David Campbell, MA discusses the literature regarding treatment of peripheral arterial disease and reviews the benefits of conservative medical treatment, stenting and surgical bypass. Dr Campbell emphasizes the dramatic change in medical treatment of peripheral vascular disease and the natural progression of those patients with claudication. He gives his recommendations for treating this disease.
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David Campbell, MA
Associate Clinical Professor of Surgery
Harvard Medical School
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Host: Now, point and counterpoint. Now, we'll ask Dr. Campbell to come up and talk about arterial bypass for PAD, still the best or second place.
Dr. David Campbell: Thank you, Bob. First, you ask me to talk about microvascular disease and then you ask me to follow this brilliant talk and say something contrary. And I should -- I should point out that we have morphed as vascular surgeons and we are vascular and endovascular surgeons unlike a typical vascular surgeon of my preoperative days, one of them is in the endovascular suite doing arteriograms, angioplasties, stents and we fix 80% of our AAAs that way. So we are -- we cover the whole spectrum. We also treat our patients medically.
The impression you might get is this is somewhat of a new phenomenon, all this angioplasty and stent, remember [indiscernible] [0:00:58], this is data from the '80s before many of you were born and if you look at the results of SFA angioplasty, two-year patency rate is around 50%. Now, this was a time when we only did this for limb savage and not for claudication but you can see the iliacs on the other hand is absolutely brilliant. This is back in the '80 to '81 '82 to '88. So this is -- this is not new. And when you -- this is a composite of all of the recorded trials of percutaneous transluminal angioplasty that Davies put together and you look at two years between stenosis and occlusion. The average patency rate is around 50% again.
So you are not seeing a dramatic difference when you're looking at large numbers. Sure, there are individual cases that do brilliantly, but you have to go with the data on the large cases particularly if you're planning a treatment regime for a nation as opposed to just looking at individual cases or individual, people who are particularly skilled. The problem I have is that all of the study in this last series, 90% of these patients were operated on for claudication and not for limb savage whereas the surgical series, a 90% for limb savage. So you're not looking at equal groups to the most part. The other part is that many of my -- is no longer done by interventional radiologists, it's done by vascular surgeons and particularly by cardiologists. So we used to select the patients and then we send the radiologist, things we thought we should do. Now because everyone is in the business, under pressure to do as many procedures as possible, there's a lot of fudging about whether neuropathic pain is ischemic rest pain.
Well, let's get an arteriogram and if we can angioplasty or stent it, we will and disabling claudication. I mean, the -- I see three or four patients a year from the cardiologist with a critical limb ischemia who started out as an inappropriate stenting for -- you know, 86 years old and you get claudication when you walk a mile, you shouldn't even be thinking of doing anything. And foot ulcers on the other hand, you have to distinguish between whether they're primarily neuropathic or primarily ischemic. A word about claudication and peripheral vascular disease, if you don't treat it, only 1% to 2% are going to become critically ischemic in five years and that's important. The medical treatment of claudication is very effective. If I say to a patient, you've got claudication, this could progress to gangrene and you could lose your leg. That is true. And then I'll say, let me do an angiogram and see if I can open it up with a balloon and stent and make sure sense but it's not completely sensible because the risk of getting -- losing your leg from the disease is probably less than from an angioplasty or stent going on. So you have to be very careful.
What nobody talks about is the dramatic change in the medical treatment of peripheral vascular disease. Statins, we got focused about cholesterol levels but statins do two things. They do lower your cholesterol, your LDL but more particularly, they hold -- they stabilize the plaque in the arteries. I used to have patients with carotid artery stenosis and you could know if they had 50% to 60% to 70%, in the couple of years, it would have progressed to greater than 80%. Put them on statins and it stays still. It's made a dramatic difference.
Other forms of treatment, Aspirin, Cilostazol, exercise and I'll show you some more studies on that, risk factor modification. I cannot tell you the importance of tobacco. In New England, in Massachusetts, they banned smoking in public places and the acute heart attack rate dropped by 50%. You do not know how dangerous to seat in a room or in a car with tobacco smoke just continually and continually going. Interestingly enough, if you control someone's diabetes, you don't change the background -- you change the heart attack rate of the problems with the leg rate which is interesting and suggest that they move in different directions. 50% of people with claudication will improve spontaneously and 30% do not deteriorate.
It's kind of like wound care. We've got 100s of 1000s of angioplasty. What sort of data do we have from all of that? A bunch of studies comparing medical treatment with transluminal angioplasty for claudication and they all show where you get a bit of a bump initially from the angioplasty, within a couple of years, there's no difference between the two groups. No benefit. You would think after the numbers of studies that have been done, you know, that more would be seen.
