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

Journal of the American College of Cardiology

Volumn 68, Issue 2, 2016, Pages 149-158

  Gold, Michael R ^a   Van Veldhuisen, Dirk J ^b   Hauptman, Paul J ^c   Borggrefe, Martin ^d   Kubo, Spencer H ^e   Lieberman, Randy A ^f   Milasinovic, Goran ^g   Berman, Brett J ^h   Djordjevic, Sanja ⁱ   Neelagaru, Suresh ^j   Schwartz, Peter J ^k   Starling, Randall C ^l   Mann, Douglas L ^m  

^a MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^b UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^c SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF HEIDELBERG   (Germany)

^e BioControl Medical   (United States)

^f DETROIT MEDICAL CENTER   (United States)

^g CLINICAL CENTER OF SERBIA   (Serbia)

^h Chula Vista Fire Department   (United States)

ⁱ Clinical Hospital Center Bezanijska Kosa   (Serbia)

^j Lone Star Arrhythmia   (United States)

^k ISTITUTO AUXOLOGICO ITALIANO   (Italy)

^l LERNER RESEARCH INSTITUTE   (United States)

^m WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

more..

Author keywords

autonomic modulation; clinical trials; heart failure; outcomes; vagus nerve stimulation

Indexed keywords

ADULT; ARTICLE; CAUSE OF DEATH; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; FEMALE; HAZARD RATIO; HEART EJECTION FRACTION; HEART FAILURE; HEART LEFT VENTRICLE ENDSYSTOLIC VOLUME; HUMAN; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; NEW YORK HEART ASSOCIATION CLASS; PATIENT SAFETY; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; VAGUS NERVE STIMULATION; WALKING; CLINICAL TRIAL; FOLLOW UP; HEART LEFT VENTRICLE FUNCTION; HEART MUSCLE CONDUCTION SYSTEM; HEART STROKE VOLUME; HEART VENTRICLE REMODELING; MIDDLE AGED; PATHOPHYSIOLOGY; PHYSIOLOGY; PROCEDURES; RETROSPECTIVE STUDY; TIME FACTOR; VAGUS NERVE;

FEMALE; FOLLOW-UP STUDIES; HEART CONDUCTION SYSTEM; HEART FAILURE; HUMANS; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; STROKE VOLUME; TIME FACTORS; TREATMENT OUTCOME; VAGUS NERVE; VAGUS NERVE STIMULATION; VENTRICULAR FUNCTION, LEFT; VENTRICULAR REMODELING;

EID: 84990178694     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2016.03.525     Document Type: Article

References (33)

