title: Catheter-based renal denervation for resistant hypertension: Twenty-four month results of the EnligHTN I first-in-human study using a multi-electrode ablation system.
abstract: BACKGROUND
  Long term safety and efficacy data of multi-electrode ablation system for renal denervation (RDN) in patients with drug resistant hypertension (dRHT) are limited.
  
  
  RESULTS
  We studied 46 patients (age: 60 ± 10 years, 4.7 ± 1.0 antihypertensive drugs) with drug resistant hypertension (dRHT). Reduction in office BP at 24 months from baseline was -29/-13 mmHg, while the reduction in 24-hour ambulatory BP and in home BP at 24 months were -13/-7 mmHg and -11/-6 mmHg respectively (p<0.05 for all). A correlation analysis revealed that baseline office and ambulatory BP were related to the extent of office and ambulatory BP drop. Apart from higher body mass index (33.3 ± 4.7 vs 29.5 ± 6.2 kg/m(2), p<0.05), there were no differences in patients that were RDN responders defined as ≥10 mmHg decrease (74%, n=34) compared to non-responders. Stepwise logistic regression analysis revealed no prognosticators of RDN response (p=NS for all). At 24 months there were no new serious device or procedure related adverse events.
  
  
  CONCLUSIONS
  The EnligHTN I study shows that the multi-electrode ablation system provides a safe method of RDN in dRHT accompanied by a clinically relevant and sustained BP reduction.
authors: First Cardiology Clinic, University of Athens, Hippocration Hospital, Athens, Greece. Electronic address: ktsioufis@hippocratio.gr.
authors: Costas P
authors: CP
authors: Tsioufis
authors: First Cardiology Clinic, University of Athens, Hippocration Hospital, Athens, Greece; Veterans Affairs Medical Center, Washington, DC, USA; Georgetown University Medical Center, Washington, DC, USA.
authors: Vasilios
authors: V
authors: Papademetriou
authors: First Cardiology Clinic, University of Athens, Hippocration Hospital, Athens, Greece.
authors: Kyriakos S
authors: KS
authors: Dimitriadis
authors: First Cardiology Clinic, University of Athens, Hippocration Hospital, Athens, Greece.
authors: Alexandros
authors: A
authors: Kasiakogias
authors: First Cardiology Clinic, University of Athens, Hippocration Hospital, Athens, Greece.
authors: Dimitrios
authors: D
authors: Tsiachris
authors: University of Adelaide, Royal Adelaide Hospital, Adelaide, Australia.
authors: Matthew I
authors: MI
authors: Worthley
authors: The Department of Cardiology, Flinders University, Bedford Park, Australia.
authors: Ajay R
authors: AR
authors: Sinhal
authors: The Department of Cardiology, Flinders University, Bedford Park, Australia.
authors: Derek P
authors: DP
authors: Chew
authors: The Monash Heart and Monash University, Melbourne, Australia.
authors: Ian T
authors: IT
authors: Meredith
authors: The Monash Heart and Monash University, Melbourne, Australia.
authors: Yuvi
authors: Y
authors: Malaiapan
authors: First Cardiology Clinic, University of Athens, Hippocration Hospital, Athens, Greece.
authors: Costas
authors: C
authors: Thomopoulos
authors: First Cardiology Clinic, University of Athens, Hippocration Hospital, Athens, Greece.
authors: Ioannis
authors: I
authors: Kallikazaros
authors: First Cardiology Clinic, University of Athens, Hippocration Hospital, Athens, Greece.
authors: Dimitrios
authors: D
authors: Tousoulis
authors: University of Adelaide, Royal Adelaide Hospital, Adelaide, Australia.
authors: Stephen G
authors: SG
authors: Worthley
mesh_terms: D000368:Aged; D001794:Blood Pressure / Q000502:physiology; D018660:Blood Pressure Monitoring, Ambulatory; D015992:Body Mass Index; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods*; D004351:Drug Resistance; D004566:Electrodes; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000503:physiopathology / Q000601:surgery*; D007668:Kidney / Q000294:innervation* / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013562:Sympathectomy / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome
keywords: Blood pressure; Drug resistant hypertension; Multi-electrode renal denervation