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Monday, May 06, 2013

New device an advance in treating strokes

Stent-retriever traps and removes obstructing clot


Common stroke warning signs

• Sudden numbness or weakness of the face, arm or leg, especially on one side of the body.
• Sudden confusion, trouble speaking or understanding.
• Sudden trouble seeing in one or both eyes.
• Sudden trouble walking, dizziness, loss of balance or coordination.
• Sudden severe headache with no known cause.
Source: U.S. Centers for Disease Control & Prevention

While hospitalized with an irregular heartbeat in March, Chris Hodges took Tylenol for an odd pain concentrated in a quarter-sized spot in his head.
The pain only worsened, though, and on the way back from the bathroom a little later, he collapsed, unable to move his left side — the victim of a stroke.
But surgery with a new medical device stopped the stroke in its tracks, saving the 33-year-old single father’s brain from severe and permanent damage.
“He goes back to take care of his kids, versus being in a nursing home, fed through a tube,” said Norton Healthcare neurosurgeon Dr. Shervin Dashti, who used a “stent-retriever” to trap and remove a large clot in a brain artery. “This really changes the game as far as being able to help people.”

The first stent-retriever used in the United States, called Solitaire and made by the Ireland-based Covidien, was approved by the U.S. Food and Drug Administration in March of 2012 and is being used at area hospitals such as Norton Brownsboro, University, Jewish and Baptist Health Louisville.
A second model, Concentric Medical’s Trevo, was approved for the market in August and is also being used at many hospitals.

While these devices don’t eliminate serious complications or deaths, doctors say they promise better outcomes for patients whose prospects once would have been bleak.
“It’s a revolution in terms of ease of use, safety and success,” said Dr. Alex Abou-Chebl, director of neurointerventional services at University Hospital.

Stroke kills almost 130,000 Americans each year, or one person every four minutes, federal figures show. Kentucky has the seventh-highest prevalence in the nation, with 3.3 percent of residents reporting in 2010 that they’ve had a stroke. The rate in Indiana was 2.7 percent.
Hodges, of Bardstown, Ky., said he’s grateful to be alive and back to cooking and fishing with his daughters, ages 7 and 11.
“I get to watch my girls grow up,” he said.
“It was a miracle,” added his mother, Tammy Hodges.

Trapping brain-killing clots

“These devices are only used when all other means of treatment have been exhausted,” said Dr. Jonathan Hodes, chairman of the neurosurgery department at the University of Louisville, who has used stent-retrievers in many surgeries, most of them at Baptist. In Hodges’ case, he was on a blood thinner for atrial fibrillation, so he couldn’t get the clot-busting drug.
After his stroke, he was rushed from Norton Audubon Hospital to Norton Brownsboro, where Dashti began the minimally invasive surgery by putting a guidewire and micro-catheter into Hodges’ leg and threading them through the vessel to the clot.

The device includes a self-expanding stent-retriever, which compresses and traps the clot. Dashti said he left it in for about five minutes, then began pulling it out slowly, along with the clot, while also using suction from the balloon guide catheter so that no pieces of clot remained.
The blocked vessel was reopened, and Hodges wound up with a small stroke that caused no symptoms, instead of the massive stroke he was in the process of having.
While doctors were working, Hodges’ family was scrambling to get to him, and his mother said that by the time she arrived, the surgery was over.
“In 10 minutes (Dashti) had the clot out, in a box, and showed it to my husband,” she said.
Every minute counts during a stroke, since about 2 million brain cells die every minute and abilities controlled by that area of the brain are lost. Outside of eight hours after a stroke begins, Dashti said, patients are “out of luck.”

Doctors said stent-retrievers outperform earlier stroke-treatment devices.
A study last August in the medical journal The Lancet, by researchers at UCLA, said Solitaire opened blocked vessels without causing brain bleeding in 61 percent of cases, and mortality rates three months after a stroke were 17 percent — both much better rates than doctors achieved with an older device called the Merci Retriever.
“It’s definitely an advance,” said Dr. Rick Paulsen, an interventional neuroradiologist at KentuckyOne Health, who treats patients from throughout that system at Jewish. “It’s probably the best system we’ve had so far.”
Tammy Hodges said when they saw Chris after his Solitaire procedure, he was moving his left hand and foot.
“He knew who we all were,” she said. “He could move his left side very well. He even knew his feet were cold.”

Complications possible

But not every patient experiences such a dramatic result.
Dashti said serious complications occur around 5 percent of the time, including hemorrhaging in the brain or leg, or vessel rupture in the brain, which is potentially deadly.
Abou-Chebl pointed to a recent clinical trial showing treatment with a clot-removing device in patients who had already received a clot-busting drug wasn’t any better than getting the clot-busting drug alone.

The study, led by a University of Cincinnati researcher and published in the New England Journal of Medicine in March, allowed doctors to choose between Solitaire and older devices. The study was stopped early after showing “no significant difference in functional independence” between the group getting the drug plus surgery and the one getting the drug alone.
That study didn’t separate out the Solitaire device, however. And doctors said that many times when they use Solitaire, the patient could not have been given the clot-busting drug.
Using a clot-removing device is far more expensive than drug treatment. Although local doctors couldn’t say how much the Solitaire procedure cost, an article in Neurology Today, a publication of the American Academy of Neurology, said the cost of a hospitalization is about $28,000 nationally when a device is used, versus $12,000 for a hospitalization involving the clot-busting drug alone.
University’s Hodes said there’s a place for all of these treatments — including the older clot-removing devices.
“One doesn’t really supplant the other,” Hodes said of the devices. But he said the new stent-retrievers do blend two important functions, combining “the suction device and the corkscrew device all in one.”

Dashti said Hodges was the perfect candidate and had the sort of outcome he always strives to achieve.
“His prognosis is good,” Dashti said. “He’s the same person he was before.”
Hodges said he tries to stay well by cutting sodium from his diet and taking walks each day. He said that after a temporary layoff he’s been cleared to return to his job at a company that builds storage containers for explosives and weapons.
In the meantime, he’s been spending time with his girls, who stay just a little bit closer to him since his stroke.
“I feel like I’ve had my second chance,” he said.




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