Presented by: Chang Wook Jeong MD, PhD
Seoul National University Hospital

Introduction

Hyperactivity of the sympathetic nervous system is recognized as a significant contributor to essential hypertension and resistant hypertension. Percutaneous catheter-based renal denervation, which selectively eliminates hyperactive renal sympathetic nerves, has demonstrated mixed success in achieving consistent reductions in blood pressure. Hence, this study aims to elucidate the effects and safety of a novel Laparoscopic Renal Denervation System (LRDNS) for treating uncontrolled hypertension.

Materials

We devised an LRDNS optimized to completely ablate renal nerves while preventing thermal damage to renal arteries, irrespective of renal arterial innervation and size, in a swine model with mildly elevated hypertension. Hypertension was induced in all swine through a 3% high-salt diet. The endpoints were evaluated over the survival period (4-week [short-term], 12-week [long-term], and 24-week [extended long-term]).

Results

,

LRDNS was performed on 18 swine (6 swine for each survival period), and a sham operation was performed on 9 swine (3 swine for each survival period). The mean time for the sham operation was 34.1±8.5 minutes, while the LRDNS averaged at 55.2±7.0 minutes. Compared to the sham control, the LRDNS group demonstrated a significant reduction in blood pressure over the 24-week survival period (SBP changes from baseline, sham control: 15.8mmHg and LRDNS: -7.8mmHg, 23.6mmHg difference, p<0.001)(Figure 1). Tissue norepinephrine levels, were significantly reduced in the LRDNS group than sham control (5.84 ± 0.94 ng/g vs. 78.06 ± 13.84 ng/g, p<0.0001). Minimal to mild medial injuries were observed, but no intimal injury was noted in the LRDNS group. Moreover, there were no significant adverse events, and all animals survived post-procedure.

Conclusion

The study affirms the safety, and effectiveness of the novel LRDNS in a swine model, which compares favorably with, or is superior to, the sham procedure. No safety concerns related to the device were assumed at 4-, 12-, and 24-week post-treatment. This novel LRDNS is guaranteed for the first-in-human trial to treat uncontrolled hypertension.

Funding

This study was supported by DeepQure Inc. (Yeoksam, Seoul, South Korea)

Co-Authors

Jang Hee Han, MD, PhD
Department of Urology, Seoul National University Hospital

Si Hyun Kim, MD
Department of Urology, Seoul National University Hospital

Sang Youn Kim, MD, PhD
Department of Radiology, Seoul National University Hospital

Bogyeong Han, MD
Department of Pathology, Seoul National University Hospital

Minh-Tung Do, MD, PhD
Department of Urology, Seoul National University Hospital