An Implantable Carotid Sinus Baroreflex Activating System: Surgical Technique and Short-Term Outcome from a Multi-Center Feasibility Trial for the Treatment of Resistant Hypertension

Tordoir, Jan H.M.; Scheffers, Ingrid; Schmidli, Juerg; Savolainen, Hannu; Liebeskind, U.; Hansky, Bert; Herold, Ulf; Irwin, Eric D.; Kroon, Abraham A.; Leeuw, Peter de; Peters, Tim K.; Kieval, Robert S.; Cody, Robert J.

doi:10.1016/j.ejvs.2006.11.025

Cited by 114 publications

(72 citation statements)

References 28 publications

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“…For BAT, the Barostim neo™ (CVRx, Minneapolis, USA) was used as described previously [21,22]. The BAT device consists of a lead, which is sutured directly on carotis sinus, and a pulse generator implanted in an infraclavicular position by performing a minimal-invasive procedure, including intraoperative testing for optimal placement of the lead for BP response [21,22].…”

Section: Methodsmentioning

confidence: 99%

“…The BAT device consists of a lead, which is sutured directly on carotis sinus, and a pulse generator implanted in an infraclavicular position by performing a minimal-invasive procedure, including intraoperative testing for optimal placement of the lead for BP response [21,22]. The optimal response during the lead position was assumed if 30 seconds of electrical stimulation (125 µs, 6 mV, 80 Hz) of the carotid sinus reduces SBP by at least 10 mm Hg and heart rate by 5 beats/min.…”

Section: Methodsmentioning

confidence: 99%

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Impact of Baroreflex Activation Therapy on Renal Function - A Pilot Study

Wallbach¹,

Lehnig²,

Schroer

et al. 2014

Am J Nephrol

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Background/Aims: Resistant hypertension and chronic kidney disease (CKD) are interlinked via sympathetic overdrive. Baroreflex activation therapy (BAT) has been shown to chronically reduce blood pressure (BP) in patients with resistant hypertension. The effect of BAT on renal function in CKD patients with resistant hypertension has not been reported. The aim of this study was to investigate the effect of sympathetic inhibition on renal function in CKD patients. Methods: 23 CKD patients with resistant hypertension were prospectively treated with BAT. Analyses were performed before and 6 months after the start of BAT. The renal function was analyzed by creatinine, cystatin C, glomerular filtration rate (GFR), renin, aldosterone, fractioned and 24-hour sodium excretion and analyses of urine marker proteins. The purpose of the control group was to investigate the influence of treating patients in a center for hypertension and regression to the mean on investigated variables. Results: The office mean BP decreased from 116.9 ± 20.9 mm Hg to 104.2 ± 22.2 mm Hg (p < 0.01), while the number of prescribed antihypertensive classes decreased from 6.6 ± 1.6 to 6.1 ± 1.7 (p = 0.02). Proteinuria and albuminuria decreased from a median of 283.9 and 47.7 to 136.5 (p = 0.01) and 45.0 mg/g creatinine (p = 0.01) with pronounced effects in higher CKD stage III + IV compared to I + II (p < 0.01). CKD-EPI cystatin C equation improved from 53.6 ± 22.7 to 60.4 ± 26.1 ml/min (p = 0.02). While creatinine and GFR were impaired after a period of 6 months, no changes of proteinuria, albuminuria, or BP were obtained in control patients. Conclusion: The data of this prospective trial demonstrate potential nephroprotective effects of BAT in therapy-resistant hypertension in CKD patients by a reduction of BP, proteinuria and moreover, a stabilization of estimated GFR.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Impact of Baroreflex Activation Therapy on Renal Function - A Pilot Study

Wallbach¹,

Lehnig²,

Schroer

et al. 2014

Am J Nephrol

View full text Add to dashboard Cite

show abstract

“…This consisted of an implantable pulse generator and leads that were tunneled subcutaneously and attached to each carotid sinus. 6 Patients were seen at regular intervals, and stimulation parameters (amplitude, frequency, and pulse width) were individually adjusted to optimize treatment. Patients were either stimulated at one side (left or right) or bilaterally, depending on which produced the greatest response.…”

