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 (TM) 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. J Am Soc Hypertens 2012;6(4):270-276