Safety profile of baroreflex activation therapy (NEO) in patients with resistant hypertension

Wallbach, Manuel; Böhning, Enrico; Lehnig, Luca-Yves; Schroer, Charlotte; Müller, Gerhard A.; Wachter, Rolf; Lüders, Stephan; Zenker, Dieter; Koziolek, Michael

doi:10.1097/hjh.0000000000001753

Cited by 21 publications

(18 citation statements)

References 34 publications

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“…Nonetheless, the findings from these studies are consistent in that they show appreciable lowering of BP in patients with RHT after no less than 6-12 months of therapy. [55][56][57][58][59][60] Acute off transient increases in BP in response to brief device deactivation in patients with chronic BA confirm true BP lowering with the Barostim neo system. In addition, these studies have included patients with prior RDN and protracted HT.…”

Section: Clinical Studies With the Barostim Neo Systemmentioning

confidence: 76%

Device-Based Neuromodulation for Resistant Hypertension Therapy

Lohmeier

Hall

2019

Circulation Research

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Despite availability of effective drugs for hypertension therapy, significant numbers of hypertensive patients fail to achieve recommended blood pressure (BP) levels while on ≥3 antihypertensive drugs of different classes. These individuals have a high prevalence of adverse cardiovascular events and are defined as having resistant hypertension (RHT) although nonadherence to prescribed antihypertensive medications is common in patients with apparent RHT. Furthermore, apparent and true RHT often display increased sympathetic activity. Based on these findings, technology was developed to treat RHT by suppressing sympathetic activity with electrical stimulation of the carotid baroreflex and catheter-based renal denervation (RDN). Over the last 15 years, experimental and clinical studies have provided better understanding of the physiological mechanisms that account for BP lowering with baroreflex activation (BA) and RDN and, in so doing, have provided insight into which patients in this heterogeneous hypertensive population are most likely to respond favorably to these device-based therapies. Experimental studies have also played a role in modifying device technology after early clinical trials failed to meet key endpoints for safety and efficacy. At the same time, these studies have exposed potential differences between BA and RDN and common challenges that will likely impact antihypertensive treatment and clinical outcomes in patients with RHT. In this review, we emphasize physiological studies that provide mechanistic insights into BP lowering with BA and RDN in the context of progression of clinical studies, which are now at a critical point in determining their fate in RHT management.

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Section: Clinical Studies With the Barostim Neo Systemmentioning

confidence: 76%

Device-Based Neuromodulation for Resistant Hypertension Therapy

Lohmeier

Hall

2019

Circulation Research

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“…The Barostim Neo system (CVRx, Inc., Minneapolis, Minnesota), a second-generation carotid sinus electrical stimulation device, overcomes these disadvantages, has a longer battery life, requires unilateral carotid sinus peri-implantation of the stimulating electrodes, and has been shown to be effective in controlling hypertension in several clinical studies ( 173 – 175 ). Although the system has a high rate of AEs, with a small sample study showing mild local adverse effects in 97.6% of subjects, most of which can be resolved by adjusting the pulse transmitter settings ( 176 ). In addition to lowering BP, the BeAT-HF study confirmed that BAT with the Neo system was beneficial in patients with HFrEF.…”

Section: Other Regulation Methodsmentioning

confidence: 99%

Device-Based Sympathetic Nerve Regulation for Cardiovascular Diseases

Xiong

et al. 2021

Front. Cardiovasc. Med.

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Sympathetic overactivation plays an important role in promoting a variety of pathophysiological processes in cardiovascular diseases (CVDs), including ventricular remodeling, vascular endothelial injury and atherosclerotic plaque progression. Device-based sympathetic nerve (SN) regulation offers a new therapeutic option for some CVDs. Renal denervation (RDN) is the most well-documented method of device-based SN regulation in clinical studies, and several large-scale randomized controlled trials have confirmed its value in patients with resistant hypertension, and some studies have also found RDN to be effective in the control of heart failure and arrhythmias. Pulmonary artery denervation (PADN) has been clinically shown to be effective in controlling pulmonary hypertension. Hepatic artery denervation (HADN) and splenic artery denervation (SADN) are relatively novel approaches that hold promise for a role in cardiovascular metabolic and inflammatory-immune related diseases, and their first-in-man studies are ongoing. In addition, baroreflex activation, spinal cord stimulation and other device-based therapies also show favorable outcomes. This review summarizes the pathophysiological rationale and the latest clinical evidence for device-based therapies for some CVDs.

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“…Patients who had stage 3 or 4 CKD experienced a greater reduction in proteinuria, and the eGFR remained stable in the treated patients despite the reduction of systemic blood pressure. 30 The MobiusHD device (Vascular Dynamics, Mountain View, CA), another secondgeneration device, is a catheter-delivered self-expanding intracarotid implant designed to activate the barorefl ex (Figure 3). 31 In its fi rst study in humans, it seemed successful in reducing blood pressure, and a larger trial designed to evaluate the safety and effectiveness of the MobiusHD device is actively enrolling patients.…”

Section: Studies Of Barorefl Ex Activation Therapymentioning

confidence: 99%