title: Baroreflex activation therapy provides durable benefit in patients with resistant hypertension: results of long-term follow-up in the Rheos Pivotal Trial.
abstract: The objective of this study was to assess long-term blood pressure control in resistant hypertension patients receiving baroreflex activation therapy (BAT). Following completion of the randomized Rheos Pivotal Trial, patients participated in open-label, nonrandomized follow-up to assess safety and efficacy of BAT. Blood pressure reductions were measured relative to a pre-implant baseline as well as the results achieved at the completion of 1 year of follow-up in the randomized phase. Clinically significant responder status was assessed according to FDA-mandated criteria. Of the 322 patients implanted, 76% (n = 245) qualified as clinically significant responders, an additional 10% were indeterminate. Among long-term responders receiving BAT, the mean blood pressure drop was 35/16 mm Hg. Medication use was reduced by the end of the randomized phase and remained lower through the follow-up period. Among responders, 55% achieved goal blood pressures (<140 mm Hg or <130 mm Hg in diabetes or kidney disease). Blood pressures of all active patients remained stable from completion of the randomized phase through long-term follow-up. BAT substantially reduced arterial pressure for most patients participating in the Rheos Pivotal Trial. This blood pressure reduction or goal achievement was maintained over long-term follow-up of 22 to 53 months.
authors.affiliation: Department of Medicine, Hypertensive Diseases Unit, University of Chicago Pritzker Medical School, Chicago, IL, USA. gbakris@gmail.com
authors.forename: George L
authors.initials: GL
authors.lastname: Bakris
authors.forename: Mitra K
authors.initials: MK
authors.lastname: Nadim
authors.forename: Hermann
authors.initials: H
authors.lastname: Haller
authors.forename: Eric G
authors.initials: EG
authors.lastname: Lovett
authors.forename: Jill E
authors.initials: JE
authors.lastname: Schafer
authors.forename: John D
authors.initials: JD
authors.lastname: Bisognano
mesh_terms: D017704:Baroreflex / Q000502:physiology*; D001794:Blood Pressure / Q000502:physiology*; D002346:Carotid Sinus / Q000502:physiology; D015331:Cohort Studies; D011211:Electric Power Supplies; D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000379:methods*; D004567:Electrodes, Implanted; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome