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Long-term effects of baroreflex activation therapy: 2-year follow-up data of the BAT Neo system

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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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Authors and Affiliations

  1. Department of Nephrology and Rheumatology, University Medical Center Göttingen, Robert-Koch-Str. 40, 37075, Göttingen, Germany

    Manuel Wallbach, Ellen Born, Deborah Kämpfer, Gerhard A. Müller & Michael J. Koziolek

  2. St. Josefs Hospital, Cloppenburg, Germany

    Stephan Lüders

  3. Department of Cardiology and Pulmonology, University Medical Center Göttingen, Göttingen, Germany

    Rolf Wachter

  4. Clinic and Policlinic for Cardiology, University Hospital Leipzig, Leipzig, Germany

    Rolf Wachter

Authors
  1. Manuel Wallbach
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  2. Ellen Born
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  7. Michael J. Koziolek
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Corresponding author

Correspondence to Manuel Wallbach.

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Conflict of interest

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

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