Springer Nature is making SARS-CoV-2 and COVID-19 research free. View research | View latest news | Sign up for updates

Baroreflex activation therapy reduces frequency and duration of hypertension-related hospitalizations in patients with resistant hypertension

Abstract

Purpose

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.

Methods

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.

Results

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).

Conclusions

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.

This is a preview of subscription content, log in to check access.

Fig. 1
Fig. 2

References

  1. 1.

    Lewington S et al (2002) Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 360(9349):1903–1913

  2. 2.

    Rapsomaniki E et al (2014) Blood pressure and incidence of twelve cardiovascular diseases: lifetime risks, healthy life-years lost, and age-specific associations in 1.25 million people. Lancet 383(9932):1899–1911

  3. 3.

    Sarafidis PA, Bakris GL (2008) Resistant hypertension: an overview of evaluation and treatment. J Am Coll Cardiol 52(22):1749–1757

  4. 4.

    Wolf-Maier K et al (2003) Hypertension prevalence and blood pressure levels in 6 European countries, Canada, and the United States. JAMA 289(18):2363–2369

  5. 5.

    Bisognano JD et al (2011) Baroreflex activation therapy lowers blood pressure in patients with resistant hypertension: results from the double-blind, randomized, placebo-controlled rheos pivotal trial. J Am Coll Cardiol 58(7):765–773

  6. 6.

    Hoppe UC et al (2012) Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: results from the Barostim neo trial. J Am Soc Hypertens 6(4):270–276

  7. 7.

    de Leeuw PW et al (2017) Sustained reduction of blood pressure with baroreceptor activation therapy: results of the 6-year open follow-up. Hypertension 69(5):836–843

  8. 8.

    Beige J et al (2017) Blood pressure after blinded, randomized withdrawal, and resumption of baroreceptor-activating therapy. J Hypertens 35(7):1496–1501

  9. 9.

    Beige J et al (2015) Baroreflex activation therapy in patients with end-stage renal failure: proof of concept. J Hypertens 33(11):2344–2349

  10. 10.

    Halbach M et al (2015) Acute on/off effects and chronic blood pressure reduction after long-term baroreflex activation therapy in resistant hypertension. J Hypertens 33(8):1697–1703

  11. 11.

    Wallbach M et al (2016) Baroreflex activation therapy in patients with prior renal denervation. J Hypertens 34(8):1630–1638

  12. 12.

    Wallbach M et al (2016) Effects of baroreflex activation therapy on ambulatory blood pressure in patients with resistant hypertension. Hypertension 67(4):701–709

  13. 13.

    Alnima T et al (2013) Renal responses to long-term carotid baroreflex activation therapy in patients with drug-resistant hypertension. Hypertension 61(6):1334–1339

  14. 14.

    Wallbach M et al (2014) Impact of baroreflex activation therapy on renal function—a pilot study. Am J Nephrol 40(4):371–380

  15. 15.

    Wallbach M et al (2015) Effects of baroreflex activation therapy on arterial stiffness and central hemodynamics in patients with resistant hypertension. J Hypertens 33(1):181–186

  16. 16.

    Mancia G et al (2013) 2013 ESH/ESC guidelines for the management of arterial hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J 34(28):2159–2219

  17. 17.

    Allen LA, Spertus JA (2013) End points for comparative effectiveness research in heart failure. Heart Fail Clin 9(1):15–28

  18. 18.

    Friberg L, Rosenqvist M (2011) Cardiovascular hospitalization as a surrogate endpoint for mortality in studies of atrial fibrillation: report from the Stockholm Cohort Study of Atrial Fibrillation. Europace 13(5):626–633

  19. 19.

    Wang G, Fang J, Ayala C (2014) Hypertension-associated hospitalizations and costs in the United States, 1979–2006. Blood Press 23(2):126–133

  20. 20.

    Abraham WT et al (2015) Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction. JACC Heart Fail 3(6):487–496

  21. 21.

    Nakamura K et al (2013) Treated and untreated hypertension, hospitalization, and medical expenditure: an epidemiological study in 314622 beneficiaries of the medical insurance system in Japan. J Hypertens 31(5):1032–1042

  22. 22.

    Esler MD et al (2014) Catheter-based renal denervation for treatment of patients with treatment-resistant hypertension: 36 month results from the SYMPLICITY HTN-2 randomized clinical trial. Eur Heart J 35(26):1752–1759

  23. 23.

    Bhatt DL et al (2014) A controlled trial of renal denervation for resistant hypertension. N Engl J Med 370(15):1393–1401

  24. 24.

    Maronde RF et al (1989) Underutilization of antihypertensive drugs and associated hospitalization. Med Care 27(12):1159–1166

  25. 25.

    Shin S et al (2013) Effect of antihypertensive medication adherence on hospitalization for cardiovascular disease and mortality in hypertensive patients. Hypertens Res 36(11):1000–1005

  26. 26.

    Sherwood A et al (2002) Nighttime blood pressure dipping: the role of the sympathetic nervous system. Am J Hypertens 15(2 Pt 1):111–118

  27. 27.

    Wu PH et al (2010) Relationship of blood pressure control and hospitalization risk to medication adherence among patients with hypertension in Taiwan. Am J Hypertens 23(2):155–160

  28. 28.

    Brenner BM et al (2001) Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med 345(12):861–869

  29. 29.

    Esler MD et al (2010) Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet 376(9756):1903–1909

Download references

Acknowledgements

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.

Funding

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.

Author information

MH, DG: These authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation. FH: collection of data. NM: surgery, collection of data. KK: statistical analysis. HR: This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.

Correspondence to Marcel Halbach.

Ethics declarations

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.

Ethical standards

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.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary file1 (DOCX 60 kb)

Supplementary file2 (DOCX 92 kb)

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

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

Download citation

Keywords

  • Baroreflex
  • Hypertension
  • Hospitalization
  • Medical device
  • Resistant hypertension