Advertisement

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

  • 311 Accesses

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.

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

Access options

Buy single article

Instant unlimited access to the full article PDF.

US$ 39.95

Price includes VAT for USA

Subscribe to journal

Immediate online access to all issues from 2019. Subscription will auto renew annually.

US$ 199

This is the net price. Taxes to be calculated in checkout.

Fig. 1
Fig. 2
Fig. 3

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

References

  1. 1.

    Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M et al (2018) 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J 39(33):3021–3104

  2. 2.

    O'Brien E, Parati G, Stergiou G, Asmar R, Beilin L, Bilo G et al (2013) European Society of Hypertension position paper on ambulatory blood pressure monitoring. J Hypertens 31(9):1731–1768

  3. 3.

    Sega R, Facchetti R, Bombelli M, Cesana G, Corrao G, Grassi G et al (2005) Prognostic value of ambulatory and home blood pressures compared with office blood pressure in the general population: follow-up results from the Pressioni Arteriose Monitorate e Loro Associazioni (PAMELA) study. Circulation 111(14):1777–1783

  4. 4.

    Banegas JR, Ruilope LM, de la Sierra A, Vinyoles E, Gorostidi M, de la Cruz JJ et al (2018) Relationship between clinic and ambulatory blood-pressure measurements and mortality. N Engl J Med 378(16):1509–1520

  5. 5.

    Dolan E, Stanton A, Thijs L, Hinedi K, Atkins N, McClory S et al (2005) Superiority of ambulatory over clinic blood pressure measurement in predicting mortality: the Dublin outcome study. Hypertension 46(1):156–161

  6. 6.

    Ohkubo T, Hozawa A, Yamaguchi J, Kikuya M, Ohmori K, Michimata M et al (2002) Prognostic significance of the nocturnal decline in blood pressure in individuals with and without high 24-h blood pressure: the Ohasama study. J Hypertens 20(11):2183–2189

  7. 7.

    Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C et al (2018) 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 71(19):e127–e248

  8. 8.

    Hoogerwaard AF, Adiyaman A, de Jong MR, Smit JJJ, Delnoy P, Heeg JE et al (2018) Changes in arterial pressure hemodynamics in response to renal nerve stimulation both before and after renal denervation. Clin Res Cardiol 107(12):1131–1138

  9. 9.

    Wallbach M, Lehnig LY, Schroer C, Helms HJ, Luders S, Patschan D 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

  10. 10.

    Stoiber L, Mahfoud F, Zamani SM, Lapinskas T, Bohm M, Ewen S et al (2018) Renal sympathetic denervation restores aortic distensibility in patients with resistant hypertension: data from a multi-center trial. Clin Res Cardiol 107(8):642–652

  11. 11.

    Ott C, Kopp C, Dahlmann A, Schmid A, Linz P, Cavallaro A et al (2018) Impact of renal denervation on tissue Na(+) content in treatment-resistant hypertension. Clin Res Cadriol 107(1):42–48

  12. 12.

    Kulenthiran S, Ewen S, Bohm M, Mahfoud F (2017) Hypertension up to date: SPRINT to SPYRAL. Clin Res Cardiol 106(7):475–484

  13. 13.

    Tsioufis C, Ziakas A, Dimitriadis K, Davlouros P, Marketou M, Kasiakogias A et al (2017) Blood pressure response to catheter-based renal sympathetic denervation in severe resistant hypertension: data from the Greek Renal Denervation Registry. Clin Res Cardiol 106(5):322–330

  14. 14.

    Bisognano JD, Bakris G, Nadim MK, Sanchez L, Kroon AA, Schafer J 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

  15. 15.

    Scheffers IJ, Kroon AA, Schmidli J, Jordan J, Tordoir JJ, Mohaupt MG et al (2010) Novel baroreflex activation therapy in resistant hypertension: results of a European multi-center feasibility study. J Am Coll Cardiol 56(15):1254–1258

  16. 16.

    Tschope C, Birner C, Bohm M, Bruder O, Frantz S, Luchner A et al (2018) Heart failure with preserved ejection fraction: current management and future strategies : Expert opinion on the behalf of the Nucleus of the "Heart Failure Working Group" of the German Society of Cardiology (DKG). Clin Res Cardiol 107(1):1–19

  17. 17.

    Wallbach M, Lehnig LY, Schroer C, Hasenfuss G, Muller GA, Wachter R et al (2014) Impact of baroreflex activation therapy on renal function—a pilot study. Am J Nephrol 40(4):371–380

  18. 18.

    Lipphardt M, Koziolek MJ, Lehnig LY, Schafer AK, Muller GA, Luders S et al (2019) Effect of baroreflex activation therapy on renal sodium excretion in patients with resistant hypertension. Clin Res Cardiol 6:4. https://doi.org/10.1007/s00392-019-01464-4 (Epub ahead of print)

  19. 19.

