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基于导管的射频肾动脉去神经支配在猪模型中分支肾动脉的安全性。

Safety of catheter-based radiofrequency renal denervation on branch renal arteries in a porcine model.

机构信息

Evaluation Center, R&D Administration and Promotion Department, Terumo Corporation, Kanagawa, Japan.

Alizée Pathology, LLC, Thurmont, Maryland.

出版信息

Catheter Cardiovasc Interv. 2019 Feb 15;93(3):494-502. doi: 10.1002/ccd.27953. Epub 2018 Nov 8.

Abstract

OBJECTIVES

We aimed to investigate the safety of radiofrequency (RF)-renal denervation (RDN) on branch renal arteries (RAs) in a porcine model.

BACKGROUND

The efficacy of RF-RDN was enhanced by treatment of the branch RA, in addition to the main RA. However, there are concerns regarding the safety of RF-RDN on branch RA because of their smaller diameter and proximity to the kidney.

METHODS

RF was delivered to 24 RA from 12 swine. A total of 8 RA from 4 swine were untreated. Treated RA were examined by angiography and histopathology at 7, 30, and 90 days. Serum creatinine concentration, biophysical parameters during RF delivery, and renal norepinephrine concentration were also assessed.

RESULTS

Angiography revealed minimal late lumen loss and diameter stenosis in the main and branch RA at any time point. There was no change in serum creatinine after RF-RDN. Histopathologically, no augmentation of medial damage or neointimal formation was found in branch RA compared with main RA. No or minimal damage to surrounding tissues including the kidneys, ureters, lymph nodes, and muscles was observed at any time point in both the main and branch RA. Equivalent electrode temperature in the main and branch RA was achieved by automatic adjustment of output power by the generator. The renal norepinephrine concentration was significantly lower in the treated group compared with the untreated group.

CONCLUSIONS

RF-RDN on branch RA was safe in a porcine model, with stenosis-free healing of treated arteries and negligible kidney damage at 7, 30, and 90 days.

摘要

目的

我们旨在研究猪模型中分支肾动脉(RA)射频(RF)去神经支配(RDN)的安全性。

背景

除了主 RA 外,治疗分支 RA 可增强 RF-RDN 的疗效。然而,由于分支 RA 的直径较小且靠近肾脏,因此人们对 RF-RDN 治疗分支 RA 的安全性存在担忧。

方法

从 12 头猪中向 24 个 RA 施加 RF。共有 4 头猪的 8 个 RA 未进行治疗。在第 7、30 和 90 天,通过血管造影和组织病理学检查检查处理过的 RA。还评估了血清肌酐浓度、RF 传递过程中的生物物理参数以及肾去甲肾上腺素浓度。

结果

血管造影显示,在任何时间点,主 RA 和分支 RA 的晚期管腔丢失和直径狭窄均最小。RF-RDN 后血清肌酐无变化。组织病理学检查显示,与主 RA 相比,分支 RA 中的中层损伤或新生内膜形成没有增加。在主 RA 和分支 RA 中,在任何时间点均未观察到周围组织(包括肾脏、输尿管、淋巴结和肌肉)的任何或最小损伤。通过发生器自动调整输出功率,实现了主 RA 和分支 RA 中等效的电极温度。与未处理组相比,治疗组的肾去甲肾上腺素浓度显著降低。

结论

在猪模型中,分支 RA 的 RF-RDN 是安全的,治疗后的动脉无狭窄愈合,7、30 和 90 天时肾脏损伤可忽略不计。

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