4A.09: SAFETY AND PERFORMANCE OF THE ENLIGHTN RENAL DENERVATION SYSTEM IN PATIENTS WITH SEVERE UNCONTROLLED HYPERTENSION: 12 MONTH RESULTS FROM THE ENLIGHTN II STUDY

• Published in: Journal of hypertension Vol. 33 Suppl 1 - ESH 2015 Abstract Book; no. Supplement 1; p. e51
• Main Authors: Lobo, M, Saxena, M, Jain, A.J, Walters, D, Pincus, M, Montarello, J, Worthley, S.G
• Format: Journal Article
• Language: English
• Published: England Copyright Wolters Kluwer Health, Inc. All rights reserved 01-06-2015
• ISSN: 0263-6352; 1473-5598
• DOI: 10.1097/01.hjh.0000467483.82320.f7

OBJECTIVE:Percutaneous sympathetic renal artery denervation is available for the treatment of patients with resistant hypertension. We further investigated the safety and efficacy of a multi-electrode renal denervation system (EnligHTN™) in patients with severe uncontrolled hypertension.
DESIGN AND METHOD:The EnligHTN-II study is a post-market clinical investigation in which patients were assigned to one of three groups; Group A, office systolic BP (OSBP) >/=160 mmHg and estimated glomerular filtration rate (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:129 patients from Group A (average age 62 ± 9.5 yrs taking on average 4.22 ± 2.21 anti-hypertensive medications) were included. Bilateral renal nerve ablation was performed using a percutaneous femoral approach. Baseline average OSBP was 181.9 ± 16.2 mmHg, average office diastolic BP (ODBP) was 97.6 ± 16 mmHg, average daytime ambulatory SBP (ASBP) was 163.3 ± 17.5 mmHg, and average daytime ambulatory DBP (ADBP) was 91.6 ± 13.8 mmHg.At present, 103 6-month and 64 12-month follow-up visits are completed. The average reduction in OSBP/ODBP was 18.2/8.5 mmHg (SD 21.5/14.3) and 17.2/9.9 mmHg (20.9/13.3) at 6- and 12-month follow up respectively (p < 0.0001 for all). The average reduction in daytime ASBP/ADBP was 7.9 (17.0) /4.8 (9.0) mmHg (p < 0.0001 for both) and 7.6 (17.1) /4.0 (9.7) mmHg (p = 0.0024/0.0049) at 6 and 12 M follow up respectively. Significant changes in nocturnal and 24 hour ambulatory BP were also observed. Neither eGFR nor serum creatinine changed significantly from baseline at either 6 or 12-months follow up.
CONCLUSIONS:In this real world, post-marketing study we demonstrate that multi-electrode renal denervation results in durable, highly significant and safe lowering of both office BP and ambulatory BP parameters in patients with severe uncontrolled hypertension up to 12 months following treatment.