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Renal denervation in hypertension patients: Proceedings from an expert consensus roundtable cosponsored by SCAI and NKF
Catheterization & Cardiovascular Interventions ( IF 2.3 ) Pub Date : 2021-08-03 , DOI: 10.1002/ccd.29884
David E. Kandzari 1 , Raymond R. Townsend 2 , George Bakris 3 , Jan Basile 4 , Michael J. Bloch 5 , Debbie L. Cohen 2 , Cara East 6, 7 , Keith C. Ferdinand 8 , Naomi Fisher 9 , Ajay Kirtane 10 , David P. Lee 11 , Gary Puckrein 12 , Florian Rader 13 , Joseph A. Vassalotti 14 , Michael A. Weber 15 , Kerry Willis 16 , Eric Secemsky 17
Affiliation  

1 INTRODUCTION

Despite the availability of efficacious pharmacological treatments, hypertension remains the leading global cause of death and disability,1 and rates of blood pressure (BP) control are stagnant, if not modestly declining. In the United States alone, for example, more than one-half of individuals with hypertension do not meet societal or guideline-directed BP goals, representing more than 29 million people.2, 3 Although reasons are multifactorial, patient non-adherence, physician inertia, as well as barriers such as lack of social support, depression and complex polypharmacy regimens are major contributors to lack of BP goal achievement.

Interventional strategies, such as catheter-based renal denervation (RDN) using radiofrequency energy, ultrasound, or perivascular injection of neurotoxic agents, are gaining increasing attention. The rationale for RDN is to interrupt the activity of afferent and efferent sympathetic nerves located in the perivascular space of the renal arteries, reducing the sympathetic nervous system's influence on renal vascular resistance and renin release and sodium reabsorption that contribute to the maintenance and progression of hypertension.4

Following a succession of promising exploratory trials, enthusiasm for the efficacy of RDN was tempered by the neutral results of the sham-controlled, randomized SYMPLICITY-3 HTN trial in 2014, which demonstrated the safety of RDN but not a significant BP reduction relative to control.5 Amidst persistent interest in the potential benefit of RDN and lessons learned regarding trial conduct, procedural technique and the study population6 a new generation of randomized, sham-controlled trials has been performed (SPYRAL HTN-OFF MED, SPYRAL HTN-ON MED, SPYRAL HTN-OFF MED PIVOTAL, RADIANCE-HTN SOLO and RADIANCE-HTN TRIO).7-11 Despite varying procedural techniques, these trials demonstrated consistent and clinically meaningful reductions in ambulatory and office BP with RDN in both the presence and absence of anti-hypertensive medications. Together, these studies have renewed interest in device-based therapies for hypertension, and additional trials are ongoing.

While RDN is included as a therapeutic option in the latest ESC/ESH guidelines,12 it remains an investigational technology in the United States. Against this background, and given the potential for this procedure, there is a need to address questions regarding the possible role of RDN as a therapeutic option in addition to medical therapy and lifestyle interventions. The assessment needs to be multifactorial and take into account the current factors influencing poor hypertension control, healthcare stakeholders, and, importantly, patient preferences.

The present communication represents considerations and consensus views from a roundtable discussion between leaders in hypertension and interventional cardiology. The consensus conference was supported by the National Kidney Foundation and the Society for Cardiovascular Angiography and Interventions; however, the content of this report represents solely the opinions of the consensus committee members.



中文翻译:

高血压患者的肾去神经支配:来自 SCAI 和 NKF 共同发起的专家共识圆桌会议的论文集

1 介绍

尽管有有效的药物治疗,但高血压仍然是全球主要的死亡和残疾原因,1并且血压 (BP) 控制率即使不是适度下降也停滞不前。例如,仅在美国,就有超过一半的高血压患者没有达到社会或指南指导的血压目标,代表了超过 2900 万人。2, 3虽然原因是多方面的,但患者不依从、医生惰性以及缺乏社会支持、抑郁和复杂的多种药物治疗等障碍是导致血压目标未能实现的主要原因。

介入策略,例如使用射频能量、超声或血管周围注射神经毒性药物的基于导管的肾去神经支配 (RDN),越来越受到关注。RDN 的基本原理是中断位于肾动脉血管周围空间的传入和传出交感神经的活动,减少交感神经系统对肾血管阻力和肾素释放和钠重吸收的影响,这些影响有助于高血压的维持和进展. 4

在一系列有希望的探索性试验之后,2014 年假对照、随机 SYMPLICITY-3 HTN 试验的中性结果削弱了对 RDN 疗效的热情,该试验证明了 RDN 的安全性,但与对照相比并未显着降低血压. 5由于对 RDN 的潜在益处和关于试验实施、程序技术和研究人群的经验教训的持续兴趣6已经进行了新一代随机、假对照试验(SPYRAL HTN-OFF MED、SPYRAL HTN-ON MED、 SPYRAL HTN-OFF MED PIVOTAL、RADIANCE-HTN SOLO 和 RADIANCE-HTN TRIO)。7-11尽管程序技术各不相同,但这些试验表明,在使用和不使用抗高血压药物的情况下,使用 RDN 均能一致且具有临床意义的降低动态血压和诊室血压。总之,这些研究重新激发了人们对基于设备的高血压疗法的兴趣,其他试验正在进行中。

虽然 RDN 被列为最新的 ESC/ESH 指南中的一种治疗选择,12但它在美国仍是一项研究性技术。在此背景下,并考虑到该程序的潜力,需要解决有关 RDN 作为除药物治疗和生活方式干预之外的治疗选择的可能作用的问题。评估需要是多因素的,并考虑影响高血压控制不佳的当前因素、医疗保健利益相关者,以及重要的是,患者的偏好。

目前的交流代表了高血压和介入心脏病学领导者之间圆桌讨论的考虑和共识意见。共识会议得到了国家肾脏基金会和心血管血管造影和干预协会的支持;然而,本报告的内容仅代表共识委员会成员的意见。

更新日期:2021-09-09
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