Cardiology Division, Medical University of South Carolina, Charleston, South Carolina.
Cardiovascular Division, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
J Am Coll Cardiol. 2016 Jul 12;68(2):149-58. doi: 10.1016/j.jacc.2016.03.525. Epub 2016 Apr 4.
Heart failure (HF) is increasing in prevalence and is a major cause of morbidity and mortality despite advances in medical and device therapy. Autonomic imbalance, with excess sympathetic activation and decreased vagal tone, is an integral component of the pathophysiology of HF.
The INOVATE-HF (Increase of Vagal Tone in Heart Failure) trial assessed the safety and efficacy of vagal nerve stimulation (VNS) among patients with HF and a reduced ejection fraction.
INOVATE-HF was a multinational, randomized trial involving 85 centers including patients with chronic HF, New York Heart Association functional class III symptoms and ejection fraction ≤40%. Patients were assigned to device implantation to provide VNS (active) or continued medical therapy (control) in a 3:2 ratio. The primary efficacy endpoint was composite of death from any cause or first event for worsening HF.
Patients (n = 707) were randomized and followed up for a mean of 16 months. The primary efficacy outcome occurred in 132 of 436 patients in the VNS group, compared to 70 of 271 in the control group (30.3% vs. 25.8%; hazard ratio: 1.14; 95% confidence interval: 0.86 to 1.53; p = 0.37). During the trial, the estimated annual mortality rates were 9.3% and 7.1%, respectively (p = 0.19). Quality of life, New York Heart Association functional class, and 6-min walking distance were favorably affected by VNS (p < 0.05), but left ventricular end-systolic volume index was not different (p = 0.49).
VNS does not reduce the rate of death or HF events in chronic HF patients. (INcrease Of VAgal TonE in CHF [INOVATE-HF]; NCT01303718).
尽管在医学和设备治疗方面取得了进步，但心力衰竭（HF）的患病率仍在增加，并且仍是发病率和死亡率的主要原因。自主神经失衡，即交感神经激活过度和迷走神经张力降低，是心力衰竭病理生理学的一个组成部分。
INOVATE-HF（心力衰竭中迷走神经刺激的增加）试验评估了心力衰竭和射血分数降低的患者中迷走神经刺激（VNS）的安全性和疗效。
INOVATE-HF 是一项多中心、随机试验，涉及 85 个中心，包括慢性心力衰竭、纽约心脏协会功能分级 III 症状和射血分数≤40%的患者。患者被分配到装置植入组以提供 VNS（主动）或继续接受药物治疗（对照），比例为 3:2。主要疗效终点是任何原因死亡或心力衰竭恶化的首次事件复合终点。
患者（n=707）被随机分组并随访平均 16 个月。VNS 组 436 例患者中有 132 例发生主要疗效终点事件，而对照组 271 例中有 70 例（30.3% vs. 25.8%；危险比：1.14；95%置信区间：0.86 至 1.53；p=0.37）。在试验期间，估计的年死亡率分别为 9.3%和 7.1%（p=0.19）。VNS 可改善生活质量、纽约心脏协会功能分级和 6 分钟步行距离（p<0.05），但左心室收缩末期容积指数无差异（p=0.49）。
VNS 不能降低慢性心力衰竭患者的死亡率或心力衰竭事件发生率。（INcrease Of VAgal TonE in CHF [INOVATE-HF]；NCT01303718）。
