Promising stroke therapy may be held up in debates

Sun Staff

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

Within 15 minutes, Maryland medics whisked the woman to North ArundelHospital, where doctors started an IV with a clot-busting drug and sent heron, sirens blaring, to the University of Maryland Medical Center. In those fewhours, 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, isamong 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 giveit. And hospitals are still wrestling with getting the staff and otherresources needed to treat patients around the clock.

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

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

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

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

The University of Maryland's Brain Attack Center advises smaller, farawayhospitals, flies patients in by helicopter and has cameras in ambulances soneurologists 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 littlefor stroke patients. Then in 1995, a study showed that the drug t-PA, used tobreak up clots in heart attacks, also worked in strokes if administeredquickly, reducing disability by a third. Neurologists were ecstatic. Somerecall getting chills when they first gave the treatment and saw some strokepatients regain movement or speak again.

Over the past several years, the improvements neurologists expected forstroke - 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. Butexperts say about 3 percent are getting the medicine.

Many of these patients recover fully or have less disability than theymight have had without the medicine. A small number, though, have sufferedbrain hemorrhages and died, provoking debate over whether the drug is safe, orwhether 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 turnedout to be much harder than anyone ever anticipated."

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

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

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

But at night, many smaller hospitals don't have the technicians orspecialists to do the scans. Nor do they have neurologists who can race inwith the expertise to diagnose a stroke and approve the patient as a candidatefor 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, the51-year-old Canadian woman and her husband were eating cereal on their boat,anchored in the water near Annapolis, when she developed classic strokesymptoms: sudden garbled language and a splitting headache. What Johnston'shusband only vaguely realized was that from those first moments, a clock wasticking.

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

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

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

So Boucher gave doctors the go-ahead. The medicine helped dissolve the clotsome, but when his wife developed more problems, medics sent her to theUniversity of Maryland Medical Center. Because Johnston's clot was in aparticular artery, the doctors were able to use a more advanced procedure upto six hours after the stroke. They threaded a catheter through an artery inthe brain and dripped the t-PA over the clot, dissolving it. LaMonte, thephysician, 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 inthe hands of such experts," said Johnston.

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

Some emergency-room physicians point out that some stroke patients recoverwithout the drug. They worry that, with complications such as bleeding in thebrain, the medicine can sometimes do more harm than good.

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

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

To answer the critics, the National Institute of Neurological Disorders andStroke recently appointed an independent panel to review the data from theoriginal 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 andhospitals 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 theneurological disorders institute. "In 10 years, it will be as unthinkable toleave a stroke patient untreated in an emergency room as it would be now toleave severe chest pain untreated."

Maryland, Hopkins, Hopkins Bayview, North Arundel, Sinai and Suburbanhospitals have set up stroke teams ready to respond 24 hours a day. But formany institutions, it's a tough call. If they give t-PA, can they do itsafely? If they don't, will they be sued, or will they lose a competitiveedge?

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

Some, such as St. Mary's Hospital, tap the expertise of physicians at theUniversity of Maryland, who review the cases over video and computer links.Others, like Franklin Square Hospital Center, set up their own programsbecause they get many stroke patients, and they fear shipping a patientelsewhere 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 Melvillestopped the policy of giving t-PA for stroke in the emergency department. Hepointed to evidence that although it can be done safely in the hands ofexperts using strict protocols, physicians in community hospitals and academicmedical centers are often giving the wrong dose, to the wrong patients, oradministering it beyond the three-hour window. Studies found higher rates ofhemorrhage and death.

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

Specialized units

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

Places such as Maryland and Hopkins have created stroke units wherepatients are monitored closely for complications, and staff are better able tocontrol 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 muchbetter in these units.

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

Until then, experts say, people should do the same things to avoid otherhealth 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 treatingacute stroke," he said. "Part of preventing strokes is to be in the placewhere they can treat it."

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