Background: Experimentally, vagal stimulation (VS) is protective in
chronic heart failure (HF). In man, VS is used in refractory epilepsy
but has never been used in cardiovascular diseases. Increased sympathetic
and reduced vagal activity predict increased mortality in HF.
Aims: This pilot study assessed feasibility and safety and tested
possible efficacy of chronic VS in HF patients.
Methods: We studied 8 patients (mean age 54 years). CardioFit (BioControl
Medical), a VS implantable system delivering pulses synchronous with
heart beats through a multiple contact bipolar cuff electrode, was
used. VS was started 2-4 weeks after implant, slowly raising intensity;
patients were followed 1, 3 and 6 months thereafter.
Results: All procedures were successful: as sole surgical side effect,
one patient had transient hoarseness. VS was well tolerated, with
only mild side effects (cough and sensation of electrical stimulation).
There was a significant improvement in NYHA class, Minnesota quality
of life (R) (from 52 14 to 31 +/- 18, pend-systolic volume (from 208 +/- 71 to 190 +/- 83 ml, p=0.03), and
a favourable trend toward reduction in end-diastolic volume.
Conclusions: This novel approach to the treatment of patients with
HF is feasible, and appears safe and tolerable. The preliminary efficacy
results appear promising. These findings suggest the opportunity
to proceed with a larger multicentre study. (C) 2008 European Society
of Cardiology. Published by Elsevier B.V. All rights reserved.
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