Validation of a Novel Renal Denervation System With Cryoablation: A Preclinical Study and Case Series

Meng Ji; Han Chen; Li Shen; Yi Zhang; Zhifeng Yao; Yizhe Wu; Yawei Xu; Junbo Ge

doi:10.1016/j.jacbts.2021.11.002

Validation of a Novel Renal Denervation System With Cryoablation: A Preclinical Study and Case Series

JACC Basic Transl Sci. 2022 Feb 2;7(2):101-112. doi: 10.1016/j.jacbts.2021.11.002. eCollection 2022 Feb.

Authors

Meng Ji^{1

2

3}, Han Chen^{1

2

3}, Li Shen^{1

2

3}, Yi Zhang⁴, Zhifeng Yao^{1

2

3}, Yizhe Wu^{1

2

3}, Yawei Xu⁴, Junbo Ge^{1

2

3}

Affiliations

¹ Department of Cardiology, Zhongshan Hospital, Fudan University, Research Unit of Cardiovascular Techniques and Devices, Chinese Academy of Medical Sciences, Shanghai, China.
² National Clinical Research Center for Interventional Medicine, Shanghai, China.
³ Shanghai Institute of Cardiovascular Diseases, Shanghai, China.
⁴ Shanghai Tenth People's Hospital, Shanghai, China.

Abstract

Recently, we designed a renal denervation with cryoablation (Cryo-RDN) system using liquid nitrogen and proved its short-term safety and effectiveness. In this study, we first conducted a 6-month follow-up in a swine model. Renal sympathetic nerve activity remained at a significantly lower level than that of the control group after 6 months. In patients with resistant hypertension, Cryo-RDN demonstrated preliminary safety. Renal function fluctuations and vascular-related complications were not detected. In addition, the average 24-hour systolic and diastolic blood pressure decreased by 12.17 ± 8.35 mm Hg and 8.50 ± 3.83 mm Hg at the 6-month follow-up, respectively, compared with their baseline values.

Keywords: 24-h ABPM, 24-hour ambulatory blood pressure monitoring; BP, blood pressure; Cryo-RDN, renal denervation with cryoablation; DBP, diastolic blood pressure; Fr, French; NE, norepinephrine; OBP, office blood pressure; RDN, renal denervation; RH, resistant hypertension; SBP, systolic blood pressure; SNS, sympathetic nerve system; TH, tyrosine hydroxylase; cryoablation; eGFR, estimated glomerular filtration rate; renal denervation; resistant hypertension.