Charles Andersen, MD presents the Veteran's Administration's current approach to the management of venous leg ulcers. Dr Andersen discusses how the VA has performed a systemic review and identified key factors to improve its outcomes. He also discusses current guidelines in place for the treatment of venous leg ulcers.
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Charles Andersen, MD
Chief of Vascular/Endovascular/Limb Preservation Service and Medical Director of the Wound Care Clinic at Madigan Army Medical Center<br /> Tacoma, Washington<br /> Clinical Professor of Surgery at the University of Washington and the Uniformed Services University of Health Sciences.
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Male Speaker: So we are going to shift gears a little bit, and we are going to talk about venous disease. It’s is very interesting to me, I am vascular surgeon that’s by in large vascular surgeons have not stepped up to the plate to take to responsibility for venous leg ulcers. They are very excited about interventional venous surgery or endovascular intervention but not so much about wound care, that’s left to void. And in many centers and certainly to some degree in the VA, podiatric surgeons have stepped up to the plate. So not only stepped up to the plate for diabetic foot ulcers but also stepped up to the plate for venous leg ulcers. So these are my disclosures, important that I work for the government and anything that I say is my opinion and certainly not the opinion of the US Government or Madigan Army Medical Center, and this presentation is not meant to endorse any specific products. This is a GME talk. Our learning objectives are to review evidence supporting that VLUs are a very morbid condition. We will touch on that but just to editorialize a little bit I think because diabetic foot ulcers have the potential to go on to amputation. Certainly, everyone is aware of that and initiatives to prevent amputations have become very popular. I suggest to you and will present some evidence that venous leg ulcers are equally as morbid and certainly infect the individual patients to the same degree. Improving outcomes requires an assessment and improvement of the healthcare system. Most of us work for the federal system, so we are going to focus on the VA. Improved outcomes requires a knowledge and ability to both treat the underlying disease as well as treat the wound, and utilization of guidelines can improve outcomes and restore function to our veterans. So those are learning objectives. So I mentioned, venous leg ulcers are a morbid condition. When you think of your wound care clinics and you think of the patients that are coming back every week, sometimes twice a week, had their dressings changed, but that has a significant impact on the individual and perhaps the family member that is bringing him to the clinic. It is the most common ulcer that we see in most wound care clinics, and when you look at the incidence, a very significant number of patients affected with venous leg ulcers. It has been estimated that as high as 70% to 90% of ulcers have a venous or at least an arterial component. Prevalence increases with age and is a little bit more common in the female population. The other unique thing about venous leg ulcers is that there is a significant incidence of recurrence, and we are going to talk about how we can help decrease the incidence of recurrence. So venous leg ulcers are common, increasing in incidence, and tend to recur. So this is the quality of life. To me, this is probably the most important slide that I have that when I look at how venous leg ulcers impact the individual patient. Psychologic, I can tell you that many of these patients do become depressed. Many of them end up on medication for pain, many of them end up on chronic antibiotics. Another facet, physical, it impacts their ability to do the activities that they like to do. Functional, impacts their ability to work many times, and certainly, social, they may elect not to go and socialize, with their dressings that sometimes as we know can have an odor. So treatment of VLUs in the VA system, the past two years of this meeting we have had kind of breakout sessions talking about what we can do to improve the care of venous leg ulcers in the VA system. When you look at the VA system, Dr. John Burgin suggested that approximately 1% of the adult US population has a venous ulcer. When you look at the VA population, 5.3 million patients, that would suggest at least 53,000 patients in the VA. When you look at the age of our population in the VA, that’s is probably an underestimate of the number of venous leg ulcers that we are trying to manage in the VA system.
