TCT-212 First Report of the 6-Month First in Human results of the OneShot™ Renal Denervation System: The RHAS Study

Abstract

Background: Catheter-based selective renal sympathetic denervation has emerged as a new therapeutic option for patients with resistant hypertension. Recent studies have shown that ablation of the renal sympathetic nerves using radiofrequency (RF) energy delivered from within the renal artery is safe and effective. The OneShot™ device (Covidien, Campbell, CA) is a balloon-based RF system using a mounted spiral electrode with a unique feature of irrigation of the vessel lumen during treatment. The non-compliant balloon is inflated under low pressure (1 atm) in the renal artery. The electrode delivers RF energy to ablate adjacent nerve bundles with a single 2-minute treatment. Methods: The RHAS study was a single-center feasibility study performed at Mercy Hospital in Auckland, New Zealand. Eligible patients had an office systolic blood pressure (SBP) ≥160 mmHg (≥150 if diabetic) despite a drug regimen that included two or more antihypertensive medications. Renal artery diameters were 4-7mm. The primary endpoint was the ability to insert the OneShot™ device into each renal artery and deliver RF energy. Secondary endpoints included office SBP at 6 months. Results: Nine patients were enrolled; baseline characteristics and outcomes are shown below. The technical success rate was 88.9%. One failure occurred in the first enrolled patient and was due to an incorrect software setting which inhibited delivery of RF energy. All remaining patients had both renal arteries treated with the OneShot™ device. The mean procedure time (device insertion to end of treatment) was 16 minutes. At 30 days, the mean office SBP was 155 ± 19 mmHg, a change of -31 ± 14 mmHg. Six-month results are pending. (Table Presented) Conclusions: The RHAS trial demonstrated rapid delivery of RF energy for renal sympathetic denervation using the OneShot™ device with safe blood pressure reduction at 1 month. Six-month data will be available at time of presentation.