Published: April 8, 2005
“If this works the way we think it’s going to work, it’s going to be an absolutely life-saving thing,” says Dr. Karl Illig, U of R’s Chief of the Division of Vascular Surgery.
The surgery took about two and a half-hours. University of Rochester surgeons implanted a device called the “Rheos System” just beneath a woman’s collarbone. Done under general anesthesia, the device resembles a small pacemaker. After the device is implanted, electrodes are attached to the carotid artery in the neck. Electrical stimulation then lowers the blood pressure by stimulating the body’s natural regulation system.
“This is probably something in the future, that can be done under local anesthesia, probably take a couple of hours or so,” says Illig.
The procedure was the first in the nation. Nine other devices have been successfully implanted in Europe. The “Rheos System” is part of a phase two clinical trial.
“There’s a set of people who’s blood pressure’s are just sky high at 180 and above, despite three or four medications, still don’t have their blood pressure to target,” says cardiologist Dr. James Bisognano, Associate Professor of Medicine at the University of Rochester.
The patient who received the investigational device is 36 year old Annette Lawrence of Rochester; she had a blood pressure level above 200.
“She’d been treated with a plethora of anti-hypertensive medications and she came in here on seven anti-hypertensives, two of which were diuretics,” says nephrologist Dr. James Sloand, also an Associate Professor of Medicine at the U of R.
However, moments after the permanent device was implanted and electrodes activated, Lawrence’s blood pressure dropped to 105.
“Even though we’d seen the data before and we’d believed it intellectually,” says Illig, “we kind of didn’t see it in our hearts an our eyes opened wide and we said–wow! That’s pretty exciting!”
“This can really provide an option to these patients to get their blood pressure down by another 20 points,” says Bisognano.
For every 20 points high blood pressure drops, so does the risk of heart attack, stroke and kidney disease by 50 percent.
“This will give her a new lease on life.”
Lawrence will continue to stay on her medications even though the device is implanted. Doctors estimate that the clinical trial could move from phase two to phase three (the stage before FDA approval) within 18 months.
If approved, the device could help the roughly half to one-million Americans who live with high blood pressure that does not respond to medication.
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