Improving outcomes really requires that we look at the system of how we deliver care that we understand and treat the disease, we understand and treat the wound, and we utilize guidelines. So this was some work that came out of this conference a couple of years ago, again we met as a group and looked at how care was being provided in the VA system for venous leg ulcers and this was published in WOUNDS, and these were some of the system issues that we identified. First of all, no defined gatekeeper, oftentimes seen by multiple specialist. Unlike limb preservation initiatives for diabetic foot ulcers, management of venous leg ulcers usually lacks an integrated team approach, so it’s fragmented care, in consistent use of compression therapy may be treating the wound but failing to treat the disease, lack of guidelines, at least guidelines that are either available or if available following any kind of guidelines, and failure to consider the role of the vascular surgeon for venous interventions. So when we talked about what we could do within the VA system to improve the care of patients with venous leg ulcers, we suggested supporting a multidisciplinary approach like we do for diabetic foot ulcers, define a gatekeeper who within the VA system is going to come forward and be the gatekeeper for venous leg ulcers, develop guidelines, and define criteria for specialty assessment, management, or treatment, in particular guidelines for vascular assessment, vascular intervention, and guidelines for advanced wound care. There is some data looking at the value of guidelines, adherence to multidisciplinary guidelines was associated with the 6.5 fold and a 2.5 fold increase on the likelihood of healing ulcers, this was a US and British study, significant decrease in the healing rate, and costs were also noted with adherence to guidelines. In the VA, patients who receive guideline wound care were 2.5 times more likely to heal their ulcers in a timely fashion. As a result of the meeting last year where we took the problems that we had identified and then tried to go to the next step, Dr. Kimmel, a member of that group, stepped up to the plate and developed some guidelines which have now been published in WOUNDS this past year, and these are the guidelines that he developed, and we discussed last year at our meeting last year. I am not going to go through these guidelines in their entirety but I think there is some key components of these guidelines that I would like to emphasize and suggest that maybe we could do better in specific areas. When we look at an overview with the diagnosis, what happens many times is we identify a patient with a wound, the wound has the appearance of a venous leg ulcer, but we are seeing the patient in a supine position. You cannot evaluate varicose veins in a supine position. A simple concept but an important concept, and if you’re really going to evaluate whether or not that patient has superficial venous incompetence, prominent varicose veins, that patient has to stand up and you have to examine that patient in that position to see the varicose veins. Certainly, we need to document and describe the appearance of the ulcer. What we found in our institution, we took all patients referred to the vascular clinic with the diagnosis of venous leg ulcers, and we did a complete workup including a venous duplex scan. What we found was 40% patients referred to our institution, to our vascular clinic, with the diagnosis of venous leg ulcers did not have any evidence of venous disease. What they had was an ulcer and they had edema. Many times these were pretibial ulcers.
Many times very large ulcers and many times very exudative ulcers. These were usually associated with significant congestive heart failure and edema. The history that you get in these patients is that they have a rapid accumulation of edema, they have blistering, and they form ulcers. It is a different type of ulcer, so no underlying venous disease. Obviously in those patients, it is very important to understand the etiology and treat the edema. So in those patients, for example, diuretics play a major role. In venous disease, a pure venous ulcer, diuretics really don’t play a role, so important to distinguish between those two. Other diagnostic studies that may be used, venography. It is interesting to look at how that has evolved. With the evolution of venous duplex scan, that has become the diagnostic tool that’s used in most labs. Now, there is a renewed interest in treating more proximal or intra-abdominal venous disease. So if you have an iliac occlusion due to previous DVTs, that is now amenable to endovenous therapy. Therefore, venography has now assumed a little different role than it did a few years ago. Venography is now utilized if you’re a concerned about more proximal disease, iliac disease which you’ll do the venography with the intent to subsequently treat that disease if identified. Very important to look for arterial disease. In our elderly population, the era of pure ulcers is rapidly disappearing. Yes, I have a venous leg ulcer. I also have rheumatoid arthritis. I also have a touch of congestive heart failure. I have had my coronary arteries fixed, and I have some peripheral vascular disease. Those are the patients that we see in real-life clinics. Therefore, when you in that patient, even if the patient has a classic appearance of a venous leg ulcer, they may have underlying arterial disease and that can become then the limiting factor as to whether or not that venous leg ulcer will progress on and heal. Certainly, looking for arterial disease if there is not clearly palpable pulses and additional arterial studies, so it’s is estimated about 20% of patients with venous leg ulcers have an arterial component. We know that debridement is critical. We had an interesting discussion just before this meeting about the application of advanced products without appropriate debridement. It is a waste of money, so the patient has to have debridement, some control of colonization if the wound is over-colonized. That all is done prior to moving on to the next step which may include advanced care products. Systemic conditions, our residents when they finish their general surgery residency, their first duty assignment now is still Afghanistan, and what they treat in Afghanistan is wounds. We felt in our institution, it was very important to develop a system for teaching wound care. We borrowed some terminology from ATLS. We know in trauma, ATLS, that it is very easy to get focused on the obvious injury, so if you have a patient that has a fracture, transected artery, they are bleeding, you’re going to focus on that obvious injury and stabilize that obvious injury. What has been shown over and over again in trauma is to then go back and look at the entire patient and make sure you haven’t missed any other injury. That is called the secondary assessment, so we borrowed that terminology. Primary assessment, we talked about looking at the wound, the etiology of the wound, the characteristics of the wound, but the secondary assessment is looking at the entire patient, looking at other systemic factors that may have a negative impact on that patient’s ability to heal a wound. That is part of again treatment of the ulcer is to look at the whole patient and address any other negative healing factors. So treatment of venous ulcer general principle, treat the wound treat the disease.
