Abstract
Objectives This study assessed the safety and efficacy of a novel implantable device therapy in resistant hypertension patients. Background Despite the availability of potent antihypertensive drugs, a substantial proportion of patients remain hypertensive. A new implantable device (Rheos system, CVRx, Inc., Minneapolis, Minnesota) that activates the carotid baroreflex may help these patients. Methods Forty-five subjects with systolic blood pressure >= 160 mm Hg or diastolic >= 90 mm Hg despite at least 3 antihypertensive drugs were enrolled in a prospective, nonrandomized feasibility study to assess whether Rheos therapy could safely lower blood pressure. Subjects were followed up for as long as 2 years. An external programmer was used to optimize and individualize efficacy. Results Baseline mean blood pressure was 179/105 mm Hg and heart rate was 80 beats/min, with a median of 5 antihypertensive drugs. After 3 months of device therapy, mean blood pressure was reduced by 21/12 mm Hg. This result was sustained in 17 subjects who completed 2 years of follow-up, with a mean reduction of 33/22 mm Hg. The device exhibited a favorable safety profile. Conclusions The Rheos device sustainably reduces blood pressure in resistant hypertensive subjects with multiple comorbidities receiving numerous medications. This unique therapy offers a safe individualized treatment option for these high-risk subjects. This novel approach holds promise for patients with resistant hypertension and is currently under evaluation in a prospective, placebo-controlled clinical trial. (J Am Coll Cardiol 2010;56:1254-8)
Original language | English |
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Pages (from-to) | 1254-1258 |
Journal | Journal of the American College of Cardiology |
Volume | 56 |
Issue number | 15 |
DOIs | |
Publication status | Published - 5 Oct 2010 |
Keywords
- baroreflex
- device
- feasibility
- hypertension
- treatment