Investig Clin Urol.  2020 Jan;61(1):107-113. 10.4111/icu.2020.61.1.107.

Animal model evaluation of a novel renal denervation system for future laparoscopic treatment of resistant hypertension

• Song WH
• Baik J
• Yang S
• Choi EK
• Park SM
• Jeong CW

• KMID: 2466799
• DOI: http://doi.org/10.4111/icu.2020.61.1.107

Abstract

PURPOSE
Although percutaneous catheter-based ablation of renal sympathetic nerve fibers has been used in the treatment of patients with resistant hypertension, a recent phase III study did not confirm its efficacy. In this study, we developed a novel laparoscopic renal denervation system and evaluated its safety and initial feasibility using an animal model.
MATERIALS AND METHODS
A novel surgical instrument that uses a smart algorithm with temperature-monitoring feedback was developed. We used 4 male pigs (6 weeks old, weighing approximately 45 kg each) to evaluate the safety and efficacy of the laparoscopic renal denervation system. We performed immunohistochemical staining analysis after renal denervation using various tip temperatures and over various durations through an open approach.
RESULTS
When the temperature of the outer wall of the renal artery was maintained at 90℃ for 180 seconds, the artery was completely denervated without damaging its inner layer, as evaluated using Masson's trichrome staining. When the temperature ranged from 70℃ to 90℃ and the duration ranged from 90 to 420 seconds, partial or complete denervation without significant vessel injury was confirmed with anti- growth-associated protein 43 and anti-S100 staining.
CONCLUSIONS
This animal study confirmed the safety and feasibility of the novel laparoscopic renal denervation system. A safe and effective protocol was developed with ablation at a constant tissue temperature of 70℃ to 90℃ within 180 seconds. However, further developments are necessary before its clinical use.

Keyword

Animals; Denervation; Hypertension; Laparoscopy; Renal artery

MeSH Terms

Animals*
Arteries
Denervation*
GAP-43 Protein
Humans
Hypertension*
Laparoscopy
Male
Models, Animal*
Nerve Fibers
Renal Artery
Surgical Instruments
Swine
GAP-43 Protein

Figure

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  Fig. 1 (A) Schematic of the proposed laparoscopy-based renal denervation (RDN) surgical approach and (B) concept design of the surgical instrument for laparoscopy-based RDN. A, curling tip of RDN device.

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  Fig. 2 Real-time energy delivery-controlling generator (A) using a smart algorithm with temperature-monitoring feedback (B). RF, radiofrequency; Amp, amplifier.

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  Fig. 3 Animal experiment using the novel surgical instrument for laparoscopy-based renal denervation (RDN). a:The electrode is wrapped 360° around the artery. b:Temperature wire electrode. c:Surgical instrument for laparoscopy-based RDN.

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