Certainly, in my experience going around and visiting wound care clinics, it is still not uncommon to see somebody put an expensive dressing on a venous leg ulcer and not use compression at the same time, treating the wound but failing to treat the disease. This comes from the guidelines that we looked at last year, and this is a review of the literature that supports compression for venous leg ulcers. They are again looking at 39 RTCs, reporting 47 comparisons, and what that showed is there is support for the use of compression, not a lot of support for distinguishing between 1 layer, 2 layer, 3 layer, or 4 layer compression although some evidence to support multilayer compression. There are some dangers associated with compression and then again it goes back to the fact that these patients may have underlying arterial disease. So certainly, if you have an AVI below 0.6 or some people would say below 0.7, then you need to be cautious with support, certainly cautious with compression. Usually, what occurs is you end up with an ulcer on the dorsal part of the ankle where there may be some friction associated with that compressive dressing that leads to skin breakdown which can then lead to ulceration. So once we have done the right thing, that is make sure the diagnosis is correct, do debridement, do compression, moist wound care, how well do we do in terms of healing those ulcers. What data has shown is many times these ulcers continue to be chronic and that we have the significant subset of the population with venous leg ulcers that are not healing in a timely fashion, so just like the literature developed for diabetic foot ulcers, popularized by Dr. Sheehan, using that same approach of reevaluating the healing rate at 4 weeks is a critical component of how we should be treating venous leg ulcers. So doing the right things, again debridement, compression, infectious control, moist wound care, reassessment at 4 weeks, if failure to progress by 40% then consider advanced therapies. We, in our institution, have modified this a little bit. At 4 weeks, for us, it is a time to reassess, is the really a venous leg ulcer, do we need to do a biopsy, are we doing adequate compression, are there other systemic factors. So we reassess all of the patient but also use that as threshold to move on to advanced wound care. Advanced therapies may include direct surgical intervention and we will talk about when that would be considered, negative pressure wound therapy can play a role, bioengineered tissue alternative, or a split thickness skin graft. Surgery for VLUs, in general, the data supports using surgical intervention to decrease the recurrence rate. So you have treated a venous leg ulcer, you’ve gotten that venous leg ulcer healed, but the patient still has a disease. They still have venous insufficiency, and to now treat that disease at least the superficial component of that disease, data supports that that will indeed decrease the recurrence rate. With the popularity and ease now of doing endovenous obliteration of superficial veins, again vascular surgeons love to do intervention, there has been a lot more interest now in patients that are slow to heal or not progressing at a timely fashion to go ahead in addition to considering advanced wound therapies to go ahead and do venous surgery and attempt again to get those patients healed in a more timely fashion, and there is emerging literature to support that.
This is the literature that supports the decrease in recurrent rate, surgical management led to ulcer healing rate of 88%. The team approach, I mentioned that when we looked at the VA system and we looked at the network or the team approach that has been set up for diabetic foot ulcers that we felt we could learn from that, use some of those same lessons to set up teams for venous leg ulcers. The question becomes who’s on the team. Our podiatric surgeon is going to step up, for example, and say we’re running many other wound care clinics, we are seeing the lower extremity wounds, and therefore we are going to have the knowledge to manage those ulcers and the appropriate knowledge to know when to refer that patient for additional vascular diagnostic studies or therapeutic intervention. In conclusions of this first part of the presentation, venous ulcers are a morbid condition often leading to significant functional disability. Improving outcomes will require not only the development of guidelines, so that first step at least we have taken some initiative, but also trying to figure out how those guidelines can then be implemented in a system like the VA. In the team approach, just like we have in the management of the diabetic foot could be used as a model then to develop teams that would evaluate, treat, and return these patients to a functional state. Limb preservation is a very catchy term. Nobody wants to lose a leg, so we tried to come up with some kind of a term that would emphasize the problems with venous leg ulcers, and we talked about things like functional restoration teams for venous leg ulcers. Because really the impact of the venous leg ulcers is on the function of the individual patients as well as our healthcare budget, so again trying to promote some kind of a team approach or some kind of a concept that would lead to the team approach for venous leg ulcers.