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Stroke therapy’s new push
Effects of controversial treatment visible

By Susan Okie
The Washington Post

WASHINGTON — Like a wisp of cloud that’s really the edge of a hurricane, the first sign of what was about to happen to Garline Perry seemed a small thing.

One morning last month, Perry complained to his wife that he couldn’t keep his balance. When he tried to walk, she said, he kept “listing to the right.”

Susana Perry took her husband, 57, to the emergency room at Inova Fair Oaks Hospital in Virginia. Minutes after they arrived, the storm hit.

“He yelled, ‘I can’t hear you! I can’t see you!’ ... He fell to the floor and started convulsing,” recalled Susana Perry. A two-inch clot had blocked a major artery at the back of Garline Perry’s brain, producing a catastrophic stroke.

James A. Parcell/WASHINGTON POST
Inova Fairfax Hospital technician Jeffrey Knode prepares a clot-dissolving drug for stroke treatment.

Unable to move, talk, breathe or even blink, the Fairfax, Va., man was placed on a respirator and flown by helicopter to Inova Fairfax Hospital, where radiologist John J. “Buddy” Connors embarked on a rescue mission that few doctors would dare attempt. He snaked a long, fine tube through an artery to reach the plug of congealed blood inside Garline Perry’s brain and began to drip in a clot-busting drug, hoping to reopen the blocked vessel.

Along with perhaps 300 other doctors in the United States, Connors works on the uncharted borders of stroke therapy, putting novel devices and powerful drugs deep into an organ where a mishap can mean death, coma or paralysis. Strokes, the third-leading cause of death in the United States, are now viewed as emergencies in which rapid and aggressive treatment may save lives and minimize disability.

Although the treatment administered by specialists such as Connors has produced dramatic results for some patients, it remains largely untested except in small pilot studies.

“The fact that (a new treatment) seems logical and does what it should doesn’t necessarily mean that it’s going to benefit the patient,” said John R. Marler, associate director for clinical trials at the National Institute of Neurological Disorders and Stroke in Bethesda, Md.

Doctors such as Connors, faced daily with desperate cases, contend that they are advancing medical knowledge as best they can.

“We have to do this,” Connors said. “We know we can help patients ... There is no regulatory process for this kind of thing.”

Some 600,000 Americans suffer strokes each year. The problem occurs when a blood vessel in the brain becomes blocked by a clot or hemorrhage, causing nerve cells supplied by the vessel to die. Until recently, there was no way to mitigate the damage, only physical therapy and the hope that the brain would partially recover in time.

That changed in 1996, when the Food and Drug Administration approved the clot-dissolving drug tPA as the first effective treatment. But only about 2 percent of U.S. stroke victims receive tPA. A major reason is time: the intravenous therapy only helps if it is started within three hours of the first symptoms, and few people with an incipient stroke make it to the emergency room and through the required battery of checkups and tests before that deadline has passed.

The approach Connors uses appears to be effective if started within six hours after symptoms begin.

pecialists in his field also believe it may produce better outcomes by delivering clot-dissolving drugs directly into an artery of the brain instead of through an arm vein, the only mode of administration approved by the FDA.

Genentech Inc., which makes tPA, also has not decided whether to study intra-arterial treatment, a spokesman said.

Connors believes that companies do not want to fund additional trials because they doubt they will recoup research costs.

Tareta Lewis, an Abbott spokeswoman, said cost is not the only consideration.

“There are many things that go into making the decision,” she said.

Lacking such studies, Connors and other specialists say they don’t know the exact benefits and risks of what they are doing.

In the meantime, Connors said, “hundreds of patients are being treated right now, all over the United States.”

He has organized a training course for doctors to be held in Washington in October and is setting up a registry to collect data on patient outcomes.

The odds in Garline Perry’s case looked to be long. His clot was in the basilar artery, a dreaded location for a stroke because it nourishes areas of the brain that control life-support functions such as breathing. Without treatment, he would certainly die. With it, he might recover and regain considerable function.

But there was a third possibility. Garline Perry might end up in a nightmarish state that neurologists call “locked in”: awake and aware, but permanently unable to speak, move or communicate.

If that were the outcome, Connors told Susana Perry that afternoon, “if it was me, I wouldn’t want to make it.”
He offered to stop treatment if she thought it best.
When Connors posed that question, he and his team had already been working on Garline Perry for an hour at Inova Fairfax Hospital. Garline Perry lay on a table in an operating room equipped with X-ray machines that took magnified pictures of blood flowing through the vessels of his brain.

Connors and another doctor, Firas Al-Ali, had threaded a long, slippery catheter, thinner than a strand of angel hair pasta, through a larger tube in Garline Perry’s groin, guiding it along major arteries of his abdomen, chest and neck until the tip rested against the clot inside his skull. Through the catheter, they squirted dye to illuminate the blocked vessel on X-rays and dribbled in medicines that they hoped would tease apart the clump of protein and blood cells.

Most clots that Connors attacks in this way are the size of a grain of rice. Garline Perry’s was the size of his little finger.

“His outlook was 99 percent death,” Connors said. “The options were so bad. It’s one thing to have a stroke where you can’t move your arm but you’re mostly still you. It’s another thing to have a stroke where you’re paralyzed from the eyes down.”

Susana Perry told Connors to go for broke.

“I said, ‘I’m not ready to get rid of this guy,’” she recalled.

Connors treated Garline Perry for eight more hours. He estimated that he had dissolved about 95 percent of the clot.

At 1 a.m. the next day, a nurse woke Susana Perry, who was asleep in a room near the intensive care unit.
“He’s responding,” the nurse said. “He’s nodding yes or no to simple questions.”

Garline Perry was still on a respirator and his left side was paralyzed, but the pace of his recovery over the next few days astonished his doctors. Three days after his stroke, he signaled to his son that he wanted something. Handed a pad and pencil, he wrote, “Beer.”

Two days later, doctors disconnected the respirator and Garline Perry breathed on his own. A week after the stroke, he had regained some movement in his left leg and was eating and cracking jokes about the hospital food.

“There’s so much I’m learning from the beginning,” he said, speaking slowly. “You take so much for granted.”

David Grass, Garline Perry’s neurologist, is amazed by the recovery.

“His level of recovery is — what can I say? — miraculous,” Grass said. “This would have been fatal, absolutely no doubt ... He’s going to need several months of rehabilitation, but I’m optimistic that he may eventually be able to return to work.”



 

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