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Speaker: And on the theme of amputation prevention, we have asked Dr. Lee Rogers to come and speak since Dr. Rogers is the Director of Amputation Prevention Centers of America and Director of the American Board of Podiatric Medicine. Lee has been a student, colleague and a friend for a number of years. He has a great deal of experience in amputation prevention programs, limb salvage programs, treating diabetic foot ulcers both here and abroad. So let's welcome Dr. Lee Rogers.
Lee Rogers: Thank you Bob and so we are going to talk about creating and auditing a system of excellence for preventing amputations and this can be done whether it's in a hospital based system or in your private office or in a clinic. And hopefully, you will get some good pointers to take back to your clinic. So these are my disclosures which were also on the title slide. So those of you that have seen me speak before probably seen the slide and this is an oldest surgery video. It happens to be a below-the-knee amputation in 1901 in Germany, not from diabetes though. And it has been said every 30 seconds somewhere in the world, a limb is lost as a consequence of diabetes. George Bernard Shaw, who is a playwright from Ireland, has made the comment that he marvels that society would pay a surgeon such a large sum of money to remove a person's leg but nothing to save it and that's still true in our pay-for-procedure type of system and not pay for performance or outcome.
So one of the things that I do want to bring you attention to is just how current events are also affecting health care within the diabetic foot and we do have you know the Diabetic Feet Matter campaign that is out. Bob is -- he is off to the side over here. You can't see him but he does like to wear this hat a lot. Make feet great again. But putting some of the jokes aside, there are these trends around the world and in the united states that are affecting health care in diabetic foot and some of these are due to automation and sedentary life style that lead to -- automation leads to specialization, so even in medicine we have -- because of specialization we have fewer people that are -- so essentially this book, "Guns, Germs and Steel" looks at the fate of human society and there are several points that going to health care and how back in the early human history 500, 600 years ago, everybody had to do everything. You had to harvest your own food, had to protect your family. But as we became more automated as a society and agriculture came along, then you no longer require to grow your own food. You got food from the market and so you are able to specialize and become a blacksmith, for example. So the same thing is happening in medicine where now because of advanced knowledge we are able to specialize in things such as vascular surgery or the diabetic foot which has led to an increase in knowledge and advancement in medical knowledge.
Also because of this automation, it's led to a more sedentary life style which has increased obesity and diabetes which has led to more disease. Also, around the world we are seeing austerity, less money to be spent on disease and health care. And then also there is this lack of trust in authority we see with this really big polarization that's going on in politics leading to lack of trust in authority, but then also leads to reduced trust in doctors and reduced trust in industry. So really what's going on around the world is also affecting what's going on in health care and so just to set the stage for that and looking here at how that affects then the diabetic foot trends specifically so because of sedentary lifestyle, more obesity, more diabetes rending up with more patients. Because of the internet, we do have a more informed patient, they may be misinformed but they are a more informed patient. There is less money to go around to treat these patients because of not only government austerity but also payer pressure, but there is also more attention on this. And so the other thing is that we are seeing at least a desire to change from the treatment of complications of diabetes like the diabetic foot to prevention of complication. Now, this is a desire, it hasn't yet been fully realized, but those are some of the changes that we are seeing that are affecting health care. It's important to speak the same language of your policymakers and so when you are setting up these systems of excellence and you need to prove your value in the system, you do have to speak their language and their language is usually one of dollars, pounds, euros or yen. And so when I meet and I meet a lot of times with payer to help them understand just how important and how expensive the diabetic foot is within this chronic disease of diabetes.
