title: Long term vagal stimulation in patients with advanced heart failure: first experience in man.
abstract: 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.
  
  
  OBJECTIVE
  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 (from 52+/-14 to 31+/-18, p < 0.001), left ventricular end-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.
authors.affiliation: Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. peter.schwartz@unipv.itt
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Schwartz
authors.forename: Gaetano M
authors.initials: GM
authors.lastname: De Ferrari
authors.forename: Antonio
authors.initials: A
authors.lastname: Sanzo
authors.forename: Maurizio
authors.initials: M
authors.lastname: Landolina
authors.forename: Roberto
authors.initials: R
authors.lastname: Rordorf
authors.forename: Claudia
authors.initials: C
authors.lastname: Raineri
authors.forename: Carlo
authors.initials: C
authors.lastname: Campana
authors.forename: Miriam
authors.initials: M
authors.lastname: Revera
authors.forename: Nina
authors.initials: N
authors.lastname: Ajmone-Marsan
authors.forename: Luigi
authors.initials: L
authors.lastname: Tavazzi
authors.forename: Attilio
authors.initials: A
authors.lastname: Odero