Mirza Baig, M.D., a vascular surgeon at Baylor Scott & White Medical Center in Irving, Texas, talks about a new approach to leg stents.
Interview conducted by Ivanhoe Broadcast News in January 2017.
Your focus is it arterial disease throughout the entire body, the veins and arteries could be anywhere?
Dr. Baig: Yes. Outside of the brain and the heart we work on pretty much all the vessels outside of those two areas.
But you do like the carotid and all that?
Dr. Baig: We do carotid arteries in the neck, arm arteries, dialysis access cases, and then the majority of my work is peripheral arterial disease which involves blockages in the arteries to the limbs, mostly to the legs.
I know that’s the story that we’re looking at today with Ellen and how many people suffer from this, say what it is and how many people are affected by it?
Dr. Baig: Peripheral arterial disease affects mostly older patients or older individuals and about fifteen to twenty percent of the population that’s over the age of sixty will have some extent of peripheral arterial disease. But not all of it causes symptoms. You can have peripheral arterial disease without any symptoms and probably about forty to fifty percent of patients that have peripheral arterial disease that you might detect on a screening test will have no symptoms at all. The only way that they would even know they have it is through a screening examination.
Now Ellen, her particular case do you know enough of her history to know when she was starting to have peripheral arterial disease?
Dr. Baig: I think she’s had peripheral arterial disease for almost ten years and she’s had multiple interventions done. She had stents placed in her leg many years ago, they lasted for a little while and then failed and her symptoms recurred. She managed to kind of hobble along for quite a few years. I think her stents had been opened and then they closed again, then they opened and then they closed again. After that she just sort of dealt with it. Finally I saw her and we decided to try to do a bypass and see if that would help her instead of stents and she didn’t have very good vein for doing bypass. We usually use a vein in the leg to re-route the blood essentially and convert that vein in to an artery and it was a suboptimal vein. We tried it and that lasted her for a little while but then that also failed. Recently drug coated balloons have been approved in the United States which is basically a chemotherapy drug. The point of the drug is to prevent proliferation of cells and this drug coated balloon if you can deliver that drug to the part of the artery that seems to redevelop stenosis or narrowing after being treated with a balloon or stent then you can try to decrease the chance of that re-stenosis occurring. What we did for her is went back and re-opened her old stents and put a fabric covered stent in there so the scar tissue could not grow through the stent and then used a drug coated balloon to treat the ends of the stents. She’s done very well with that, she’s been a year and a half and she’s been doing great. She’s got excellent circulation to her legs now. She’s been doing 5K runs and she’s quite happy and there’s been a complete change in her lifestyle.
What’s new is it the type of stent or the balloon or what is it that sort of the newest development that you were able to use to help her?
Dr. Baig: Well the type of stent has been around for quite some time. I’m not exactly sure the year of approval but it’s a very commonly used stent especially after failed stents that have no fabric covering on them. The nice thing about this stent is you can treat a very long blockage with a stent and the only place that you really have for failure is at the beginning of the stent or at the end of the stent. Other stents if you put a stent in a very long blockage you can essentially get scar tissue growing through that stent, anywhere along the length of that stent and then cause an obstruction. In this case you only have to worry about two points of failure, at the top and at the bottom of that stent. Then the newer technology that’s been available in the US relatively recently compared to Europe where it’s been there for quite a few years is a drug coated balloon. This drug coated balloon has a chemotherapy drug on it called pacqutaxal and it suppresses growth of smooth muscle cells which are responsible for causing re-stenosis in arteries. Really the holy grail of vascular surgery is to be able to suppress growth of these smooth muscle cells. They are the primary cause of failure of bypass grafts, of heart bypasses, of stents that people put in the heart. If somebody can find a way to eliminate that you essentially can treat people’s blockages and not have to worry about failure.
These treated balloons that have the chemicals within them, would you sort of describe the impact of this development. Would you say is it like a medical breakthrough?
Dr. Baig: I think drug coated balloons are going to turn out to be a medical breakthrough. I think that the data so far is pretty good. Obviously you need really long term data to be able to say this is a complete revolution. I need to see if five or six years from now if she’s gone without having to have any other intervention or any other procedures to do any kind of maintenance work on her stents then that’s a real breakthrough for her. Because she’s had very rapid failures from multiple previous stent procedures as well as the gold standard which would be a bypass. I think from that point of view anticdotally my experience with these balloons has been great. The data from companies and from independent studies is very good but most of it is out one, two, three years. Then it also depends on what you’re treating. If you’re treating short blockages then the data is very, very good. When you have a blockage that’s almost thirty centimeters long like hers from basically the groin down to the knee then the data with the balloon alone is I think going to be not as good as if you can put a stent and then just have to treat the ends of that stent with this drug coated balloon. That’s kind of been my approach for these complicated patients.
