Abstract
Objective: Percutaneous sympathetic renal artery denervation is a treatment option for patients with severe resistant hypertension. We investigated the safety and efficacy of a multi-electrode renal denervation system (EnligHTN™) in patients with moderate uncontrolled hypertension. Design and method: The EnligHTN-II study is a post-market clinical investigation in which patients with uncontrolled hypertension were assigned to one of three groups; Group A, office systolic BP (OSBP) > / = 160 mmHg and estimated GFR (eGFR) > / = 45 mL/min per 1.73 m2, Group B, OSBP > / = 140–159 mmHg and eGFR > / = 45 mL/min per 1.73 m2 and Group C, OSBP > / = 140 mmHg and eGFR > / = 15 mL/min per 1.73 m2. For all three groups subjects were required to be on at least 3 anti-hypertensive medications (including 1 diuretic), or to have documented drug intolerance such that they are unable to take 3 anti-hypertensive drugs. Results: The results of the moderate hypertension cohort, Group B, are presented here. A total of 89 patients (average age 57.5 (SD 11.7) yrs taking an average of 4.28 (1.71) medications were included in this sub-analysis. Bilateral renal nerve ablation was performed using a percutaneous femoral approach. Baseline average OSBP was 149.2 (5.8) mmHg, average office diastolic BP (ODBP) was 86.8 (11.8) mmHg, average 24-hour ambulatory SBP (ASBP) was 146.6 (12.1) mmHg, and average 24-hour ambulatory DBP (ADBP) was 87.3 (14.3) mmHg. At present 71 6-month and 34 12-month follow-up visits are completed. The average reduction in OSBP/ODBP was 1.0 (16.0)/0.3 (10.5) mmHg (p = ns/ns) and 5.7 (16.2)/1.5 (8.4) mmHg (p = 0.0487/ns) at 6 and 12 month follow up respectively. The average reduction in 24-hour ASBP/ADBP was 4.3 (16.4)/4.3 (13.6) mmHg (p = 0.0384/0.0078) and 5.0 (16.3)/4.5 (8.1) mmHg (p = ns/0.0105) at 6 and 12 month follow up respectively. Neither eGFR nor serum creatinine had significant changes from baseline at either 6 or 12-months follow up. Conclusions: : In patients with moderate uncontrolled hypertension, multi-electrode renal denervation resulted in safe but modest reductions in office and 24-hour ambulatory BP at 12 months follow up. Significant lowering of ADBP levels may lead to improved prognosis in this group of patients.
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