Abstract 17520: Renal Sympathetic Denervation for the Management of Chronic Hypertension (RELIEF): 40 Patient Analysis
Introduction RSDN using a specialized solid-tip RFA catheter has recently been demonstrated to offer safe and sustained systemic blood pressure lowering in patients with refractory hypertension. For cardiac tissue ablation, RFA technology has evolved from non-irrigated to saline-irrigated ablation electrodes to improve both safety and effectiveness. Thus we considered whether renal sympathetic denervation (RSDN) could be achieved using an off-the-shelf saline-irrigated radiofrequency ablation (RFA) catheter typically employed for cardiac tissue ablation.
Methods In this prospective, randomized, single-blinded trial of 40 patients with hypertension refractory to ≥3 anti-hypertensive drugs, including one diuretic, patients were randomized 1:1 experimental (bilateral RSDN with a saline-irrigated RFA catheter) : sham procedure control (manipulation of catheter within the renal arteries without the delivery of any energy). Prior to randomization, all patients underwent renal angiography to assess the appropriateness of the renal anatomy for ablation. Ambulatory blood pressure recordings (24-hour) were obtained at baseline, 1, and 3 months post-procedure.
Results A total of 40 patients were randomized to either experimental (n=19) or sham procedure control (n=21) and followed for 3 months. At the 3-month follow-up, 1) the 24-hour systolic/diastolic BPs decreased by -17/-12 mmHg (p=0.006/p=0.001) in the bilateral RSDN group vs -5/-5 mm Hg (p=0.22/p=0.42) in the sham control group (Table).
Conclusions These data provide the proof-of-principle that RSDN can be performed safely and effectively using an off-the-shelf saline-irrigated radiofrequency ablation catheter.
- © 2012 by American Heart Association, Inc.