title: Novel baroreflex activation therapy in resistant hypertension: results of a European multi-center feasibility study.
abstract: OBJECTIVE
  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.
authors.affiliation: University Hospital Maastricht and Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.
authors.forename: Ingrid J M
authors.initials: IJ
authors.lastname: Scheffers
authors.forename: Abraham A
authors.initials: AA
authors.lastname: Kroon
authors.forename: Jürg
authors.initials: J
authors.lastname: Schmidli
authors.forename: Jens
authors.initials: J
authors.lastname: Jordan
authors.forename: Jan J M
authors.initials: JJ
authors.lastname: Tordoir
authors.forename: Markus G
authors.initials: MG
authors.lastname: Mohaupt
authors.forename: Friedrich C
authors.initials: FC
authors.lastname: Luft
authors.forename: Hermann
authors.initials: H
authors.lastname: Haller
authors.forename: Jan
authors.initials: J
authors.lastname: Menne
authors.forename: Stefan
authors.initials: S
authors.lastname: Engeli
authors.forename: Jiri
authors.initials: J
authors.lastname: Ceral
authors.forename: Siegfried
authors.initials: S
authors.lastname: Eckert
authors.forename: Andrejs
authors.initials: A
authors.lastname: Erglis
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Narkiewicz
authors.forename: Thomas
authors.initials: T
authors.lastname: Philipp
authors.forename: Peter W
authors.initials: PW
authors.lastname: de Leeuw
mesh_terms: D000328:Adult; D017704:Baroreflex / Q000502:physiology*; D004599:Electric Stimulation Therapy / Q000295:instrumentation* / Q000379:methods; D005060:Europe / Q000453:epidemiology; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000453:epidemiology / Q000503:physiopathology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome