Neurostimulation Treatment for End-Stage Peripheral Vascular Disease

Mr. Abul Quddus:

I'm Mr. Abul Quddus. I did my medicine bachelor degree from Dhaka University in Bangladesh, and then I did my FRCS from University of Edinburgh in the UK. I'm a consultant vascular surgeon at Manchester Foundation Trust. I was also a consultant vascular surgeon in Johannesburg, South Africa, and then in the United Arab Emirates. Due to my background in trauma in South Africa, I was Head of the Department of Vascular Surgery and Head of A&E in UAE, the United Arab Emirates. So I also have the opportunity to establish a vascular unit in Bangladesh, where I am the visiting professor trying to educate the junior vascular surgeon and get that unit going smoothly.

I do have some educational activities. I am the Educational Supervisor of medical students in University of Manchester. I'm also the Educational Lead in my Manchester Foundation Trust. I am also a faculty in Manchester University Biobank. I have also affiliation with Planetary Health Academia, which is an international organization delivering teaching training education to various parts in the world, and I'm the Faculty Lead of Vascular Surgery in that Planetary Health Academia. I do run and lead the neurostimulation treatment in my trust in Manchester, and also I'm lead of a vivo step treatment, which is a special treatment for wound healing.

Neurostimulation treatment is a novel and innovative treatment. What is basically we do face lot of end of stage peripheral vascular disease that we all know what involved in this wound healing, wound care, and the peripheral vascular problem, the vascular surgeons. About 14% of the critical limb ischemia or the chronic limb threatening ischemia can proceed to end as peripheral vascular disease where we have no option to do any revascularization. Either they have so extensive disease that there is no target artery to do any endo or open procedure, or they have exhausted all their options already, or they are so comorbid that they cannot tolerate any more complex operation. So we do face this difficulty in end of stage arterial disease where there is big tissue loss, big wound, patient is having rest pain, and the only solution we've been having so far is to amputate that leg, amputate that limb, which is of course not good for the patient.

Our whole entire effort of us, the community, dealing the wound, the peripheral vascular disease is to salvage the leg. Unfortunately, a big group need to go for a major limb amputation. And I was wondering that could there be something else we could do to serve those legs who has end of stage peripheral vascular disease and we cannot do any operation or endovascular intervention? So then I somehow found that this neurostimulation treatment was practiced by some vascular surgeon in Austria and they have some positive results. I got interested, so I got involved, get little bit of feedback on that, bit of an inside bit of a training you can say. And then I started using this neurostimulation treatment in our patients in Manchester.

So I started that in September, 2018, so it will be nearly five years in this September. I have actually very positive results and day by day the results are improving. So overall, I can see that almost 70 to 80% of my patient treated with neurostimulation are responder. We all know that no treatment is effective in 100% of patients, so about 20% maybe non-responder where I tried and then we explained the patient that sorry this treatment is not for you, we did try. Those who respond, their responding level is very variable. Some had excellent result, which sometime I myself cannot believe to be honest. Some have good results, moderate result, little result, but a little result, a little improvement is also quite good for a patient who is about to lose the leg.

So that inspired me for this work. I started with a very pilot, small pilot study, and then started treating. It is not only part of research, it's a treatment. In our center, it's one of the protocol that when the patient has no option, "Please go and see Mr. Quddus." Many patient get benefit from this.

I would mention one patient in particular, which is actually quite remarkable. This gentleman, he is in his early sixties, very fit and young man, still works. He was admitted to our hospital with CLI left leg with an ulcer on the dorsal of the foot, and the big toe, and also an interdigital ulcer between the fourth and fifth toe. He was in tremendous rest pain. He couldn't sleep. He was on opioid, analgesics, still not controlled. So we did investigate him and try to do something on him. When we did a catheter angiogram on him, there was no visible named artery below the knee. You can see few color trials but they were not in the foot either.

So he was under one of my colleagues. And in that scenario, because somebody's on pain day and night, cannot sleep, and we do not see any option to improve blood flow and his blood flow is critically short, so they very sensibly offered this gentleman a below knee amputation. When somebody's in pain, they look for any remedy. He said, "Fine, if that takes my pain off, I'll go for it." But the colleague at the same time say, "We'll ask one of our colleague to see you and see if he can offer you anything different. But more likely you'll need this amputation and we are thinking of next week."

So I was given a referral to consult this patient, and I went to see this patient. I strongly believe that yes, neurostimulation treatment has a role on him. I've explained it to him. He said, "Oh, anything. If it can save my leg, I'll be so glad. Please try it." Then on the same day, we had a MDT, and this gentleman, this patient was on that MDT. So, we discussed. In MDT everyone agrees that yes he need a below knee amputation. So I then interrupted. I said, "I was given a referral to consult this patient. I've seen this patient, and I'm offering his neurostimulation treatment." So my plan was to let him go home tonight and he comes to my clinic after two days, and then I will try.

Then everybody agreed this is fine. This is the last salve attempt to do that. So he came to my clinic, I put a neurostimulation treatment. Before I put a neurostimulation treatment, in almost every patient I try to do a pre-new re stimulation duplex scan and I have a set protocol where I record the diameter of the TBL arteries, the peak systolic velocity in those arteries, the volume flow, the ankle pressure with ABPI, and the toe pressure with TBPI. So I've done that, and a very little flow. You know can see the peak systolic velocity is probably around seven.

So I have treated him with that. So the neurostimulation treatment is basically a small device. It goes into the fossa triangularis of the ear where we have identified branches of the great aurical nerve, which is a connection with the vagus nerve, and the stimulation goes to the mid-brain. The efferent pathway is through the vagus nerve, which is a parasympathetic nerve, and we know that parasympathetic stimulation will cause vasodilatation, arterial dilatation. So, it dilates the artery. So that's the whole mechanism.

Now to assess if it is dilating and if the blood flow is improving, I do a post neurostimulation duplex on them, measuring the diameter, the flow volume, and the ankle pressure, toe pressure if necessary. So it not only gives a subjective impression of improvement because many patients will say, "Oh, I feel a lot better." So we can prove it in an objective way by science as well. So I do the pre- and post-neurostimulation duplex. So that patient, and the one session of treatment is now for three weeks. So he came back to me in three weeks and he was probably the happiest person I have seen. He said, "Oh, Mr. Quddus, I can work better. I have no pain. I'm sleeping well at night. And I can see that ulcer on the dorsum of the foot is almost healed, and the great toe ulcer is healing."

So I did a post neurostimulation duplex and I see about 8 to 10 fold increase in the flow volume in the TBL artery, and the TBL diameters were increased. And so, if I see a positive response to that patient, to any patient who is getting this treatment, I put a second session with another neurostimulator for further three weeks. Normally the six weeks will suffice for the whole treatment. Once the TBL flow is improved, the diameter improved, if they're on appropriate medical management, appropriate medication, and they can take some walking exercise, so they hardly go back into the position where the symptom deteriorated. Actually that improved is maintained. This improvement is maintained for a long, long period of time. I have not seen many relapses on my patients. Once it is improved, it remains improved for a significant period of time.

So that patient, he came to my clinic recently, this was quite some time now, so he can walk up to a mile now. He's a delivery man and he delivers, he said, "Altogether it's more than a mile I have to work every day." He was working seven days a week; now he works five days a week." He's quite happy. I'm very happy. His all wounds are healed finally. So that is something. Otherwise this gentleman was having the below the knee amputation next week, and you can see the difference in his life in that scenario and this scenario.

So there are many more cases like this. People could not walk from the stair to my office, which is around 50 yards. Then after this treatment they go to park, they walk their dog. It is something very, very pleasing and satisfying in many times.

That's the most important thing now. So far, I have done more than 150 patients treatment with this neurostimulation. I have presented it in various international meetings. There are abstract publications on this. So I want to make aware of people in our community, those who deal with this circulation problem, the vascular surgeons, for the at risk wound care specialists. So at least we know that yes, there is something. That's the first thing, the awareness of this treatment. That this is something which we can consider, it is a present treatment.

The next thing would be, which is very important, to do a control study. Two groups. If we can do a randomized control, it would be even much better. But at least a case control study would be something, give us very good information on this. My ultimate aim is that when we have this patient with end of stage peripheral arterial disease, where there is no option other than an amputation, to make a treatment protocol that before we go to amputation which is a major measure undertaking for a patient, try this neurostimulation treatment if it can salvage the limb of the patient.

I always tell my patient that if it does not work, we are not losing much because he has come to an inevitable condition where he may have to lose his leg. So trying this treatment is worth because it doesn't do any harm. If it works, it can save the leg, it can improve patient's lifestyle, quality of life. In few patients, 20% of patient, it may not work, but it's worth to explore that potential possibility that it may help the patient.