BACKGROUND: The Rheos System is a chronically implanted carotid sinus baroreflex activating system with a pulse generator and bilateral perivascular carotid sinus leads (CSLs) that is being evaluated in prospective clinical trials for the treatment of drug-resistant hypertension. We evaluated carotid artery structural integrity after implantation of the CSLs. METHODS: To assess the effect of chronic CSL attachment, 29 CSLs were implanted on the common carotid arteries of eight sheep. The studies were terminated at 3 and 6 months postimplantation to assess anatomic and histologic changes. Additionally, 10 patients with resistant hypertension were enrolled in the Rheos Multicenter Feasibility Trial. Duplex ultrasound (DUS) was performed before device implantation and at 1 and 4 months postimplantation in this patient cohort. An independent core laboratory assessed all DUSs. RESULTS: Ovine carotid angiography revealed no significant stenoses, while anatomic and histologic evaluations demonstrated electrode encapsulation in a thin layer of connective tissue with no evidence of stenosis, erosion, or inflammation. DUS evaluation revealed no significant increase in peak systolic velocities of the common and internal carotid arteries 1 and 4 months after initial implantation, indicating a lack of injury, remodeling, or stenosis. CONCLUSION: The current data suggest that the CSLs used with the Rheos System are not associated with the development of carotid stenosis or injury. These short-term data support the concept of CSL placement and merit long-term investigation in a larger multicenter prospective trial. Copyright 2009. Published by Elsevier Inc.
BACKGROUND: The Rheos System is a chronically implanted carotid sinus baroreflex activating system with a pulse generator and bilateral perivascular carotid sinus leads (CSLs) that is being evaluated in prospective clinical trials for the treatment of drug-resistant hypertension. We evaluated carotid artery structural integrity after implantation of the CSLs. METHODS: To assess the effect of chronic CSL attachment, 29 CSLs were implanted on the common carotid arteries of eight sheep. The studies were terminated at 3 and 6 months postimplantation to assess anatomic and histologic changes. Additionally, 10 patients with resistant hypertension were enrolled in the Rheos Multicenter Feasibility Trial. Duplex ultrasound (DUS) was performed before device implantation and at 1 and 4 months postimplantation in this patient cohort. An independent core laboratory assessed all DUSs. RESULTS: Ovine carotid angiography revealed no significant stenoses, while anatomic and histologic evaluations demonstrated electrode encapsulation in a thin layer of connective tissue with no evidence of stenosis, erosion, or inflammation. DUS evaluation revealed no significant increase in peak systolic velocities of the common and internal carotid arteries 1 and 4 months after initial implantation, indicating a lack of injury, remodeling, or stenosis. CONCLUSION: The current data suggest that the CSLs used with the Rheos System are not associated with the development of carotid stenosis or injury. These short-term data support the concept of CSL placement and merit long-term investigation in a larger multicenter prospective trial. Copyright 2009. Published by Elsevier Inc.