Research Article
An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems

https://doi.org/10.1016/j.jash.2016.12.003Get rights and content
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Highlights

  • Propensity score matching was used to compare first and second generation baroreflex activation therapy (BAT) systems.

  • Second-generation BAT outperformed the first generation sham cohort by 20 ± 28 mm Hg.

  • Second-generation BAT produced equivalent blood pressure reductions to first-generation BAT.

  • Procedure time, safety, and battery life improved with the second-generation BAT.

Abstract

Baroreflex activation therapy (BAT) is a device-based therapy for patients with treatment-resistant hypertension. In a randomized, controlled trial, the first-generation system significantly reduced blood pressure (BP) versus sham. Although an open-label validation study of the second-generation system demonstrated similar BP reductions, controlled data are not presently available. Therefore, this investigation compares results of first- and second-generation BAT systems. Two cohorts of first-generation BAT system patients were generated with propensity matching to compare against the validation group of 30 second-generation subjects. The first cohort was drawn from the first-generation randomized trial sham group and the second cohort from the active therapy group. Safety and efficacy were compared for the second-generation group relative to the first generation. At 6 months, second-generation BAT outperformed first-generation sham systolic BP reduction by 20 ± 28 mm Hg (mean ± standard deviation, P = .008), while BP reduction in first- and second-generation active groups was similar. At 12 months, efficacy was comparable between all three groups after the sham group had received 6 months of therapy; 47% of second-generation patients achieved goal systolic BP of 140 mm Hg or less after 12 months, comparable to 50% of patients at goal in the first-generation group (P > .999). Implant procedure time, system/procedural safety, and pulse generator longevity improved with the second-generation system. Propensity-matched cohort analysis of the first- and second-generation BAT systems suggests similar therapeutic benefit and superior BP reduction of the second-generation system relative to sham control. Implantation procedure duration and perioperative safety were improved with the second-generation device. These findings should be validated in a prospective randomized trial.

Keywords

Autonomic nervous system
baroreflex
resistant hypertension
sham control

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ClinicalTrials.gov Identifiers: NCT00442286, NCT01471834.

This study was funded by CVRx, Inc., Minneapolis, Minnesota, USA.

Conflict of interest: G.L.B., J.D.B., P.W.d.L., H.H., and M.K.N. have received research fees, speaking honoraria, and consultant fees from CVRx. J.B., A.A.K., and R.W. have received research fees and consultant fees from CVRx. M.H. has received research fees and speaking honoraria from CVRx. J.E.S. is a statistical consultant for CVRx. E.G.L. is an employee of CVRx.