Wachter, Rolf ORCID: 0000-0003-2231-2200, Halbach, Marcel, Bakris, George L., Bisognano, John D., Haller, Hermann, Beige, Joachim ORCID: 0000-0002-1907-825X, Kroon, Abraham A., Nadim, Mitra K., Lovett, Eric G., Schafer, Jill E. and de Leeuw, Peter W. ORCID: 0000-0002-4949-5812 (2017). An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems. J. Am. Soc. Hypertens., 11 (2). S. 81 - 92. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1878-7436

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Wachter, RolfUNSPECIFIEDorcid.org/0000-0003-2231-2200UNSPECIFIED
Halbach, MarcelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bakris, George L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bisognano, John D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haller, HermannUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beige, JoachimUNSPECIFIEDorcid.org/0000-0002-1907-825XUNSPECIFIED
Kroon, Abraham A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nadim, Mitra K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lovett, Eric G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schafer, Jill E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Leeuw, Peter W.UNSPECIFIEDorcid.org/0000-0002-4949-5812UNSPECIFIED
URN: urn:nbn:de:hbz:38-241780
DOI: 10.1016/j.jash.2016.12.003
Journal or Publication Title: J. Am. Soc. Hypertens.
Volume: 11
Number: 2
Page Range: S. 81 - 92
Date: 2017
Publisher: ELSEVIER SCIENCE INC
Place of Publication: NEW YORK
ISSN: 1878-7436
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
LOWERS BLOOD-PRESSURE; RESISTANT HYPERTENSION; HEART-FAILURE; DENERVATION; SAFETY; TRIALMultiple languages
Peripheral Vascular DiseaseMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/24178

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