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

- The EnligHTN I study provides evidence that the multi-electrode ablation system constitutes a safe method of renal denervation (RDN) in patients with drug resistant hypertension RDN is accompanied by sustained reduction of office, ambulatory and home blood pressure (BP) at 24 months after the procedure Additionally, given that there is no patient phenotype, clinical or procedural parameter that could predict RDN BP response, further research with appropriate controlled studies should be undertaken.

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 ± 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. Apart from higher body mass index (33.3 ± 4.7 vs 29.5 ± 6.2 kg/m2, 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.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.