Sustained Blood Pressure Reduction by Baroreflex Activation Therapy With a Chronically Implanted System: 4-Year Data of Rheos Debut-Ht Study in Patients With Resistant Hypertension: 9d.01

Objective: The Device Based Therapy of Hypertension (DEBuT-HT) study uses an implantable device and electrodes implanted around the carotid sinus to electrically activate the carotid baroreflex chronically. An external programmer is used to optimize and individualize efficacy. (Rheos® System). The long-term (more than 4 years) blood pressure (BP) data in a cohort of patients who underwent chronic Rheos therapy were assessed to determine if magnitude of response was sustained at 4 years. Design and Method: Of 45 patients enrolled in DEBuT-HT, a cohort of 18 patients (9f / 9m, age: 53 ± 8 yrs, BMI: 31 ± 6 kg/m2) from 4 European centers have completed more than 4 years of Rheos chronic therapy. The mean duration of Rheos therapy in this cohort is currently 58 ± 6 months. Results: We observed clinically meaningful and statistically significant reductions in blood pressure at each follow-up interval through 4 years.At 4 years and 12 of 18 (67%) achieved a systolic BP of less than 140 mmHg and a drop in systolic BP of at least 30 mmHg was achieved in 13 of 18 (72%) patients a at 4 years. Heart rate was also reduced over time. These reductions were sustained while the average number of antihypertensive medications decreased. During the total observation period (1042 patient months), there were no unexpected system- or procedure- related serious adverse events. Conclusions: The Rheos system is a unique therapeutic advance that permits individualized treatment of resistant hypertension. These 4-year results demonstrate that the response to the Rheos therapy is clinically significant and sustainable long-term.