An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems
Rolf Wachter, Marcel Halbach, George L Bakris, John D Bisognano, Hermann Haller, Joachim Beige, Abraham A Kroon, Mitra K Nadim, Eric G Lovett, Jill E Schafer, Peter W de Leeuw, Rolf Wachter, Marcel Halbach, George L Bakris, John D Bisognano, Hermann Haller, Joachim Beige, Abraham A Kroon, Mitra K Nadim, Eric G Lovett, Jill E Schafer, Peter W de Leeuw
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.
Trial registration: ClinicalTrials.gov NCT00442286 NCT01471834.
Keywords: Autonomic nervous system; baroreflex; resistant hypertension; sham control.
Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed