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IRRAflow: Saving Horace’s Brain – In-Depth Doctor’s Interview

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Sumeet Vadera, Associate Professor of Neurosurgery, Director of Epilepsy Surgery, Associate Program Director at University of California in Irvine, talks about a new procedure that may save some people from a brain bleed.

Interview conducted by Ivanhoe Broadcast News in February 2022.

What is intracranial bleeding?

VADERA: There’s different types of intracranial bleeding. There’s what’s called a subdural hematoma, which is blood that accumulates on the surface of the brain underneath the covering of the brain, called the dura. Then there’s blood that sits within the brain itself. We call that an intracerebral hemorrhage, and then there’s also intraventricular hemorrhage, which is blood which sits in the deep pockets within the brain.

What causes it?

VADERA: Well, a variety of things can cause it. Aneurysms in the brain can cause it. Trauma can cause it. High blood pressure, tumors can sometimes have bleeding within them. Aneurysms can cause bleeding in the brain. Tumors can cause a blood clot to form in the brain. All sorts of different pathologies can cause bleeding within the brain. Just like the pathologies are very different, in the same way, their presentation can be very different. Some types of bleeding, which can occur very slowly, like a subdural hematoma. Sometimes in the elderly what can happen is if you have even a minor bump to your head, you can cause some bleeding to form in that subdural space like we talked about. What can happen is that that can slowly bleed and then cause a little more pressure and bleed and cause more pressure. You may not even notice it, or you may just notice, you know, some mild headache, which is new, and then that can continue to grow and cause more pressure until it becomes symptomatic. Another type is something more acute where the bleeding occurs suddenly, and it causes a lot of pressure in the brain. Sometimes with that, people can become sleepy or non-arousable. They can have severe headaches; all sorts of different presentations can develop. Basically, it depends on why the bleeding is there and how quickly it showed up.

Other than like a fall, are some people more at risk?

VADERA: People who take blood thinning medications are at risk. I would say that probably the biggest one it would be blood thinning medications. If you have aneurysms or other types of pathology that are more prone to bleeding, that can also cause bleeding as well.

I was talking to someone about a different story about aneurysms, and he really stressed that women are more at risk for aneurysms. Do you see more patients with this who are women?

VADERA: What I use the IRRAflow for was for subdural hematomas. I found that that is a really good novel use for this device, and so in that population, I don’t think there is a male or female distribution. For the most part, a lot of the patients that we have who have subdural are more elderly, probably on some, you know, anticoagulation. They may have just had a minor fall, even like, you know, two weeks to a month before they presented to the hospital. So, it really kind of depends on what was the cause of it. I would say, for the most part in the population we’re talking about, it’s more trauma related.

Before IRRAflow, how would you traditionally treat this?

VADERA: Most people will either do a small what we call a burr hole, which is a very small hole within the skull and then drain that fluid out. You can also do what’s called a mini craniotomy, which means I make a small window in the bone and then actually visualize the blood clot and remove it. The big problem with both things is that when you have this chronic blood clot that’s there, that blood is very watery. It’s like almost like motor oil. What that can do is that can cause pressure on the brain and push the brain away from the dura, which is that covering of the brain. When you do this procedure, sometimes if the brain doesn’t re-expand, you’re left with this potential space inside the head. Unfortunately, sometimes that can create a space for more blood to accumulate. So, in the literature, we know that there’s a high percentage of patients who have new acute blood after this type of procedure, like I just mentioned. The reason for that is that, like I said, if you do this small craniotomy surgery or do a burr hole, you’re getting out as much fluid as you can, but very often the brain doesn’t fully expand during that surgery. The really nice thing about the IRRAflow is that it’s a continuous irrigating system that then drains out that fluid. So, what I like to tell people, or I like to think about is that it’s continuing to do that surgery even after the portion of the surgery you did, you know, at the time of surgery. What I mean by that is, let’s say you did the same type of procedure. So, you make a small window in the bone. You place this catheter into the area where the blood clot was. Then you turn it on. What it’s doing is it’s continuously flushing that subdural space. If any new acute blood shows up in that area, that blood can very quickly get washed out of the system. The whole point of doing this is that it allows for time for the brain to re-expand slowly and for, you know, to prevent any kind of new acute blood from showing up. As I mentioned in the literature, it says, about 10 percent or higher of people can have a new acute blood clot after this surgery. If you have acute blood, generally you must go back to the operating room and have more surgery done. So, with this device, one of the real benefits is that it’s prevented any of those, you know, re-accumulations in our patients. The other thing that’s nice with this device is that you don’t have to be as aggressive about removing all that blood clot. You can be much less aggressive. You can just take out what you can safely get out, put the catheter in and then allow that to continue as I said, doing that surgery after the fact. Like I said, even in some of our very sick patients who are elderly, who we really don’t want them to be under anesthesia for a long period, this really reduces their surgical time. Then on top of that, as I mentioned that you can continue to do that surgery. So, you can feel more comfortable with the idea of leaving it in there because of the fact that it’s continuing to wash out any additional blood. We’ve done this surgery many times now. I’ve seen several patients where I think they probably would have had to go back to the operating room or require some sort of further intervention, but because of the device, it’s helped us and saved us from having, you know, to put the patient through another surgery. So, it really is a very valuable and novel device. There’s no other system like it on the market, and especially for the patients, I think it’s a great option because, like I said, it reduces that risk for having to go back to the O.R. It’s not really any more different than what most people do anyway. I think it’s a great device.

