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

  • Manuel WallbachEmail author
  • Ellen Born
  • Deborah Kämpfer
  • Stephan Lüders
  • Gerhard A. Müller
  • Rolf Wachter
  • Michael J. Koziolek
Original Paper
  • 316 Downloads

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.

Keywords

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

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

Notes

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.

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.

Supplementary material

392_2019_1536_MOESM1_ESM.pptx (62 kb)
Supplementary file1 (PPTX 61 kb)

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):3021–3104PubMedCrossRefGoogle Scholar
  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):1731–1768PubMedCrossRefGoogle Scholar
  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):1777–1783PubMedCrossRefGoogle Scholar
  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):1509–1520PubMedCrossRefGoogle Scholar
  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):156–161PubMedPubMedCentralCrossRefGoogle Scholar
  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):2183–2189PubMedCrossRefGoogle Scholar
  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–e248PubMedCrossRefGoogle Scholar
  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):1131–1138PubMedCrossRefGoogle Scholar
  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):181–186PubMedCrossRefGoogle Scholar
  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):642–652PubMedPubMedCentralCrossRefGoogle Scholar
  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):42–48CrossRefGoogle Scholar
  12. 12.
    Kulenthiran S, Ewen S, Bohm M, Mahfoud F (2017) Hypertension up to date: SPRINT to SPYRAL. Clin Res Cardiol 106(7):475–484PubMedCrossRefGoogle Scholar
  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):322–330PubMedCrossRefGoogle Scholar
  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):765–773PubMedCrossRefGoogle Scholar
  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):1254–1258PubMedCrossRefGoogle Scholar
  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):1–19PubMedCrossRefGoogle Scholar
  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):371–380PubMedCrossRefGoogle Scholar
  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) CrossRefGoogle Scholar
  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):1496–1501PubMedCrossRefGoogle Scholar
  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):81–91PubMedCrossRefGoogle Scholar
  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):585–591PubMedPubMedCentralCrossRefGoogle Scholar
  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):765–773PubMedCrossRefGoogle Scholar
  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):836–843PubMedCrossRefGoogle Scholar
  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):2159–2219CrossRefGoogle Scholar
  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):68–75PubMedGoogle Scholar
  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):701–709PubMedCrossRefGoogle Scholar
  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) CrossRefGoogle Scholar
  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):1762–1769PubMedCrossRefGoogle Scholar
  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):281–286PubMedCrossRefGoogle Scholar
  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):2346–2355PubMedCrossRefGoogle Scholar
  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):2160–2170PubMedCrossRefGoogle Scholar
  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):3–20PubMedCrossRefGoogle Scholar
  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):93–100PubMedGoogle Scholar
  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):193–199PubMedCrossRefGoogle Scholar
  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) Google Scholar
  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):373–379PubMedCrossRefGoogle Scholar
  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):1393–1401PubMedCrossRefGoogle Scholar
  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):766–774PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of Nephrology and RheumatologyUniversity Medical Center GöttingenGöttingenGermany
  2. 2.St. Josefs HospitalCloppenburgGermany
  3. 3.Department of Cardiology and PulmonologyUniversity Medical Center GöttingenGöttingenGermany
  4. 4.Clinic and Policlinic for CardiologyUniversity Hospital LeipzigLeipzigGermany

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