Abstract
BackgroundVagus Nerve Stimulation (VNS) delivers Autonomic Regulation Therapy (ART) for heart failure (HF), and has been associated with improvement in cardiac function and heart failure symptoms. VNS is delivered using an implantable pulse generator (IPG) and lead with electrodes placed around the cervical vagus nerve. Because HF patients may receive concomitant cardiac defibrillation therapy, testing was conducted to determine the effect of defibrillation (DF) on the VNS system.MethodsDF testing was conducted on three ART IPGs (LivaNova USA, Inc.) according to international standard ISO14708-1, which evaluated whether DF had any permanent effects on the system. Each IPG was connected to a defibrillation pulse generator and subjected to a series of high-energy pulses.ResultsThe specified series of pulses were successfully delivered to each of the three devices. All three IPGs passed factory electrical tests, and interrogation confirmed that software and data were unchanged from the pre-programmed values. No shifts in parameters or failures were observed.ConclusionsImplantable VNS systems were tested for immunity to defibrillation, and were found to be unaffected by a series of high-energy defibrillation pulses. These results suggest that this VNS system can be used safely and continue to function after patients have been defibrillated.
Highlights
Heart failure (HF) is characterized by hemodynamic abnormalities that result in, and are exacerbated by, a marked imbalance created by increased sympathetic activity and withdrawal of parasympathetic tone
Autonomic Regulation Therapy (ART) using open-loop Vagus Nerve Stimulation (VNS) has been shown in a pilot study to be associated with long-term improvement in left ventricular function, 6-minute walk distance, NYHA class, heart rate, heart rate variability, and quality of life in patients with heart failure (HF) and reduced ejection fraction (EF) (HFrEF), [2,3,4] and is being evaluated further in an ongoing mortality and morbidity pivotal study in patients
Each implantable pulse generator (IPG) was exposed to three sets of pulses: 1. A damped sinus defibrillation waveform with rise time of 1.5–2.5 ms, with a pulse shape specified by ISO 14708-1 clause 20.2
Summary
Heart failure (HF) is characterized by hemodynamic abnormalities that result in, and are exacerbated by, a marked imbalance created by increased sympathetic activity and withdrawal of parasympathetic tone. This pronounced pathological adrenergic hyperactivation contributes to the progression of HF, and increases the risk of mortality and morbidity independent of left ventricular ejection fraction (EF) and ventricular arrhythmias [1]. ART utilizes cervical vagus nerve stimulation (VNS) to increase parasympathetic activity and to restore autonomic balance. Vagus Nerve Stimulation (VNS) delivers Autonomic Regulation Therapy (ART) for heart failure (HF), and has been associated with improvement in cardiac function and heart failure symptoms. Because HF patients may receive concomitant cardiac defibrillation therapy, testing was conducted to determine the effect of defibrillation (DF) on the VNS system
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