Could you tell me how do you insert it? Is the catheter through the wrist or the groin?

VADERA: When I talk about catheters, this is a long, thin tube that we place right in the surgical cavity. So, that unlike aneurysm treatment or where you go through an artery or a vein to get to the area, basically what we’re doing is doing our surgery like we normally would. We’re removing as much of that blood clot as we can. Then you just basically lay this long, thin tube right in the area where you did that surgery where the blood clot was. So, it’s not an endovascular technique, necessarily. It’s a catheter very similar to what neurosurgeons generally use. So, it looks like what’s called a ventricular catheter, meaning it’s a long, thin tube that is flexible. We generally use it when we’re putting catheters into the ventricles, the deep pockets of the brain. The reason for doing that is if there’s a lot of pressure building up for some other reason, so a lot of the neurosurgeons are very, they understand the process and it’s no different to that than with the current processes look like. It’s really in that post-operative phase where you’re irrigating and using the device that it’s a little different than what we normally use.

How long does it stay in? Does it dissolve? How does that work?

VADERA: So generally, we keep it, an average for our patients, we’ve had it in for about a day or two. In that time, we’ve seen really, you know, surprising and good results. The brain tends to expand in that period, which allows us to continue to wash out that blood. Then after that, we just remove it right out of the skin. It’s a very simple, you know, procedure to remove. What we’ve noticed is that it hasn’t actually increased our length of stay at all. In fact, it’s actually reduced our length of stay because we haven’t had any risk of any patients who had to go back to the operating room or have had a post-operative CT scan that showed still some blood there. And you keep monitoring them and watching them. For the most part, we continue to see improvement with every cat scan that we get.

Can tell me the difference, like without it and with it, the length of stay, is it two days too?

VADERA: So, we wrote a paper on this, and we looked at what the national length of stay is for this type of procedure. In the larger studies, it looked like about four to six, even up to seven days length of stay. For our patients, on average, we were in about the one and a half to two-day range. So, it’s a significant reduction in compared to what’s out there. Again, it really depends on the type of patient that comes in and, you know, what other morbidities they have. But we’ve had very good success with this device in terms of allowing it to continue to, you know, do the procedure once we’ve closed the skin. That’s been our really good experience with this.

Do you have any more stats that would say the difference between anything else between the traditional and IRRAflow?

VADERA: We’ve looked at several different things. Length of stay was probably the biggest one. We’ve also looked at the cost of our hospitalization with this new device versus the old process.  Since the length of stay is shorter, the actual cost for the hospitalization goes down.

Do you have exact numbers on that?

VADERA: I don’t have them. I’m sorry. I don’t have them on hand. I would say that’s been a big one. As I mentioned, the acute blood re-accumulation rate in the literature is about 10 percent or more, and in our series that we’ve done now, we have had no re-accumulations of acute blood. So, it’s basically like as of now, we’ve not had any patients who had acute blood form which needed to go back to the operating room, which I think is really like probably the best, you know, piece of news. As a patient, you wouldn’t, if you had the surgery done, you really don’t want to go back to the operating room. There’s more risk for infection. You must go back, and you go under anesthesia again. Really, having it done this way is a much safer and better option for most patients.

Now I talked to Horace. I did interview him. Would it be riskier for him to go back for a second surgery.?

