflux management as part of the multidisci- plinary team caring for these challenging patients. These patients often need physical therapy, management of obesi- ty, and treatment of central venous hypertension related to CHF, obesity, and COPD. This study opens the door for vein centers to approach wound centers assuring them we can help, and that we will not poach your patients. Reflux management is known to enhance the speed of ulcer healing, reduce the risk of recurrence by 50%, and is proven to be cost-effective. We are a civilized country, and we can simply do better. It is my personal belief that patients with venous leg ulcers are woefully undertreated as the rule.

Venous Leg Ulcer Benchmarks

Think of how far we have come from 2017. Meetings for a long time have been focused on overutilization as we all know the guy down the street who does X, Y, and Z and believe it inappropriate. The fact that we have benchmarks today is relevant as we are seeing standards of appropriate care. Today’s standards are based on both epidemiology of

the disease process and claims studies. The AVLS PRO Vein Registry ulcer study revealed those with isolated superficial disease or mixed reflux disease have an average of 1.5 axial veins that may be contributing to the problem. Furthermore, 97% of those patients have a reflux problem that is potentially correctable. This is consistent with other per limb findings and serves as a benchmark by limb for VLU subjects and begs the need to break down barriers for those suffering.

Other benchmarks we have been published since 2017 include the Crawford, Baber, and Improving Wisely studies. Each of these studies approached utilization from a claims-based angle, yet from a separate study design. The results yielded near identical claim-based findings for ablations per patient, e.g. 1.8 thermal procedures per patient. When utilization (claims-based studies) and expected utilization (epidemiology studies) match, we can begin to assume certain standards of care may be needed depending upon disease severity and that is what we are beginning to see. Why does BCBS of North Carolina only allow a single ablation technique for each limb for life? Epidemiology metrics like those in the ulcer study show that a single ablation will only touch the surface in those subjects. As seen in Improving Wisely, those with VLUs had even less of an intervention rate than those with pain, swelling, and inflammation (32% vs 40%, respectively).

Big data can change policy and help to shape a young specialty. The AVLS invested in the AVLS PRO Vein Registry in 2014 based on policy pressures and a lack of data that could demonstrate what we were doing was more than cosmetic. The ulcer study was a subset and an important subset that provided potentially policy-changing evidence to support all parties. We have more than 144 unique providers entering every encounter by simply doing their daily documentation in an EMR that reports to the database. More benchmarks will be forthcoming as we dissect the records of 276,000 unique patients where more than 65% have detailed duplex data. This endeavor will stratify patients by disease severity to bring more clarity to the burden of disease and what treatment may be necessary for a patient entering a vein practice. Stay tuned!


Where do ulcer patients fit in your practice? Do you have relationships in your market, and opportunities to build relationships? If we are collectively going to make a difference for the patients with the greatest need, it will take relationship building and patience. The AVLS PRO Vein study on VLU has been submitted to Journal Vascular Surgery Venous and Lymphatic and demonstrates a clear role for the vein specialist in helping those with the greatest need.

Breaking down barriers is not easy, it takes time, effort, and patience. If you can shift the referral to both vein center and wound center at diagnosis, relationships begin to develop. Keep in mind that the wound centers may not know what your practice can offer, and a simple call sharing your findings may be all that is necessary to bridge that gap. V