Steve Elias: Welcome everybody once again to the Vein Magazine Podcast, or better known as vein specialists sitting around and talking, having drinks. Today we're at the American Venous Forum annual meeting, and with us is Peter Lawrence from UCLA, Peter Gloviczki from the Mayo Clinic and Mark Meissner, from the entire world because he is the world's best-known vein specialist. Is this true Mark Meissner? Mark Meissner: I have no response to that Steve, because that clearly is not true. Steve Elias: It takes three vein specialists to do a good job writing new guidelines on the care of varicose veins. And that's why we're here today. We have three people that are on the SVS AVF committee to rewrite the guidelines for the care of patients with varicose veins. Why do we need new guidelines? Don't we already know what we need to do to take care of varicose veins, Peter? Peter Gloviczki: We have an idea of how to take care of varicose veins, but it's time to write new guidelines. The last guidelines we wrote were published in 2011, so that covered the literature until about the end of 2009. A lot has happened since that time. New evidence emerged, new treatment modalities were introduced and independent of the progress, every clinical practice guideline has to be rewritten every five years. Steve Elias: What are some of the new things we need to address in the guidelines? Peter Lawrence: We need to both respond to the MEDCAC report, which was done by CMS and has a big impact on reimbursement. There were several issues there that many of us disagreed with. There were the conclusion, the MEDCAC, one of them being the optimal way of imaging, and the conclusion that duplex ultrasound was not established as the best way to image veins. And you know, all of us, I think, believe that that's the case. So there needs to be, the guidelines need to really address that issue and look at the literature. The second is since 2011 there's been the introduction of non-thermal as well as thermal techniques to close veins. The third thing new guidelines need to address is that we see many physicians who are considered vein specialists ablate the perforator vein without any other vein being ablated in the extremity. So the role of certain locations, particularly perforators need to be addressed in the guidelines. Steve Elias: There is actually a process by which people need to evaluate the literature and the data that's available when you're writing guidelines. I had a little bit of trouble getting my arms around what we need to know when we write guidelines. What are the guidelines for writing guidelines? Mark Meissner: The guidelines to writing guidelines were part of the Medicare Improvement for Patients and Physicians Act in 2008 that authorize the Institute of Medicine to develop guidelines for writing guidelines. That is a document that's out there. It's a very good document. It's very long, but the executive summary is fairly short, and you can read that and come away with what you need. Peter already mentioned one of them, which is those trustworthy guidelines need to be updated every five years because new information, new data, new evidence comes along, practice patterns change, so they need to be updated. But there's actually eight elements of it that need to be included in trustworthy guidelines, and essentially that establishes the process and the process is, first of all, coming up with the panel that's going to do the guidelines and there are criteria for that. Any guidelines should include all stakeholders in the guideline, whether you're a vascular surgeon, radiologist, phlebologist in the community. It should include all stakeholders. It should include a methodologist, always, to help you evaluate the data. Optimally it would include patients as well, although that's a bigger hurdle. Mark Meissner: The second is that every guideline should be based on a systematic review of the literature. It may not be strong enough to do a meta-analysis on, but the literature should be systematically reviewed, and my takeaway from that, which may or may not be true, is that if you can't generate a data table from it showing the outcome and the results, it probably shouldn't be in a guideline. You ought to be able to do that. The third essential component is grading the evidence, the Society of Vascular Surgery as well as most organizations throughout the year, throughout the world, have chosen the grade approach to do it. So you grade the evidence. The fourth component is writing it and then having an external review of it and I missed the second component which is developing the questions, which is probably the most important thing is developing a reasonable question for... Steve Elias: Did the original guidelines follow the approach that Mark just outlined or this approach came into being after those guidelines are written? Peter Gloviczki: I think this so-called PICO guideline, or PICO technique to develop a guideline, came after 2010 when we really wrote the guidelines, but the guidelines had a lot of the components of currently anticipated guidelines. Very specifically, we had explicit and transparent questions that we pose and we used the appropriate evaluation when we graded the evidence, the level of evidence and the strength of recommendations. There are additional components that we will be very careful to include in the new guidelines, and very specifically that transparent representation of the data that we collect and that's what Mark was referring to, the data tables. And that really just makes it transparent to everyone who reads the guidelines, what the literature offers in regard to the evaluation or the treatment that we recommend. Steve Elias: Is the audience MEDCAC that we're playing to, or are we playing to the practicing physician to give them real guidelines and then MEDCAC can come in secondarily, but there are people out there want to know, "Oh hey, I got this patient, has this problem. What do the guidelines tell me I should consider doing?" What audience are we playing too? Peter Lawrence: Both, but most importantly to the patient. I think Mark's talked today about being patient-focused. That's always the best approach to use, and what is in the best interest of patients. But guidelines require or are followed or used by well-intentioned physicians who want to do the right thing and the reason that the MEDCAC comes in is because they also have a huge impact on reimbursement because many people follow the CMS guidelines, and they're based on MEDCAC, so if they come to conclusions which are felt to be by most people practicing inappropriate, then I think that you can be misled or they can be misled. The challenge of MEDCAC is that having sat on that for six years, and particularly on the venous MEDCAC, is that the group that does the research is given some limits and they were told, as I understand it, because I got all the data that they provided to the MEDCAC committee, was that they only would consider prospective studies less than 10 years with more than 500 patients. And as we all know, things like duplex ultrasound was developed and established the standard of care well before that. So there are a lot of changes that could be done, that are needed in the MEDCAC decision in summary, which happened as you probably know, because you are involved in it, over a period of six hours. In six hours made decisions that probably should have been done over a year with several meetings. Steve Elias: What are some of the questions we should ask so that we can help the practicing physician? As Peter said, do the MEDCAC people understand what it takes to manage patients with varicose vein disease? What are some of those? Mark Meissner: Part of the thing for trustworthy guidelines, which I'm surprised MEDCAC didn't realize, is having all stakeholders involved in the systematic review. And that was part of the problem with the MEDCAC systematic review, it was done by people with no knowledge of venous disease, with no clinical input whatsoever. And not that as clinicians we can do the methodology of it, but we can guide it and do not have clinical input in a systematic review is just not appropriate. The SVS and the AVF have used the Mayo Group to do their statistical part of it, but they have always offered, if there was an interested panel member, which I participated in it for the thrombolytic guidelines, to be part of the systematic review and actually review the evidence with them, which I think is very valuable. And I think the Mayo Group recognizes that some clinical input is required. So I think that's part of the problem with the MEDCAC process. To answer your question directly, I think we need to look at what's been developed since 2011 when the last guidelines came along. Probably the biggest thing in superficial venous disease is the non-thermal technologies. Those need to be addressed. Unfortunately a lot of the data is not real strong to support them, but I think if you follow the guideline process on what raises or lowers the degrees of confidence in the estimate of the effect for those guidelines, we can confidently recommend non-thermal technologies in an evidence-based fashion that will influence, I think, both patients, physicians as well as payers and really that's our role, is to interpret the data in light of... Lend some clinical credibility to what evidence is out there. So I think that's a big one in 2019, is what is the role of non-tumescent technologies?. I think there are other things; a big question is what is the role of compression after endovenous ablation? And I think there's been some evidence that's come along since 2011. I think the management of complications, particularly thrombus extension at the saphenofemoral junction, not a lot of data, but that can be addressed. And those are some of the, three of the important questions, as well as I, think Peter's
