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

Abstract

BackgroundLong 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 resultsWe studied 46 patients (age: 60±10years, 4.7±1.0 antihypertensive drugs) with drug resistant hypertension (dRHT). Reduction in office BP at 24months from baseline was −29/−13mmHg, while the reduction in 24-hour ambulatory BP and in home BP at 24months were −13/−7mmHg and −11/−6mmHg 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. Apart from higher body mass index (33.3±4.7 vs 29.5±6.2kg/m2, p<0.05), there were no differences in patients that were RDN responders defined as ≥10mmHg decrease (74%, n=34) compared to non-responders. Stepwise logistic regression analysis revealed no prognosticators of RDN response (p=NS for all). At 24months there were no new serious device or procedure related adverse events. ConclusionsThe EnligHTN I study shows that the multi-electrode ablation system provides a safe method of RDN in dRHT accompanied by a clinically relevant and sustained BP reduction.