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

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...

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Veröffentlicht in:Clinical research in cardiology 2020-04, Vol.109 (4), p.513-522
Hauptverfasser: Wallbach, Manuel, Born, Ellen, Kämpfer, Deborah, Lüders, Stephan, Müller, Gerhard A., Wachter, Rolf, Koziolek, Michael J.
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container_end_page 522
container_issue 4
container_start_page 513
container_title Clinical research in cardiology
container_volume 109
creator Wallbach, Manuel
Born, Ellen
Kämpfer, Deborah
Lüders, Stephan
Müller, Gerhard A.
Wachter, Rolf
Koziolek, Michael J.
description 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  
doi_str_mv 10.1007/s00392-019-01536-5
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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  &lt; 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  &lt; 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.</description><identifier>ISSN: 1861-0684</identifier><identifier>EISSN: 1861-0692</identifier><identifier>DOI: 10.1007/s00392-019-01536-5</identifier><identifier>PMID: 31388741</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Activation ; Aged ; Antihypertensive Agents - therapeutic use ; Antihypertensives ; Baroreceptors ; Baroreflex ; Blood pressure ; Blood Pressure - drug effects ; Cardiology ; Cardiovascular diseases ; Clinical trials ; Drug Resistance ; Drugs ; Electric Stimulation Therapy - adverse effects ; Electric Stimulation Therapy - instrumentation ; Female ; Health risks ; Humans ; Hypertension ; Hypertension - diagnosis ; Hypertension - physiopathology ; Hypertension - therapy ; Implantable Neurostimulators ; Implantation ; Long-term effects ; Male ; Medicine ; Medicine &amp; Public Health ; Middle Aged ; Original Paper ; Pressure measurement ; Prospective Studies ; Reduction ; Reflexes ; Therapy ; Time Factors ; Treatment Outcome</subject><ispartof>Clinical research in cardiology, 2020-04, Vol.109 (4), p.513-522</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2019</rights><rights>Clinical Research in Cardiology is a copyright of Springer, (2019). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-461310aa2f136ef25dc0ce60ae68fb233e910e1e985d7f926f433c7de77f3cad3</citedby><cites>FETCH-LOGICAL-c375t-461310aa2f136ef25dc0ce60ae68fb233e910e1e985d7f926f433c7de77f3cad3</cites><orcidid>0000-0002-1162-4682</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00392-019-01536-5$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00392-019-01536-5$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,41467,42536,51297</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31388741$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Wallbach, Manuel</creatorcontrib><creatorcontrib>Born, Ellen</creatorcontrib><creatorcontrib>Kämpfer, Deborah</creatorcontrib><creatorcontrib>Lüders, Stephan</creatorcontrib><creatorcontrib>Müller, Gerhard A.</creatorcontrib><creatorcontrib>Wachter, Rolf</creatorcontrib><creatorcontrib>Koziolek, Michael J.</creatorcontrib><title>Long-term effects of baroreflex activation therapy: 2-year follow-up data of the BAT Neo system</title><title>Clinical research in cardiology</title><addtitle>Clin Res Cardiol</addtitle><addtitle>Clin Res Cardiol</addtitle><description>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  &lt; 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  &lt; 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. 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Medical Complete (Alumni)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biochemistry Abstracts 1</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical research in cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wallbach, Manuel</au><au>Born, Ellen</au><au>Kämpfer, Deborah</au><au>Lüders, Stephan</au><au>Müller, Gerhard A.</au><au>Wachter, Rolf</au><au>Koziolek, Michael J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term effects of baroreflex activation therapy: 2-year follow-up data of the BAT Neo system</atitle><jtitle>Clinical research in cardiology</jtitle><stitle>Clin Res Cardiol</stitle><addtitle>Clin Res Cardiol</addtitle><date>2020-04-01</date><risdate>2020</risdate><volume>109</volume><issue>4</issue><spage>513</spage><epage>522</epage><pages>513-522</pages><issn>1861-0684</issn><eissn>1861-0692</eissn><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  &lt; 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  &lt; 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.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>31388741</pmid><doi>10.1007/s00392-019-01536-5</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-1162-4682</orcidid></addata></record>
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subjects Activation
Aged
Antihypertensive Agents - therapeutic use
Antihypertensives
Baroreceptors
Baroreflex
Blood pressure
Blood Pressure - drug effects
Cardiology
Cardiovascular diseases
Clinical trials
Drug Resistance
Drugs
Electric Stimulation Therapy - adverse effects
Electric Stimulation Therapy - instrumentation
Female
Health risks
Humans
Hypertension
Hypertension - diagnosis
Hypertension - physiopathology
Hypertension - therapy
Implantable Neurostimulators
Implantation
Long-term effects
Male
Medicine
Medicine & Public Health
Middle Aged
Original Paper
Pressure measurement
Prospective Studies
Reduction
Reflexes
Therapy
Time Factors
Treatment Outcome
title Long-term effects of baroreflex activation therapy: 2-year follow-up data of the BAT Neo system
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