Early Intervention

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Early Intervention
Device invented by local doctor could stop strokes before they happen

By Judy Benson
Published on 6/18/2007

Mary Hammerstein’s persistent headaches were so painful they were keeping the high school English teacher out of work and hop scotching from one doctor’s office to the next in what quickly became a frustrating search for a diagnosis.

“I was referred to someone who referred me to someone who referred me to someone,” she recalls, sitting next to her fiancé Justin Madison as she waited for a check-up with the local doctor who eventually helped her. “I really can’t fault anyone for this, because what I had is so rare.” The episodes began last January. Sometimes, when her head started to pound, her vision would falter. One day it got so bad the 36-year-old Groton resident, who teaches at Robert E. Fitch Senior High School, went to the emergency room at Pequot Medical Center. There, she was put on an intravenous drip of Demerol, a powerful painkiller.

“It wasn’t helping,” she says. “They kept asking me who treats my migraines.”
But she had never had migraines before, and none of the doctors she’d been to thus far suspected that was her problem. Then an ear, nose and throat doctor noticed her left eyelid was drooping. Looking closer, he noticed her left pupil was constricted.

That led to a referral to Dr. Francis Falck, an ophthalmologist with offices in Mystic and Waterford. The referring doctor knew Falck had invented a new imaging device, and thought it might be just the thing to get to the bottom of Hammerstein’s headaches. Called the Falck Medical Multi-Function Tonometer, it has undergone
trials for Food & Drug Administration approval but has not yet come up for review, so Falck was the only doctor who had one.

Falck looked at Hammerstein’s eyes through the tonometer, and saw the telltale signs of an aneurysm in one of the main arteries feeding the brain and the eyes. It could rupture at any moment, leaving the young woman paralyzed on one side. Worse, she could have died.

“The way I see it,” says Hammerstein, “this device pretty much saved me.”
While Hammerstein’s story offers a dramatic example of the usefulness of this device, she is not the typical patient it would be used for, Falck says. He envisions much broader use for screening the millions of older Americans at risk of stroke. It could also have applications for treatments for the wet form of macular degeneration and glaucoma, he says.

Still, the way he used it to diagnose Hammerstein illustrates how it could one day be used in the offices of ophthalmologists, primary care doctors and internists.

In Hammerstein’s case, Falck used the tonometer to conduct a few-seconds test in his office that showed that the blood flowing to the left eye was a trickle compared to the amount going to the other. That meant something was blocking the flow. The type of aneurysm she had was causing the blood to become diverted between the layers of the lining of the artery walls, and the opening of the artery itself was nearly squeezed

Immediately after the test, Falck gave Hammerstein and Madison a very specific directive. “He told us to go straight to the hospital. Don’t even stop for coffee,” Madison recalls.

Once at Lawrence & Memorial Hospital, doctors confirmed the aneurysm with an MRI test using dye, a much more involved and risky procedure than the one Falck did in his office. Since aneurysms like Hammerstein’s are inoperable, doctors opted for treatment with medications, total bed rest and close monitoring. Hammerstein
was admitted to the hospital’s neurology ward and given blood-pressure-lowering drugs and anticoagulants to prevent a clot from becoming lodged in the constricted artery or elsewhere.

“They wouldn’t even let me get out of bed for the first five days,” Hammerstein says.
Eventually, she was able to return to work, but will remain on anticoagulants for the rest of her life, Falck says, because the aneurysm apparently was the result of a congenital weakness in her artery walls. She had no known risk factors for developing one.

Basically, it was by measuring the differences in the level of blood flow to the eyes with the tonometer that Falck was able to deduce Hammerstein’s aneurysm. That’s the same measurement, he says, that could help detect a buildup of plaque in the carotid arteries that are just below the vessels to the eyes. A stroke occurs when a piece of the plaque dislodges and gets stuck in one of the smaller vessels of the brain. When one of those vessels bursts or becomes clogged, part of the brain is deprived of blood flow.

“One of the things I observed early in my career was the pulsation of the eye,” he says. “I realized that if I could design a system to capture that pulse, I can use that as a diagnostic tool to determine if a person has carotid artery disease.”

The prototype machine he used in his office as part of the FDA trial was built by Product Insight Inc. of Acton, Mass. A hand-held version that could be used by primary care doctors, emergency room physicians and internists, he says, will be tested in a future trial in collaboration with Yale, Duke, Tufts and Harvard medical
schools. The stationary machine would cost about $5,000, he says, while the hand-held one would be about $2,250.

It consists of a split-light microscope a standard piece of ophthalmologic equipment used to magnify the eye attached to sensors that track and plot the pulse of blood flowing through the eye onto a laptop computer. By comparing the flow of the left eye to the right, Falck explains, he can determine if blood flow to both is normal.
Recently, Falck did the test on Hammerstein. As she sat in the examining chair, he first numbed her eyes with medicated drops. With her chin resting on a shelf on the tonometer, Falck adjusted the microscope, fitted with a special disposable plastic prism that would touch the eye. This prevents the spread of infection as different
patients use the machine.

Peering through the microscope lens, Falck adjusted it with a joystick to reach just the right spot. The screen laptop computer wired to the tonometer soon showed a graphic depiction of the pulse rate of that eye. “This shows you she’s got good flow through the internal carotid artery system,” he says, pointing to the graph on the computer. “This is a noninvasive test, and it was done in 3.5 seconds.”

Dr. Louise McCollough, director of stroke research and education at the University of Connecticut Health Center in Farmington, sees great promise for a device that could be used in a doctor’s office to quickly screen patients for early signs of stroke. A Doppler ultrasound is the only test currently available that can detect plaque buildup in the carotid arteries, she says. The test is very inaccurate, takes up to 45 minutes and
requires the patient make a special appointment.

“It’s not a great test,” she says. “It’s not that sensitive, or specific.”
And because most stroke victims report no warning symptoms, few get the test before they end up in the hospital emergency room, already with brain damage from the stroke.

If a clogged carotid artery could be found early, she says, surgical placement of a stent and other procedures can sometimes be done to prevent a stroke.

The device, which she has not seen, could be a big advance in stroke screening, she says, provided it proves to be reliable, quick, cheap and easy. Falck says most of the tonometer tests would cost about $25. Hammerstein and Madison are already believers.

“We’re very grateful for this technology,” says Madison. Hammerstein says the medication does make her tired, and the athletic activities she and Madison enjoyed in their spare time are out for the time being.

“The biggest challenge has been the lack of activity,” she says. “But I’m alive, right?”

Suzanne Ouellette – Francis Y. Falck, M.S., PhD, M.D., demonstrates his new device that helps diagnose life-threatening aneurisms, among other ailments, with patient Mary Hammerstein, a Groton resident whose life was saved by the device’s diagnosis, at Falck’s office in Mystic.

Suzanne Ouellette – Dr. Francis Falck fits a disposable plastic prism onto part of the Falck Medical Multi-Function Tonometer before using it to measure patient Mary Hammerstein’s ocular pulse.