Joachim Beige1, Theresa Jentzsch, Ralph Wendt, Gert Hennig, Michael Koziolek, Manuel Wallbach. 1. aDepartment of Nephrology, KfH Renal Unit, Hospital St. Georg, Leipzig and Martin-Luther-University Halle/Wittenberg, Halle bDepartment of Vascular Surgery, Hospital St. Georg, Leipzig cDepartment of Nephrology and Rheumatology, University of Göttingen, Göttingen, Germany *Joachim Beige and Theresa Jentzsch contributed equally to this article.
Abstract
BACKGROUND:Baroreceptor-activating therapy (BAT) has been shown to control resistant hypertension in one sham-controlled and further observational studies. Incremental but significant reincrease of blood pressure (BP) have been described after open-label temporary withdrawal of such therapy. METHOD: Our study in 16 randomized patients investigated the course of automated office, ambulatory, and home BP in a randomized, controlled cross-over design. RESULTS: After 4 weeks of blinded and randomized withdrawal in hypertension-controlled long-term carriers of BAT (2.67 ± 1.3 years, 145/104 mmHg), the primary end point of 35 mmHg difference, similar to initial BP drop after BAT initiation, was not reached in any patient. Ambulatory BP rose significantly during BAT off by 10/8 ± 4/3 mmHg (3.13/2.10, P = 0.007/0.002) and automated office BP by 10/4 ± 2/1 (4.17/0.58, P = 0.005/0.03) at 4 weeks after BAT on while mean home BP did not change significantly by 2/2 ± 3/2 mmHg (-5.9/-3.5, P = 0.6/0.5). CONCLUSION: Our data in a limited study population show, that BP rise after temporary BAT withdrawal is significant but does not reach a magnitude comparable with the initial drop after de novo implantation. Such results points to preserved hypertension control after electrical BAT withdrawal and deserves further pathophysiological and clinical clarification.
RCT Entities:
BACKGROUND: Baroreceptor-activating therapy (BAT) has been shown to control resistant hypertension in one sham-controlled and further observational studies. Incremental but significant reincrease of blood pressure (BP) have been described after open-label temporary withdrawal of such therapy. METHOD: Our study in 16 randomized patients investigated the course of automated office, ambulatory, and home BP in a randomized, controlled cross-over design. RESULTS: After 4 weeks of blinded and randomized withdrawal in hypertension-controlled long-term carriers of BAT (2.67 ± 1.3 years, 145/104 mmHg), the primary end point of 35 mmHg difference, similar to initial BP drop after BAT initiation, was not reached in any patient. Ambulatory BP rose significantly during BAT off by 10/8 ± 4/3 mmHg (3.13/2.10, P = 0.007/0.002) and automated office BP by 10/4 ± 2/1 (4.17/0.58, P = 0.005/0.03) at 4 weeks after BAT on while mean home BP did not change significantly by 2/2 ± 3/2 mmHg (-5.9/-3.5, P = 0.6/0.5). CONCLUSION: Our data in a limited study population show, that BP rise after temporary BAT withdrawal is significant but does not reach a magnitude comparable with the initial drop after de novo implantation. Such results points to preserved hypertension control after electrical BAT withdrawal and deserves further pathophysiological and clinical clarification.
Authors: M Koziolek; J Beige; M Wallbach; D Zenker; G Henning; M Halbach; N Mader; F Mahfoud; G Schlieper; V Schwenger; M Hausberg; J Börgel; M Lodde; M van der Giet; J Müller-Ehmsen; J Passauer; S Parmentier; S Lüders; B K Krämer; S Büttner; F Limbourg; J Jordan; O Vonend; H-G Predel; H Reuter Journal: Internist (Berl) Date: 2017-10 Impact factor: 0.743
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