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


CONCLUSIONS
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.
Department of Internal Medicine II, Paracelsus Medical University Salzburg, Salzburg, Austria. u.hoppe@salk.at
Uta C
UC
Hoppe
Mathias-Christoph
MC
Brandt
Rolf
R
Wachter
Joachim
J
Beige
Lars Christian
LC
Rump
Abraham A
AA
Kroon
Adam W
AW
Cates
Eric G
EG
Lovett
Hermann
H
Haller
D000368:Aged; D017704:Baroreflex / Q000502:physiology*; D004599:Electric Stimulation Therapy / Q000379:methods*; D004567:Electrodes, Implanted; D004867:Equipment Design; D005260:Female; D006801:Humans; D006973:Hypertension / Q000503:physiopathology / Q000628:therapy*; D007668:Kidney / Q000294:innervation; D008297:Male; D008875:Middle Aged; D019919:Prosthesis Implantation / Q000379:methods; D013686:Telemetry; D016896:Treatment Outcome