Giacomo Clerici, MD discusses the revascularization results of the diabetic foot and lower limb using his own case experiences in Milan. Dr Clerici discusses peripheral angioplasty and bypass graft results and advantages of both methods. He also examines the significance of addressing cardiovascular disease when poor blood flow occurs in the lower limb.
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Release Date: 03/16/2018 Expiration Date: 12/31/2018
Giacomo Clerici, MD
Chief Diabetic Foot Unit
IRCCS MultiMedica Hospital
Sesto San Giovanni
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[Dr Frykberg] I have, for the last five, six, seven years, believed that no one does better endovascular, revascularization, than do the Italians. I�ve seen some amazing things on angiogram. I go to a lot of meetings overseas, and I�m always amazed at the Italian ability to revascularize with endovascular procedures. And viewing that, I�ve asked our favorite Italian in the room, Dr Clerici, to come and talk to us about the endovascular approach to CLI, the Italian experience. So let�s welcome back Dr Clerici.
[Dr Clerici] Thank you again. I think that if there is a field where we can make the differences, there is in diabetic foot field. Just a few seconds, because Alan needs to change my computer. Okay, very good. Oh, really? Yeah, please. Please improve your Italian, amen! Oh my gosh! Here. No, here. Here, here. Okay. Here now. Button to the left. Here. Okay. Very good. Perfect!
Well, so, and so we can I think change the fate of our patients, and as you remember, in my speech in the morning, we have talked about the experience of LoGerfo, Frank W. Pomposelli, Campbell, and others, and we have learned many things about the revascularization. We have learned, for example, that we can remove away, because today we know exactly that revascularization is the only therapy we have in order to reduce the amputation risk, in order to reduce the amputation rate. So the problem is, and we had a lot of problem in the middle of the �90s, because our patients were and are aged, with many comorbidities, and if you look at the literature, the mortality rate for a bypass graft is between zero and 11%. And so if you look at even the literature in particular, the literature in the �90s, you can see that many of these studies were with the selected population. So in other words, many patients were excluded from surgical revascularization because poor runoff and poor clinical conditions. So we didn�t have an information about these excluded patients.
So what we were looking for was the idea of revascularization as stated in the Task 2000, the idea of revascularization is the procedures that avoids the general anesthesia or spinal anesthesia, poses a lesser systemic stress, and has fewer serious complications. And angioplasty actually is very close to this description, because general spinal anesthesia is not required. There is a very low mortality rate, no surgical wounds and minimal side-effects. And we are going to talk about today, the outcomes.
So actually, in the middle of the �90s, we were able to treat these long occlusions, down to the foot, the multi-segmental, and this was the first paper we have published in 2000. We enrolled consecutively 221 patients, and we treated more than 80% with PTA and the others with bypass graft. And this was the brilliant results. We have this kind of results in term of revascularization rate � 91% of patients with critical limb ischemia, and this kind of amputation rate to 5%. Of course, when we talk about revascularization in patients with diabetes, I totally agree with my good friend Campbell that we need to revascularize the foot, because the problem is in the foot. So if you look at these patients, if I had visited this patient in the �90s, maybe I would have considered him for a major amputation. But with these new technologies, in this case, we tried to revascularize, to give the maximal blood flow in the foot. This is the balloon angioplasty in the plantar arch, and this is the final result in this patient. And so we were able to save at least, with the Shepard amputation, the leg. And so I think that this is not only a limb salvage. This is an improvement of the quality of life, of the patient�s quality of life. But this is also an improvement of the family
quality of life. This is the same patient, the day of his daughter�s wedding, and this is the same patient with the first nephew. So I think that everything is not just limb salvage.
So our experience went on. We enrolled almost 1000 patients with critical limb ischemia consecutively. We didn�t exclude anyone, and these were the results, very similar to the results we had at the beginning of 2000, with a very low amputation rate among patients treated with PTA.
And if we are going to talk about complications, with the very few systemic complications, and also local complications. In this study with 1000 patients, we had just one sudden death, the day after the PTA. So even if we want to look at, in the long term, for lot, we have very good results in patients treated by PTA. As you can see here, the group treated with PTA has a very low amputation rate, but once again I would like to point out the difference between patients who underwent revascularization and patients who are not eligible for both these procedures.
Which one � PTA or bypass graft? This is the same problem we had in the morning with topical oxygen and hyperbaric oxygen. This is not a fight between two procedures. In my opinion, this is an alliance, because in many cases we can use both in order to save the limb. All procedures are welcome if they save the limb and if they are safe for our patients. And in many cases, angioplasty is a very good friend of the bypass graft. This is a series of patients that we have treated. This is a typical example, pattern, to femoral popliteal bypass graft, with occlusion of the three vessels below the knee. And you can see with angioplasty, we passed it through the bypass graft. We reopened the tibial anterior artery. This is another case. Peripheral angioplasty, and the distal occlusion of fem pop bypass graft, and PTA of the origin of the tibial anterior artery. Again, peripheral angioplasty a stent of the native superficial femoral artery, after the occlusion of the bypass graft, and this is the final result in the foot.
So the big problem is the feasibility of the PTA and bypass graft in patients with diabetes. Patients with diabetes are completely different from patients without diabetes. Peripheral arterial disease in diabetes is something very, very different. And if you look at this paper, in order to evaluate the feasibility of these two procedures, we enrolled 344 diabetic patients with critical limb ischemia, 360 limbs we have treated by means of PTA. 85% of patients with, by means of PTA, and 11% with bypass graft. So then we asked our vascular surgeon for look at these patients treated by PTA, in order to have an evaluation for doing a bypass graft. It is possible to do a bypass graft in this patient that we have treated by means of PTA, and if you look at the results, he told us that more or less, the feasibility of bypass grafts in patients with critical limb ischemia, at least in these patients with critical limb ischemia, is close to 70%.
So what is the final message? The final message is that if we want to have 95% of revascularization rate, we need both these procedures. This is a typical example: female, 80 years old, gangrene, rest pain, chronic renal failure, coronary artery disease, and diabetes mellitus for 34 years, 44 years. And I would like to show you the angiography. You can see in the fem district, you have this disease. Not bad. Some stenosis. You have the occlusion in the distal part of the femoral superficial artery. We have the occlusion of the popliteal artery, and you do not have any artery below the knee. The three vessels
occlusion, this movement is because of rest pain. And if you look at distally, this is the ankle, no vessels in the leg, no vessels in the foot.
So in this case, it is very difficult to carry out a bypass graft, because you do not have any runoff. So our intervention radiologist carried out a PTA in the femoral artery. This is the result � very good results. He carried out the revascularization in the fem pop artery and in the tibia anterior and in the peroneal artery. This is the post tibial, posterior, sorry � this is the balloon angioplasty in the foot, and this is the final results in the foot. If you remember, we didn�t have any vessels in the foot. And what about the intervention? This was the intervention we carried out. Transmetatarsal amputation, and if you have any doubts about the duration of these procedures, this is the follow up after one year. We have still the transmetatarsal amputation healed.
This is another interesting case. If you look at this patient, who has critical limb ischemia, 13mm of mercury, this lesion in the Achilles tendon area, this edema is because of the hanging foot position because of the rest pain, and this was the consultation of a vascular surgeon. I�m sorry because the translation, but I think that the meaning is quite good. The only thing that he prescribed was pentoxifylline, and it was very funny because walk as much as possible. This patient has rest pain. And come back if you need something. My God! He needs something!
So this is the situation of the arteries. And you can see a very severe disease, in particular below the knee, and the problem is here � we have a lesion here and we have this artery that has an occlusion here. So we by means of PTA we were able to restore a partial blood flow, a partial but direct blood flow in this area, and after a very good foot care, this is the second important part, foot care, surgical debridement, skin graft, we have these results. No edema, because this patient now is able to go bed and sleep very well.
This is another interesting case. Patient with this situation, but it�s better to look at the arteriogram. If you look at in the femoral artery, no big problems. Some problems here and here, but the main problem is always in patients with diabetes below the knee. You can see we have just a peroneal artery, a small peroneal artery, okay, but when we arrive in the foot, this is the situation. You can see the ankle here. We have the small peroneal artery, and everything finished here. And this is the situation in the foot. No arteries at all. So the target for a bypass graft is very difficult to find. So even in this case, we carried out a PTA in the fem pop district. Then we have this situation in the below the knee arteries as you can see, very good blood flow. This is the angioplasty in the tibial anterior artery. This is the final results in the tibial arterior peroneal artery. And this is the result in the foot where we didn�t have any vessels. So with this blood flow, with this direct blood flow, now it is possible to think about the reconstruction. We remove everything was necrotic, was infected. We carried out a transmetatarsal amputation after the debridement with ultrasound. We carried out graft with dermal substitute. Of course we don�t forgetting off loading, reduce the risk of trauma. This is the result after five days. After the skin graft. This is the final result in this patient � very, very old.
And what about the amputation rate in these patients? What about their stenosis rate? As you can see here, the amputation rate is very good and even their stenosis in PTA and bypass graft failure estimates is in the Kaplan-Meier quite good, if you consider that we have a very good follow-up of this patient. So the message is that the high revascularization,
more than 95%, is because of both these procedures, and because of another important point. As you know, revascularization does not mean limb salvage always, because it is important to remember that revascularization is important. You know very well this philosophy, toe and foot philosophy, that is the same because of PTA or bypass graft, are an important part of this protocol but always a part. So I would like to show you the last two cases, because I think that we are all aware there are a lot of podiatrists, it�s important understand, better understand, what does toe and foot philosophy means. Why this fair?
This is the situation at the beginning: occlusion of the tibial anterior, occlusion of the tibial posterior, occlusion of the peroneal artery, just a small peroneal artery here. So revascularization of the tibial anterior, but tibial anterior pedal artery here. No more blood flow here. The good, the correct amputation in this case is the transmetatarsal amputation, because you have a very low failure rate. And this is the result after a few months. And this is another case. If you look at gangrene of the first toe, this is the situation at the baseline � stenosis of the tibial peroneal tract, occlusion of both anterior and posterior tibial artery. This is the revascularization. It seems a very good revascularization because you have a very good blood flow, but if you look at here, there is the occlusion of the pedal artery. And if we carry out this kind of amputation, of course the result is this. Why? It�s not because of the recurrence. It�s not because of the stenosis. It�s because if you look at where we have carried out this kind of amputation, we do not have any direct blood flow. So if you repeat your angiogram, you can see that everything is open, but in this case, we were able to reopen the posterior tibial artery, we were able to restore a plantar loop, and in this case, if you look at the difference between before and after, you can see that now we have a very good blood flow for thinking about the correct amputation. Again, in this case, is the transmetatarsal amputation or something more proximal.
But the main problem among patients with critical limb ischemia is not the amputation rate, is not the infection, is the survival. If you look at this statistic, the leading cause of death is the cardiovascular disease. So if you look at the mortality rate among patients treated with the revascularization of patients that were not eligible for any kind of revascularization, there is a very big gap - 50% of one year, and 50% in this group after five years.
So my final message is, that when we visited the patients because of critical limb ischemia, we have to pay attention to the coronary artery disease that in these patients, in the large part of these patients, is a silent myocardial disease, is a silent coronary artery disease.
Thank you for your attention.