Sustained Reduction of Blood Pressure With Baroreceptor Activation Therapy

Abstract

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...

Clinical Implications of Baroreflex Sensitivity in Type 2 Diabetes

“…Recently, baroreflex activation therapy (BAT), which activates baroreceptors in the carotid sinus by electrostimulation induced by an implantable device (Rheos System, CVRx Inc., Minneapolis, MN, USA), inhibits sympathetic nerve activity, and eventually decreases blood pressure, has drawn attention as a nondrug treatment. BAT was shown to decrease blood pressure 39,40) and BPV 41) in patients with resistant hypertension. BAT also improved BRS and muscle sympathetic nerve activity in patients with chronic heart failure with elevated sympathetic nerve activity.…”

Pacemaker‐Mediated Programmable Hypertension Control Therapy

“…These include baroreceptor activation therapy,17, 18, 19 renal denervation,7, 20 arteriovenous shunting,10, 21 carotid body resection or denervation,12, 22 and mechanical stimulation of the baroreceptors 23. Prior review articles have provided overviews and comparisons of these different approaches and will not be repeated here,24, 25 other than to say that treatment of isolated systolic hypertension (ie, patients with office diastolic blood pressure <90 mm Hg), which is characterized by increased vascular stiffness, has proved to be particularly challenging for some of these approaches, with such patients excluded from the recently complete SPYRAL HTN‐OFF MED study 19, 26. It is therefore noteworthy that 78% of patients in the present study had isolated systolic hypertension with an excellent response rate.…”

Effects of different input pressure waveforms on the carotid sinus baroreflex-mediated sympathetic arterial pressure response in rats

“…Clinical implication. In addition to a possible application to the LVAD therapy, the issue of baroreflex responses to pulsatile blood pressure signals at the carotid sinus is especially important in the context of the advent of nonpharmacological therapies for hypertension such as the electrical baroreflex activation (6,28). A previous study has shown that a burstmode stimulation is more effective than a constant-mode stimulation in reducing AP during an electrical stimulation of the myelinated fibers of the aortic depressor nerve (7).…”