In fact it's about a third of total cost of diabetes, which is the most expensive chronic disease that the payer is paying for. So oftentimes when you meet with people and you say, hey, this diabetic foot is such an expensive and big problem, they often are just thinking about one part of the diabetic foot which is diabetic foot ulcers and instead not thinking about the whole diabetic foot syndrome which includes all of these things such as PAD, abscesses, gangrenes, foot deformity, Charcot neuropathy, critical limb ischemia, amputations, cellulitis in addition to those foot ulcers. So these payers who have a tremendous amount of data and are looking at this data may only be looking at certain codes and saying well, this isn't that big of a problem. But when they look at the rest of the diabetic foot syndrome, then they realize wow, this is a really big problem and we need to advance these systems in order to take care of this problem. So again speaking their language and if you are speaking a language of dollars, you can see that over the course of one year, this is the cost in the first year of somebody with diabetes and foot ulcer with diabetes and same comorbidities except no foot ulcer. So there are about $26,000 spent in the first year in a person foot ulcer and about $5000 spent in a patient with the same comorbidities including diabetes but without a foot ulcer. And where is all that money being spent? 77% of that total expenditures are being spent in the in-patient side and so if you are looking at creating these systems how to help reduce cost, then you can say, how can we reduce in-patient hospitalization because this is where most of the money is being spent.
Why are in-patient hospitalizations a big expenditure not only because of lot of procedures that are required but also if you look at the average length of stay -- this is small, so I will read it for you, I'm sorry, but the average length of stay in the typical complications of diabetes, so we have diabetic ketoacidosis, ischemic heart disease, both about three and half days average length of stay; congestive heart failure, strokes about five days average length of stay. For the diabetic foot ulcer has a 7.7 days average length of stay and lower extremity amputation has 9.6 days average length of stay. So these are expensive because these patients are staying long time in the hospital. They have difficulty with their discharge plan. They are also expensive because there is a high recurrence rate. And if you look at this which is kind of meta analysis or at least a report on multiple studies that are looking at the recurrence rate of diabetic foot ulcers, these are the percent of patients who said they've had ulcer recurrence and this is the number of years after the ulcer has healed. After one year, all of these studies are somewhere between 30% and 40% reulceration rate in these patients. After two years, they were somewhere around 50% reulceration rate, after three years around 60% and after five years if they make it that long, almost 80% reulceration rate. So when you are explaining this to a payer or an ACO or whatever systems that you are involved in, this is a problem that has a very short horizon and oftentimes the payer doesn't see the benefit if you would go to them and say, hey I've got a bunch of 40-year-old patients who by the time they are 60 because of their sedentary lifestyle and poor eating habits, they might get diabetes.
The payer really doesn't care because over the next 20 years they are going to change insurance companies multiple times and then soon as it's just going to be Medicare's problem. But if you do go to them and you say, hey, look, within one year, you are going to have -- and there are some studies are up as 50% but within one year, you are going to have a 30% to 40% or maybe even 50% reulceration rate in something that you just spent $26,000 on, you are going to spend it again within a year in a large majority of these patients. Now, this is something that is concerning and generally will raise some eyebrows. So before we talk about some of the systems and I think that Dr. Fryeburg has probably talked about Dr. Brand during the course of this conference with the Brand lecture which was a couple of days ago but let's talk just briefly about the prevention of ulcers since this is such an important topic in the prevention of amputations and looking at the what Dr. Brand had discovered was the link between neuropathy and ulceration in patients with leprosy in India but kind of already conceptualizing these early warning system for the diabetic foot at that time or for the neuropathic foot looking at inflammation as the first indicator of ulceration knowing that dolor which is pain is really not applicable in this group of patients because of neuropathy, trying to find some other marker of inflammation to help identify patients at risk for ulceration and really settled on heat because of its ease of measurement.
