Cardiac-neuromodulation: Neural based approaches for management of heart failure

      Background: Autonomic imbalance, characterized by increased sympathetic and decreased vagal activity, contributes to progressive worsening of heart failure (HF) and increased morbidity and mortality. In the past decade interest has risen regarding the potential of the novel non pharmacological approach of neumodulation as a result of either a one time intervention (e.g. denervation) or of chronic electric stimulation. Goal of these approaches is to improve the sympatho-vagal imbalance present in HF, usually acting by increasing vagal activity. The two approaches currently in the most advanced phase of development appear vagus nerve stimulation and baroreceptor stimulation, the former slightly more than the latter. Both techniques have multiple experimental studies suggesting their benefit in animal models of systolic heart failure. Three phase II clinical studies have been completed in NYHA II-III HF patients with vagal stimulation with favorable results in two and no benefit in one. The latter was the only blinded study, but it also employed the lowest amplitude of stimulation, a factor that may have played a role. A 650-patient phase III study has almost completed enrolment. Baroreceptor stimulation in patients with systolic HF has been evaluated in a single-center feasibility study and in a multicenter phase II study. Both reported positive results suggesting the opportunity to start a phase III study that is currently in advanced stage of preparation. Conclusions: Neuromodulation is a promising new approach for patients with systolic HF. Better understanding of ideal doses and techniques will help to maximize the possibility of a favorable clinical application.
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