Ricardo Hanel, MD, PhD, neurosurgeon, Baptist Stroke & Cerebrovascular Center, Jacksonville, Fla., talks about a new clinical trial for a device to treat brain aneurysms.
Interview conducted by Ivanhoe Broadcast News in November 2021
Can you just go ahead and tell me what a brain aneurysm is?
DR HANEL: A brain aneurysm is a dilation or stretching on a blood vessel. I typically explain it to patients as it’s like a little balloon on the side of a blood vessel or if you think about a rubber tire that is stretched the tire on the side. It’s a thinning of the blood vessel wall, which becomes a weak spot more prone for rupturing/bleeding.
What happens if it ruptures?
DR HANEL: A ruptured brain aneurysm is a deadly situation. About four out of ten people don’t survive the bleeding when it because the pressure inside the head goes to the sky and the blood flow cannot get to the brain. When/if the person gets to the hospital, then we have treatment options. But even for those that get to the hospital, many don’t survive.
Can catch it before it ruptures?
DR HANEL: Oh, yeah, absolutely, and that’s, I think, one very good thing that we’re living through with all the advances in imaging. Namely, you can find a CAT scan and MRI in any city in the country. So, people get headaches, people have sinusitis, people have dizziness, and they get pictures for other reasons and, voila, you find an aneurysm before it bursts. The symptoms can be related to the aneurysm. Most of the time the symptoms are not related to the aneurysm. More and more we’re finding aneurysms that we call incidental (found for other reasons).
So, you are the first physician in the United States to try this new procedure (Contour Neurovascular System)?
DR HANEL: Yes. We’re the first center in the United States to enter the clinical trial. There were cases done elsewhere in what the FDA calls the compassionate use of the tool. This was the first time that the contour device, which is a kind of neck shield for the aneurysm, was used in this clinical trial. The company is seeking FDA approval for its use in the United States, so they have to do a clinical trial and present the results to the FDA.
So, can you tell me about the procedure?
DR HANEL: Coiling is the beginning of all this. In the early ’90s, coiling became approved as a way to treat aneurysms with this little cylindrical mini slinky, as I explain to the patients, that you put inside the aneurysm. The problem with the mini slinky is it’s a bunch of little wires tangling on themselves. The surface is not very stable. Fast forward 30 years, now we have this very nice, fine mesh that’s like a shield that can go inside through the wrist or through the groin without opening anybody’s head, travelling under X-ray guidance right on the aneurysm. You put the shield there…shield looks good and stable–press a button on the outside, the wire that carries the shield disconnects. Tshield stays behind, the wire comes out and that’s the end of the treatment.
It’s almost like a heart repair, how they do like a stent?
DR HANEL: The concept is very similar to a stent for the heart, but this is not a stent. This is a shield. The procedure is exactly the same. It’s through the wrist or through the groin, just like we would do a heart CAT or heart stenting angioplasty, or a stent for blocked heart vessels. Very similar entry zone.
You’re just making that wall strong again?
DR HANEL: We’re patching the hole from the inside. If you could look at an aneurysm from the inside, you’re seeing the hole on the wall. We’re putting a patch right there so now the blood flow cannot come through that, which eliminates the aneurysm. Over time, when you put a stent on the heart, or when you put this patch on an aneurysm, the body is going to grow a new layer on the inside. We call this neointima formation. The inner layer of the vessel’s going to grow over these devices. If you go back there four, six, eight weeks later, you don’t see the metal of the device anymore. You see a very fine little layer of wall that grew over that. That’s why the patch potentially is better than the coiling because you have a nice, stable, straight surface for these little cells to grow over, where on the coils, you have a bunch of cylindrical wires, so it becomes all uneven and harder for the cells to grow over.
So, is it something that stays for life, or you have to replace it?
DR HANEL: It stays for life. There’s no reason to remove it. The trial is there to study for how many people it works, and how many people that doesn’t work.
What’s the safety profile for the tool?
DR HANEL: That’s why we need a clinical trial like this. We’re excited to be involved in it.
Is this trial nationwide?
DR HANEL: Yes, and some sites in Europe, as well.
Is there a certain patient that is a better patient?
DR HANEL: Yes, it’s a very specific type of aneurysm called bifurcation aneurysms that are the target aneurysm for the trial.
What’s the difference?
DR HANEL: So, some aneurysms come on the side of the blood vessel. We call that a side wall. Bifurcation is a fork on the road. Think about your driving on a road. There’s a road going left and one going right, and the aneurysm is right in the middle or top of the fork. That’s what we call bifurcation aneurysm.
Now, if you get one aneurysm, are you more likely to get another?
