The Society for Vascular Surgery (SVS), American Venous Forum (AVF), and American Vein & Lymphatic Society (AVLS) have joined forces to update the clinical practice guidelines (CPGs) for the management of varicose veins of the lower extremities. This eagerly anticipated second edition builds on the original guidelines published in 2011. The CPGs are being released in two parts, with Part I already available since October 2022 and Part II scheduled for release in the summer of 2023. Joining us today are Dr. Manu Aggarwal and Dr. Mark Meissner, who will provide an in-depth analysis of Part I and a preview of what to expect in Part II.
Dr. Manu Aggarwal: Dr. Mark Meissner, thanks for meeting with me today regarding the 2022/2023 SVS, AVF, and AVLS CPGs for the management of varicose veins of the lower extremities. Will you give us some background on the guidelines and what we should gather from each part?
Dr. Mark Meissner: This is an update to the first set of guidelines published in 2011. There will be two parts to the guidelines, based on slightly different methodologies. The Institute of Medicine has established rigorous parameters set forth in the publication Clinical Practice Guidelines That We Can Trust, and Part I of the guidelines (“Duplex Scanning and Treatment of Superficial Truncal Reflux”) attempts to adhere to these standards as closely as possible. Although there are several standards, the foremost among these is that guidelines be based on a high-quality systematic review of the literature. Accordingly, Part I of the guidelines is very rigorously based on a dedicated systematic review that was published in 2022 and performed in support of the guidelines.1-2
Although the national guidelines clearinghouse no longer exists, Part I of the guidelines would hopefully meet the rigorous requirements for inclusion. Although very important, such rigorous methodology does not lend itself well to answering many questions of importance to clinicians. High-quality evidence does not exist for every question, and rigorous, dedicated systematic reviews take time and money. Part II, which is well along, will accordingly address many questions for which high quality evidence and systematic reviews are not necessarily
available.
They will, however, be of value to clinicians in providing a thorough review of the literature and guidance based on the best available evidence. Part I of the CPGs, published in October 2022, addresses five questions and is supported by a dedicated systematic review of the literature. Part II will address questions of critical importance to clinicians, but will be less rigorously evidence-based and will rely on systematic reviews that have been done by others as well as less rigorous forms of evidence.
Part II will include a broader look at the literature in an attempt to answer questions that perhaps can’t be answered in the rigorous part one of the guidelines. Parts I and II will be complimentary and will cover a broad range of questions that are of importance to clinicians taking care of patients with venous disease.
MA: The first guideline in Part I is about the performance of venous ultrasound reflux studies, and it talks about how they should be performed in accredited facilities. Are we saying that all facilities should be accredited? Is this something that clinicians need to be really moving towards? Is that what we are going to say in our guidelines a little bit more definitively, even though we’re just kind of saying it’s a good practice statement?
MM: The first guideline in Part I addresses the utility of duplex ultrasound in the management of chronic venous disease. One impetus for this was the systematic review performed for the Medicare Coverage Advisory Committee (MedCAC) a few years ago that questioned the value of duplex ultrasound.
Part of the problem with that systematic review was that it only went back to 2000 and much of the literature supporting ultrasound was published before that date. So, this is a broader look at some of the older data establishing ultrasound as the standard of care for the diagnosis of venous reflux. The second impetus was to define standard evidence-based parameters for the performance and interpretation of venous duplex ultrasound.
This includes performing reflux studies in the upright position, a description of what veins should be interrogated and how, and thresholds for reflux. And yes, the guidelines do suggest that examinations be performed by an appropriately credentialed technologist in an accredited vascular laboratory. There are certainly good examinations being done by some non-accredited facilities, but it is far from uniform, and there are certainly a number of poorly performed ultrasound studies. If everybody did good ultrasounds, there’d be no need for accreditation. Credentialing and accreditation establish a standard and raise the bar for good patient care across the healthcare system.