And we can do things with thermography or thermometry. In thermography, you can have a thermal imager looking at pictures of person's feet. This is extremely sensitive but not very specific for ulceration. It's sensitive for any type of inflammation which could be arthritis, Charcot foot, cellulitis or pre-ulceration like you see here but not extremely specific for that but very sensitive. These thermographic imagers used to be around $15,000. They are now as cheap as $250 and will fit on your iPhone or your Android and can be used as good educational tool. One of the first dermal thermometers that was used is this one called TempTouch which showed in series of studies that it was able to predict ulceration based on the variation of temperature differences between the same point on both extremities. So if you look at, let's say, the hallux for example, it's not the temperature that makes the difference, it's the difference in temperature that makes the difference. So between the same points on both feet, if it's 4 degrees or greater Fahrenheit, that's significant for inflammation which could predict an ulceration. So in the early studies that was done by Larry Lavery, they found that the thermometer if used properly predicted ulceration -- by using a thermometer as part of a preventative program, it reduced the ulceration rate from 12.2% to 4.7% over 18 months. So this group of patients got thermometer and education and so critics said, well, they got thermometer plus education. So obviously, it's the education that makes the difference and not really the thermometer.
So then the study was repeated looking at a group of patients that had no thermometer, no education; no thermometer education; and thermometer plus education and you can see there is a big difference here. So virtually, no difference in education alone in preventing ulceration but there is a huge difference between those two groups and education and thermometer. So using dermal temperature as a predictor of ulceration is a good predictor and where we are moving into now is home monitoring of temperature using things like a mat that the patient can stand on, uploads their temperature, sends back a signal and gives them warning in green yellow or red based on their risk for getting an ulcer. And this was the study that was done by Dr. Fryeburg actually looking at the alert time in the prediction of ulceration, one based on Lavery's data but then looking at various thresholds and changing the sensitivity and specificity but predicting ulcers somewhere around 35 days in advance based on dermal temperature. So the last part of Dr. Anderson's lecture mentioned how these limb preservation teams can make a big difference in preventing amputation and I think even in performing amputation when it's necessary. So the questions are why do I need a team to be able to do this? You know, isn't just having good doctor good enough? And here are some quotes from some papers that really elicits this point that the acute foot team is in interdisciplinary team model whose core ability to rapidly diagnose and provide effective treatment to patients with lower extremity complications and the team of dedicated specialists is required to prevent the lower extremity amputation in persons with diabetes because it would be exceedingly rare to find one practitioner capable of managing all aspects of care of a complicated diabetic foot.
And then looking at studies from actually around the world, we see that in the Netherlands, multidisciplinary teams reduced amputations by 34% in the entire country. In other places in United states, 72% in US hospital and the studies from all around the world that have shown an equal reduction by the use of teams. So one of the big question is who do I need in my team and instead of asking who because there are people that will do different things. You can have a vascular surgeon that can do the revascularization or in some cases you might have interventional radiologist or interventional cardiologist, might be speaking to Dr. Anderson but that exists in parts of the country. So instead of asking who, you should ask what skills are needed on my team and then fill in the blanks afterwards on who. So what do we need to do to have a team of people that will prevent amputation? We need to have the ability to perform hemodynamic and anatomic vascular assessment with revascularization. We need to have the ability to perform a neurologic workup, the ability to perform site appropriate culture technique, the ability to perform wound assessment staging grading of the infection and ischemia, the ability to perform site specific bed site and intraoperative debridement to initiate modified cultures specific in patient appropriate antibiotic therapy and to perform appropriate postoperative monitoring to reduce the risk of reulceration and infection.
So these are the essential components, essential skills that you would need for a team. So then you put these into kind of an algorithm here, so you have an area that focuses on infection. We have some that focus on ischemia, wound care, surgery and rehab and prevention. Some of these are going to be diagnostic antibiotic surgery for infection and who are the people that can fulfill this role? Radiologist, ID, podiatry surgeon. Who are the people that would fill these roles here? Wound care specialist, radiologist, cardiologist, vascular surgeon. So you plug these people into your clinical practice pathway knowing where they fit and that's how you create the skeleton of your team. The team structures have been written about a lot and there are different models. Wound care center models. There is a VA model, military hospital model, endocrinology directed model which is popular in UK and Italy. The Georgetown University model, the toe and flow model and interventionist led model. At the end of presentation, I have a QR code and website that this whole presentation is on, that's why I put the references here for you and you can just take a picture of that QR code and you can download the presentation. So looking at the team approach to limb salvage, this is from the paper that I wrote in the Journal of Vascular Surgery on setting up for center of excellence and we divided this into really three tiers of care; basic, intermediate or center of excellence level of tiers and what was needed for each level. But really let's talk about that center of excellence level care and what do we need to do to create excellence.
