Objectives: First-generation radiofrequency renal denervation devices may have had limited efficacy due to incomplete circumferential ablation and dependence on individual operator technique. This study evaluated a next-generation catheter-based technology using ultrasound designed to maximize nerve coverage using circumferential ultrasound energy.
Methods: This was a prospective, multicenter, nonrandomized, postmarket study evaluating the safety and efficacy of an endovascular ultrasound renal denervation system (Paradise) in patients who met the European Society of Hypertension/European Society of Cardiology definition of resistant hypertension. Major exclusion criteria included renal artery stenosis and renal insufficiency. Patients were followed for 12 months. Safety and efficacy endpoints included procedural safety and renal artery patency, as well as changes in systolic office and 24-h ambulatory bllod pressure (BP) measurement.
Results: A total of 96 patients from eight European sites were included. Mean age was 63.9 years and 41% of patients were female. At baseline, mean 24-h ambulatory BP was 156.2/88.4 ± 15.4/12.7 mmHg, and mean office BP was 176.2/95.0 ± 20.6/16.0 mmHg. Patients were on average on 5.1 ± 2.5 antihypertensive agents. At 12 months, the average 24-h ambulatory BP change was -7.5/-3.8 ± 18.3/10.6 mmHg (P = 0.0007; P = 0.0024) with an average office BP change of -15.0/-7.0 ± 27.0/12.3 mmHg (P < 0.0001 for both). At 12 months, there was a single patient death unrelated to the device or procedure.
Conclusion: This single-arm study represents the largest cohort of patients treated with endovascular ultrasound renal denervation to date. Within this trial, the therapy appeared safe and resulted in sustained reductions in both office BP and 24-h ambulatory BP through 12 months.