Novel baroreflex activation therapy in resistant hypertension results of a European multi-center feasibility study


  • I.J. Scheffers
  • A.A. Kroon
  • J. Schmidli
  • J. Jordan
  • J.J. Tordoir
  • M.G. Mohaupt
  • F.C. Luft
  • H. Haller
  • J. Menne
  • S. Engeli
  • J. Ceral
  • S. Eckert
  • A. Erglis
  • K. Narkiewicz
  • T. Philipp
  • P.W. de Leeuw


  • Journal of the American College of Cardiology


  • J Am Coll Cardiol 56 (15): 1254-1258


  • 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.