Abstract 19523: Catheter-Based Renal Denervation for the Treatment of Patients with Drug-Resistant Hypertension: EnligHTN I: Three-Month Data of a First in Man Study Using a Multi-Electrode Radiofrequency Ablation Catheter

Abstract

Introduction: Renal denervation has emerged as a novel approach for the treatment of patients with drug-resistant hypertension. To-date studies in humans have been done using a single-tip electrode radiofrequency ablation catheter to achieve circumferential sympathetic fiber interruption through the renal artery wall. We investigated the safety and efficacy of a multi-electrode catheter ablation system developed by St Jude Medical (EnligHTN). Methods and results: The EnligHTN catheter has 4 electrodes attached on a basket mounted at the tip of the catheter. The basket is collapsed and can be expanded via an external mechanism once the catheter is placed in the desired location of the renal artery. The electrodes can then be activated sequentially to achieve the desired lesion pattern. In preclinical studies, in large animal models we found that using a predetermined algorithm, transmural lesions can be placed strategically in the renal artery so to achieve optimal renal denervation. In the present study we assessed the efficacy and safety of the EnligHTN catheter in 46 patients with drug resistant hypertension (av. age 60±10years, 33% women, BMI 32kg/m², 20% with CAD, 59% with hyperlipidemia , 33% with type II DM and 30% with sleep apnea). Patients were on an avg. of 4±0.6 antihypertensive medications at baseline. Bilateral renal nerve ablation was done using the femoral percutaneous approach. On av. 7.7±0.8 lesions were created in the right renal artery and 7.4±1.4 lesions in the left renal artery. The median procedure time was 34 minutes. At one month there was a 28/10 mmHg (n=46) reduction in BP (p<0.001) and at three months a 35/14mmHg (n=24) reduction (baseline BP of 176±16). There was no significant change in serum creatinine or eGFR. There were no significant procedure related complications. Small hematomas were noted in 4 patients, vasovagal reaction in 3 and transient bradycardia in 1. Conclusions: In conclusion this data indicates that the EnligHTN ablation system is safe and effective. Sympathetic renal denervation can substantially improve BP control in patients with drug resistant hypertension.