Specialist Examining Pacemaker-Like Device to Control Hypertension

A specialist in the Department of Surgery at The Ohio State University Medical Center is participating in a national, multicenter clinical trial to determine the efficacy and safety of a new pacemaker-like device to control hypertension, or high blood pressure, in patients resistant to treatment with antihypertensive drugs.

Jean E. Starr, M.D.

The device, the Rheos Baroreflex Hypertension Therapy System, is a programmable, implantable pulse generator designed to electrically activate the carotid baroreceptors, specialized neurons within the left and right carotid arteries, in the neck, that monitor blood pressure.

When the baroreceptors are activated, they send signals to the brain that are interpreted as an increase in blood pressure. The brain responds to the perceived increase by dilating blood vessels, reducing the heart rate, and causing the kidneys to release fluid, all of which contribute to a decrease in blood pressure.

Dr. Jean E. Starr, assistant professor of clinical surgery in the Division of General Vascular Surgery and director of endovascular services at Ohio State’s Medical Center, is principal investigator for the clinical study at Ohio State.

“This is a unique way of allowing your own body to control its blood pressure naturally,” Starr says. “Because poorly-controlled blood pressure leads to serious complications, including heart attack, kidney failure, and stroke, we need another option for patients who are resistant to antihypertension medications.”

Dr. Randell Wexler, assistant professor of clinical family medicine, is co-investigator for the study at OSU.

The study, a randomized, blinded 12-month trial, is for pre-market approval of the device by the Food and Drug Administration. Up to 300 patients will participate in the study at up to 50 medical centers.

Patients must have a systolic blood pressure of 160 mmHg, or greater, and hypertension that is resistant to at least three antihypertensive drugs, one of which is a diuretic.

In the implantation procedure, the battery-powered pulse generator is inserted under the skin near the collarbone. Two electric leads extend from the generator to the left and right carotid arteries. Experts say the procedure is somewhat similar to implantation of a cardiac pacemaker, but more involved.

According to the American Heart Association, one in three adults in the United States has high blood pressure, which is the primary modifiable risk factor for stroke. The condition also contributes to heart attacks, heart failure, kidney failure, and atherosclerosis, or fatty buildups in arteries. In some cases, high blood pressure can cause blindness.

Experts say that each increase of 20 mmHg in systolic blood pressure or 10 mmHg in diastolic blood pressure above normal is associated with a twofold increase in death rates from stroke, coronary heart disease, and other vascular conditions.