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Pipeline for Aneurysm – In-Depth Doctor Interview

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Ricardo Hanel MD, PhD, a Neurovascular Surgeon at Baptist in Jacksonville, a Director for Stroke and Cerebrovascular Program, and Director for the Baptism Neurological Institute, talks about a new procedure to treat small and medium sized aneurysms.

Interview Ivanhoe Broadcast News June 2017.

Tell us about an aneurysm, can you tell us what’s going on?

Dr. Hanel: A brain aneurysm, the term aneurysm means dilation and applies to any blood vessel of the body. When you’re talking specifically about brain aneurysm, it is a stretch in one of the blood vessels. In general, arteries are high flow pipes taking blood from the heart to the brain, and there is a stretch in this vessel. So think about a rubber band, think about blood vessels as a rubber, a pipe, there’s a stretch zone of the thinner rubber more prone for bursting.

What is the danger when you have an aneurysm?

Dr. Hanel: With thinner rubber, last components of the wall, that area of the vessel that is diseased; the aneurysm itself, is definitely an area that is at high risk for rupture. And there are many factors involved in a lower or higher risk for bleeding in brain aneurysms. But in general if you have a brain aneurysm, you need to know that you’re more prone for brain bleeding because of that component, the weak spot in the wall.

When you have a rupture, this is an emergency situation? How critical is it for the patient when he gets in to that situation?

Dr. Hanel: Unfortunately if you happen to have an aneurysm burst in your head, for a lot of them most people don’t make it to the hospital because the pressure inside their head goes through the roof. The brain is encased by a closed box that is the skull, so there’s no place for this pressure to go. If you happen to survive time is of essence to be treated. It’s a different type of stroke; we call it an ischemic stroke where every minute counts, so we have up to four and a half hours to give a medication, when you have a clot on the pipe. If you have a burst pipe, typically time is not as critical but you should go to a place that can offer all options from clipping, to coiling, to craniotomy, to flow diverters. Because there’s plenty of evidence showing that if you are in a place that offers all possibilities for treatment your odds of doing better are much higher.

What are the options when someone has first of all and aneurysm that hasn’t burst? Do you have signs, do you have symptoms very often or how do you know there might be a potential problem?

Dr. Hanel: Probably in 2017 it’s kind of a 50-50 that somebody had a headache and that led to a CAT scan or MRI to end up finding the aneurysm. Very often it’s very hard to say if the aneurysm is or not related to the headache. So it could be a completely different source of headache, sinus infection for example and they end up getting a CAT scan or MRI and finding a brain aneurysm. But we have patients just like Ms. Meyer that get a CAT scan because of other symptoms and it’s just serendipitous that we end up finding the aneurysm. Aneurysms when they get bigger they can give you more headaches. When they get bigger they can put pressure on nerves so eye paralysis, other types of paralysis from pressure of the sheer mass of the aneurysm putting pressure on those structures. But those are less common, this is for unruptured aneurysm. For aneurysms that never bled, they can also give you a stroke. A little piece of clot can form inside the little balloon that is the aneurysm, go up stream and give people a stroke. But most of the time these days we find the aneurysms unrelated to symptoms.

What are the treatments, obviously watch and wait is not a good idea in this kind of a situation?

Dr. Hanel: If you have an aneurysm, never bled and have no symptoms it’s a very individualized discussion patient by patient. What are your risks of this aneurysm rupturing, and we use many factors that we can talk about to decide that. Watching is reasonable for any aneurysm under seven millimeters, depending on the location. Very often we discuss and council them, and we will probably have more aneurysms in the office that we follow with no treatment than aneurysms that are treated. But in certain circumstances people said oh my mom died from an aneurysm, or the aneurysm is larger, or one of those high risk features that we can talk about, and then we discuss treatment. For aneurysms never bled, that is the best timing and possibility for treatment because all options are available. We can go from the most traditional one that is a craniotomy, opening up the skull for aneurysm clipping. But all the options of treatment through the groin using new tools like the pipeline device among others, where we need people to be on blood thinners, aspirin and plavix or aspirin and a cousin of the plavix like ticagrelor or presacral, those are much better used in people that never ruptured. Once you have bleeding from an aneurysm it makes much higher risk to use these medications and to use these tools in people that just bled from an aneurysm. So your best chance if you get treated before bleeding.

I want to talk about this new Pipeline device. Can you tell me what it is and how it works?

Dr. Hanel: Since the nineties we knew as a field that aneurysms are a completely flow dependent entity. So if we could change the flow in a certain way, we could make the aneurysm disappear. This new device is the first in the United States; it’s called the Pipeline embolization device. What this device does is it creates a very fine screen right at the mouth of the aneurysm, creating resistance for the blood flow to go in and to get out of the aneurysm. Probably equally as important it creates a little tray just like when you are planting a vine you plant a tree and the vine is going to grow over that and seal the holes. This is the same concept, we have this very fine mesh of wires, and the vine here is the inner lining of the blood cell. The blood vessel are called endothelial cells, these grow over, literally if we could go a year after these aneurysms that we just talked about, and go on the inside where the day of the procedure you would see metal, you don’t see metal anymore. You would see a very fine layer of endothelial cells covering the metal sealing the holes in between and closing the aneurysm.

Once you close the blood from that aneurysm what happens to that little section?

Dr. Hanel: That aneurysm will shrink.

So it’s no longer a problem?

Dr. Hanel: No longer a problem, most of the time.

You had mentioned that new tool; can you walk me through the surgery? How do you approach it, how is it inserted, a couple of those details.

