title: Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of the balloon-based bipolar Vessix Renal Denervation System in treating patients with resistant hypertension.
  
  
  RESULTS
  In this prospective, multicentre, single-arm study, 146 patients (age 58.6±10.5 years; 61% men) with office systolic blood pressure (BP) ≥160 mmHg despite ≥3 antihypertensive medications at maximally tolerated doses were treated with the Vessix System. Efficacy endpoints were reductions in office and 24-hour ambulatory systolic and diastolic BPs at six months. Acute and long-term safety, with a focus on the renal artery and estimated glomerular filtration rate (eGFR), were assessed. Baseline office and ambulatory BPs were 182.4±18.4/100.2±14.0 mmHg and 153.0±15.1/87.5±13.2 mmHg, respectively. No acute renal artery injury requiring intervention or serious periprocedural cardiovascular events occurred. At six months, office BP was reduced by 24.7±22.1/10.3±12.7 mmHg (p<0.0001) and ambulatory BP was reduced by 8.4±14.4/5.9±9.1 mmHg (N=69; p<0.0001). Twenty-six patients (18%) achieved an office systolic BP <140 mmHg. One patient had renal artery stenosis which required stenting. Mean eGFR remained stable.
  
  
  CONCLUSIONS
  Renal artery denervation with the Vessix System reduced both office and ambulatory BP at six months in patients with resistant hypertension. Renal artery safety and renal function results are favourable.
authors.affiliation: CardioVascular Center Frankfurt CVC, Frankfurt, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
authors.forename: John
authors.initials: J
authors.lastname: Ormiston
authors.forename: Uta C
authors.initials: UC
authors.lastname: Hoppe
authors.forename: Ian T
authors.initials: IT
authors.lastname: Meredith
authors.forename: Darren L
authors.initials: DL
authors.lastname: Walters
authors.forename: Michel
authors.initials: M
authors.lastname: Azizi
authors.forename: Juan
authors.initials: J
authors.lastname: Diaz-Cartelle
authors.forename: Meital
authors.initials: M
authors.lastname: Cohen-Mazor
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D018660:Blood Pressure Monitoring, Ambulatory; D017115:Catheter Ablation / Q000295:instrumentation* / Q000379:methods; D015331:Cohort Studies; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012077:Renal Artery / Q000294:innervation / Q000601:surgery*; D013562:Sympathectomy / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents