Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: results from the Barostim neo trial

J Am Soc Hypertens. Jul-Aug 2012;6(4):270-6. doi: 10.1016/j.jash.2012.04.004. Epub 2012 Jun 12.

Abstract

Background: Previous trials have demonstrated clinically significant and durable reductions in arterial pressure from baroreflex activation therapy (BAT), resulting from electrical stimulation of the carotid sinus using a novel implantable device. A second-generation system for delivering BAT, the Barostim neo™ system, has been designed to deliver BAT with a simpler device and implant procedure.

Methods: BAT, delivered with the advanced system, was evaluated in a single-arm, open-label study of patients with resistant hypertension, defined as resting systolic blood pressure (SBP) ≥140 mm Hg despite treatment with ≥3 medications, including ≥1 diuretic. Stable medical therapy was required for ≥4 weeks before establishing pretreatment baseline by averaging two SBP readings taken ≥24 hours apart.

Results: Thirty patients enrolled from seven centers in Europe and Canada. From a baseline of 171.7 ± 20.2/99.5 ± 13.9 mm Hg, arterial pressure decreased by 26.0 ± 4.4/12.4 ± 2.5 mm Hg at 6 months. In a subset (n = 6) of patients with prior renal nerve ablation, arterial pressure decreased by 22.3 ± 9.8 mm Hg. Background medical therapy for hypertension was unchanged during follow-up. Three minor procedure-related complications occurred within 30 days of implant. All complications resolved without sequelae.

Conclusion: BAT delivered with the second-generation system significantly lowers blood pressure in resistant hypertension with stable, intensive background medical therapy, consistent with studies of the first-generation system for electrical activation of the baroreflex, and provides a safety profile comparable to a pacemaker.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Baroreflex / physiology*
  • Electric Stimulation Therapy / methods*
  • Electrodes, Implanted
  • Equipment Design
  • Female
  • Humans
  • Hypertension / physiopathology
  • Hypertension / therapy*
  • Kidney / innervation
  • Male
  • Middle Aged
  • Prosthesis Implantation / methods
  • Telemetry
  • Treatment Outcome