背景:利用颈迷走神经刺激(VNS)的自主调节疗法(ART)似乎是安全的,并且可以改善自主神经张力,症状,在ANTHEM-HF研究中,有症状的心力衰竭和射血分数降低的患者的心脏机械功能。ANTHEM-HFpEF研究是第一个评估ART在有症状的心力衰竭和保留或轻度降低的射血分数患者中的安全性和可行性的研究(HFpEF,HFmrEF)。
方法:这项开放标记的介入研究纳入了52例HFpEF或HFmrEF患者,NYHAII-III级,LVEF≥40%,谁接受了稳定的指导指导药物治疗。所有患者均成功植入了LivaNovaVNSTherapy®系统,并在右颈迷走神经周围安装了电导线。
结果:不良事件发生率较低。12个月时,NYHA等级(p<0.0001),6分钟步行距离(p<0.05),生活质量(p<0.0001)得到改善。基线时心脏机械功能测量值正常,除了女性的左心室质量指数和所有患者的E/e比值,在基线时升高,并被ART改变。自主神经的音调和反应得到改善,低频/高频心率变异性降低29%至正常水平(p=0.028)和心率湍流斜率增加(p=0.047)。T波交替(p=0.001)和T波异质性(p=0.001)从异常范围降低到正常范围。非持续性室性心动过速发生率降低(p=0.027)。
结论:ART在HFpEF或HFmrEF患者中表现出良好的耐受性和安全性。慢性ART并未改变机械功能测量,但与心力衰竭症状改善有关。运动耐受力,自主音调,和心脏电稳定性。
背景:自主神经调节疗法可增强射血分数保留的心力衰竭的心肌功能[ClinicalTrials.gov#NCT03163030,注册于2017年5月22日]。
Autonomic regulation therapy (ART) utilizing cervical vagus nerve stimulation (VNS) appeared to be safe and to improve autonomic tone, symptoms, and cardiac mechanical function in patients with symptomatic heart failure and reduced ejection fraction in the ANTHEM-HF Study. The ANTHEM-HFpEF Study is the first investigation to evaluate the safety and feasibility of ART in patients with symptomatic heart failure and preserved or mildly reduced ejection fraction (HFpEF, HFmrEF).
This open-label interventional study enrolled 52 patients with HFpEF or HFmrEF, NYHA Class II-III, and LVEF ≥40%, who received stable guideline-directed medical therapy. All patients were successfully implanted with LivaNova VNS Therapy® system with an electrical lead surrounding the right cervical vagus nerve.
Adverse event incidence was low. At 12 months, NYHA class (p <0.0001), 6-min walk distance (p <0.05), and quality of life (p <0.0001) were improved. Cardiac mechanical function measures were normal at baseline, except for left ventricular mass index in women and E/e\' ratio in all patients, which were elevated at baseline, and were unchanged by ART. Autonomic tone and reflexes improved, indicated by 29% decrease in low-frequency/high-frequency heart rate variability to normal levels (p = 0.028) and by increased heart rate turbulence slope (p = 0.047). T-wave alternans (p = 0.001) and T-wave heterogeneity (p = 0.001) were reduced from abnormal to normal ranges. Nonsustained ventricular tachycardia incidence decreased (p = 0.027).
ART appeared well-tolerated and safe in patients with HFpEF or HFmrEF. Chronic ART did not alter mechanical function measures but was associated with improved heart failure symptoms, exercise tolerance, autonomic tone, and cardiac electrical stability.
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure with Preserved Ejection Fraction [ClinicalTrials.gov #NCT03163030, registered 05/22/2017].