Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial

Stephen Worthley, CP Tsioufis, Matthew Worthley, Ajay Sinhal, Derek Chew, I Meredith, Y Malaiapan, V Papademetriou

    Research output: Contribution to journalArticle

    223 Citations (Scopus)

    Abstract

    Aims: Catheter-based renal artery sympathetic denervation has emerged as a novel therapy for treatment of patients with drug-resistant hypertension. Initial studies were performed using a single electrode radiofrequency catheter, but recent advances in catheter design have allowed the development of multi-electrode systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and efficacy of the EnligHTN multi-electrode system. Methods and results: We conducted the first-in-human, prospective, multi-centre, non-randomized study in 46 patients (67% male, mean age 60 years, and mean baseline office blood pressure 176/96 mmHg) with drug-resistant hypertension. The primary efficacy objective was change in office blood pressure from baseline to 6 months. Safety measures included all adverse events with a focus on the renal artery and other vascular complications and changes in renal function. Renal artery denervation, using the EnligHTN system significantly reduced the office blood pressure from baseline to 1, 3, and 6 months by -28/10, -27/10 and -26/10 mmHg, respectively (P < 0.0001). No acute renal artery injury or other serious vascular complications occurred. Small, non-clinically relevant, changes in average estimated glomerular filtration rate were reported from baseline (87 ± 19 mL/min/1.73 m2) to 6 months post-procedure (82 ± 20 mL/min/1.73 m2). Conclusion: Renal sympathetic denervation, using the EnligHTN multi-electrode catheter results in a rapid and significant office blood pressure reduction that was sustained through 6 months. The EnligHTN system delivers a promising therapy for the treatment of drug-resistant hypertension.

    Original languageEnglish
    Pages (from-to)2132-2140
    Number of pages9
    JournalEuropean Heart Journal
    Volume34
    Issue number28
    DOIs
    Publication statusPublished - 2013

    Fingerprint Dive into the research topics of 'Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial'. Together they form a unique fingerprint.

  • Cite this

    Worthley, S., Tsioufis, CP., Worthley, M., Sinhal, A., Chew, D., Meredith, I., Malaiapan, Y., & Papademetriou, V. (2013). Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial. European Heart Journal, 34(28), 2132-2140. https://doi.org/10.1093/eurheartj/eht197