VADERA: Absolutely, I mean, Horace is a great example of what the benefit and the value of this system is. As I mentioned, when we did his surgery, his brain was not re-expanding, and he was very much at risk for developing new acute blood in that space. Just like he had presented with these symptoms, he was very much at risk to have to come back and do another surgery, but I felt very comfortable with leaving that catheter in because I knew that any blood that would accumulate would get very quickly washed out of that area and basically, that’s what we saw. So, over the course of a day or so, we got another cat scan and we saw that his brain had re-expanded and that the space in between the subdural space had closed. So, once we felt comfortable with how much space we had removed, then we took the catheter out and he was able to go home. He was very happy with that result, and I think he’s a perfect example of why this is such a valuable and beneficial system.

Was Horace patient no. 1 for you?

VADERA: No. The first patient we did was probably about two years ago. We did a patient with subdural hematoma, we were the first in the country to use this system on that patient, and very similar to Horace, it was a really, good outcome, just like he had been. To date now we’ve used it on well over 20 patients, and so it’s every time we use it, I think we just find new and novel ways to do it. The newest approach we’re doing is, like I mentioned, instead of doing a larger, like a mini craniotomy, we’re just doing it through a burr hole. In certain patients, we’ve even been able to do it at the bedside, which means that we don’t have to take you to the operating room. We can actually do it in even lower risk environment or low-pressure environment.

Is that a first for you to be the first in the country to do a procedure?

VADERA: That was the first for me. The first to do a new procedure in a new type of patient. I mean, I felt very comfortable with it because it makes a lot of sense. Every neurosurgeon that I talk to about it when I explain the device and what it does, they immediately say. That makes perfect sense. It is a very useful and valuable process, and it is one of those things where when you do these surgeries, it’s you have a little bit of anxiety at the end of that surgery because you really don’t know what’s happening. Is there new blood going to accumulate? If so, you know, does a patient have to go back at some point? Those are all things that the patient doesn’t want, the neurosurgeon doesn’t want. This allows you to really feel a little more comfortable at the end of that procedure because you can say, you know, I know that is going to continue to do that work that we did. We allow the patient’s brain to continue to re-expand, and then in a day or so we can remove it. Like I said in all the patients we’ve done, we’ve had no real issues with it and the patient’s been happy with it. So, I found it to be a really great addition to treating types of patients.

When you first met Horace, what were his symptoms and what was he like?

VADERA: So, with his story, what happened was that about two weeks prior, it was right around Christmas time, and he was, I believe, hanging some lights up. He had a very minor fall and that’s something that can happen in the elderly. So, what happens is that as we age, our brain starts to shrink, and as it shrinks away from that subdural space the brain creates these like subdural spaces. There are veins that cross from the brain to that surface, that dura. As we age, the brain starts to shrink, and those veins start to get more stretched. So, even with a very minor head trauma you can bump your head on a cabinet or have a very minor jolt, and that can cause those veins to tear. When they tear, that’s how blood starts to accumulate, and because of the location of where his bleeding was, he started to have some very minor symptoms, headaches, and some very minor language problems, but because of all those things, he came in. We saw a very large subdural and it looked like a very chronic subdural and very interestingly, he said I never had symptoms like this before. I’m not a headache-y person, and really, this was the first time that it happened. Again, it kind of shows you that the brain can accommodate a lot of pressure before it actually presents symptoms like what he had. So, I believe it was two or three weeks later from that incident that he came into the E.R, and when I saw it, the blood clot, and his story, I said, you know, he’s a great candidate for this device, and so we took him to the operating room and did our normal process and then placed his catheter. It was very impressive to see just how quickly his brain re-expanded, how he was able to get back to normal. Almost immediately after surgery, he woke up and was back to normal and then just continued to have continued improvement over the next few days. Then once we felt comfortable, we removed that catheter and then sent him, you know, home. Then since that time, he’s been very happy, and we’ve done repeat CT scans, which show that there’s no re-accumulation of that blood.

A lot of pressure for that one because, you know, he’s a very cerebral man.

VADERA: Very much so, yeah. He was a dean and he’s had lots of very high appointments. So, we really wanted to make sure we kept him in that kind of very high level.

Are you connected with the company who makes the IRRAflow in any way or?

VADERA: I do serve as a consultant in terms of helping them design the new catheter that they’re working on.

END OF INTERVIEW

This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.

If you would like more information, please contact:

Sumeet Vadera

svadera1@hs.uci.edu

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