This Oxford Study was supervised exercise and a bunch -- a bunch of studies since then comparing medical treatment including exercise with angioplasty and the only one that has -- the only one, the only study of all of these is one in 2008, the MIMIC Study appeared to show that angioplasty was better than -- than medical treatment, multicenter study but they only had 40 patients in each arm. Interesting. The maximum benefit from angioplasty was seen at two years but you'd expect to see it at two weeks because your best effect is right when you do it so probably this had nothing to do -- this improvement had nothing to do with that. In any event, the maximum walking distance was 200 meters versus 300 meters and we probably -- you know, in our elderly patients, we probably wouldn't have treated any of those anyway.
When I was younger, we would -- the claudication was an indication for intervention if it stops somebody working but our population has gotten so much older. Almost none of our patients are working now. So what are the indications for operating on claudication? In the States, it's for a woman who can't shop and got to have something done. And for a man, it's when you can't play golf even using a golf cab. Those are the two indications for really, really intervening.
So there's been only one randomized controlled study comparing surgery with angioplasty and as you might expect, as with the -- as with the medical treatment and angioplasty does very well for the first couple of years but for anybody who looks like they're going to survive more than two years, do better having a bypass than having angioplasty. Again, they're all individual cases, can show you different things but we can only look at the numbers and that's all we can do to determine what's effective.
This is Dr. Wilson at the VA Medical Center of Long Beach which is looking at his experience, an article in 2008. And you could see, they were still seeing the same number of patients but the numbers of bypasses dropped significantly, the number of angioplasties increased dramatically and amputation rate remained about same. Your natural tendency is to say, "My gosh, that just shows how effective angioplasty is concerned." But you got to face that with the declining incidence of the disease and improved medical treatment to try and work out what's going on.
The concerns with the public papers I eluded to is that you don't -- no one even mentions the word neuropathic lesion when you look at these papers. It's as if all the papers we're seeing have pure ischemia. Well, you know as well as I do that most of your patients have a measure of both of those. So it's very hard to know what's being evaluated here.
So if I see a patient like this with a neuropathic ulcer of the foot and I get an arteriogram and find a few little divots and I angioplasty them, is that a successful limb salvage with an angioplasty or is it just a neuropathic ulcer that I can treat with an amputation? That's the problem. So how come so many procedures have been performed with such little evidence of success? Well, intense competition with cardiology to interventional radiology has lead to bloody indications. Our reimbursements have gone down. And you know when you're making -- you can tolerate making the same amount. You can obviously tolerate making more but by making less, mortgage still has to be paid, the kids still have to be educated and it's a huge pressure on the physicians to increase the number of studies that they are doing. In my academic center, though I'm independent, the academic doctors are beaten on by their chief all the time if they're not doing enough procedures. And there's been change in practice style, there's no gatekeeper like we used to be the gatekeeper for the interventional radiologist. That doesn't happen anymore. And the patients demand minimally invasive high tech -- high tech.
The other thing which you don't think about is -- and -- is the impact of industry because industry is working on all of us. It's working on the patient. It's working on the physician and all the trials are organized by industry and this is from Peter Gloviczki of the Mayo Clinic and says it's very hard to get a realistic view of what is going because there are so many people in different agendas moving in on the equation.
Look at this. This is a Nitinol Stent. This is a bioabsorbable stent. This is a Viabahn-covered stent. This is a Silver Hawk Atherectomy, we presented their data -- they presented their data at the meeting, Vascular Meeting and it caused a great outrage when it was pointed that all of the authors were shareholders in the company that produced it and a laser atherectomy. Here's a cryoballoon and a cutting balloon which raises the issue if there are many ways of doing something and probably none of them are any good and I sometimes wonder that about wound management too but that's not the topic I'm talking about today.
So how is percutaneous intervention done? I mean, is it brilliant at other place? Coronary artery disease, no improvement in mortality with interventions compared to medical therapy. Patients with multivessel disease four times is likely to die or to be alive after CABG than those who are stented. Angioplasty and stenting do produce significant short term improvements but they're not -- no difference in cardiac output a year, the only benefit that appears to be for patients with acute heart attack who are stented within the first 12 hours.
Diabetics, 1980s, a study showing that coronary artery bypass graft is better. The cardiologist said, "Ahh" but we only had angioplasty and then we've got stents. Another study showed exactly the same thing. We said, "Ahh." But now we've got drug-eluting stents. And not this week, I didn't have time to put it in. Another big studies coming out showing that the multivessel disease, coronary artery bypass graft is much more durable and much more effective than angioplasty and stenting but again, the cardiologists are the gatekeepers. So you know, it's going to be interesting to see how much attention will pay to that.
Renal artery stenting. We would drive -- drive by stenting up until this ASTRAL study show that there was no difference in outcome between medical treatments and stenting.