    Beige J, Jentzsch T, Wendt R, Hennig G, Koziolek M, Wallbach M (2017) Blood pressure after blinded, randomized withdrawal, and resumption of baroreceptor-activating therapy. J Hypertens 35(7):1496–1501

  20. 20.

    Wachter R, Halbach M, Bakris GL, Bisognano JD, Haller H, Beige J et al (2017) An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems. J Am Soc Hypertens 11(2):81–91

  21. 21.

    Heusser K, Tank J, Brinkmann J, Menne J, Kaufeld J, Linnenweber-Held S et al (2016) Acute response to unilateral unipolar electrical carotid sinus stimulation in patients with resistant arterial hypertension. Hypertension 67(3):585–591

  22. 22.

    Bisognano JD, Bakris G, Nadim MK, Sanchez L, Kroon AA, Schafer J, de Leeuw PW, Sica DA (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

  23. 23.

    de Leeuw PW, Bisognano JD, Bakris GL, Nadim MK, Haller H, Kroon AA (2017) Sustained reduction of blood pressure with baroreceptor activation therapy: results of the 6-year open follow-up. Hypertension 69(5):836–843

  24. 24.

    Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M 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

  25. 25.

    Hathout GM, Fink JR, El-Saden SM, Grant EG (2005) Sonographic NASCET index: a new doppler parameter for assessment of internal carotid artery stenosis. Am J Neuroradiol 26(1):68–75

  26. 26.

    Wallbach M, Lehnig LY, Schroer C, Luders S, Bohning E, Muller GA et al (2016) Effects of baroreflex activation therapy on ambulatory blood pressure in patients with resistant hypertension. Hypertension 67(4):701–709

  27. 27.

    Vischer AS, Socrates T, Winterhalder C, Eckstein J, Mayr M, Burkard T (2019) Impact of single-visit American versus European office blood pressure measurement procedure on individual blood pressure classification: a cross-sectional study. Clin Res Cardiol 6:1. https://doi.org/10.1007/s00392-019-01426-w (Epub ahead of print)

  28. 28.

    Wallbach M, Bohning E, Lehnig LY, Schroer C, Muller GA, Wachter R et al (2018) Safety profile of baroreflex activation therapy (NEO) in patients with resistant hypertension. J Hypertens 36(8):1762–1769

  29. 29.

    Niiranen TJ, Maki J, Puukka P, Karanko H, Jula AM (2014) Office, home, and ambulatory blood pressures as predictors of cardiovascular risk. Hypertension 64(2):281–286

  30. 30.

    Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S et al (2018) Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet 391(10137):2346–2355

  31. 31.

    Townsend RR, Mahfoud F, Kandzari DE, Kario K, Pocock S, Weber MA et al (2017) Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet 390(10108):2160–2170

  32. 32.

    Esler M, Jennings G, Korner P, Willett I, Dudley F, Hasking G et al (1988) Assessment of human sympathetic nervous system activity from measurements of norepinephrine turnover. Hypertension 11(1):3–20

  33. 33.

    Mahfoud F, Bakris G, Bhatt DL, Esler M, Ewen S, Fahy M et al (2017) Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. Eur Heart J 38(2):93–100

  34. 34.

    Ewen S, Ukena C, Linz D, Kindermann I, Cremers B, Laufs U et al (2015) Reduced effect of percutaneous renal denervation on blood pressure in patients with isolated systolic hypertension. Hypertension 65(1):193–199

  35. 35.

    Fengler K, Rommel KP, Lapusca R, Blazek S, Besler C, Hartung P, et al. Renal denervation in isolated systolic hypertension using different catheter techniques and technologies. Hypertension 2019:HYPERTENSIONAHA11913019 (Epub ahead of print)

  36. 36.

    Lohmeier TE, Hildebrandt DA, Dwyer TM, Barrett AM, Irwin ED, Rossing MA et al (2007) Renal denervation does not abolish sustained baroreflex-mediated reductions in arterial pressure. Hypertension 49(2):373–379

  37. 37.

    Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT et al (2014) A controlled trial of renal denervation for resistant hypertension. N Engl J Med 370(15):1393–1401

  38. 38.

    Jung O, Gechter JL, Wunder C, Paulke A, Bartel C, Geiger H et al (2013) Resistant hypertension? Assessment of adherence by toxicological urine analysis. J Hypertens 31(4):766–774

Download references

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.

Author information

Correspondence to Manuel Wallbach.

Ethics declarations

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.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary file1 (PPTX 61 kb)

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

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 (2019). https://doi.org/10.1007/s00392-019-01536-5

Download citation

Keywords

  • Ambulatory blood pressure monitoring
  • Baroreflex activation therapy
  • Office blood pressure
  • Resistant hypertension