Novel Baroreflex Activation Therapy in Resistant Hypertension Results of a European Multi-Center Feasibility Study

Ingrid J. M. Scheffers, Abraham A. Kroon, Juerg Schmidli, Jens Jordan, Jan H. M. Tordoir, Markus G. Mohaupt, Friedrich C. Luft, Hermann Haller, Jan Menne, Stefan Engeli, Jiri Ceral, Siegfried Eckert, Andrejs Erglis, Krzysztof Narkiewicz, Thomas Philipp, Peter W. de Leeuw*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

223 Citations (Web of Science)

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 languageEnglish
Pages (from-to)1254-1258
JournalJournal of the American College of Cardiology
Volume56
Issue number15
DOIs
Publication statusPublished - 5 Oct 2010

Keywords

  • baroreflex
  • device
  • feasibility
  • hypertension
  • treatment

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