MIAMI ( Ivanhoe Newswire) - In the time it takes you to read this story two people will have a stroke. They kill 133,000 Americans each year. Half the people who survive a stroke will have some degree of paralysis, but doctors believe a new device could help that number drop dramatically.
Two million brain cells die every minute during a stroke.
"Time is brain," Dileep R. Yavagal, M.D., director interventional neurology and co-director of endovascular neurosurgery at the University of Miami Health System, told Ivanhoe.
Jorge Lazo recently suffered a major stroke.
"My mouth was turning to the side," Jorge Lazo said.
"I thought that he was not going to be alive," Beatriz Rodriguez, Jorge's girlfriend, said.
Two blood clots stopped the flow of blood and oxygen to his brain, paralyzing the left side of his body
"This is the kind of stroke that leaves the patient disabled for life," Dr. Yavagal said.
Clot-busting drugs couldn't dissolve the blockages, but Doctor Dileep Yavagal at Jackson Memorial Hospital had something brand new to try on Jorge, something FDA approved just 29 days before Jorge's stroke. Five and half hours after the stroke the doctor performed a catheter-based surgery with the solitaire device. Once in the brain the closed mesh tube goes through the clot. Then the tube opens up and grabs it.
"Allowing us to retain the clot as we're pulling the device out of the body," Dr. Yavagal said.
Studies show solitaire is twice as effective as similar clot-removing tools.
"The procedure went really fast," Dr. Yavagal said. "I was able to get both clots out within the hour."
When the blood flow was restored something amazing happened.
"He lifted his leg right off the bed, which was so thrilling," Dr. Yavagal said
Jorge regained function of his left side. He's able to walk and thanks to rehab is lifting his left arm too.
"Usually patients need more time to achieve what he's achieving," Dr. Ana Delgado, M.D., a neurologist and neuro rehabilitation fellow at the University of Miami Health System, said.
He's mobile because of a micro-blood clot remover that made it to market just in the nick of time. Jorge is now home and is doing outpatient rehab to help restore more of his function. The doctor said he's gotten similar paralysis reversing results with other patients he's used the solitaire device on. He said the biggest risk with the device is bleeding in the brain, but the risk is lower than with similar devices.
RESEARCH SUMMARY
BACKGROUND: A stroke is like a "brain attack"; it occurs when a blood clot blocks an artery or a blood vessel breaks, interrupting blood flow to an area of the brain. When either happens, brain cells begin to die and brain damage occurs. Stroke is the third leading cause of death in the United States, and more than 140,000 people in the US die each year from stroke. It is the leading cause of serious, long-term disability in the United States. (Source: National Stroke Association, the Stroke Center.org)
TYPES:
- Ischemic Stroke
Blood clots are dangerous because they can block arteries and cut off blood flow, a process called ischemia. An ischemic stroke can occur in two ways: embolic and thrombotic strokes
- Embolic Stroke
A blood clot forms somewhere in the body (usually the heart) and travels through the bloodstream to your brain. Once in your brain, the clot will travel to a blood vessel small enough to block its passage. The clot lodges there, blocking the blood vessel and causing a stroke.
- Thrombotic Stroke
In the second type of blood-clot stroke, blood flow is impaired because of a blockage to one or more of the arteries supplying blood to the brain. The process leading to this blockage is known as thrombosis.
- Hemorrhagic Stroke
Strokes caused by the breakage or "blowout" of a blood vessel in the brain are called hemorrhagic strokes. (Source: National Stroke Association)
TREATMENT: Tissue plasminogen activator (TPA), or alteplase, is a clot-buster drug that dissolves the blood clot causing the stroke. There is a narrow window of opportunity to use this drug, so the earlier that it is given, the better the result and the less potential for bleeding into the brain. Aspirin or anticoagulants like heparin are also used. Rehabilitation is also used to restore strength to the patient and get them used to their post-stroke lifestyle. (Source: MedicineNet.com)
NEW TECHNOLOGY: Solitaire™ FR Revascularization Device is a mechanical thrombectomy device combining the ability to restore blood flow, administer medical therapy, and retrieve clot in patients experiencing acute ischemic stroke. It mechanically breaks up and removes the blood clot. It has optimal radial force for flowing through all clot types, stable recanalization for the adjunctive use of medical therapy, and optimal metal to tissue ratio for reliable clot retrieval. It has demonstrated effective clot removal in vessels sized 2 to 5.5 mm. (Source: Covidien)
INTERVIEW
Dileep R. Yavagal, MD, Director Interventional Neurology and Neurosurgery at Jackson Memorial Hospital at University of Miami, talks about what's helping stroke patients reverse paralysis.
Tell me about Jorge.