Dr. Hanel: This is a minimally invasive procedure through the groin or through the wrist it depends on the patient’s anatomy. We have the patient under local or general anesthesia; it can be done both ways. With X-ray guidance we go and navigate this little catheter up twenty seven thousandths of an inch in diameter into the vessel. Once this twenty seven thousandths of an inch catheter is in position, we have the tip of the catheter inside the brain vessel and the other end of the catheter outside of the groin. Through that tube I can feed this little mesh and very carefully push the mesh to get on the contour of the vessel. Once we get a perfect match of the vessel wall nice and tight against it, over time; in a month, three months, six months, a year later the aneurysm will go away.

What’s the benefit of using this tool?

Dr. Hanel: I think there are a couple of different benefits of the new tool. One it allows us to treat the aneurysms that before were very high risk for treatment. For example, giant aneurysms where we would have a high morbidity and mortality of treating, now with this tool we definitely became better in treating these aneurysms. Before, small aneurysms with a broad base like what we’re having here we knew the minimally invasive treatment, the weakest link was aneurysms coming back. Now with this tool, once the aneurysm is closed there is not a single case reported all over the world that an aneurysm came back. Once you close this aneurysm, you can very nicely tell the patient you’re cured. This aneurysm, very likely with ten, fifteen years of follow up this is not going to come back, so we dare to say you’re cured. We have to keep an eye on your other blood vessels but for this one you’re cured and that’s very empowering.

How important is that for a patient who is worried about what is going on?

Dr. Hanel: I think it’s very important to give these patients peace of mind that the aneurysm is fixed and is not going to come back. Because we see ourselves in some situations with clipping, and much more coiling, where we have little aneurysm remnants that we have to keep following. And with some patients this can occur twice, three times. It’s unusual by far the exception, but for those that get stuck with the aneurysms recurring, coming back, it’s very, very frustrating psychologically. To live knowing that you underwent a surgery and you couldn’t fix the problem.

For whom is this not a good fit, a good procedure?

Dr. Hanel: This is all about location of the aneurysm, size of the aneurysm, anatomy of the patient. In general this is not a first line treatment for people that have ruptured brain aneurysms because of the need for two medications, aspirin and clopidogrel, or aspirin and plavicks. So we only use this tool, the Pipeline device, for patients with ruptured aneurysms in a desperate situation where you have no other option available. They are very rare, we are part of a study called the intrepid study that covered 906 aneurysms treated with this device. Only 66 of the 900+ aneurysms were treated for rupture. So you see that it’s much more common to be utilized in an un-ruptured situation like in a one to ten or fifteen ratio.

Could you tell me why this was appropriate in Christine’s case?

Dr. Hanel: Ms. Meyers was part of a study called, the Premier study, where 141 patients were treated with the Pipeline device. These patients were a very specific group with aneurysms up to 12 millimeters on two common locations for aneurysms. So the question that we had to ask ourselves as investigators is how does this device work on the treatment of these patients. We knew that for large aneurysms it worked really well, we knew from using this on many patients in all the studies that this would work well.  We just present a couple of months ago at the International Stroke Conference in Houston, the results of this study called, the Premier, where we had one 141 patients treated, 84 percent of the patients had complete recovery from their aneurysms, best results ever for a endovascular treatment for aneurysms with only 1.4 percent of complications. This was very, very good results.  So for her we had the option of monitoring and watching, but she didn’t like that option because she has young kids and this option comes with a risk of bleeding, she wanted to have that eliminated. The location of her aneurysm made it very trick, very tricky to use the clipping option because this is right underneath the optic nerve and you have to put an eighty thousand RPM diamond bar right against the nerve, right against carotid, it is a lot of work to be able to put a clip there. We have done that successfully before, but there is no question it is a lot of work. If we do that through the groin with minimally invasive coiling, there is a chance of three or four percent of these aneurysms coming back. With the pipeline one 20 minute or 30 minute procedure, if I remember correctly that is how long her procedure was, and device is in place. Easy for her one day in the hospital, the next day she is out, and now a year later she is cured and set for life.

She will have to monitor though, that is the last question I want to ask you; what would she have to watch for?

Dr. Hanel: Our protocol for these patients is that every five years we monitor them; we have a protocol specifically for the Premier Study.  We check in at one year, and we check with MRI’s at year two, and at the three year anniversary and then after that every five years. Once you have had one aneurysm, you are a little more prone to have a second one; so every five years we keep an eye on your vessels. That’s an MRI, come to the office get an MRI, nothing major involved with that.

Is there anything that I did not ask you that you would want to make sure that people know about?

Dr. Hanel: I think it is very important for people to know cigarettes have everything to do with brain aneurysms. If you don’t remember anything else, please remember if you don’t want to have an aneurysm stay away from cigarettes. We now have evidence that if let’s say mom had an aneurysm what can you do, you cannot change your mother or father, somebody from your family. But we know that cigarettes are very important even for people who have a familiar history; it seems like cigarettes trigger those genes to work against you. So you’ve got to remember stay healthy, anything that is good for your heart is good for your brain vessels. Stay in good shape, keep your blood pressure under control, and stay away from the darn cigarettes. If you have familial history that is another very important piece of information that not everybody knows. If you have one of your first relatives, my mom had an aneurysm for example, the risk goes from four to five point six percent it’s almost fifty percent increase. If you have two first degree relatives, mom had an aneurysm and sister had an aneurysm, now my risk goes from four to almost eight percent. It pretty much doubles your chances of having an aneurysm if you have two first degree relatives. So we recommend a screening for these people, and I have no question that we are going to start seeing this more and more in the future.

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:

Ricardo A Hanel

904-487-2469

rhanel@lyerlyneuro.como

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