FUNCTIONAL SAFETY IN RESISTANT HYPERTENSIVE PATIENTS WITH BAROREFLEX ACTIVATION THERAPY: PP.33.298

Abstract

Objective: Present study measures functional safety of a novel implantable device to treat resistant hypertension. This device activates the carotid baroreflex to reduce blood pressure. Effects on functional safety are to be investigated. Methods: We measured the effects of chronic continuous device therapy on renal function, (using serum creatinine), ability to exercise (using 6-minute hall walk), development of carotid artery stenosis (using ultrasound), and occurrence of orthostatic hypotension (using postural-related blood pressure readings). Results: Blood pressure (BP) was significantly reduced by the device with 27/13 mmHg in 38 subjects who completed 3 months of therapy. This reduction was sustained and showed a mean fall of 31/18 mmHg in 31 subjects who completed 1 year of therapy (all: P < 0.005). Serum creatinine, measured in 22 subjects was 91.3 μmol/l after 1 year of therapy and not changed compared with 91.8 μmol/l at pre-implant. The walk distance was significantly increased after 1 year from 469 m to 516 m (P = 0.02) as measured in 14 subjects. None of the subjects had developed carotid artery stenosis after 1 year and no subjects had shown orthostatic hypotension. Conclusions: Chronic carotid baroreflex activation significantly reduces arterial pressure, causing no decrease in renal function and an increase in ability to exercise. There is no evidence for development of carotid artery stenosis or the occurrence of orthostatic hypotension. The reproducibility of these findings will have to be determined via a randomized controlled trial which is currently underway.