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Promising stroke therapy may be held up in debates

When Ruth Johnston got a crushing headache and started to slur words that morning on the sailboat, her husband took action. He radioed the Coast Guard that she was having a stroke.

Within 15 minutes, Maryland medics whisked the woman to North Arundel Hospital, where doctors started an IV with a clot-busting drug and sent her on, sirens blaring, to the University of Maryland Medical Center. In those few hours, the treatment stopped the massive stroke spreading across her brain. The only mark the attack left was an occasional cold tingling in her hand.But six years after the discovery of this stroke therapy, Johnston, 51, is among a relative few who happened to be in the right place at the right time. Most patients don't get to a hospital within the required three-hour window. Some doctors, worried that that the drug is too risky, are reluctant to give it. And hospitals are still wrestling with getting the staff and other resources needed to treat patients around the clock.

"The miracle cases are the exception. Most of the cases are the miserable cases," said Dr. Kieran Murphy, director of interventional neuroradiology at Johns Hopkins Hospital. He routinely sees patients who have been transferred from other hospitals too late to save them from a nursing home.

It's one of the oldest stories in medicine: Researchers come up with a breakthrough, but it takes years to figure out how to make it work at the local hospital. This week, neurologists, emergency-room physicians and others from around the country are meeting on the issue at the National Institutes of Health.

But solutions require answering tough questions, such as whether only certain hospitals should become stroke centers, how to pay for care, and why, after millions of dollars spent in media campaigns, the public isn't getting the message that a stroke is an emergency.

In Maryland, doctors are working on many fronts. They have spread the word on billboards and buses. The state's emergency system is developing a list of hospitals that can give advanced care, and starting in the summer, medics will reroute stroke patients to these facilities.

The University of Maryland's Brain Attack Center advises smaller, faraway hospitals, flies patients in by helicopter and has cameras in ambulances so neurologists can evaluate patients en route.

"The whole field is close to a revolution," said the center's director, Dr. Marian LaMonte, who has led the efforts.

Clot-busting drug

It has been a long time coming. For generations, doctors could do little for stroke patients. Then in 1995, a study showed that the drug t-PA, used to break up clots in heart attacks, also worked in strokes if administered quickly, reducing disability by a third. Neurologists were ecstatic. Some recall getting chills when they first gave the treatment and saw some stroke patients regain movement or speak again.

Over the past several years, the improvements neurologists expected for stroke - the country's No. 3 killer and a leading cause of disability - haven't panned out. Of the 600,000 Americans who have strokes every year, about four-fifths have the type of stroke that can be helped by t-PA. But experts say about 3 percent are getting the medicine.

Many of these patients recover fully or have less disability than they might have had without the medicine. A small number, though, have suffered brain hemorrhages and died, provoking debate over whether the drug is safe, or whether some physicians are giving it wrong.

"Everyone assumed, `Hey, we've got a treatment for stroke now,' " said Dr. Eric Aldrich, an assistant professor of neurology at Hopkins. "But it's turned out to be much harder than anyone ever anticipated."

For starters, many people ignore common stroke symptoms, or wait hours and sometimes days before going to a hospital. Others suffer a stroke in their sleep, and it's difficult to determine what time it happened.

At the hospital, physicians must distinguish a stroke from other conditions that mimic it, such as seizures or complicated migraines, but they don't have quick, reliable tests - such as monitors or blood work that help verify heart attacks.

Because the clot-busting drug can cause bleeding in the brain, doctors must do a CT scan to make sure the patient doesn't have the type of stroke, known as hemorrhagic, in which a blood vessel bursts.

But at night, many smaller hospitals don't have the technicians or specialists to do the scans. Nor do they have neurologists who can race in with the expertise to diagnose a stroke and approve the patient as a candidate for the drug.

And all this has to be done within three hours. That's because by then, brain tissue has begun to die, and there is little chance of reversing damage - and some think the threat of bleeding is greater.

'Incredibly lucky'

Johnston's case shows how the system can work. Two years ago, the 51-year-old Canadian woman and her husband were eating cereal on their boat, anchored in the water near Annapolis, when she developed classic stroke symptoms: sudden garbled language and a splitting headache. What Johnston's husband only vaguely realized was that from those first moments, a clock was ticking.

Without blood and oxygen, the cells in the immediate area of the blockage had died. A larger section of tissue surrounding these cells had essentially gone to sleep. If blood flow was not soon restored, those brain cells would also be doomed.