The guidelines offer at least two opportunities, either from the Intersocietal Accreditation Commission (IAC) or from the American College of Radiology. There may be a future move by the IAC to bring Vein Center and Venous Ultrasound accreditation together in a single application, potentially reducing the cost for smaller vein centers.
MA: Yes, that would be a positive move. We have had both of those accreditations, but there’s a lot of overlap between both. But I really like the guidelines, honestly, because it gives you a footprint to go by. It helps when you are bringing on new technologists to the practice; it keeps everything consistent, especially with QA/QI. Venous mapping becomes more consistent among the ultrasound technicians in the office. I really am a huge advocate for accreditation.
MM: And there is now at least some data that venous accreditation does improve patient care. Fedor Lurie compared IAC-accredited and non-accredited vein centers using data from the VQI and AVLS PRO Venous Registry. Utilization was higher in nonaccredited facilities, while accredited facilities treated patients with more advanced venous disease and had greater improvement in venous clinical severity scores after intervention. Although many non-accredited vein centers provide high-quality care, accreditation does improve care across the board and at least some data from the IAC suggests that accreditation makes good vein centers better.
MA: Do you feel that insurance companies look at this guideline and say procedures cannot be done in a non-accredited facility? They’re already doing this in some states. So again, are we saying that people really need to get accredited? [cringe face]
MM: It is all a very slippery slope, isn’t it? We all want uniformly good vein care and good ultrasound. It benefits both patients and providers in insuring regulators and payors that we are providing high-quality, beneficial, and appropriate care. That is not to say that high-quality care is not performed in many non-accredited facilities, but some degree of oversight is probably the only way to ensure quality care across the board.
There is reasonable data to suggest that, on average, care is probably better in accredited vein centers. Even if you are a very good vein center, accreditation makes many centers better. Should that be tied to reimbursement? I think in an ideal world, accreditation would be voluntary, and the market would drive patients to high-quality vein centers.
Unfortunately, given the large number of patients with chronic venous disease, strictly linking reimbursement to accreditation has some negative implications for patient access to needed care.
MA: Looking at the other guidelines, aside from the great saphenous vein (GSV) recommendation, all the other truncal vein treatment recommendations were weak. Is there something that we could be doing that could bolster this evidence? Is this going to be something we will see in part two?
MM: It is absolutely necessary to understand how these, or any other, guidelines should be interpreted. There are two components to each guideline – the strength of the recommendation and the quality of the supporting evidence. Many clinicians, as well as payors, don’t fully understand the implications of these two components. The strength of a recommendation, GRADE 1 (strong) versus GRADE 2 (weak), is based on the relative balance of risk and harms of an intervention, patient values and preferences, costs to the healthcare system, and other contextual factors.
The implications of a strong GRADE 1 recommendation are that every informed patient would choose that option based on the data.
Therapy with a weak GRADE 2 suggestion may be equally as good, but other considerations such as patient values and preferences come into play.
For GRADE 2 (weak) recommendations, different patients may make different choices and it is necessary that the provider fully inform the patients of the options. GRADE 2 recommendations may be equally as good of a recommendation, but other things come into play like patient preference. For example, cyanoacrylate and thermal ablation of the GSV both provide good clinical outcomes, but some patients may wish to avoid a permanent implant while others place a higher value on avoiding tumescent anesthesia. Both can be recommended to the patient, but it does require a thorough discussion with the patient, respecting their values and preferences. GRADE 2 interventions should therefore not be interpreted as having a lesser value than GRADE 1 recommendations.
The second component of any guideline is the strength of the evidence and this is where we can do better. High-quality evidence requires comparison with a standard therapy such that the magnitude of the effect can be estimated. The randomized, controlled trial remains the gold standard although other comparative study methodologies can contribute to the evidence.
For superficial venous reflux, most randomized trials have included the GSV, and interventions on the GSV are supported by the best quality evidence. In contrast, there have been few comparative studies including the anterior accessory saphenous vein. As the outcomes of anterior accessory saphenous ablation appear to be similar to that for great saphenous ablation, it can be recommended, although because the evidence is indirect (extrapolated from the GSV), the level of evidence must be reduced by one category.
