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美国食品药品监督管理局(FDA)批准后的肾去神经支配:介入心脏病专家视角的最新进展

Renal Denervation After USA FDA Approval: An Update from an Interventional Cardiologist's Perspective.

作者信息

Zhang Jiandong, Belford Peter M, Stouffer George A

机构信息

Department of Cardiovascular Medicine, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA.

Division of Cardiology, Department of Medicine, University of North Carolina, Chapel Hill, NC 27514, USA.

出版信息

J Clin Med. 2025 May 19;14(10):3554. doi: 10.3390/jcm14103554.

DOI:10.3390/jcm14103554
PMID:40429549
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12112698/
Abstract

In late 2023, the U.S. Food and Drug Administration (FDA) approved two renal denervation (RDN) systems for the treatment of hypertension. Several professional societies, including the Society of Cardiovascular Angiography and Intervention (SCAI), the American Heart Association (AHA), and numerous European associations, have recognized the potential role of RDN in managing hypertension. Despite widespread enthusiasm from clinicians, patients, and the industry, the American Medical Association's Current Procedural Terminology (CPT) panel rejected the introduction of new codes for renal denervation at its September 2024 meeting. This article analyzes the latest evidence from clinical trials and registries, reviews current challenges in clinical practice, and explores the role of contemporary hypertension treatment from the perspective of interventional cardiologists.

摘要

2023年末,美国食品药品监督管理局(FDA)批准了两种用于治疗高血压的肾去神经支配(RDN)系统。包括心血管造影和介入学会(SCAI)、美国心脏协会(AHA)以及众多欧洲协会在内的多个专业学会,都认可了RDN在管理高血压方面的潜在作用。尽管临床医生、患者和行业对此普遍热情高涨,但美国医学协会现行程序术语(CPT)小组在其2024年9月的会议上拒绝引入肾去神经支配的新编码。本文分析了来自临床试验和注册研究的最新证据,回顾了临床实践中当前面临的挑战,并从介入心脏病学家的角度探讨了当代高血压治疗的作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b48b/12112698/3235fc068f28/jcm-14-03554-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b48b/12112698/3235fc068f28/jcm-14-03554-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b48b/12112698/3235fc068f28/jcm-14-03554-g001.jpg

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本文引用的文献

1
Long-Term, Patient-Level Analysis of Radiofrequency Renal Denervation in the SYMPLICITY Clinical Trial Program.在SYMPLICITY临床试验项目中对肾交感神经射频消融术进行的长期、患者层面分析
JACC Adv. 2025 Mar;4(3):101606. doi: 10.1016/j.jacadv.2025.101606. Epub 2025 Feb 21.
2
Abolition of Aorticorenal Ganglia Pacing Responses Improves Denervation Efficacy.消除主动脉肾神经节起搏反应可提高去神经支配疗效。
Hypertension. 2025 Apr;82(4):680-689. doi: 10.1161/HYPERTENSIONAHA.124.24250. Epub 2025 Jan 30.
3
Medication Changes After Renal Denervation: Current Evidence and Patient Perspectives.
肾去神经支配术后的药物变化:当前证据及患者观点
J Am Heart Assoc. 2024 Dec 17;13(24):e037187. doi: 10.1161/JAHA.124.037187. Epub 2024 Dec 14.
4
Response of Blood Pressure to Renal Denervation Is Not Associated With Genetic Variants.血压对肾去神经支配的反应与基因变异无关。
Hypertension. 2025 Jan;82(1):118-125. doi: 10.1161/HYPERTENSIONAHA.124.23393. Epub 2024 Nov 21.
5
Novel approaches to define responders to interventional treatment in hypertension: insights from the SPYRAL HTN-OFF and HTN-ON MED trials.定义高血压介入治疗反应者的新方法:来自SPYRAL HTN-OFF和HTN-ON MED试验的见解
Hypertens Res. 2025 Jan;48(1):327-335. doi: 10.1038/s41440-024-01949-4. Epub 2024 Nov 14.
6
Catheter-Based Radiofrequency Renal Denervation in the United States: A Cost-Effectiveness Analysis Based on Contemporary Evidence.美国基于导管的射频肾去神经术:基于当代证据的成本效益分析。
J Soc Cardiovasc Angiogr Interv. 2024 Aug 13;3(10):102234. doi: 10.1016/j.jscai.2024.102234. eCollection 2024 Oct.
7
Trends in Blood Pressure Control among US Adults With Hypertension, 2013-2014 to 2021-2023.2013 - 2014年至2021 - 2023年美国高血压成年患者的血压控制趋势
Am J Hypertens. 2025 Jan 16;38(2):120-128. doi: 10.1093/ajh/hpae141.
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The Netrod™ six-electrode radiofrequency renal denervation system for uncontrolled hypertension: a sham-controlled trial.用于治疗难治性高血压的Netrod™六电极射频肾去神经支配系统:一项假手术对照试验。
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Circulation. 2024 Nov 12;150(20):1588-1598. doi: 10.1161/CIRCULATIONAHA.124.069215. Epub 2024 Sep 4.