1. 1 Yancy, C.W., Jessup, M., Bozkurt, B., et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol 62 (2013), 1495–1539.
2. 2 Lloyd-Jones, D., Adams, R.J., Brown, T.M., et al. Heart disease and stroke statistics—2010 update: a report from the American Heart Association. Circulation 121 (2010), e46–e215.
3. 3 McMurray, J.J.V., Adamopoulos, S., Anker, S.D., et al. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J 33 (2012), 1787–1847.
4. 4 Zannad, F., McMurray, J.J.V., Krum, H., et al. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med 364 (2011), 11–21.
5. 5 McMurray, J.J., Packer, M., Desai, A.S., et al., PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med 371 (2014), 993–1004.
6. 6 Swedberg, K., Komajda, M., Böhm, M., et al. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placeb-controled study. Lancet 376 (2010), 875–885.
7. 7 Kuck, K.H., Bordachar, P., Borggrefe, M., et al. New devices in heart failure: an European Heart Rhythm Association report. Europace 16 (2014), 109–128.
8. 8 Li, M., Zheng, C., Sato, T., Kawada, T., Sugimachi, M., Sunagawa, K., Vagal nerve stimulation markedly improves long-term survival after chronic heart failure in rats. Circulation 109 (2004), 120–124.
9. 9 Zhang, Y., Popovic, Z.B., Bibevski, S., et al. Chronic vagus nerve stimulation improves autonomic control and attenuates systemic inflammation and heart failure progression in a canine high-rate pacing model. Circ Heart Fail 2 (2009), 692–699.
10. 10 Sabbah, H.N., Ilsar, I., Zaretsky, A., Rastogi, S., Wang, M., Gupta, R.C., Vagus nerve stimulation in experimental heart failure. Heart Fail Rev 16 (2011), 171–178.
11. 11 Binkley, P.F., Haas, G.J., Starling, R.C., et al. Sustained augmentation of parasympathetic tone with angiotensin-converting enzyme inhibition in patients with congestive heart failure. J Am Coll Cardiol 21 (1993), 655–661.
12. 12 Desai, M.Y., Watanabe, M.A., Laddu, A., Hauptman, P.J., Pharmacologic modulation of parasympathetic activity in heart failure. Heart Fail Rev 16 (2011), 179–193.
13. 13 Schwartz, P.J., La Rovere, M.T., De Ferrari, G.M., Mann, D.L., Autonomic modulation for the management of patients with chronic heart failure. Circ Heart Fail 8 (2015), 619–628.
14. 14 De Ferrari, G.M., Crijns, H.J., Borggrefe, M., et al. Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure. Eur Heart J 32 (2011), 847–855.
15. 15 Zannad, F., De Ferrari, G.M., Tuinenburg, A.E., et al. Chronic vagal stimulation for the treatment of low ejection fraction heart failure: results of the neural cardiac therapy for heart failure (NECTAR-HF) randomized controlled trial. Eur Heart J 36 (2015), 425–433.
16. 16 Premchand, R.K., Sharma, K., Mittal, S., et al. Autonomic regulation therapy via left or right cervical vagus nerve stimulation in patients with chronic heart failure: results of the ANTHEM-HF trial. J Card Fail 20 (2014), 808–816.
17. 17 Torre-Amione, G., Alo, K., Estep, J.D., et al. Spinal cord stimulation is safe and feasible in patients with advanced heart failure: early clinical experience. Eur J Heart Fail 16 (2014), 788–795.
18. 18 Zipes, D.P., Neuzil, P., Theres, H., et al. Determining the feasibility of spinal cord neuromodulation for the treatment of chronic systolic heart failure: the DEFEAT-HF Study. J Am Coll Cardiol HF 4 (2016), 129–136.
19. 19 Abraham, W.T., Zile, M.R., Weaver, F.A., et al. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction. J Am Coll Cardiol HF 3 (2015), 487–496.
20. 20 Hauptman, P.J., Schwartz, P.J., Gold, M.R., et al. Rationale and study design of the increase of vagal tone in heart failure study: INOVATE-HF. Am Heart J 163 (2012), 954–962.
21. 21 Hauptman, P.J., Mann, D.L., The vagus nerve and autonomic imbalance in heart failure: past, present, and future. Heart Fail Rev 16 (2011), 97–99.
22. 22 Schwartz, P.J., Vagal stimulation for heart diseases: from animals to men — an example of translational cardiology. Circ J 75 (2011), 20–27.
23. 23 Brouwer, J., Van Veldhuisen, D.J., Man in't Veld, A.J., et al. Prognostic value of heart rate variability during long-term follow-up in patients with mild to moderate heart failure. The Dutch Ibopamine Multicenter Trial Study Group. J Am Coll Cardiol 28 (1996), 1183–1189.
24. 24 Terry, R., Vagus nerve stimulation: a proven therapy for treatment of epilepsy strives to improve efficacy and expand applications. Conf Proc IEEE Eng Med Biol Soc 2009 (2009), 4631–4634.
25. 25 Calvillo, L., Vanoli, E., Andreoli, E., et al. Vagal stimulation, through its nicotinic action, limits infarct size and the inflammatory response to myocardial ischemia and reperfusion. J Cardiovasc Pharmacol 58 (2011), 500–507.
26. 26 Tracey, K.J., The inflammatory reflex. Nature 420 (2002), 853–859.
27. 27 Schwartz, P.J., De Ferrari, G.M., Sanzo, A., et al. Long term vagal stimulation in patients with advanced heart failure: First experience in man. Eur J Heart Fail 10 (2008), 884–891.
28. 28 Hauptman, P.J., Gottlieb, S.S., Clinical trial design in contemporary device studies in heart failure: is there a gold standard?. J Card Fail 20 (2014), 223–228.
29. 29 Gold, M.R., van Veldhuisen, D.J., Mann, D.L., Vagal nerve stimulation for heart failure: new pieces to the puzzle?. Eur J Heart Fail 17 (2015), 125–127.
30. 30 Ingle, L., Rigby, A.S., Butterfly, R., et al. Prognostic value of 6 min walk test and self-percieived symptom severity in older patients with chronic heart failure. Eur Heart J 28 (2007), 560–568.
31. 31 Gold, M.R., Daubert, J.C., Abraham, W.T., et al. The effect of reverse remodeling on long term survival in mildly symptomatic patients with heart failure receiving cardiac resynchronization therapy: results from the REVERSE study. Heart Rhythm 12 (2015), 524–530.
32. 32 Kramer, D.G., Trikalinos, T.A., Kent, D.M., Antonopoulos, G.V., Konstam, M.A., Udelson, J.E., Quantitative evaluation of drug or device effects on ventricular remodeling as predictors of therapeutic effects on mortality in patients with heart failure and reduced ejection fraction: a meta-analytic approach. J Am Coll Cardiol 56 (2010), 392–406.
33. 33 Upadhyay, G.A., Singh, J.P., Spinal cord stimulation for heart failure in the DEFEAT-HF study: lost battle or lasting opportunities?. J Am Coll Cardiol HF 4 (2016), 137–139.