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

Autor: Gold, Michael R., Van Veldhuisen, Dirk J., Hauptman, Paul J., Borggrefe, Martin, Kubo, Spencer H., Lieberman, Randy A., Milasinovic, Goran, Berman, Brett J., Djordjevic, Sanja, Neelagaru, Suresh, Schwartz, Peter J., Starling, Randall C., Mann, Douglas L.
Přispěvatelé: Cardiovascular Centre (CVC)
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Zdroj: Journal of the American College of Cardiology, 68(2), 149-158. ELSEVIER SCIENCE INC
ISSN: 0735-1097
Popis: 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 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
Databáze: OpenAIRE