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

Costas Tsioufis, Vasilios Papademetriou, Kyriakos Dimitriadis, Alexandros Kasiakogias, Dimitrios Tsiachris, Matthew Worthley, Ajay Sinhal, Derek Chew, Ian Meredith, Yuvi Malaiapan, Costas Thomopoulos, Ioannis Kallikazaros, Dimitrios Tousoulis, Stephen Worthley

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Abstract

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. 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. Conclusions The 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.

Original languageEnglish
Pages (from-to)345-350
Number of pages6
JournalInternational Journal of Cardiology
Volume201
DOIs
Publication statusPublished - 2015

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    Tsioufis, C., Papademetriou, V., Dimitriadis, K., Kasiakogias, A., Tsiachris, D., Worthley, M., Sinhal, A., Chew, D., Meredith, I., Malaiapan, Y., Thomopoulos, C., Kallikazaros, I., Tousoulis, D., & Worthley, S. (2015). 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. International Journal of Cardiology, 201, 345-350. https://doi.org/10.1016/j.ijcard.2015.08.069