Carotid artery stenting. It turns out and it doesn't surprise, you've got a big plaque and you push away through it and it's going to break off but the stroke rate is higher. What is interesting? So, it's been authorized in the States for high risk patients for carotid endarterectomy, we could have a stent, but you look at the Medicare data, in fact, they're actually being put in lower risk patients because to the cardiologist, everybody is too high risk for surgery. And so that's why I think it's helpful having a specialty you could handle all aspects of it, both medical treatments, intervention and the surgical treatment.
Typical bypass in situ, this is a series from our institution of 6500 major operations and I showed this to the operative mortality actually less than the diabetics and the nondiabetics extremely low and that represents the total experience of about 15 to 20 years.
Look -- look at this, this author here and that was when he was -- he was at the School of Public Health and he was considered an expert on statistics. So he was invited in to do the statistics for this paper. I had to show it but you know, you take what is the considerable approach for a lady with an ischemic -- anybody with ischemic rest pain in their 80s or 90s? If you do an amputation, they're going to end up in the nursing home if they are living by themselves so this was nearly 300 operations performed on patients aged between 80 and 96. And as you expect because the elderly looked like diabetics, fewer of them are diabetic than in the younger population. And the perioperative mortality of 2.3% is probably what it would be for a 102 -- 100 or 90 years old with or without the surgery in any given month and interesting, the five-year limb salvage was great but the ambulatory status was the same or improved in 88% and residential and close to 80%. So the patient was able to go back to living at home rather than ending up in a nursing home.
This just shows how -- looking at that experience, about quarter go to the fem-pops, about a quarter to the dorsalis pedis and the rest of the other tibial vessels and the limb salvage for this group was very good. This is the operation which we're most famous for, the dorsalis pedis bypass graft and this, we think, has replaced the TMA as a diabetic operation in terms of surgery. This is over a 1000 pedal bypass grafts. And as you can see, instead of five years, you get a second patency of 62% and as is always the case and that's because of the difficulty of distinguishing the neuropathic components of the arterial component, the limb salvage rate is better than the graft patency rate and you can see it is pretty good in the 78%. This is a, Albert said, a better analysis of pedal bypass graft and you can see where our experience is compared with all the other reported series.
Patients with a renal failure, this is in 2001, this would be put -- this paper together and it's interesting. Even in patients on dialysis, the graft patency was pretty good but look at this, survival of the patients from comorbid disease is awful, only 17% alive at one year. On the other hand, if you go to your grave with your boots that's definitely an improvement and it's certainly less expensive than doing a major amputation. And again, our experience with renal failure is so much greater than anybody else�s because of the Joslin Clinic.
So that leaves the question, why do multiple percutaneous intervention followed by surgery is necessary? Why not do it? It's good for the surgeon. It's good for the hospital and we're seeing because of the effective medical treatment, the number of patients requiring treatment is declining. It's easy to convince the patient that a non-invasive procedure is a better option. Well, Medicare has just gone risk with Pioneer. And what this is going to mean is that the primary care physician is going to foot the bill for what we do. And you can believe both in the terms of room care management and in terms of intervention, that's going to dramatically change what we do because if you stick the primary care physician with the bill for $100,000, he is not going to send you too many more patients. So it's going to be very interesting to see how all of that plays out.
So what do I like? What do I think the current treatment plan after all of this is we should treat claudication medically, obviously initially and everybody -- every one of your patient with diabetes should be on a statin. Ideally, I like the LDL to be in the 70 range but certainly under a 100. And as we both -- you as podiatrists and us as vascular surgeons increasingly can play the role of being of monitoring that. You know, I see patients in the office and face them, you know, when I started in practice, most people would die around 70 and I said, they key now is how -- now, if you follow the rules, you can expect to live to 90. So this is what you got to have to do if that's what you want to do and it seems to be a reasonable approach in terms of losing weight, exercising and so forth. And the daily exercise, I don't know if you guys have been keeping up with the literature but the impressive results of people exercising more is extraordinary, it makes a huge difference.
So everybody who's at risk, statin, aspirin, exercise and obviously no smoking. Pletal is useful in some patients who have claudication symptoms. For extensive disease, bypass where possible for long term result. The endovascular option is my procedure of choice for the focal iliac disease and focal SFA disease. And I don't think multiple vascular interventions are appropriate or cost effective. But I think before we spend billions of dollars, we have to do some studies to look at the results and it's really a negligence of our system that we have done these many procedures with no good data of the effectiveness of what we do. And that's not unconscionable to my way of thinking. Evidence-based medicine is the key. If there is no evidence that it works, don't do it.
Now, this next slide here, you're going to say, oh this proves it, definitely here is right. This is the amputation rates in the elderly for Medicare data. It's going down the tubes, very little. The amputation rate is dropping precipitously and you could say to me, well, that's because of angioplasty. I told you that. That's what -- this is because of medical treatment. This is because of the statins they are not smoking and all of those benefits. So bear that in mind and last slide, this is looking across Buzzards Bay and Cape Cod, and a nice time this evening. Nice to see you.