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

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

19 Citations (Web of Science)

Abstract

Barorefiex 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. (C) 2016 The Authors. Published by Elsevier Inc. on behalf of American Society of Hypertension.

Original languageEnglish
Pages (from-to)81-91
Number of pages11
JournalJournal of the American Society of Hypertension
Volume11
Issue number2
DOIs
Publication statusPublished - Feb 2017

Keywords

  • Autonomic nervous system
  • baroreflex
  • resistant hypertension
  • sham control
  • REDUCED EJECTION FRACTION
  • LOWERS BLOOD-PRESSURE
  • RHEOS PIVOTAL TRIAL
  • RESISTANT HYPERTENSION
  • HEART-FAILURE
  • DENERVATION
  • SAFETY

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