This approach that you’re taking how many vascular surgeons are taking that approach. Or is this something that only a few of you are doing?
Dr. Baig: I think this is a very common treatment modality. I don’t think there’s anything particularly revolutionary about the way that she was treated other than that she’s had multiple failed stents before. I think putting the fabric covered stent in there and then treating with the drug coated balloon is really an option that has only become available relatively recently just because the drug coated balloons are new to the US market.
It made all of the difference in the world to her.
Dr. Baig: Yes, she is as happy as can be. I mean she is a very active person, I think for her not to be able to walk or run or engage in a lot of physical activity was essentially her quality of life was extremely poor because that’s what she thrives on. Obviously for me professionally is very satisfying to have been able to help her get that quality of life back.
Talk about how severe it was because some physician or different types of providers told her that she was almost at the point of facing like amputation.
Dr. Baig: Peripheral vascular disease or peripheral arterial disease has different manifestations in people depending on the severity. Some people you get symptoms that we call claudication which is when you try to walk or use the muscles that have poor blood flow and those muscles need oxygen in order to continue to function. If the blood supply is not adequate to deliver as much oxygen as the muscle needs then the muscle tires, cramps and causes fatigue. That’s the first stage of peripheral arterial disease. People can walk a certain amount of distance then they have to stop and rest and then their muscle recovers and then they can walk again. The risk of amputation if you have that level of peripheral arterial disease is relatively low, it’s essentially a quality of life issue. What Ellen actually had was something worse that’s called critical limb ischemia which is ischemic rest pain. She would have pain even at rest. It can get so bad that the only way you can get relief from that pain is if you hang your leg in a dependent position. That little bit of help that gravity provides in getting blood flow down to your foot can kind of calm the nerves and relieve the pain. Many people with rest pain, when they lie down at night to go to sleep and they put their legs up on the bed their toes and their foot will start hurting because they’ve lost that aid from gravity. They’ll hang their leg off the bed. She was at a point where she was having rest pain and her walking distance was very, very limited. I think eventually if she progressed to the next stage which is where you get ulceration in the legs, where there’s not even enough blood supply to keep the skin and the muscle and the tissues well profuse and alive then if she gets any small injury it turns in to an open wound that doesn’t heal and then eventually can lead to an amputation, if you don’t get restoration of circulation.
One of the things that seemed interesting in terms of her history is that she said her dad died at forty nine from cardiovascular disease and that she thought she was in good health and then she was diagnosed with severe heart problems at forty four and had a lot of stents in her heart. My question was does somebody like her maybe have some kind of a genetic predisposition to problems with her veins and arteries?
Dr. Baig: Well certainly genetics play a big role in cardiovascular disease in general. The nice thing about peripheral arterial disease is it’s very easy to screen for peripheral arterial disease and if you screen people for peripheral arterial disease and you find it, it doesn’t mean that they need surgery or need a procedure for their peripheral arterial disease if they don’t have any symptoms. But it’s a marker for atherosclerotic disease which could also affect the heart. But it’s much harder to screen for coronary artery disease because it usually will require a more expensive test. You might need to do a stress test or you might need to do an angiogram or other things to look for blockages in the heart whereas peripheral arterial disease can be diagnosed with a stethoscope and a blood pressure cuff. You take a blood pressure cuff in the arm, and you take a blood pressure at the ankle and if there’s a difference in the blood pressure in between the two then you know more than ten percent then that means they have some level of peripheral arterial disease. Then you can identify people that are at increased risk for having heart disease because now they’ve got blockages in the arteries and if they’ve got blockages in some arteries it means that they are at more risk for having blockages in other arteries. Screening for peripheral arterial disease allows you to get people on the proper regiment of whether it’s medication or diet or exercise. But proper medical therapy to decrease their future risk of cardiovascular complications or even neurological complications such as stroke from blockages in the arteries to the brain.
It kind of worked in the reverse with her because she had the heart things identified first and then she later developed it in the legs.