When societies get together or groups of experts get together, they usually publish clinical practice guidelines and that can be on any aspect of diabetic foot. So even as specific as diabetic foot infections or offloading, any of those things, these clinical practice guidelines are being published. But clinical practice guidelines aren't necessarily applicable in every setting, so what you would do for your setting is you would take those clinical practice guidelines, you turn it into clinical practice pathway. Those clinical practice pathways are very broad. They are more descriptive and less prescriptive but underneath those clinical practice pathways, you do have some descriptive policies and procedures that are going to let the team know -- all the staff in the team know how we are going to stay on the clinical practice pathway and I'm going to show you a couple of examples of these. So you create this policy and procedures underneath there. You would want to have a quality assurance program to ensure that you are following the policies and procedures in the clinical practice pathway. And if you don't meet quality assurance in your system, then you have performance improvement which says, this is what we are going to do if we don't meet these guidelines. So let's just look at this for example with one part and I have all these references again after this and you can just take this presentation. But the society for vascular surgery has published guidelines. The American Heart Association has published guidelines, all related to diabetic foot. The ADA has guidelines on inpatient management of the diabetic foot. NICE which is in the UK, they have diabetic foot prevention and management guidelines. Also European wound management association has guidelines. There is Infectious Disease Society of America has guidelines. And we have the Charcot foot guidelines from the ADA.
All of these things which are all here and you can grab this at the end, are available for you to use and create your clinical practice pathways. So let's look specifically at just one small component because we don't have time to go through all of them, but let's look at how you would do this just for PAD in a diabetic foot, for example. We would SVS, Society for Vascular Surgery guidelines and we look at some of the recommendation. So on this one, one of the recommendations is that in patients with diabetic foot ulcer who have PAD, we recommend revascularization either by surgical, bypass or endovascular therapy. There is recommendation here on the diagnostics. So we are going to -- and then also here, this was the diabetes care inpatient guidelines. They have recommendation for PAD. Identifying critical limb ischemia and arrange for appropriate diagnostic testing and vascular consultation. IDSA guidelines, if there is clinical or imaging evidence of ischemia in the infected limb, we recommend the clinician consult the vascular surgeon for consideration of revascularization. So all of these guidelines published by different people refer to the PAD in the diabetic foot. So you take those, you create your clinical practice pathway which might look something like this. Here is a perfusion pathway. So it starts with clinical diagnosis of PAD. Laboratory diagnosis, in this case, lot of our clinics, we use skin perfusion pressure and we use that as a differentiator between who needs vascular consult and who doesn't. So above 50, vascular impairment is unlikely. Below 50 mmHg, we move on to imaging. That's the angiography including ankle and foot. The goals are to restore inline perfusion to the foot. This can be done by either of these methods.
And again, this is kept open because you don't know who is going to do this if it's a vascular surgeon or interventionist. And then your restoration of perfusion to the foot either adequate or inadequate. If adequate, you proceed to the wound care. Inadequate, revision and consider alternatives. Unsuccessful again, wound hospice perhaps or amputation. Successful, we move on over here and risk surveillance. So these are how you create the pathways and again as I said it's a very large overview. Then underneath those pathways, you want to have policies and procedures that are going to force you to stay on the pathway and have this communication with the rest of the team. So in this case, we have policy and procedure on noninvasive vascular studies and it describes a purpose, background, what the policy is going to be, how to interpret these guidelines. So all new patients with lower extremity wound will have a noninvasive vascular study which includes an ABI, TBI, skin perfusion pressure to determine the ability to heal and if vascular intervention is needed. Patients who fail a 30-day re-evaluation or fail wound and we have been following it trying to heal the wound and we do a 30-day reevaluation, it's not getting any better, they need to have perfusion reassessed performed. A noninvasive vascular study on any patient with intermittent claudication or rest pain and then the test should be performed according to the manufacturer's recommendation. So we put these in writing so that everybody has agreed to them and we can follow those. So then what the quality assurance measures would be after this, we put, I guess, numbers to this. So a skin perfusion pressure changes to vascular study but vascular study should be completed within seven days of a new ulcer. Patient comes in and within seven days, you need to have the study done and this needs to be completed 90% of the time. So it helps when you have electronic medical records that will capture this data for you and do these reports.
