Renal denervation of accessory renal arteries: First experience in 10 subjects with uncontrolled hypertension using a novel RF balloon catheter.

Abstract

Purpose: Renal sympathetic denervation (RSDN) using radiofrequency (RF) has emerged as a safe intervention, effectively reducing blood pressure in patients with uncontrolled hypertension. Accessory renal arteries (ARA) are prevalent in 25%-30% patients; however these patients have been excluded from previous studies. A patient subset (N = 10) in the REDUCE-HTN Clinical Study (NCT01541865) underwent successful RSDN of the primary, and at least one accessory, renal artery. Material(s) and Method(s): Subjects with ARA (62 +/- 8 years, 90% men, 5.2 antihypertensive medications) were treated using the V2 Renal Denervation System (Boston Scientific, MA) that includes up to 8 gold electrodes mounted on a balloon surface, which deliver a temperature- controlled (approximately 68degreeC) bipolar RF energy for 30 s. The ARA average diameter was 4.1 +/- 1 mm, and 90% patients underwent RSDN in one ARA. ARAs were treated with an average of 8.5 +/- 3 electrodes and used mainly 4 and 5 mm balloon diameters. The main renal arteries were treated with an average of 20 electrodes. Result(s): No peri-procedural complications were reported and immediate post-procedure angiography results indicated an absence of renal artery spasm and other deleterious effects. Preliminary results indicate significant improvement in the ARA subset at one month post-procedure with a mean reduction in office blood pressure (OBP) of -22/-9 mmHg (177/92 to 155/83, p < 0.05). Six-month results will be presented. Conclusion(s): The results described herein demonstrate that the Vessix RSDN procedure of both the primary and accessory renal arteries is a safe therapeutic option, with initial trends of significant OBP reduction for patients with uncontrolled hypertension.