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PP.26.22: SAFETY AND PERFORMANCE OF THE ENLIGHTN RENAL DENERVATION SYSTEM IN PATIENTS WITH UNCONTROLLED HYPERTENSION AND CHRONIC KIDNEY DISEASE 12 MONTH RESULTS FROM THE ENLIGHTN II STUDY

Objective: Percutaneous sympathetic renal artery denervation is available for the treatment of patients with resistant hypertension and preserved renal function. We investigated the safety and efficacy of a multi-electrode renal denervation system (EnligHTN™) in the treatment of patients with hypertension and chronic kidney disease (CKD). 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: A total of 26 patients with CKD with average age 68.3 (SD 8.2) yrs taking an average of 5.15 (1.54) anti-hypertensive medications were included in this sub-analysis. Bilateral renal nerve ablation was performed using a percutaneous femoral approach. Baseline average OSBP was 167.9 (19.8) mmHg, average ODBP was 85.8 (14) mmHg, average daytime ambulatory SBP (ASBP) was 162.6 (19.3) mmHg, and average daytime ambulatory DBP (ADBP) was 84.9 (15.4) mmHg. At present 22 6-month and 11 12-month follow-up visits are completed. The average reduction in OSBP/ODBP was 6.7 (25.0)/8.0 (10.7) mmHg (p = ns/ < 0.0069) and 10.3 (28.5)/9.5 (13.5) mmHg (p = ns/0.0430) at 6 and 12 M follow up respectively. The average reduction in daytime ASBP/ADBP was 8.5 (22.5)/5.8 (11.4) mmHg (p = ns/0.0217) and 21.9 (22.8)/13.3 (11.9) mmHg (p = 0.0442/0.0251) at 6 and 12 month follow up respectively. Changes in eGFR, serum creatinine, and urine albumin to creatinine ratio were not statistically different from baseline at either 6 or 12 M follow up. Conclusions: In this challenging cohort with uncontrolled hypertension and chronic kidney disease, multi-electrode renal denervation appears to be safe and results in durable reduction in daytime ambulatory BP which was significant at 12 months follow up.