Dr. Baig: In some people where atherosclerotic disease is going to present first, it varies. Some people might present first in the heart, others they might present first in the leg or in arteries to the intestines and so on. However if somebody like her maybe at the age of forty had been screened for peripheral arterial disease and it was identified early when it was asymptomatic and she had been put on optimal medical therapy then who knows things might have been different. I don’t know enough of her history from twenty five years ago to know the details of that. In general I think screening for peripheral arterial disease should be part of a routine physical examination in order to identify people at risk and change their lifestyle, get them on proper medication to prevent complications.
That would be as simple as basically doing two blood pressures?
Dr. Baig: Yeah. Or even simpler you could just put your finger on a person’s foot and check for a pulse in the foot. If there’s no pulse in the foot then you can do a test with the blood pressure cuffs to see well what is the extent of blockages. Where if there’s a blockage in the artery then the blood pressure beyond that blockage is going to be lower than it is in another part of the body where there is no blockage. It’s as simple as checking pulses in people’s feet and if you can’t feel the pulse then you can move on to another simple test which is just checking the blood pressure in their leg.
You examined her today, that was what you were doing you were checking the pulse in her feet, was that the main thing you were doing?
Dr. Baig: For Ellen since we’ve put a stent in and we’ve opened the artery down to her lower leg the way we check to see if that artery is still open and that stent is still open there are two ways. One I ask her how she’s feeling and how her walking is. If that stent were to get blocked up she’s probably going to have significant pain again and inability to walk. Beyond that it could be that there’s some narrowing occurring in the stent but it’s not quite shut down yet. That might manifest itself as a loss of the pulse in her foot. I always check her pulse when I get in there even if she’s feeling fine to make sure I still feel a strong pulse and it feels as strong as it did before. The third way we check and we do it on a routine basis especially for people that are high risk or that have had multiple procedures done to maintain their patency of their blood vessels, is we do ultrasounds. With ultrasound we can look at the stent, we can look at the way the blood is flowing through the stent, above the stent and beyond the stent and determine whether that scar tissue which I mentioned earlier is kind of reforming at the ends of that stent. We can predict who is going to be at risk for having that stent shutdown and so we can intervene and open that blockage before it completely shuts down the stent which is much harder to fix.
It sounds like everything has been remarkable considering where she was would you say?
Dr. Baig: Yes, that she was at a point where she had so much pain in her foot that if she required an amputation she probably would have been relieved. There are people who end up you know with amputations and in the end they’re relieved because their pain is gone. Because the pain you get from ischemia is very hard to control with pain medication. It’s a very strong and nagging pain which you just can’t get comfort from and it’s continuous. It causes people a lot of distress, emotional distress, and in some cases when you cannot fix the circulation people are relieved to actually have an amputation and end that pain. I think she was at a point where if this didn’t work she was going to get an amputation.
That’s awful isn’t it, so how do you feel about that considering the alternatives?
Dr. Baig: Well I mean I think professionally that’s obviously the reason we go in to this specialty is to try to preserve people’s quality of life and there are some diseases that are life threatening which we treat such as aneurysms. There are other diseases which really cause significant disability and this is one of them. An amputation has such an adverse impact on most people’s lives. I mean if you have an amputation when you’re young and you have great opportunity to recover. There are prosthesis that are great and let people lead full and normal lives with a prosthesis and that’s much harder to do when you’re at an advanced age, and it takes a lot more stress on your heart to walk with a prosthesis than to walk with your own limbs. The body mechanics are so much different. I think anything you can do to save a limb has a big impact. But like I said prosthetics are just amazing now, you can’t even tell sometimes when people have a prosthesis and they can live complete normal lives. Getting an amputation shouldn’t be looked at as my quality of life is now going to be really poor. It’s just going to be different and you can return to a perfectly good quality of life if you are willing to work at it and get stronger.
You had to actually do a bypass in her leg, is that right?
Dr. Baig: Yes, after the first time I saw her she had already been treated with stents multiple times and reopened those stents and those were filled a few times and so she was sent to me originally to do a bypass. For doing a bypass we have a couple of options. We can use your own vein or we can use prosthetic bypasses but she had blockages all the way down to below her knee and if she got a bypass it was going to be to one of the smaller vessels in the calf muscle. I don’t really like to use prosthetic material for that if it’s not absolutely necessary. She had a vein which we thought it was marginal but we thought we could make it work and we were able to do the bypass but unfortunately it didn’t last for even six months. Her vein scarred down tremendously; in fact I had to go in and try to maintain that vein by using a balloon to open up areas that had developed narrowing in the middle of that bypass. But each time it recurred very, very quickly. Finally I said, this bypass is about to fail and we can’t just keep going in there and treating this bypass over and over again. Why don’t we try opening your old stents, we’ll put a new stent in that’s got this covering you can’t get any scar tissue inside of it. We’ve got these drug coated balloons we’ll treat the ends of it and we’ve got a good chance of getting it to stay open and we’ll keep a really close eye on you and see if it starts to fail then we’ll have to think of something else. Maybe we’ll have to use a prosthetic or bypass graft to do another bypass. We did that and fortunately thank God it’s worked out really, really well for her.