Section: See Editorial Commentary Pp 782-784mentioning

confidence: 99%

Sustained Reduction of Blood Pressure With Baroreceptor Activation Therapy

et al. 2017

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Baroreflex activation therapy (BAT) is a novel way of treating hypertensive patients who respond inadequately to medical therapy. After short-term human studies had shown that electric stimulation of the carotid sinus can lower blood pressure, 1,2 the DEBuT-HT study (Device-Based Therapy of Hypertension) demonstrated a substantial and sustained reduction in blood pressure over a period of 3 months in treatment-resistant hypertensive patients.3 Subsequently, the Rheos Pivotal Trial evaluated the effect of BAT in a doubleblind, randomized, prospective, sham-controlled trial in which patients were randomized to receive BAT either immediately or 6 months after implantation of the Rheos device.4 This study also showed that BAT can safely reduce blood pressure in patients with resistant hypertension in the long run. At this point, however, the technique has not yet been introduced into clinical practice. One of the drawbacks is that it is an invasive method, and there is still some concern as to whether efficacy is sustained over longer periods of time. In this regard, the 3 trials that have evaluated this device-based therapy (the US Rheos Feasibility Trial, the DEBuT-HT Trial, and the Rheos Pivotal Trial) offered a unique opportunity to address this problem. Indeed, after the formal completion of both trials, patients were followed up at regular intervals to assess the long-term effect of BAT on blood pressure and heart rate. The purpose of the present report, therefore, is to describe the follow-up results of BAT during a 6-year period. MethodsThe present analyses are based on the group of patients who were included in the US Rheos Feasibility Trial, 2 the DEBuT-HT Trial, 3 and See Editorial Commentary, pp 782-784Abstract-Baroreflex activation therapy is a novel technique for treating patients with resistant hypertension. Although short-term studies have demonstrated that it lowers blood pressure, long-term results have not yet been reported. The aim of the present study is to assess the long-term efficacy and safety of baroreflex activation therapy. Long-term followup data were analyzed from all patients who had been included in 1 of the 3 trials that focused on treatment-resistant hypertensive patients. Altogether, 383 patients were available for analysis: 143 of these had completed 5 years of followup and 48 patients had completed 6 years of follow-up. In the entire cohort, office systolic blood pressure fell from 179±24 mm Hg to 144±28 mm Hg (P<0.0001), whereas office diastolic pressure dropped from 103±16 mm Hg to 85±18 mm Hg (P<0.0001). Heart rate fell from 74±15 beats per minute to 71±13 beats per minute (P<0.02). The effect of baroreflex activation therapy is greater than average in patients with signs of heart failure and less than average in patients with isolated systolic hypertension. In ≈25% of patients, it was possible to reduce the number of medications from a median of 6 to a median of 3. Temporary side effects, related to either the surgical procedure or the cardiovascular instability, do occur, bu...

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“…5,6 The device mimics the body's blood pressure (BP) regulator by electrically activating the baroreceptors that sense an aberrant increase in the BP level. 7 Bypassing mechanotransduction by electric activation of the carotid sinus provides afferent baroreceptor input into the brain.…”

mentioning

confidence: 99%

Effects of Baroreflex Activation Therapy on Ambulatory Blood Pressure in Patients With Resistant Hypertension

et al. 2016

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Baroreflex activation therapy (BAT) has been demonstrated to decrease office blood pressure (BP) in the randomized, double-blind Rheos trial. There are limited data on 24-hour BP changes measured by ambulatory BP measurements (ABPMs) using the first generation rheos BAT system suggesting a significant reduction but there are no information about the effect of the currently used, unilateral BAT neo device on ABPM. Patients treated with the BAT neo device for uncontrolled resistant hypertension were prospectively included into this study. ABPM was performed before BAT implantation and 6 months after initiation of BAT. A total of 51 patients were included into this study, 7 dropped out from analysis because of missing or insufficient follow-up. After 6 months, 24-hour ambulatory systolic (from 148±17 mm Hg to 140±23 mm Hg, P <0.01), diastolic (from 82±13 mm Hg to 77±15 mm Hg, P <0.01), day- and night-time systolic and diastolic BP (all P ≤0.01) significantly decreased while the number of prescribed antihypertensive classes could be reduced from 6.5±1.5 to 6.0±1.8 ( P =0.03). Heart rate and pulse pressure remained unchanged. BAT was equally effective in reducing ambulatory BP in all subgroups of patients. This is the first study demonstrating a significant BP reduction in ABPM in patients undergoing chronically stimulation of the carotid sinus using the BAT neo device. About that BAT-reduced office BP and improved relevant aspects of ABPM, BAT might be considered as a new therapeutic option to reduce cardiovascular risk in patients with resistant hypertension. Randomized controlled trials are needed to evaluate BAT effects on ABPM in patients with resistant hypertension accurately.

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An Implantable Carotid Sinus Baroreflex Activating System: Surgical Technique and Short-Term Outcome from a Multi-Center Feasibility Trial for the Treatment of Resistant Hypertension

Abstract: These preliminary data suggest an acceptable safety of the procedure with a low rate of adverse events and support further clinical development of baroreflex activation as a new concept to treat resistant hypertension.

Cited by 114 publications

References 28 publications

Impact of Baroreflex Activation Therapy on Renal Function - A Pilot Study

Impact of Baroreflex Activation Therapy on Renal Function - A Pilot Study

Sustained Reduction of Blood Pressure With Baroreceptor Activation Therapy

Effects of Baroreflex Activation Therapy on Ambulatory Blood Pressure in Patients With Resistant Hypertension

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