By Faiez Zannad, FESC (Vandoeuvre Les Nancy, France)
List of Authors
Faiez Zannad, Gaetano M. De Ferrari, Anton E. Tuinenburg, David Wright, Josep Brugada, Christian Butter, Helmut Klein, Scott Meyer, Agnes Ramuzat, Bernd Schubert, Craig Stolen, Doug Daum, Kenneth M. Stein, Petr Neuzil, Cornelis Botman, Maria Angeles Castel, Antonio D’Onofrio, Scott Solomon, Nicholas Wold, Stephen Ruble.
The NECTAR-HF (NEural Cardiac TherApy foR Heart Failure) 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.
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 left ventricular end systolic diameter (LVESD) at 6 months for control versus therapy, with secondary endpoints of other echocardiography measurements, exercise capacity, quality of life assessments, 24-hour Holter, and circulating biomarkers.
Of the 96 implanted patients, 87 had paired data sets 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 LVEDD, LVESV, LVEDV, LVEF, peak V02 and NT-proBNP failed to show superiority compared to sham treatment. There were statistically significant improvements in quality of life for the MLHFQ (p = 0.049), NYHA class (p=0.032) and the SF-36 Physical Component (p=0.016) in the therapy group.
VNS as delivered in the NECTAR-HF trial failed to demonstrate a significant effect on primary and secondary endpoint measures of cardiac remodeling and functional capacity in symptomatic HF patients.