© 2008 European Society of Cardiology
Long term vagal stimulation in patients with advanced heart failure First experience in man
a Department of Cardiology, Fondazione IRCCS Policlinico San Matteo Pavia, Italy
b Department of Vascular Surgery, Fondazione IRCCS Policlinico San Matteo Pavia, Italy
c Department of Lung, Blood and Heart, University of Pavia Pavia, Italy
d Laboratory of Cardiovascular Genetics, IRCCS Istituto Auxologico Milan, Italy
e Cardiovascular Genetics Laboratory, Hatter Institute for Cardiovascular Research, Department of Medicine, University of Cape Town South Africa
* Corresponding author. Department of Cardiology, Fondazione IRCCS Policlinico S. Matteo, Viale Golgi, 19-27100, Pavia, Italy. Tel.: +39 0382 503567; fax: +39 0382 503002. E-mail address: peter.schwartz{at}unipv.itt (P.J. Schwartz).
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Abstract |
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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 onlymild 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 enddiastolic 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.
Key Words: Autonomic nervous system • Cardiomyopathy • Heart failure • Vagus nerve
Received June 12, 2008; Revised June 27, 2008; Accepted July 21, 2008
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