Going forward, it can be anticipated that higher quality evidence will be generated.
MA: That’s a good point. I think that kind of speaks to staging versus doing the treatments altogether.
MM: There were a lot of discussions particularly around that recommendation as good clinical outcomes can be obtained with either approach if there is careful follow-up. Concomitant ablation and treatment of tributary varicosities are associated with better early outcomes and less need for reintervention, although results do tend to equalize over the long term.
Choosing between the alternatives, therefore, comes down to the preferences of a well-informed patient.
Does one choose potential overtreatment in some patients who may not need phlebectomy versus the need for two procedures, increased expense, and having to miss work more days of work? Patient preference is important. The guidelines do recommend concomitant over staged treatment of tributaries in the absence of medical or anatomic contraindications, but this is a GRADE 2 (weak) recommendation, because different informed patients may choose different treatments, not because the therapy does not yield good results.
MA: What do you think our readers, our colleagues, can do to help with these weak evidence points? Is it the registry? Not all of us can be involved in research, unfortunately, nor have time to write papers, or we’re not in academia. What is it that we can do to help this all along?
MM: Participation in the registry is certainly important in providing the evidence base for what we do. If practitioners can participate, they should, as this data supports the value we provide to patients. I do understand that there may be some impediments as not every medical record can communicate directly with the registry. But if you can participate, that is certainly the best thing any individual can do. The second thing we can do is form better partnerships with industry.
Getting FDA approval for a product is far easier than generating the evidence that’s necessary to make it high-quality data. Meaningful data requires comparison with an accepted therapy. We need to continually challenge the data supporting our technology. Just because a product is FDA-approved, doesn’t mean it is supported by high-quality evidence-- challenge the fact that there needs to be some comparative data to support it.
MA: What about Part II coming out this summer?
MM: I think a lot of clinicians will read Part I and say, well, this is a lot of things that I know—duplex ultrasound is the standard of care for the evaluation of chronic venous disease and both thermal and nonthermal options provide good clinical outcomes and are better than stripping. However, even though most clinicians will accept this, these very rigorous guidelines are important in establishing the standard of care. Part II will answer many more questions of interest to clinicians. Admittedly, it won’t be as rigorous as Part I, but it will provide practical answers to questions that clinicians are interested in.
Some of the sections are outstanding, such as those addressing phlebotonic supplements. This is an area that a lot of our colleagues in the US aren’t necessarily well informed about. Part II will also include several recommendations regarding junctional reflux, treatment of the below knee GSV, and treatment of superficial venous disease with concomitant deep venous disease. It will also include some provocative areas such as the management of thrombosis after ablation. There is a lot to look forward to in part two of the guidelines.
In addition to providing guidance for clinical practice, the guidelines also provide the clinician with a concise summary of the evidence supporting each guideline. Busy clinicians usually don’t have the time to do an exhaustive review of the literature for every clinical question, and the guidelines do provide both a rationale and evidence summary for each guideline. This includes questions for which reliable data is hard to find, such as the management of bleeding varicosities.
MA: This is the second iteration of varicose vein guidelines, correct?
MM: This is the second iteration of the venous guidelines, the first being published in 2011. In the interim, there has been a concerted effort to make the guidelines more rigorous, to comply with the Institute of Medicine’s recommendations. And as I mentioned, Part I of the guidelines really is that part and Part II may or may not make it into a national guideline clearing house, but it will contain a lot more practical information for the practicing clinician.
References:
- Farah MD et al. A systematic review supporting the AVS, AVF, And AVLS guidelines on the management of varicose veins. J Vasc Surg Venous Lymphat Disord. 2022 Sept; 10: 1155 – 1171.
- Gloviczki P. et al. The 2022 SVS, AVF, and AVLS clinical practice guidelines for the management of varicose veins. J Vasc Surg. Venous Lymphat Disord. 2022: October. Online ahead of Print
