Document Detail


Novel baroreflex activation therapy in resistant hypertension: results of a European multi-center feasibility study.
MedLine Citation:
PMID:  20883933     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Ingrid J M Scheffers; Abraham A Kroon; Jürg Schmidli; Jens Jordan; Jan J 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
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  56     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-10-04     Completed Date:  2010-10-22     Revised Date:  2012-05-29    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1254-8     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Affiliation:
University Hospital Maastricht and Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.
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MeSH Terms
Descriptor/Qualifier:
Adult
Baroreflex / physiology*
Electric Stimulation Therapy / instrumentation*,  methods
Europe / epidemiology
Feasibility Studies
Female
Follow-Up Studies
Humans
Hypertension / epidemiology,  physiopathology*,  therapy*
Male
Middle Aged
Prospective Studies
Treatment Outcome
Comments/Corrections
Comment In:
Auton Neurosci. 2012 Jan 26;166(1-2):1-3   [PMID:  22137183 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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