Abstract 2751: An Implantable Carotid Sinus Baroreflex Activating System for Drug-Resistant Hypertension: Interim Chronic Efficacy Results from the Multi-Center Rheos Feasibility Trial
The Rheos™ System is an active implantable medical device designed to electrically activate afferent baroreflex receptors of the carotid sinus. The Rheos Feasibility Trial is an open-label clinical trial designed to assess device efficacy in patients with resistant hypertension (SBP of 160 mmHg or greater despite being on at least 3 anti-hypertension medications). To date, ten patients (4f / 6m, age: 50 ± 13 yrs) have undergone successful system implantation and continued taking their anti-hypertension medications (mean 6 ± 1 drugs) throughout the follow-up period. The device was activated after one-month of surgical recovery and baseline office cuff and ambulatory BP were assessed at this time point. Implants were well tolerated with a good safety profile. There was no excessive hypotension, bradycardia, or adverse renal effects. Chronic efficacy was assessed after 3 months of active device therapy. The mean (±SD) blood pressure response is shown in Table 1⇓. Three months of device therapy resulted in clinically and statistically significant reductions in office cuff SBP (-22 mmHg) and DBP (-18 mmHg). These findings were confirmed by concurrent reductions of mean 24-hour ambulatory pressure: SBP (-14 mmHg; p=0.02) and DBP (-9 mmHg; p=0.04).
Conclusions: The Rheos™ System is a novel chronically implanted medical device that stimulates the carotid baroreflex by a programmable algorithm. These open-label results demonstrate efficacy in stage II drug-resistant hypertension. Observations from the ongoing feasibility trial will be used to develop a randomized controlled trial of the Rheos system for patients with drug-resistant stage II hypertension.