DR HANEL: That’s a great question. Yes, it’s very common. 20 to 30 percent of people that have one aneurysm have more than one and you can be born with a propensity for aneurysms. That is very important to know, because it runs in families. I don’t have anybody in my family with an aneurysm, my risk is four percent. If you have mom with an aneurysm, from the genetic component of that, you go from four to six percent. If you have a mom and a sister with an aneurysm, so two first degree relatives with an aneurysm, you double your odds of having an aneurysm. We are in a good, state-wide campaign to educate people because very few people know about that. When you go to your primary care physician, you answer the questions: do you have anybody with diabetes in your family? Do you have anybody with breast cancer in your family if you’re a female? Prostate cancer if you’re a man? Do you have anybody in your family with colon cancer? Nobody asks if you have anybody with a brain aneurysm. Fifteen years ago, it was very high risk to treat an aneurysm. Now it’s a different ballgame. It’s much safer to treat brain aneurysms, and it makes sense today to do a screening for people that are higher risk: females, smoker, age 30 to 50, a family history of brain aneurysm, if you have a condition called fibro muscular dysplasia. You should be aware because your odds of having an aneurysm goes from two times to six times more if you have some of these conditions. There are no questions about screening being done anywhere unless you to go to very specific places like here (Baptist Health of Northeast Florida). There is a need for a national campaign to educate primary care providers and patients that we should be talking about this with patients because if you find an aneurysm before it bleeds, you can prevent a stroke that is potentially catastrophic with a 4 out of 10 chances of dying. It’s phenomenal when we find these before they bleed. We can treat them safely; eliminate that risk of stroke and you follow your normal life.
Has this already been approved in Europe? Do you have any, like, stats from their survival rates?
DR HANEL: The complication rate is pretty low on the study done in Europe. They just published that in 36 patients treated, there wasn’t a single case of dying from the aneurysm, but a couple of cases of strokes during the treatment. That’s something can happen. We’re traveling inside the vessels, scraping the walls to get there, putting a foreign body that is a shield that can form a clot. So, the safety profile from Europe seems to be pretty good. We cannot talk about anything on the U.S. study until the study is published in the United States.
Just for another thing that we do, we do these, like, little medical minutes, but I think this would be a good thing, the difference between a stroke and a brain aneurysm.
DR HANEL: Stroke is a big umbrella. Under stroke, we have two types of events: events that come from clogged pipes, which we call ischemic stroke, and events that come from a burst pipe, which we call hemorrhagic strokes. Aneurysms are under the umbrella of hemorrhagic stroke. So, in general, if you say somebody had a stroke, an expert will say, ‘which type of stroke?’ Clogged pipe or burst pipe? When a non-medical person talks about stroke, in general, they would talk about clogged pipes. When they talk about the bleeding, they would say, ‘oh, my grandma had a bleeding’ or ‘my son had a bleeding’. They typically don’t say stroke referring to a bleeding.
A bleed? An aneurysm is a stroke.
DR HANEL: An aneurysm is a potential stroke. And an aneurysm that bleeds is a hemorrhagic stroke.
Got it. Anything I’m missing?
DR HANEL: We talked about screening. If you’re a female listening to this, this is a female’s issue. In the two most recent studies that we published, the odds of having an aneurysm is much higher if you’re a female. So, you’ve got to know your numbers and your family history. 80 to 90 percent of the aneurysms that we treat these days are in females. We don’t know exactly why yet. There’s some research going, estrogen related, as to why this is happening more in females.
OK, great. Anything else? It seems like a simple fix to just ask that.
DR HANEL: When we have somebody with an aneurysm, the physician looks at that person’s risk profile for treatment. If it’s bleeding, it’s an emergency. It has to be done almost no matter what. If you come here to have a conversation–I have a brain aneurysm, what should we do? —it’s our job to say, ‘this is very small, low risk for bleeding, let’s leave this alone.’ There’s a series of patients that we just decide to leave it alone because it’s a very small aneurysm and doesn’t have any signs or hints that it could be a dangerous lesion. Probably half of the aneurysms we see, we don’t treat. It is a case-by-case discussion, but there’s no question, the safety of treatment became way better the last 10 years, and that’s beautiful for the patients.
You said women need to know their numbers. What numbers would be?
DR HANEL: Know their numbers, know their facts. High blood pressure is an aneurysm generator, so you’ve got to ask, ‘what’s my blood pressure?’ If you don’t want to have an aneurysm, throw away your cigarettes. So, if you’re smoking, you’ve got to kick that out. Anything that is good for blood vessel care, high blood pressure care, diabetes care–so know your blood sugar, know your cholesterol, all those. That’s what I meant with know your numbers. Plus, add to that, do I have this condition, fibromuscular dysplasia? This is something we don’t screen for, but a lot of people when they get carotid ultrasounds or high blood pressure, or they get renal artery ultrasound, the diagnosis will be fibromuscular dysplasia. A lot of the times, primary care physicians don’t know that there’s a very strong relationship between fibromuscular dysplasia which is a common problem to be found, especially for females. If you know you have that, it is your job to tell your primary care physician, ‘I know fibromuscular dysplasia is related to brain aneurysms and I want to be screened because I have a four times higher chance of having a brain aneurysm.’ Every year, we have a primary care physician conference. We talk specifically about what primary care physicians should know about that because they’re there to help the population identify this before it burns somebody.
When do you think it would be available?
DR HANEL: It’s probably going to take another year or 18 months to finish all the patients that need to be enrolled, and then it’s another year waiting for everybody to get their one-year follow-up picture. So, I think we’re about two years before the end of this study and then the company has to wrap up all the data present to the FDA. Then the FDA has time. So, for this to be widely available for U.S. population, we’re probably talking about three years.
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:
Kristi Tucker
904-202-4927
Sign up for a free weekly e-mail on Medical Breakthroughs called First to Know by clicking here
