Division of Cardiology, Department of Medical Sciences, Citta della Salute e della Scienza Hospital, University of Turin, Corso Bramante 88, 10126, Turin, Italy.
Herz. 2021 Dec;46(6):541-549. doi: 10.1007/s00059-021-05076-5. Epub 2021 Oct 30.
Vagal nerve stimulation (VNS) has a strong pathophysiological rationale as a potentially beneficial treatment for heart failure with reduced ejection fraction. Despite several promising preclinical studies and pilot clinical studies, the two large, controlled trials-NECTAR-HF and INOVATE-HF-failed to demonstrate the expected benefit. It is likely that clinical application of VNS in phase III studies was performed before a sufficient degree of understanding of the complex pathophysiology of autonomic electrical modulation had been achieved, therefore leading to an underestimation of its potential benefit. More knowledge on the complex dose-response issue of VNS (i.e., pulse amplitude, frequency, duration and duty cycle) has been gathered since these trials and a new randomized study is currently underway with an adaptive design and a refined approach in an attempt to deliver the proper dose to a more selected group of patients.
迷走神经刺激 (VNS) 具有很强的病理生理学原理，可作为射血分数降低的心力衰竭的潜在有益治疗方法。尽管有几项有前途的临床前研究和试点临床研究，但两项大型对照试验-NECTAR-HF 和 INOVATE-HF-未能证明预期的益处。在对自主电调制的复杂病理生理学有足够程度的理解之前，VNS 的临床应用很可能已经在 III 期研究中进行，因此导致对其潜在益处的低估。自这些试验以来，人们对 VNS 的复杂剂量反应问题（即脉冲幅度、频率、持续时间和占空比）有了更多的了解，目前正在进行一项新的随机研究，采用适应性设计和改进的方法，试图向更具选择性的患者群体提供适当的剂量。