"This could go either way," a nurse at North Arundel Hospital told Johnston's husband, Byron Boucher.

Doctors determined that Johnston had the most common type of stroke, in which a clot blocks a blood vessel in the neck or brain. They explained to her husband that although there was a 10 percent chance the clot-busting drug could cause bleeding in the brain, the medicine gave his wife a much better chance of minimizing disability. And with or without the drug, neurologists said, her risk of dying was the same.

So Boucher gave doctors the go-ahead. The medicine helped dissolve the clot some, but when his wife developed more problems, medics sent her to the University of Maryland Medical Center. Because Johnston's clot was in a particular artery, the doctors were able to use a more advanced procedure up to six hours after the stroke. They threaded a catheter through an artery in the brain and dripped the t-PA over the clot, dissolving it. LaMonte, the physician, said all of Johnston's care was done in five hours.

"I was incredibly lucky. It was because of where we were that I ended up in the hands of such experts," said Johnston.

From hospital to hospital, the level of stroke care varies widely. With an aging population and a lifetime cost that ranges between $90,000 and $225,000 per patient, the issue is taking on more urgency nationwide. But physicians are divided about what constitutes the best care, and who should do it.

Some emergency-room physicians point out that some stroke patients recover without the drug. They worry that, with complications such as bleeding in the brain, the medicine can sometimes do more harm than good.

The American College of Emergency Physicians has taken the position that the drug is not the standard of care for stroke, unless doctors have the expert backup and resources.

"It's kind of like the `Mom test.' Would you give this to your mom? A lot of us are `No,' " said Dr. Linda DeFeo, an emergency physician at Prince George's Hospital Center who heads the group's Maryland chapter.

To answer the critics, the National Institute of Neurological Disorders and Stroke recently appointed an independent panel to review the data from the original t-PA study. At the same time, the Centers for Disease Control and Prevention have set up a registry in several states to monitor how medics and hospitals handle strokes.

Doctors say the debate is a natural part of the give-and-take in medicine, and that over time, as more evidence comes out, the course will be clear.

"There was a time when heart attacks were not treated so aggressively," said Dr. John Marler, associate director for clinical trials at the neurological disorders institute. "In 10 years, it will be as unthinkable to leave a stroke patient untreated in an emergency room as it would be now to leave severe chest pain untreated."

Maryland, Hopkins, Hopkins Bayview, North Arundel, Sinai and Suburban hospitals have set up stroke teams ready to respond 24 hours a day. But for many institutions, it's a tough call. If they give t-PA, can they do it safely? If they don't, will they be sued, or will they lose a competitive edge?

Several hospitals in the state report that they give t-PA, although it may depend on the time of day and which physicians are available.

Some, such as St. Mary's Hospital, tap the expertise of physicians at the University of Maryland, who review the cases over video and computer links. Others, like Franklin Square Hospital Center, set up their own programs because they get many stroke patients, and they fear shipping a patient elsewhere could be a costly delay.

"The longer you wait, the more irreversible damage is occurring, " said Dr. Jerry Fleishman, chief of neurology at Franklin Square.

At Calvert Memorial Hospital in Southern Maryland, Dr. Kraig Melville stopped the policy of giving t-PA for stroke in the emergency department. He pointed to evidence that although it can be done safely in the hands of experts using strict protocols, physicians in community hospitals and academic medical centers are often giving the wrong dose, to the wrong patients, or administering it beyond the three-hour window. Studies found higher rates of hemorrhage and death.

Melville said his team is able to evaluate patients, alert University of Maryland, and get patients there for treatment within three hours.

Specialized units

Ultimately, many believe these patients will be sent to specialized stroke centers, just as trauma patients are handled.

Places such as Maryland and Hopkins have created stroke units where patients are monitored closely for complications, and staff are better able to control factors such as fever, which can have a big impact on recovery. Studies show that even patients who do not get the clot-busting drug do much better in these units.

Eventually, neurologists hope to expand the time window in which patients can get t-PA. They are also working on other medicines and trying to cool the body as a way to protect the brain after stroke.

Until then, experts say, people should do the same things to avoid other health problems, such as exercising and eating right, and stopping smoking. And because hospitals are handling these cases differently, Marler, of NIH, advises one more step:

"Call your local hospital and see if they have a good system for treating acute stroke," he said. "Part of preventing strokes is to be in the place where they can treat it."

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