Dr. Yavagal: He developed a sudden onset of left-sided weakness. He is 58 years old. He had high blood pressure and diabetes and had one episode years ago where his left side had gone weak, but this time, the left side weakness came on around 12:30 in the afternoon and stayed and did not improve. His wife called 911 right away and they took him to an outside hospital, Palmetto General, where they got the clot busting medications to go in. But, that did not improve his symptoms whatsoever. That is when we got a call to bring him here for doing a catheter based surgery for strokes as a comprehensive stroke center. When I heard about the story, I accepted the transfer, brought him here and we took him to our MRI scanner first. That is where we bring most of our transfer patients to see how much brain is at risk from the stroke that the patient is having and how much brain can be saved. The MRI gives us a good assessment of that. Once we got the MRI and we saw that he had only minimal damage and there was a lot of brain that we could salvage, we brought him up here right away. That was about 5 to 5-1/2 hours from when the symptoms began. The device that we used is a recently approved device that is approved up to 8 hours from stroke symptoms starting.
And this was recently approved correct?
Dr. Yavagal: Absolutely. It was just approved on March 5, 2012 and we were doing the procedure on April 4, 2012. We had gotten this device right away because the studies of this device that lead to its approval showed that the device was twice as effective as previous devices.
How long does the procedure take?
Dr. Yavagal: The procedure went really fast. We do this on a daily basis, so we are very good at it, but the challenge is always how many clots, and how well the device performs. Mr. Lazo, had 2 clots sitting in his carotid artery on the right side and that is very challenging because one has to go after each of them and make sure that the artery is open. I was able to get both clots out within the hour and get the artery fully opened with the Solitaire device.
How important is time when you are working on something like this?
Dr. Yavagal: The saying goes, time is brain and that is because we know for a fact that every minute that passes without blood flow in the brain, 2 million neurons in your brain die. We are really on the most tightest timeline that there can be to save the patient's brain. We try our best. We have a very well oiled team that facilitates going fast with all of these including technologists and nurses and trainees that help me do this.
What did Jorge's brain look like?
Dr. Yavagal: What we saw is that there should be a nice big pipe going up and all you see is just a part of the pipe filling. That tells us that this pipe is completely blocked except for a little bit of flow, actually coming from the artery going to the eye that is trying to fill the artery going to the brain. It is a remarkable thing that the body tries to do, but obviously, it is not succeeding very well.
How severe is this compared to other strokes?
Dr. Yavagal: This is what we would call a major stroke. This is the kind of stroke that leaves the patient disabled for life, possibly bedbound if we are not able to open the artery. This is also the kind of stroke that does not respond to intravenous clot busting medication because it is just too much blockage that is present for the medication given through vein to open up.
How big of a clot are we talking about?
Dr. Yavagal: We are talking about two clots; one is about 2 cm long and one is about 1.5 cm long. We are talking about a lot of clot burden sitting in the artery blocking blood flow from going up.
Can you walk me through the procedure?
Dr. Yavagal: We has Jorge lying on the table. We actually gave him just medication to make him a little sleepy and comfortable through the vein. We did not use general anesthesia for 2 reasons. One is speed. We did not have time or we do not do general anesthesia to avoid any delays and once we had him a little sleepy and comfortable, I used a needle, after giving local anesthesia, to puncture the artery in the groin. That artery allows me access to all the arteries in the body including the one in the brain. And then using a very sophisticated x-ray machines, I get a 2-dimensional picture from the front and from the side of the arteries allowing me to navigate from the groin all the way up into the neck first and then into the brain. That allowed me to get the pictures and then the device up into the clot and pull the clots out to open up the artery.
What makes the Solitaire different than past devices?
Dr. Yavagal: That is a great question and I think the reason the Solitaire is proving to be so much more effective is because the surface area of interaction between the clot and the Solitaire device, which is like a tube, is a lot more than the previous device which is a corkscrew. The amount of metal that interacts with clot is a lot more and it is circumferential. I think it gives a much better engagement of clot to the device allowing us to retain the clot as we are pulling the device out of the body. It is a split tube and that also allows the tube to sort of adjust to the artery size as it goes in the smaller and bigger arteries without really without getting squished. It is just like a fishing hook and you can always lose it if the clot is not well engaged to the device.
How much blood flow does he have now?
Dr. Yavagal: Both of the clots were out and we had full blood flow. There was no remaining blockage which is the goal we have. We want the artery to become completely opened. One of the problems with this procedure is that we may get partial opening and not complete.
Is this better than the Mercy device?
Dr. Yavagal: It is possible. It is consistent with our experience. We were not getting that good recannulization with the Mercy device. There is another FDA approved device called the Penumbra which the Solitaire has not been compared to head to head, but the performance of Penumbra was better than Mercy, so it is possible that these two are going to be equivalent. The neat thing about this is that it navigates much faster in older patients than the Penumbra device. So, you
Did it take much practice to insert the catheter?
Dr. Yavagal: The other good thing about this device is it is very similar to other procedures we do. For example, I put stents in the brain all the time and this is, in that sense, no different. The main learning curve is really in teaching oneself to pull the device slowly because you an easily lose the clot if you pull too fast. It will just come out.
How excited are you?
Dr. Yavagal: These studies showed dramatic results. I think that suddenly is major incentive for neurointerventionalists to really figure out if it really works like that. If it does, then, it has tremendous benefit for our patients.
FOR MORE INFORMATION, PLEASE CONTACT:
Lorraine Nelson
Media Relations
Jackson Memorial Hospital
lnelson@jhsmiami.org
