Chronic vagal stimulation in patients with congestive heart failure.

Increased sympathetic and reduced vagal activity predict increased mortality in patients with congestive heart failure (CHF). Experimentally, vagal stimulation (VS) is protective both during acute myocardial ischemia and in chronic heart failure. In man, VS is used in refractory epilepsy but has never been used in cardiovascular diseases. Thus, there is a strong rationale to investigate the effects of chronic VS in patients with CHF. We assesses the feasibility and safety of chronic VS with CardioFit (BioControl Medical), a VS implantable system delivering pulses synchronous with heart beats to the right cervical vagus nerve in a preliminary pilot study in eight advanced CHF patients with favorable results, and subsequently in a larger multicenter study. Overall, 32 patients have been successfully implanted (mostly in NYHA Class III; mean age 56 years, ischemic etiology in 69%; prior implantable cardioverter-defibrillator (ICD) in 63%; concomitant beta blocker and angiotensin converting enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB) in 100%). Preliminary results confirm feasibility of the study, an acceptable side effect profile and promising preliminary efficacy data. Several mechanisms may contribute to the beneficial effect observed in patients with heart failure. Should these results be confirmed in larger controlled studies, chronic vagal stimulation could be a further treatment option for CHF patients, possibly integrated with defibrillator and resynchronization therapies.