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Durability of the Blood Pressure Effects of Renal Pelvis Denervation in Patients with Hypertension During a 12-Month Observation.

INTRODUCTION: We previously completed a trial of renal pelvic denervation for treating hypertension that reduced blood pressure by the 2-month primary endpoint. However, information on the durability of effectiveness is a critical requirement for device therapy and we now report data up to 12 months.

METHODS: This was an open label single-arm feasibility study in patients with increased blood pressure despite taking an average of 2.7 medications. The key endpoint reported here was ambulatory blood pressure at 12 months following renal pelvic denervation.

RESULTS: In the 17 patients (mean age 56) studied, there was a reduction from the baseline of 148 + 8.7 mmHg in the primary endpoint of mean daytime systolic blood pressure at 12 months of 19.1 (26.7, 11.6) mmHg, P<0.001, as compared with the 2-month result of 19.4 (24.9, 14.0) mmHg. The 24-hour systolic blood pressure fell by 19.3 (26.7, 11.9), P<0.001, and nighttime systolic fell by 18.7 (27.5, 9.8), P<0.001, mmHg at 12 months. Diastolic pressures also fell significantly from baseline at 12 months. As well, automated office systolic blood pressure was reduced from the baseline of 156.5 + 12.3 by 24.8 (33.2. 16.8) mmHg, P<0.001, at 12 months as compared with 22.4 (31.5, 13.3) at 2-months. . All blood pressure changes at 12 months were not different from those at 2 months, thus confirming the durability of the procedure. There were no serious procedural, clinical or laboratory adverse events related to the intervention. Serum creatinine fell from 1.03 + 0.22 to 0.82 + 0.16 mg/dl and estimated glomerular filtration rate rose from 79.6 + 17.8 to 96.3 + 16.4 ml/min/1.73m2 by 12 months, again sustaining effects seen at 2 months.

DISCUSSION/CONCLUSION: These findings provide evidence that the significant blood pressure-lowering effects of renal pelvis denervation are durable and safe for at least one year and provide the basis for a pivotal randomized blinded trial to further define the safety and effectiveness of this procedure.

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