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新型冷冻肾去神经支配系统的临床前评估

Preclinical Evaluation of a Novel Cryo Renal Denervation System.

作者信息

Krackhardt Florian, Tsioufis Konstantinos, Lauder Lucas, Drude Natascha, Adaway Jo, Keevil Brian, Klemm Holger, Haider Wolfram, Beele Alicia, Wild Léa, Joner Michael, Mahfoud Felix

机构信息

Deutsches Herzzentrum der Charité Universitätsmedizin Berlin, Klinik mit Schwerpunkt Kardiologie, Angiologie und Intensivmedizin, Berlin, Germany.

First Cardiology Department, School of Medicine, "Hippokration" General Hospital, National and Kapodistrian University of Athens, Athens, Greece.

出版信息

JACC Basic Transl Sci. 2025 Feb 21;10(6):745-54. doi: 10.1016/j.jacbts.2025.01.014.

DOI:10.1016/j.jacbts.2025.01.014
PMID:40423644
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12230487/
Abstract

The objective of this study was to demonstrate the safety and efficacy of a novel cryo renal denervation system (Cryo-RDN) in a porcine model. Procedural and mid-term safety of the Cryo-RDN was demonstrated. Efficacy of the cryoablation was evidenced by histological findings in the renal arteries and reduced renal tissue norepinephrine concentrations on the treated sides. Despite some morphological nerve repair observed between 7 and 28 days, the greater renal norepinephrine suppression in the 28-day animals suggests irreversibly ablated sympathetic nerves.

摘要

本研究的目的是在猪模型中证明一种新型冷冻肾去神经支配系统(Cryo-RDN)的安全性和有效性。证明了Cryo-RDN的操作安全性和中期安全性。肾动脉的组织学发现以及治疗侧肾组织去甲肾上腺素浓度降低证明了冷冻消融的有效性。尽管在7至28天之间观察到一些神经形态修复,但28天龄动物中更大程度的肾去甲肾上腺素抑制表明交感神经已被不可逆地消融。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13fc/12230487/5cebd2f782ef/gr5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13fc/12230487/e766e9d56ba4/ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13fc/12230487/c09c1dd63d5c/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13fc/12230487/247c32fbe09c/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13fc/12230487/bbcc229dcd98/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13fc/12230487/91f073834fbc/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13fc/12230487/5cebd2f782ef/gr5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13fc/12230487/e766e9d56ba4/ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13fc/12230487/c09c1dd63d5c/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13fc/12230487/247c32fbe09c/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13fc/12230487/bbcc229dcd98/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13fc/12230487/91f073834fbc/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13fc/12230487/5cebd2f782ef/gr5.jpg

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引用本文的文献

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JACC Basic Transl Sci. 2025 Jun;10(6):755-758. doi: 10.1016/j.jacbts.2025.03.012.

本文引用的文献

1
Efficacy and safety of sympathetic mapping and ablation of renal nerves for the treatment of hypertension (SMART): 6-month follow-up of a randomised, controlled trial.肾神经交感神经标测与消融治疗高血压的疗效及安全性(SMART):一项随机对照试验的6个月随访
EClinicalMedicine. 2024 May 7;72:102626. doi: 10.1016/j.eclinm.2024.102626. eCollection 2024 Jun.
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Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications.抗高血压药物治疗患者的肾脏去神经术的安全性和疗效。
J Am Coll Cardiol. 2023 Nov 7;82(19):1809-1823. doi: 10.1016/j.jacc.2023.08.045.
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Global Effect of Modifiable Risk Factors on Cardiovascular Disease and Mortality.
全球可改变风险因素对心血管疾病和死亡的影响。
N Engl J Med. 2023 Oct 5;389(14):1273-1285. doi: 10.1056/NEJMoa2206916. Epub 2023 Aug 26.
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Histological examination of renal nerve distribution, density, and function in humans.人类肾神经分布、密度和功能的组织学检查。
EuroIntervention. 2023 Sep 18;19(7):612-620. doi: 10.4244/EIJ-D-23-00264.
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2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA).2023ESH 动脉高血压管理指南 欧洲高血压学会动脉高血压管理工作组:得到国际高血压学会 (ISH) 和欧洲肾脏协会 (ERA) 的认可。
J Hypertens. 2023 Dec 1;41(12):1874-2071. doi: 10.1097/HJH.0000000000003480. Epub 2023 Sep 26.
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Histological evidence supporting the durability of successful radiofrequency renal denervation in a normotensive porcine model.组织学证据支持在正常血压的猪模型中成功的射频肾去神经支配的持久性。
J Hypertens. 2022 Oct 1;40(10):2068-2075. doi: 10.1097/HJH.0000000000003236. Epub 2022 Jul 18.
7
Validation of a Novel Renal Denervation System With Cryoablation: A Preclinical Study and Case Series.新型冷冻消融肾去神经支配系统的验证:一项临床前研究及病例系列
JACC Basic Transl Sci. 2022 Feb 2;7(2):101-112. doi: 10.1016/j.jacbts.2021.11.002. eCollection 2022 Feb.
8
Percutaneous cryoanalgesia for pain palliation: Current status and future trends.经皮冷冻镇痛治疗疼痛缓解:现状和未来趋势。
Diagn Interv Imaging. 2021 May;102(5):273-278. doi: 10.1016/j.diii.2020.11.007. Epub 2020 Dec 3.
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Effect of Renal Denervation and Catheter Ablation vs Catheter Ablation Alone on Atrial Fibrillation Recurrence Among Patients With Paroxysmal Atrial Fibrillation and Hypertension: The ERADICATE-AF Randomized Clinical Trial.肾动脉去神经术联合导管消融与单纯导管消融治疗阵发性心房颤动伴高血压患者心房颤动复发的效果:ERADICATE-AF 随机临床试验。
JAMA. 2020 Jan 21;323(3):248-255. doi: 10.1001/jama.2019.21187.
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A Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension (RADIOSOUND-HTN).一种随机三臂试验比较不同的肾动脉去神经术设备和技术在高血压抵抗患者中的应用(RADIOSOUND-HTN)。
Circulation. 2019 Jan 29;139(5):590-600. doi: 10.1161/CIRCULATIONAHA.118.037654.