Catheter-based renal denervation for resistant hypertension: Twenty-four month results of the EnligHTN™ I first-in-human study using a multi-electrode ablation system

Background: Long term safety and efficacy data of multi-electrode ablation system for renal denervation (RDN) in patients with drug resistant hypertension (dRHT) are limited. Methods and results: We studied 46 patients (age: 60 +/- 10 years, 4.7 +/- 1.0 antihypertensive drugs) with drug resistant hypertension (dRHT). Reduction in office BP at 24 months from baseline was -29/-13 mm Hg, while the reduction in 24-hour ambulatory BP and in home BP at 24 months were -13/-7 mm Hg and -11/-6 mm Hg respectively (p < 0.05 for all). A correlation analysis revealed that baseline office and ambulatory BP were related to the extent of office and ambulatory BP drop. A part from higher body mass index (33.3 +/- 4.7 vs 29.5 +/- 6.2 kg/m(2), p < 0.05), there were no differences in patients that were RDN responders defined as =10 mm Hg decrease (74%, n=34) compared to non-responders. Stepwise logistic regression analysis revealed no prognosticators of RDN response (p=NS for all). At 24 months there were no new serious device or procedure related adverse events. Conclusions: The EnligHTN I study shows that themulti-electrode ablation systemprovides a safe method of RDN in dRHT accompanied by a clinically relevant and sustained BP reduction. (C) 2015 Elsevier Ireland Ltd. All rights reserved.