Vagus Nerve Stimulation for the Treatment of Heart Failure The INOVATE-HF Trial

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:68

Article

Gold, Michael R.¹  Van Veldhuisen, Dirk J.²  Hauptman, Paul J.³  Borggrefe, Martin^4,5  Kubo, Spencer H.⁶  Lieberman, Randy A.⁷  Milasinovic, Goran⁸  Berman, Brett J.⁹  Djordjevic, Sanja¹⁰  Neelagaru, Suresh¹¹  Schwartz, Peter J.^12,13  Starling, Randall C.¹⁴  Mann, Douglas L.¹⁵ 

[1] Med Univ S Carolina, Div Cardiol, 114 Daughty St,MSC 592, Charleston, SC 29425 USA

[2] Univ Groningen, Univ Med Ctr Groningen, Div Cardiovasc, Groningen, Netherlands

[3] St Louis Univ, Div Cardiol, Sch Med, St Louis, MO USA

[4] Univ Med Ctr Mannheim, Dept Med Cardiol 1, Partner Site Heidelberg Mannheim, Mannheim, Germany

[5] DZHK German Ctr Cardiovasc Res, Partner Site Heidelberg Mannheim, Mannheim, Germany

[6] BioControl Med, New Hope, MN USA

[7] Detroit Med Ctr, Detroit, MI USA

[8] Clin Ctr Serbia, Belgrade, Serbia

[9] Chula Vista Cardiac Ctr, Chula Vista, CA USA

[10] Clin Hosp Ctr Bezanijska Kosa, Belgrade, Serbia

[11] Lone Star Heart Ctr, Amarillo, TX USA

[12] IRCCS Ist Auxol Italiano, Ctr Cardiac Arrhythmias Genet Origin, Milan, Italy

[13] IRCCS Ist Auxol Italiano, Lab Cardiovasc Genet, Milan, Italy

[14] Cleveland Clin, Dept Cardiovasc Med, Cleveland, OH USA

[15] Washington Univ, Sch Med, St Louis, MO USA

关键词: autonomic modulation;    clinical trials;    heart failure;    outcomes;    vagus nerve stimulation;   

DOI  :  10.1016/j.jacc.2016.03.525

来源: Elsevier

【 摘 要 】

BACKGROUND 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. OBJECTIVES 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. METHODS 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. RESULTS 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). CONCLUSIONS VNS does not reduce the rate of death or HF events in chronic HF patients. (INcrease Of VAgal TonE in CHF [INOVATE-HF]; NCT01303718) (C) 2016 by the American College of Cardiology Foundation.

【 授权许可】

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