Renal Sympathetic Denervation in Patients with Resistant Hypertension: A Feasibility Study

Abstract

Background/Aims: We assessed the feasibility of renal sympathetic denervation (RDN) treatment in patients with resistant hypertension using the Iberis® RDN system. This study was a prospective, multicenter, single-arm feasibility registry. Methods: We collected data from patients who underwent RDN treatment using the Iberis system. From November 2014 to February 2016, 16 patients from 6 centers in Europe were enrolled in this registry. Results: Consistent reductions in the 24-h systolic blood pressure (SBP) and diastolic blood pressure were obtained. At any follow-up point, more than 70% of the patients were responders. The change in the 24-h SBP at 1 month was strongly correlated with that at 12 months. Conclusion: The Iberis system is safe and effective in patients for the treatment of resistant hypertension. Furthermore, our results suggest that we can estimate the effect of RDN in the long term at the 1-month follow-up point using the 24-h SBP.

Percutaneous renal denervation in the management of hypertension: Chinese expert scientific statement

“…During this phase, a variety of new ablation catheters with different designs and energy sources were developed and subsequently evaluated in clinical studies with sham-controlled. At present, in addition to Medtronic SYMPLICITY Flex™ and Spyral™ catheters, other RDN catheters certified by European Union (excluding discontinued devices) include those using radiofrequency energy: Iberis (Terumo Corporation, Tokyo, Japan) [19] , DENEX™ (Handok Kalos Medical, Seoul, Korea) [20] , ConfidenHT™ System (Pythagoras Medical Ltd, Herzliya, Israel) [21] ; those utilizing ultrasound energy: Paradise (Paradise ultrasound system; ReCor Medical, Palo Alto, CA, USA) [18] and TIVUS™ (CardioSonic, Tel Aviv, Israel) [22] ; and those using anhydrous alcohol injection for ablation: Peregrine (Ablative Solutions Inc., Wakefield, MA, United States) [23] . These catheters represent a diverse range of technologies aimed at achieving RDN, providing clinicians with various options to tailor treatment according to individual patient needs and preferences.…”

Current Status and Future Perspectives of Renal Denervation

“…Beyond the SYMPLICITY Flex™ and Spyral™ ablation catheters, other RF ablation systems have been developed and approved for use in Europe (EnligHTN [St. Jude Medical, St. Paul, MN, USA], Vessix [Boston Scientific, Marlborough, Massachusetts, USA], OneShot [Covidien, Dublin, OH, USA], and Iberis [Terumo, Ann Arbor, MI, USA]), China (GL-06E15WA ablator and GL-6W ablation catheter [Shanghai Golden Leaf Medtech Company, Shanghai, China]), and Korea (DENEX™ [Handok Kalos Medical, Seoul, Korea]). 53) 54) 55) 56) 57) 58) However, those devices still need their efficacy and safety proven in well-designed, randomized, sham-controlled trials. Among them, the recent randomized, sham-controlled Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN REINFORCE) trial evaluated the efficacy of balloon-type bipolar RF-based RDN devices (Vessix; Boston Scientific).…”