Abstract
Objective
Baroreflex activation therapy (BAT) reduces office blood pressure (BP) in patients with resistant hypertension (HTN). Whereas sustained effects from the BAT Rheos device have already been reported, no long-term data on 24-h ambulatory BP (ABP) are currently available for the unilateral BAT Neo device.
Methods
Patients treated with the BAT neo device for resistant hypertension were prospectively included into this observational study. Office and ABP measurements were performed before BAT implantation as well as 6, 12 and 24 months after initiation of BAT.
Results
A total of 60 patients with resistant HTN (office BP 172 ± 25/90 ± 17 mmHg, 24-h ABP 150 ± 16/80 ± 12 mmHg, median of antihypertensive drugs 7 (IQR 6–8)) were included. After 24 months, there was a significant reduction of − 25 ± 33/− 9 ± 18 mmHg (n = 50, both p < 0.01) in office BP and − 8 ± 23/− 5 ± 13 mmHg (n = 46, both p = 0.02) in 24-h ABP, while the number of antihypertensive medications was reduced to a median of 5 (4–6) drugs (p < 0.01). Patients with isolated systolic HTN (ISH) experienced a BP-lowering effect in office BP, but not in ABPM at month 24. Using unadjusted BP values, BAT seems to be more effective in combined hypertension (CH) than in ISH. After adjustment for baseline BP values, there was no significant difference in BP reduction between ISH and CH patients. Ambulatory SBP at baseline was the only independent correlate of BP response at month 24.
Conclusion
BAT reduced office BP and improved relevant parameters of ABP, which is associated with a high cardiovascular risk, in patients with resistant HTN, whereas, after adjustment for baseline BP, BP reduction was not different in patients with CH compared with patients with ISH. However, randomized controlled trials are needed to confirm the effects of BAT on 24-h ABP.
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Abbreviations
- ABP:
-
Ambulatory blood pressure
- AOBP:
-
Automated office blood pressure
- ABPM:
-
Ambulatory blood pressure monitoring
- BAT:
-
Baroreflex activation therapy
- BP:
-
Blood pressure
- BMI:
-
Body mass index
- CKD:
-
Chronic kidney disease
- DBP:
-
Diastolic blood pressure
- eGFR:
-
Estimated glomerular filtration rate
- HTN:
-
Arterial hypertension
- ISH:
-
Isolated systolic hypertension
- MRA:
-
Mineralocorticoid receptor antagonist
- RDN:
-
Renal denervation
- SBP:
-
Systolic blood pressure
- SE:
-
Standard error
- SD:
-
Standard deviation
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Acknowledgements
The authors thank Mrs. C. Biegler for assistance, Dr. D. Zenker, Department of Thoracic and Cardiovascular Surgery, University Medical Center Göttingen, for BAT implantation, and the employees of CVRx for technical support.
Funding
This study was a prospectively designed cohort study planned by an interdisciplinary team of nephrologists and cardiologists. All study-related procedures were financed by own resources of the participating departments. MW received intramural funding by the Medical Faculty for a 6-month period of dedicated research time (Research program, Faculty of Medicine, Georg-August-University Göttingen). No other funding was provided.
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MW, MK and RW have received speaking honoraria and research grants from CVRx. RW declares having received lecture fees and enumeration for including subjects into clinical trials from CVRx. RW has received consultant fees from CVRx. MK is a member of the CVRx Barostim Hypertension Registry Steering Committee. EB, DK, SL and GM declare no conflict of interest.
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Wallbach, M., Born, E., Kämpfer, D. et al. Long-term effects of baroreflex activation therapy: 2-year follow-up data of the BAT Neo system. Clin Res Cardiol 109, 513–522 (2020). https://doi.org/10.1007/s00392-019-01536-5
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DOI: https://doi.org/10.1007/s00392-019-01536-5