Skip to main content
Top
Published in: Clinical Research in Cardiology 4/2020

01-04-2020 | Hypertension | Original Paper

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

Authors: Manuel Wallbach, Ellen Born, Deborah Kämpfer, Stephan Lüders, Gerhard A. Müller, Rolf Wachter, Michael J. Koziolek

Published in: Clinical Research in Cardiology | Issue 4/2020

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
go back to reference 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):3021–3104CrossRef 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):3021–3104CrossRef
2.
go back to reference 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):1731–1768CrossRef 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):1731–1768CrossRef
3.
go back to reference 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):1777–1783CrossRef 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):1777–1783CrossRef
4.
go back to reference 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):1509–1520CrossRef 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):1509–1520CrossRef
5.
go back to reference 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):156–161CrossRef 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):156–161CrossRef
6.
go back to reference 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):2183–2189CrossRef 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):2183–2189CrossRef
7.
go back to reference 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–e248CrossRef 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–e248CrossRef
8.
go back to reference 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):1131–1138CrossRef 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):1131–1138CrossRef
9.
go back to reference 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):181–186CrossRef 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):181–186CrossRef
10.
go back to reference 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):642–652CrossRef 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):642–652CrossRef
11.
go back to reference 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):42–48CrossRef 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):42–48CrossRef
12.
go back to reference Kulenthiran S, Ewen S, Bohm M, Mahfoud F (2017) Hypertension up to date: SPRINT to SPYRAL. Clin Res Cardiol 106(7):475–484CrossRef Kulenthiran S, Ewen S, Bohm M, Mahfoud F (2017) Hypertension up to date: SPRINT to SPYRAL. Clin Res Cardiol 106(7):475–484CrossRef
13.
go back to reference 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):322–330CrossRef 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):322–330CrossRef
14.
go back to reference 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):765–773CrossRef 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):765–773CrossRef
15.
go back to reference 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):1254–1258CrossRef 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):1254–1258CrossRef
16.
go back to reference 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):1–19CrossRef 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):1–19CrossRef
17.
go back to reference 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):371–380CrossRef 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):371–380CrossRef
19.
go back to reference 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):1496–1501CrossRef 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):1496–1501CrossRef
20.
go back to reference 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):81–91CrossRef 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):81–91CrossRef
21.
go back to reference 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):585–591CrossRef 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):585–591CrossRef
22.
go back to reference 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):765–773CrossRef 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):765–773CrossRef
23.
go back to reference 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):836–843CrossRef 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):836–843CrossRef
24.
go back to reference 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):2159–2219CrossRef 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):2159–2219CrossRef
25.
go back to reference 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):68–75PubMed 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):68–75PubMed
26.
go back to reference 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):701–709CrossRef 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):701–709CrossRef
27.
go back to reference 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) CrossRef 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) CrossRef
28.
go back to reference 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):1762–1769CrossRef 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):1762–1769CrossRef
29.
go back to reference 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):281–286CrossRef 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):281–286CrossRef
30.
go back to reference 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):2346–2355CrossRef 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):2346–2355CrossRef
31.
go back to reference 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):2160–2170CrossRef 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):2160–2170CrossRef
32.
go back to reference 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):3–20CrossRef 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):3–20CrossRef
33.
go back to reference 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):93–100PubMed 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):93–100PubMed
34.
go back to reference 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):193–199CrossRef 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):193–199CrossRef
35.
go back to reference 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) 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.
go back to reference 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):373–379CrossRef 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):373–379CrossRef
37.
go back to reference 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):1393–1401CrossRef 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):1393–1401CrossRef
38.
go back to reference 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):766–774CrossRef 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):766–774CrossRef
Metadata
Title
Long-term effects of baroreflex activation therapy: 2-year follow-up data of the BAT Neo system
Authors
Manuel Wallbach
Ellen Born
Deborah Kämpfer
Stephan Lüders
Gerhard A. Müller
Rolf Wachter
Michael J. Koziolek
Publication date
01-04-2020
Publisher
Springer Berlin Heidelberg
Published in
Clinical Research in Cardiology / Issue 4/2020
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI
https://doi.org/10.1007/s00392-019-01536-5

Other articles of this Issue 4/2020

Clinical Research in Cardiology 4/2020 Go to the issue