Baroreflex activation therapy (BAT) has been shown to lower blood pressure in patients with resistant hypertension. The purpose of this study was to analyze whether this translates into a reduction of more relevant clinical endpoints.
Patients with resistant hypertension were treated with the second-generation BAT system. Records on hospitalization (dates of admission and discharge, main diagnosis) were obtained from medical insurance companies.
Records on hospitalization were available for a period of 1 year before BAT in two patients and 2 years in 22 patients. The total number of hospitalizations per patient was 3.3 ± 3.5/year before BAT and 2.2 ± 2.7/year after BAT (p = 0.03). Hospitalizations related to hypertension were significantly decreased from 1.5 ± 1.6/year before BAT to 0.5 ± 0.9/year after BAT (p < 0.01). The cumulative duration of hypertension-related hospital stays was significantly reduced from 8.0 ± 8.7 days/year before BAT to 1.8 ± 4.8 days/year after BAT (p < 0.01). Office cuff blood pressure was 183 ± 27 mmHg over 102 ± 17 mmHg under 6.6 ± 2.0 antihypertensive drugs before BAT and 157 ± 32 mmHg over 91 ± 20 mmHg (both p < 0.01) under 5.9 ± 1.9 antihypertensive drugs (p = 0.09 for number of drugs) at latest follow-up. Daytime ambulatory blood pressure was 164 ± 21 mmHg over 91 ± 14 mmHg before BAT and 153 ± 21 mmHg (p = 0.03) over 89 ± 15 mmHg (p = 0.56) at latest follow-up. Heart rate was 75 ± 16 bpm before BAT and 72 ± 12 bpm at latest follow-up (p = 0.35).
Rate and duration of hypertension-related hospitalizations in patients with severe resistant hypertension were lowered after BAT. Whether the response is mediated through improvements in blood pressure control requires further studies.
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We acknowledge the assistance of our study nurse Tatjana Schewior as well as the support provided by Michael Steinkamp, Stephan Wiedenfeld and Seth Wilks from CVRx Inc.
We received no specific grant support for this study. Patients participated in a multicenter post-market BAT registry funded by CVRx Inc., but hospitalization data were not included in this registry.
Conflict of interest
M.H. and H.R. are principal investigators of trials sponsored by CVRx Inc. and received a research grant for another trial and speaker honoraria from CVRx Inc. N.M. is a paid consultant of CVRx Inc. We received no specific grants for the present work.
All procedures adhered to the principles of the Declaration of Helsinki and Title 45, U.S. Code of Federal Regulations, Part 46, Protection of Human Subjects, revised November 13, 2001, effective December 13, 2001. The study protocol was approved by an institutional review committee, and patients gave written informed consent for collection and analysis of all data.
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Halbach, M., Grothaus, D., Hoffmann, F. et al. Baroreflex activation therapy reduces frequency and duration of hypertension-related hospitalizations in patients with resistant hypertension. Clin Auton Res (2020). https://doi.org/10.1007/s10286-020-00670-9
- Medical device
- Resistant hypertension