But for an SPP below 50 which is significant impairment of perfusion, a consult should be obtained with the vascular specialist and this needs to be done 90% of the time. And recommendation for intervention should be carried out within seven days of this and that needs to be done 90% of the time and if it's not done 90% of the time, we move on to performance improvement and what we are going to do to improve our performance and that might involve education of all the clinicians, might involve a new process maybe the nurses have hard time completing the test in certain period of time. So it involves a little investigation. These are some of the quality assurance audit measures that we use for the rest of wound healing in diabetic foot. I put these on here for your benefit if you like to use the same measures. But we track healing percent of all wounds and the target is we want 85% of all wound to heal over their treatment. Healing percent of diabetic foot only wounds and this is based on some data over years, we see about 100,000 foot ulcers a year [indecipherable] [00:27:10], so we want the target to be 88% overall healing with diabetic foot ulcers which do have a higher healing rate than all wounds in our data. Median days to heal, we find that this is better than looking at the average. If you look at mean for days to heal and you have essentially three patients. You have one patient that heals in 14 days, one patient that heals in 40 days and another patient that has been in your clinic forever and has had wound for 380 days and you try to average those together, you are going to get a very large number because you have these outliers. But if you look at median, that just takes the middle number which is going to be the 40 days. So if you have hundreds of patients in this and you are looking at median, we find that as a better indicator of wound healing. So median days to heal, we have target of 55 days, high-low amputation ratio.
This is the number of high amputation you are doing above-the-knee and below-the-knee amputation or limb sparing amputation, that target needs to be 0.5. Noninvasive studies on all new ulcers, that target is 90%. Debridement interval with diabetic foot ulcer visits, we have target of 70% of all DFU visits need to have a debridement. Total contact cast uses with DFU, we have target of 40%. Some of these things are really surrogate markers of quality. You look at what all of us want are prevention of amputation. We want low median days to heal. And then we say, well, what's the difference between these centers that very low median days to heal and the centers that have high median days to heal. And you look at maybe the top quartile performers and the bottom quartile performers and again we have lot of data because we have about 237 centers in 35 states, so we can look at all of these. And we see that the people who are on the top quartile of performers for low median days to heal, they do more frequent debridements and they use more frequently total contact cast than people that have a higher median days to heal or worse outcomes. So we call that surrogate markers of quality. While the markers by itself may not be enough to indicate quality but it is a surrogate marker of quality. So I will leave you with this and again here is this QR code that you can just take a picture of this if you have an iPhone. It should pop up automatically on your phone and take you right to the presentation or you can go to this website and just pull the whole presentation down. I'm going to leave you with this quote from Hannibal, not Hannibal -- I think I said this the other day but Hannibal the cannibal, but Hannibal the general, who says that we either find a way or we make one. This is one of my favorite quotes because it's so true in the diabetic foot how complicated it is and how difficult. And Hannibal was moving elephants over the Alps in the Italy and as general told me there is no way you are ever going to get this elephants over the alps. And in the diabetic foot, he said, we will either find the way or make one and I look at it as the same level of complexity and the same difficulty is that we face lots of challenges whether they are institutional based challenges, educational based challenges or patient level challenges and you have to go into this with the mentality and philosophy of we either find the way or we are going to make one. So thank you very much.
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