Catheter-Based Renal Denervation for Resistant Hypertension
12-Month Results of the EnligHTN I First-in-Human Study Using a Multielectrode Ablation System
Renal denervation has emerged as a novel approach for the treatment of patients with drug-resistant hypertension. To date, only limited data have been published using multielectrode radiofrequency ablation systems. In this article, we present the 12-month data of EnligHTN I, a first-in-human study using a multielectrode ablation catheter. EnligHTN I enrolled 46 patients (average age, 60±10 years; on average 4.7±1.0 medications) with drug-resistant hypertension. Eligible patients were on ≥3 antihypertensive medications and had a systolic blood pressure (BP) ≥160 mm Hg (≥150 mm Hg for diabetics). Bilateral renal artery ablation was performed using a percutaneous femoral approach and standardized techniques. The average baseline office BP was 176/96 mm Hg, average 24-hour ambulatory BP was 150/83 mm Hg, and average home BP was 158/90 mm Hg. The average reductions (mm Hg) at 1, 3, 6, and 12 months were as follows: office: −28/−10, −27/−10, −26/−10, and −27/−11 mm Hg (P<0.001 for all); 24-hour ambulatory: −10/−5, −10/−5, −10/−6 (P<0.001 for all), and −7/−4 for 12 months (P<0.0094). Reductions in home measurements (based on 2-week average) were −9/−4, −8/−5,−10/−7, and −11/−6 mm Hg (P<0.001 at 12 months). At 12 months, there were no signals of worsening renal function and no new serious or life-threatening adverse events. One patient with baseline nonocclusive renal artery stenosis progressed to 75% diameter stenosis, requiring renal artery stenting. The 12-month data continue to demonstrate safety and efficacy of the EnligHTN ablation system in patients with drug-resistant hypertension. Home BP measurements parallel measurements obtained with 24-hour ambulatory monitoring.
- Received March 24, 2014.
- Revision received April 6, 2014.
- Accepted May 16, 2014.
- © 2014 American Heart Association, Inc.