Device Lowers Blood Pressure in Resistant Patients
For people who have resistant hypertension—high blood pressure that does not respond to typical treatment methods—a new device may provide relief. News of the Phase III study of the device was presented at the American College of Cardiology’s Annual Scientific Sessions in New Orleans.
An implantable device could lower blood pressure
Resistant hypertension is blood pressure that remains above goal despite the use of at least three antihypertensive drugs from different classes and adjustments to diet and exercise. According to the American Heart Association Scientific Statement on resistant hypertension, ideally one of the three drugs should be a diuretic, and all of the drugs should be prescribed at optimal doses.
The exact prevalence of resistant hypertension is not known, but some clinical trials indicate that 20 to 30 percent of participants in studies have this condition. Both older age and obesity are two of the strongest risk factors.
In the Phase III study, investigators evaluated the use of the Rheos® System, a device designed to treat individuals with resistant hypertension. The trial included 265 patients who were being treated at 40 medical centers in the United States and two in Europe. Overall, the device helped lower blood pressure by 33 points and was shown to be safe.
An effective treatment for resistant hypertension is needed, as individuals with this condition are at high risk for stroke, heart failure, heart attack, kidney disease, and death. John Bisognano, MD, PhD, a lead study investigator from the University of Rochester Medical Center, noted that he treats many people “who are doing everything right—taking their medications, maintaining a healthy diet, working out—and they still develop resistant hypertension.”
The Rheos System is an implantable, battery-powered generator that works much like a pacemaker for the heart. Once implanted under the skin near the collarbone, the two leads from the device run to the two main arteries that supply blood to the head.
The device triggers certain receptors (carotid baroreceptors), which in turn send signals to the brain that are interpreted and result in actions to lower blood pressure. According to Bisognano, the device lowers blood pressure and “improves the structure of the heart which in turn improves overall cardiac function.”
Even though the device produced a considerable decline in blood pressure in resistant patients, it did not meet all of the study’s goals, which means another testing trial is needed before the Food and Drug Administration will consider approving it. Bisognano noted that although the initial results did not meet the grade, “it is clear from looking at the data that there are therapeutic benefits to pursue.”
American Heart Association Scientific Statement: Resistant Hypertension: Diagnosis, Evaluation, and Treatment
University of Rochester Medical Center