• Vascular Annual Meeting^®
• Registration
• Hotel Reservations
• Schedule-at-a-Glance
• Program-in-Detail
• Wednesday, June 9 - Postgraduate Courses Day
• Thursday, June 10
• Friday, June 11
• Saturday, June 12
• Sunday, June 13
• International Attendee Information
• General Information
• New in 2010
• Call for Abstracts
• Speaker Information
• Exhibitor Information
• Alumni Association Information
• Future Meeting Dates
• 2009 Meeting Information
• Contact Us

Home > Vascular Annual Meeting^® > PP29. Unilateral Baroreceptor Stimulation Is as Effective...

PP29. Unilateral Baroreceptor Stimulation Is as Effective as Bilateral Therapy for Blood Pressure Reduction in Patients with Resistant Hypertension: Multicenter Trial Results of the Rheos® System

John Blebea1, Christopher Kaufman2
1Case Western Reserve University, Cleveland, OH; 2CVRx, Minneapolis, MN

OBJECTIVES: Surgically-implanted carotid baroreceptor stimulators for the treatment of resistant hypertension are being evaluated in a prospective multicenter research trial. Although bilateral implantation and activation is prescribed by protocol, we examined the effect of unilateral stimulation to determine if satisfactory results can be attained with single-sided treatment.

METHODS: Patients were recruited into the trial if they had a blood pressure (BP)≥180/85 while on=3 antihypertensive drugs. The Rheos® system consists of a pacemaker-like battery/pulse generator unit implanted subcutaneously in an infraclavicular position. Electrical stimulator leads were tunneled subcutaneously and, through separate neck incisions, circumferentially wrapped around the carotid bifurcation. Once the electrodes and device were implanted, dose-response voltage testing was done for each side and bilaterally. Similar testing was performed post-operatively at each follow-up visit. Data is reported as mean±sem. Changes in BP and heart rate (HR) were analyzed by ANOVA.

RESULTS: A total of 170 patients (95 males/75 females) with a mean age of 55±1 years were implanted. With both unilateral and bilateral stimulation, there were significant intra-operative decreases in both systolic and diastolic BP, along with HR. These therapeutic results were maintained at one year follow-up (n=49) at which time a large percentage of patients (53%) were being treated unilaterally and there were no differences in results between unilateral and bilateral stimulation:

Table 1.

* p<0.01 vs. Baseline; # p<0.05 vs. Bilateral
Two-year follow-up data (n=32) indicated a sustained systolic BP reduction of 23±6 mmHg [p<0.001 vs. baseline].

CONCLUSIONS: Baroreceptor stimulation has sustained efficacy in decreasing both systolic and diastolic blood pressure in patients with resistant hypertension. Similar results were attained with unilateral stimulation suggesting single-sided implantation may be an acceptable clinical alternative in the future.

AUTHOR DISCLOSURES:  J. Blebea, CVRx; C. Kaufman, CVRx.