TY - JOUR
T1 - Endovascular baroreflex amplification and the effect on sympathetic nerve activity in patients with resistant hypertension
T2 - A proof-of-principle study
AU - van Kleef, Monique E A M
AU - Heusser, Karsten
AU - Diedrich, André
AU - Oey, P Liam
AU - Tank, Jens
AU - Jordan, Jens
AU - Blankestijn, Peter J
AU - Williams, Bryan
AU - Spiering, Wilko
N1 - Funding Information:
The study was funded by the manufacturer of the MobiusHD implant, Vascular Dynamics, Inc. André Diedrich is supported by the National Heart, Lung, and Blood Institute of the National Health (Award Number NIH 1R56HL142583-01, 1R01HL142583-01). Bryan Williams is supported by the NIHR University College London Hospitals Biomedical Research Centre. Vascular Dynamics, Inc. was involved in the design of the main study, data monitoring and central storage of study data. The funder had no role in data analysis or preparation of the manuscript which was directed by the manuscript authors. Monique E.A.M. van Kleef and Wilko Spiering had access to all study data and had final responsibility for the decision to submit the paper for publication. The National Heart, Lung, and Blood Institute of the National Health and the NIHR University College London Hospitals Biomedical Research Centre had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Publisher Copyright:
© 2021 van Kleef et al.
PY - 2021
Y1 - 2021
N2 - BACKGROUND: First in human studies suggest that endovascular baroreflex amplification (EVBA) lowers blood pressure (BP). To explore potential mechanisms for BP reduction, this study examines the effects of EVBA on muscle sympathetic nerve activity (MSNA) and baroreceptor sensitivity (BRS).METHODS: In a single-center sub-study of the CALM-DIEM study (Controlling And Lowering blood pressure with the MobiusHD-Defining Efficacy Markers), 14 patients with resistant hypertension were treated with EVBA. Microneurography and non-invasive continuous BP measurements were performed at baseline and three months after MobiusHD implantation. The primary outcome was change in MSNA. Secondary outcomes were change in baroreflex sensitivity (BRS), cardiovascular responses to a sympathetic stimulus, BP, heart rate (HR) and heart rate variability (HRV).RESULTS: The primary endpoint was obtained in 10 of 14 patients enrolled in the sub-study. MSNA burst frequency and burst incidence decreased in 6 of 10 patients: mean change -4.1 bursts/min (95% confidence interval -12.2 to 4.0) and -3.8 bursts/100 heartbeats (-15.2 to 7.7). MSNA spike frequency and spike count decreased in 8 of 10 patients: mean change -2.8 spikes/sec (-7.3 to 1.8) and -3.0 spikes/heartbeat (-6.1 to 0.1). Change in MSNA and BP were not correlated. Office BP decreased by -14/-6 mmHg (-27 to -2/-15 to 3). We observed a trend towards decreased HR (-5 bpm, -10 to 1) and increased total power HRV (623 msec2, 78 to 1168). In contrast, BRS and cardiovascular responses remained unchanged after EVBA.CONCLUSIONS: In this proof-of-principle study, EVBA did not significantly decrease MSNA in patients with resistant hypertension. EVBA did not impair baroreflex function.TRIAL REGISTRATION: Clinical trial registration at NCT02827032.
AB - BACKGROUND: First in human studies suggest that endovascular baroreflex amplification (EVBA) lowers blood pressure (BP). To explore potential mechanisms for BP reduction, this study examines the effects of EVBA on muscle sympathetic nerve activity (MSNA) and baroreceptor sensitivity (BRS).METHODS: In a single-center sub-study of the CALM-DIEM study (Controlling And Lowering blood pressure with the MobiusHD-Defining Efficacy Markers), 14 patients with resistant hypertension were treated with EVBA. Microneurography and non-invasive continuous BP measurements were performed at baseline and three months after MobiusHD implantation. The primary outcome was change in MSNA. Secondary outcomes were change in baroreflex sensitivity (BRS), cardiovascular responses to a sympathetic stimulus, BP, heart rate (HR) and heart rate variability (HRV).RESULTS: The primary endpoint was obtained in 10 of 14 patients enrolled in the sub-study. MSNA burst frequency and burst incidence decreased in 6 of 10 patients: mean change -4.1 bursts/min (95% confidence interval -12.2 to 4.0) and -3.8 bursts/100 heartbeats (-15.2 to 7.7). MSNA spike frequency and spike count decreased in 8 of 10 patients: mean change -2.8 spikes/sec (-7.3 to 1.8) and -3.0 spikes/heartbeat (-6.1 to 0.1). Change in MSNA and BP were not correlated. Office BP decreased by -14/-6 mmHg (-27 to -2/-15 to 3). We observed a trend towards decreased HR (-5 bpm, -10 to 1) and increased total power HRV (623 msec2, 78 to 1168). In contrast, BRS and cardiovascular responses remained unchanged after EVBA.CONCLUSIONS: In this proof-of-principle study, EVBA did not significantly decrease MSNA in patients with resistant hypertension. EVBA did not impair baroreflex function.TRIAL REGISTRATION: Clinical trial registration at NCT02827032.
UR - http://www.scopus.com/inward/record.url?scp=85119348198&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0259826
DO - 10.1371/journal.pone.0259826
M3 - Article
C2 - 34784359
SN - 1932-6203
VL - 16
JO - PLoS ONE
JF - PLoS ONE
IS - 11
M1 - e0259826
ER -