New medical device helps save Forsyth Co. woman from major stroke

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Dr. Don Heck asks Iva Lee Black, a stroke patient in May who had a remarkable and quick recovery from a medical device in a clinical trial. Heck is co-director of Forsyth Medical Center's stroke program. (Richard Craver/Journal)

WINSTON-SALEM, N.C. — Iva Lee Black is living proof that a breakthrough device for treating strokes caused by large clots in the brain works, according to the Winston-Salem Journal.

Black, 69, of Kernersville suffered a major stroke on May 16 that paralyzed her right side and took away her ability to speak.

With no phone in her kitchen, Black had just enough strength to drag herself to the door of her senior living apartment and open it.

“I knew it was bad because I felt so, so weak,” Black said.

Because of the quick intervention of her neighbor and two sets of alert emergency personnel, Black was taken to the comprehensive stroke center at Forsyth Medical Center.

There, she was treated by Dr. Don Heck with a retrievable stent and Penumbra aspiration catheter. The Penumbra clot-removal system is part of a research initiative in which Forsyth has participated.

Within 45 minutes of the clot being removed and normal blood flow resuming in her brain, Black was able to speak and move her right side.

“I felt so good that I wanted to go right home, but they said they wanted to observe me overnight,” Black said.

“There’s been no residual effects, no limitations in my speech or my walking. I don’t know what else to call it all but a miracle.”

Heck said that although Black’s remarkably quick recovery is a hoped-for outcome of the treatment, he cautioned she is the exception to the rule.

“Everyone is not going to do as well as Iva,” said Heck, co-director of the hospital’s stroke center. “It is remarkable she had such little brain tissue damage from her experience.

“The goal is treating the stroke patient within the six-hour window where damage to the brain tissue can be limited, and their recovery through rehabilitation is measured in weeks and a few months, rather than debilitating for years, if not for life.”

Black’s experience is noteworthy also because it is connected to an international study of a similar stroke treatment. Those results were released Wednesday in the New England Journal of Medicine.

Study shows success

The “Mr. Clean” study in the Netherlands found the clot-removal device had better results than traditional clot-busting t-PA medication alone for large strokes if used on the six-hour window. There were 500 patients in the clinical trial, of which 233 were treated by the clot-removal device.

“This treatment leads to a clinically significant increase in functional independence in daily life by three months, without an increase in mortality,” the Netherlands researchers said in their conclusion.

The medication option has been the standard of care for U.S. stroke patients for nearly 20 years.

However, it also has drawbacks, including a narrow window during which it can be administered and limited effectiveness for dissolving large clots.

The challenge with clot removal devices was that there had not been definitive proof that they were a better option.

The Netherlands treatment device is similar to those involved in clinical trials at Forsyth, as well as a select number of hospitals in the United States, Canada and Australia. As a result of the success of the Netherlands study, the clinical trials at Forsyth and the other hospitals have been halted. Each trial is expected to publish similar results.

“This is a watershed moment in stroke treatment,” Heck said. “There are about 700,000 strokes in the United States every year, primarily in the Southeast, and somewhere between 30 percent and 40 percent involved a large blood vessel blockage.

“While stroke may be the No. 4 cause of the death in the United States, it is the No. 1 cause of life-changing disability. This device could significantly shift the balance of stroke outcomes.”

In an editorial accompanying the study, Dr. Werner Hacke of the neurology department at Heidelberg University Hospital, said “we need, and will get, results from other well-designed trials, not only to confirm or refute the results of Mr. Clean, but also to look at effects in subgroups, according to stroke severity, occlusion site or time to treatment initiation.

“Mr. Clean the first step in the right direction.”

Hope for coverage

Many private insurers – including Blue Cross Blue Shield of N.C. – have not covered clot removal treatments.

However, the Merci retriever device gained Food and Drug Administration approval in August.

“Our current policy describes mechanical clot removal as investigational,” Blue Cross spokesman Lew Borman said. “But we will assess this information (from the studies) as we update our policy.

“We are in discussions with Triangle-based academic institutions around medical policies, such as this matter. We anticipate our policy evolving over time.”

Blue Cross Blue Shield of N.C.’s medical policies are developed using a variety of sources, including evidence from well-designed comparative clinical trials and their long-term outcomes. Medical policies receive an intense review a minimum of every year and more frequently as needed based on new information.

Heck said as it became clearer that the clot-removal device were working with the larger clots, it became harder to participate in clinical trials that require randomization of patient treatment.

“We had a lot of angst because we were confident that this method was the better method,” Heck said. “Now, we can tell the patient or their family we’re confident this is the best option for their situation.”

Heck hopes that if the American Heart Association and American Stroke Association support the device as a preferred treatment options, insurers will agree to cover the procedure.

One of the goals of Heck and the Forsyth stroke center is to educate first responders and emergency medical personnel to be able to quickly identify patients with large strokes and transport them to comprehensive stroke centers capable of providing clot removal procedures.

Dorothy Weatherman, Black’s neighbor at Mountain View senior apartments, called her role in saving Black’s life “a God thing because I didn’t have any reason to go to the door.”

“I was playing with my computer when I had a sudden urge to open my door. That urge would not leave me alone, so I opened it and there I found her on the floor.

“I knew she had had a stroke, so I called 911 and sat with her until the emergency folks came. Having seen her condition at that time, for her to be here doing as well as she is, it can only be a God thing.”