title: Catheter-based renal denervation for resistant hypertension: 12-month results of the EnligHTN I first-in-human study using a multielectrode ablation system.
abstract: Renal denervation has emerged as a novel approach for the treatment of patients with drug-resistant hypertension. To date, only limited data have been published using multielectrode radiofrequency ablation systems. In this article, we present the 12-month data of EnligHTN I, a first-in-human study using a multielectrode ablation catheter. EnligHTN I enrolled 46 patients (average age, 60±10 years; on average 4.7±1.0 medications) with drug-resistant hypertension. Eligible patients were on ≥3 antihypertensive medications and had a systolic blood pressure (BP) ≥160 mm Hg (≥150 mm Hg for diabetics). Bilateral renal artery ablation was performed using a percutaneous femoral approach and standardized techniques. The average baseline office BP was 176/96 mm Hg, average 24-hour ambulatory BP was 150/83 mm Hg, and average home BP was 158/90 mm Hg. The average reductions (mm Hg) at 1, 3, 6, and 12 months were as follows: office: -28/-10, -27/-10, -26/-10, and -27/-11 mm Hg (P<0.001 for all); 24-hour ambulatory: -10/-5, -10/-5, -10/-6 (P<0.001 for all), and -7/-4 for 12 months (P<0.0094). Reductions in home measurements (based on 2-week average) were -9/-4, -8/-5,-10/-7, and -11/-6 mm Hg (P<0.001 at 12 months). At 12 months, there were no signals of worsening renal function and no new serious or life-threatening adverse events. One patient with baseline nonocclusive renal artery stenosis progressed to 75% diameter stenosis, requiring renal artery stenting. The 12-month data continue to demonstrate safety and efficacy of the EnligHTN ablation system in patients with drug-resistant hypertension. Home BP measurements parallel measurements obtained with 24-hour ambulatory monitoring.
authors.affiliation: From the Veterans Affairs and Georgetown University Medical Centers, Washington, DC (V.P.); The First Cardiology Clinic, University of Athens, Ippokration Hospital, Athens, Greece (V.P., C.P.T.); Department of Cardiology, Flinders University, Bedford Park, Australia (A.S., D.P.C.); Monash Heart and Monash University, Melbourne, Australia (I.T.M., Y.M.); Royal Adelaide Hospital, Adelaide, Australia (M.I.W.); and University of Adelaide, Adelaide, Australia (S.G.W.). vasilios.papademetriou@va.gov.
authors.forename: Vasilios
authors.initials: V
authors.lastname: Papademetriou
authors.affiliation: From the Veterans Affairs and Georgetown University Medical Centers, Washington, DC (V.P.); The First Cardiology Clinic, University of Athens, Ippokration Hospital, Athens, Greece (V.P., C.P.T.); Department of Cardiology, Flinders University, Bedford Park, Australia (A.S., D.P.C.); Monash Heart and Monash University, Melbourne, Australia (I.T.M., Y.M.); Royal Adelaide Hospital, Adelaide, Australia (M.I.W.); and University of Adelaide, Adelaide, Australia (S.G.W.).
authors.forename: Costas P
authors.initials: CP
authors.lastname: Tsioufis
authors.affiliation: From the Veterans Affairs and Georgetown University Medical Centers, Washington, DC (V.P.); The First Cardiology Clinic, University of Athens, Ippokration Hospital, Athens, Greece (V.P., C.P.T.); Department of Cardiology, Flinders University, Bedford Park, Australia (A.S., D.P.C.); Monash Heart and Monash University, Melbourne, Australia (I.T.M., Y.M.); Royal Adelaide Hospital, Adelaide, Australia (M.I.W.); and University of Adelaide, Adelaide, Australia (S.G.W.).
authors.forename: Ajay
authors.initials: A
authors.lastname: Sinhal
authors.affiliation: From the Veterans Affairs and Georgetown University Medical Centers, Washington, DC (V.P.); The First Cardiology Clinic, University of Athens, Ippokration Hospital, Athens, Greece (V.P., C.P.T.); Department of Cardiology, Flinders University, Bedford Park, Australia (A.S., D.P.C.); Monash Heart and Monash University, Melbourne, Australia (I.T.M., Y.M.); Royal Adelaide Hospital, Adelaide, Australia (M.I.W.); and University of Adelaide, Adelaide, Australia (S.G.W.).
authors.forename: Derek P
authors.initials: DP
authors.lastname: Chew
authors.affiliation: From the Veterans Affairs and Georgetown University Medical Centers, Washington, DC (V.P.); The First Cardiology Clinic, University of Athens, Ippokration Hospital, Athens, Greece (V.P., C.P.T.); Department of Cardiology, Flinders University, Bedford Park, Australia (A.S., D.P.C.); Monash Heart and Monash University, Melbourne, Australia (I.T.M., Y.M.); Royal Adelaide Hospital, Adelaide, Australia (M.I.W.); and University of Adelaide, Adelaide, Australia (S.G.W.).
authors.forename: Ian T
authors.initials: IT
authors.lastname: Meredith
authors.affiliation: From the Veterans Affairs and Georgetown University Medical Centers, Washington, DC (V.P.); The First Cardiology Clinic, University of Athens, Ippokration Hospital, Athens, Greece (V.P., C.P.T.); Department of Cardiology, Flinders University, Bedford Park, Australia (A.S., D.P.C.); Monash Heart and Monash University, Melbourne, Australia (I.T.M., Y.M.); Royal Adelaide Hospital, Adelaide, Australia (M.I.W.); and University of Adelaide, Adelaide, Australia (S.G.W.).
authors.forename: Yuvi
authors.initials: Y
authors.lastname: Malaiapan
authors.affiliation: From the Veterans Affairs and Georgetown University Medical Centers, Washington, DC (V.P.); The First Cardiology Clinic, University of Athens, Ippokration Hospital, Athens, Greece (V.P., C.P.T.); Department of Cardiology, Flinders University, Bedford Park, Australia (A.S., D.P.C.); Monash Heart and Monash University, Melbourne, Australia (I.T.M., Y.M.); Royal Adelaide Hospital, Adelaide, Australia (M.I.W.); and University of Adelaide, Adelaide, Australia (S.G.W.).
authors.forename: Matthew I
authors.initials: MI
authors.lastname: Worthley
authors.affiliation: From the Veterans Affairs and Georgetown University Medical Centers, Washington, DC (V.P.); The First Cardiology Clinic, University of Athens, Ippokration Hospital, Athens, Greece (V.P., C.P.T.); Department of Cardiology, Flinders University, Bedford Park, Australia (A.S., D.P.C.); Monash Heart and Monash University, Melbourne, Australia (I.T.M., Y.M.); Royal Adelaide Hospital, Adelaide, Australia (M.I.W.); and University of Adelaide, Adelaide, Australia (S.G.W.).
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Worthley
mesh_terms: 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*; D003714:Denervation / Q000379:methods*; D004351:Drug Resistance; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery*; D015994:Incidence; D007668:Kidney / Q000098:blood supply / Q000294:innervation; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D012077:Renal Artery / Q000294:innervation*; D012078:Renal Artery Obstruction / Q000453:epidemiology / Q000601:surgery; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents
keywords: ambulatory blood pressure; home blood pressure; multielectrode; renal denervation; resistant hypertension