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The Charlotte Observer Posted on Tue, Mar. 19, 2002 Implant patients may suffer infections, hemorrhages KAREN GARLOCH Staff Writer The risk of infection after brain surgery is one in 100, said Dr. Stephen Tatter, a neurosurgeon at Wake Forest University. But deep brain stimulation -- the new operation for Parkinson's disease symptoms -- is more risky because it involves implanting foreign objects. Electrodes are implanted deep in the brain. A stimulator goes in the chest near the collarbone. And a wire connects the two. Prior to approval by the federal Food and Drug Administration, a study of deep brain stimulation found that 17 of 160 enrolled patients, or 10.6 percent, experienced at least one device-related infection and several had more than one. In nine of the 17, the infection resulted in removal of at least part of the implant. In a separate study, reported in the New England Journal of Medicine in September, two of 143 patients had the implant removed because of infection. Tatter said three of his 100 patients who've had deep brain stimulation developed infections, including one who developed an infection twice. Charlotte patient Deborah Setzer, who had the surgery in December, was the first with an infection in the brain. The other infections had involved only the chest stimulator or the wire. Setzer's infection may have started at the stimulator in her chest and spread up the connecting wire, Tatter said. He removed her implants. Since Setzer's infection, Tatter has made changes. He's allowing fewer people in the operating room and less coming and going. He's also begun telling patients not to cut their own hair before surgery. Setzer had her head shaved by a beautician two days before surgery. She also shaved it again herself the day before. Tatter said he can't find studies documenting any connection between head shaving and infection risk. But as a resident at Massachusetts General Hospital in Boston, he learned that there was a higher risk of infection if patients' heads were shaved the night before surgery than if they were shaved that morning. "It's just better to be on the extra-cautious side," he said. The other major complication of deep brain stimulation is hemorrhage, or bleeding. In the study leading to FDA approval, 12 of 160 patients, or 7.5 percent, had intracranial hemorrhage. The study reported in the New England Journal said intracranial hemorrhage occurred in seven of 143 patients. Of those, two had the implant removed. Despite adverse side effects, the study concluded -- and many doctors agree -- that deep brain stimulation is safer than two decades-old operations for Parkinson's symptoms -- pallidotomy and thalamotomy. In those procedures, brain cells are destroyed to stop the signals that produce symptoms of pain, stiffness and tremor. Unlike those procedures, deep brain stimulation is reversible. "It's extremely safe," said Martin Bootin, a neurophysiologist at Presbyterian Hospital who consults on deep brain stimulation. "That's one of the reasons why it's received increased popularity over the previous surgery. "With these stimulators, you are causing far less permanent damage ... There's very low risk, and you have an increasing opportunity to optimize the treatment after the surgery." SOURCE: The Charlotte Observer http://www.charlotte.com/mld/charlotte/living/columnists/karen_garloch/2888846.htm * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn