[PP.26.11] RENAL DENERVATION USING THE ENLIGHTN RENAL DENERVATION SYSTEM IN ALTERNATIVE HYPERTENSIVE POPULATIONS: 24 MONTH RESULTS FROM THE ENLIGHTN II STUDY. (September 2016)

• Record Type: Journal Article
• Authors: Lobo, M.D.; Montarello, J.; Saxena, M.; Jain, A.K.; Walters, D.; Pincus, M.; Worthley, S.G.
• Is Part Of: Journal of hypertension. Volume 34:(2016) Supplement 2
• Publication Date: 2016-09
• Subjects: Hypertension -- Periodicals; Hypertension -- Periodicals; 616.132005
• DOI: 10.1097/01.hjh.0000492141.86216.8b
• Languages: English
• ISSNs: 1473-5598

Abstract

Abstract : Objective: In this study, we examine real world experience with radiofrequency renal denervation (RDN) in patients with resistant hypertension and those with chronic kidney disease (CKD). Design and method: Patients were assigned to one of three groups; Group A (n = 139) OSBP >/ = 160 mmHg and estimated GFR (eGFR) >/ = 45 mL/min per 1.73 m 2, Group B (n = 100), OSBP >/ = 140–159 mmHg and eGFR >/ = 45 mL/min per 1.73 m 2 and Group C (n = 28), OSBP >/ = 140 mmHg and eGFR >/ = 15 mL/min per 1.73 m 2 . Results: A: Baseline mean office systolic BP (OSBP) 181.8 ± 15.9 mmHg, mean office diastolic BP (ODBP) 97.6 ± 15.9 mmHg. Mean 24-hour ambulatory SBP (ASBP) 159.5 ± 16.7 mmHg and mean 24-hour ambulatory DBP (ADBP) 88.8 ± 12.8 mmHg. The mean reduction in OSBP/ODBP was 21.2(±20.8) /13.8(±12.8) mmHg at 24-month follow up (p < 0.0001), ASBP/ADBP was 7.7 (±19.7) /5.4 (±)9.4 mmHg (p = 0.05/0.01). Baseline eGFR was 80.9 ± 20.6 mL/min/1.73 m 2 ; 24-month eGFR was 80.3 ± 22.3 mL/min/1.73 m 2 . B: Baseline mean OSBP 149.1 ± 5.6 mmHg, ODBP 86.5 ± 11.5 mmHg, ASBP 146.7 ± 12.2 mmHg, and (ADBP) 86.7 ± 14.1 mmHg. The mean reduction in OSBP/ODBP was 6.2 (±13.9)/5.0 (±13.3) mmHg (p = 0.04/0.08) at 24-months, mean reduction in 24-hour ASBP/ADBP was 3.9 (±16.9)/2.4 (±7.9) mmHg (p = 0.3371/0.3290). Baseline eGFR was 77.9 ± 18.2 mL/min/1.73 m 2 ; 24-month eGFR was 79.4 ± 18.2 mL/min/1.73 m 2 . C: Baseline mean OSBP 169.7 ± 20.2 mmHg, ODBP 85.7 ± 13.7 mmHg, ASBP 160.5 ± 17.9 mmHg, and ADBP 82.1 ± 14.7 mmHg. The mean reduction in OSBP/ODBP was 11.8 (±27.4)/3.8 (±19.2) mmHg (p = ns/p = ns) at 24-months, mean reduction in 24-hour ASBP/ADBP was 12.8 (±10.9) /6.3 (±7.5) mmHg (p = 0.03/0.09). Baseline eGFR was 35.3 ± 8 mL/min/1.73 m 2 ; 24-month eGFR was 49.2 ± 8.1 mL/min/1.73 m 2 . Conclusions: RDN results in durable, highly significant and safe lowering of both office and ambulatory BP parameters in patients with severe uncontrolled hypertension up to 24-months following treatment. In patients with moderate uncontrolled-hypertension, RDN resulted in safe but modest reductions in office and 24-hour ambulatory BP at 24-months follow up. In patients with CKD, RDN results in safe, durable reduction in daytime ambulatory BP which was significant at 24-months follow up. The change in eGFR at 24-month was not significant in all groups and Serious Renal Artery Adverse Events occurred in < 2% of patients.