TY - JOUR
T1 - Chronic vagal stimulation for the treatment of low ejection fraction heart failure
T2 - results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) randomized controlled trial
AU - Zannad, Faiez
AU - De Ferrari, Gaetano M
AU - Tuinenburg, Anton E
AU - Wright, David
AU - Brugada, Josep
AU - Butter, Christian
AU - Klein, Helmut
AU - Stolen, Craig
AU - Meyer, Scott
AU - Stein, Kenneth M
AU - Ramuzat, Agnes
AU - Schubert, Bernd
AU - Daum, Doug
AU - Neuzil, Petr
AU - Botman, Cornelis
AU - Castel, Maria Angeles
AU - D'Onofrio, Antonio
AU - Solomon, Scott D
AU - Wold, Nicholas
AU - Ruble, Stephen B
N1 - © The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.
PY - 2015/2/14
Y1 - 2015/2/14
N2 - AIM: The neural cardiac therapy for heart failure (NECTAR-HF) was a randomized sham-controlled trial designed to evaluate whether a single dose of vagal nerve stimulation (VNS) would attenuate cardiac remodelling, improve cardiac function and increase exercise capacity in symptomatic heart failure patients with severe left ventricular (LV) systolic dysfunction despite guideline recommended medical therapy.METHODS: Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period. The primary endpoint was the change in LV end systolic diameter (LVESD) at 6 months for control vs. therapy, with secondary endpoints of other echocardiography measurements, exercise capacity, quality-of-life assessments, 24-h Holter, and circulating biomarkers.RESULTS: Of the 96 implanted patients, 87 had paired datasets for the primary endpoint. Change in LVESD from baseline to 6 months was -0.04 ± 0.25 cm in the therapy group compared with -0.08 ± 0.32 cm in the control group (P = 0.60). Additional echocardiographic parameters of LV end diastolic dimension, LV end systolic volume, left ventricular end diastolic volume, LV ejection fraction, peak V02, and N-terminal pro-hormone brain natriuretic peptide failed to show superiority compared to the control group. However, there were statistically significant improvements in quality of life for the Minnesota Living with Heart Failure Questionnaire (P = 0.049), New York Heart Association class (P = 0.032), and the SF-36 Physical Component (P = 0.016) in the therapy group.CONCLUSION: Vagal nerve stimulation as delivered in the NECTAR-HF trial failed to demonstrate a significant effect on primary and secondary endpoint measures of cardiac remodelling and functional capacity in symptomatic heart failure patients, but quality-of-life measures showed significant improvement.
AB - AIM: The neural cardiac therapy for heart failure (NECTAR-HF) was a randomized sham-controlled trial designed to evaluate whether a single dose of vagal nerve stimulation (VNS) would attenuate cardiac remodelling, improve cardiac function and increase exercise capacity in symptomatic heart failure patients with severe left ventricular (LV) systolic dysfunction despite guideline recommended medical therapy.METHODS: Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period. The primary endpoint was the change in LV end systolic diameter (LVESD) at 6 months for control vs. therapy, with secondary endpoints of other echocardiography measurements, exercise capacity, quality-of-life assessments, 24-h Holter, and circulating biomarkers.RESULTS: Of the 96 implanted patients, 87 had paired datasets for the primary endpoint. Change in LVESD from baseline to 6 months was -0.04 ± 0.25 cm in the therapy group compared with -0.08 ± 0.32 cm in the control group (P = 0.60). Additional echocardiographic parameters of LV end diastolic dimension, LV end systolic volume, left ventricular end diastolic volume, LV ejection fraction, peak V02, and N-terminal pro-hormone brain natriuretic peptide failed to show superiority compared to the control group. However, there were statistically significant improvements in quality of life for the Minnesota Living with Heart Failure Questionnaire (P = 0.049), New York Heart Association class (P = 0.032), and the SF-36 Physical Component (P = 0.016) in the therapy group.CONCLUSION: Vagal nerve stimulation as delivered in the NECTAR-HF trial failed to demonstrate a significant effect on primary and secondary endpoint measures of cardiac remodelling and functional capacity in symptomatic heart failure patients, but quality-of-life measures showed significant improvement.
KW - Electrocardiography, Ambulatory
KW - Exercise Tolerance
KW - Female
KW - Heart Failure
KW - Humans
KW - Male
KW - Middle Aged
KW - Patient Safety
KW - Quality of Life
KW - Treatment Outcome
KW - Vagus Nerve Stimulation
KW - Ventricular Dysfunction, Left
KW - Ventricular Remodeling
KW - Vagal stimulation
KW - Autonomic nervous system
U2 - 10.1093/eurheartj/ehu345
DO - 10.1093/eurheartj/ehu345
M3 - Article
C2 - 25176942
SN - 0195-668X
VL - 36
SP - 425
EP - 433
JO - European Heart Journal
JF - European Heart Journal
IS - 7
ER -