Abstract 15050: Long Term Safety and Efficacy of a Multi-Electrode Renal Artery Denervation Catheter in Patients With Drug-Resistant Hypertension: Twelve and 18 Month Results of a First-in-Human, Multicenter Study
Background: Recent estimates indicate that 8-12% of patients with hypertension do not respond adequately to optimal medical therapy. Sympathetic renal artery denervation is emerging as a viable treatment option for patients with drug resistant HTN but long-term results using multi-electrode ablations systems have not been reported.
Methods and results: The EnligHTN renal denervation system (St Jude Medical) has 4 electrodes attached on a basket mounted at the tip of the catheter and can deliver multiple transmural lesions in a predetermined pattern. The EnligHTN-I first-in-human study was designed to assess the safety and efficacy of this multi-electrode ablation system in patients with drug-resistant hypertension. A total of 46 pts (av. age 60±10yrs, on 4.8±0.6 meds) were enrolled. Of these pts 33% were female, 98% were white, 20% had Coronary Artery Disease, 59% had hyperlipidemia, 33% had type II Diabetes Mellitus, and 30% had history of sleep apnea. On average 7.7±0.8 lesions were created in the right renal artery and 7.4±1.4 in the left.
Baseline av. office BP was 176/96 mmHg and average 24 hr ambulatory BP 150/83 mmHg. Average reductions (mmHg) of office BP at 1, 3, 6 and 12 months were -28/10, -27/10, -26/10 and -27/11 mmHg (p<0.001) respectively and for 24hr ambulatory BP -10/5, -10/5 and -10/6 mmHg (p<0.001) data for 12 month N/A. At 12 months 80% of patients were responders, 75% had office BP <160 systolic and 29% had normalized BP. At 6 months there was a small reduction in the estimated glomerular filtration rate (from 87 to 82 μL/min/1.73m2) driven by a small increase in serum creatinine from 78 to 83 μmol/L), but both values returned to baseline at 12 months. Cystatin C levels and microalbuminuria improved significantly up to 12 months. There were 3 device/procedure related serious adverse events reported to date: hypertensive renal disease progression, symptomatic hypotension and worsening of pre-existing renal artery stenosis. Eighteen month efficacy and safety data will be available to be presented at the meeting.
Conclusions: We conclude that data demonstrates that the EnligHTN ablation system continues to be safe and effective in the treatment of patients with drug-resistant hypertension.
- © 2013 by American Heart Association, Inc.