Περίληψη:
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 drugresistant 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. © 2014 American Heart Association, Inc.
Συγγραφείς:
Papademetriou, V.
Tsioufis, C.P.
Sinhal, A.
Chew, D.P.
Meredith, I.T.
Malaiapan, Y.
Worthley, M.I.
Worthley, S.G.
Λέξεις-κλειδιά:
ablation catheter; adult; adverse outcome; arterial stent; article; blood pressure measurement; blood pressure monitoring; blood pressure regulation; catheter ablation; clinical article; clinical effectiveness; controlled study; device safety; female; first in human study; human; kidney artery stenosis; kidney denervation; kidney denervation system; kidney function; male; multielectrode ablation catheter; priority journal; randomized controlled trial (topic); renal artery; resistant hypertension; treatment outcome, ambulatory blood pressure; home blood pressure; multielectrode; renal denervation; resistant hypertension, Aged; Antihypertensive Agents; Blood Pressure; Blood Pressure Monitoring, Ambulatory; Catheter Ablation; Denervation; Drug Resistance; Female; Follow-Up Studies; Humans; Hypertension; Incidence; Kidney; Longitudinal Studies; Male; Middle Aged; Renal Artery; Renal Artery Obstruction; Stents; Time Factors; Treatment Outcome