She’s been good for more than a year now.
Dr. Baig: About a year and a half. June will be two years.
Potentially what you did there could that last for a long time?
Dr. Baig: I think so. The fact that she’s had ultrasounds pretty routinely since then to look for any problems with any re-stenosis and so far she has not had any and it’s been a year and a half and her stent is wide open. Usually that intimal hyperplasia we call it, that’s growth of the smooth muscle cells, in the first year is when it tends to be the most intense, within that first year. After that the issue is not as much of the scar tissue or the intimal hyperplasia forming it’s more of progressive of atherosclerotic disease. In that case you know we’ve got her on optimal medications and then she’s exercising and she tells me she’s quit smoking. If we’ve optimized all of those things then we’ve reduced that risk as much as possible. The only thing that we can’t reduce is the genetic risk that she has for developing progressive atherosclerotic disease so we have to watch for that. She’s still at risk because of that but I think in terms of failure of the stent from what we call intimal hyperplasia I think that risk is going down with time because she’s past that initial burst of intimal hyperplasia.
How long is the stent that you actually put in?
Dr. Baig: She’s got two stents, one of them is twenty five centimeters long and the other one is fifteen but they overlap a little. She’s a tall woman so I think the total length is almost thirty to thirty five centimeters of stent that we had to put in there.
That seems pretty long right?
Dr. Baig: Yes that’s very long, anything more than a ten centimeter and the entire artery was occluded. It’s not like we had some narrowing in the artery or we had short occlusion with some narrowing. She had stents already in for that—a little bit less than that length and the entire artery was occluded from the groin down to the knee. We have a lot of tools here at the hospital, the hospital is extremely supportive of this program and we’ve tried to build a reputation for Limb Salvage Institution. People come and kind of go hey, I’m about to lose my leg is there anything you can do and so we’ve developed a lot of tools to help open these blockages. We come from the groin, we come from the foot, we come from every direction possible to try to get through these blockages, open them up and really I think make a huge difference in people’s lives.
And you just referred to it, Limbs Salvage—
Dr. Baig: Limb salvage or limb preservation.
That sounds like that’s part of your mission?
Dr. Baig: Yes.
That’s why they come to you.
Dr. Baig: Yes, vascular surgery is one of the main pillars of vascular surgery and really the mission, the goal is to preserve limbs. I love doing it and have a lot of passion for it. It’s really not too many better feelings than when you are able to do something like that for a patient and they themselves or their family member, it’s just ecstatic, the impact you have on people’s lives, and it’s amazing. Sometimes you might save somebody’s life from a ruptured aneurysm but their response is nowhere near as when you get somebody walking again or you get somebody’s foot healed from restoring their circulation and save their leg. People are even more grateful and happy.
What we’ve heard you are extremely busy, that you work all the time so you must be extremely dedicated to your job to help people.
Dr. Baig: Well I love what I do and I have a hard time saying no. When people that you operate on them or touch them with any kind of instrument they basically trust you to take care of them. They’re basically giving you their most sacred trust to basically injure them essentially when you cut on them or poke them or do anything. I personally take that pretty seriously and I don’t want to ever go home thinking hey, you know I didn’t do the best that I could. I mean I’m not always successful, nobody is, but at least I can say that I did my best. Whatever amount of time it takes to do that I’m willing to put in.
This particular problem is it mostly with the legs?
Dr. Baig: No, peripheral arterial disease could be the arms. It’s uncommon. Usually the arm has a lot of alternate pathways for blood to get to it. Even the main artery to your arm is blocked most people won’t have symptoms. Every once in a while people will. I mean I’ve had one woman who had blockage in her arm and after I opened up her arm she told me that it was almost like she had a brand new body part because the difference she felt in the circulation to her arm. It was like as if it was a foreign body part to her she had to get used to having this arm again because of the feeling that was restored to that arm. That’s very uncommon, most people that have blockage in the arms do just fine you can’t even tell. They can have complete blockage in their arm artery and they have no symptoms at all.
END OF INTERVIEW
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