Universität zu Köln

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:	Creators Email ORCID ORCID Put Code Wachter, Rolf UNSPECIFIED orcid.org/0000-0003-2231-2200 UNSPECIFIED Halbach, Marcel UNSPECIFIED UNSPECIFIED UNSPECIFIED Bakris, George L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bisognano, John D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Haller, Hermann UNSPECIFIED UNSPECIFIED UNSPECIFIED Beige, Joachim UNSPECIFIED orcid.org/0000-0002-1907-825X UNSPECIFIED Kroon, Abraham A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nadim, Mitra K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lovett, Eric G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schafer, Jill E. UNSPECIFIED UNSPECIFIED UNSPECIFIED de Leeuw, Peter W. UNSPECIFIED orcid.org/0000-0002-4949-5812 UNSPECIFIED
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:	Keywords Language LOWERS BLOOD-PRESSURE; RESISTANT HYPERTENSION; HEART-FAILURE; DENERVATION; SAFETY; TRIAL Multiple languages Peripheral Vascular Disease Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/24178