title: Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial.
abstract: OBJECTIVE
  Catheter-based renal artery sympathetic denervation has emerged as a novel therapy for treatment of patients with drug-resistant hypertension. Initial studies were performed using a single electrode radiofrequency catheter, but recent advances in catheter design have allowed the development of multi-electrode systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and efficacy of the EnligHTN(™) multi-electrode system.
  
  
  RESULTS
  We conducted the first-in-human, prospective, multi-centre, non-randomized study in 46 patients (67% male, mean age 60 years, and mean baseline office blood pressure 176/96 mmHg) with drug-resistant hypertension. The primary efficacy objective was change in office blood pressure from baseline to 6 months. Safety measures included all adverse events with a focus on the renal artery and other vascular complications and changes in renal function. Renal artery denervation, using the EnligHTN system significantly reduced the office blood pressure from baseline to 1, 3, and 6 months by -28/10, -27/10 and -26/10 mmHg, respectively (P < 0.0001). No acute renal artery injury or other serious vascular complications occurred. Small, non-clinically relevant, changes in average estimated glomerular filtration rate were reported from baseline (87 ± 19 mL/min/1.73 m2) to 6 months post-procedure (82 ± 20 mL/min/1.73 m2).
  
  
  CONCLUSIONS
  Renal sympathetic denervation, using the EnligHTN multi-electrode catheter results in a rapid and significant office blood pressure reduction that was sustained through 6 months. The EnligHTN system delivers a promising therapy for the treatment of drug-resistant hypertension.
authors.affiliation: Cardiovascular Research Centre, c/o The Cardiovascular Investigational Unit, Level 6 Theatre Block, University of Adelaide, Royal Adelaide Hospital, Adelaide 5000, Australia. stephen.worthley@adelaide.edu.au
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Worthley
authors.forename: Costas P
authors.initials: CP
authors.lastname: Tsioufis
authors.forename: Matthew I
authors.initials: MI
authors.lastname: Worthley
authors.forename: Ajay
authors.initials: A
authors.lastname: Sinhal
authors.forename: Derek P
authors.initials: DP
authors.lastname: Chew
authors.forename: Ian T
authors.initials: IT
authors.lastname: Meredith
authors.forename: Yuvi
authors.initials: Y
authors.lastname: Malaiapan
authors.forename: Vasilios
authors.initials: V
authors.lastname: Papademetriou
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001794:Blood Pressure / Q000502:physiology; D018660:Blood Pressure Monitoring, Ambulatory; D017115:Catheter Ablation / Q000295:instrumentation / Q000379:methods*; D003404:Creatinine / Q000378:metabolism; D055316:Cystatin C / Q000378:metabolism; D004566:Electrodes; D005260:Female; D005919:Glomerular Filtration Rate / Q000502:physiology; D006801:Humans; D006973:Hypertension / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D012077:Renal Artery / Q000294:innervation; D013562:Sympathectomy / Q000295:instrumentation / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents; D055316:Cystatin C; D003404:Creatinine
keywords: Blood pressure; Hypertension; Percutaneous; Renal denervation